Die Erfindung bezieht sich auf eine Vorrichtung zum Ausfiltern makroskopischer Teilchen aus einer Blutbahn beim lokalen Abtrag einer Aortenklappe am menschlichen oder tierischen Herz mit wenigstens einem schirmartig aufspannbaren Filterschirm, der aus einem zusammengefalteten Zustand in einen aufgespannten Zustand aufspannbar ist und mittels eines Arbeitskatheters betätigbar ist.The invention relates to a device for filtering macroscopicParticles from a bloodstream during local removal of an aortic valve onhuman or animal heart with at least one umbrella-like stretchableFilter screen that from a collapsed state to a clampedCondition is clamped and can be actuated by means of a working catheter.
Bei einer Vielzahl von Patienten kommt es vor, dass sich im Laufe der Zeit Ablagerungen an der Herzklappe bilden, insbesondere an der Aortenklappe, häufig in Form von Kalkablagerungen oder sonstigen Materialdepositionen. Durch derartige Materialablagerungen an der Aortenklappe, die in einem gesunden Zustand als ein feines flexibles Gewebesegel ausgebildet ist, kommt es zu einer irreversiblen Versteifung der Aortenklappe, wodurch insbesondere der Blutabfluss aus dem Herz erheblich in Mitleidenschaft gezogen wird. Blutunterversorgung im gesamten Körper ist die Folge, so dass in einem derart fortgeschrittenen Stadium ein akuter Handlungsbedarf besteht, will man schwerwiegende Folgen für den Patienten vermeiden. Bisher bekannte medikamentöse Behandlungsmethoden zeigen jedoch nur begrenzten Erfolg, so dass nach heutiger Kenntnis einer Verkalkung von Aortenklappen lediglich durch einen schwerwiegende chirurgischen Eingriff begegnet werden kann.In a large number of patients it happens that over timeDeposits on the heart valve often form, especially on the aortic valvein the form of limescale or other material deposition. Through suchMaterial deposits on the aortic valve that are in a healthy state as afine flexible fabric sail is formed, there is an irreversibleStiffening of the aortic valve, which in particular causes blood drainage from the heartis significantly affected. Undersupply of blood throughout the bodyis the consequence, so at such an advanced stage an acuteAction is needed if there are serious consequences for the patientavoid. However, previously known drug treatment methods showonly limited success, so that, according to current knowledge, calcification ofAortic valves are only countered by a serious surgical procedurecan be.
Üblicherweise wird in diesem Fall im Rahmen einer Sternotomie der Brustkorb eines Menschen geöffnet um Zugang zum Herz und insbesondere zu den verkalkten Aortenklappen zu erhalten, die mit bekannten Schneidewerkzeugen aus dem Körper extrahiert wird. Beispielsweise eignen sich hierzu Extraktionswerkzeuge wie sie in den amerikanischen Druckschriften US 6,033,419 sowie US 5,827,316 beschrieben sind. Nach erfolgtem operativen Eingriff und Wiederverschluss des Brustkorbes steht dem Patienten eine langwierige Heilungsdauer bevor, die in den meisten Fällen mit einer ebenso langwierigen Rehabilitationszeit gefolgt ist.In this case, the chest is usually made as part of a sternotomyPeople open to access to the heart and especially to the calcifiedGet aortic valves out of the body using known cutting toolsis extracted. For example, extraction tools such as those inthe American publications US 6,033,419 and US 5,827,316are. After the surgery and the chest resealthe patient is given a lengthy healing period, which in most cases withfollowed an equally lengthy rehabilitation period.
Nun sind auch Operationstechniken bekannt geworden, die unter Einsatz von Kathetern und Endoskopen eine Behandlung der Aortenklappe auch mit weit geringeren Belastungen für den Patienten ermöglichen. Dies jedoch setzt voraus, dass die verkalkte Aortenklappe mit Hilfe geeigneter Katheterwerkzeuge vor Ort abgetragen wird. Ein derartiger Abtrag der verkalkten Aortenklappe, unabhängig davon mit welchen Abtragungstechniken gearbeitet wird, führt jedoch nahezu unvermeidbar zu zerkleinerten, abgetragenen, d. h. abgetrennten und losgelösten Gewebebruchstücken, die in die freie Blutbahn gelangen können, sofern sie nicht durch entsprechende Absaugtechniken extrakorporal extrahiert werden können. Derartige, sich in der Blutbahn befindliche Bruchstücke mit makroskopischen Teilchendurchmessern von < 7,5 µm erhöhen jedoch drastisch die Thrombose- und Emboliegefahr des Patienten, so dass nach Maßnahmen gesucht wird, eben jene, bei der Extraktion der verkalkten Aortenklappe möglicherweise entstehenden Abbruchstücke vollständig aus der Blutbahn zu entfernen.Now surgical techniques have also become known which useCatheters and endoscopes also treat the aortic valve with wideallow less stress for the patient. However, this assumesthat the calcified aortic valve with the help of suitable catheter tools on siteis removed. Such removal of the calcified aortic valve, independentlyof which ablation techniques are used, however, leads almostunavoidable to shredded, worn, d. H. detached and detachedTissue fragments that can enter the free bloodstream if they do not can be extracted extracorporeally by appropriate suction techniques.Such fragments in the bloodstream with macroscopicHowever, particle diameters of <7.5 µm drastically increase the thrombosis andRisk of embolism of the patient, so that measures are sought, precisely thosemay arise during the extraction of the calcified aortic valveRemove any fragments from the bloodstream.
Der Erfindung liegt die Aufgabe zugrunde, eine Vorrichtung zum Ausfiltern bzw. Auffangen makroskopischer Teilchen aus einer Blutbahn für den lokalen Abtrag einer Aortenklappe am menschlichen oder tierischen Herz mit wenigstens einem schirmartig aufspannbaren Filterschirm, der aus einem zusammengefalteten Zustand in einen aufgespannten Zustand aufspannbar ist und mittels eines Arbeitskatheters betätigbar ist, derart weiterzubilden, dass während des chirurgischen Eingriffes zum Abtrag der Aortenklappe entstehende makroskopisch große Teilchen, die nicht entsprechend entsorgt werden und in die Blutbahn gelangen, vollständig aufgefangen werden sollen. Es soll insbesondere erreicht werden, dass der chirurgische Eingriff zur Ablation der Aortenklappe sicherer durchführbar ist. Insbesondere soll die Vorrichtung auch einen minimal invasiven Eingriff zur Ablation der Aortenklappe nicht hinderlich im Wege stehen, sondern überdies den Eingriff erleichtern.The invention has for its object a device for filtering orCollecting macroscopic particles from a bloodstream for local ablationAortic valve on the human or animal heart with at least onescreen-like filter screen that can be opened from a folded statecan be clamped in a clamped state and by means of a working cathetercan be actuated in such a way that during the surgical procedure forRemoval of the aortic valve creates macroscopically large particles that are notbe disposed of accordingly and enter the bloodstream completelyshould be caught. In particular, it should be achieved that thesurgical intervention for ablation of the aortic valve can be carried out more safely.In particular, the device should also perform a minimally invasive procedure for ablationnot obstruct the aortic valve, but also the interventionfacilitate.
Die Lösung der Aufgabe ist im Anspruch 1 angegeben. Vorteilhafte Weiterbildungen des Erfindungsgedankens sind Gegenstand der Unteransprüche sowie dem Beschreibungstext unter Bezugnahme auf das Ausführungsbeispiel zu entnehmen.The solution to the problem is specified in claim 1. Advantageous further trainingof the inventive concept are the subject of the dependent claims and theDescriptive text can be found with reference to the embodiment.
Erfindungsgemäß ist eine Vorrichtung zum Ausfiltern makroskopischer Teilchen aus einer Blutbahn beim lokalen Abtrag einer Aortenklappe, insbesondere am menschlichen Herz, gemäß dem Oberbegriff des Anspruchs 1 derart ausgebildet, dass zwei Filterschirme vorgesehen sind, die derart in Wirkverbindung stehen, dass im aufgespannten Zustand ihre konkav ausgebildeten Filterschirmseiten gegenüberliegen.According to the invention, a device for filtering out macroscopic particles is made ofa bloodstream during local ablation of an aortic valve, especially onhuman heart, designed according to the preamble of claim 1,that two filter screens are provided which are operatively connected such thattheir concave filter screen sides in the open stateare opposite.
Der Erfindung liegt die Idee zugrunde, dass durch die Kombination zweier Filterschirme, deren Konkavseiten sich gegenüberliegen, ein Volumen einbeschrieben wird, das in Art eines Käfigs von den Filterschirmen umgeben wird und in dem die chirurgischen Maßnahmen an der Aortenklappe durchgeführt werden kann. Hierzu ist es erforderlich, dass ein Filterschirm vor und der andere Filterschirm hinter der Aortenklappe angeordnet wird. Nach entsprechendem Aufspannen der Filterschirme kann innerhalb des durch die Filterschirme einbeschriebenen Volumens die Ablation der Aortenklappe vorgenommen werden. Während der Ablation entstehende makroskopische Bruchstücke werden von den Filterschirmflächen aufgefangen und daran gehindert, in die übrige Blutbahn zu gelangen. Nach Vollendung der Ablation und sonstiger chirurgischer Maßnahmen werden die Filterschirme zusammengefaltet und die darin gefangenen makroskopischen Teilchen wie auch evtl. die als Ganzes entfernte Aortenklappe eingeschlossen. Die Dimensionierung der Filterschirmchen ist dabei derart gewählt, dass sie durch übliche Arbeitshohlkatheter geschoben werden können, so dass nach Beendigung der chirurgischen Maßnahme die mit makroskopischen Teilchen gefüllten Filterschirmchen durch einen entsprechenden Arbeitskanal extrakorporal verbracht werden können.The invention is based on the idea that by combining twoFilter screens, the concave sides of which face each other, are a volumeis inscribed, which is surrounded in the manner of a cage by the filter screensand in which the surgical measures are carried out on the aortic valvecan. For this it is necessary that one filter screen in front and the other filter screenis placed behind the aortic valve. After opening theFilter screens can be within the volume inscribed by the filter screensaborting the aortic valve. During ablationMacroscopic fragments that arise are removed from the filter screen surfacescaught and prevented from entering the rest of the bloodstream. ToCompletion of the ablation and other surgical measures are theFilter screens folded and the macroscopic trapped insideParticles as well as the aortic valve removed as a whole are included. TheDimensioning of the filter screen is chosen such that it isUsual hollow working catheter can be pushed so that after completionthe surgical measure is filled with macroscopic particlesFilter screens are placed extracorporeally through a corresponding working channelcan be.
Das Filtermaterial, aus dem die einzelnen Filterschirme bestehen, ist derart gewählt, dass die natürlichen Blutbestandteile ungehindert durch das Filtermaterial hindurchtreten können. Makroskopische Teilchen mit Teilchengrößen von mehr als 7,5 µm bleiben jedoch im Filtermaterial hängen und können entsprechend entsorgt werden.The filter material from which the individual filter screens are made is selected in such a waythat the natural blood components are unhindered by the filter materialcan step through. Macroscopic particles with particle sizes larger thanHowever, 7.5 µm remains in the filter material and can be disposed of accordinglybecome.
Die Erfindung wird nachstehend ohne Beschränkung des allgemeinen Erfindungsgedankens anhand von Ausführungsbeispielen unter Bezugnahme auf die Zeichnung exemplarisch beschrieben. Es zeigen:The invention is hereinafter described without limitation of the generalThe inventive concept based on exemplary embodiments with reference to theDrawing described as an example. Show it:
Fig. 1a, b schematisierte Darstellung der Filterschirmanordnung im zusammengefalteten sowie entspannten Zustand, sowieFig. 1a, b schematic representation of the filter screen arrangement in the folded and relaxed state, and
Fig. 2 Filterschirmanordnung innnerhalb eines Blutgefäßes.Fig. 2 filter screen assembly within a blood vessel.
InFig. 1a sind schematisiert zwei alternative Filterschirmanordnungen in zusammengefaltetem Zustand dargestellt. Entlang einer Verbindungsachse1, die mit einem Arbeitskatheter2 verbunden ist, sind zwei zusammengefaltete Filterschirme3 und4 angeordnet. Die Filterschirme3,4 liegen im zusammengefalteten Zustand eng an der Verbindungsachse1 an, so dass sie durch einen dünnen Arbeitshohlkanal7 eines Katheters geschoben werden können. Mittig zur Filterschirmfläche sind beide Filterschirme3 und4 mit der Verbindungsachse1 fest verbunden, so dass sie im aufgespannten Zustand gemäßFig. 1b mit ihren konkaven Seiten spiegelsymmetrisch relativ zu einer senkrecht zur Verbindungsachse ausgebildet sind.InFig. 1a two alternative filter screen arrangements are shown schematically in the folded state. Two folded filter screens3 and4 are arranged along a connecting axis1 , which is connected to a working catheter2 . In the folded state, the filter screens3 ,4 lie closely against the connecting axis1 , so that they can be pushed through a thin working hollow channel7 of a catheter. In the middle of the filter screen surface, both filter screens3 and4 are firmly connected to the connecting axis1 , so that in the clamped state according toFIG. 1b their concave sides are mirror-symmetrical relative to one perpendicular to the connecting axis.
Alternativ zur der inFig. 1a oben dargestellten zweigeteilten Ausführungsform der Filterschirme3 und4 ist es auch möglich durch entsprechende Wahl des Filterschirmmaterials die Filterschirme3 und4 an ihren Randbereichen zusammenzufügen, so dass sie im zusammengefalteten Zustand lediglich einen geschlossenen zusammenhängenden Schlauch darstellen, der auch ohne die Verwendung eines Arbeitshohlkanals2 in das Gefäß eingeführt werden kann. Hierbei ist insbesondere darauf zu achten, dass das disale Ende der zusammengefalteten Filterschirmanordnung über eine Abrundung8 verfügt, so dass die Gefäßwand während des Einführvorganges nicht beschädigt wird.As an alternative to the two-part embodiment of the filter screens3 and4 shown above inFig. 1a, it is also possible by appropriate selection of the filter screen material to assemble the filter screens3 and4 at their edge areas, so that in the folded state they only represent a closed, contiguous hose, which also can be inserted into the vessel without the use of a working hollow channel2 . It is particularly important to ensure that the disal end of the folded filter screen arrangement has a rounding8 so that the vessel wall is not damaged during the insertion process.
Zum Aufspannen der beiden Filterschirme ist jeweils ein Schlittenelement5 vorgesehen, das längs der Verbindungsachse1 beweglich angeordnet ist. Mit dem Schlittenelement5 sind Spreizstreben6 verbunden, die am Randbereich der Filterschirme angelenkt sind. Durch entsprechendes Verschieben der Schlittenelemente5 in Richtung der Fixierstellen, an denen das Filtermaterial fest an der Verbindungsachse1 angebracht ist, entfalten sich die Spreizstreben6, wodurch die Filterschirme radial zur Verbindungsachse1 gespreizt werden.To clamp the two filter screens, a slide element5 is provided, which is arranged to be movable along the connecting axis1 . Spreading struts6 are connected to the slide element5 and are articulated on the edge area of the filter screens. By appropriately moving the slide elements5 in the direction of the fixing points at which the filter material is firmly attached to the connecting axis1 , the expansion struts6 unfold, whereby the filter screens are spread radially to the connecting axis1 .
Im gespannten Zustand der Filterschirmanordnung umschließen beide Filterschirme3 und4 ein inneres Volumen, in dem die Ablation der Aortenklappe vorgenommen werden kann. Selbstverständlich ist es möglich, beide Randbereiche der Filterschirme derart miteinander zu verbinden, so dass das innere Volumen vollständig umschlossen ist. Entsprechende Öffnungen innerhalb des Filtermaterials sind vorzusehen, um die für die Ablation erforderlichen Werkzeugkatheter einzuführen. Diese können jedoch auch längs zur Verbindungsachse1 in das Innere der aufgespannten Filterschirme hineinreichen.In the tensioned state of the filter screen arrangement, both filter screens3 and4 enclose an inner volume in which the aortic valve can be ablated. Of course, it is possible to connect the two edge areas of the filter screens to one another in such a way that the inner volume is completely enclosed. Appropriate openings within the filter material are to be provided in order to introduce the tool catheter required for the ablation. However, these can also extend into the interior of the clamped filter screens along the connecting axis1 .
Zur Durchführung der Ablation einer verkalkten Aortenklappe wird die Filterschirmanordnung im zusammengefalteten Zustand durch eine, in der Aortenklappe vorhandene Öffnung hindurchgeschoben, so dass ein Filterschirm3 auf der einen Seite der Aortenklappe zu liegen kommt und der andere Filterschirm4 auf der gegenüberliegenden Seite. Im aufgeklappten Zustand vermögen die Filterschirme die zu ablatierende Aortenklappe vollständig zu umschließen. Da das Filtermaterial für die natürlichen Blutbestandteils durchlässig ist, können die chirurgischen Maßnahmen trotz andauernder Herztätigkeit unternommen werden.To carry out the ablation of a calcified aortic valve, the filter screen arrangement is pushed through an opening in the aortic valve in the folded state, so that a filter screen3 comes to rest on one side of the aortic valve and the other filter screen4 on the opposite side. When opened, the filter screens are able to completely enclose the aortic valve to be ablated. Since the filter material is permeable to the natural blood component, the surgical measures can be taken despite constant cardiac activity.
Nach entsprechender Positionierung und Zentrierung der Filterschirmanordnung innerhalb des Aortenbogens respektive nach Justierung relativ zur ablatierenden Aortenklappe zentriert sich die Filterschirmanordnung selbständig durch Aufspreizen der einzelnen Filterschirme an der Innenwandung der Aorta. Die Filterschirmanordnung dient in diesem Fall auch zugleich als mechanischer Fixpunkt bzw. Auflagemöglichkeit für die für die Ablation einzusetzenden mikrochirurgischen Instrumente. Auf diese Weise ist eine Mikronavigation der für die Ablation erforderlichen Katheterwerkzeuge erheblich vereinfacht im Vergleich zu bisherigen Techniken, bei denen eine derartige Justierhilfe nicht vorhanden ist.After appropriate positioning and centering of the filter screen arrangementwithin the aortic arch or after adjustment relative to the ablating oneThe aortic flap centers the filter screen arrangement automatically by spreadingof the individual filter screens on the inner wall of the aorta. TheIn this case, the filter screen arrangement also serves as a mechanical fixed pointor support for the microsurgical used for the ablation Instruments. In this way, micronavigation is the one for ablationrequired catheter tools considerably simplified compared to previous onesTechniques in which such an adjustment aid is not available.
InFig. 2 ist nochmals die Filterschirmanordnung innerhalb des Aortenbogens in zwei Stellungen1 und2 gezeigt. In Stellung1 ist die stark schematisiert dargestellte Filterschirmanordnung im zusammengefalteten Zustand dargestellt und wird in dieser Weise durch das Innere der Aorta geschoben. Die Filterschirmanordnung ist proximal mit einem elastischen Arbeitskatheter verbunden, der zugleich auch für die Navigation der Filterschirmanordnung innerhalb der Aorta sorgt. Besonders vorteilhaft ist die distalseits abgerundete Form der Filterschirmanordnung im zusammengefalteten Zustand, die dafür sorgt, dass keine traumatischen Gewebeirritationen während des Einbringvorgangs der Filterschirmanordnung in den Körper entstehen. In der Position2 gemäßFig. 2 ist die Filterschirmanordnung im aufgespannten Zustand dargestellt und es wird deutlich, dass die Filterschirmrandbereiche an die Innenwandung der Aorta anstoßen. Hierdurch ist gewährleistet, dass eine Selbstzentrierung der Filterschirmanordnung erfolgt.InFig. 2 the filter screen assembly within the aortic arch in two positions1 and2 is shown again. In position1 the filter screen arrangement, shown in a highly schematic form, is shown in the folded state and is pushed through the interior of the aorta in this way. The filter screen arrangement is connected proximally to an elastic working catheter, which at the same time also ensures the navigation of the filter screen arrangement within the aorta. The shape of the filter screen arrangement which is rounded off on the distal side in the folded state is particularly advantageous, since it ensures that there are no traumatic tissue irritations during the insertion process of the filter screen arrangement into the body. In position2 according toFIG. 2, the filter screen arrangement is shown in the open state and it is clear that the filter screen edge areas abut the inner wall of the aorta. This ensures that the filter screen arrangement is self-centered.
Neben dem inFig. 1 dargestellten Ausführungsbeispiel sind auch andere Lösungen zum Aufspannen der Filterschirme denkbar, wie beispielsweise ein Aufspannmechanismus der durch Rotation der Filterschirmanordnung um die Längsachse des Arbeitskatheters erfolgt. Ebenso kann der Arbeitskatheter gemäßFig. 2 auch als Durchführkanal für die für die Ablation erforderlichen Katheterwerkzeuge dienen, so dass diese unmittelbar nach Austritt aus dem Arbeitskatheter in das Innenvolumen der aufgespannten Filterschirme gelangen.In addition to the exemplary embodiment shown inFIG. 1, other solutions for clamping the filter screens are also conceivable, such as, for example, a clamping mechanism which is carried out by rotating the filter screen arrangement about the longitudinal axis of the working catheter. Likewise, the working catheter according toFIG. 2 can also serve as a lead-through channel for the catheter tools required for ablation, so that these get into the inner volume of the clamped filter screens immediately after exiting the working catheter.
11
Verbindungsachse
connecting axis
22
Arbeitskatheter
working catheter
33
,.
44
Filterschirm
filter screen
55
Schlittenelement
carriage element
66
Spreizstreben
expansion braces
| Application Number | Priority Date | Filing Date | Title | 
|---|---|---|---|
| DE10049812ADE10049812B4 (en) | 2000-10-09 | 2000-10-09 | Device for filtering out macroscopic particles from the bloodstream during local removal of an aortic valve on the human or animal heart | 
| Application Number | Priority Date | Filing Date | Title | 
|---|---|---|---|
| DE10049812ADE10049812B4 (en) | 2000-10-09 | 2000-10-09 | Device for filtering out macroscopic particles from the bloodstream during local removal of an aortic valve on the human or animal heart | 
| Publication Number | Publication Date | 
|---|---|
| DE10049812A1true DE10049812A1 (en) | 2002-04-18 | 
| DE10049812B4 DE10049812B4 (en) | 2004-06-03 | 
| Application Number | Title | Priority Date | Filing Date | 
|---|---|---|---|
| DE10049812AExpired - Fee RelatedDE10049812B4 (en) | 2000-10-09 | 2000-10-09 | Device for filtering out macroscopic particles from the bloodstream during local removal of an aortic valve on the human or animal heart | 
| Country | Link | 
|---|---|
| DE (1) | DE10049812B4 (en) | 
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| Date | Code | Title | Description | 
|---|---|---|---|
| OP8 | Request for examination as to paragraph 44 patent law | ||
| 8364 | No opposition during term of opposition | ||
| R119 | Application deemed withdrawn, or ip right lapsed, due to non-payment of renewal fee | Effective date:20120501 |