WO1997046174A1 - Endoprothese pour bifurcation vasculaire - Google Patents

Endoprothese pour bifurcation vasculaire Download PDF

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Publication number
WO1997046174A1
WO1997046174A1 PCT/FR1997/000999 FR9700999W WO9746174A1 WO 1997046174 A1 WO1997046174 A1 WO 1997046174A1 FR 9700999 W FR9700999 W FR 9700999W WO 9746174 A1 WO9746174 A1 WO 9746174A1
Authority
WO
WIPO (PCT)
Prior art keywords
segment
bifurcation
segments
section
expanded state
Prior art date
Application number
PCT/FR1997/000999
Other languages
English (en)
Inventor
Jacques Seguin
Jean-Claude Laborde
Original Assignee
Jacques Seguin
Laborde Jean Claude
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
Priority to EP97927244A priority Critical patent/EP0909147B9/fr
Application filed by Jacques Seguin, Laborde Jean Claude filed Critical Jacques Seguin
Priority to AT97927244T priority patent/ATE281798T1/de
Priority to JP10500284A priority patent/JP2000511444A/ja
Priority to CA002257340A priority patent/CA2257340C/fr
Priority to US09/011,214 priority patent/US6068655A/en
Priority to DE69731533T priority patent/DE69731533T2/de
Priority to AU31801/97A priority patent/AU3180197A/en
Publication of WO1997046174A1 publication Critical patent/WO1997046174A1/fr
Priority to US09/580,597 priority patent/US6666883B1/en
Priority to US10/292,385 priority patent/US8728143B2/en
Priority to US11/737,652 priority patent/US7686846B2/en
Priority to US11/767,422 priority patent/US8603157B2/en
Priority to US12/750,379 priority patent/US9101501B2/en

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Definitions

  • the present invention relates to a device for the treatment of bodily conduits at a bifurcation, that is to say at the separation of a main conduit into two secondary conduits. It also relates to equipment for installing this device.
  • This device can be used for the treatment of vascular bifurcations, in particular carotid, femoral, iliac, popliteal, renal, or coronary, or non-vascular bifurcations, such as tracheal or biliary bifurcations, for example between the bile duct and cystic channels, or at the bifurcation of the main bile duct.
  • vascular bifurcations in particular carotid, femoral, iliac, popliteal, renal, or coronary, or non-vascular bifurcations, such as tracheal or biliary bifurcations, for example between the bile duct and cystic channels, or at the bifurcation of the main bile duct.
  • the treatment can consist in restoring the adequate diameter of the bifurcation, in the event of arteriosclerosis or internal cellular proliferation, to remedy a localized dissection or not of the wall of the conduit, or, in the event of aneurysm, to recreate a bifurcation of normal diameter while excluding the aneurysmal pocket.
  • a radially expandable tubular device commonly known as a "stent”.
  • This device is introduced in the unexpanded state into the internal lumen of the vessel, in particular percutaneously, up to the level of narrowing. Once in place, it is expanded to support the vessel wall and restore the proper section of the vessel.
  • the device can be made of a non-elastic material, and is then expanded by means of an inflatable balloon, on which it is engaged, or can be "self-expanding", that is to say made of an elastic material , spontaneously expanding during its removal from a sheath which keeps it in the contracted state.
  • a conventional stent is not perfectly suited for the treatment of a narrowing located at a bifurcation, since its engagement both in the main duct and in one of the secondary ducts can cause immediate or delayed occlusion of the another secondary conduit.
  • One of the two elements has two parts of diameter corresponding respectively to the diameter of the main vessel and to the diameter of one of the secondary vessels, and is intended to be engaged on the one hand in this main vessel and on the other hand in this secondary vessel.
  • the other element has a diameter corresponding to the diameter of the other secondary vessel and is coupled to the first element, after positioning of the latter, by engagement of one or more of its turns in the turns of the first element.
  • This material allows a reinforcement of the bifurcation but appears unsuitable to treat a vascular narrowing or an occlusive lesion, given its structure and the low possibility of radial expansion of its two constituent elements.
  • the shape of the first element does not correspond to the shape of a bifurcation, which has a flared transition zone between the end of the main vessel and the ends of the secondary vessels. This material therefore does not allow to perfectly support this wall or to treat a dissection at this wall. In addition, the separate installation of these two elements seems relatively difficult.
  • the present invention aims to remedy these various drawbacks, by providing a device making it possible to treat a pathology at the level of a bifurcation, by perfectly supporting the vascular wall and by being relatively simple to install.
  • the device which it concerns comprises, in a manner known per se, segments delimiting longitudinal conduits, one of which is intended to be engaged through the bifurcation and another of which is intended to be engaged in a secondary conduit of this bifurcation.
  • this device comprises: - at least one radially expandable segment, having, in the expanded state, a cross section substantially greater than the cross section of one of the secondary conduits;
  • the segment having, in the expanded state, a cross section substantially greater than the cross section of one of the secondary conduits will be called hereinafter "secondary segment", while the segment having, in the expanded state , a frustoconical form will be referred to below as “frustoconical segment”.
  • the secondary segment is intended to be introduced into the secondary duct in the contracted state and to take support, in the expanded state, against the wall of this duct. This expansion makes it possible not only to treat a narrowing or a dissection situated at the level of this duct, but also to ensure perfect immobilization of the device in the duct.
  • the device also has a unitary character, and is therefore relatively easy to install.
  • At least the frustoconical segment is covered by a wall giving it a seal in a radial direction.
  • This wall makes it possible to trap, between it and the wall of the duct, the particles which may come from the lesion treated, such as arteriosclerotic particles or cellular agglomerates, and thus avoid the migration of these particles in the organism.
  • the device can allow the treatment of an aneurysm, by guiding the liquid through the bifurcation, and thus preventing the wall forming the aneurysm from being stressed.
  • the device can comprise several secondary segments, placed one after the other, to provide additional shoring of the wall of the secondary conduit and to increase, if necessary, the anchoring force of the device in the bifurcation.
  • the device may comprise, on the side of the frustoconical segment facing the main duct, at least one radially expandable segment, having, in the expanded state, a cross section substantially greater than the cross section of the main duct.
  • the flexible connection between two consecutive segments is constituted by one or more bridges of material connecting the two adjacent ends of these two segments.
  • This or these bridges are advantageously made of the same material as that constituting the segments.
  • each segment has a mesh structure, the meshes being elongated in the longitudinal direction of the device and each having a substantially hexagonal shape; the meshes of the frustoconical segment have a width which increases progressively in the longitudinal direction of the device, towards the end of this segment having the largest section in the expanded state.
  • This increase in the width of the meshes results from an increase in the length of the edges of the meshes arranged longitudinally and / or from an increase in the angle that two edges form between them facing the same mesh.
  • the frustoconical segment may have an axis not coincident with the longitudinal axis of the device but oblique with respect to this axis, in order to be best suited to the anatomy of the bifurcation to be treated.
  • the widths of the meshes of this segment also gradually increase, in the transverse direction of the device, in the direction of a generator diametrically opposite to that located in the extension of the bridge connecting this segment to the adjacent segment.
  • the device can be made of a shape memory metal, becoming malleable without elasticity at a temperature significantly lower than that of the human body, to allow the device to retract on itself, and regaining its neutral form at a temperature corresponding substantially to that of the human body.
  • This metal is preferably the nickel-titanium alloy known under the name "NITINOL".
  • the installation material of the device comprises, in a manner known per se, means for allowing the expansion of this device when it is in place.
  • These means may include a removable sheath in which the device is placed in the contracted state, when this device is made of an elastic material, or a support core comprising an inflatable balloon on which the device is placed, when this device is made made of a non-elastic material.
  • this material comprises, according to the invention, means making it possible to identify, through the patient's body, the longitudinal location of the frustoconical segment, so that it can be correctly positioned at the level of the flared area of the bifurcation.
  • the equipment also comprises means making it possible to identify, through the patient's body, the angular orientation of the device by with respect to the bifurcation, so that the part of this segment with the greatest expansion can be placed adequately with respect to the bifurcation.
  • Figure 1 is a side view, according to a first embodiment
  • Figure 2 is a perspective view of this device in a state of radial contraction, and, with partial cutaway, of the material for its installation
  • Figure 3 is a longitudinal sectional view of the bifurcation to be treated
  • Figures 4 to 6 are views of this bifurcation similar to Figure 3, during three successive steps of setting up the device
  • Figure 7 is a view similar to Figure 3 of a bifurcation having an aneurysm, in which the device is placed
  • Figure 8 is a side view of the device according to a second embodiment.
  • Figure 1 shows an expandable device 1 for the treatment of body conduits at a bifurcation, that is to say, as shown in Figure 3, at the separation of a main conduit 2 in two secondary ducts 3.
  • the device 1 comprises four successive segments 5,6,7,8 with a mesh structure, connected to each other by three bridges of material 9.
  • the meshes 10 of these segments are elongated in the longitudinal direction of the device 1 and each have a substantially hexagonal shape.
  • the segment 5 has a tubular shape and has a diameter substantially greater than the diameter of the main duct 2.
  • the segment 6 has meshes 10 whose width increases progressively, compared with that of the meshes of segment 5, on the one hand, in the longitudinal direction of the device 1, towards the end of the segment 6 located opposite the segment 5, and, on the other hand, in the transverse direction of the device 1, in direction of a generator diametrically opposite to that located in the extension of the bridge 9.
  • This increase in the width of the meshes 10 results from an increase in the length of the edges 10a of the meshes 10 arranged longitudinally as well as an increase in the angle formed between two edges
  • This segment 6 thus has a frustoconical shape with an oblique axis relative to the longitudinal axis of the device 1. This shape corresponds to the shape of the bifurcation at the flared transition zone 11 which separates the end of the main duct 2 the ends of the secondary conduits 3.
  • the segments 7 and 8 are identical to each other and have a tubular shape with a diameter substantially greater than the diameter of one of the secondary conduits 3.
  • the material bridges 9 connect the adjacent ends of the segments 5 to 8 and have a small width, so that they can undergo a certain bending making it possible to orient these segments relative to each other, in particular segment 6 relative to in segment 7.
  • the device 1 is produced by adequate cutting of a sheet of nickel-titanium alloy known under the name "NITINOL", then circular folding of the blank obtained and welding of the parts of this blank coming in the vicinity of each other.
  • NITINOL nickel-titanium alloy
  • This alloy is malleable at a temperature of the order of 10 ° C., but can regain its neutral form at a temperature corresponding substantially to that of the human body.
  • Figure 2 shows the device 1 in a state of radial contraction, obtained by cooling its constituent material. During this contraction, the edges 10a pivot relative to the transverse edges 10b of the meshes 10, so that the meshes 10 have, in this state of contraction, a substantially rectangular shape.
  • the segments 5 to 8 have a cross section smaller than that of the conduits 2 and 3, and can be introduced therein, as will be described later.
  • the device 1 is engaged on a central support core 15, then is contracted radially thereon.
  • This core 15 comprises an axial stop, such as a shoulder (not visible in FIG. 2), of diameter less than that of the device 1 when this device is expanded, but greater than the diameter of this device 1 when the latter is contracted. This stop therefore allows the axial immobilization of the device 1 on the core 15, when the latter is contracted.
  • a sheath 16 is then engaged on the device 1 in order to contain it in its contracted state.
  • This sheath 16 has four radiopaque markers 20,21,22,23 printed on it, for example containing a barium compound.
  • Three pins 20, 21, 22 have an annular shape and extend over the entire periphery of the sheath 16. They are located respectively at the free ends of the segments 5 and 8 and at the level of the bridge 9 separating the segments 6 and 7.
  • the fourth reference 23 is located substantially mid-distance from the generator of the segment 6 located in the extension of the bridge 9 and the diametrically opposite generator. It has the shape of a diamond and has a small thickness.
  • the core 15 has a longitudinal axial hole allowing its engagement on a guide wire 25 (Figures 4 to 6).
  • This wire 25 can be engaged, percutaneously, in the conduit 2, through the zone 11 then in one of the conduits 3, through which it can slide, and comprises a cone 26 of synthetic material, located in front of the core 15 - device 1 - sheath 16 assembly.
  • the bifurcation 30 shown in FIG. 3 has protuberances 31 which create a narrowing of the section which impedes the flow of the liquid circulating in the conduits 2 and 3. When it is a vascular bifurcation, these protuberances are due by example to arteriosclerosis or to cell growth.
  • the device 1 makes it possible to treat this bifurcation, by restoring the appropriate diameter of the conduits 2,3 and of the flared area 11.
  • the core 15 - device 1 - sheath 16 assembly is engaged on the wire 25 as far as the cone 26.
  • this wire 25 allows the engagement and then the guiding of this assembly in the conduit 2, the zone 11 then the conduit 3.
  • the cone 26 facilitates the sliding of the assembly and reduces the traumatic risk.
  • the reference 22 makes it possible to display, using an appropriate radiographic device, the position of the bridge 9 separating the segments 6 and 7, and therefore to display the location of the segment 6, so that it can be correctly positioned relative to the flared area 11.
  • the marks 20 and 21 make it possible to ensure that the segments 5 and 8 are correctly positioned, respectively in the main conduit 2 and the secondary conduit 3.
  • the reference 23 is, in turn, visible in plan or by its edge, depending on whether it is oriented perpendicular or parallel to the radius of the radiography device. It thus makes it possible to identify the angular orientation of the device 1 relative to the bifurcation 30, so that the part of the segment 6 having the greatest expansion can be placed adequately relative to the zone 11.
  • the sheath 16, which has a length such that it opens beyond the opening that allowed the introduction of the assembly is then gradually withdrawn, as shown in FIGS. 5 and 6, to allow the complete expansion of the device 1.
  • the latter is warmed by body temperature, which allows its expansion.
  • the core 15 and the wire 25 are removed.
  • FIG. 7 shows that the device 1 can also be used for the treatment of an aneurysm 40.
  • the segment 6 and part of the segment 5 are then covered with a polyester film 41, impermeable to the liquid circulating in the conduits 2 and 3, which is sewn on them.
  • the device then guides this liquid through the bifurcation 30, and consequently prevents the wall forming the aneurysm 40 from being stressed.
  • FIG. 8 shows a device 100 according to the invention, having segments 105, 106, 107, 108 and a bridge 109, connecting the segments 106 and 107, of structure similar to that of segments 5 to 8 and of bridge 9 of the device shown in FIG. 1.
  • two consecutive segments, apart from the segments 106 and 107, are connected by six bridges 190 in the shape of an omega.
  • the curved central part 190a of these bridges 190 has a multi-directional elasticity allowing the adequate longitudinal orientation of the different segments with respect to each other.
  • These bridges 190 have the advantage of giving longitudinal continuity to the device, which facilitates the passage of the latter through a zone with a large curvature and which eliminates the need to reduce this curvature, which is always dangerous in the event of arteriosclerosis. , to allow the passage of the device.
  • the invention thus provides a device for the treatment of a pathology at a bifurcation 30.
  • This device has the many advantages indicated higher, especially those to ensure perfect support of the vascular wall and to be relatively simple to install.
  • the 1,100 device can comprise several segments 5,8,105,108 placed one after the other, to provide additional shoring and to increase, if necessary, the maintenance of the device in the bifurcation 30.
  • the core 15 could include an inflatable balloon, either to achieve the expansion of the device 1, in the case where the latter is made of a non-elastic material, or to ensure the total expansion of a self-expanding device 1 , after setting it up.
  • the marks 20 to 23 could be printed on the core 15 or directly on the device 1, in particular on the bridge 9,109, and not on the sheath 16.
  • the segment 6.106 could have an axis coincident with the longitudinal axis of the device, and not oblique with respect to this axis, if this is made necessary by the anatomy of the bifurcation to be treated.
  • the segment 7,107 could itself present, in the expanded state, a flared shape corresponding to the shape of the flared connection zone by which, in certain bifurcations, the secondary conduits 3 are connected to the flared transition zone 11. This segment 7, 107 would thus have a: rme corresponding precisely to the shape of this flared connection zone, of which it would ensure perfect shoring.
  • the bridges 190 could be in number greater than or less than six between two consecutive segments, and could have a shape other than in omega, allowing their multi-directional elasticity, and in particular a V or W shape.

Abstract

Selon l'invention, ce dispositif (1) comprend: au moins un segment (7, 8) expansible radialement, présentant, à l'état expansé, une section transversale sensiblement supérieure à la section transversale de l'un des conduits secondaires (3); un segment (6) présentant, à l'état expansé, une forme tronconique, correspondant à la forme de la bifurcation au niveau de la zone de transition évasée (11) qui sépare le conduit principal (2) des conduits secondaires (3); et une liaison souple (9) entre ces deux segments (6, 7), permettant l'orientation de ceux-ci l'un par rapport à l'autre, selon l'orientation du conduit secondaire (3) recevant ledit segment (7) par rapport à ladite zone de transition évasée (11).

Description

ENDOPROTHESE POUR BIFURCATION VASCULAIRE
La présente invention concerne un dispositif permettant le traitement de conduits corporels au niveau d'une bifurcation, c'est-à-dire au niveau de la séparation d'un conduit principal en deux conduits secondaires. Elle concerne également un matériel pour la pose de ce dispositif.
Ce dispositif peut être utilisé pour le traitement de bifurcations vasculaires, notamment les bifurcations carotidiennes, fémorales, iliaques, poplitée, rénale, ou coronaires, ou non vasculaires, telles que des bifurcations trachéale ou biliaires, par exemple entre les canaux cholédoque et cystique, ou au niveau de la bifurcation de la voie biliaire principale.
Le traitement peut consister à rétablir le diamètre adéquat de la bifurcation, en cas d'artériosclérose ou de prolifération cellulaire interne, à remédier à une dissection localisée ou non de la paroi du conduit, ou, en cas d'anévrisme, à recréer une bifurcation de diamètre normal tout en excluant la poche anévrismale.
Il est connu de traiter le rétrécissement d'un vaisseau sanguin rectiligne au moyen d'un dispositif tubulaire radialement expansible, couramment dénommé "stent". Ce dispositif est introduit à l'état non expansé dans la lumière interne du vaisseau, notamment par voie percutanée, jusqu'au niveau du rétrécissement. Une fois mis en place, il est expansé de manière à étayer la paroi vasculaire et à rétablir la section adéquate du vaisseau.
Le dispositif peut être constitué en un matériau non élastique, et est alors expansé au moyen d'un ballonnet gonflable, sur lequel il est engagé, ou peut être "auto-expandable", c'est-à-dire constitué en un matériau élastique, s'expansant spontanément lors de son retrait hors d'une gaine qui le maintient à l'état contracté.
Les documents US 4 733 665 et US 4 886 062 sont illustratifs de dispositifs existants et de techniques de pose correspondantes.
Un stent classique ne convient pas parfaitement pour le traitement d'un rétrécissement situé au niveau d'une bifurcation, puisque son engagement à la fois dans le conduit principal et dans l'un des conduits secondaires peut provoquer une occlusion immédiate ou retardée de l'autre conduit secondaire.
Il est connu de renforcer une bifurcation vasculaire au moyen d'un dispositif comprenant deux éléments constitués chacun par enroulement hélicoïdal d'un fil métallique. L'un des deux éléments présente deux parties de diamètre correspondant respectivement au diamètre du vaisseau principal et au diamètre de l'un des vaisseaux secondaires, et est destiné à être engagé d'une part dans ce vaisseau principal et d'autre part dans ce vaisseau secondaire. L'autre élément présente un diamètre correspondant au diamètre de l'autre vaisseau secondaire et est accouplé au premier élément, après mise en place de ce dernier, par engagement d'une ou plusieurs de ses spires dans les spires du premier élément. Ce matériel permet un renforcement de la bifurcation mais apparaît impropre à traiter un rétrécissement vasculaire ou une lésion occlusive, compte tenu de sa structure et de la faible possibilité d'expansion radiale de ses deux éléments constitutifs. De plus, la forme du premier élément ne correspond pas à la forme d'une bifurcation, qui présente une zone de transition évasée entre l'extrémité du vaisseau principal et les extrémités des vaisseaux secondaires. Ce matériel ne permet donc pas de parfaitement soutenir cette paroi ni de traiter une dissection au niveau de cette paroi. En outre, la pose séparée de ces deux éléments semble relativement difficile.
La présente invention vise à remédier à ces différents inconvénients, en fournissant un dispositif permettant de traiter une pathologie au niveau d'une bifurcation, en soutenant parfaitement la paroi vasculaire et en étant relativement simple à poser.
Le dispositif qu'elle concerne comprend, de manière connue en soi, des segments délimitant des conduits longitudinaux, dont un est destiné à être engagé au travers de la bifurcation et dont un autre est destiné à être engagé dans un conduit secondaire de cette bifurcation.
Selon l'invention, ce dispositif comprend : - au moins un segment expansible radialement, présentant, à l'état expansé, une section transversale sensiblement supérieure à la section transversale de l'un des conduits secondaires ;
- un segment présentant, à l'état expansé, une forme tronconique, correspondant à la forme de la bifurcation au niveau de la zone de transition évasée qui sépare le conduit principal des conduits secondaires, et
- une liaison souple entre ces deux segments, permettant l'orientation de ceux-ci l'un par rapport à l'autre, selon l'orientation du conduit secondaire recevant ledit segment par rapport à ladite zone de transition évasée.
Par simplification, le segment présentant, à l'état expansé, une section transversale sensiblement supérieure à la section transversale de l'un des conduits secondaires sera dénommé ci-après "segment secondaire", tandis que le segment présentant, à l'état expansé, une forme tronconique sera dénommé ci-après "segment tronconique" . Le segment secondaire est destiné à être introduit dans le conduit secondaire à l'état contracté et à prendre appui, à l'état expansé, contre la paroi de ce conduit. Cette expansion permet non seulement de traiter un rétrécissement ou une dissection situé au niveau de ce conduit, mais également d'assurer une parfaite immobilisation du dispositif dans le conduit.
Dans cette position du dispositif, le segment tronconique vient prendre appui contre la paroi du conduit délimitant la zone de transition évasée de la bifurcation, qu'il permet d'étayer parfaitement. Un rétrécissement ou une dissection survenant à cet endroit peut donc être traité grâce à ce dispositif, avec un soutien uniforme de la paroi vasculaire, donc sans risque de lésion de celle-ci.
Grâce à la liaison souple qui les relie, les deux segments s'orientent de manière adéquate l'un par rapport à l'autre lors de leur expansion. Le dispositif présente en outre un caractère unitaire, et est donc relativement facile à implanter.
De préférence, au moins le segment tronconique est recouvert par une paroi lui conférant une étanchéité dans une direction radiale.
Cette paroi permet de piéger entre elle et la paroi du conduit les particules pouvant provenir de la lésion traitée, telles que des particules artérioscléreuses ou des agglomérats cellulaires, et d'éviter ainsi la migration de ces particules dans l'organisme.
De plus, le dispositif peut permettre le traitement d'un anévrisme, en assurant le guidage du liquide au travers de la bifurcation, et en évitant donc que la paroi formant l'anévrisme soit sollicitée.
Le dispositif peut comprendre plusieurs segments secondaires, placés les uns à la suite des autres, pour assurer un étayage supplémentaire de la paroi du conduit secondaire et augmenter, si nécessaire, la force d'ancrage du dispositif dans la bifurcation. Dans le même but, le dispositif peut comprendre, du côté du segment tronconique tourné vers le conduit principal, au moins un segment expansible radialement, présentant, à l'état expansé, une section transversale sensiblement supérieure à la section transversale du conduit principal.
Ces différents segments supplémentaires peuvent être reliés entre eux et aux deux segments précités par des liaisons souples telles qu'indiquées plus haut.
De préférence, la liaison souple entre deux segments consécutifs est constituée par un ou plusieurs ponts de matière reliant les deux extrémités adjacentes de ces deux segments. Ce ou ces ponts sont avantageusement constitués par le même matériau que celui constituant les segments. Selon une forme de réalisation préférée de l'invention, chaque segment a une structure maillée, les mailles étant allongées dans la direction longitudinale du dispositif et présentant chacune une forme sensiblement hexagonale ; les mailles du segment tronconique ont une largeur qui augmente progressivement dans le sens longitudinal du dispositif, en direction de l'extrémité de ce segment ayant la plus forte section à l'état expansé.
Cette augmentation de la largeur des mailles résulte d'une augmentation de la longueur des bords des mailles disposés longitudinalement et/ou d'une augmentation de l'angle que forment entre eux deux bords en regard d'une même maille.
En outre, le segment tronconique peut avoir un axe non confondu avec l'axe longitudinal du dispositif mais oblique par rapport à cet axe, afin d'être adapté au mieux à l'anatomie de la bifurcation à traiter. Dans ce cas, les largeurs des mailles de ce segment augmentent également progressivement, dans le sens transversal du dispositif, en direction d'une génératrice diamétralement opposée à celle se trouvant dans le prolongement du pont reliant ce segment au segment adjacent. Le dispositif peut être réalisé en un métal à mémoire de forme, devenant malléable sans élasticité à une température nettement inférieure à celle du corps humain, pour permettre la rétractation du dispositif sur lui-même, et retrouvant sa forme neutre à une température correspondant sensiblement à celle du corps humain. Ce métal est de préférence l'alliage nickel-titane connu sous la dénomination "NITINOL" .
Le matériel de pose du dispositif comprend, de manière connue en soi, des moyens pour permettre l'expansion de ce dispositif lorsque celui-ci est mis en place. Ces moyens peuvent comprendre une gaine amovible dans laquelle est placé le dispositif à l'état contracté, lorsque ce dispositif est constitué en un matériau élastique, ou une âme de support comprenant un ballonnet gonflable sur lequel le dispositif est placé, lorsque ce dispositif est constitué en un matériau non élastique.
Dans un cas comme dans l'autre, ce matériel comprend, selon l'invention, des moyens permettant de repérer, au travers du corps du patient, l'emplacement longitudinal du segment tronconique, afin que celui-ci puisse être correctement positionné au niveau de la zone évasée de la bifurcation.
Dans le cas où l'expansion de ce même segment n'est pas uniforme par rapport à l'axe du dispositif, le matériel comprend en outre des moyens permettant de repérer, au travers du corps du patient, l'orientation angulaire du dispositif par rapport à la bifurcation, afin que la partie de ce segment ayant la plus forte expansion puisse être placée de manière adéquate par rapport à la bifurcation.
Pour sa bonne compréhension, l'invention est à nouveau décrite ci-dessous en référence au dessin schématique annexé représentant, à titre d'exemple non limitatif, deux formes de réalisation préférées du dispositif qu'elle concerne. La figure 1 en est une vue en de côté, selon une première forme de réalisation ; la figure 2 est une vue en perspective de ce dispositif dans un état de contraction radiale, et, avec arrachement partiel, du matériel permettant sa pose ; la figure 3 est une vue en coupe longitudinale de la bifurcation à traiter ; les figures 4 à 6 sont des vues de cette bifurcation similaires à la figure 3, au cours de trois étapes successives de mise en place du dispositif ; la figure 7 est une vue similaire à la figure 3 d'une bifurcation présentant un anévrisme, dans laquelle est placé le dispositif, et la figure 8 est une vue de côté du dispositif selon une deuxième forme de réalisation.
La figure 1 représente un dispositif expansible 1 permettant le traitement de conduits corporels au niveau d'une bifurcation, c'est-à-dire, ainsi que le montre la figure 3, au niveau de la séparation d'un conduit principal 2 en deux conduits secondaires 3.
Le dispositif 1 comprend quatre segments successifs 5,6,7,8 à structure maillée, reliés les uns aux autres par trois ponts de matière 9.
Les mailles 10 de ces segments sont allongées dans la direction longitudinale du dispositif 1 et présentent chacune une forme sensiblement hexagonale.
Le segment 5 présente une forme tubulaire et a un diamètre sensiblement supérieur au diamètre du conduit principal 2. Le segment 6 présente des mailles 10 dont la largeur augmente progressivement, par rapport à celle des mailles du segment 5, d'une part, dans le sens longitudinal du dispositif 1, en direction de l'extrémité du segment 6 située à l'opposé du segment 5, et, d'autre part, dans le sens transversal du dispositif 1, en direction d'une génératrice diamétralement opposée à celle se trouvant dans le prolongement du pont 9.
Cette augmentation de la largeur des mailles 10 résulte d'une augmentation de la longueur des bords 10a des mailles 10 disposés longitudinalement ainsi que d'une augmentation de l'angle que forment entre eux deux bords
10a en regard.
Ce segment 6 présente ainsi une forme tronconique d'axe oblique par rapport à l'axe longitudinal du dispositif 1. Cette forme correspond à la forme de la bifurcation au niveau de la zone de transition évasée 11 qui sépare l'extrémité du conduit principal 2 des extrémités des conduits secondaires 3.
Les segments 7 et 8 sont identiques entre eux et présentent une forme tubulaire de diamètre sensiblement supérieur au diamètre de l'un des conduits secondaires 3.
Les ponts de matière 9 relient les extrémités adjacentes des segments 5 à 8 et ont une faible largeur, de sorte qu'ils peuvent subir une certaine flexion permettant d'orienter ces segments les uns par rapport aux autres, en particulier le segment 6 par rapport au segment 7.
Le dispositif 1 est réalisé par découpe adéquate d'une tôle en alliage nickel-titane connu sous la dénomination "NITINOL", puis repliage circulaire du flan obtenu et soudure des parties de ce flan venant au voisinage les unes des autres.
Cet alliage est malléable à une température de l'ordre de 10° C, mais peut retrouver sa forme neutre à une température correspondant sensiblement à celle du corps humain.
La figure 2 montre le dispositif 1 dans un état de contraction radiale, obtenu par refroidissement de son matériau constitutif. Lors de cette contraction, les bords 10a pivotent par rapport aux bords transversaux 10b des mailles 10, de sorte que les mailles 10 présentent, dans cet état de contraction, une forme sensiblement rectangulaire.
Grâce à cette contraction, les segments 5 à 8 ont une section transversale inférieure à celle des conduits 2 et 3, et peuvent être introduits dans ceux-ci, ainsi que cela sera décrit plus loin.
Le dispositif 1 est engagé sur une âme centrale de support 15, puis est contracté radialement sur celle-ci. Cette âme 15 comprend une butée axiale, tel qu'un épaulement (non visible sur la figure 2), de diamètre inférieur à celui du dispositif 1 lorsque ce dispositif est expansé, mais supérieur au diamètre de ce dispositif 1 lorsque ce dernier est contracté. Cette butée permet par conséquent l'immobilisation axiale du dispositif 1 sur l'âme 15, lorsque celui-ci est contracté.
Une gaine 16 est ensuite engagée sur le dispositif 1 afin de le contenir dans son état contracté. Cette gaine 16 comporte quatre repères radio-opaques 20,21,22,23 imprimés sur elle, contenant par exemple un composé de baryum. Trois repères 20,21,22 ont une forme annulaire et s'étendent sur l'ensemble de la périphérie de la gaine 16. Ils sont situés respectivement au niveau des extrémités libres des segments 5 et 8 et au niveau du pont 9 séparant les segments 6 et 7. Le quatrième repère 23 est situé à sensiblement mi-distance de la génératrice du segment 6 située dans le prolongement du pont 9 et de la génératrice diamétralement opposée. Il a la forme d'un losange et a une faible épaisseur.
L'âme 15 présente un trou axial longitudinal permettant son engagement sur un fil de guidage 25 (figures 4 à 6). Ce fil 25 peut être engagé, par voie percutanée, dans le conduit 2, au travers de la zone 11 puis dans l'un des conduits 3, au travers desquels il peut coulisser, et comprend un cône 26 de matière synthétique, situé en avant de l'ensemble âme 15 - dispositif 1 - gaine 16. La bifurcation 30 montrée à la figure 3 présente des excroissances 31 qui créent un rétrécissement de section venant gêner l'écoulement du liquide circulant dans les conduits 2 et 3. Lorsqu'il s'agit d'une bifurcation vasculaire, ces excroissances sont dues par exemple à une artériosclérose ou a une croissance cellulaire.
Le dispositif 1 permet de traiter cette bifurcation, en rétablissant le diamètre adéquat des conduits 2,3 et de la zone évasée 11.
En pratique, ainsi que cela apparaît à la figure 4, l'ensemble âme 15 - dispositif 1 - gaine 16 est engagé sur le fil 25 jusqu'au cône 26. Par son coulissement, ce fil 25 permet l'engagement puis le guidage de cet ensemble dans le conduit 2, la zone 11 puis le conduit 3. Le cône 26 facilite le glissement de l'ensemble et diminue le risque traumatique.
Le repère 22 permet de visualiser, à l'aide d'un appareil radiographique approprié, la position du pont 9 séparant les segments 6 et 7, et donc de visualiser l'emplacement du segment 6, afin que celui-ci puisse être correctement positionné par rapport à la zone évasée 11.
Les repères 20 et 21 permettent de s'assurer que les segments 5 et 8 sont correctement positionnés, respectivement dans le conduit principal 2 et le conduit secondaire 3.
Le repère 23 est, quant à lui, visible en plan ou par sa tranche, selon qu'il est orienté perpendiculairement ou parallèlement au rayon de l'appareil de radiographie. Il permet ainsi de repérer l'orientation angulaire du dispositif 1 par rapport à la bifurcation 30, afin que la partie du segment 6 ayant la plus forte expansion puisse être placée de manière adéquate par rapport à la zone 11. La gaine 16, qui présente une longueur telle qu'elle débouche au-delà de l'ouverture ayant permis l'introduction de l'ensemble, est ensuite progressivement retirée, comme montré aux figures 5 et 6, pour permettre l'expansion complète du dispositif 1.
Ce dernier est réchauffé par la température corporelle, ce qui permet son expansion.
Après expansion complète du dispositif 1, l'âme 15 et le fil 25 sont retirés.
La figure 7 montre que le dispositif 1 peut également servir au traitement d'un anévrisme 40. Le segment 6 et une partie du segment 5 sont alors recouverts d'un film en polyester 41, étanche au liquide circulant dans les conduits 2 et 3, qui est cousu sur eux. Le dispositif guide alors ce liquide au travers de la bifurcation 30, et évite par conséquent que la paroi formant l'anévrisme 40 soit sollicitée.
La figure 8 montre un dispositif 100 selon l'invention, présentant des segments 105,106,107,108 et un pont 109, reliant les segments 106 et 107, de structure similaire à celle des segments 5 à 8 et du pont 9 du dispositif montré à la figure 1.
Dans le dispositif 100, deux segments consécutifs, hormis les segments 106 et 107, sont reliés par six ponts 190 en forme d'oméga. La partie centrale courbe 190a de ces ponts 190 présente une élasticité multi-directionnelle permettant l'orientation longitudinale adéquate des différents segments les uns par rapport aux autres.
Ces ponts 190 ont pour avantage de conférer une continuité longitudinale au dispositif, qui facilite le passage de ce dernier dans une zone à forte courbure et qui élimine la nécessité de procéder à une réduction de cette courbure, toujours dangereuse en cas d'artério¬ sclérose, pour permettre le passage du dispositif.
L'invention fournit ainsi un dispositif permettant le traitement d'une pathologie au niveau d'une bifurcation 30. Ce dispositif présente les nombreux avantages indiqués plus haut, notamment ceux d'assurer un parfait soutien de la paroi vasculaire et d'être relativement simple à poser.
Il va de soi que l'invention n'est pas limitée à la forme de réalisation décrite ci-dessus à titre d'exemple mais qu'elle en embrasse, au contraire, toutes les variantes de réalisation.
Ainsi, le dispositif 1,100 peut comprendre plusieurs segments 5,8,105,108 placés les uns à la suite des autres, pour assurer un étayage supplémentaire et augmenter, si nécessaire, le maintien du dispositif dans la bifurcation 30.
L'âme 15 pourrait comprendre un ballonnet gonflable, soit pour réaliser l'expansion du dispositif 1, dans le cas où ce dernier serait en un matériau non élastique, soit pour s'assurer de la totale expansion d'un dispositif 1 auto-expandable, après mise en place de celui-ci.
Les repères 20 à 23 pourraient être imprimés sur l'âme 15 ou directement sur le dispositif 1, notamment sur le pont 9,109, et non sur la gaine 16.
Le segment 6,106 pourrait avoir un axe confondu avec l'axe longitudinal du dispositif, et non oblique par rapport à cet axe, si cela est rendu nécessaire par 1'anatomie de la bifurcation à traiter. En outre, le segment 7,107 pourrait présenter lui-même, à l'état expansé, une forme évasée correspondant à la forme de la zone de raccordement évasée par laquelle, dans certaines bifurcations, les conduits secondaires 3 sont reliés à la zone de transition évasée 11. Ce segment 7,107 présenterait ainsi une : rme correspondant précisément à la forme de cette zone de raccordement évasée, dont il assurerait un parfait étayage.
Les ponts 190 pourraient être en nombre supérieur ou inférieur à six entre deux segments consécutifs, et pourraient avoir une forme autre qu'en oméga, permettant leur élasticité multi-directionnelle, et notamment une forme en V ou en W.

Claims

REVENDICATIONS
1 - Dispositif permettant le traitement de conduits corporels au niveau d'une bifurcation, c'est-à-dire au niveau de la séparation d'un conduit principal (2) en deux conduits secondaires (3), comprenant des segments (5 à 8, 105 à 108) délimitant des conduits longitudinaux, dont un est destiné à être engagé au travers de la bifurcation et dont un autre est destiné à être engagé dans un conduit secondaire de cette bifurcation, dispositif (1,100) caractérisé en ce qu'il comprend :
- au moins un segment (7,8 ; 107,108) expansible radialement, présentant, à l'état expansé, une section transversale sensiblement supérieure à la section transversale de l'un des conduits secondaires (3) ;
- un segment (6,106) présentant, à l'état expansé, une forme tronconique, correspondant à la forme de la bifurcation au niveau de la zone de transition évasée (11) qui sépare le conduit principal (2) des conduits secondaires (3), et
- une liaison souple (9,109) entre ces deux segments (6,7 ; 106,107), permettant l'orientation de ceux-ci l'un par rapport à l'autre, selon l'orientation du conduit secondaire (3) recevant ledit segment (7,107) par rapport à ladite zone de transition évasée (11).
2 - Dispositif selon la revendication 1, caractérisé en ce qu'au moins le segment (6) présentant, à l'état expansé, une forme tronconique est recouvert par une paroi (41) lui conférant une étanchéité dans une direction radiale.
3 - Dispositif selon la revendication 1 ou la revendication 2, caractérisé en ce qu'il comprend plusieurs segments (7,8 ; 107,108) expansibles radialement, placés les uns à la suite des autres et présentant, à l'état expansé, une section transversale sensiblement supérieure à la section transversale de l'un des conduits secondaires (3).
4 - Dispositif selon l'une des revendications 1 à
3, caractérisé en ce qu'il comprend, du côté du segment tronconique (6,106) tourné vers le conduit principal (2), au moins un segment (5,105) expansible radialement, présentant, à l'état expansé, une section transversale sensiblement supérieure à la section transversale du conduit principal (2). 5 - Dispositif selon l'une des revendications 1 à
4, caractérisé en ce que la liaison souple entre deux segments consécutifs (5 à 8 ; 105 à 108) est constituée par un ou plusieurs ponts de matière (9,190) reliant les deux extrémités adjacentes de ces deux segments (5 à 8 ; 105 à 108) .
6 - Dispositif selon la revendication 5, caractérisé en ce que le ou les ponts de matière (9) sont constitués par le même matériau que celui constituant les segments (5 à 8 ; 105 à 108). 7 - Dispositif selon l'une des revendications 1 à
6, caractérisé en ce que chaque segment (5 à 8 ; 105 à 108) a une structure maillée, les mailles (10) étant allongées dans la direction longitudinale du dispositif (1) et présentant chacune une forme sensiblement hexagonale, et en ce que les mailles (10) du segment (6 ; 106) présentant, à l'état expansé, une forme tronconique ont une largeur qui augmente progressivement dans le sens longitudinal du dispositif (1), en direction de l'extrémité de ce segment (6 ; 106) ayant la plus forte section à l'état expansé.
8 - Dispositif selon l'une des revendications 1 à
7, caractérisé en ce que le segment (6 ; 106) présentant une forme tronconique après expansion a un axe non confondu avec l'axe longitudinal du dispositif (1) mais oblique par rapport à cet axe, afin d'être adapté au mieux à l'anatomie de la bifurcation (30) à traiter. 9 - Matériel de pose du dispositif (1) selon l'une des revendications 1 à 8, comprenant des moyens (16) pour permettre l'expansion de ce dispositif (1) lorsque celui-ci est mis en place, caractérisé en ce qu'il comprend des moyens (20,21,22) permettant de repérer, au travers du corps du patient, l'emplacement longitudinal du segment (6 ; 106) présentant une forme tronconique après expansion.
10 - Matériel de pose selon la revendication 9, caractérisé en ce qu'il comprend des moyens (23) permettant de repérer, au travers du corps du patient, l'orientation angulaire du dispositif (1) par rapport à la bifurcation (30).
PCT/FR1997/000999 1996-06-06 1997-06-05 Endoprothese pour bifurcation vasculaire WO1997046174A1 (fr)

Priority Applications (12)

Application Number Priority Date Filing Date Title
DE69731533T DE69731533T2 (de) 1996-06-06 1997-06-05 Endoprothese für eine vaskuläre bifurcation
AT97927244T ATE281798T1 (de) 1996-06-06 1997-06-05 Endoprothese für eine vaskuläre bifurcation
JP10500284A JP2000511444A (ja) 1996-06-06 1997-06-05 二股状管腔のための管腔内プロテーゼ
CA002257340A CA2257340C (fr) 1996-06-06 1997-06-05 Endoprothese pour bifurcation vasculaire
US09/011,214 US6068655A (en) 1996-06-06 1997-06-05 Endoprosthesis for vascular bifurcation
EP97927244A EP0909147B9 (fr) 1996-06-06 1997-06-05 Endoprothese pour bifurcation vasculaire
AU31801/97A AU3180197A (en) 1996-06-06 1997-06-05 Vascular bifurcation endoprosthesis
US09/580,597 US6666883B1 (en) 1996-06-06 2000-05-30 Endoprosthesis for vascular bifurcation
US10/292,385 US8728143B2 (en) 1996-06-06 2002-11-11 Endoprosthesis deployment system for treating vascular bifurcations
US11/737,652 US7686846B2 (en) 1996-06-06 2007-04-19 Bifurcation stent and method of positioning in a body lumen
US11/767,422 US8603157B2 (en) 1996-06-06 2007-06-22 Endoprosthesis deployment methods for treating vascular bifurcations
US12/750,379 US9101501B2 (en) 1996-06-06 2010-03-30 Bifurcation stent and method of positioning in a body lumen

Applications Claiming Priority (2)

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FR9607245A FR2749500B1 (fr) 1996-06-06 1996-06-06 Dispositif permettant le traitement de conduits corporels au niveau d'une bifurcation
FR96/07245 1996-06-06

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US09/580,597 Continuation-In-Part US6666883B1 (en) 1996-06-06 2000-05-30 Endoprosthesis for vascular bifurcation

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JP (3) JP2000511444A (fr)
AT (1) ATE281798T1 (fr)
AU (1) AU3180197A (fr)
CA (1) CA2257340C (fr)
DE (1) DE69731533T2 (fr)
ES (1) ES2232870T3 (fr)
FR (1) FR2749500B1 (fr)
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ATE281798T1 (de) 2004-11-15
EP0909147B1 (fr) 2004-11-10
DE69731533T2 (de) 2005-11-24
CA2257340C (fr) 2005-08-23
EP0909147A1 (fr) 1999-04-21
JP2000511444A (ja) 2000-09-05
FR2749500A1 (fr) 1997-12-12
JP2007313337A (ja) 2007-12-06
ES2232870T3 (es) 2005-06-01
FR2749500B1 (fr) 1998-11-20
US6068655A (en) 2000-05-30
EP0909147B9 (fr) 2005-03-23
DE69731533D1 (en) 2004-12-16
JP2011031086A (ja) 2011-02-17
AU3180197A (en) 1998-01-05
PT909147E (pt) 2005-04-29
CA2257340A1 (fr) 1997-12-11

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