WO1999017681A1 - Occlusive internal vascular prosthesis for cerebral and intra-cerebral aneurysms - Google Patents

Occlusive internal vascular prosthesis for cerebral and intra-cerebral aneurysms Download PDF

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Publication number
WO1999017681A1
WO1999017681A1 PCT/FR1997/001784 FR9701784W WO9917681A1 WO 1999017681 A1 WO1999017681 A1 WO 1999017681A1 FR 9701784 W FR9701784 W FR 9701784W WO 9917681 A1 WO9917681 A1 WO 9917681A1
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WO
WIPO (PCT)
Prior art keywords
vascular prosthesis
prosthesis according
internal
cerebral
sleeve
Prior art date
Application number
PCT/FR1997/001784
Other languages
French (fr)
Inventor
Alain Fouere
Original Assignee
Alain Fouere
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 Alain Fouere filed Critical Alain Fouere
Priority to PCT/FR1997/001784 priority Critical patent/WO1999017681A1/en
Priority to AU46267/97A priority patent/AU4626797A/en
Publication of WO1999017681A1 publication Critical patent/WO1999017681A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91516—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other the meander having a change in frequency along the band
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions

  • the present invention relates to an internal occlusive vascular prosthesis for cerebral and intracerebral aneurysms.
  • Arterial aneurysms are generally the result of atherosclerotic lesions which destroy the elastic fibers of the middle lining of the vessel and make the arterial wall fragile. They increase slowly in volume and can rupture, giving rise to an often lightning internal hemorrhage or being at the origin of thromboses leading to cerebral attacks in the case of vessels supplying the brain.
  • Aneurysm is a particularly daunting condition which occurs mainly in elderly men and must be followed by a rapid therapeutic sanction: resection of the dilated segment or occlusion by the surgical route using an internal prosthesis.
  • a French company provides neurosurgeons with “coils” with a mechanical release system, while the “coils” supplied by the second company, located in the United States, uses an electromagnetic release system.
  • the "coils" can be carried by the blood flow or cause a burst of
  • stents are almost always intended to dilate the vessels in the case of stenosis to allow the passage of blood.
  • These are thin-walled cylindrical metallic tubular members, with a diameter allowing them to pass inside the duct to be treated, this diameter being able to be increased in order to expand the duct.
  • the rare aneurysms treated using this device are concealed by means of a tube or a plastic film covering the expandable member, the latter playing the role of reinforcement.
  • the device according to the present invention makes it possible to treat cerebral and intracerebral aneurysms by practicing their occlusion and their thrombosis without risk of bursting, during a surgical intervention of very reduced duration compared to that required by current techniques.
  • It consists of a malleable metallic cylindrical sleeve able to extend radially under the effect of internal pressure and to keep the shape thus obtained, formed by a portion of hollow cylinder with semi-solid thin wall with circular section with a diameter close to one millimeter before expansion, this wall comprising one or more uncut zones alternating along the circumference with one or more cut zones formed by elongate deformable elements separated by slots not allowing the passage of blood.
  • FIGS. 1 to 6 are developed views of several variants of expandable vascular prostheses comprising between one and four solid areas and FIG. 7 is an end view of the prosthesis of FIG. 6.
  • FIGS. 1 to 7 consists of a tubular micro-sheath, or sleeve 1, formed of a portion of hollow cylinder of circular section, the wall of which is cut so as to determine alternately along the periphery, expandable zones 2 allowing the expansion of the device and full zones 3 intended to allow the total or partial occlusion of
  • the sleeve 1 made of semi-rigid malleable material, is arranged so as to allow it to extend radially under the effect of internal pressure and to keep the shape thus obtained, this pressure being caused for example by means of an inflatable balloon mounted at the end of a catheter according to a known technique.
  • the expandable zones 2 are cut so as to form elongate deformable elements 4 arranged in meanders consisting of straight parts 5 connected by curved parts 6, so that, before expansion, the straight parts are substantially parallel to the axis of the sleeve 1.
  • the number, the shape and the dimension of the solid and extensible zones can vary according to the various cases which can arise and will be in particular determined so that, after expansion of the sleeve 1, the slots 7 separating two straight parts 5 of elongated elements, or a straight part and a solid area 3 remain thin enough to prevent the passage of blood and cause its clotting.
  • the maximum diameter D of the sleeve 1 is 2 mm expanded and 1 mm unexpanded, its length L is between 2 and 4 mm, the wall has a thickness E of the order of 0.1 mm, the width of the elongated elements being substantially equal to 0.1 mm and that of the slots before expansion at 0.12 mm.
  • the vascular prosthesis can be made up of two or more sleeves connected together by articulations formed of one or more longitudinal connecting bars arranged between the modules in a contiguous, staggered or peripherally offset fashion. from one module to another. These bars can have the form of lines broken in a "zigzag", which allows them to be distributed over the entire periphery of the device without breaking its continuity.
  • the joints can also be obtained by means of a net or a flexible film, or by any other means making it possible to set up in a single operation an assembly made up of several modules.
  • an internal or external coating made up of a film of silicone or of similar material, possibly combined with micro-articulations, can coat the internal or external face of the wall of the sleeve 1, or d 'a set of modules.
  • the vascular prosthesis will preferably be produced in a single piece by laser EDM from a metal block such as stainless steel or tantalum, or by laser engraving or machining of a thin-walled metal tube. It can advantageously be manufactured in expanded form, then "crushed" on an inflatable balloon intended to be mounted at the end of a catheter, or be made of an elastic material of the "NITINOL” type in order to be self-stretching and compressed to be introduced into a tube or other suitable member removed when it has reached its final location, or else be made of a shape memory material, making it possible to compress it after machining, to remain in this state at low temperature, and get back in shape expanded initial when it reaches body temperature once in place, eliminating the need for an inflatable balloon.
  • the sleeve 1 may include integrated hooking means, directed radially outward so as to sink into the internal wall of the vessel during expansion, thus preventing any possibility of movement of the device.
  • Stainless steel is barely visible on X-rays.
  • the sleeves made of this material will advantageously have radiopaque markers visible on X-rays made up of layers of a heavy metal such as tantalum, titanium or gold deposited electrolytically.

Abstract

The invention concerns an occlusive internal vascular prosthesis for cerebral and intra-cerebral aneurysms, consisting of a malleable metal cylindrical sleeve (1) capable of extending radially by the effect of internal pressure and maintaining the resulting shape, formed by a hollow cylinder portion with thin semisolid wall circular in cross-section with a diameter of about one millimetre before expansion, said wall comprising one or several uncut zones (3) alternating along the circumference with one or several cut zones (2) formed of elongated deformable elements separated by slots obstructing the passage of blood. It is designed to be set in a cervical artery or vein for locally preventing risks of concealed haemorrhage caused by a burst aneurysm.

Description

PROTHESE VASCULAIRE INTERNE OCCLUSIVE POUR ANEVRISMES CÉRÉBRAUX ET INTRA-CÉRÉBRAUX OCCLUSIVE INTERNAL VASCULAR PROSTHESIS FOR CEREBRAL AND INTRA-CEREBRAL ANEVRISMS
La présente invention a pour objet une prothèse vasculaire interne occlusive pour anévris es cérébraux et intra-cérébraux.The present invention relates to an internal occlusive vascular prosthesis for cerebral and intracerebral aneurysms.
Elle est constituée d'un manchon extensible à usage chirurgical destiné à être mis en place dans une artère ou une veine cervicale pour empêcher localement les risques d'hémorragie interne provoqués par l'éclatement d'un anévrisme.It consists of an extensible sleeve for surgical use intended to be placed in an artery or a cervical vein to locally prevent the risks of internal hemorrhage caused by the bursting of an aneurysm.
Les anévrismes artériels sont en général la conséquence de lésions d'athérosclérose qui détruisent les fibres élastiques de la tunique moyenne du vaisseau et rendent la paroi artérielle fragile. Ils augmentent lentement de volume et peuvent se rompre donnant lieu à une hémorragie interne fréquemment foudroyante ou être à l'origine de thromboses entraînant des attaques cérébrales dans le cas de vaisseaux irrigant le cerveau.Arterial aneurysms are generally the result of atherosclerotic lesions which destroy the elastic fibers of the middle lining of the vessel and make the arterial wall fragile. They increase slowly in volume and can rupture, giving rise to an often lightning internal hemorrhage or being at the origin of thromboses leading to cerebral attacks in the case of vessels supplying the brain.
L' anévrisme constitue une affection particulièrement redoutable qui survient essentiellement chez l'homme âgé et doit être suivie d'une sanction thérapeutique rapide : résection du segment dilaté ou occlusion par voie chirurgicale au moyen d'une prothèse interne .Aneurysm is a particularly formidable condition which occurs mainly in elderly men and must be followed by a rapid therapeutic sanction: resection of the dilated segment or occlusion by the surgical route using an internal prosthesis.
A notre connaissance, il n'existe à ce jour en neurochirurgie aucun dispositif, ni aucune technique, permettant l'occlusion des anévrismes intra-cérébraux. Le moyen mis en oeuvre actuellement consiste à remplir la lésion pour tenter de la colmater.To our knowledge, there is to date in neurosurgery no device, nor any technique, allowing the occlusion of intra-cerebral aneurysms. The means currently used consists in filling the lesion in an attempt to seal it.
Les praticiens utilisent des ressorts à mémoire de forme habituellement désignés sous le nom anglais de "coils", destinés à combler les anévrismes et à les thromboser pour éviter leur rupture. Il faut prévoir jusqu'à dix coils pour un anévrisme. Deux sociétés seulement fabriquent ces dispositifs, chacune proposant un système de pose différent :Practitioners use shape memory springs usually designated by the English name of "coils", intended to fill the aneurysms and to thrombose them to avoid their rupture. It is necessary to provide up to ten coils for an aneurysm. Only two companies manufacture these devices, each offering a different installation system:
Une entreprise française met à la disposition des neurochirurgiens des "coils" à système de largage mécanique, alors que les "coils" fournis par la seconde entreprise, installée aux Etats Unis, utilise un système de largage électromagnétique.A French company provides neurosurgeons with "coils" with a mechanical release system, while the "coils" supplied by the second company, located in the United States, uses an electromagnetic release system.
La mise en place de ces dispositifs demande des manipulations très délicates et de très longue durée, en particulier pour les seconds, les coils devant être introduits l'un après l'autre, ce qui entraîne des interventions pouvant prendre plusieurs heures.The installation of these devices requires very delicate and very long-lasting manipulations, in particular for the second, the coils having to be introduced one after the other, which leads to interventions which can take several hours.
Par ailleurs, les "coils" peuvent être entraîné par le flux sanguin ou provoquer un éclatement deIn addition, the "coils" can be carried by the blood flow or cause a burst of
1' anévrisme et migrer dans le tissu cervical avec des conséquences imprévisibles.1 aneurysm and migrate into the cervical tissue with unpredictable consequences.
Les prothèses vasculaires expansibles connues ("stents") sont presque toujours destinées à dilater les vaisseaux dans le cas de sténoses pour permettre le passage du sang. Il s'agit d'organes métalliques tubulaires cylindriques à paroi mince, d'un diamètre permettant de les faire passer à l'intérieur du conduit à traiter, ce diamètre pouvant être augmenté afin de dilater le conduit.Known expandable vascular prostheses ("stents") are almost always intended to dilate the vessels in the case of stenosis to allow the passage of blood. These are thin-walled cylindrical metallic tubular members, with a diameter allowing them to pass inside the duct to be treated, this diameter being able to be increased in order to expand the duct.
Ce résultat est généralement obtenu soit par l'application d'une pression à l'intérieur d'une prothèse défor able montée sur un élément gonflable selon une technique connue (voir par exemple les brevets N° EP 221 570 de M. Julio Palmaz et N° PCT/FR 95/01 460 déposé par l'auteur de la présente invention ), soit en comprimant une prothèse auto-extensible pour l'introduire dans un tube, l'élasticité du matériau constitutif assurant son extension radiale dès qu'elle est libérée (brevet N° WO 92 06 734 de M. Young SONG) , l'élément gonflable et le tube étant montés à l'extrémité d'un cathéter.This result is generally obtained either by applying pressure inside a deformable prosthesis mounted on an inflatable element according to a known technique (see for example the patents No. EP 221 570 of M. Julio Palmaz and PCT / FR 95/01 460 filed by the author of the present invention), either by compressing a self-expanding prosthesis to introduce it into a tube, the elasticity of the constituent material ensuring its radial extension as soon as it is released (patent No. WO 92 06 734 by M. Young SONG), the inflatable element and the tube being mounted at the end of a catheter.
Les rares anévrismes traités à l'aide ce de ces dispositifs sont occultés au moyen d'un tube ou d'un film en matière synthétique recouvrant l'organe expansible, ce dernier jouant le rôle d'armature.The rare aneurysms treated using this device are concealed by means of a tube or a plastic film covering the expandable member, the latter playing the role of reinforcement.
Cependant cette technique est difficilement envisageable pour les anévrismes intra-cérébraux en raison de la faible section des vaisseaux concernés.However, this technique is difficult to envisage for intracerebral aneurysms due to the small section of the vessels concerned.
Le dispositif selon la présente invention permet de traiter les anévrismes cérébraux et intra- cérébraux en pratiquant leur occlusion et leur thrombose sans risque d'éclatement, au cours d'une intervention chirurgicale de durée très réduite comparativement à celle nécessitée par les techniques actuelles.The device according to the present invention makes it possible to treat cerebral and intracerebral aneurysms by practicing their occlusion and their thrombosis without risk of bursting, during a surgical intervention of very reduced duration compared to that required by current techniques.
Il est constitué d'un manchon cylindrique métallique malléable apte à s'étendre radialement sous l'effet d'une pression interne et à garder la forme ainsi obtenue, formé d'une portion de cylindre creux à paroi mince semi-pleine à section circulaire d'un diamètre voisin de un millimètre avant expansion, cette paroi comportant une ou plusieurs zones non découpées alternant le long de la circonférence avec une ou plusieurs zones découpées formées d'éléments déformables allongés séparés par des fentes ne permettant pas le passage du sang.It consists of a malleable metallic cylindrical sleeve able to extend radially under the effect of internal pressure and to keep the shape thus obtained, formed by a portion of hollow cylinder with semi-solid thin wall with circular section with a diameter close to one millimeter before expansion, this wall comprising one or more uncut zones alternating along the circumference with one or more cut zones formed by elongate deformable elements separated by slots not allowing the passage of blood.
Sur les dessins annexés, donnés à titre d'exemples non limitatifs de formes de réalisation de l'objet de l'invention: les figures 1 à 6 sont des vues développées de plusieurs variantes de prothèses vasculaires expansibles comportant entre une et quatre zones pleines et la figure 7 est une vue en bout de la prothèse de la figure 6.In the appended drawings, given by way of nonlimiting examples of embodiments of the subject of the invention: FIGS. 1 to 6 are developed views of several variants of expandable vascular prostheses comprising between one and four solid areas and FIG. 7 is an end view of the prosthesis of FIG. 6.
Le dispositif, figures 1 à 7, est constitué d'une micro-gaine tubulaire, ou manchon 1, formé d'une portion de cylindre creux de section circulaire, dont la paroi est découpée de manière à déterminer alternativement le long de la périphérie, des zones extensibles 2 permettant l'expansion du dispositif et des zones pleines 3 destinées à permettre l'occlusion totale ou partielle deThe device, FIGS. 1 to 7, consists of a tubular micro-sheath, or sleeve 1, formed of a portion of hollow cylinder of circular section, the wall of which is cut so as to determine alternately along the periphery, expandable zones 2 allowing the expansion of the device and full zones 3 intended to allow the total or partial occlusion of
1' anévrisme à traiter.1 aneurysm to be treated.
Le manchon 1, réalisée en matériau semi-rigide malléable, est agencé de manière à lui permettre de s'étendre radialement sous l'effet d'une pression interne et de garder la forme ainsi obtenue, cette pression étant provoquée par exemple au moyen d'un ballonnet gonflable monté à l'extrémité d'un cathéter selon une technique connue.The sleeve 1, made of semi-rigid malleable material, is arranged so as to allow it to extend radially under the effect of internal pressure and to keep the shape thus obtained, this pressure being caused for example by means of an inflatable balloon mounted at the end of a catheter according to a known technique.
Les zones extensibles 2 sont découpées de manière à former des éléments allongés 4 déformables disposés en méandres constitués de parties droites 5 reliées par des parties courbes 6, de telle façon, qu'avant expansion, les parties droites soient sensiblement parallèles à l'axe du manchon 1.The expandable zones 2 are cut so as to form elongate deformable elements 4 arranged in meanders consisting of straight parts 5 connected by curved parts 6, so that, before expansion, the straight parts are substantially parallel to the axis of the sleeve 1.
Le nombre, la forme et la dimension des zones pleines et extensibles peuvent varier en fonction des différents cas pouvant se présenter et seront en particulier déterminés de manière à ce que, après expansion du manchon 1, les fentes 7 séparant deux parties droites 5 d'éléments allongés, ou une partie droite et une zone pleine 3 demeurent suffisamment fines pour empêcher le passage du sang et provoquer sa coagulation.The number, the shape and the dimension of the solid and extensible zones can vary according to the various cases which can arise and will be in particular determined so that, after expansion of the sleeve 1, the slots 7 separating two straight parts 5 of elongated elements, or a straight part and a solid area 3 remain thin enough to prevent the passage of blood and cause its clotting.
A titre indicatif, le diamètre D maximum du manchon 1 est de 2 mm expansé et de 1 mm non expansé, sa longueur L est comprise entre 2 et 4 mm, la paroi a une épaisseur E de l'ordre de 0,1 mm, la largeur des éléments allongés étant sensiblement égale à 0,1 mm et celle des fentes avant expansion à 0,12 mm.As an indication, the maximum diameter D of the sleeve 1 is 2 mm expanded and 1 mm unexpanded, its length L is between 2 and 4 mm, the wall has a thickness E of the order of 0.1 mm, the width of the elongated elements being substantially equal to 0.1 mm and that of the slots before expansion at 0.12 mm.
Il est à noter que plus le diamètre est faible, plus il est possible d'aller loin dans les artères .It should be noted that the smaller the diameter, the further it is possible to go through the arteries.
Lorsque la lésion s'étend sur une partie importante du vaisseau à traiter, il est généralement nécessaire de mettre en place plusieurs gaines extensibles à la suite les unes des autres, en raison des sinuosités du conduit.When the lesion extends over a large part of the vessel to be treated, it is generally necessary to put in place several extensible sheaths one after the other, due to the sinuosities of the duct.
Pour éviter d'avoir à réaliser plusieurs manipulations, la prothèse vasculaire peut être constituée de deux manchons ou plus reliés entre eux par des articulations formées d'une ou plusieurs barres de liaison longitudinales disposées entre les modules de façon contiguë, en quinconce ou décalées périphériquement d'un module à l'autre. Ces barres peuvent avoir la forme de lignes brisées en "zigzag", ce qui leur permet d'être réparties sur toute la périphérie du dispositif sans rompre sa continuité. Les articulations peuvent également être obtenues au moyen d'un filet ou un film souple, ou de tout autre moyen permettant de mettre en place en une seule opération un ensemble constitué de plusieurs modules .To avoid having to carry out several manipulations, the vascular prosthesis can be made up of two or more sleeves connected together by articulations formed of one or more longitudinal connecting bars arranged between the modules in a contiguous, staggered or peripherally offset fashion. from one module to another. These bars can have the form of lines broken in a "zigzag", which allows them to be distributed over the entire periphery of the device without breaking its continuity. The joints can also be obtained by means of a net or a flexible film, or by any other means making it possible to set up in a single operation an assembly made up of several modules.
Afin de rendre les zones extensibles 3 etanches, une enduction interne ou externe constituée d'un film de silicone ou de matériau similaire, combinée éventuellement avec des micro-articulations, pourra revêtir la face interne ou externe de la paroi du manchon 1, ou d'un ensemble de modules.In order to make the extensible zones 3 waterproof, an internal or external coating made up of a film of silicone or of similar material, possibly combined with micro-articulations, can coat the internal or external face of the wall of the sleeve 1, or d 'a set of modules.
La prothèse vasculaire sera de préférence réalisée en une seule pièce par électro-érosion laser à partir d'un bloc de métal tel que l'acier inoxydable ou le tantale, ou par gravure ou usinage laser d'un tube métallique à paroi mince. Elle pourra avantageusement être fabriquée sous forme expansée, puis "écrasée" sur un ballonnet gonflable destiné à être monté à l'extrémité d'un cathéter, ou être réalisée dans un matériau élastique de type "NITINOL" afin d'être auto-extensible et comprimée pour être introduite dans un tube ou autre organe adéquat retiré lorsqu'elle a atteint son emplacement définitif, ou encore être constituée d'un matériau à mémoire de forme, permettant de la comprimer après usinage, de rester dans cet état à basse température, et de retrouver la forme initiale expansée lorsqu'elle atteint la température du corps une fois mise en place, ce qui permet de supprimer l'utilisation de ballonnet gonflable.The vascular prosthesis will preferably be produced in a single piece by laser EDM from a metal block such as stainless steel or tantalum, or by laser engraving or machining of a thin-walled metal tube. It can advantageously be manufactured in expanded form, then "crushed" on an inflatable balloon intended to be mounted at the end of a catheter, or be made of an elastic material of the "NITINOL" type in order to be self-stretching and compressed to be introduced into a tube or other suitable member removed when it has reached its final location, or else be made of a shape memory material, making it possible to compress it after machining, to remain in this state at low temperature, and get back in shape expanded initial when it reaches body temperature once in place, eliminating the need for an inflatable balloon.
Pour certaines applications, le manchon 1 pourra comporter des moyens d'accrochage intégrés, dirigés radialement vers l'extérieur de façon à s'enfoncer dans la paroi interne du vaisseau lors de l'expansion, empêchant ainsi toute possibilité de déplacement du dispositif.For certain applications, the sleeve 1 may include integrated hooking means, directed radially outward so as to sink into the internal wall of the vessel during expansion, thus preventing any possibility of movement of the device.
L'acier inoxydable est peu visible aux rayons X. Pour y remédier, les manchons réalisés dans ce matériau comporteront avantageusement des repères radio-opaques visibles aux rayons X constitués de couches d'un métal lourd tel que le tantale, le titane ou l'or déposé par voie électrolytique.Stainless steel is barely visible on X-rays. To remedy this, the sleeves made of this material will advantageously have radiopaque markers visible on X-rays made up of layers of a heavy metal such as tantalum, titanium or gold deposited electrolytically.
Le positionnement des divers éléments constitutifs donne à l'objet de l'invention un maximum d'effets utiles qui n'avaient pas été, à ce jour, obtenus par des dispositifs similaires. The positioning of the various constituent elements gives the object of the invention a maximum of useful effects which had not, to date, been obtained by similar devices.

Claims

REVENDICATIONS
1°. Prothèse vasculaire interne occlusive pour anévrismes cérébraux et intra-cérébraux, constituée d'un élément extensible à usage chirurgical destiné à être mis en place dans une artère ou une veine cervicale pour empêcher localement les risques d'hémorragie interne provoqués par l'éclatement d'un anévrisme. caractérisée en ce qu'elle est constituée d'un ou plusieurs manchons (1) cylindriques métalliques malléables aptes à s'étendre radialement sous l'effet d'une pression interne et à garder la forme ainsi obtenue, chaque manchon (1) étant formé d'une portion de cylindre creux à paroi mince semi-pleine à section circulaire d'un diamètre égal ou inférieur à un millimètre avant expansion, cette paroi comportant alternativement le long de la périphérie, des zones extensibles (2) permettant l'expansion du dispositif et des zones pleines (3) destinées à permettre l'occlusion totale ou partielle de 1' anévrisme à traiter.1 °. Internal occlusive vascular prosthesis for cerebral and intracerebral aneurysms, consisting of an extensible element for surgical use intended to be placed in an artery or a cervical vein to locally prevent the risks of internal bleeding caused by the bursting of an aneurysm. characterized in that it consists of one or more malleable metallic cylindrical sleeves (1) able to extend radially under the effect of internal pressure and to keep the shape thus obtained, each sleeve (1) being formed of a portion of hollow cylinder with a semi-solid thin wall with circular section of a diameter equal to or less than one millimeter before expansion, this wall comprising alternately along the periphery, expandable zones (2) allowing the expansion of the device and solid areas (3) intended to allow total or partial occlusion of the aneurysm to be treated.
2°. Prothèse vasculaire selon la revendication2 °. Vascular prosthesis according to claim
1, se caractérisant par le fait que les zones extensibles (2) sont découpées de manière à former des éléments allongés (4) déformables disposés en méandres constitués de parties droites (5) reliées par des parties courbes (6), de telle façon, qu'avant expansion, les parties droites soient sensiblement parallèles à l'axe du manchon (1).1, characterized by the fact that the extensible zones (2) are cut so as to form elongate deformable elements (4) arranged in meanders consisting of straight parts (5) connected by curved parts (6), in such a way, that before expansion, the straight parts are substantially parallel to the axis of the sleeve (1).
3°. Prothèse vasculaire selon la revendication3 °. Vascular prosthesis according to claim
2, se caractérisant par le fait que les fentes (7) séparant deux parties droites (5) d'éléments allongés (4), ou une partie droite et une zone pleine (3) demeurent suffisamment fines pour empêcher le passage du sang et provoquer sa coagulation. 4°. Prothèse vasculaire selon l'une quelconque des revendications précédentes, se caractérisant par le fait que le diamètre (D) maximum d'un manchon (1) est de 2 millimètres expansé et de 1 millimètre non expansé, l'épaisseur (E) de sa paroi voisine de 0,1 millimètre, la largeur des éléments allongés (4) sensiblement égale à 0,1 millimètre et celle des fentes avant expansion à 0,12 millimètre .2, characterized by the fact that the slots (7) separating two straight parts (5) of elongated elements (4), or a straight part and a solid area (3) remain sufficiently thin to prevent the passage of blood and cause its coagulation. 4 °. Vascular prosthesis according to any one of the preceding claims, characterized in that the maximum diameter (D) of a sleeve (1) is 2 millimeters expanded and 1 millimeter unexpanded, the thickness (E) of its wall close to 0.1 millimeter, the width of the elongated elements (4) substantially equal to 0.1 millimeter and that of the slots before expansion to 0.12 millimeter.
5°. Prothèse vasculaire selon l'une quelconque des revendications précédentes, se caractérisant par le fait que le ou les manchons (1) sont réalisés chacun en une seule pièce par gravure ou usinage laser d'un tube métallique à paroi mince.5 °. Vascular prosthesis according to any one of the preceding claims, characterized in that the sleeve (s) (1) are each made in one piece by etching or laser machining of a thin-walled metal tube.
6°. Prothèse vasculaire selon l'une quelconque des revendications 1 à 4, se caractérisant par le fait que le ou les manchons (1) sont réalisés chacun en une seule pièce par électro-érosion laser à partir d'un bloc de métal tel que l'acier inoxydable ou le tantale.6 °. Vascular prosthesis according to any one of claims 1 to 4, characterized in that the sleeve (s) (1) are each made in one piece by laser EDM from a block of metal such as stainless steel or tantalum.
7°. Prothèse vasculaire selon l'une quelconque des revendications précédentes, se caractérisant par le fait qu'elle est fabriquée sous forme expansée, puis "écrasée" sur un ballonnet gonflable destiné à être monté à l'extrémité d'un cathéter.7 °. Vascular prosthesis according to any one of the preceding claims, characterized in that it is produced in expanded form, then "crushed" on an inflatable balloon intended to be mounted at the end of a catheter.
8°. Prothèse vasculaire selon l'une quelconque des revendications 1 à 6, se caractérisant par le fait qu'elle est fabriquée sous forme expansée dans un matériau élastique, de manière à pouvoir être comprimée et introduite dans un tube ou autre organe adéquat pour la mise en place, cet organe étant retiré lorsque l'emplacement définitif est atteint.8 °. Vascular prosthesis according to any one of claims 1 to 6, characterized in that it is produced in expanded form in an elastic material, so that it can be compressed and introduced into a tube or other suitable organ for delivery. place, this organ being removed when the final location is reached.
9°. Prothèse vasculaire selon l'une quelconque des revendications 1 à 6, se caractérisant par le fait qu'elle est fabriquée sous forme expansée dans un matériau à mémoire de forme, de manière à pouvoir être comprimée après usinage, de rester dans cet état à basse température, et de retrouver sa forme initiale expansée lorsqu'elle atteint la température du corps une fois mise en place.9 °. Vascular prosthesis according to any one of claims 1 to 6, characterized in that it is produced in expanded form in a shape memory material, so that it can be compressed after machining, to remain in this state at low temperature, and to regain its initial expanded form when it reaches body temperature once it is in place.
10°. Prothèse vasculaire selon l'une quelconque des revendications précédentes, se caractérisant par le fait qu'elle est constituée de plusieurs manchons (1) reliés entre eux par des articulations formées d'une ou plusieurs barres de liaison longitudinales, d'un filet ou un film souple, ou de tout autre moyen permettant de mettre en place en une seule opération un ensemble constitué de plusieurs modules.10 °. Vascular prosthesis according to any one of the preceding claims, characterized in that it consists of several sleeves (1) connected together by articulations formed by one or more longitudinal connecting bars, a net or a flexible film, or any other means allowing an assembly consisting of several modules to be put in place in a single operation.
11° . Prothèse vasculaire selon la revendication 10, se caractérisant par le fait que les manchons (1) sont reliés entre eux par des barres de liaison ayant la forme de lignes brisées en "zigzag" réparties sur toute la périphérie.11 °. Vascular prosthesis according to claim 10, characterized in that the sleeves (1) are interconnected by connecting bars in the form of lines broken in a "zigzag" distributed over the entire periphery.
12°. Prothèse vasculaire selon la revendication 10, se caractérisant par le fait que les manchons (1) sont reliés entre eux au moyen d'un filet ou un film souple.12 °. Vascular prosthesis according to claim 10, characterized in that the sleeves (1) are interconnected by means of a net or a flexible film.
13°. Prothèse vasculaire selon l'une quelconque des revendications précédentes, se caractérisant par le fait que la surface interne ou externe de sa paroi est recouverte d'un film de silicone ou de matériau similaire, combinée éventuellement avec des micro-articulations .13 °. Vascular prosthesis according to any one of the preceding claims, characterized in that the internal or external surface of its wall is covered with a film of silicone or of similar material, possibly combined with micro-articulations.
14°. Gaine vasculaire interne selon l'une quelconque des revendications précédentes, se caractérisant par le fait qu'elle comporte des repères radio-opaques visibles aux rayons X constitués de couches d'un métal lourd or déposé par voie électrolytique . 15°. Gaine vasculaire interne selon l'une quelconque des revendications précédentes, se caractérisant par le fait qu'elle comporte des moyens d'accrochage intégrés, dirigés radialement vers l'extérieur de façon à s'enfoncer dans la paroi interne du vaisseau lors de l'expansion de manière à empêcher toute possibilité de déplacement du dispositif. 14 °. Internal vascular sheath according to any one of the preceding claims, characterized in that it includes radiopaque markers visible on X-rays made up of layers of a heavy metal or electrolytically deposited. 15 °. Internal vascular sheath according to any one of the preceding claims, characterized in that it has integrated hooking means, directed radially outwards so as to sink into the internal wall of the vessel during expansion so as to prevent any possibility of displacement of the device.
PCT/FR1997/001784 1997-10-07 1997-10-07 Occlusive internal vascular prosthesis for cerebral and intra-cerebral aneurysms WO1999017681A1 (en)

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WO1992006734A1 (en) 1990-10-18 1992-04-30 Ho Young Song Self-expanding endovascular stent
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WO1996018359A1 (en) 1994-12-16 1996-06-20 Alain Fouere Stent for expanding physiological vessels
WO1996039102A1 (en) * 1995-06-05 1996-12-12 Localmed, Inc. Radially expansible and articulated vessel scaffold
EP0795304A1 (en) * 1996-03-10 1997-09-17 Terumo Kabushiki Kaisha Implanting stent
US5669932A (en) * 1996-05-29 1997-09-23 Isostent, Inc. Means for accurately positioning an expandable stent

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WO2000047134A1 (en) * 1999-02-12 2000-08-17 Novo Rps Ulc Endovascular prosthesis
US6695876B1 (en) 1999-02-12 2004-02-24 Thomas R. Marotta Endovascular prosthesis
CN1309353C (en) * 1999-02-12 2007-04-11 依维希奥医用设备无限责任公司 Intravascular proshesis

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