WO2001097716A1 - Metal sheet sealing system for an internal vascular prosthesis - Google Patents

Metal sheet sealing system for an internal vascular prosthesis Download PDF

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Publication number
WO2001097716A1
WO2001097716A1 PCT/FR2001/001921 FR0101921W WO0197716A1 WO 2001097716 A1 WO2001097716 A1 WO 2001097716A1 FR 0101921 W FR0101921 W FR 0101921W WO 0197716 A1 WO0197716 A1 WO 0197716A1
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WO
WIPO (PCT)
Prior art keywords
sleeve
sealing system
metal sheet
metal
prosthesis
Prior art date
Application number
PCT/FR2001/001921
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 AU2001269200A priority Critical patent/AU2001269200A1/en
Publication of WO2001097716A1 publication Critical patent/WO2001097716A1/en

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Classifications

    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching

Definitions

  • the present invention relates to a sealing system by metal sheet (s) of an internal vascular prosthesis.
  • endovascular prostheses intended to be placed by the surgical route, or by percutaneous endovascular route, in an artery or a vein to locally prevent the risks of internal hemorrhage caused by the leakage or bursting of an aneurysm.
  • endovascular prostheses intended to be placed by the surgical route, or by percutaneous endovascular route, in an artery or a vein to locally prevent the risks of internal hemorrhage caused by the leakage or bursting of an aneurysm.
  • stents used for other channels and body vessels, for example in the case of stenosis.
  • 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.
  • the "coils” can be carried by the blood flow or cause an aneurysm to burst and migrate into the cervical tissue with unpredictable consequences.
  • Known expandable vascular prostheses 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 dilate the duct.
  • Patent application No. PCT / FR 98/02355 filed by the applicant describes a vascular prosthesis consisting of a main element formed by a split head ring secured to one or more longitudinal bars, and a series of independent split rings intended to be placed contiguously at the location of the aneurysm by means of a catheter tube, the longitudinal bar or bars being arranged across the latter and serving to support the independent rings.
  • This implant requires several successive operations for the installation of the support and open rings, which significantly increases the duration of the intervention.
  • the device according to the present invention allows the production of an expandable internal vascular prosthesis relatively simple to manufacture, having a perfect seal and particularly suitable for the treatment of aneurysms in particular cerebral and intracerebral 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.
  • a cylindrical metallic sleeve with a semi-rigid wall formed of elongated meshes or longitudinal bars connected by extensible peripheral elements constituting a self-extensible trellis radially, or malleable and able to extend radially under the effect of a internal pressure and to keep the shape thus obtained, this sleeve being sealed by means of one or more very thin flexible metal sheets fixed on it and completely or partially covering its wall when it is in place.
  • FIGS. 1 and 2 are cross sections, respectively before and after expansion, showing an endovascular prosthesis provided with a single metallic peripheral sealing sheet
  • FIGS. 3 and 4 represent, under the same conditions, an endovascular prosthesis provided with several metallic peripheral sealing sheets
  • FIGS. 5 and 6 represent, always under the same conditions, an endovascular prosthesis, the sealing is ensured by means of a tubular metallic sheet interlaced with the longitudinal elements of the prosthesis
  • FIGS. 7 and 8 are cross sections before and after expansion of an endovascular prosthesis provided with a peripheral tubular metallic sheet.
  • the device consists of a tubular sheath, or radially expandable sleeve 1, formed by a portion of hollow cylinder of circular section with thin lattice wall comprising one or more metal sheets 2, 3, 4 very fine, preferably gold or titanium, integral with its wall and pressing on it to make it watertight when the prosthesis is in the expanded position.
  • the trellis constituting the wall of the prosthesis will for example be made up of longitudinal bars 5 connected to each other by extensible annular connections arranged in staggered rows (FIGS. 1 and 2), but may have any configuration allowing a radial extension. It may in particular be formed several elongated mesh rings assembled at their ends by deformable elements allowing the expansion of the sheath 1 as well as a certain bending of the latter.
  • the sleeve 1 can be made of a semi-rigid malleable material and 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 an inflatable balloon mounted at the end of a catheter according to a known technique.
  • the prosthesis will preferably be manufactured in expanded form, then "crushed" on the inflatable balloon.
  • the sleeve 1 is self-expanding and produced in expanded form in a flexible material or with shape memory, which eliminates the use of an inflatable balloon. For its establishment, it is compressed radially and introduced into a hollow tube of small diameter mounted at the end of a catheter and driven from said tube by an appropriate means when it is in the chosen location.
  • the shape memory material makes it possible to maintain the sleeve in the compressed state by lowering its temperature, and to return to the initial expanded shape when it reaches the temperature of the body once it has been put in place.
  • the sheath 1 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 an itietallic thin-walled tube.
  • the sealing of the sleeve 1 can be obtained by a single metal sheet 2 of rectangular shape fixed by welding, gluing or sewing one of its edges along a longitudinal bar 5.
  • the dimensions of this sheet will be determined so to what it completely covers the periphery of the sheath in the expanded state, slightly overflowing on the opposite edge (FIG. 2), the sheet being wound in a spiral around the sleeve 1 when the latter is in the compressed state ( figure 1).
  • the same principle can be applied by using several rectangular sheets 3 distributed over the periphery of the sheath ( Figures 3 and 4).
  • the metal sheet may consist of a tube 4 interlaced with the longitudinal bars 5 of the sleeve passing alternately inside and outside of the sheath ( Figures 5 and 6), or a tube 4 'arranged around of the sleeve 1 and welded, glued or sewn along one of its generatrix on a longitudinal bar 5, this tube being folded back on itself when the prosthesis is in the compressed state ( Figures 7 and 8).
  • each of these rings will be arranged in the manner described above, the longitudinal bars of the meshes forming the rings playing the same role as the bars 5 of the sleeve 1.
  • the sheath 1 may possibly include radio-opaque markers visible by X-rays deposited electrolytically on the metal sheet or sheets 2, 3, 4 to facilitate identification during the progression of the prosthesis during its installation. This location can also be done by cutting the metal sheet (s). Such a cut also makes it possible to use the prosthesis in the case of aneurysms located in the vicinity of venous or arterial diversions, and very particularly for an aneurysm of the abdominal aorta located near the departures of the renal arteries.
  • the diameter of the sleeve 1 may be between 2 and 5 mm expanded and close to 1 mm unexpanded, and its length between 2 and 16 mm.

Abstract

The invention concerns a metal sheet sealing system for an internal vascular prosthesis. It consists of a metal cylindrical sleeve (1) with semirigid wall formed with elongated meshes or longitudinal bars (5) linked by extensible peripheral elements forming a radially self-extensible lattice, or a malleable lattice capable of being radially expanded under the effect of internal pressure and preserve the resulting shape, said sleeve being sealed by means of one or several very fine flexible metal sheets (3) fixed thereon and entirely or partly covering its wall when it is set in place. The invention concerns in particular endovascular prostheses designed to be set by surgical procedure, or by percutaneous endovascular path, in an artery a vein to locally prevent risks of internal haemorrhage caused by leakage or rupture of an aneurysm.

Description

SYSTÈ E D'ÉTANCHÉITÉ PAR FEUILLE(S) MÉTALLIQUE(S) D'UNE PROTHÈSE VASCULAIRE INTERNE METAL SHEET (S) OF AN INTERNAL VASCULAR PROSTHESIS SEALING SYSTEM
La présente invention a pour objet un système d'étanchéité par feuille(s) métallique(s) d'une prothèse vasculaire interne.The present invention relates to a sealing system by metal sheet (s) of an internal vascular prosthesis.
Il concerne en particulier les prothèses endovasculaires destinée à être mise en place par voie chirurgicale, ou par voie endovasculaire percutanée, dans une artère ou une veine pour empêcher localement les risques d'hémorragie interne provoqués par la fuite ou l'éclatement d'un anévrisme, mais peut également être utilisée pour les endoprothèses utilisées pour d'autres canaux et vaisseaux corporels, par exemple dans le cas de sténoses.It relates in particular to endovascular prostheses intended to be placed by the surgical route, or by percutaneous endovascular route, in an artery or a vein to locally prevent the risks of internal hemorrhage caused by the leakage or bursting of an aneurysm. , but can also be used for stents used for other channels and body vessels, for example in the case of stenosis.
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 irriguant 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.
En neurochirurgie, le moyen mis en oeuvre actuellement consiste à remplir la lésion pour tenter de la colmater. 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 thromboses pour éviter leur rupture. Il faut prévoir jusqu'à dix coils pour un anévrisme.In neurosurgery, the means currently used consists in filling the lesion in an attempt to seal it. Practitioners use memory springs usually designated by the English name of "coils", intended to fill aneurysms and thromboses to avoid their rupture. It is necessary to provide up to ten coils for an aneurysm.
La mise en place de ces dispositifs demande des manipulations très délicates et de très longue durée, 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 handling operations, the "coils" having to be introduced one after the other, which leads to interventions that can take several hours.
Par ailleurs, les "coils" peuvent être entraîné par le flux sanguin ou provoquer un éclatement de l'anévrisme et migrer dans le tissu cervical avec des conséquences imprévisibles. 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.In addition, the "coils" can be carried by the blood flow or cause an aneurysm to burst and migrate into the cervical tissue with unpredictable consequences. 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 dilate the duct.
Ce résultat est généralement obtenu soit par l'application d'une pression à l'intérieur d'une prothèse déformable montée sur un élément gonflable selon une technique connue (voir par exemple le brevet 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 patent N ° PCT / FR 95/01 460 filed by l 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 N ° WO 92 06 734 of M . Young SONG), the inflatable member 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. Cependant cette technique est difficilement envisageable pour les anévrismes intra-cérébraux en raison de la faible section des vaisseaux concernés.The rare aneurysms treated using this device are concealed by means of a tube or a plastic film covering the expandable organ, the latter playing the role of reinforcement. However, this technique is difficult to envisage for intracerebral aneurysms due to the small section of the vessels concerned.
La demande de brevet N° PCT/FR 98/02355 déposée par le demandeur décrit une prothèse vasculaire constituée d'un élément principal formé d'un anneau fendu de tête solidaire d'une ou plusieurs barres longitudinales, et d'une séries d'anneaux fendus indépendants destinés à être placés de façon jointive à l'emplacement de l'anévrisme au moyen d'un tube cathéter, la ou les barres longitudinales étant disposées en travers de celui-ci et servant d'appui aux anneaux indépendants. Cet implant exige plusieurs opérations successives pour la mise en place du support et des anneaux ouverts, ce qui augmente de façon importante la durée de l'intervention.Patent application No. PCT / FR 98/02355 filed by the applicant describes a vascular prosthesis consisting of a main element formed by a split head ring secured to one or more longitudinal bars, and a series of independent split rings intended to be placed contiguously at the location of the aneurysm by means of a catheter tube, the longitudinal bar or bars being arranged across the latter and serving to support the independent rings. This implant requires several successive operations for the installation of the support and open rings, which significantly increases the duration of the intervention.
Le dispositif selon la présente invention permet la réalisation d'une prothèse vasculaire interne expansible relativement simple à fabriquer, présentant une étanchéité parfaite et particulièrement adaptée au traitement des anévrismes notamment 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 allows the production of an expandable internal vascular prosthesis relatively simple to manufacture, having a perfect seal and particularly suitable for the treatment of aneurysms in particular cerebral and intracerebral 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 consiste en un manchon cylindrique métallique à paroi semi-rigide formée de mailles allongées ou de barres longitudinales reliés par des éléments périphériques extensibles constituant un treillis auto-extensible radialement, ou malléable et apte à s'étendre radialement sous l'effet d'une pression interne et à garder la forme ainsi obtenue, ce manchon étant rendu étanche au moyen d'une ou plusieurs feuilles métalliques souples très fines fixées sur lui et recouvrant totalement ou partiellement sa paroi lorsque il est en place.It consists of a cylindrical metallic sleeve with a semi-rigid wall formed of elongated meshes or longitudinal bars connected by extensible peripheral elements constituting a self-extensible trellis radially, or malleable and able to extend radially under the effect of a internal pressure and to keep the shape thus obtained, this sleeve being sealed by means of one or more very thin flexible metal sheets fixed on it and completely or partially covering its wall when it is in place.
Sur les dessins annexés, donnés à titre d'exemples non limitatifs de formes de réalisation de l'objet de l'invention : les figures 1 et 2 sont des coupes transversales, respectivement avant et après expansion, montrant une prothèse endovasculaire pourvue d'une feuille métallique périphérique d'étanchéité unique, les figures 3 et 4 représentent dans les mêmes conditions une prothèse endovasculaire pourvue de plusieurs feuilles métalliques périphériques d'étanchéité, les figures 5 et 6 représentent, toujours dans les mêmes conditions, une prothèse endovasculaire dont l'étanchéité est assurée au moyen d'une feuille métallique tubulaire entrelacée avec les éléments longitudinaux de la prothèse et les figures 7 et 8 sont des coupes transversales avant et après expansion d'une prothèse endovasculaire pourvue d'une feuille métallique tubulaire périphérique.In the accompanying drawings, given by way of non-limiting examples of embodiments of the subject of the invention: FIGS. 1 and 2 are cross sections, respectively before and after expansion, showing an endovascular prosthesis provided with a single metallic peripheral sealing sheet, FIGS. 3 and 4 represent, under the same conditions, an endovascular prosthesis provided with several metallic peripheral sealing sheets, FIGS. 5 and 6 represent, always under the same conditions, an endovascular prosthesis, the sealing is ensured by means of a tubular metallic sheet interlaced with the longitudinal elements of the prosthesis and FIGS. 7 and 8 are cross sections before and after expansion of an endovascular prosthesis provided with a peripheral tubular metallic sheet.
Le dispositif, figures 1 à 8, est constitué d'une gaine tubulaire, ou manchon 1 expansible radialement, formé d'une portion de cylindre creux de section circulaire à paroi mince en treillis comportant une ou plusieurs feuilles métalliques 2, 3, 4 très fines, de préférence en or ou en titane, solidaires de sa paroi et se plaquant sur elle pour la rendre étanche lorsque la prothèse est en position expansée. Le treillis constituant la paroi de la prothèse sera par exemple constitué de barres longitudinales 5 reliées entre elles par des raccords annulaires extensibles disposés en quinconce (figures 1 et 2), mais pourra présenter toute configuration permettant une extension radiale. Il pourra en particulier être formé plusieurs anneaux de mailles allongées assemblées à leurs extrémités par des éléments déformables permettant l'expansion de la gaine 1 ainsi qu'un certain cintrage de celle-ci.The device, FIGS. 1 to 8, consists of a tubular sheath, or radially expandable sleeve 1, formed by a portion of hollow cylinder of circular section with thin lattice wall comprising one or more metal sheets 2, 3, 4 very fine, preferably gold or titanium, integral with its wall and pressing on it to make it watertight when the prosthesis is in the expanded position. The trellis constituting the wall of the prosthesis will for example be made up of longitudinal bars 5 connected to each other by extensible annular connections arranged in staggered rows (FIGS. 1 and 2), but may have any configuration allowing a radial extension. It may in particular be formed several elongated mesh rings assembled at their ends by deformable elements allowing the expansion of the sheath 1 as well as a certain bending of the latter.
Le manchon 1 peut être réalisée dans un matériau semi-rigide malléable et 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. La prothèse sera de préférence fabriquée sous forme expansée, puis "écrasée" sur le ballonnet gonflable. Selon une variante d'exécution, le manchon 1 est auto-extensible et réalisé sous forme expansée dans un matériau flexible ou à mémoire de forme, ce qui permet de supprimer l'utilisation de ballonnet gonflable. Pour sa mise en place, il est comprimé radialement et introduit dans un tube creux de faible diamètre monté à l'extrémité d'un cathéter et chassé dudit tube par un moyen approprié lorsqu'il se trouve à l'emplacement choisi. Le matériau à mémoire de forme, permet de maintenir le manchon dans l'état comprimé en abaissant sa température, et de retrouver la forme initiale expansée lorsqu'il atteint la température du corps une fois mis en place.The sleeve 1 can be made of a semi-rigid malleable material and 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 an inflatable balloon mounted at the end of a catheter according to a known technique. The prosthesis will preferably be manufactured in expanded form, then "crushed" on the inflatable balloon. According to an alternative embodiment, the sleeve 1 is self-expanding and produced in expanded form in a flexible material or with shape memory, which eliminates the use of an inflatable balloon. For its establishment, it is compressed radially and introduced into a hollow tube of small diameter mounted at the end of a catheter and driven from said tube by an appropriate means when it is in the chosen location. The shape memory material makes it possible to maintain the sleeve in the compressed state by lowering its temperature, and to return to the initial expanded shape when it reaches the temperature of the body once it has been put in place.
La gaine 1 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 itiétallique à paroi mince.The sheath 1 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 an itietallic thin-walled tube.
L'étanchéité du manchon 1 pourra être obtenue par une feuille métallique unique 2 de forme rectangulaire fixée par soudure, collage ou couture de l'un de ses bords le long d'une barre longitudinale 5. Les dimensions de cette feuille seront déterminées de façon à ce quelle recouvre entièrement le pourtour de la gaine à l'état expansé, en débordant légèrement sur le bord opposé (figure 2), la feuille s'enroulant en spirale autour du manchon 1 lorsque celui-ci est à l'état compressé (figure 1). Le même principe peut s'appliquer en utilisant plusieurs feuilles rectangulaires 3 réparties sur la périphérie de la gaine (figures 3 et 4).The sealing of the sleeve 1 can be obtained by a single metal sheet 2 of rectangular shape fixed by welding, gluing or sewing one of its edges along a longitudinal bar 5. The dimensions of this sheet will be determined so to what it completely covers the periphery of the sheath in the expanded state, slightly overflowing on the opposite edge (FIG. 2), the sheet being wound in a spiral around the sleeve 1 when the latter is in the compressed state ( figure 1). The same principle can be applied by using several rectangular sheets 3 distributed over the periphery of the sheath (Figures 3 and 4).
La feuille métallique pourra être constituée d'un tube 4 entrelacé avec les barres longitudinales 5 du manchon en passant alternativement à l'intérieur et à l'extérieur de la gaine (figures 5 et 6), ou d'un tube 4' disposé autour du manchon 1 et soudé, collé ou cousu le long d'une de ses génératrice sur une barre longitudinale 5, ce tube étant replié sur lui-même lorsque la prothèse est à l'état compressé (figures 7 et 8).The metal sheet may consist of a tube 4 interlaced with the longitudinal bars 5 of the sleeve passing alternately inside and outside of the sheath (Figures 5 and 6), or a tube 4 'arranged around of the sleeve 1 and welded, glued or sewn along one of its generatrix on a longitudinal bar 5, this tube being folded back on itself when the prosthesis is in the compressed state (Figures 7 and 8).
Lorsque la prothèse est constituée d'anneaux formés de mailles allongées, chacun de ces anneaux sera agencé de la façon décrite ci-dessus, les barres longitudinales des mailles formant les anneaux jouant le même rôle que les barres 5 du manchon 1.When the prosthesis consists of rings formed of elongated meshes, each of these rings will be arranged in the manner described above, the longitudinal bars of the meshes forming the rings playing the same role as the bars 5 of the sleeve 1.
La gaine 1 pourra éventuellement comporter des repères radio-opaques visibles aux rayons X déposés par voie électrolytique sur la ou les feuilles métalliques 2, 3, 4 pour faciliter le repérage au cours de la progression de la prothèse lors de sa mise en place. Ce repérage peut également s'effectuer grâce à une découpe de la ou des feuilles métalliques. Une telle découpe permet en outre d'utiliser la prothèse dans le cas d'anévrismes situés au voisinage de dérivations veineuses ou artérielles, et tout particulièrement pour un anévrisme de l'aorte abdominale situé près des départs des artères rénales.The sheath 1 may possibly include radio-opaque markers visible by X-rays deposited electrolytically on the metal sheet or sheets 2, 3, 4 to facilitate identification during the progression of the prosthesis during its installation. This location can also be done by cutting the metal sheet (s). Such a cut also makes it possible to use the prosthesis in the case of aneurysms located in the vicinity of venous or arterial diversions, and very particularly for an aneurysm of the abdominal aorta located near the departures of the renal arteries.
A titre indicatif, le diamètre du manchon 1 pourra être compris entre 2 et 5 mm expansé et voisin de 1 mm non expansé, et sa longueur comprise entre 2 et 16 mm.As an indication, the diameter of the sleeve 1 may be between 2 and 5 mm expanded and close to 1 mm unexpanded, and its length between 2 and 16 mm.
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 systèmes 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 systems.

Claims

REVENDICATIONS
1°. Système d'étanchéité par feuille(s) métallique(s) d'une prothèse vasculaire interne, destinée en particulier à être mise en place par voie chirurgicale, ou par voie endovasculaire percutanée, dans une artère ou une veine pour empêcher localement les risques d'hémorragie interne provoqués par l'éclatement d'un anévrisme, constituée d'une gaine tubulaire ou manchon (1) cylindrique auto-expansible radialement ou malléable et apte à s'étendre radialement sous l'effet d'une pression interne et à garder la forme ainsi obtenue, à paroi semi-rigide en treillis formée d'anneaux de mailles allongées assemblées à leurs extrémités par des éléments déformables, ou de barres longitudinales (5) reliées par des raccords annulaires extensibles, caractérisé en ce que le manchon (1) comporte une ou plusieurs feuilles métalliques très fines solidaire de sa paroi et se plaquant sur celle-ci pour la rendre étanche lorsque la prothèse est expansée une fois mise en place.1. Sealing system by metal sheet (s) of an internal vascular prosthesis, intended in particular to be placed by surgery, or by percutaneous endovascular route, in an artery or a vein to locally prevent the risks of internal bleeding caused by the bursting of an aneurysm, consisting of a tubular sheath or sleeve (1) cylindrical self-expanding radially or malleable and able to extend radially under the effect of internal pressure and to keep the shape thus obtained, with a semi-rigid lattice wall formed of elongated mesh rings assembled at their ends by deformable elements, or of longitudinal bars (5) connected by extensible annular connections, characterized in that the sleeve (1 ) has one or more very thin metal sheets secured to its wall and pressed against it to make it watertight when the prosthesis is expanded once put in place .
2°. Système d'étanchéité selon la revendication 1 , se caractérisant par le fait que le métal utilisé pour la fabrication de la ou des feuille(s) métallique(s) est de l'or ou du titane.2 °. Sealing system according to claim 1, characterized in that the metal used for the manufacture of the metal sheet (s) is gold or titanium.
3°. Système d'étanchéité selon l'une quelconque des revendications précédentes, se caractérisant par le fait que l'étanchéité du manchon (1) est obtenue au moyen d'une feuille métallique unique (2), ou d'une feuille unique par anneau, ladite feuille étant de forme rectangulaire et fixée par soudure, collage ou couture de l'un de ses bords le long d'une barre longitudinale (5), les dimensions de cette feuille étant déterminées de façon à ce quelle recouvre entièrement le pourtour de la gaine à l'état expansé, en débordant légèrement sur le bord opposé, la feuille s'enroulant en spirale autour du manchon (1) lorsque celui-ci est à l'état compressé.3 °. Sealing system according to any one of the preceding claims, characterized in that the sealing of the sleeve (1) is obtained by means of a single metal sheet (2), or of a single sheet per ring, said sheet being of rectangular shape and fixed by welding, gluing or sewing one of its edges along a longitudinal bar (5), the dimensions of this sheet being determined so that it completely covers the periphery of the sheath in the expanded state, slightly overflowing on the opposite edge, the sheet spiraling around the sleeve (1) when the latter is in the compressed state.
4°. Système d'étanchéité selon l'une quelconque des revendications 1 et 2, se caractérisant par le fait que l'étanchéité du manchon (1) est obtenue au moyen de plusieurs feuilles rectangulaires (3) métalliques réparties sur la périphérie du manchon (1) ou de chaque anneau, les dimensions desdites feuilles étant déterminées de façon à ce quelles recouvrent entièrement le pourtour de la gaine ou d'un anneau à l'état expansé.4 °. Sealing system according to any one of claims 1 and 2, characterized in that the sealing of the sleeve (1) is obtained by means of several rectangular metal sheets (3) distributed over the periphery of the sleeve (1) or of each ring, the dimensions of said sheets being determined so that they entirely cover the periphery of the sheath or of a ring in the expanded state.
5°. Système d'étanchéité selon l'une quelconque des revendications5 °. Sealing system according to any one of the claims
1 et 2, se caractérisant par le fait que l'étanchéité du manchon (1) est obtenue au moyen d'une feuille métallique constituée d'un tube (4) entrelacé avec les barres longitudinales (5) du manchon ou d'un anneau en passant alternativement à l'intérieur et à l'extérieur de la gaine.1 and 2, characterized in that the tightness of the sleeve (1) is obtained by means of a metal sheet consisting of a tube (4) intertwined with the longitudinal bars (5) of the sleeve or of a ring passing alternately inside and outside the sheath.
6°. Système d'étanchéité selon l'une quelconque des revendications 1 et 2, se caractérisant par le fait que l'étanchéité du manchon (1) est obtenue au moyen d'une feuille métallique constituée d'un tube (4') disposé autour du manchon (1) ou d'un anneau et soudé, collé ou cousu le long d'une de ses génératrice sur une barre longitudinale (5).6 °. Sealing system according to any one of claims 1 and 2, characterized in that the sealing of the sleeve (1) is obtained by means of a metal sheet consisting of a tube (4 ') arranged around the sleeve (1) or a ring and welded, glued or sewn along one of its generators on a longitudinal bar (5).
7°. Système d'étanchéité selon l'une quelconque des revendications précédentes, se caractérisant par le fait que la ou des feuille(s) métallique(s) (2, 3, 4) comporte(nt) une découpe permettant d'utiliser la prothèse dans le cas d'anévrismes situés au voisinage de dérivations veineuses ou artérielles, et de faciliter le repérage par rayons X au cours de la progression de la prothèse lors de sa mise en place.7 °. Sealing system according to any one of the preceding claims, characterized in that the metal sheet (s) (2, 3, 4) comprises (s) a cutout making it possible to use the prosthesis in the case of aneurysms located in the vicinity of venous or arterial diversions, and to facilitate the identification by X-rays during the progression of the prosthesis during its installation.
8°. Système d'étanchéité selon l'une quelconque des revendications 1 à 6, se caractérisant par le fait qu'il comporte des repères radio-opaques visibles aux rayons X déposés par voie électrolytique sur la ou des feuille(s) métallique(s) (2, 3, 4).8 °. Sealing system according to any one of claims 1 to 6, characterized in that it comprises radiopaque markers visible by X-rays deposited by electrolytic means on the metal sheet (s) (s) ( 2, 3, 4).
9°. Système d'étanchéité selon l'une quelconque des revendications précédentes, se caractérisant par le fait que le manchon (1) est réalisé en une seule pièce par gravure ou usinage laser d'un tube métallique à paroi mince.9 °. Sealing system according to any one of the preceding claims, characterized in that the sleeve (1) is produced in one piece by etching or laser machining of a thin-walled metal tube.
10°. Système d'étanchéité selon l'une quelconque des revendications 1 à 8, se caractérisant par le fait que le manchon (1) est réalisé en une seule pièce par électro-érosion laser à partir d'un bloc de métal tel que l'acier inoxydable ou le tantale.10 °. Sealing system according to any one of Claims 1 to 8, characterized in that the sleeve (1) is produced in one part by laser EDM from a metal block such as stainless steel or tantalum.
11 °. Système d'étanchéité selon l'une quelconque des revendications précédentes, se caractérisant par le fait que le manchon (1) est réalisé dans un matériau semi-rigide malléable et 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 au moyen d'un ballonnet gonflable monté à l'extrémité d'un cathéter selon une technique connue, ou par un dispositif similaire.11 °. Sealing system according to any one of the preceding claims, characterized in that the sleeve (1) is made of a semi-rigid malleable material and 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 by means of an inflatable balloon mounted at the end of a catheter according to a known technique, or by a similar device.
12°. Système d'étanchéité selon la revendication 11, se caractérisant par le fait que le manchon (1) est fabriqué sous forme expansée, puis "écrasé" sur un ballonnet gonflable destiné à être monté à l'extrémité d'un cathéter.12 °. Sealing system according to claim 11, characterized in that the sleeve (1) is produced in expanded form, then "crushed" on an inflatable balloon intended to be mounted at the end of a catheter.
13°. Système d'étanchéité selon l'une quelconque des revendications 1 à 10, se caractérisant par le fait que le manchon (1) est fabriqué sous forme expansée dans un matériau flexible, de manière à pouvoir être comprimé radialement et introduit dans un tube creux de faible diamètre monté à l'extrémité d'un cathéter et chassé dudit tube par un moyen approprié lorsqu'il se trouve à l'emplacement choisi.13 °. Sealing system according to any one of Claims 1 to 10, characterized in that the sleeve (1) is produced in expanded form in a flexible material, so that it can be compressed radially and inserted into a hollow tube of small diameter mounted at the end of a catheter and expelled from said tube by an appropriate means when it is in the chosen location.
14°. Système d'étanchéité selon l'une quelconque des revendications 1 à 10, se caractérisant par le fait que le manchon (1) est fabriqué sous forme expansée dans un matériau à mémoire de forme permettant de maintenir ledit manchon dans l'état comprimé en abaissant sa température, et de retrouver la forme initiale expansée lorsqu'il atteint la température du corps une fois mis en place.14 °. Sealing system according to any one of Claims 1 to 10, characterized in that the sleeve (1) is produced in expanded form in a shape memory material making it possible to maintain said sleeve in the compressed state by lowering its temperature, and to return to the initial expanded form when it reaches the temperature of the body once it is in place.
15°. Système d'étanchéité interne selon l'une quelconque des revendications précédentes, se caractérisant par le fait que le diamètre du manchon (1) est compris entre 2 et 5 millimètres sous forme expansé et voisin de 1 millimètre sous forme comprimée, sa longueur étant comprise entre 2 et 16 millimètres. 15 °. Internal sealing system according to any one of the preceding claims, characterized in that the diameter of the sleeve (1) is between 2 and 5 millimeters in expanded form and close to 1 millimeter in compressed form, its length being included between 2 and 16 millimeters.
PCT/FR2001/001921 2000-06-20 2001-06-20 Metal sheet sealing system for an internal vascular prosthesis WO2001097716A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001269200A AU2001269200A1 (en) 2000-06-20 2001-06-20 Metal sheet sealing system for an internal vascular prosthesis

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0007830A FR2810229B3 (en) 2000-06-20 2000-06-20 WATERPROOFING SYSTEM BY METAL SHEET (S) OF AN INTERNAL VASCULAR PROSTHESIS
FR00/07830 2000-06-20

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WO (1) WO2001097716A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100106234A1 (en) * 2008-10-23 2010-04-29 Medtronic Vascular, Inc. Medical Devices With Extended Drug Diffusion Pathway

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5676697A (en) * 1996-07-29 1997-10-14 Cardiovascular Dynamics, Inc. Two-piece, bifurcated intraluminal graft for repair of aneurysm

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5676697A (en) * 1996-07-29 1997-10-14 Cardiovascular Dynamics, Inc. Two-piece, bifurcated intraluminal graft for repair of aneurysm

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100106234A1 (en) * 2008-10-23 2010-04-29 Medtronic Vascular, Inc. Medical Devices With Extended Drug Diffusion Pathway

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FR2810229B3 (en) 2002-07-19
AU2001269200A1 (en) 2002-01-02

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