WO2004107992A1 - Device for the implantation of occlusion coils in body cavities - Google Patents

Device for the implantation of occlusion coils in body cavities Download PDF

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Publication number
WO2004107992A1
WO2004107992A1 PCT/DE2004/001130 DE2004001130W WO2004107992A1 WO 2004107992 A1 WO2004107992 A1 WO 2004107992A1 DE 2004001130 W DE2004001130 W DE 2004001130W WO 2004107992 A1 WO2004107992 A1 WO 2004107992A1
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WO
WIPO (PCT)
Prior art keywords
connecting part
occlusion
helix
occlusion helix
guiding
Prior art date
Application number
PCT/DE2004/001130
Other languages
German (de)
French (fr)
Inventor
Frank Czerwinski
Original Assignee
Frank Czerwinski
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Frank Czerwinski filed Critical Frank Czerwinski
Publication of WO2004107992A1 publication Critical patent/WO2004107992A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, 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, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, 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
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, 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
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12095—Threaded connection

Definitions

  • the invention relates to a device for implanting occlusion spirals in body cavities with the features in the preamble of patent claim 1.
  • the treatment of intracranial aneurysms by neuroradiological forms of therapy is state of the art.
  • a catheter is inserted subcutaneously from the groin into the vascular system and the aneurysm is probed.
  • Application of embolization materials will fill the aneurysm. This removes the hemodynamic pressure from the vessel wall to avoid the risk of aneurysm rupture and concomitant cerebral hemorrhage.
  • microtubules made of platinum are preferably used in neuroradiology.
  • a particular problem is the separation of these occlusive agents from the carrier system following their placement.
  • a device for introducing an implant in which a pusher has at its distal portion a connecting part which consists of a material with thermal memory effect and temperature-dependent assumes different configurations, wherein the connecting part with the implant to the to be occluded when the connector is in a first configuration and disengages from the implant when in a second configuration.
  • the implant may be a micro-helix into which the connecting part engages.
  • the connecting part may also be helically configured in the first configuration, either pushing against the individual turns of the micro-coil from the inside or pushing apart the turns of the micro-coil and extending outwards beyond the generatrix of the micro-coil, so that the connecting part extends beyond the micro-coil Outside perimeter of the micro spiral protrudes.
  • the pitch or the pitch of the turns of the connecting part can correspond to that of the micro-helix.
  • a device for implanting occlusion coils in which a connecting part which engages in the interior of the occlusion helix is also provided at the distal end of a pre-shifter. It is at the connecting part to a corrugated rigid wire, whose corrugation is so strong that an inverted Okissesionssheddingl is held solely by frictional forces and can be stripped by retracting the feed dog and overcome the frictional forces of the connecting part.
  • the disadvantage is that the rigid connecting part projecting like a dagger and therefore there is a risk of perforating the aneurysm in case of improper handling.
  • Arrangements in which the connecting part engages in the interior of the micro-helix have the disadvantage that the proximal end of the micro-helix, which is protected during insertion by the pre-shifter, is open after disconnection of the connecting part and retraction of the pre-shifter is unprotected. It can not be ruled out that the open proximal end of the microcooling leads to vascular lesions in the region of the aneurysm.
  • a device for implanting occlusion helices is already proposed in EP 0826 341 A1, in which at least the distal end of the occlusion helix is closed by a rounded end piece.
  • a coupling piece is provided at the proximal end, which has a sharp-edged geometry after detachment from the pusher, which can lead to damage to the vessel wall.
  • the invention is based on the object to show a device for implantation of occlusion spirals in body cavities, in which a particularly simple and inexpensive to produce connecting part is provided, which is also used in closed at both ends Okklusionsdietaryln.
  • the occlusion helix can be brought into abutment upon retraction of the guiding and detaching means on an abutment of a slide sheath which receives the guiding and detaching means and then the connecting part can be detached from the occlusion helix by overcoming a mechanical holding force and by non-reversible plastic deformation of the connecting part , It is furthermore essential that the connecting part is a plastically deformable component which is transferred from its original configuration holding the occlusion helix into a second configuration by applying a mechanical force, in which the occlusion helix is released.
  • connecting parts with an elongated Configuration, for example in the form of a wire, the geometric design is particularly simple, wherein the connecting part of the elongated shape can be easily converted into the desired shape for fixing the occlusion helix.
  • a corresponding wire can thus have the same constant thickness over its entire length, including the longitudinal section forming the guiding and detaching means, and including the longitudinal section forming the connecting part.
  • the connecting part surrounds the proximal end of the occlusion helix radially on the outside.
  • Particularly advantageous connecting parts are considered, which are adapted in their contour to the occlusion helix. This can be the case for elongate, in particular wire-shaped connecting parts in that the connecting part according to claim 3 is designed as a helix and as such may have the same pitch as the occlusion helix (claim 4).
  • the individual turns of the connecting part are thereby optimally adapted to the outer contour of the occlusion helix and engage at least partially in the helically circulating grooves of two adjacent turns in this intermeshing contact of the helical connecting part with two adjacent turns to understand.
  • the length sections of the connecting part which are to some extent wound around the occlusion helix, must be pulled off the occlusion helix under plastic deformation.
  • At least one longitudinal section of a helical connecting part is clamped by adjacent widenings of the occlusion helix.
  • the spring force acting in the longitudinal direction of the occlusion helix is used to clamp at least one longitudinal section of the helical connection part between two adjacent turns of the occlusion helix.
  • the Clamping holders of a longitudinal section or a turn of the connecting part can take place in that, for example, a distal end of the connecting part is guided from the outside into the interior of the occlusion helix and is held by the turns of the occlusion helix.
  • the clamping-retained longitudinal section of the connecting part can be a secant of the circular cross-section of the occlusion helix. In principle, it may also be sufficient if a distal end of the connecting part is guided by the turns of the occlusion helix from the inside to the outside.
  • At least one turn-wrapped turn of the helical connection part may lie in the same sheath plane as the turns of the occlusion helix (claim 6).
  • the length section is helical between the turns of the occlusion helix. This means that the turns of the occlusion helix and of the connecting part alternate in the longitudinal direction of the occlusion helix, whereby a close-fitting bond between the connecting part and occlusion helix is given.
  • the wire diameter of the helical connection part is smaller than the wire diameter of the occlusion helix.
  • the wire diameter of the helical connecting part is dimensioned such that the connecting part can be plastically deformed even with little effort. The effort must be so small that only the connecting part is plastically deformed, whereas the occlusion helix should experience no plastic deformation.
  • the wire diameter of the occlusion helix and the connecting part are matched to one another according to this principle.
  • the helical connection part is releasably connected to the Fuhrungs- and release agent.
  • an occlusion helix with the connection part can form a preassembled unit, which in turn can be connected to the guiding and detaching means via a coupling.
  • the connecting part can be detached from the guiding and detaching means by decoupling, in order subsequently to possibly couple another unit consisting of connecting part and occlusion helix.
  • the connecting parts which essentially consist of a wire, can be supplied for disposal or recycling after their use.
  • the helical connecting part may be made of a different material than the guiding and detaching means itself (claim 9). This is particularly useful when the connecting part is detachably connected to the Fuhrungs- and release agent. It can therefore be used for the connecting part materials that allow a particularly simple plastic deformation and therefore allow detachment from the occlusion helix at low tensile forces.
  • the connecting part consists of a relation to the material of Fuhrungs- and release agent more elastic material. These may be metallic as well as non-metallic materials, e.g. Plastics act. The choice of an elastic material also ensures that the occlusion helix undergoes no damage even under mechanical stress in connection with the plastic deformation of the connecting part and maintains its intended configuration.
  • the material of the connecting part has a greater plastic deformability than the material of the occlusion helix (claim 11).
  • a sufficiently different ductility of the mutually engaged components ensures a separation of these components with very little effort.
  • the easier plastic deformability is a desired property of the connecting part.
  • the ends can be provided with rounded end elements. This may be, for example, a hemispherical end element, which is releasably or non-detachably connected to the coiled length section of the occlusion helix according to the features of claim 13.
  • a helical connection part may be guided past such a closure element on the outside and be held directly in the shell plane of the occlusion helix, so that neither an engagement in the interior of the occlusion helix is required nor does the occlusion helix reach around the outer circumference. It is therefore a very compact design possible.
  • the device according to the invention is suitable inter alia for implantation in vascular channels, e.g. in a duct Botalli, since there the Okklusionsplanetaryl is firmly anchored within the vessel channel and even with a rotation of the occlusion helix about its longitudinal axis, as it may occur when detaching the Okissesionssheddingl, no vascular damage is to be expected.
  • Figure 1 shows an aneurysm sac in cross section, in which by a
  • Catheter is inserted an occlusion helix
  • FIG. 2 is an enlarged view of the distal end of an endovascular guide and detachment device to which an occlusive device is fastened;
  • Figure 3 is a greatly enlarged view of a connecting part on a
  • Figure 4 shows a further embodiment of the connecting part on a
  • Figure 5 shows a third embodiment of a connecting part on a
  • Occlusion spiral also in partial section.
  • FIG. 1 shows a device 1 for implanting occlusion spirals 2 in body cavities 3.
  • the device is guided in a catheter 4, which protrudes into the aneurysm sack 3 in this exemplary embodiment.
  • the occlusion helix 2 is introduced through the catheter 4 into the aneurysm 3.
  • the occlusion helix 2 is fastened with its proximal end 5 to a guiding and detaching means 6, which is pushed through the catheter 4.
  • the guiding and detaching means 6 is a guide wire, at the distal end 7 of which a connecting part 10 is fixed.
  • the guidewire or the guiding and detaching means 6 is accommodated in a pusher sheath 8, which is introduced into the catheter 4 as a separate component.
  • FIG. 2 shows an embodiment with a catheter 4 and a slider sheath 8 arranged inside the catheter 4.
  • the guiding and detaching means 6 Within the slider sheath 8 is the guiding and detaching means 6, the distal end 7 of which is shown.
  • the distal end 7 is pointed or cone-shaped.
  • the diameter of the guiding and detaching means 6 may correspond to the diameter of the connecting part 10.
  • the diameter of the guiding and detaching means is 6 g greater than the diameter of the connecting part 10.
  • a schematically drawn coupling 9 is arranged. via which the connecting part 10 is connected to the guiding and detaching means 6.
  • the connecting part 10 is in this embodiment, a bent wire, made of a different material exists as the guiding and detaching means 6.
  • the coupling 10 between the guiding and detaching means 6 and the connecting part 10 may be detachable or insoluble. Preferably, it is a releasable coupling 9 according to the principle of positive engagement. It is also conceivable that the connecting part 10 is adhesively fixed to the Fuhrungs- and release agent 6.
  • the connecting part 10 itself is guided on the outside past the proximal end 5 of an occlusion helix 2 and in its further course passes between adjacent turns 12 of the occlusion helix 2.
  • the turns 12 of the helix-like connecting part 10 lie in the shell plane M of the occlusion helix 2.
  • the occlusion helix 2 For insertion into a body cavity, the occlusion helix 2 is pushed in front of the slider sheath 8 within the catheter 4 until it has reached its destination. In this case, the occlusion helix 2 is connected to the guiding and detaching means 6. For separating the occlusion helix 2 from the connecting part 10, the guiding and detaching means 6 is pulled into the catheter 4, whereby the proximal closed end 5 of the occlusion helix 2 comes to bear against the end face of the slider sheath 8.
  • the slider sheath 8 is provided at its distal end with a funnel-shaped mouth portion 13, which acts as an abutment.
  • the funnel-shaped mouth portion 13 is configured in this embodiment so that it engages in the recess between the distal end 7 of the guiding and detaching means 6 and the proximal end 5 of the occlusion helix 2.
  • the funnel-shaped mouth portion 13 may be provided with a plurality of circumferentially distributed slots 14, so that a plurality of obliquely inwardly pointing tongues prevent the Okissesionssheddingl 2 when retracting the Fuhrungs- and release agent 6 at the entrance to the slider sheath 8 , The connecting part 10 is thereby pulled through one of the slots 14, without being clamped between the occlusion helix 2 and the slider sheath 8.
  • both the distal end 15 and the proximal end 5 of the occlusion helix 2 are rounded. It is possible within the scope of the invention that the proximal end 5 has a flattening corresponding to the abutment 13 of the guiding and detaching means 6, in order to ensure a perfect abutment of the proximal end 5 of the occlusion helix 2 on the abutment 13.
  • FIGS. 3 to 5 illustrate possible arrangements of the helix-shaped connecting parts 16, 17, 18 on occlusion helixes 2.
  • the helical connecting part 16 is wound around the occlusion helix 2 on the outside.
  • the helical connecting part 16 in this case has the same pitch as the occlusion helix 2.
  • the sheath planes M, Mi of the helical connecting part 16 and the occlusion helix 2 are not in the same spatial plane, but rather describe cylinder jacket surfaces of different diameters.
  • the turns 19 of the helical connecting part 16 are supported on adjacent turns 11 of the occlusion helix 2.
  • the wire diameter D of the helical connecting part 16 is smaller than the wire diameter Di of the turns 11 of the occlusion helix 2, so that an easy stripping of the connecting part 16 by plastic deformation is possible.
  • FIG. 4 differs from that of FIG. 3 in that the indices 20 of the helical connection part 17 lie in the same shell level M 2 as the turns 11 of the occlusion helix 2.
  • the turns 20 of the connection part 17 are between the two Windings 11 of the occlusion helix 2 are clamped. This is possible because the distance A of two adjacent turns 11 of the occlusion helix 2 in a relaxed position is smaller than the wire diameter D of the connection part 17.
  • the turns 21 of the helical connecting part 18 are located on the turns 11 of the occlusion helix 2 from the inside on.
  • the sheath planes M 3 , M of the occlusion helix 2 and the helical connecting part 18 describe different cylinder jacket surfaces.
  • the occlusion helix 2 and the connecting part 18 have mutually matched pitches, so that a positive connection between these teeth is obtained.
  • a radially outwardly acting force can be exerted on the occlusion helix 2.
  • a radially inwardly directed force of the helical connecting part 16 can be provided in order to allow secure fixing by virtue of adhesion in addition to the positive connection.
  • the number of turns of the helical connection part 16, 17, 18 depends on the choice of the material of the connecting part, the elasticity and ductility of this material and the geometry of the connecting part 16, 17, 18 and the Okklusionsplanetaryl 2. Under certain circumstances, therefore, a or two turns should be sufficient to fix a Okklusionsplanetaryl 2 sufficiently.
  • the proximal ends of the occlusion helices 2 are not shown in detail. These can, like their distal ends 15, be closed by a hemispherical end element 22 which either engages in the interior of the occlusion helix 2 as an insert or, as shown in FIGS. 3 to 5, is connected to it in a materially bonded manner.
  • the occlusion helixes 2 are in practice significantly longer than they are shown in the schematic drawings, as the basis of the drawings n ur d the essential E elements at the proximal and distal ends are illustrated.

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Abstract

A device, for the implantation of occlusion coils (2) in body cavities, comprises a guide and release means (6), with a mechanically acting connector piece (10), arranged at the distal end (7) thereof, which has a direct positive engagement at least partly between the windings (11) on the occlusion coil (2). The occlusion coil (2) may be brought into contact with a projection (13) of a slide sleeve (8) housing the guide and release means (6) for the axial withdrawal of the guide and release means (6). The connector piece (10) is thus disconnected from the occlusion agent (2) by exceeding a mechanical retaining force with non-reversible plastic deformation.

Description

Vorrichtung zur Implantation von Okklusionswendeln in KörperhohlräumeDevice for implantation of occlusion coils in body cavities
Die Erfindung betrifft eine Vorrichtung zur Implantation von Okklusionswendeln in Körperhohlräume mit den Merkmalen im Oberbegriff des Patentanspruchs 1.The invention relates to a device for implanting occlusion spirals in body cavities with the features in the preamble of patent claim 1.
Die Behandlung intrakranieller Aneurysmen durch neuroradiologische Therapieformen zählt zum Stand der Technik. Hierbei wird subkutan von der Leiste aus ein Katheter in das Gefäßsystem eingeführt und das Aneurysma sondiert. Durch Applikation von Embolisationsmaterialien kann das Aneurysma verfüllt werden. Dadurch wird der hämodynamische Druck von der Gefäßwand genommen, um die Gefahr einer Aneurysmaruptur und einer damit einhergehenden Hirnblutung zu vermeiden.The treatment of intracranial aneurysms by neuroradiological forms of therapy is state of the art. Here, a catheter is inserted subcutaneously from the groin into the vascular system and the aneurysm is probed. Application of embolization materials will fill the aneurysm. This removes the hemodynamic pressure from the vessel wall to avoid the risk of aneurysm rupture and concomitant cerebral hemorrhage.
Als Okklusionsmittel zur Embolisation werden in der Neuroradiologie vorzugsweise Mikrowendeln aus Platin eingesetzt. Ein besonderes Problem ist die Trennung dieser Okklusionsmittel von dem Trägersystem im Anschluss an ihre Platzierung. Aus der EP 0 717 961 B1 ist ein Gerät zur Einführung eines Implantats bekannt, bei welchem ein Vorschieber an seinem distalen Abschnitt ein Verbindungsteil aufweist, der aus einem Werkstoff mit thermischem Memoryeffekt besteht und temperaturabhängig verschiedene Konfigurationen annimmt, wobei der Verbindungsteil mit dem Implantat zu dem zu okkludierenden Ort einrückt, wenn der Verbindungsteil sich in einer ersten Konfiguration befindet, und sich von dem Implantat löst, wenn er sich in einer zweiten Konfiguration befindet. Es kann sich bei dem Implantat um eine Mikrowendel handeln, in die der Verbindungsteil einfasst. Der Verbindungsteil kann in der ersten Konfiguration ebenfalls wendeiförmig konfiguriert sein, wobei er entweder von innen gegen die einzelnen Windungen der Mikrowendel drückt oder aber die Windungen der Mikrowendel auseinander drängt und sich über die Mantellinie der Mikrowendel hinausgehend nach außen erstreckt, so dass der Verbindungsteil über den Außenumfang der Mikrowendel vorsteht. Die Teilung bzw. die Steigung der Windungen des Verbindungsteils kann mit derjenigen der Mikrowendel korrespondieren.As occlusion agents for embolization, microtubules made of platinum are preferably used in neuroradiology. A particular problem is the separation of these occlusive agents from the carrier system following their placement. From EP 0 717 961 B1 a device for introducing an implant is known, in which a pusher has at its distal portion a connecting part which consists of a material with thermal memory effect and temperature-dependent assumes different configurations, wherein the connecting part with the implant to the to be occluded when the connector is in a first configuration and disengages from the implant when in a second configuration. The implant may be a micro-helix into which the connecting part engages. The connecting part may also be helically configured in the first configuration, either pushing against the individual turns of the micro-coil from the inside or pushing apart the turns of the micro-coil and extending outwards beyond the generatrix of the micro-coil, so that the connecting part extends beyond the micro-coil Outside perimeter of the micro spiral protrudes. The pitch or the pitch of the turns of the connecting part can correspond to that of the micro-helix.
Aus der WO 99/32037 ist eine Vorrichtung zum Implantieren von Okklusionswendeln bekannt, bei welcher am distalen Ende eines Vorschiebers ebenfalls ein Verbindungsteil vorgesehen ist, der in das Innere der Okklusionswendel eingreift. Es handelt sich bei dem Verbindungsteil um einen gewellten starren Draht, dessen Wellung so stark ausgeführt ist, dass eine darüber gestülpte Okklusionswendel allein durch Reibungskräfte daran gehalten ist und durch Zurückziehen des Vorschiebers und Überwindung der Reibungskräfte von dem Verbindungsteil abgestreift werden kann. Nachteilig ist, dass das starre Verbindungsteil dolchartig vorsteht und daher die Gefahr besteht, das Aneurysma bei unsachgemäßer Handhabung zu perforieren.From WO 99/32037 a device for implanting occlusion coils is known in which a connecting part which engages in the interior of the occlusion helix is also provided at the distal end of a pre-shifter. It is at the connecting part to a corrugated rigid wire, whose corrugation is so strong that an inverted Okklusionswendel is held solely by frictional forces and can be stripped by retracting the feed dog and overcome the frictional forces of the connecting part. The disadvantage is that the rigid connecting part projecting like a dagger and therefore there is a risk of perforating the aneurysm in case of improper handling.
Anordnungen, bei denen der Verbindungsteil in das Innere der Mikrowendel eingreift, haben den Nachteil, dass das beim Einführen durch den Vorschieber geschützte proximale Ende der Mikrowendel nach dem Abtrennen des Verbindungsteils und Zurückziehen des Vorschiebers offen und damit ungeschützt ist. Es ist nicht auszuschließen, dass das offene proximale Ende der Mikrowendel zu Gefäßverletzungen im Bereich des Aneurysmas führt.Arrangements in which the connecting part engages in the interior of the micro-helix have the disadvantage that the proximal end of the micro-helix, which is protected during insertion by the pre-shifter, is open after disconnection of the connecting part and retraction of the pre-shifter is unprotected. It can not be ruled out that the open proximal end of the microcooling leads to vascular lesions in the region of the aneurysm.
In der EP 0826 341 A1 wird bereits eine Vorrichtung zur Implantation von Okklusionswendeln vorgeschlagen, bei welcher zumindest das distale Ende der Okklusionswendel durch ein abgerundetes Abschlussstück verschlossen ist. Allerdings ist am proximalen Ende ein Kupplungsstück vorgesehen, das nach dem Ablösen von dem Vorschieber eine scharfkantige Geometrie aufweist, die zu Beschädigungen der Gefäßwand führen kann.A device for implanting occlusion helices is already proposed in EP 0826 341 A1, in which at least the distal end of the occlusion helix is closed by a rounded end piece. However, a coupling piece is provided at the proximal end, which has a sharp-edged geometry after detachment from the pusher, which can lead to damage to the vessel wall.
Hiervon ausgehend liegt der Erfindung die Aufgabe zu Grunde, eine Vorrichtung zur Implantation von Okklusionswendeln in Körperhohlräumen aufzuzeigen, bei welcher ein besonders einfacher und kostengünstig herstellbarer Verbindungsteil vorgesehen ist, der auch bei an beiden Enden verschlossenen Okklusionswendeln verwendbar ist.On this basis, the invention is based on the object to show a device for implantation of occlusion spirals in body cavities, in which a particularly simple and inexpensive to produce connecting part is provided, which is also used in closed at both ends Okklusionswendeln.
Die Erfindung löst d iese A ufgabe d urch e ine V orrichtung m it d en M erkmalen des Patentanspruchs 1.The invention solves this task by means of a device with the features of patent claim 1.
Erfindungswesentlich ist, dass die Okklusionswendel beim Zurückziehen des Fuhrungs- und Ablösemittels an einem Widerlager einer das Fuhrungs- und Ablösemittel aufnehmenden Schieberhülle zur Anlage bringbar ist und anschließend der Verbindungsteil durch Überwinden einer mechanischen Haltekraft und durch nicht reversible plastische Verformung des Verbindungsteils von der Okklusionswendel abkoppelbar ist. Wesentlich ist weiterhin, dass es sich bei dem Verbindungsteil um ein plastisch verformbares Bauteil handelt, der aus seiner ursprünglichen, die Okklusionswendel halternden Konfiguration durch Aufbringen einer mechanischen Kraft in eine zweite Konfiguration überführt wird, in welcher die Okklusionswendel freigegeben ist. Die Verwendung eines nicht reversiblen Verbindungsteils lässt bei der Herstellung größere Fertigungstoleranzen zu als es bei anderen formschlüssig ineinander greifenden Bauteilen möglich ist. Derartige Verbindungsteile sind daher kostengünstiger herstellbar. Bei Verbindungsteilen mit einer langgestreckten Konfiguration, beispielsweise in Form eines Drahtes, ist die geometrische Gestaltung besonders einfach, wobei der Verbindungsteil aus der langgestreckten Form sehr einfach in die gewünschte Form zur Fixierung der Okklusionswendel überführt werden kann. Ein entsprechender Draht kann über seine gesamte Länge also einschließlich des das Fuhrungs- und Ablösemittel bildenden Längenabschnitts und einschließlich des den Verbindungsteil bildenden Längenabschnitts die gleiche konstante Dicke besitzen.It is essential to the invention that the occlusion helix can be brought into abutment upon retraction of the guiding and detaching means on an abutment of a slide sheath which receives the guiding and detaching means and then the connecting part can be detached from the occlusion helix by overcoming a mechanical holding force and by non-reversible plastic deformation of the connecting part , It is furthermore essential that the connecting part is a plastically deformable component which is transferred from its original configuration holding the occlusion helix into a second configuration by applying a mechanical force, in which the occlusion helix is released. The use of a non-reversible connecting part allows for greater manufacturing tolerances in the production than is possible with other components that intermesh positively. Such connecting parts are therefore cheaper to produce. For connecting parts with an elongated Configuration, for example in the form of a wire, the geometric design is particularly simple, wherein the connecting part of the elongated shape can be easily converted into the desired shape for fixing the occlusion helix. A corresponding wire can thus have the same constant thickness over its entire length, including the longitudinal section forming the guiding and detaching means, and including the longitudinal section forming the connecting part.
Gemäß den Merkmalen des Patentanspruchs 2 umgreift der Verbindungsteil das proximale Ende der Okklusionswendel radial außenseitig. Als besonders vorteilhaft werden Verbindungsteile angesehen, die in ihrer Kontur an die Okklusionswendel angepasst sind. Dies kann bei langgestreckten, insbesondere drahtförmigen Verbindungsteilen dadurch der Fall sein, dass der Verbindungsteil gemäß Patentanspruch 3 als Helix ausgestaltet ist und als solcher die gleiche Steigung aufweisen kann, wie die Okklusionswendel (Patentanspruch 4). Die einzelnen Windungen des Verbindungsteils sind dadurch optimal an die äußere Kontur der Okklusionswendel angepasst und greifen zumindest teilweise in die helixartig umlaufenden Rillen zweier benachbarter Windungen e in. U nter E ingreifen i st i n d iesem Z usammenhang ein Anliegen des helixartigen Verbindungsteils an je zwei benachbarten Windungen zu verstehen. Zum Ablösen des Verbindungsteils müssen die gewissermaßen um die Okklusionswendel gewickelten Längenabschnitte des Verbindungsteils unter plastischer Verformung von der Okklusionswendel abgezogen werden.According to the features of claim 2, the connecting part surrounds the proximal end of the occlusion helix radially on the outside. Particularly advantageous connecting parts are considered, which are adapted in their contour to the occlusion helix. This can be the case for elongate, in particular wire-shaped connecting parts in that the connecting part according to claim 3 is designed as a helix and as such may have the same pitch as the occlusion helix (claim 4). The individual turns of the connecting part are thereby optimally adapted to the outer contour of the occlusion helix and engage at least partially in the helically circulating grooves of two adjacent turns in this intermeshing contact of the helical connecting part with two adjacent turns to understand. In order to detach the connecting part, the length sections of the connecting part, which are to some extent wound around the occlusion helix, must be pulled off the occlusion helix under plastic deformation.
In der Ausführungsform des Patentanspruchs 5 ist vorgesehen, dass wenigstens ein Längenabschnitt eines helixartigen Verbindungsteils von einander b enachbarten W indungen der Okklusionswendel klemmgehaltert ist. Bei dieser Konfiguration wird zur Fixierung des helixartigen Verbindungsteils die in Längsrichtung der Okklusionswendel wirkende Federkraft dazu benutzt, wenigstens einen Längenabschnitt des helixartigen Verbindungsteils zwischen zwei benachbarten Windungen der Okklusionswendel einzuklemmen. Das Klemmhaltern eines Längenabschnitts oder einer Windung des Verbindungsteils kann dadurch erfolgen, dass beispielsweise ein distales Ende des Verbindungsteils von außen in das Innere der Okklusionswendel geführt ist und von den Windungen der Okklusionswendel gehalten ist. Dabei kann der klemmgehalterte Längenabschnitt des Verbindungsteils eine Sekante des Kreisquerschnitts der Okklusionswendel sein. Grundsätzlich kann es auch ausreichend sein, wenn ein distales Ende des Verbindungsteils durch die Windungen der Okklusionswendel von innen nach außen geführt ist.In the embodiment of patent claim 5, it is provided that at least one longitudinal section of a helical connecting part is clamped by adjacent widenings of the occlusion helix. In this configuration, to fix the helical connection part, the spring force acting in the longitudinal direction of the occlusion helix is used to clamp at least one longitudinal section of the helical connection part between two adjacent turns of the occlusion helix. The Clamping holders of a longitudinal section or a turn of the connecting part can take place in that, for example, a distal end of the connecting part is guided from the outside into the interior of the occlusion helix and is held by the turns of the occlusion helix. In this case, the clamping-retained longitudinal section of the connecting part can be a secant of the circular cross-section of the occlusion helix. In principle, it may also be sufficient if a distal end of the connecting part is guided by the turns of the occlusion helix from the inside to the outside.
Es ist auch möglich, dass wenigstens eine klemmgehalterte Windung des helixartigen Verbindungsteils in der gleichen Mantelebene liegt wie die Windungen der Okklusionswendel (Patentanspruch 6). Bei dieser Konfiguration liegt der Längenabschnitt helixartig zwischen den Windungen der Okklusionswendel. Das bedeutet, dass sich die Windungen der Okklusionswendel und des Verbindungsteils im Längsverlauf der Okklusionswendel einander abwechseln, wodurch ein eng anliegender Verbund zwischen Verbindungsteil und Okklusionswendel gegeben ist.It is also possible for at least one turn-wrapped turn of the helical connection part to lie in the same sheath plane as the turns of the occlusion helix (claim 6). In this configuration, the length section is helical between the turns of the occlusion helix. This means that the turns of the occlusion helix and of the connecting part alternate in the longitudinal direction of the occlusion helix, whereby a close-fitting bond between the connecting part and occlusion helix is given.
In der Ausführungsform des Patentanspruchs 7 ist der Drahtdurchmesser des helixartigen Verbindungsteils kleiner als der Drahtdurchmesser der Okklusionswendel. Der Drahtdurchmesser des helixartigen Verbindungsteils ist dabei so bemessen, dass der Verbindungsteil bereits bei geringem Kraftaufwand plastisch verformt werden kann. Der Kraftaufwand muss so gering sein, dass lediglich der Verbindungsteil plastisch verformt wird, wohingegen die Okklusionswendel keinerlei plastische Verformung erfahren soll. Die Drahtdurchmesser der Okklusionswendel und des Verbindungsteils sind nach diesem Grundsatz aufeinander abgestimmt.In the embodiment of claim 7, the wire diameter of the helical connection part is smaller than the wire diameter of the occlusion helix. The wire diameter of the helical connecting part is dimensioned such that the connecting part can be plastically deformed even with little effort. The effort must be so small that only the connecting part is plastically deformed, whereas the occlusion helix should experience no plastic deformation. The wire diameter of the occlusion helix and the connecting part are matched to one another according to this principle.
Gemäß Patentanspruch 8 ist der helixartige Verbindungsteil lösbar mit dem Fuhrungs- und Ablösemittel verbunden. In der Praxis kann eine Okklusionswendel mit dem Verbindungsteil eine vormontierte Einheit bilden, die wiederum über eine Kupplung mit dem Fuhrungs- und Ablösemittel verbunden sein kann. Nach der Platzierung der Okklusionswendel und dem Zurückziehen des Fuhrungs- und Ablösemittels kann d er Verbindungsteil d urch Entkuppeln von dem Fuhrungs- und Ablösemittel gelöst werden, um anschließend ggf. eine weitere Einheit, bestehend aus Verbindungsteil und Okklusionswendel, anzukoppeln. Die Verbindungsteile, die im Wesentlichen aus einem Draht bestehen, können nach ihrer Verwendung der Entsorgung oder dem Recycling zugeführt werden.According to claim 8, the helical connection part is releasably connected to the Fuhrungs- and release agent. In practice, an occlusion helix with the connection part can form a preassembled unit, which in turn can be connected to the guiding and detaching means via a coupling. After the placement of the occlusion helix and the retraction of the guiding and detaching means, the connecting part can be detached from the guiding and detaching means by decoupling, in order subsequently to possibly couple another unit consisting of connecting part and occlusion helix. The connecting parts, which essentially consist of a wire, can be supplied for disposal or recycling after their use.
Grundsätzlich kann der helixartige Verbindungsteil aus einem anderen Werkstoff bestehen als der Fuhrungs- und Ablösemittel selbst (Patentanspruch 9). Dies ist insbesondere dann zweckmäßig, wenn der Verbindungsteil lösbar mit dem Fuhrungs- und Ablösemittel verbunden ist. Es können daher für den Verbindungsteil Werkstoffe eingesetzt werden, die eine besonders einfache plastische Verformung zulassen und daher eine Ablösung von der Okklusionswendel bei geringen Zugkräften ermöglichen. In diesem Zusammenhang ist nach Patentanspruch 10 vorgesehen, dass der Verbindungsteil aus einem gegenüber dem Werkstoff des Fuhrungs- und Ablösemittel elastischeren Werkstoff besteht. Hierbei kann es sich sowohl um metallische als auch um nicht metallische Werkstoffe wie z.B. Kunststoffe handeln. Die Wahl eines elastischen Werkstoffs stellt zudem sicher, dass die Okklusionswendel auch bei mechanischer Beanspruchung im Zusammenhang mit der plastischen Umformung des Verbindungsteils keine Beschädigungen erfährt und die ihr zugedachte Konfiguration beibehält.In principle, the helical connecting part may be made of a different material than the guiding and detaching means itself (claim 9). This is particularly useful when the connecting part is detachably connected to the Fuhrungs- and release agent. It can therefore be used for the connecting part materials that allow a particularly simple plastic deformation and therefore allow detachment from the occlusion helix at low tensile forces. In this context, it is provided according to claim 10, that the connecting part consists of a relation to the material of Fuhrungs- and release agent more elastic material. These may be metallic as well as non-metallic materials, e.g. Plastics act. The choice of an elastic material also ensures that the occlusion helix undergoes no damage even under mechanical stress in connection with the plastic deformation of the connecting part and maintains its intended configuration.
Es ist auch von Vorteil, wenn der Werkstoff des Verbindungsteils eine größere plastische Verformbarkeit aufweist als der Werkstoff der Okklusionswendel (Patentanspruch 11). Eine hinreichend unterschiedliche Duktilität der miteinander im Eingriff stehenden Bauteile gewährleistet eine Trennung dieser Bauteile bei sehr geringem Kraftaufwand. Die leichtere plastische Verformbarkeit ist eine gewünschte Eigenschaft des Verbindungsteils. Als vorteilhaft wird es angesehen, dass bei der erfindungsgemäßen Vorrichtung die Möglichkeit besteht, die Okklusionswendel sowohl an ihrem proximalen als auch an ihrem distalen Ende verschlossen zu gestalten (Patentanspruch 12). Insbesondere können die Enden mit abgerundeten Abschlusselementen versehen sein. Dies kann nach den Merkmalen des Patentanspruchs 13 beispielsweise ein halbkugelartiges Abschlusselement sein, das lösbar oder unlösbar mit dem gewendelten Längenabschnitt der Okklusionswendel verbunden ist.It is also advantageous if the material of the connecting part has a greater plastic deformability than the material of the occlusion helix (claim 11). A sufficiently different ductility of the mutually engaged components ensures a separation of these components with very little effort. The easier plastic deformability is a desired property of the connecting part. It is regarded as advantageous that in the device according to the invention it is possible to make the occlusion helix both at its proximal end and at its distal end closed (claim 12). In particular, the ends can be provided with rounded end elements. This may be, for example, a hemispherical end element, which is releasably or non-detachably connected to the coiled length section of the occlusion helix according to the features of claim 13.
Ein helixartiger Verbindungsteil kann außenseitig an einem solchen Abschlusselement vorbeigeführt sein und unmittelbar in der Mantelebene der Okklusionswendel gehaltert sein, so dass weder ein Eingriff in das Innere der Okklusionswendel erforderlich ist noch ein Umgreifen der Okklusionswendel im Bereich des Außenumfangs erfolgt. Es ist daher eine sehr kompakte Bauweise möglich.A helical connection part may be guided past such a closure element on the outside and be held directly in the shell plane of the occlusion helix, so that neither an engagement in the interior of the occlusion helix is required nor does the occlusion helix reach around the outer circumference. It is therefore a very compact design possible.
Die erfindungsgemäße Vorrichtung eignet sich unter anderem zur Implantation in Gefäßkanäle, z.B. in einen Ductus Botalli, da dort die Okklusionswendel fest innerhalb des Gefäßkanals verankert ist und auch bei einer Drehung der Okklusionswendel um ihre Längsachse, wie es beim Ablösen der Okklusionswendel auftreten kann, keine Gefäßbeschädigung zu erwarten ist.The device according to the invention is suitable inter alia for implantation in vascular channels, e.g. in a duct Botalli, since there the Okklusionswendel is firmly anchored within the vessel channel and even with a rotation of the occlusion helix about its longitudinal axis, as it may occur when detaching the Okklusionswendel, no vascular damage is to be expected.
Die Erfindung wird nachfolgend anhand von den in Zeichnungen dargestellten Ausführungsbeispielen näher erläutert. Es zeigen:The invention will be explained in more detail with reference to the embodiments illustrated in the drawings. Show it:
Figur 1 einen Aneurysmasack im Querschnitt, in welchen durch einenFigure 1 shows an aneurysm sac in cross section, in which by a
Katheter eine Okklusionswendel eingeführt wird;Catheter is inserted an occlusion helix;
Figur 2 in vergrößerter Darstellung das distale Ende eines endovaskulä- ren Fuhrungs- und Ablösemittels, an welchem ein Okklusionsmittel befestigt ist; Figur 3 eine stark vergrößerte Darstellung eines Verbindungsteils an einerFIG. 2 is an enlarged view of the distal end of an endovascular guide and detachment device to which an occlusive device is fastened; Figure 3 is a greatly enlarged view of a connecting part on a
Okklusionswendel im Teilschnitt;Occlusion helix in partial section;
Figur 4 eine weitere Ausführungsform des Verbindungsteils an einerFigure 4 shows a further embodiment of the connecting part on a
Okklusionswendel im Teilschnitt undOcclusion helix in partial section and
Figur 5 eine dritte Ausführungsform eines Verbindungsteils an einerFigure 5 shows a third embodiment of a connecting part on a
Okklusionswendel, ebenfalls im Teilschnitt.Occlusion spiral, also in partial section.
Figur 1 zeigt eine Vorrichtung 1 zur Implantation von Okklusionswendeln 2 in Körperhohlräumen 3. Die Vorrichtung ist in einem Katheter 4 geführt, der in diesem Ausführungsbeispiel in den Aneurysmasack 3 ragt. Die Okklusionswendel 2 wird dabei durch den Katheter 4 in das Aneurysma 3 eingeführt. Die Okklusionswendel 2 ist hierzu mit ihrem proximalen Ende 5 an einem Fuhrungs- und Ablösemittel 6 befestigt, das durch den Katheter 4 geschoben wird.FIG. 1 shows a device 1 for implanting occlusion spirals 2 in body cavities 3. The device is guided in a catheter 4, which protrudes into the aneurysm sack 3 in this exemplary embodiment. The occlusion helix 2 is introduced through the catheter 4 into the aneurysm 3. For this purpose, the occlusion helix 2 is fastened with its proximal end 5 to a guiding and detaching means 6, which is pushed through the catheter 4.
Bei dem Fuhrungs- und Ablösemittel 6 handelt es sich um einen Führungsdraht, an dessen distalem Ende 7 ein Verbindungsteil 10 fixiert ist. Der Führungsdraht bzw. das Fuhrungs- und Ablösemittel 6 ist in einer Schieberhülle 8 aufgenommen, die als separates Bauteil in den Katheter 4 eingeführt ist. Figur 2 zeigt eine Ausführungsform mit einem Katheter 4 und einer innerhalb des Katheters 4 angeordneten Schieberhülle 8. Innerhalb der Schieberhülle 8 befindet sich das Fuhrungs- und Ablösemittel 6, dessen distales Ende 7 dargestellt ist. Das distale Ende 7 ist angespitzt bzw. kegelförmig ausgeführt. Grundsätzlich kann der Durchmesser des Fuhrungs- und Ablösemittels 6 dem Durchmesser des Verbindungsteils 10 entsprechen. In diesem Ausführungsbeispiel ist der Durchmesser des Fuhrungs- und Ablösemittels 6 g rößer a Is d er Durchmesser des Verbindungsteils 10. A n d er ä ußersten S pitze d es d istalen Endes 7 des Fuhrungs- und Ablösemittels 6 ist eine schematisch gezeichnete Kupplung 9 angeordnet, über die der Verbindungsteil 10 mit dem Führungsund Ablösemittel 6 verbunden ist. Der Verbindungsteil 10 ist in diesem Ausführungsbeispiel ein gebogener Draht, der aus einem anderen Werkstoff besteht als das Fuhrungs- und Ablösemittel 6. Die Kupplung 10 zwischen dem Fuhrungs- und Ablösemittel 6 und dem Verbindungsteil 10 kann lösbar oder unlösbar sein. Vorzugsweise handelt es sich um eine lösbare Kupplung 9 nach dem Prinzip des Formschlusses. Es ist auch denkbar, dass der Verbindungsteil 10 klebetechnisch an dem Fuhrungs- und Ablösemittel 6 fixiert ist.The guiding and detaching means 6 is a guide wire, at the distal end 7 of which a connecting part 10 is fixed. The guidewire or the guiding and detaching means 6 is accommodated in a pusher sheath 8, which is introduced into the catheter 4 as a separate component. FIG. 2 shows an embodiment with a catheter 4 and a slider sheath 8 arranged inside the catheter 4. Within the slider sheath 8 is the guiding and detaching means 6, the distal end 7 of which is shown. The distal end 7 is pointed or cone-shaped. In principle, the diameter of the guiding and detaching means 6 may correspond to the diameter of the connecting part 10. In this exemplary embodiment, the diameter of the guiding and detaching means is 6 g greater than the diameter of the connecting part 10. At the outermost point of the distal end 7 of the guiding and detaching means 6, a schematically drawn coupling 9 is arranged. via which the connecting part 10 is connected to the guiding and detaching means 6. The connecting part 10 is in this embodiment, a bent wire, made of a different material exists as the guiding and detaching means 6. The coupling 10 between the guiding and detaching means 6 and the connecting part 10 may be detachable or insoluble. Preferably, it is a releasable coupling 9 according to the principle of positive engagement. It is also conceivable that the connecting part 10 is adhesively fixed to the Fuhrungs- and release agent 6.
Der Verbindungsteil 10 selbst ist an dem proximalen Ende 5 einer Okklusionswendel 2 außenseitig vorbei geführt und fasst in seinem weiteren Verlauf zwischen einander benachbarte Windungen 12 der Okklusionswendel 2. Bei diesem Ausführungsbeispiel liegen die Windungen 12 des helixartigen Verbindungsteils 10 in der Mantelebene M der Okklusionswendel 2.The connecting part 10 itself is guided on the outside past the proximal end 5 of an occlusion helix 2 and in its further course passes between adjacent turns 12 of the occlusion helix 2. In this embodiment, the turns 12 of the helix-like connecting part 10 lie in the shell plane M of the occlusion helix 2.
Zum Einführen in einen Körperhohlraum wird die Okklusionswendel 2 vor der Schieberhülle 8 innerhalb des Katheters 4 hergeschoben bis sie ihr Ziel erreicht hat. Dabei ist die Okklusionswendel 2 mit dem Fuhrungs- und Ablösemittel 6 verbunden. Zum Abtrennen der Okklusionswendel 2 von dem Verbindungsteil 10 wird das Fuhrungs- und Ablösemittel 6 in den Katheter 4 hinein gezogen, wobei das proximale geschlossene Ende 5 der Okklusionswendel 2 an der Schieberhülle 8 stirnseitig zur Anlage gelangt. Die Schieberhülle 8 ist an ihrem distalen Ende mit einem trichterförmigen Mündungsabschnitt 13 versehen, der als Widerlager fungiert. Der trichterförmige Mündungsabschnitt 13 ist in diesem Ausführungsbeispiel so konfiguriert, dass er in die Aussparung zwischen dem distalen Ende 7 des Fuhrungs- und Ablösemittels 6 und dem proximalen Ende 5 der Okklusionswendel 2 einfasst. Um das Ablösen der Okklusionswendel 2 zu erleichtern, kann der trichterförmige Mündungsabschnitt 13 mit mehreren a m Umfang verteilten Schlitzen 14 versehen sein, so dass mehrere schräg nach innen weisende Zungen die Okklusionswendel 2 beim Zurückziehen des Fuhrungs- und Ablösemittels 6 am Eintritt in die Schieberhülle 8 hindern. Der Verbindungsteil 10 wird dabei durch einen der Schlitze 14 gezogen, ohne dass er zwischen der Okklusionswendel 2 und der Schieberhülle 8 eingeklemmt wird. In diesem Ausführungsbeispiel ist sowohl das distale Ende 15 als auch das proximale Ende 5 der Okklusionswendel 2 abgerundet ausgeführt. Es ist im Rahmen der Erfindung möglich, dass das proximale Ende 5 eine mit dem Widerlager 13 des Fuhrungs- und Ablösemittels 6 korrespondierende Abflachung aufweist, um eine einwandfreie Anlage des proximalen Endes 5 der Okklusionswendel 2 am Widerlager 13 zu gewährleisten.For insertion into a body cavity, the occlusion helix 2 is pushed in front of the slider sheath 8 within the catheter 4 until it has reached its destination. In this case, the occlusion helix 2 is connected to the guiding and detaching means 6. For separating the occlusion helix 2 from the connecting part 10, the guiding and detaching means 6 is pulled into the catheter 4, whereby the proximal closed end 5 of the occlusion helix 2 comes to bear against the end face of the slider sheath 8. The slider sheath 8 is provided at its distal end with a funnel-shaped mouth portion 13, which acts as an abutment. The funnel-shaped mouth portion 13 is configured in this embodiment so that it engages in the recess between the distal end 7 of the guiding and detaching means 6 and the proximal end 5 of the occlusion helix 2. In order to facilitate the detachment of the occlusion helix 2, the funnel-shaped mouth portion 13 may be provided with a plurality of circumferentially distributed slots 14, so that a plurality of obliquely inwardly pointing tongues prevent the Okklusionswendel 2 when retracting the Fuhrungs- and release agent 6 at the entrance to the slider sheath 8 , The connecting part 10 is thereby pulled through one of the slots 14, without being clamped between the occlusion helix 2 and the slider sheath 8. In this embodiment, both the distal end 15 and the proximal end 5 of the occlusion helix 2 are rounded. It is possible within the scope of the invention that the proximal end 5 has a flattening corresponding to the abutment 13 of the guiding and detaching means 6, in order to ensure a perfect abutment of the proximal end 5 of the occlusion helix 2 on the abutment 13.
Die Figuren 3 bis 5 verdeutlichen mögliche Anordnungen der als Helix ausgestalteten Verbindungsteile 16, 17, 18 an Okklusionswendeln 2. In der Ausführungsform der Figur 3 ist der helixartige Verbindungsteil 16 außen um die Okklusionswendel 2 herum gewickelt. Der helixartige Verbindungsteil 16 weist dabei die gleiche Steigung auf wie die Okklusionswendel 2. B ei d ieser Anordnung liegen die Mantelebenen M, Mi des helixartigen Verbindungsteils 16 und der Okklusionswendel 2 nicht in der gleichen räumlichen Ebene, sondern beschreiben vielmehr Zylindermantelflächen unterschiedlichen Durchmessers. Die Windungen 19 des helixartigen Verbindungsteils 16 stützen sich dabei an jeweils benachbarten Windungen 11 der Okklusionswendel 2 ab. Der Drahtdurchmesser D des helixartigen Verbindungsteils 16 ist kleiner als der Drahtdurchmesser Di der Windungen 11 der Okklusionswendel 2, so dass ein leichtes Abstreifen des Verbindungsteils 16 durch plastische Verformung möglich ist.FIGS. 3 to 5 illustrate possible arrangements of the helix-shaped connecting parts 16, 17, 18 on occlusion helixes 2. In the embodiment of FIG. 3, the helical connecting part 16 is wound around the occlusion helix 2 on the outside. The helical connecting part 16 in this case has the same pitch as the occlusion helix 2. In this arrangement, the sheath planes M, Mi of the helical connecting part 16 and the occlusion helix 2 are not in the same spatial plane, but rather describe cylinder jacket surfaces of different diameters. The turns 19 of the helical connecting part 16 are supported on adjacent turns 11 of the occlusion helix 2. The wire diameter D of the helical connecting part 16 is smaller than the wire diameter Di of the turns 11 of the occlusion helix 2, so that an easy stripping of the connecting part 16 by plastic deformation is possible.
Die Ausführungsform der Figur 4 unterscheidet sich von derjenigen der Figur 3 dadurch, d ass d ie W indungen 20 des helixartigen Verbindungsteils 17 in der gleichen Mantelebene M2 liegen, wie die Windungen 11 der Okklusionswendel 2. Die Windungen 20 des Verbindungsteils 17 sind zwischen den Windungen 11 der Okklusionswendel 2 klemmgehaltert. Dies ist möglich, weil der Abstand A zweier benachbarter Windungen 11 der Okklusionswendel 2 in entspannter Position kleiner ist als der Drahtdurchmesser D des Verbindungsteils 17.The embodiment of FIG. 4 differs from that of FIG. 3 in that the indices 20 of the helical connection part 17 lie in the same shell level M 2 as the turns 11 of the occlusion helix 2. The turns 20 of the connection part 17 are between the two Windings 11 of the occlusion helix 2 are clamped. This is possible because the distance A of two adjacent turns 11 of the occlusion helix 2 in a relaxed position is smaller than the wire diameter D of the connection part 17.
In der Ausführungsform der Figur 5 liegen die Windungen 21 des helixartigen Verbindungsteils 18 von innen an den Windungen 11 der Okklusionswendel 2 an. Die Mantelebenen M3, M der Okklusionswendel 2 und des helixartigen Verbindungsteils 18 beschreiben unterschiedliche Zylindermantelflächen. Bei dieser Ausführungsform besitzen die Okklusionswendel 2 und der Verbindungsteil 18 aufeinander abgestimmte Steigungen, so dass sich ein formschlüssiger Verbund zwischen d iesen B auteilen ergibt. Zusätzlich kann je nach Vorspannung des helixartigen Verbindungsteils 18 eine radial nach außen wirkende Kraft auf die Okklusionswendel 2 ausgeübt werden. Umgekehrt kann bei der in Figur 3 dargestellten außenseitigen Umwicklung eine radial nach innen gerichtete Kraft des helixartigen Verbindungsteils 16 vorgesehen sein, um zusätzlich zu der formschlüssigen Verbindung eine sichere Fixierung durch Kraftschluss zu ermöglichen.In the embodiment of FIG. 5, the turns 21 of the helical connecting part 18 are located on the turns 11 of the occlusion helix 2 from the inside on. The sheath planes M 3 , M of the occlusion helix 2 and the helical connecting part 18 describe different cylinder jacket surfaces. In this embodiment, the occlusion helix 2 and the connecting part 18 have mutually matched pitches, so that a positive connection between these teeth is obtained. In addition, depending on the bias of the helical connecting part 18, a radially outwardly acting force can be exerted on the occlusion helix 2. Conversely, in the case of the outer side winding shown in FIG. 3, a radially inwardly directed force of the helical connecting part 16 can be provided in order to allow secure fixing by virtue of adhesion in addition to the positive connection.
Die Anzahl der Windungen des helixartigen Verbindungsteils 16, 17, 18 ist abhängig von der Wahl des Materials des Verbindungsteils, der Elastizität und Duktilität dieses Materials sowie der Geometrie des Verbindungsteils 16, 17, 18 und der Okklusionswendel 2. Unter Umständen können daher bereits ein oder zwei Windungen ausreichend sein, um eine Okklusionswendel 2 hinreichend zu fixieren. In den Ausführungsbeispielen der Figuren 3 bis 5 sind die proximalen Enden der Okklusionswendeln 2 nicht näher dargestellt. Diese können ebenso wie ihre distalen Enden 15 mit einem halbkugelartigen Abschlusselement 22 verschlossen sein, das entweder als Einsatz in das Innere der Okklusionswendel 2 greift oder, wie es in den Figuren 3 bis 5 dargestellt ist, stoffschlüssig mit diesem verbunden ist. Die Okklusionswendeln 2 sind in der Praxis deutlich länger als sie in den schematischen Zeichnungen dargestellt sind, da anhand der Zeichnungen n ur d ie wesentlichen E lemente am proximalen und distalen Ende verdeutlicht werden. Bezuαszeichenaufstellunq:The number of turns of the helical connection part 16, 17, 18 depends on the choice of the material of the connecting part, the elasticity and ductility of this material and the geometry of the connecting part 16, 17, 18 and the Okklusionswendel 2. Under certain circumstances, therefore, a or two turns should be sufficient to fix a Okklusionswendel 2 sufficiently. In the embodiments of Figures 3 to 5, the proximal ends of the occlusion helices 2 are not shown in detail. These can, like their distal ends 15, be closed by a hemispherical end element 22 which either engages in the interior of the occlusion helix 2 as an insert or, as shown in FIGS. 3 to 5, is connected to it in a materially bonded manner. The occlusion helixes 2 are in practice significantly longer than they are shown in the schematic drawings, as the basis of the drawings n ur d the essential E elements at the proximal and distal ends are illustrated. Bezuαszeichenaufstellunq:
1 - Vorrichtung1 - device
2 - Okklusionswendel2 - occlusion helix
3 - Körperhohlraum3 - body cavity
4 - Katheter4 - Catheter
5 - proximales Ende von 25 - proximal end of 2
6 - Fuhrungs- und Ablösemittel6 - Guiding and detaching means
7 - distales Ende von 67 - distal end of 6
8 - Schieberhülle8 - slider cover
9 - Kupplung9 - coupling
10 - Verbindungsteil 11 - Windung von 210 - connecting part 11 - winding of 2
12 - Windung von 1012 - turn of 10
13 - Mündungsabschnitt, Widerlager13 - mouth section, abutment
14 - Schlitz14 - slot
15 - distales Ende von 215 - distal end of 2
16 - Verbindungsteil16 - connecting part
17 - Verbindungsteil17 - connecting part
18 - Verbindungsteil18 - connecting part
19 - Windung von 1619 - turn of 16
20 - Windungen von 1720 - turns of 17
21 - Windungen von 1821 - turns of 18
22 - Abschlusselement22 - end element
M - Mantelebene von 2M - sheath level of 2
M1 - Mantelebene von 16M1 - shell level of 16
M2 - Mantelebene von 17M2 - shell level of 17
M3 - Mantelebene von 18M3 - shell level of 18
D - Drahtdurchmesser von 16, 17D - wire diameter of 16, 17
D1 - Drahtdurchmesser von 11 D1 - wire diameter of 11

Claims

Patentansprüche Claims
1. Vorrichtung zur Implantation von Okklusionswendeln in Körperhohlräume, mit einem Fuhrungs- und Ablösemittel (6), an dessen distalen Ende (7) ein mechanisch wirkendes Verbindungsteil (10, 16, 17, 18) angeordnet ist, welches unmittelbar formschlüssig zumindest teilweise zwischen die Windungen (11 ) der Okklusionswendel (2) fasst, dadurch gekennzeichnet, dass die Okklusionswendel (2) beim axialen Zurückziehen des Fuhrungs- und Ablösemittels (6) an einem Widerlager (13) einer das Fuhrungs- und Ablösemittel (6) aufnehmenden Schieberhülle (8) zur Anlage bringbar und der Verbindungsteil (10, 16, 17, 18) durch Überwinden einer mechanischen Haltekraft und durch nichtreversible plastische Verformung des Verbindungsteils (10, 16, 17, 18) von der Okklusionswendel (2) abkoppelbar ist.1. Device for implanting occlusion coils in body cavities, with a guiding and detaching means (6), at the distal end (7) of which a mechanically acting connecting part (10, 16, 17, 18) is arranged, which is at least partially directly interlocked between the Windings (11) of the occlusion helix (2), characterized in that the occlusion helix (2) during axial withdrawal of the guiding and releasing means (6) on an abutment (13) of a slide sleeve (8) receiving the guiding and releasing means (6) ) can be brought into contact and the connecting part (10, 16, 17, 18) can be uncoupled from the occlusion helix (2) by overcoming a mechanical holding force and by non-reversible plastic deformation of the connecting part (10, 16, 17, 18).
2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass der Verbindungsteil (10, 16) das proximale Ende (5) der Okklusionswendel (2) radial außenseitig umgreift.2. Device according to claim 1, characterized in that the connecting part (10, 16) surrounds the proximal end (5) of the occlusion coil (2) radially on the outside.
3. Vorrichtung nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass das Verbindungsteil (10, 16, 17, 18) als Helix ausgestaltet ist.3. Device according to claim 1 or 2, characterized in that the connecting part (10, 16, 17, 18) is designed as a helix.
4. Vorrichtung nach Anspruch 3, dadurch gekennzeichnet, dass der helixartige Verbindungsteil (10, 16, 17, 18) eine an die Okklusionswendel (2) angepasste Steigung aufweist.4. The device according to claim 3, characterized in that the helical connecting part (10, 16, 17, 18) has a slope adapted to the occlusion helix (2).
5. Vorrichtung nach Anspruch 3 oder 4, dadurch gekennzeichnet, dass wenigstens ein Längenabschnitt des helixartigen Verbindungsteils (10, 17) von einander benachbarten Windungen (11) der Okklusionswendel (2) klemmgehaltert ist.5. The device according to claim 3 or 4, characterized in that at least one longitudinal section of the helical connecting part (10, 17) of adjacent turns (11) of the occlusion helix (2) is clamped.
6. Vorrichtung nach Anspruch 5, dadurch gekennzeichnet, dass die wenigstens eine klemmgehalterte Windung (17) des helixartigen Verbindungsteils in der gleichen Mantelebene (M, M2) liegt wie die Windungen (11) der Okklusionswendel (2).6. The device according to claim 5, characterized in that the at least one clamp-held turn (17) of the helical connecting part lies in the same jacket plane (M, M 2 ) as the turns (11) of the occlusion helix (2).
7. Vorrichtung nach einemd erAnsprüche 3 bis 6, d ad u rch gekennzeichnet, dass der Drahtdurchmesser (D) des Verbindungsteils (10, 16, 17, 18) kleiner ist als der Drahtdurchmesser (Di) der Okklusionswendel (2).7. Device according to one of claims 3 to 6, characterized in that the wire diameter (D) of the connecting part (10, 16, 17, 18) is smaller than the wire diameter (Di) of the occlusion coil (2).
8. Vorrichtung nach e inem d er A nsprüche I bis 7, dadurch gekennzeichnet, dass der Verbindungsteil (10) lösbar mit dem Fuhrungs- und Ablösemittel (6) verbunden ist.8. The device according to one of claims I to 7, characterized in that the connecting part (10) is detachably connected to the guiding and releasing means (6).
9. Vorrichtung nach e inem d er A nsprüche I bis 8, d adurch gekennzeichnet, dass der Verbindungsteil (10,16,17,18) aus einem anderen Werkstoff besteht als das Fuhrungs- und Ablösemittel (6).9. Device according to one of the claims I to 8, characterized in that the connecting part (10, 16, 17, 18) consists of a different material than the guiding and releasing means (6).
10.Vorrichtung nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, dass der Verbindungsteil (10, 16, 17, 18) aus einem gegenüber dem Werkstoff des Fuhrungs- und Ablösemittels (6) elastischeren Werkstoff besteht.10.Device according to one of claims 1 to 9, characterized in that the connecting part (10, 16, 17, 18) consists of a material which is more elastic than the material of the guiding and releasing means (6).
11.Vorrichtung nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass der Werkstoff des Verbindungsteils (10, 16, 17, 18) eine größere plastische Verformbarkeit aufweist als der Werkstoff der Okklusionswendel (2). 11.The device according to one of claims 1 to 10, characterized in that the material of the connecting part (10, 16, 17, 18) has a greater plastic deformability than the material of the occlusion helix (2).
12. Vorrichtung nach Anspruch einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass die Okklusionswendel (2) an ihrem proximalen (5) und an ihrem distalen Ende (15) verschlossen ist.12. The device according to claim 1, characterized in that the occlusion helix (2) is closed at its proximal end (5) and at its distal end (15).
13. Vorrichtung nach einem der Ansprüche 1 bis 12, dadurch gekennzeichnet, dass die Okklusionswendel an ihren Enden (5, 15) mit halbkugelartigen Abschlusselementen (22) verschlossen ist. 13. Device according to one of claims 1 to 12, characterized in that the occlusion coil is closed at its ends (5, 15) with hemispherical end elements (22).
PCT/DE2004/001130 2003-06-04 2004-06-02 Device for the implantation of occlusion coils in body cavities WO2004107992A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10325130.8 2003-06-04
DE10325130A DE10325130B3 (en) 2003-06-04 2003-06-04 Device for implanting occlusion helixes into hollow body chambers comprises a guiding and a detaching unit having a connecting part arranged on its distal end

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DE102009009003A1 (en) * 2009-02-16 2010-08-26 Justus-Liebig-Universität Giessen implant
WO2010117883A1 (en) 2009-04-06 2010-10-14 Boston Scientific Scimed, Inc. Delivery wire for occlusive device delivery system
US9314250B2 (en) 2009-04-16 2016-04-19 Stryker Corporation Electrical contact for occlusive device delivery system
US8398671B2 (en) 2009-04-16 2013-03-19 Stryker Corporation Electrical contact for occlusive device delivery system

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