WO2004107992A1 - Dispositif d'implantation de spires dans des cavites corporelles - Google Patents

Dispositif d'implantation de spires dans des cavites corporelles 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
Authority
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)
English (en)
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/fr

Links

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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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Vascular Medicine (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Neurosurgery (AREA)
  • Surgical Instruments (AREA)

Abstract

Dispositif d'implantation de spires d'occlusion (2) dans des cavités corporelles, comportant un élément de guidage et de libération (6) à l'extrémité distale (7) duquel est placée une partie de liaison (10) à action mécanique qui se trouve directement introduite par liaison de forme au moins en partie entre les tours (11) de la spire d'occlusion (2). En vue du retrait axial de l'élément de guidage et de libération (6), la spire (2) peut être amenée à reposer contre la butée (13) d'un manchon de coulissement dans lequel est logé l'élément de guidage et de libération (6). La partie de liaison (10) se trouve alors détachée de l'élément d'occlusion (2) par déformation plastique non réversible, sous l'effet d'une force supérieure à une force de retenue mécanique.
PCT/DE2004/001130 2003-06-04 2004-06-02 Dispositif d'implantation de spires dans des cavites corporelles WO2004107992A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10325130A DE10325130B3 (de) 2003-06-04 2003-06-04 Vorrichtung zur Implantation von Okklusionswendeln in Körperhohlräume
DE10325130.8 2003-06-04

Publications (1)

Publication Number Publication Date
WO2004107992A1 true WO2004107992A1 (fr) 2004-12-16

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PCT/DE2004/001130 WO2004107992A1 (fr) 2003-06-04 2004-06-02 Dispositif d'implantation de spires dans des cavites corporelles

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DE (1) DE10325130B3 (fr)
WO (1) WO2004107992A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8764788B2 (en) 2002-07-31 2014-07-01 Microvention, Inc. Multi-layer coaxial vaso-occlusive device
CN110536649A (zh) * 2017-04-19 2019-12-03 波士顿科学国际有限公司 可变长度血管封堵系统

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2155077A2 (fr) 2007-05-18 2010-02-24 Boston Scientific Scimed, Inc. Systèmes de détachement d'implant médical
CN102186426B (zh) 2008-10-13 2013-05-15 斯瑞克公司 血管闭塞线圈输送系统
DE102009009003A1 (de) * 2009-02-16 2010-08-26 Justus-Liebig-Universität Giessen Implantat
EP2416712B1 (fr) 2009-04-06 2018-12-19 Stryker Corporation Fil de placement pour système de placement de dispositif occlusif
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

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0717961A1 (fr) 1994-12-22 1996-06-26 Target Therapeutics, Inc. Méthode et ensemble d'introduction d'un implant
EP0826341A1 (fr) 1995-07-07 1998-03-04 Target Therapeutics Dispositif d'occlusion vasculaire
US5725546A (en) * 1994-06-24 1998-03-10 Target Therapeutics, Inc. Detachable microcoil delivery catheter
WO1999032037A1 (fr) 1997-12-19 1999-07-01 Boston Scientific Limited Ensemble spirale a poussoir detachable pour occlusion vasculaire
EP1010396A1 (fr) * 1998-12-16 2000-06-21 Arthesys Système à cathéter destiné à la libération hydraulique d'une spirale d'embolisation
EP1290988A1 (fr) * 1994-12-22 2003-03-12 Boston Scientific Limited Ensemble pour positioner un implant, avec mécanisme de couplage ou découplage extensible

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5725546A (en) * 1994-06-24 1998-03-10 Target Therapeutics, Inc. Detachable microcoil delivery catheter
EP0717961A1 (fr) 1994-12-22 1996-06-26 Target Therapeutics, Inc. Méthode et ensemble d'introduction d'un implant
EP1290988A1 (fr) * 1994-12-22 2003-03-12 Boston Scientific Limited Ensemble pour positioner un implant, avec mécanisme de couplage ou découplage extensible
EP0826341A1 (fr) 1995-07-07 1998-03-04 Target Therapeutics Dispositif d'occlusion vasculaire
WO1999032037A1 (fr) 1997-12-19 1999-07-01 Boston Scientific Limited Ensemble spirale a poussoir detachable pour occlusion vasculaire
EP1010396A1 (fr) * 1998-12-16 2000-06-21 Arthesys Système à cathéter destiné à la libération hydraulique d'une spirale d'embolisation

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8764788B2 (en) 2002-07-31 2014-07-01 Microvention, Inc. Multi-layer coaxial vaso-occlusive device
CN110536649A (zh) * 2017-04-19 2019-12-03 波士顿科学国际有限公司 可变长度血管封堵系统

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