DE9413645U1 - Device for closing a duct, in particular the ductus arteriosus - Google Patents
Device for closing a duct, in particular the ductus arteriosusInfo
- Publication number
- DE9413645U1 DE9413645U1 DE19949413645 DE9413645U DE9413645U1 DE 9413645 U1 DE9413645 U1 DE 9413645U1 DE 19949413645 DE19949413645 DE 19949413645 DE 9413645 U DE9413645 U DE 9413645U DE 9413645 U1 DE9413645 U1 DE 9413645U1
- Authority
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- Germany
- Prior art keywords
- implant
- duct
- fixing elements
- patent attorney
- ductus
- 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.)
- Expired - Lifetime
Links
- 210000003017 ductus arteriosus Anatomy 0.000 title claims description 6
- 239000007943 implant Substances 0.000 claims description 21
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 9
- 230000008878 coupling Effects 0.000 claims description 9
- 238000010168 coupling process Methods 0.000 claims description 9
- 238000005859 coupling reaction Methods 0.000 claims description 9
- 239000000463 material Substances 0.000 claims description 8
- 229910052719 titanium Inorganic materials 0.000 claims description 6
- 239000010936 titanium Substances 0.000 claims description 6
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 claims description 5
- 238000003466 welding Methods 0.000 claims description 5
- 239000011324 bead Substances 0.000 claims description 4
- 239000003356 suture material Substances 0.000 claims description 3
- 230000002085 persistent effect Effects 0.000 claims description 2
- 230000001681 protective effect Effects 0.000 claims 1
- 210000001147 pulmonary artery Anatomy 0.000 description 9
- 210000000709 aorta Anatomy 0.000 description 7
- 230000006378 damage Effects 0.000 description 6
- 239000006261 foam material Substances 0.000 description 3
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 244000309464 bull Species 0.000 description 2
- 230000004087 circulation Effects 0.000 description 2
- 210000001105 femoral artery Anatomy 0.000 description 2
- 239000006260 foam Substances 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 230000000284 resting effect Effects 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 229910001260 Pt alloy Inorganic materials 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 210000003191 femoral vein Anatomy 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000004088 pulmonary circulation Effects 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 210000005245 right atrium Anatomy 0.000 description 1
- 210000005241 right ventricle Anatomy 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000001839 systemic circulation Effects 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00592—Elastic or resilient implements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00601—Implements entirely comprised between the two sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00623—Introducing or retrieving devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Vascular Medicine (AREA)
- Reproductive Health (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Air-Flow Control Members (AREA)
- Duct Arrangements (AREA)
- Details Of Indoor Wiring (AREA)
Description
Vorrichtung zum Verschließen eines Ductus, insbesondere des Ductus arteriosusDevice for closing a ductus, in particular the ductus arteriosus
Die Erfindung bezieht sich auf eine Vorrichtung zum Verschließen einer Shuntverbindung, insbesondere des persistierenden Ductus arteriosus, umfassend ein Implantat sowie wenigstens ein Arretierungsmittel.The invention relates to a device for closing a shunt connection, in particular the persistent ductus arteriosus, comprising an implant and at least one locking means.
Der menschliche Blutkreislauf besteht aus einem Herz- und einem Lungenkreislauf. In der embryonalen Phase der Entwicklung eines Menschen sind die beiden Kreisläufe durch den Ductus arteriosus miteinander verbunden. Der Ductus verbindet die Aorta (Körperkreislauf) mit der Pulmonalarterie (Lungenkreislauf). Bei einer normalen Entwicklung eines Säuglings verwächst dieser Ductus nach der Geburt. Bei krankhafter Entwicklung kann der Fall eintreten, daß der Ductus nicht zuwächst, wodurch die beiden Blutkreisläufe auch nach der Geburt miteinander verbunden bleiben. Dadurch kann die Lebenserwartung des Säuglings stark reduziert werden.The human circulatory system consists of a cardiac and a pulmonary system. In the embryonic phase of a person's development, the two systems are connected by the ductus arteriosus. The ductus connects the aorta (systemic circulation) with the pulmonary artery (pulmonary circulation). If an infant develops normally, this ductus grows together after birth. If the development is abnormal, the ductus may not grow together, meaning that the two systems remain connected even after birth. This can greatly reduce the infant's life expectancy.
Es ist bekannt, den Ductus durch einen chirurgischen Eingriff zu verschließen. Dieser Eingriff ist jedoch sehr kostenintensiv und ist mit einem Risiko für den Patienten verbunden.It is known that the ductus can be closed by surgery. However, this procedure is very expensive and involves risks for the patient.
Weiterhin ist es bekannt, den Ductus mittels eines Ivalon-Schaumstoffpfropfens zu ver-It is also known to seal the ductus using an Ivalon foam plug.
23. August 1994-33453B1/si23 August 1994-33453B1/si
Patentanwalt-European Patent AttorneyPatent Attorney-European Patent Attorney
• · · ♦• · · ♦
schließen (Porstmann-Technik). Dabei wird eine Leitschiene durch eine Femoralarterie in die Aorta eingeführt, durch den Ductus in die Pulmonalarterie und von dort durch die rechte Herzkammer und den rechten Vorhof und schließlich über die gegenseitige Femoralvene wieder nach außen geführt. Anschließend wird der Ductuspfropfen in den Ductus geschoben, wo er "festgeklemmt" wird. Aufgrund des hohen Druckunterschiedes zwischen Aorta und Pulmonalarterie werden an die Arretierung des Ductuspfropfens innerhalb des Ductus hohe Anforderungen gestellt.close (Porstmann technique). A guide rail is inserted through a femoral artery into the aorta, through the ductus into the pulmonary artery and from there through the right ventricle and the right atrium and finally out again via the opposite femoral vein. The ductus plug is then pushed into the ductus, where it is "clamped". Due to the high pressure difference between the aorta and the pulmonary artery, high demands are placed on the locking of the ductus plug within the ductus.
Daher müssen verhältnismäßig große Pfropfen (30% größer als der Durchmesser des Ductus) verwendet werden. Entsprechend große Schleusen werden zur Einführung des Pfropfens in die Femoralarterie benötigt. Bei Säuglingen ist das Kaliber der Gefäße zu klein und oft bei Kindern < 30 kg auch nicht ausreichend für einen derartigen Eingriff.Therefore, relatively large plugs (30% larger than the diameter of the ductus) must be used. Correspondingly large sheaths are required to introduce the plug into the femoral artery. In infants, the caliber of the vessels is too small and often insufficient for such an operation in children < 30 kg.
Der vorliegenden Erfindung liegt das Problem zugrunde, eine Vorrichtung zum Verschließen eines Ductus arteriosus derart weiterzubilden, daß die Arretierung der Vorrichtung innerhalb des Ductus verbessert und somit ein dauerhaft sicherer Verschluß zur Verfügung gestellt wird.The present invention is based on the problem of developing a device for closing a ductus arteriosus in such a way that the locking of the device within the ductus is improved and thus a permanently secure closure is provided.
Das Problem der vorliegenden Erfindung wird dadurch gelöst, daß das Arretierungsmittel ein das Implantat axial durchsetzendes Mittelteil mit Endbereichen aufweist, die zur Aufnahme von wenigstens einem Fixierelement ausgebildet sind, das an Innenwandungen von durch einen Ductus verbundenen Gefäßen wenigstens punktförmig anliegt. Durch diese Vorrichtung wird eine sichere Arretierung des Implantats innerhalb des Ductus gewährleistet. Auch bei hohem Druckunterschied der zwischen den durch den Ductus verbundenen Gefäße wird eine sichere Arretierung durch die Fixierelemente, die vorzugsweise an der Innenwandung der Gefäße anliegen, erreicht.The problem of the present invention is solved in that the locking means has a central part that passes axially through the implant and has end regions that are designed to accommodate at least one fixing element that rests at least at points on the inner walls of vessels connected by a ductus. This device ensures that the implant is securely locked within the ductus. Even with a high pressure difference between the vessels connected by the ductus, secure locking is achieved by the fixing elements, which preferably rest on the inner walls of the vessels.
Vorzugsweise erstrecken sich die Fixierelemente strahlenförmig von den Endbereichen des Mittelteils. Durch diese Anordnung der Fixierelemente entsteht eine Art Ankerwirkung, durch die das Implantat in der gewünschten Position arretiert werden kann.Preferably, the fixing elements extend radially from the end areas of the middle part. This arrangement of the fixing elements creates a kind of anchor effect, through which the implant can be locked in the desired position.
Auch ist es möglich, die Fixierelemente als Schleifen auszubilden. Dadurch wird eine größereIt is also possible to design the fixing elements as loops. This allows a larger
16. August 1994-33453B1/S116 August 1994-33453B1/S1
Patentanwalt-European Patent AttorneyPatent Attorney-European Patent Attorney
Auflagefläche der Fixierelemente an der Innenwandung der Gefäße erreicht. Weiterhin bietet die Schleifenform den Vorteil, daß Verletzungen der Gefäßinnenwände durch Fixierelementenden vermieden werden können.The contact surface of the fixing elements on the inner wall of the vessels is reached. Furthermore, the loop shape offers the advantage that injuries to the inner walls of the vessels caused by the ends of the fixing elements can be avoided.
In einer bevorzugten Ausführungsform sind die Fixierelemente Drähte, wie hoch elastische Titandrähte, wodurch eine Anpassung der Fixierelemente an die Form der Gefäße ermöglicht wird. Verletzungen können dadurch weitgehend vermieden werden. Auch wird das Einführen des Verschlusses mittels eines Katheters dadurch vereinfacht.In a preferred embodiment, the fixation elements are wires, such as highly elastic titanium wires, which allows the fixation elements to be adapted to the shape of the vessels. Injuries can thus be largely avoided. This also simplifies the insertion of the closure using a catheter.
Bevorzugt weisen die Drähte an ihren Enden polierte Laserschweißperlen auf. Durch diese Maßnahmen sollen Verletzungen der Gefäßinnenwände aufgrund spitzer Drahtenden vermieden bzw. ausgeschlossen werden.Preferably, the wires have polished laser welding beads at their ends. These measures are intended to prevent or exclude damage to the inner walls of the vessels due to sharp wire ends.
Das Mittelteil weist in seinen Endbereichen vorzugsweise Aufnahmen für wenigstens ein Fixierelemt auf und ist im wesentlichen hanteiförmig ausgebildet. Durch das Mittelteil wird eine Verbindung hergestellt zwischen den den jeweiligen Gefäßen zugeordneten Fixierelementeinheiten. Das Mittelteil ist in dieser Ausführungsform einteilig ausgebildet. Die Aufnahmen sind als Durchbrechungen ausgebildet, die zur Aufnahme der Fixierelemente wie Drähte aus hochelastischem Titandraht vorgesehen sind.The middle part preferably has receptacles for at least one fixing element in its end regions and is essentially dumbbell-shaped. The middle part creates a connection between the fixing element units assigned to the respective vessels. In this embodiment, the middle part is formed in one piece. The receptacles are designed as openings that are intended to accommodate the fixing elements such as wires made of highly elastic titanium wire.
Auch können die Endbereiche des Mittelteils als separate Fixierelementaufnahmen ausgebildet sein, die mit dem Mittelteil verbunden wie verschweißt sind. Diese Ausführungsform zeichnet sich gegenüber der vorher Beschriebenen durch eine kostengünstigere Herstellung aus.The end areas of the middle part can also be designed as separate fixing element holders that are connected to the middle part by welding. This design is characterized by more cost-effective production compared to the previously described one.
Bei einer besonders bevorzugten Ausführungsform weist das Arretierungsmittel an wenigstens einem Endbereich in axialer Erstreckung eine Anformung wie Kupplung zur Aufnahme in eine Führungszange auf. Mit dieser vorzugsweise kugelförmigen Anformung ist die Möglichkeit gegeben, daß die Vorrichtung zum Verschließen des Ductus mittels einer flexiblen Führungszange innerhalb eines Führungskatheters handhabbar ist. Auch ist die Vorrichtung zum Verschließen des Ductus derart ausgebildet, daß sie zum Transport durch ein Gefäß innerhalb eines Führungskatheters verstaubar ist. Dadurch können Verletzungen beimIn a particularly preferred embodiment, the locking means has a coupling-like shape on at least one end region in the axial extension for receiving in a guide forceps. This preferably spherical shape makes it possible for the device for closing the ductus to be handled by means of a flexible guide forceps within a guide catheter. The device for closing the ductus is also designed in such a way that it can be stowed within a guide catheter for transport through a vessel. This can prevent injuries during
23. August 1994-33453B1/si23 August 1994-33453B1/si
Dipl.-Phys. Dr. H.-H. Stoffregen .' "&Ggr; &idigr; · · · · · Seite 4 Dipl.-Phys. Dr. H.-H. Stoffregen .'"&Ggr;&idigr; · · · · · Page 4
Patentanwalt-European Patent AttorneyPatent Attorney-European Patent Attorney
Einführen des Ductusverschlusses vermieden werden.Insertion of the ductus closure can be avoided.
Der erfindungsgemäße Ductusverschluß weist vorteilhaft einen komprimierten Schaumstoffkörper aus einem Material wie "IVALON" auf. Das Material zeichnet sich dadurch aus, daß es bei Kontakt mit Flüssigkeit wie Blut aufquillt, wodurch der Ductus dicht verschlossen werden kann. Weiterhin zeichnet sich dieses Material dadurch aus, daß es eine gute Gewebeverträglichkeit aufweist und mit den Gefäßwänden verwächst.The duct closure according to the invention advantageously has a compressed foam body made of a material such as "IVALON". The material is characterized by the fact that it swells when it comes into contact with liquid such as blood, which allows the duct to be tightly closed. This material is also characterized by the fact that it has good tissue compatibility and grows together with the vessel walls.
Um die Verbindung zwischen der Arretierungsvorrichtung und dem schaumstoffförmigen Material zu verbessern ist vorgesehen, daß das schaumstoffförmige Material mittels chirurgischem Nahtmaterial mit der Arretierungsvorrichtung vernäht wird. Dadurch wird sichergestellt, daß das Implantat aufgrund hoher Druckschwankungen zwischen Aorta (Körperkreislauf) und Pulmonalarterie (Lungenkreislauf) nicht innerhalb des Ductus "hin- und herbewegt" wird.In order to improve the connection between the locking device and the foam material, the foam material is sewn to the locking device using surgical suture material. This ensures that the implant is not "moved back and forth" within the ductus due to high pressure fluctuations between the aorta (body circulation) and the pulmonary artery (lung circulation).
Weitere Einzelheiten, Vorteile und Merkmale der Erfindung ergeben sich nicht nur aus den Ansprüchen, den diesen zu entnehmenden Merkmalen -für sich und/oder in Kombination-, sondern auch aus der nachfolgenden Beschreibung des der Zeichnung zu entnehmenden bevorzugten Ausführungsbeispiels.Further details, advantages and features of the invention emerge not only from the claims, the features derived therefrom - individually and/or in combination -, but also from the following description of the preferred embodiment shown in the drawing.
Es zeigen:Show it:
Fig. 1 Eine erste Ausführungsform eines Ductusverschlusses in perspektivischerFig. 1 A first embodiment of a duct closure in perspective
Darstellung,Depiction,
Fig. 2 eine zweite Ausführungsform eines Ductusverschlusses in perspektivischerFig. 2 a second embodiment of a duct closure in perspective
Darstellung,Depiction,
Fig. 3 den Ductusverschluß gemäß Fig. 1 eingeführt in einen Führungskatheter,Fig. 3 the duct closure according to Fig. 1 inserted into a guide catheter,
Fig. 4 den an seinem Einsatzort eingesetzten Ductusverschluß gemäß Fig. 1.Fig. 4 shows the duct closure device used at its place of use according to Fig. 1.
15. August 1994-33453B1/si ,, ,15 August 1994-33453B1/si ,, ,
• *• *
Patentanwalt-European Patent AttorneyPatent Attorney-European Patent Attorney
Fig. 1 zeigt eine erste Ausfuhrungsform eines Ductusverschusses (10). Der Ductusverschluß (10) umfaßt eine Arretierungsvorrichtung (12) sowie ein vorzugsweise zylinderförmiges Implantat (14). Das Implantat (14) kann aus einem schaumstoffförmigen Material wie IVALON (eingetrages Warenzeichen) bestehen, das sich dadurch auszeichnet, daß es von dem Körper gut aufgenommen wird und mit dem umschließenden Gefäßgewebe eine Verbindung eingeht. In seinem Zentrum weist der Dichtungskörper (14) eine achsparallele Durchbrechung (16) auf, die zur Aufnahme der Arretierungs vorrichtung (12) ausgebildet ist.Fig. 1 shows a first embodiment of a duct closure (10). The duct closure (10) comprises a locking device (12) and a preferably cylindrical implant (14). The implant (14) can consist of a foam material such as IVALON (registered trademark), which is characterized by the fact that it is well absorbed by the body and forms a bond with the surrounding vascular tissue. In its center, the sealing body (14) has an axially parallel opening (16) which is designed to accommodate the locking device (12).
Die Arretierungsvorrichtung (12) besteht im wesentlichen aus einem Mittelteil (18), daß in der ersten Ausführungsform als Einheit ausgebildet ist. Das Mittelteil (18) weist Endbereiche (20, 22) auf, in die Durchbrechungen (24, 26, 28) eingebracht sind, die zur Aufnahme von Fixierelementen (30, 32, 34) dienen. Weiterhin weist das Mittelteil (18) an dem Endbereich (22) durch einen Steg (36) beabstandet ein kugelförmiges oder zylinderförmiges Kupplungselement (38) auf. Das Mittelteil (18), der Steg (36) und die kugelförmige Kupplung (38) weisen eine gemeinsame Mittelachse auf.The locking device (12) consists essentially of a central part (18) which is designed as a unit in the first embodiment. The central part (18) has end regions (20, 22) in which openings (24, 26, 28) are made, which serve to accommodate fixing elements (30, 32, 34). Furthermore, the central part (18) has a spherical or cylindrical coupling element (38) at the end region (22) spaced apart by a web (36). The central part (18), the web (36) and the spherical coupling (38) have a common central axis.
Das Mittelteil (18) ist vorzugsweise aus einem Teil geschliffen oder gedreht, wobei ein Rundmaterial, z. B. aus Titan oder einem anderen Material wie Platinlegierung, mit einem Durchmesser von ca. 1 mm zur Erreichung einer hohen Flexibilität zwischen den Endbereichen (20, 22) auf einen Durchmesser von ca. 0,4 mm - 0,6 mm geschliffen oder gedreht wird. Die Endbereiche (20, 22) können eine kugelförmige oder zylindrische Form aufweisen. Die in den Endbereich (20) eingebrachten Durchbrechungen (24, 26) verlaufen übereinander und sind vorzugsweise um einen Winkel von 90° zueinander versetzt.The middle part (18) is preferably ground or turned from one part, whereby a round material, e.g. made of titanium or another material such as platinum alloy, with a diameter of approx. 1 mm is ground or turned to a diameter of approx. 0.4 mm - 0.6 mm to achieve a high degree of flexibility between the end areas (20, 22). The end areas (20, 22) can have a spherical or cylindrical shape. The openings (24, 26) made in the end area (20) run one above the other and are preferably offset from one another by an angle of 90°.
Die Fixierelemente (30, 32, 34) bestehen aus hochelastischem Titandraht, und weisen an ihren Enden polierte Laserschweißperlen (40) auf, um Verletzungen der Gefäßwände zu vermeiden. Die Enden können auch mit polierten Titankugeln versehen sein, die eine Sacklochbohrung von ca. 0,3 mm - 0,4 mm Durchmesser aufweisen und mit den Enden der Fixierelemente (30, 32, 34) verschweißt sind.The fixing elements (30, 32, 34) are made of highly elastic titanium wire and have polished laser welding beads (40) on their ends to prevent damage to the vessel walls. The ends can also be provided with polished titanium balls that have a blind hole of approximately 0.3 mm - 0.4 mm in diameter and are welded to the ends of the fixing elements (30, 32, 34).
Fig. 2 zeigt eine zweite Ausführungsform eines Ductusverschlusses (22), der sich im wesentlichen durch eine geänderte Gestaltung eines Arretierungsmittels (44) von der Ausführungs-Fig. 2 shows a second embodiment of a duct closure (22), which differs essentially by a modified design of a locking means (44) from the embodiment
17. August 1994-33453B1/SI 17 August 1994-33453B1/SI
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Patentanwalt-European Patent AttorneyPatent Attorney-European Patent Attorney
form gemäß Fig. 1 unterscheidet. Das Arretierungsmittel (44) weist ein Mittelteil (46) auf, das aus einem Mittelstück (47) besteht an dessen Enden Halterungen (48, 50) befestigt wie verschweißt sind. Die Halterungen (48, 50) haben eine zylindrische Form und weisen an zumindest einer Stirnseite Aufnahmen (52, 54) für das Mittelstück (47) auf. An der Halterung (50) ist an der der Aufnahme (52) gegenüberliegenden Seite ein Steg (56) angeformt, der in eine kugelförmige Kupplung (58) übergeht. Wie schon mit Bezug zu Fig. 1 erwähnt, liegen das Mittelstück (47), der Steg (56) und die kugelförmige Kupplung (58) auf einer gemeinsamen Mittelachse.form according to Fig. 1. The locking means (44) has a middle part (46) consisting of a middle piece (47) to the ends of which brackets (48, 50) are fastened and welded. The brackets (48, 50) have a cylindrical shape and have receptacles (52, 54) for the middle piece (47) on at least one end face. A web (56) is formed on the bracket (50) on the side opposite the receptacle (52), which merges into a spherical coupling (58). As already mentioned with reference to Fig. 1, the middle piece (47), the web (56) and the spherical coupling (58) lie on a common central axis.
Die Halterungen (48, 50) weisen weiterhin Aufnahmen (60) zur Aufnahme von Fixier- bzw. Halteelementen (62, 64, 66, 68, 70) auf. Die Aufnahmen (60) sind in Außenflächen (72, 74) der Halterungen (48, 50) auf einer Umfangslinie liegend eingebracht. Zur Bildung einer Schleife sind die Fixier- bzw. Halteelemente (62, 64, 66, 68, 70) jeweils mit ihren Enden die Aufnahmen (60) der Halteelemente (48, 50) eingebracht. Die Halte- bzw. Fixierelemente, die vorzugsweise aus hochelastischem Titandraht bestehen, werden in den Aufnahmen (60) mechanisch fixiert. Durch die bevorzugte schleifenförmige Ausbildung der Fixier- bzw. Halteelemente werden Verletzungen der Gefäßwände vermieden. Auch wird dadurch eine möglichst große Auflagefläche an den Gefäßinnenwänden erreicht.The holders (48, 50) also have receptacles (60) for receiving fixing or holding elements (62, 64, 66, 68, 70). The receptacles (60) are inserted into the outer surfaces (72, 74) of the holders (48, 50) lying on a circumferential line. To form a loop, the fixing or holding elements (62, 64, 66, 68, 70) are each inserted with their ends into the receptacles (60) of the holding elements (48, 50). The holding or fixing elements, which preferably consist of highly elastic titanium wire, are mechanically fixed in the receptacles (60). The preferred loop-shaped design of the fixing or holding elements prevents damage to the vessel walls. This also achieves the largest possible contact surface on the vessel inner walls.
Fig. 3 zeigt den in einen Führungskatheter (74) eingelegten Ductusverschluß (10) gemäß Fig. 1. Der Ductusverschluß (10) liegt dabei mit seinen gebogenen Fixierelementen (30, 32, 34) sowie den polierten Laserschweißperlen oder Titankugeln (40) an einer Innenwandung (76) des Katheters (74) an. Durch das punktförmige Anliegen des Ductusverschlusses (10) innerhalb des Katheters (74) wird ein leichtes Bewegen des Ductusverschlusses (10) ermöglicht. Im ursprünglichen Zustand läßt sich das zylinderförmige Dichtungsimplantat wie IVALON (eingetrages Warenzeichen) zusammen mit der Arretierungsvorrichtung (12, 44) leicht in den Katheter einführen. Innerhalb des Katheters wird der Ductusverschluß (10) durch eine flexible Führungszange (78), die an der kugel- beziehungsweise zylinderförmigen Kupplung (38) des Ductusverschlusses (10) eingreift, gehalten.Fig. 3 shows the duct closure (10) inserted into a guide catheter (74) according to Fig. 1. The duct closure (10) rests with its curved fixing elements (30, 32, 34) as well as the polished laser welding beads or titanium balls (40) on an inner wall (76) of the catheter (74). The point-like resting of the duct closure (10) within the catheter (74) enables the duct closure (10) to be easily moved. In its original state, the cylindrical sealing implant such as IVALON (registered trademark) can be easily inserted into the catheter together with the locking device (12, 44). Inside the catheter, the duct closure (10) is held by a flexible guide forceps (78) which engages the ball- or cylinder-shaped coupling (38) of the duct closure (10).
Fig. 4 zeigt den in einen Ductus (80) eingebrachten Ductusverschuß (10). Der Ductus (80) bildet hier die Verbindung zwischen einem Gefäß (82) wie Aorta und einem weiteren GefäßFig. 4 shows the duct closure (10) inserted into a ductus (80). The ductus (80) forms the connection between a vessel (82) such as the aorta and another vessel
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Patentanwalt-European Patent AttorneyPatent Attorney-European Patent Attorney
(84) wie Lungenarterie. In der wie in Fig. 3 gezeigten Anordnung wird der Ductusverschluß (10) mittels des Katheters (74) in den Ductus (80) eingesetzt. Dazu wird der Katheter (74) mit eingelegtem Ductusverschluß (10) durch die Lungenarterie (84) in den Ductus (80) eingeführt, bis eine Oberkante (86) des Katheters (74) in die Aorta (82) hineinragt. Der Ductusverschluß (10) liegt dabei in Höhe des Ductus (80). Anschließend wird die Wandung (76) des Katheters (74) bei konstant gehaltener Position des Ductusverschlusses (10) in Richtung zur Arterie (84) bewegt, wodurch sich die Fixierelemente (30, 32) an eine Innenwandung (88) der Aorta (82) anlegen können. Anschließend wird das Implantat (14) freigelegt, so daß es sich an eine Innenwandung (90) des Ductus (80) anschmiegen kann. Die Position des Ductusverschlusses (10) wird dabei durch die Führungszange (78), die an der Kupplung (38) des Ductusverschlusses (10) angreift, konstant gehalten. Nachdem das Implantant (14) freigelegt ist, wird schließlich das der Lungenarterie (84) zugewandte Fixierelement (34) freigelegt, daß sich somit an eine Innenwandung (92) der Lungenarterie (84) anschmiegen kann.(84) like the pulmonary artery. In the arrangement shown in Fig. 3, the duct closure (10) is inserted into the duct (80) using the catheter (74). To do this, the catheter (74) with the duct closure (10) inserted is inserted through the pulmonary artery (84) into the duct (80) until an upper edge (86) of the catheter (74) extends into the aorta (82). The duct closure (10) is at the level of the duct (80). The wall (76) of the catheter (74) is then moved in the direction of the artery (84) while the position of the duct closure (10) is kept constant, whereby the fixing elements (30, 32) can be placed against an inner wall (88) of the aorta (82). The implant (14) is then exposed so that it can cling to an inner wall (90) of the ductus (80). The position of the ductus closure (10) is kept constant by the guide forceps (78), which engages the coupling (38) of the ductus closure (10). After the implant (14) is exposed, the fixing element (34) facing the pulmonary artery (84) is finally exposed so that it can cling to an inner wall (92) of the pulmonary artery (84).
Durch den Kontakt mit Flüssigkeit wie Blut quillt das Implantat (14) auf, so daß der Ductus (80) dicht verschlossen wird. Durch die an den Innenwandungen (88, 92) anliegenden Fixierelemente (30, 32, 34) wird eine axiale Verschiebung des Implantats (14) aufgrund des hohen Druckunterschiedes zwischen den Gefäßen (82, 84) verhindert. Zur weiteren Fixierung des Implantats ist vorgesehen, daß das Implantat (14) mit der Arretierungsvorrichtung (12) mittels Nahtmaterial vernäht wird. Dadurch wird eine Relativbewegung zwischen Implantat (14) und Arretierungsvorrichtung (12) unterbunden. Nachdem der Ductusverschluß innerhalb des Ductus (80) eingesetzt ist, und die Fixierelemente (30, 32, 34) wunschgemäß an den Innenwandungen (88, 92) der Gefäße (82, 84) anliegen, kann die flexible Führungszange (78) von der kugelförmigen Kupplung (38) gelöst werden und aus der Lungenarterie (84) entfernt werden. Die Geometrie des Implantats (14) ist derart ausgelegt, daß die Endbereiche (20, 22) und die Fixierelemente (30, 32, 34) wenigstens teilweise von dem aufgequillten Implantatmaterial eingefaßt werden. Durch die erfindungsgemäße Vorrichtung kann somit auf einfache und kostengünstige Weise ein sicherer Ductusverschluß realisiert werden.The implant (14) swells when it comes into contact with liquid such as blood, so that the ductus (80) is tightly closed. The fixing elements (30, 32, 34) resting on the inner walls (88, 92) prevent axial displacement of the implant (14) due to the high pressure difference between the vessels (82, 84). To further fix the implant, the implant (14) is sewn to the locking device (12) using suture material. This prevents relative movement between the implant (14) and the locking device (12). After the duct closure has been inserted within the duct (80) and the fixing elements (30, 32, 34) are in contact with the inner walls (88, 92) of the vessels (82, 84) as desired, the flexible guide forceps (78) can be released from the spherical coupling (38) and removed from the pulmonary artery (84). The geometry of the implant (14) is designed such that the end regions (20, 22) and the fixing elements (30, 32, 34) are at least partially enclosed by the swollen implant material. The device according to the invention can thus be used to achieve a secure duct closure in a simple and cost-effective manner.
23. August 1994-33453B1/si23 August 1994-33453B1/si
Claims (1)
dadurch gekennzeichnet,2. Device according to claim 1,
characterized,
dadurch gekennzeichnet,3. Device according to claim 1 or 2,
characterized,
dadurch gekennzeichnet,7. Device according to claim 1,
characterized,
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19949413645 DE9413645U1 (en) | 1994-08-24 | 1994-08-24 | Device for closing a duct, in particular the ductus arteriosus |
| DE29500381U DE29500381U1 (en) | 1994-08-24 | 1995-01-11 | Device for closing a duct, in particular the ductus arteriosus |
| AT95113341T ATE253326T1 (en) | 1994-08-24 | 1995-08-24 | CLOSURE DEVICE FOR CLOSING A VESSEL OPENING |
| DE59510820T DE59510820D1 (en) | 1994-08-24 | 1995-08-24 | Closure device for closing a vessel opening |
| EP95113341A EP0698373B1 (en) | 1994-08-24 | 1995-08-24 | Occlusion device for closing an opening in a vessel |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19949413645 DE9413645U1 (en) | 1994-08-24 | 1994-08-24 | Device for closing a duct, in particular the ductus arteriosus |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DE9413645U1 true DE9413645U1 (en) | 1994-10-27 |
Family
ID=6912773
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE19949413645 Expired - Lifetime DE9413645U1 (en) | 1994-08-24 | 1994-08-24 | Device for closing a duct, in particular the ductus arteriosus |
Country Status (1)
| Country | Link |
|---|---|
| DE (1) | DE9413645U1 (en) |
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| EP0698373A2 (en) * | 1994-08-24 | 1996-02-28 | Bernhard Schneidt | Occlusion device for closing an opening in a vessel |
| DE19547617C1 (en) * | 1995-12-20 | 1997-09-18 | Malte Neus | Appliance for inserting and replacing surgical implant |
| EP0832607A1 (en) * | 1996-09-27 | 1998-04-01 | Target Therapeutics, Inc. | Ball lock joint and introducer for vasoocclusive member |
| WO1999007293A1 (en) * | 1997-08-05 | 1999-02-18 | Boston Scientific Limited | Detachable aneurysm neck bridge (i) |
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| EP1018943A1 (en) * | 1997-08-08 | 2000-07-19 | Cardia, Inc. | Occlusion device for the closure of a physical anomaly |
| WO2001010306A1 (en) * | 1999-08-09 | 2001-02-15 | Salviac Limited | An occluder with anchor |
| WO2003022159A1 (en) * | 2001-09-06 | 2003-03-20 | Core Medical, Inc. | Clip apparatus for closing septal defects and methods of use |
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| EP0698373A2 (en) * | 1994-08-24 | 1996-02-28 | Bernhard Schneidt | Occlusion device for closing an opening in a vessel |
| EP0698373B1 (en) * | 1994-08-24 | 2003-11-05 | Cardia, Inc. | Occlusion device for closing an opening in a vessel |
| DE19547617C1 (en) * | 1995-12-20 | 1997-09-18 | Malte Neus | Appliance for inserting and replacing surgical implant |
| US5895391A (en) * | 1996-09-27 | 1999-04-20 | Target Therapeutics, Inc. | Ball lock joint and introducer for vaso-occlusive member |
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| US7867250B2 (en) | 2001-12-19 | 2011-01-11 | Nmt Medical, Inc. | Septal occluder and associated methods |
| US7318833B2 (en) | 2001-12-19 | 2008-01-15 | Nmt Medical, Inc. | PFO closure device with flexible thrombogenic joint and improved dislodgement resistance |
| US8758403B2 (en) | 2001-12-19 | 2014-06-24 | W.L. Gore & Associates, Inc. | PFO closure device with flexible thrombogenic joint and improved dislodgement resistance |
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