DE10049812B4 - Device for filtering out macroscopic particles from the bloodstream during local removal of an aortic valve on the human or animal heart - Google Patents

Device for filtering out macroscopic particles from the bloodstream during local removal of an aortic valve on the human or animal heart Download PDF

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DE10049812B4
DE10049812B4 DE10049812A DE10049812A DE10049812B4 DE 10049812 B4 DE10049812 B4 DE 10049812B4 DE 10049812 A DE10049812 A DE 10049812A DE 10049812 A DE10049812 A DE 10049812A DE 10049812 B4 DE10049812 B4 DE 10049812B4
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filter screens
filter
filter screen
aortic valve
screens
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DE10049812A1 (en
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Ulrich Dr. Matern
Rico Bergmann
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Universitaetsklinikum Freiburg
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2/0103With centering means
    • 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2/0105Open ended, i.e. legs gathered only at one side
    • 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2/012Multiple filtering units
    • 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/018Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0006Rounded shapes, e.g. with rounded corners circular
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0069Three-dimensional shapes cylindrical
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/0076Quadric-shaped ellipsoidal or ovoid
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/008Quadric-shaped paraboloidal

Abstract

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, dadurch gekennzeichnet, dass zwei Filterschirme vorgesehen sind, die derart in Wirkverbindung stehen, dass im aufgespannten Zustand ihre konkav ausgebildeten Seiten gegenüberliegen.Device for filtering out macroscopic particles from a bloodstream during the local ablation of an aortic valve on the human or animal heart with at least one filter screen that can be stretched out like an umbrella, which can be stretched out from a folded state into a stretched out state and can be actuated by means of a working catheter, characterized in that two filter screens are provided are in operative connection in such a way that their concave sides are opposite in the open state.

Figure 00000001
Figure 00000001

Description

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 macroscopic particles from a bloodstream when removing an aortic valve locally on human or animal Heart with at least one screen-like filter screen that from a folded state to a stretched state can be clamped and actuated by means of a working catheter.

Stand der TechnikState of the art

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 there may be deposits on the heart valve over time form, especially on the aortic valve, often in the form of limescale or other material deposition. Through such material deposits on the aortic valve, which is in a healthy state as a fine flexible fabric sail is formed, there is an irreversible Stiffening of the aortic valve, which in particular causes blood drainage is severely affected from the heart. Blood shortage in the whole body is the result, so at such an advanced stage there is an acute need for action if one wants serious consequences for the Avoid patients. Show previously known drug treatment methods However, only limited success, so that, according to today's knowledge, Calcification of aortic valves only by a serious one surgical intervention can be countered.

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 of a person is usually opened as part of a sternotomy in order to gain access to the heart and in particular to the calcified aortic valves, which are extracted from the body using known cutting tools. For example, extraction tools such as those found in American publications are suitable for this purpose US 6,033,419 such as US 5,827,316 are described. After the surgical procedure and the resection of the chest, the patient is faced with a lengthy healing period, which in most cases is followed by 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 Iosgelösten 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 there are also surgical techniques become known using catheters and endoscopes treatment of the aortic valve even with far lower loads for the Enable patients. However, this presupposes that the calcified aortic valve with the help suitable catheter tools is removed on site. Such a deduction the calcified aortic valve, regardless of which ablation techniques is worked, leads however almost inevitably to shredded, worn, i.e. separated and loosened Tissue fragments, that can get into the free bloodstream if they cannot get through appropriate suction techniques can be extracted extracorporeally. such, fragments in the bloodstream with macroscopic particle diameters of> 7.5 μm, however, increase drastically the risk of thrombosis and embolism of the patient, so that after measures that is, the extraction of the calcified aortic valve may be sought resulting demolition pieces Completely to remove from the bloodstream.

Aus der DE 298 80 158 U1 geht ein Embolieschutzgerät in Art eines intravenös einbringbaren Faltschirmes hervor, der als eine Art Filter in der Blutbahn innerhalb eines Blutgefäßes aufgespannt werden kann, um auf diese Weise die Emboliegefahr erhöhende Partikel aus der Blutbahn auszufiltern.From the DE 298 80 158 U1 shows an embolic protection device in the form of an intravenously insertable folding screen, which can be opened as a kind of filter in the bloodstream within a blood vessel, in order to filter out particles that increase the risk of embolism from the bloodstream.

Darstellung der ErfindungPresentation of the invention

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 or collecting macroscopic particles from a bloodstream for the local removal of an aortic valve on the human or animal Heart with at least one screen-like filter screen, the from a folded state to a stretched state can be clamped and actuated by means of a working catheter, to train in such a way that during surgical intervention to remove the aortic valve macroscopically large particles, that are not properly disposed of and enter the bloodstream, Completely should be caught. In particular, that surgery to abort the aortic valve is safer feasible is. In particular, the device should also have a minimally invasive procedure are not a hindrance to ablation of the aortic valve, but moreover make the intervention easier.

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 in the claim 1 specified. Advantageous further developments of the inventive concept are the subject of the subclaims and the description text with reference to the embodiment refer to.

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 is a device for filtering macroscopic particles from a bloodstream during local ablation an aortic valve, especially on the human heart, according to the generic term of claim 1 designed such that two filter screens are provided are in operative connection in such a way that in the spanned Condition their concave filter screen sides are 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 entfente 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 the combination of two filter screens, the concave sides of which lie opposite one another, inscribes a volume which is surrounded by the filter screens in the manner of a cage and in which the surgical measures can be carried out on the aortic valve. For this it is necessary that one filter screen is placed in front and the other filter screen is placed behind the aortic valve. According to As the filter screens are opened, the aortic valve can be ablated within the volume inscribed by the filter screens. Macroscopic fragments that occur during ablation are caught by the filter screen surfaces and prevented from entering the rest of the bloodstream. After completion of the ablation and other surgical measures, the filter screens are folded up and the macroscopic particles trapped therein, as well as possibly the aortic valve removed as a whole, are enclosed. The dimensions of the filter screens are chosen such that they can be pushed through conventional hollow working catheters, so that after the surgical measure has been completed, the filter screens filled with macroscopic particles can be moved extracorporeally through a corresponding working channel.

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 exist, is chosen so that the natural Blood components pass freely through the filter material can. Macroscopic particles with particle sizes of more than 7.5 μm remain however, hang in the filter material and can accordingly to be disposed of.

Kurze Beschreibung der ErfindungBrief description of the invention

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 without restriction the general inventive concept based on exemplary embodiments described by way of example with reference to the drawing. Show it:

1a,b schematisierte Darstellung der Filterschirmanordnung im zusammengefalteten sowie entspannten Zustand, sowie 1a, b schematic representation of the filter screen arrangement in the folded and relaxed state, and

2 Filterschirmanordnung innnerhalb eines Blutgefäßes. 2 Filter screen arrangement within a blood vessel.

Wege zur Ausführung der Erfindung, gewerbliche VerwendbarkeitWays to Execute the Invention, industrial applicability

In 1a sind schematisiert zwei alternative Filterschirmanordnungen in zusammengefaltetem Zustand dargestellt. Entlang einer Verbindungsachse 1, die mit einem Arbeitskatheter 2 verbunden ist, sind zwei zusammengefaltete Filterschirme 3 und 4 angeordnet. Die Filterschirme 3, 4 liegen im zusammengefalteten Zustand eng an der Verbindungsachse 1 an, so dass sie durch einen dünnen Arbeitshohlkanal 7 eines Katheters geschoben werden können. Mittig zur Filterschirmfläche sind beide Filterschirme 3 und 4 mit der Verbindungsachse 1 fest verbunden, so dass sie im aufgespannten Zustand gemäß 1b mit ihren konkaven Seiten spiegelsymmetrisch relativ zu einer senkrecht zur Verbindungsachse ausgebildet sind.In 1a two alternative filter screen arrangements are shown schematically in the folded state. Along a connecting axis 1 with a working catheter 2 connected, are two folded filter screens 3 and 4 arranged. The filter screens 3 . 4 lie close to the connecting axis when folded 1 so that it passes through a thin working hollow channel 7 of a catheter can be pushed. Both filter screens are in the center of the filter screen area 3 and 4 with the connecting axis 1 firmly connected so that they are in the open state according to 1b are formed with their concave sides mirror-symmetrical relative to one perpendicular to the connection axis.

Alternativ zur der in 1a oben dargestellten zweigeteilten Ausführungsform der Filterschirme 3 und 4 ist es auch möglich durch enstrprechende Wahl des Filterschirmmaterials die Filterschirme 3 und 4 an ihren Randbereichen zusammenzufügen, so dass sie im zusammengefalteten Zustand lediglich einen geschlossenen zusammenhängenden Schlauch darstellen, der auch ohne die Verwendung eines Arbeitshohlkanals 2 in das Gefäß eingeführt werden kann. Hierbei ist insbesondere darauf zu achten, dass das disale Ende der zusammengefalteten Filterschirmanordnung über eine Abrundung 8 verfügt, so dass die Gefäßwand während des Einführvorganges nicht beschädigt wird.As an alternative to the in 1a Above shown two-part embodiment of the filter screens 3 and 4 it is also possible to select the filter screens by selecting the filter screen material accordingly 3 and 4 to join together at their edge areas, so that in the folded state they only represent a closed coherent hose, which can also be used without the use of a working hollow channel 2 can be inserted into the vessel. It is particularly important to ensure that the disal end of the folded filter screen arrangement is rounded 8th so that the vessel wall is not damaged during the insertion process.

Zum Aufspannen der beiden Filterschirme ist jeweils ein Schlittenelement 5 vorgesehen, das längs der Verbindungsachse 1 beweglich angeordnet ist. Mit dem Schlittenelement 5 sind Spreizstreben 6 verbunden, die am Randbereich der Filterschirme angelenkt sind. Durch entsprechendes Verschieben der Schlittenelemente 5 in Richtung der Fixierstellen, an denen das Filtermaterial fest an der Verbindungsachse 1 angebracht ist, entfalten sich die Spreizstreben 6, wodurch die Filterschirme radial zur Verbindungsachse 1 gespreizt werden.There is a slide element for each of the two filter screens 5 provided that along the connecting axis 1 is arranged movably. With the slide element 5 are struts 6 connected, which are hinged to the edge area of the filter screens. By moving the slide elements accordingly 5 in the direction of the fixing points at which the filter material is firmly attached to the connecting axis 1 attached, the struts unfold 6 , making the filter screens radial to the connecting axis 1 be spread.

Im gespannten Zustand der Filterschirmanordnung umschließen beide Filterschirme 3 und 4 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 Verbindungsachse 1 in das Innere der aufgespannten Filterschirme hineinreichen.Both filter screens enclose in the tensioned state of the filter screen arrangement 3 and 4 an internal 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 must be provided in order to introduce the tool catheter required for the ablation. However, these can also be along the connection axis 1 reach into the interior of the open filter screens.

Zur Durchführung der Ablation einer verkalkten Aortenklappe wird die Filterschirmanordnung im zusammengefalteten Zustand durch eine, in der Aortenklappe vorhandene Öffnung hindurchgeschoben, so dass ein Filterschirm 3 auf der einen Seite der Aortenklappe zu liegen kommt und der andere Filterschirm 4 auf der gegenüberliegenden Seite. Im aufgeklappten Zustand vermögen die Filterschirme die zu ablatierende Aortenklappe vollständig zu umschließen. Da das Filtermaterial für die natürlichen Blutbestandteile 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 screen 3 comes to rest on one side of the aortic valve and the other filter screen 4 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 components, the surgical measures can be taken despite persistent 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 arrangement within the aortic arch, or after adjustment relative to the ablating aortic valve, the filter screen arrangement centers itself by spreading the individual filter screens on the inner wall of the aorta. In this case, the filter screen arrangement also serves as a mechanical fixed point or support for the microsurgical instruments to be used for the ablation. In this way, micro-navigation of the catheter tools required for the ablation is considerably simplified compared to previous techniques in which one such adjustment aid is not available.

In 2 ist nochmals die Filterschirmanordnung innerhalb des Aortenbogens in zwei Stellungen 1 und 2 gezeigt. In Stellung 1 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 Position 2 gemäß 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.In 2 is again the filter screen arrangement within the aortic arch in two positions 1 and 2 shown. In position 1 the filter screen arrangement shown in a highly schematic form is shown in the folded state and is pushed in this way through the interior of the aorta. 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 no traumatic tissue irritation occurs during the process of inserting the filter screen arrangement into the body. In position 2 according to 2 the filter screen arrangement is shown in the open state and it becomes 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 in 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 gemäß 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 in 1 In the exemplary embodiment illustrated, 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 can 2 also serve as a lead-through channel for the catheter tools required for ablation, so that they get into the inner volume of the clamped filter screens immediately after exiting the working catheter.

11
Verbindungsachseconnecting axis
22
Arbeitskatheterworking catheter
3, 43, 4
Filterschirmfilter screen
55
Schlittenelementcarriage element
66
Spreizstrebenexpansion braces

Claims (9)

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, dadurch gekennzeichnet, dass zwei Filterschirme vorgesehen sind, die derart in Wirkverbindung stehen, dass im aufgespannten Zustand ihre konkav ausgebildeten Seiten gegenüberliegen.Device for filtering out macroscopic particles from a bloodstream during local ablation of an aortic valve on the human or animal heart with at least one filter screen that can be stretched out like an umbrella, which can be stretched from a folded state into a stretched-out state and can be actuated by means of a working catheter, characterized in that two filter screens are provided are in operative connection in such a way that their concave sides are opposite in the open state. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass die Filterschirme auf einer gemeinsamen Verbindungsachse angebracht sind, entlang der die Filterschirme im zusammengefalteten Zustand anliegen und von der sich die Filterschirme radial im aufgespannten Zustand erstrecken.Device according to claim 1, characterized in that the filter screens are attached to a common connection axis are along which the filter screens are folded apply and from which the filter screens radially in the clamped State stretch. Vorrichtung nach Anspruch 2, dadurch gekennzeichnet, dass die Filterschirme bezogen auf eine die Verbindungsachse senkrecht schneidenden Achse spiegelsymmetrisch ausgebildet sind.Device according to claim 2, characterized in that the filter screens are perpendicular to the connection axis intersecting axis are mirror-symmetrical. Vorrichtung nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Filterschirme aus einem Filtermaterial bestehen, durch das die natürlichen Blutbestandteile ungehindert hindurchtreten aber makroskopische Teilchen mit Teilchengrößen von 7,5 um und mehr das Filtermaterial nicht passieren.Device according to one of claims 1 to 3, characterized in that that the filter screens consist of a filter material through that the natural Blood components pass through unhindered but macroscopic Particles with particle sizes of 7.5 µm and more do not pass the filter material. Vorrichtung nach einem der Ansprüche 2 bis 4, dadurch gekennzeichnet, dass die Filterschirme mittig zu ihrer Filterschirmfläche an der Verbindungsachse befestigt sind und mit jeweils einem Schlittenelement, das längs zur Verbindungsachse beweglich ist, über Spreizstreben, die jeweils mit dem Randbereich der Filterschirmfläche, verbunden sind.Device according to one of claims 2 to 4, characterized in that that the filter screens are centered on their filter screen area on the Connection axis are attached and each with a slide element, the lengthways is movable to the connecting axis, via struts, each are connected to the edge area of the filter screen surface. Vorrichtung nach Anspruch 5, dadurch gekennzeichnet, dass der Arbeitskatheter mit den Schlittenelementen in Wirkverbindung steht.Apparatus according to claim 5, characterized in that the working catheter is operatively connected to the slide elements stands. Vorrichtung nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass die Filterschirme im aufgespannten Zustand ein nahezu vollständig umschlossenes Volumen mit den Filterschirmen einschließen.Device according to one of claims 1 to 6, characterized in that that the filter screens in the open state are almost completely enclosed Enclose volume with the filter screens. Vorrichtung nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass die Filterschirme im aufgespannten Zustand einen Filterschirmdurchmesser von bis zu 2,9 cm aufweisen und im zusammengefalteten Zustand längs durch einen Hohlkatheter mit einem Arbeitskanaldurchmesser von maximal 1 cm Durchmesser schiebbar sind.Device according to one of claims 1 to 7, characterized in that that the filter screens have a filter screen diameter in the open state of up to 2.9 cm and when folded through lengthways a hollow catheter with a maximum working channel diameter 1 cm diameter can be pushed. Vorrichtung nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass die Filterschirme mit ihren Randbereichen der Filterschirmfläche peripher verbunden sind.Device according to one of claims 1 to 8, characterized in that that the filter screens are connected peripherally to their edge areas of the filter screen surface are.
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