La présente invention a pour objet un dispositif d'angioplastie pour bifurcation artérielle. The present invention relates to an angioplasty device for arterial bifurcation.
De façon plus précise, l'invention concerne un dispositif spécialement adapté pour le traitement non chirurgical des lésions artérielles qui affectent des bifurcations d'artères, ce dispositif permettant le traitement de la lésion par inflation d'un ballonnet et d'autre part, la mise en place d'un élément de prothèse au niveau de la bifurcation. More specifically, the invention relates to a device specially adapted for the non-surgical treatment of arterial lesions which affect bifurcations of arteries, this device allowing the treatment of the lesion by inflation of a balloon and on the other hand, the placement of a prosthesis element at the bifurcation.
Ce problème se rencontre notamment mais non exclusivement dans le cas de lésion de coronaire. This problem is encountered in particular but not exclusively in the case of coronary injury.
Les lésions athéromateuses de gros vaisseaux artériels constituent le première cause de morbidité et de mortalité des pays développés. Atheromatous lesions of large arterial vessels are the leading cause of morbidity and mortality in developed countries.
Depuis 1978, à la suite des travaux de Gruntzig, la majorité de ces lésions sont accessibles par angioplastie percutanée à ballonnet. Cette technique, comme cela est bien connu, consiste à mettre en place par voie percutanée un ballonnet gonflable à la hauteur de la lésion artérielle et à gonfler ce ballonnet pour remédier aux lésions sténosautes des artères.Since 1978, following Gruntzig's work, the majority of these lesions are accessible by percutaneous balloon angioplasty. This technique, as is well known, consists in placing percutaneously an inflatable balloon at the height of the arterial lesion and in inflating this balloon to remedy the stenosaut lesions of the arteries.
En pleine évolution depuis cette date, l'angioplastie est utilisée en pratique courante dans le traitement des lésions sténosautes des artères coronaires, rénales et des gros vaisseaux des membres inférieurs. Cette technique présente l'avantage considérable d'éviter une intervention chirurgicale au niveau de l'artère ayant subie la lésion. En outre, dans certains cas, une intervention chirurgicale serait non envisageable, en raison de la durée de l'intervention qu'il y aurait lieu de faire et des conséquences de celle-ci sur le patient. In full evolution since this date, angioplasty is used in current practice in the treatment of stenosaut lesions of the coronary, renal arteries and large vessels of the lower limbs. This technique has the considerable advantage of avoiding surgical intervention at the level of the artery having undergone the lesion. In addition, in some cases, a surgical intervention would not be possible, because of the duration of the intervention that should be done and the consequences of this on the patient.
Cependant, dans le cas où la lésion affecte une bifurcation artérielle, par exemple une lésion au niveau des coronaires, les techniques classiques d'angioplastie sont inutilisables du fait que c'est la bifurcation elle-même qu'il faut traiter. On a proposé d'utiliser dans ce cas deux ballonnets d'angioplastie introduits respectivement dans chacune des branches de la bifurcation artérielle. Cependant, une telle technique est difficile à mettre en oeuvre du fait qu'il faut introduire deux ballonnets dans le même réseau artériel et donc deux cathéters séparés. En outre, dans la partie de l'artère en amont de la bifurcation, on se trouve en présence de deux ballonnets indépendants dont le gonflement ne permet pas d'obtenir une surface externe globale continue mais en fait deux portions de surface cylindrique.Cette technique ne permet donc pas la mise en oeuvre d'un effet d'angioplastie réellement efficace. However, in the case where the lesion affects an arterial bifurcation, for example a lesion at the level of the coronaries, conventional angioplasty techniques cannot be used because it is the bifurcation itself which must be treated. It has been proposed to use in this case two angioplasty balloons introduced respectively into each of the branches of the arterial bifurcation. However, such a technique is difficult to implement because it is necessary to introduce two balloons into the same arterial network and therefore two separate catheters. In addition, in the part of the artery upstream of the bifurcation, there are two independent balloons, the swelling of which does not make it possible to obtain a continuous overall external surface but in fact two portions of cylindrical surface. therefore does not allow the implementation of a truly effective angioplasty effect.
Il existe donc un réel besoin de disposer d'un dispositif de traitement par angioplastie de sténose artérielle au niveau des bifurcations artérielles qui permette d'obtenir un traitement par angioplastie efficace et également la mise en place de prothèses artérielles au niveau de ces bifurcations. There is therefore a real need for a device for treatment by arterial stenosis angioplasty at the level of arterial bifurcations which makes it possible to obtain effective angioplasty treatment and also the installation of arterial prostheses at the level of these bifurcations.
Un objet de la présente invention est donc de fournir un tel matériel qui permette notamment dans le cas du traitement des coronaires une intervention par angioplastie intéressant l'ensemble de la zone de bifurcation artérielle. An object of the present invention is therefore to provide such material which allows in particular in the case of coronary treatment intervention by angioplasty involving the entire area of arterial bifurcation.
Pour atteindre ce but, selon l'invention, le dispositif d'angioplastie se caractérise en ce qu'il comprend :un ballonnet gonflable en forme de
Y présentant un tronc et deux bras raccordés au dit tronc limité par une unique paroi étanche déformable, ledit tronc présentant une extrémité de raccordement et chaque bras présentant une extrémité terminale, ledit ballonnet présentant deux conduits internes pour des fils de guidage, chaque conduit s'étendant de l'extrémité de raccordement à une des extrémités terminales et un cathéter présentant une première extrémité interne solidaire de l'extrémité de raccordement dudit ballonnet et une deuxième extrémité externe, ledit cathéter présentant un canal d'inflation s'étendant sur toute la longueur du cathéter, une première extrémité dudit canal d'inflation débouchant dans ledit ballonnet, la deuxième extrémité dudit canal d'inflation débouchant à l'extrémité externe dudit cathéter, et deux canaux de guidage s'étendant au moins sur la partie terminale du cathéter, chaque canal présentant une première extrémité d'introduction d'un fil guidé et une deuxième extrémité raccordée à un conduit dudit ballonnet, chaque canal de guidage étant apte à recevoir un fil de guidage.To achieve this object, according to the invention, the angioplasty device is characterized in that it comprises: an inflatable balloon in the form of
Y having a trunk and two arms connected to said trunk bounded by a single deformable waterproof wall, said trunk having a connection end and each arm having a terminal end, said balloon having two internal conduits for guide wires, each conduit extending from the connection end to one of the terminal ends and a catheter having a first internal end integral with the connection end of said balloon and a second external end, said catheter having an inflation channel extending over the entire length of the catheter, a first end of said inflation channel opening into said balloon, the second end of said inflation channel opening to the external end of said catheter, and two guide channels extending at least over the terminal part of the catheter, each channel having a first guide wire insertion end é and a second end connected to a conduit of said balloon, each guide channel being adapted to receive a guide wire.
Grâce aux dispositifs selon l'invention, on comprend que le ballonnet étant en une seule pièce, il peut se conformer effectivement à la forme de la bifurcation artérielle et donc produire un effet d'angioplastie efficace en tout point de la paroi artérielle. On comprend également que le dispositif d'angioplastie ne comportant qu'un seul cathéter dans lequel sont introduits les deux fils de guidage, l'introduction du cathéter unique et des fils de guidage sera bien sûr beaucoup plus simple que dans le cas où on devait utiliser deux cathéters associés chacun à un des ballons. Thanks to the devices according to the invention, it is understood that the balloon being in one piece, it can effectively conform to the shape of the arterial bifurcation and therefore produce an effective angioplasty effect at any point of the arterial wall. It is also understood that the angioplasty device comprising only one catheter into which the two guide wires are introduced, the introduction of the single catheter and the guide wires will of course be much simpler than in the case where it was necessary to use two catheters each associated with one of the balloons.
D'autres caractéristiques et avantages de l'invention apparaîtront mieux à la lecture de la description qui suit de plusieurs modes de réalisation de l'invention donnés à titre d'exemples non limitatifs. Other characteristics and advantages of the invention will appear better on reading the following description of several embodiments of the invention given by way of nonlimiting examples.
La figure 1 est une vue simplifiée de l'ensemble du dispositif d'angioplastie;
La figure 2a représente la coupe du cathéter dans sa zone terminale;
La figure 2b représente cette même coupe selon une variante de réalisation;
Les figures 2c, 2d et 2e montrent la coupe du cathéter selon le plan
CC de la figure 1 pour différents modes de réalisation de l'invention;
La figure 3 montre en coupe partielle l'extrémité de raccordement du cathéter;
La figure 4 montre un mode préféré de réalisation du ballonnet d'angioplastie;
La figure 5 est une vue de détail de la figure 4 montrant le raccordement entre le cathéter et le ballonnet d'angioplastie; et
La figure 6 illustre la mise en place d'une prothèse artérielle en Y sur le ballonnet.Figure 1 is a simplified view of the entire angioplasty device;
Figure 2a shows the section of the catheter in its terminal area;
Figure 2b shows this same section according to an alternative embodiment;
Figures 2c, 2d and 2e show the section of the catheter according to the plan
CC of FIG. 1 for different embodiments of the invention;
Figure 3 shows in partial section the connecting end of the catheter;
Figure 4 shows a preferred embodiment of the angioplasty balloon;
Figure 5 is a detail view of Figure 4 showing the connection between the catheter and the angioplasty balloon; and
Figure 6 illustrates the placement of an arterial prosthesis in Y on the balloon.
En se référant d'abord aux figures 1 et 2, on va décrire l'ensemble du dispositif d'angioplastie. Celui-ci est constitué essentiellement par un cathéter 10 dont l'extrémité externe 12 est munie d'un dispositif de raccordement 14. Le dispositif de raccordement 14 est de préférence relié à une source de fluide sous pression qui peut être un manomètre équipé d'un clapet anti-retour 18. L'extrémité interne 20 du cathéter 10 est raccordée à un ballonnet d'angioplastie 22 qui comporte d'une part un tronc 24 et d'autre part deux branches 26 et 28, le ballonnet ayant ainsi la forme générale d'un Y. Le tronc 24 et les branches 26 et 28 sont limités par une même paroi déformable 30 préformée pour définir la forme en Y.A l'intérieur de l'ensemble du ballonnet 22, sont prévus deux conduits respectivement 32 et 34, qui s'étendent depuis l'extrémité de raccordement 36 du tronc 24 jusqu'à chacune des extrémités 38 et 40 des bras 26 et 28. Les conduits 32 et 34 traversent la paroi 30 du ballonnet de façon étanche. Referring first to Figures 1 and 2, we will describe the entire angioplasty device. This essentially consists of a catheter 10, the external end 12 of which is provided with a connection device 14. The connection device 14 is preferably connected to a source of pressurized fluid which can be a pressure gauge equipped with a non-return valve 18. The internal end 20 of the catheter 10 is connected to an angioplasty balloon 22 which comprises on the one hand a trunk 24 and on the other hand two branches 26 and 28, the balloon thus having the shape general of a Y. The trunk 24 and the branches 26 and 28 are limited by the same deformable wall 30 preformed to define the shape in YA inside the assembly of the balloon 22, two conduits 32 and 34 are provided respectively, which extend from the connection end 36 of the trunk 24 to each of the ends 38 and 40 of the arms 26 and 28. The conduits 32 and 34 pass through the wall 30 of the balloon in a sealed manner.
Selon une caractéristique de l'invention, le cathéter 10 présente un canal axial d'inflation 42 qui s'étend sur la totalité de la longueur du cathéter. Une première extrémité 42a du canal 42 débouche dans le dispositif de raccordement 14, tandis que son autre extrémité 42b, comme on l'expliquera ultérieurement, débouche à l'intérieur du ballonnet 22. According to a characteristic of the invention, the catheter 10 has an axial inflation channel 42 which extends over the entire length of the catheter. A first end 42a of the channel 42 opens into the connection device 14, while its other end 42b, as will be explained later, opens inside the balloon 22.
Le cathéter 10 comprend également deux canaux de guidage 44 et 46 destinés à recevoir chacun un fil de guidage 48 et 50. Les canaux de guidage s'étendent sur au moins la partie terminale 10a du cathéter qui a une longueur L1. L'extrémité distale de chaque canal de guidage est raccordée à un des conduits de guidage 32, 34 du ballonnet, ces conduits constituant des prolongements des canaux de guidage. De préférence, le cathéter 10 a une longueur totale de l'ordre de 175 cm et sa partie terminale a une longueur L1 de l'ordre de 30 cm. The catheter 10 also comprises two guide channels 44 and 46 intended to each receive a guide wire 48 and 50. The guide channels extend over at least the end portion 10a of the catheter which has a length L1. The distal end of each guide channel is connected to one of the guide conduits 32, 34 of the balloon, these conduits constituting extensions of the guide channels. Preferably, the catheter 10 has a total length of the order of 175 cm and its terminal part has a length L1 of the order of 30 cm.
Selon un premier mode de réalisation, les deux canaux de guidage s'étendent sur toute la longueur du cathéter. Cest ce qu'illustre la figure 2c. Dans ce cas, chaque canal débouche par une ouverture latérale 52 à proximité de l'organe de raccordement 14. Cette solution nécessite l'emploi de fils de guidage dont la largeur est le double de celle du cathéter. According to a first embodiment, the two guide channels extend over the entire length of the catheter. This is illustrated in Figure 2c. In this case, each channel opens out through a lateral opening 52 near the connection member 14. This solution requires the use of guide wires the width of which is twice that of the catheter.
Une autre solution consiste à prévoir un premier canal 44 qui s'étend sur toute la longueur du cathéter, l'autre canal 46 ne s'étend que sur la longueur de la partie terminale 10a du cathéter. Cest ce que montre la figure 2d. Le canal 46 débouche dans la paroi latérale du cathéter à la fin de la zone terminale 10a. Another solution consists in providing a first channel 44 which extends over the entire length of the catheter, the other channel 46 extends only over the length of the end portion 10a of the catheter. This is shown in Figure 2d. The channel 46 opens into the side wall of the catheter at the end of the terminal zone 10a.
Une troisième solution est de munir le cathéter d'un premier canal 46 qui s'étend seulement sur la longueur de la partie terminale 10a, l'autre canal 44 s'étendant sur toute la longueur du cathéter mais le canal 44 présente une fente longitudinale 60 qui débouche dans la paroi externe du cathéter. La fente 60 s'étend sur toute la longueur du cathéter à I'exception de la portion terminale 10a. Cette dernière solution permet l'enlèvement rapide du fil de guidage correspondant. A third solution is to provide the catheter with a first channel 46 which extends only over the length of the end portion 10a, the other channel 44 extending over the entire length of the catheter but the channel 44 has a longitudinal slot 60 which opens into the outer wall of the catheter. The slot 60 extends over the entire length of the catheter with the exception of the terminal portion 10a. The latter solution allows rapid removal of the corresponding guide wire.
Selon une variante illustrée par la figure 2b correspondant au cas où les deux canaux de guidage font toute la longueur du cathéter, au moins un des canaux 44, 46 comporte, dans sa partie terminale, des orifices 64 qui débouchent dans le canal et dans la face externe du cathéter. Ces orifices permettent de maintenir une certaine circulation sanguine même lorsque le ballonnet 22 mis en place dans l'artère est gonflé, alors que le fil guide est retiré vers l'amont jusqu'à une marque radio-opaque. According to a variant illustrated in FIG. 2b corresponding to the case where the two guide channels run the entire length of the catheter, at least one of the channels 44, 46 has, in its terminal part, orifices 64 which open into the channel and into the outer side of the catheter. These orifices make it possible to maintain a certain blood circulation even when the balloon 22 placed in the artery is inflated, while the guide wire is withdrawn upstream to a radiopaque mark.
Comme le montre mieux la figure 3, la pièce de raccordement 14 permet de relier l'extrémité 42a du canal d'inflation à une source de fluide sous pression 62, ce fluide servant à gonfler le ballonnet 22. Il s'agit par exemple d'une pompe ou d'un manomètre. De préférence, la pompe 62 est montée sur la pièce de raccordement 14 par l'intermédiaire d'un clapet anti-retour 64 de telle manière que, lorsque la pompe est déconnectée, l'extrémité 42a du canal d'inflation soit fermée. As best shown in Figure 3, the connecting piece 14 allows to connect the end 42a of the inflation channel to a source of pressurized fluid 62, this fluid serving to inflate the balloon 22. This is for example d '' a pump or a pressure gauge. Preferably, the pump 62 is mounted on the connecting piece 14 by means of a non-return valve 64 so that, when the pump is disconnected, the end 42a of the inflation channel is closed.
En se référant maintenant aux figures 4 et 5, on va décrire plus en détails le ballonnet 22 d'angioplastie et son raccordement au cathéter 10. Referring now to FIGS. 4 and 5, a description will be given in more detail of the angioplasty balloon 22 and its connection to the catheter 10.
Les extrémités 38 et 40 des branches du ballonnet présentent une certaine rigidité afin de préformer le ballonnet avec sa forme en Y même lorsqu'il n'est pas gonflé. Ces extrémités sont raccordées de façon étanche à la face externe des conduits 32 et 34. De même, l'extrémité 36 du tronc du ballonnet présente également une plus grande rigidité et est fixée par tout moyen convenable, par exemple, par soudure, à l'extrémité terminale du cathéter. Sur la figure 5, on a représenté plus clairement la continuité entre le canal de guidage 44 et le conduit 32 ainsi que la continuité entre le canal 46 et le conduit 34. Sur cette figure, on voit plus clairement que l'extrémité 42b du canal d'inflation débouche dans un orifice 70 aménagé dans l'extrémité 36 du ballonnet. The ends 38 and 40 of the branches of the balloon have a certain rigidity in order to preform the balloon with its Y shape even when it is not inflated. These ends are tightly connected to the external face of the conduits 32 and 34. Likewise, the end 36 of the trunk of the balloon also has greater rigidity and is fixed by any suitable means, for example, by welding, to the end of the catheter. In FIG. 5, the continuity between the guide channel 44 and the conduit 32 as well as the continuity between the channel 46 and the conduit 34 is more clearly represented. In this figure, it is more clearly seen that the end 42b of the channel inflation opens into an orifice 70 arranged in the end 36 of the balloon.
Sur la figure 4, on a représenté le ballonnet mis en place dans la bifurcation artérielle A et gonflé.In Figure 4, there is shown the balloon placed in the arterial bifurcation A and inflated.
De préférence, le diamètre D du tronc du ballonnet est légèrement supérieur au diamètre D' de chaque branche du ballonnet mais inférieur à la somme des deux diamètres des branches. Ainsi, le ballonnet une fois gonflée peut se conformer non seulement aux dimensions des artères formant la bifurcation mais également à celle de l'artère en amont de la bifurcation. Preferably, the diameter D of the trunk of the balloon is slightly greater than the diameter D 'of each branch of the balloon but less than the sum of the two diameters of the branches. Thus, the balloon once inflated can conform not only to the dimensions of the arteries forming the bifurcation but also to that of the artery upstream of the bifurcation.
On va maintenant décrire la mise en place du dispositif d'angioplastie qui vient d'être décrit. We will now describe the installation of the angioplasty device which has just been described.
Comme cela est bien connu, on met en place un désilet introducteur comportant une valve, soit l'artère fémorale, soit sur l'artère radiale ou sur l'artère humérale droite ou gauche, selon la position de la bifurcation artérielle que l'on veut traiter. Dans un premier temps, on introduit un premier fil guide, par exemple, le fil 50 de telle manière que celui-ci pénètre dans une des deux artères constituant la bifurcation. Puis en se servant du fil guide, on met en place le cathéter 10 de telle manière que les extrémités 38 et 40 du ballonnet qui, bien sûr, n'est pas gonflé, soit légèrement en amont de la bifurcation proprement dite. Puis on met en place le deuxième fil guide 52 de telle manière que celui-ci pénètre dans l'autre artère constituant la bifurcation. La mise en place de ce deuxième fil guide peut être obtenue de deux manières différentes.Soit le deuxième fil guide est introduit à l'aide du deuxième canal de guidage, dans le cas où le cathéter présente effectivement deux canaux de guidage sur toute sa longueur. Soit l'extrémité du deuxième fil guide peut être mise en place dans le canal de guidage et dans le conduit de guidage correspondant avant la mise en place du ballonnet et du cathéter dans ma position d'attente indiquée précédemment. Dans ce cas, il suffit alors d'agir sur l'extrémité terminale du deuxième fil guide pour faire pénétrer l'extrémité libre de celui-ci dans l'artère voulue de la bifurcation. Lorsque les deux fils guide ont été mis en place dans les artères de la bifurcation, il suffit alors de provoquer le déplacement du ballonnet à l'aide du cathéter.On comprend que, du fait que chaque fil guide pénètre dans une des artères de la bifurcation, chaque branche ou bras du ballonnet pénètre aisément dans chacune des artères de la bifurcation. Le positionnement correct du ballonnet peut être contrôlé à l'aide d'un marqueur radio-opaque prévu sur le cathéter. On peut alors procéder au gonflage voulu du ballonnet pour provoquer l'extension des parois artérielles dans la zone de la bifurcation. As is well known, an introducer mesil is put in place comprising a valve, either the femoral artery, or on the radial artery or on the right or left humeral artery, depending on the position of the arterial bifurcation which is wants to deal with. Firstly, a first guide wire is introduced, for example, the wire 50 so that it enters one of the two arteries constituting the bifurcation. Then using the guide wire, the catheter 10 is placed in such a way that the ends 38 and 40 of the balloon which, of course, is not inflated, is slightly upstream of the bifurcation proper. Then the second guide wire 52 is put in place so that it enters the other artery constituting the bifurcation. This second guide wire can be placed in two different ways: either the second guide wire is introduced using the second guide channel, in the case where the catheter actually has two guide channels over its entire length . Either the end of the second guide wire can be put in place in the guide channel and in the corresponding guide duct before putting the balloon and the catheter in my waiting position indicated above. In this case, it then suffices to act on the terminal end of the second guide wire to make the free end of the latter penetrate into the desired artery of the bifurcation. When the two guide wires have been placed in the arteries of the bifurcation, it suffices to cause the displacement of the balloon using the catheter. We understand that, since each guide wire enters one of the arteries of the bifurcation, each branch or arm of the balloon easily penetrates into each of the arteries of the bifurcation. The correct positioning of the balloon can be checked using a radiopaque marker provided on the catheter. We can then proceed to the desired inflation of the balloon to cause the extension of the arterial walls in the bifurcation area.
Selon un autre aspect de l'invention, illustré par la figure 6, le ballonnet 22 peut servir à la mise en place d'un élément de prothèse artérielle en forme de Y. La prothèse 70 est réalisée en un matériau convenable capable de conserver son extension après le retrait du ballonnet 22 de mise en place. Cette prothèse 70 a bien sûr une forme de Y et est engagée sur le ballonnet 22 non gonflé, comme le montre la figure 6. Après mise en place de la prothèse 70, le ballonnet 22 de mise en place est dégonflé puis retiré de l'artère en libérant ainsi l'élément de prothèse qui demeure en place au niveau de la bifurcation. According to another aspect of the invention, illustrated by FIG. 6, the balloon 22 can be used for fitting a Y-shaped arterial prosthesis element. The prosthesis 70 is made of a suitable material capable of retaining its extension after the withdrawal of the balloon 22 for placement. This prosthesis 70 of course has a Y shape and is engaged on the balloon 22 which is not inflated, as shown in FIG. 6. After placing the prosthesis 70, the balloon 22 for positioning is deflated and then removed from the artery thereby releasing the prosthesis element which remains in place at the bifurcation.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR9512769AFR2740346A1 (en) | 1995-10-30 | 1995-10-30 | ANGIOPLASTY DEVICE FOR ARTERIAL BIFURCATION |
| AU74992/96AAU7499296A (en) | 1995-10-30 | 1996-10-30 | Angioplasty device for arterial bifurcation |
| PCT/FR1996/001709WO1997016217A1 (en) | 1995-10-30 | 1996-10-30 | Angioplasty device for arterial bifurcation |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR9512769AFR2740346A1 (en) | 1995-10-30 | 1995-10-30 | ANGIOPLASTY DEVICE FOR ARTERIAL BIFURCATION |
| Publication Number | Publication Date |
|---|---|
| FR2740346A1true FR2740346A1 (en) | 1997-04-30 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FR9512769APendingFR2740346A1 (en) | 1995-10-30 | 1995-10-30 | ANGIOPLASTY DEVICE FOR ARTERIAL BIFURCATION |
| Country | Link |
|---|---|
| AU (1) | AU7499296A (en) |
| FR (1) | FR2740346A1 (en) |
| WO (1) | WO1997016217A1 (en) |
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