WO1997000093A1 - Angioplasty device - Google Patents

Angioplasty device Download PDF

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Publication number
WO1997000093A1
WO1997000093A1 PCT/FR1996/000875 FR9600875W WO9700093A1 WO 1997000093 A1 WO1997000093 A1 WO 1997000093A1 FR 9600875 W FR9600875 W FR 9600875W WO 9700093 A1 WO9700093 A1 WO 9700093A1
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WO
WIPO (PCT)
Prior art keywords
catheter
angioplasty
channel
balloon
guide channel
Prior art date
Application number
PCT/FR1996/000875
Other languages
French (fr)
Inventor
Luc Maillard
Original Assignee
Debiotech S.A.
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 Debiotech S.A. filed Critical Debiotech S.A.
Priority to EP96922088A priority Critical patent/EP0831952A1/en
Priority to AU63086/96A priority patent/AU6308696A/en
Publication of WO1997000093A1 publication Critical patent/WO1997000093A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters

Definitions

  • the present invention relates to an angioplasty device. More specifically, the invention relates to a device which allows the placement of instruments by angioplasty of large arterial vessels and in particular but not exclusively in the carotid arteries. Atheromatous lesions of large arterial vessels are the leading cause of morbidity and mortality in developed countries. 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 an inflatable balloon at the height of the arterial lesion and in inflating this balloon to remedy the stenosaut lesions of the arteries.
  • An object of the present invention is therefore to provide such material which allows in particular in the case of carotid treatment intervention by angioplasty without risking causing cerebrovascular accidents.
  • the angioplasty device comprises: a first catheter intended to be introduced into the artery to be treated, comprising a first internal end and a second external end, said catheter being provided with a first internal inflation channel extending over the entire length of the catheter and with a second guide channel extending over the entire length of said catheter and capable of allowing a guide wire to pass, a first inflatable obturation balloon fixed at the first end of the catheter and connected to the first internal end of the first inflation channel, and a connection integral with the second end of the first catheter and capable of temporarily connecting said first channel to a source inflation fluid of said first balloon, a second catheter having a first inner end and a second outer end, said second ca theter comprising at its first end an angioplasty instrument, said second catheter comprising a first guide channel capable of at least partially surrounding said first catheter to be guided by it and a second activation channel of said angioplasty instrument, said second catheter being placed in said artery being guided by said first catheter.
  • the angioplasty device it is possible, after the initial placement of the balloon protection using the first catheter upstream of the intervention area, to set up using the first catheter as a guiding element, an angioplasty instrument suitable for carrying out the intervention itself.
  • the first obturation balloon after inflation, prevents entrainment of detritus resulting from the intervention by angioplasty to the cerebral arteries.
  • a portion of said first catheter close to its first end comprises from its first end said inflatable balloon, a zone for placing said angioplasty instrument and a perforated zone, over the entire length of said portion of said guide channel not opening into the side wall of said first catheter, said guide channel being provided, in its perforated area, with openings communicating said guide channel with the outside of the catheter, said guide channel extending beyond said balloon and being open at its first end, said guide channel being split over its entire length outside said catheter portion to leave said guide wire free.
  • the guide channel is only provided over a reduced length of the second end of the second catheter.
  • the effective guiding of the second catheter by the first therefore only concerns a reduced length of the latter.
  • the second catheter with its angioplasty instrument can, if necessary, be quickly removed from the patient's body.
  • FIG. 1 is a schematic view showing the placement on a patient of the entire angioplasty device
  • FIG. 1 is an elevational view of the first catheter provided with its inflatable balloon
  • FIG. 3 is a sectional view along line III-III of Figure 2;
  • - Figure 4 is a sectional view along the line IV-IV of Figure 2;
  • FIG. 5 is a sectional view along the line V-V of Figure 2;
  • FIG. 6 is a partial view showing the establishment of the protective balloon in the carotid artery
  • FIG. 7 is a partial view showing a preferred embodiment of the connector of the first catheter
  • FIG. 8 shows the establishment of the protective balloon using the first catheter and the second angioplasty intervention balloon using the second catheter in the carotid
  • FIG. 9 is a cross-sectional view of the second catheter associated with the angioplasty instrument.
  • FIGS. 9a, 9b and 9c are views of the second catheter of FIG. 9 in cross section respectively along the planes A-A, B-B and C-C of FIG. 9.
  • This device essentially consists of a first catheter 10 at the end of which is mounted an artery obturation balloon 12 and which comprises at its second end a connector 14 on which an inflation pump can be mounted 16.
  • the angioplasty device also comprises a second catheter 18 whose internal end is provided with an angioplasty balloon 20 and whose second end 22 is provided with a connection to a pump 24 for injecting the inflation liquid of the angioplasty balloon 20.
  • the angioplasty device can comprise a third catheter 26, one end of which is provided with a prosthesis support tool 28 and the other end of which is provided with an instrument 30 the prosthesis.
  • a guide wire 32 which is previously placed in the artery network allowing access to the area 34 where we want to perform the intervention and in particular beyond the connection of the carotid 36 as shown in Figure 1.
  • the means of positioning the angioplasty device which consist essentially of an introducer mesh 40 comprising a valve. This desilet is placed either on the femoral artery, or on the radial artery, or on the right or left humeral artery.
  • the catheter 10 is in known manner in the form of an elongated element of length equal, preferably, to 175 cm of circular section and sufficiently flexible. More generally, this catheter has a length of between 100 and 250 cm.
  • the catheter 10 has a first end 10a intended to be introduced into the body of the patient and an external end 10b on which the connector 14 is mounted. From its internal end 10a, the catheter has a first end zone A and a current zone B whose length is of the order of 145 cm.
  • a first zone A1 can be distinguished on which the obturation balloon 12 is fixed, then a free zone A2 on which the angioplasty balloon or another angioplasty tool will be positioned, then a zone A3 called perforated.
  • the catheter 10 has a first longitudinal inflation channel 44 and a longitudinal guide channel 46. Over its entire length, the inflation channel 44 is surrounded by the material constituting the catheter and the first end of the channel 44 is connected to the connector 14 while the second end 44a of the channel 44 is open beyond the zone A1 of the fixing of the obturation balloon 12.
  • the guide channel 46 is preferably provided with perforations such as 48 extending over the entire area A3. On the zone corresponding to the current part of the catheter, the guide channel 46 is provided with a slot 50 opening into the external wall of the catheter 10.
  • the guide wire which is disposed in the guide channel 46 can be pulled out conveniently of the latter in the portion B.
  • the inflation channel 44 opens into the sealing balloon 12 to allow inflation.
  • the guide channel 46 is interrupted by a notch 50 constituting a guide wire stop.
  • the connector 14 is provided with a check valve 54.
  • the valve 54 is preferably of the ball type.
  • This connection has a threaded portion 56 on which the pump or the syringe used to introduce the physiological saline can be fixed to inflate the obturation balloon 12. Thanks to the presence of the valve 54, the inflation channel 44 is closed when removes the inflation pump, which keeps the sealing balloon under pressure. After the guide wire is placed in the artery network
  • the first catheter 10 is put in place using the wire as a guide so that the obturation balloon is disposed beyond the zone of intervention.
  • Figure 6 there is shown the catheter 10 with its closure balloon 12 in place.
  • the balloon 12 is properly inflated to effectively seal the artery. Thanks to the presence of the valve 54, the balloon remains inflated even after the inflation pump has been withdrawn. It is also understood that, thanks to the presence of the perforations 48 opening into the guide channel 46, despite obstruction of the artery by the balloon 12, a blood circulation via the guide channel is maintained downstream of the artery.
  • the total length of the catheter 10 is of the order of 175 cm and its diameter of the order of 1 mm and the area A has a length of the order of 30 cm.
  • the area A2 for placing the angioplasty balloon has a length of the order of 20 cm.
  • the balloon 12 is made of latex or similar material and has a length of the order of 1 cm. This inflated balloon can reach a diameter of 9 mm.
  • the second catheter 18 used for the actual angioplasty operation.
  • This catheter 18 is provided at its end with the angioplasty balloon 20.
  • the catheter 18 has a first zone C1 close to its terminal end 18a on which the angioplasty balloon 20 is mounted, a second zone C2 and then a running part D.
  • the catheter 18 Over its entire length, the catheter 18 has an inflation channel 60, the first end of which opens into the balloon 20 and the second end of which is connected to a connector 62 which can itself be connected to an inflation pump 64.
  • the catheter 18 has a guide channel 68 in which the first catheter 10 can slide for the placement of the angioplasty balloon.
  • the guide channel is interrupted after a length 1 and in the main part D the catheter 18 simply includes the inflation channel 60.
  • the guide channel 68 in the portion where it exists a diameter which is slightly greater than the external diameter of the first catheter 10. It is thus possible to place the angioplasty balloon 20 in the area of the artery where the operation is to take place.
  • the angioplasty balloon is placed relative to the first catheter in the free area A2 thereof.
  • the angioplasty device may include a third catheter 30 which can be engaged on the first catheter 10 in place of the catheter 18.
  • This catheter 30 is provided at its internal end with a tool for positioning an angioplasty prosthesis.
  • This third catheter also includes a guide channel similar to that of the second catheter and a second channel for containing the remote control means of the tool for placing the prosthesis.
  • the device described above applies in particular to stenosing lesions of the vessels of the neck and in particular of the carotid arteries.
  • the embolism protection system of the downstream bed sees its application widened to the treatment of lesions of venous grafts aorto-coronary saphenous.
  • the downstream bed being protected, it is possible to slide the catheter of the protective balloon a "hydrolyzer" allowing to suck in and bring back the trombus safely.
  • peripheral monorail dilation balloon can also be used for leg arteries, renal arteries, coronary arenas and bypasses (large caliber).

Abstract

An angioplasty device including a first catheter (10) insertable into the artery to be treated and provided with a first, internal inflation channel extending from one end of the catheter to the other and a second, guiding channel (46) for a guide wire, as well as a first inflatable sealing balloon (12) attached to the first end of the catheter and connected to the first inflation channel, and a connector (14) secured to the second end of the first catheter; and a second catheter (18) with a first end comprising an angioplasty instrument (20), said second catheter having a first guiding channel capable of at least partially surrounding said first catheter so that it is guided thereby, and a second channel (60) for actuating said angioplasty instrument.

Description

Dispositif d'angioplastie Angioplasty device
La présente invention a pour objet un dispositif d'angioplastie. De façon plus précise, l'invention concerne un dispositif qui permet la mise en place d'instruments par angioplastie de gros vaisseaux artériels et notamment mais non exclusivement dans les artères carotides. Les lésions athéromateuses de gros vaisseaux artériels constituent la première cause de morbidité et de mortalité des pays développés. 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 un ballonnet gonflable à la hauteur de la lésion artérielle et à gonfler ce ballonnet pour remédier aux lésions sténosautes des artères.The present invention relates to an angioplasty device. More specifically, the invention relates to a device which allows the placement of instruments by angioplasty of large arterial vessels and in particular but not exclusively in the carotid arteries. Atheromatous lesions of large arterial vessels are the leading cause of morbidity and mortality in developed countries. 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 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. Cependant, dans le cas des vaisseaux du cou, et notamment des artères carotides, le problème se pose de manière différente. En effet, comme l'expose l'article de Alain Rosa et Sandrine Canaple publié dans la revue STV No. 9, volume 6, Novembre 1994, ces lésions sont responsables d'une ischémie cérébrale et de séquelles à type d'accident vasculaire cérébrale irréversible avec des déficits fonctionnels importants. Le traumatisme engendré par le ballonnement entraîne des embolies athéromateuses ou plaquettaires responsables de tels déficits préjudiciables pour les patients qui rend cette technique inopérante pour les artères carotides, du moins jusqu'à présent. Le traitement des lésions des artères carotides reste donc de type chirurgical pour l'instant.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. However, in the case of the vessels of the neck, and in particular the carotid arteries, the problem is posed in a different way. Indeed, as exposed by the article by Alain Rosa and Sandrine Canaple published in the journal STV No. 9, volume 6, November 1994, these lesions are responsible for cerebral ischemia and sequelae of the cerebrovascular accident type. irreversible with significant functional deficits. The trauma caused by bloating leads to atheromatous or platelet embolism responsible for such detrimental deficits for patients, which makes this technique ineffective for the carotid arteries, at least so far. The treatment of lesions of the carotid arteries therefore remains surgical for the time being.
Cependant, comme toute agression artérielle, l'endartériectomie chirurgicale entraîne une resténose symptomatique dans 20 à 30% des cas. Le traitement chirurgical de telles lésions ne donne pas de bons résultats.However, like any arterial attack, surgical endarterectomy leads to symptomatic restenosis in 20 to 30% of cases. Surgical treatment of such lesions does not give good results.
Devant les échecs des techniques chirurgicales, plusieurs équipes ont abordé les resténoses chirurgicales avec du matériel de dilatation périphérique coaxiale et les lésions de novo chez des patients non recevables par une intervention chirurgicale. Les séries de résultats obtenus sont limitées, les résultats sont intéressants mais grevés d'une morbidité par accident vasculaire cérébral qui reste élevée.Faced with the failures of surgical techniques, several teams approached surgical restenosis with coaxial peripheral dilation material and de novo lesions in patients who are not eligible for surgical intervention. Result series results are limited, the results are interesting but burdened by a morbidity from stroke which remains high.
Il existe donc un réel besoin de disposer d'un dispositif de traitement par angioplastie de sténoses artérielles et notamment de sténoses des artères carotides qui permettent d'éviter les inconvénients secondaires des techniques classiques d'angioplastie permettant, en particulier, une protection cérébrale transitoire pour améliorer le résultat global de l'intervention de type non chirurgical.There is therefore a real need to have a device for angioplasty treatment of arterial stenoses and in particular stenoses of the carotid arteries which make it possible to avoid the secondary drawbacks of conventional angioplasty techniques allowing, in particular, transient cerebral protection for improve the overall result of the non-surgical intervention.
Un objet de la présente invention est donc de fournir un tel matériel qui permette notamment dans le cas de traitement des carotides une intervention par angioplastie sans risquer d'entraîner des accidents vasculaires cérébraux.An object of the present invention is therefore to provide such material which allows in particular in the case of carotid treatment intervention by angioplasty without risking causing cerebrovascular accidents.
Pour atteindre ce but, selon l'invention, le dispositif d'angioplastie se caractérise en ce qu'il comprend : un premier cathéter destiné à être introduit dans l'artère à traiter, comprenant une première extrémité interne et une deuxième extrémité externe, ledit cathéter étant muni d'un premier canal d'inflation interne s'étendant sur toute la longueur du cathéter et d'un deuxième canal de guidage s'étendant sur toute la longueur dudit cathéter et apte à laisser passer un fil de guidage, un premier ballonnet gonflable d'obturation fixé à la première extrémité du cathéter et raccordé à la première extrémité interne du premier canal d'inflation, et un raccord solidaire de la deuxième extrémité du premier cathéter et apte à relier de façon temporaire ledit premier canal à une source de fluide de gonflage dudit premier ballonnet, un deuxième cathéter comportant une première extrémité interne et une deuxième extrémité externe, ledit deuxième cathéter comportant à sa première extrémité un instrument d'angioplastie, ledit deuxième cathéter comprenant un premier canal de guidage apte à entourer au moins partiellement ledit premier cathéter pour être guidé par celui-ci et un deuxième canal d'activation dudit instrument d'angioplastie, ledit deuxième cathéter étant mis en place dans ladite artère en étant guidé par ledit premier cathéter. On comprend que, grâce au dispositif d'angioplastie selon l'invention, il est possible, après la mise en place initiale du ballonnet de protection à l'aide du premier cathéter en amont de la zone d'intervention, de mettre en place en se servant du premier cathéter comme élément de guidage un instrument d'angioplastie adapté pour procéder à l'intervention proprement dite. Le premier ballonnet d'obturation, après son gonflage, empêche l'entraînement vers les artères cérébrales des détritus résultant de l'intervention par angioplastie.To achieve this object, according to the invention, the angioplasty device is characterized in that it comprises: a first catheter intended to be introduced into the artery to be treated, comprising a first internal end and a second external end, said catheter being provided with a first internal inflation channel extending over the entire length of the catheter and with a second guide channel extending over the entire length of said catheter and capable of allowing a guide wire to pass, a first inflatable obturation balloon fixed at the first end of the catheter and connected to the first internal end of the first inflation channel, and a connection integral with the second end of the first catheter and capable of temporarily connecting said first channel to a source inflation fluid of said first balloon, a second catheter having a first inner end and a second outer end, said second ca theter comprising at its first end an angioplasty instrument, said second catheter comprising a first guide channel capable of at least partially surrounding said first catheter to be guided by it and a second activation channel of said angioplasty instrument, said second catheter being placed in said artery being guided by said first catheter. We understand that, thanks to the angioplasty device according to the invention, it is possible, after the initial placement of the balloon protection using the first catheter upstream of the intervention area, to set up using the first catheter as a guiding element, an angioplasty instrument suitable for carrying out the intervention itself. The first obturation balloon, after inflation, prevents entrainment of detritus resulting from the intervention by angioplasty to the cerebral arteries.
Selon un mode préféré de mise en oeuvre, une portion dudit premier cathéter proche de sa première extrémité comprend depuis sa première extrémité ledit ballonnet gonflable, une zone de mise en place dudit instrument d'angioplastie et une zone perforée, sur toute la longueur de ladite portion ledit canal de guidage ne débouchant pas dans la paroi latérale dudit premier cathéter, ledit canal de guidage étant muni, dans sa zone perforée, d'ouvertures faisant communiquer ledit canal de guidage avec l'extérieur du cathéter, ledit canal de guidage se prolongeant au-delà dudit ballonnet et étant ouvert à sa première extrémité, ledit canal de guidage étant fendu sur toute sa longueur en dehors de ladite portion de cathéter pour laisser libre ledit fil de guidage.According to a preferred embodiment, a portion of said first catheter close to its first end comprises from its first end said inflatable balloon, a zone for placing said angioplasty instrument and a perforated zone, over the entire length of said portion of said guide channel not opening into the side wall of said first catheter, said guide channel being provided, in its perforated area, with openings communicating said guide channel with the outside of the catheter, said guide channel extending beyond said balloon and being open at its first end, said guide channel being split over its entire length outside said catheter portion to leave said guide wire free.
On comprend que, grâce aux dispositions de ce mode préféré de mise en oeuvre de l'invention, non seulement on obtient une protection vis-à-vis des risques de remontée des détritus vers les artères cérébrales mais de plus, grâce à la présence des perforations dans le canal de guidage du premier cathéter, on entretient une circulation permanente de sang vers les artères cérébrales, c'est-à-dire au-delà du ballonnet de protection mis en place. En outre, grâce à la présence du premier cathéter servant d'élément de guidage pour le deuxième cathéter muni de l'instrument d'angioplastie, il est possible de procéder très rapidement au retrait de l'instrument d'angioplastie après son utilisation ou de procéder au changement de la nature de l'instrument d'angioplastie utilisé.It is understood that, thanks to the provisions of this preferred mode of implementation of the invention, not only is protection obtained against the risks of the detritus going back up to the cerebral arteries, but moreover, thanks to the presence of perforations in the guide channel of the first catheter, there is a permanent circulation of blood to the cerebral arteries, that is to say beyond the protective balloon in place. In addition, thanks to the presence of the first catheter serving as a guiding element for the second catheter provided with the angioplasty instrument, it is possible to proceed very quickly with the removal of the angioplasty instrument after use or change the nature of the angioplasty instrument used.
En outre, du fait que sur la plus grande partie de sa longueur le canal de guidage est fendu, la longueur de guidage effective est réduite et le premier cathéter avec son ballonnet d'obturation pourra donc être retiré du corps du patient rapidement. Selon un mode préféré de réalisation, le canal de guidage n'est prévu que sur une longueur réduite de la deuxième extrémité du deuxième cathéter. Le guidage effectif du deuxième cathéter par le premier ne concerne donc qu'une longueur réduite de celui-ci. Il en résulte que le deuxième cathéter avec son instrument d'angioplastie peut être, en cas de besoin, retiré rapidement du corps du patient. D'autres caractéristiques et avantages de la présente invention apparaîtront mieux à la lecture de la description qui suit d'un mode préféré de mise en oeuvre de l'invention donné à titre d'exemple non limitatif. La description se réfère aux figures annexées sur lesquelles :In addition, because over most of its length the guide channel is split, the effective guide length is reduced and the first catheter with its sealing balloon can therefore be withdrawn from the patient's body quickly. According to a preferred embodiment, the guide channel is only provided over a reduced length of the second end of the second catheter. The effective guiding of the second catheter by the first therefore only concerns a reduced length of the latter. As a result, the second catheter with its angioplasty instrument can, if necessary, be quickly removed from the patient's body. Other characteristics and advantages of the present invention will appear better on reading the following description of a preferred embodiment of the invention given by way of nonlimiting example. The description refers to the appended figures in which:
- la figure 1 est une vue schématique montrant la mise en place sur un patient de l'ensemble du dispositif d'angioplastie ;- Figure 1 is a schematic view showing the placement on a patient of the entire angioplasty device;
- la figure 2 est une vue en élévation du premier cathéter muni de son ballonnet gonflable ;- Figure 2 is an elevational view of the first catheter provided with its inflatable balloon;
- la figure 3 est une vue en coupe selon la ligne III— III de la figure 2 ; - la figure 4 est une vue en coupe selon la ligne IV-IV de la figure 2 ;- Figure 3 is a sectional view along line III-III of Figure 2; - Figure 4 is a sectional view along the line IV-IV of Figure 2;
- la figure 5 est une vue en coupe selon la ligne V-V de la figure 2 ;- Figure 5 is a sectional view along the line V-V of Figure 2;
- la figure 6 est une vue partielle montrant la mise en place du ballonnet de protection dans l'artère carotide ;- Figure 6 is a partial view showing the establishment of the protective balloon in the carotid artery;
- la figure 7 est une vue partielle montrant un mode de réalisation préféré du raccord du premier cathéter ;- Figure 7 is a partial view showing a preferred embodiment of the connector of the first catheter;
- la figure 8 montre la mise en place du ballonnet de protection à l'aide du premier cathéter et du deuxième ballonnet d'intervention d'angioplastie à l'aide du deuxième cathéter dans la carotide ; et- Figure 8 shows the establishment of the protective balloon using the first catheter and the second angioplasty intervention balloon using the second catheter in the carotid; and
- la figure 9 est une vue en coupe transversale du deuxième cathéter associé à l'instrument d'angioplastie ; et- Figure 9 is a cross-sectional view of the second catheter associated with the angioplasty instrument; and
- les figures 9a, 9b et 9c sont des vues du deuxième cathéter de la figure 9 en coupe transversale respectivement selon les plans A-A, B-B et C-C de la figure 9.FIGS. 9a, 9b and 9c are views of the second catheter of FIG. 9 in cross section respectively along the planes A-A, B-B and C-C of FIG. 9.
En se référant tout d'abord à la figure 1, on va décrire de façon simplifiée l'ensemble du dispositif d'angioplastie. Ce dispositif se compose essentiellement d'un premier cathéter 10 à l'extrémité duquel est monté un ballonnet d'obturation d'artère 12 et qui comporte à sa deuxième extrémité un raccord 14 sur lequel est susceptible d'être montée une pompe d'inflation 16. Le dispositif d'angioplastie comporte également un deuxième cathéter 18 dont l'extrémité interne est munie d'un ballonnet d'angioplastie 20 et dont la deuxième extrémité 22 est munie d'un raccord à une pompe 24 d'injection du liquide d'inflation du ballonnet d'angioplastie 20. De préférence, le dispositif d'angioplastie peut comporter un troisième cathéter 26 dont une extrémité est munie d'un outil 28 support de prothèse et dont l'autre extrémité est munie d'un instrument 30 de libération de la prothèse.Referring first to Figure 1, we will describe in a simplified way the entire angioplasty device. This device essentially consists of a first catheter 10 at the end of which is mounted an artery obturation balloon 12 and which comprises at its second end a connector 14 on which an inflation pump can be mounted 16. The angioplasty device also comprises a second catheter 18 whose internal end is provided with an angioplasty balloon 20 and whose second end 22 is provided with a connection to a pump 24 for injecting the inflation liquid of the angioplasty balloon 20. Preferably, the angioplasty device can comprise a third catheter 26, one end of which is provided with a prosthesis support tool 28 and the other end of which is provided with an instrument 30 the prosthesis.
En outre, comme cela est bien connu pour la mise en place d'un dispositif d'angioplastie, il est prévu un fil de guidage 32 qui est mis préalablement en place dans le réseau d'artères permettant d'accéder à la zone 34 où l'on veut réaliser l'intervention et notamment au-delà du raccordement de la carotide 36 comme cela est représenté sur la figure 1. En outre, sur cette figure, on a illustré schématiquement les moyens de mise en place du dispositif d'angioplastie qui sont constitués essentiellement par un désilet introducteur 40 comportant une valve. Ce désilet est mis en place soit sur l'artère fémorale, soit sur l'artère radiale, ou sur l'artère humérale droite ou gauche. En se référant maintenant plus particulièrement aux figures 2 àIn addition, as is well known for the establishment of an angioplasty device, there is provided a guide wire 32 which is previously placed in the artery network allowing access to the area 34 where we want to perform the intervention and in particular beyond the connection of the carotid 36 as shown in Figure 1. In addition, in this figure, we schematically illustrated the means of positioning the angioplasty device which consist essentially of an introducer mesh 40 comprising a valve. This desilet is placed either on the femoral artery, or on the radial artery, or on the right or left humeral artery. Referring now more particularly to FIGS. 2 to
5, on va décrire le premier cathéter 10 avec son ballonnet d'obturation 12.5, we will describe the first catheter 10 with its obturation balloon 12.
Le cathéter 10 se présente de façon connue sous la forme d'un élément allongé de longueur égale, de préférence, à 175 cm de section circulaire et suffisamment souple. Plus généralement, ce cathéter a une longueur comprise entre 100 et 250 cm. Le cathéter 10 présente une première extrémité 10a destinée à être introduite dans le corps du patient et une extrémité externe 10b sur laquelle est monté le raccord 14. Depuis son extrémité interne 10a, le cathéter comporte une première zone A d'extrémité et une zone courante B dont la longueur est de l'ordre de 145 cm. Dans la zone A on peut distinguer une première zone Al sur laquelle est fixé le ballonnet d'obturation 12 puis une zone libre A2 sur laquelle on viendra mettre en position le ballonnet d'angioplastie ou un autre outil d'angioplastie puis une zone A3 dite perforée. A la limite de la zone perforée, on peut trouver de préférence une marque opaque 42. Sur toute sa longueur, comme le montre mieux les figures 3 à 5, le cathéter 10 comporte un premier canal longitudinal 44 d'inflation et un canal longitudinal 46 de guidage. Sur la totalité de sa longueur, le canal d'inflation 44 est entouré par le matériau constituant le cathéter et la première extrémité du canal 44 est relié au raccord 14 tandis que la deuxième extrémité 44a du canal 44 est ouverte au-delà de la zone Al de la fixation du ballonnet d'obturation 12. Dans la zone A3 perforée, on voit que le canal de guidage 46 est de préférence pourvu de perforations telles que 48 s'étendant sur toute la zone A3. Sur la zone correspondant à la partie courante du cathéter, le canal de guidage 46 est pourvu d'une fente 50 débouchant dans la paroi externe du cathéter 10. Ainsi, le fil de guidage qui est disposé dans le canal de guidage 46 peut être sorti commodément de celui-ci dans la portion B. Dans la zone Al, il va de soi que le canal d'inflation 44 débouche dans le ballonnet d'obturation 12 pour en permettre le gonflage. A proximité de l'extrémité 10b, le canal de guidage 46 est interrompu par une encoche 50 constituant un stop de fil de guidage.The catheter 10 is in known manner in the form of an elongated element of length equal, preferably, to 175 cm of circular section and sufficiently flexible. More generally, this catheter has a length of between 100 and 250 cm. The catheter 10 has a first end 10a intended to be introduced into the body of the patient and an external end 10b on which the connector 14 is mounted. From its internal end 10a, the catheter has a first end zone A and a current zone B whose length is of the order of 145 cm. In zone A, a first zone A1 can be distinguished on which the obturation balloon 12 is fixed, then a free zone A2 on which the angioplasty balloon or another angioplasty tool will be positioned, then a zone A3 called perforated. At the edge of the perforated area, one can preferably find an opaque mark 42. Over its entire length, as best shown in Figures 3 at 5, the catheter 10 has a first longitudinal inflation channel 44 and a longitudinal guide channel 46. Over its entire length, the inflation channel 44 is surrounded by the material constituting the catheter and the first end of the channel 44 is connected to the connector 14 while the second end 44a of the channel 44 is open beyond the zone A1 of the fixing of the obturation balloon 12. In the perforated area A3, it can be seen that the guide channel 46 is preferably provided with perforations such as 48 extending over the entire area A3. On the zone corresponding to the current part of the catheter, the guide channel 46 is provided with a slot 50 opening into the external wall of the catheter 10. Thus, the guide wire which is disposed in the guide channel 46 can be pulled out conveniently of the latter in the portion B. In the zone A1, it goes without saying that the inflation channel 44 opens into the sealing balloon 12 to allow inflation. Near the end 10b, the guide channel 46 is interrupted by a notch 50 constituting a guide wire stop.
Comme le montre mieux la figure 7, de préférence, le raccord 14 est muni d'un clapet ou valve anti-retour 54. Le clapet 54 est de préférence du type à bille. Ce raccord comporte une partie filetée 56 sur laquelle peut être fixée la pompe ou la seringue servant à introduire le sérum physiologique pour gonfler le ballonnet d'obturation 12. Grâce à la présence du clapet 54 le canal d'inflation 44 est obturé lorsqu'on retire la pompe d'inflation, ce qui permet de maintenant en pression le ballonnet d'obturation. Après la mise en place dans le réseau d'artères du fil de guidageAs best shown in Figure 7, preferably, the connector 14 is provided with a check valve 54. The valve 54 is preferably of the ball type. This connection has a threaded portion 56 on which the pump or the syringe used to introduce the physiological saline can be fixed to inflate the obturation balloon 12. Thanks to the presence of the valve 54, the inflation channel 44 is closed when removes the inflation pump, which keeps the sealing balloon under pressure. After the guide wire is placed in the artery network
32 jusqu'à ce que celui-ci atteigne la zone d'intervention, on met en place en se servant du fil comme guide le premier cathéter 10 de telle manière que le ballonnet d'obturation soit disposé au-delà de la zone d'intervention. Sur la figure 6, on a représenté le cathéter 10 avec son ballonnet d'obturation 12 mis en place. Le ballonnet 12 est gonflé de manière convenable pour assurer effectivement l'obturation de l'artère. Grâce à la présence du clapet ou de la valve 54, le ballonnet reste gonflé même après le retrait de la pompe d'inflation. On comprend également que, grâce à la présence des perforations 48 débouchant dans le canal de guidage 46, malgré l'obturation de l'artère par le ballonnet 12, une circulation sanguine par l'intermédiaire du canal de guidage est maintenue vers l'aval de l'artère. Selon un mode préféré de réalisation, la longueur totale du cathéter 10 est de l'ordre de 175 cm et son diamètre de l'ordre de 1 mm et la zone A a une longueur de l'ordre de 30 cm. La zone A2 de mise en place du ballonnet d'angioplastie a une longueur de l'ordre de 20 cm. Le ballonnet 12 est réalisé en latex ou matériau similaire et il présente une longueur de l'ordre de 1 cm. Ce ballonnet gonflé peut atteindre un diamètre de 9 mm. En se référant maintenant aux figures 9, on va décrire le deuxième cathéter 18 servant à l'opération d'angioplastie proprement dite. Ce cathéter 18 est muni à son extrémité du ballonnet d'angioplastie 20. Le cathéter 18 comporte une première zone Cl proche de son extrémité terminale 18a sur laquelle est monté le ballonnet d'angioplastie 20, une deuxième zone C2 puis une partie courante D. Sur toute sa longueur, le cathéter 18 comporte un canal d'inflation 60 dont la première extrémité débouche dans le ballonnet 20 et dont la deuxième extrémité est raccordée à un raccord 62 qui peut lui-même être raccordé à une pompe d'inflation 64. Dans les zones Cl et C2, le cathéter 18 comporte un canal de guidage 68 dans lequel peut coulisser le premier cathéter 10 pour la mise en place du ballonnet d'angioplastie. Comme on le voit sur la figure 9b, le canal de guidage s'interrompt après une longueur 1 et dans la partie courante D le cathéter 18 comporte simplement le canal d'inflation 60. Le canal de guidage 68 dans la portion où il existe présente un diamètre qui est légèrement supérieur au diamètre externe du premier cathéter 10. On peut ainsi mettre en place le ballonnet d'angioplastie 20 dans la zone de l'artère où doit avoir lieu l'opération. Le ballonnet d'angioplastie est mis en place par rapport au premier cathéter dans la zone libre A2 de celui-ci.32 until the latter reaches the intervention zone, the first catheter 10 is put in place using the wire as a guide so that the obturation balloon is disposed beyond the zone of intervention. In Figure 6, there is shown the catheter 10 with its closure balloon 12 in place. The balloon 12 is properly inflated to effectively seal the artery. Thanks to the presence of the valve 54, the balloon remains inflated even after the inflation pump has been withdrawn. It is also understood that, thanks to the presence of the perforations 48 opening into the guide channel 46, despite obstruction of the artery by the balloon 12, a blood circulation via the guide channel is maintained downstream of the artery. According to a preferred embodiment, the total length of the catheter 10 is of the order of 175 cm and its diameter of the order of 1 mm and the area A has a length of the order of 30 cm. The area A2 for placing the angioplasty balloon has a length of the order of 20 cm. The balloon 12 is made of latex or similar material and has a length of the order of 1 cm. This inflated balloon can reach a diameter of 9 mm. Referring now to Figures 9, we will describe the second catheter 18 used for the actual angioplasty operation. This catheter 18 is provided at its end with the angioplasty balloon 20. The catheter 18 has a first zone C1 close to its terminal end 18a on which the angioplasty balloon 20 is mounted, a second zone C2 and then a running part D. Over its entire length, the catheter 18 has an inflation channel 60, the first end of which opens into the balloon 20 and the second end of which is connected to a connector 62 which can itself be connected to an inflation pump 64. In zones C1 and C2, the catheter 18 has a guide channel 68 in which the first catheter 10 can slide for the placement of the angioplasty balloon. As seen in Figure 9b, the guide channel is interrupted after a length 1 and in the main part D the catheter 18 simply includes the inflation channel 60. The guide channel 68 in the portion where it exists a diameter which is slightly greater than the external diameter of the first catheter 10. It is thus possible to place the angioplasty balloon 20 in the area of the artery where the operation is to take place. The angioplasty balloon is placed relative to the first catheter in the free area A2 thereof.
Sur la figure 8, on a représenté l'ensemble du dispositif d'angioplastie mis en place par exemple dans l'artère carotide 70. On trouve successivement le ballonnet d'obturation 12 puis en retrait le ballonnet d'angioplastie 20 raccordé au cathéter 18. On comprend en particulier que, grâce au fait que le canal de guidage 68 n'existe que sur une portion terminale réduite de la longueur du deuxième cathéter 18, le deuxième cathéter et son ballonnet d'angioplastie 20 peuvent être retirés rapidement de son site d'implantation puisqu'il n'est guidé par le premier cathéter 10 que sur une partie réduite de sa longueur. Selon un mode préféré de réalisation, la longueur (1) de la zoneIn Figure 8, there is shown the entire angioplasty device implemented for example in the carotid artery 70. There is successively the obturation balloon 12 and then withdrawing the angioplasty balloon 20 connected to the catheter 18 It is understood in particular that, thanks to the fact that the guide channel 68 exists only over a reduced terminal portion of the length from the second catheter 18, the second catheter and its angioplasty balloon 20 can be withdrawn quickly from its implantation site since it is guided by the first catheter 10 only over a reduced part of its length. According to a preferred embodiment, the length (1) of the zone
C du deuxième cathéter est de l'ordre de 20 cm. Selon la nature de l'intervention, le ballonnet d'angioplastie peut avoir une longueur de 10 à 30 mm. Le diamètre du ballonnet de dilatation gonflé peut aller de 3 à 9 mm. II faut ajouter que le dispositif d'angioplastie peut comporter un troisième cathéter 30 qui peut être engagé sur le premier cathéter 10 à la place du cathéter 18. Ce cathéter 30 est muni à son extrémité interne d'un outil de mise en place d'une prothèse d'angioplastie. Ce troisième cathéter comprend également un canal de guidage semblable à celui du deuxième cathéter et un deuxième canal pour contenir les moyens de commande à distance de l'outil de mise en place de la prothèse.C of the second catheter is of the order of 20 cm. Depending on the nature of the intervention, the angioplasty balloon can be 10 to 30 mm long. The diameter of the inflated dilatation balloon can range from 3 to 9 mm. It should be added that the angioplasty device may include a third catheter 30 which can be engaged on the first catheter 10 in place of the catheter 18. This catheter 30 is provided at its internal end with a tool for positioning an angioplasty prosthesis. This third catheter also includes a guide channel similar to that of the second catheter and a second channel for containing the remote control means of the tool for placing the prosthesis.
Le dispositif décrit précédemment s'applique en particulier aux lésions sténosantes des vaisseaux du cou et notamment des artères carotides. Le système de protection d'emboles du lit d'aval voit son application élargie au traitement des lésions des greffons veineux saphème aorto-coronaire. Le lit d'aval étant protégé, il est possible de glisser le cathéter du ballon protecteur un "hydrolyseur" permettant d'aspirer et de ramener du trombus en toute sécurité.The device described above applies in particular to stenosing lesions of the vessels of the neck and in particular of the carotid arteries. The embolism protection system of the downstream bed sees its application widened to the treatment of lesions of venous grafts aorto-coronary saphenous. The downstream bed being protected, it is possible to slide the catheter of the protective balloon a "hydrolyzer" allowing to suck in and bring back the trombus safely.
Il en est de même pour le traitement des embolies pulmonaires massives mal tolérées avec échec ou contre-indication à une thrombolyse. Le ballon périphérique de dilatation monorail est utilisable également pour les artères de jambes, les artères rénales, les artènes coronaires et les pontages (de gros calibre). The same is true for the treatment of poorly tolerated massive pulmonary embolism with failure or contraindication to thrombolysis. The peripheral monorail dilation balloon can also be used for leg arteries, renal arteries, coronary arenas and bypasses (large caliber).

Claims

REVENDICATIONS
1. Dispositif d'angioplastie, caractérisé en ce qu'il comprend : un premier cathéter (10) destiné à être introduit dans l'artère à traiter, comprenant une première extrémité interne et une deuxième extrémité externe, ledit cathéter étant muni d'un premier canal d'inflation (44) interne s'étendant sur toute la longueur du cathéter et d'un deuxième canal de guidage (46) s'étendant sur toute la longueur dudit cathéter et apte à laisser passer un fil de guidage, un premier ballonnet gonflable d'obturation (12) fixé à la première extrémité du cathéter et raccordé à la première extrémité interne du premier canal d'inflation, et un raccord (14) solidaire de la deuxième extrémité du premier cathéter et apte à relier de façon temporaire ledit premier canal à une source de fluide de gonflage dudit premier ballonnet, un deuxième cathéter (18) comportant une première extrémité interne et une deuxième extrémité externe, ledit deuxième cathéter comportant à sa première extrémité un instrument d'angioplastie (20), ledit deuxième cathéter comprenant un premier canal de guidage (68) apte à entourer au moins partiellement ledit premier cathéter pour être guidé par celui-ci et un deuxième canal (60) d'activation dudit instrument d'angioplastie, ledit deuxième cathéter étant mis en place dans ladite artère en étant guidé par ledit premier cathéter.1. Angioplasty device, characterized in that it comprises: a first catheter (10) intended to be introduced into the artery to be treated, comprising a first internal end and a second external end, said catheter being provided with a first internal inflation channel (44) extending over the entire length of the catheter and a second guide channel (46) extending along the entire length of said catheter and capable of passing a guide wire, a first inflatable obturation balloon (12) fixed to the first end of the catheter and connected to the first internal end of the first inflation channel, and a connector (14) integral with the second end of the first catheter and capable of temporarily connecting said first channel to a source of inflation fluid from said first balloon, a second catheter (18) having a first internal end and a second external end, said second catheter comprises at its first end an angioplasty instrument (20), said second catheter comprising a first guide channel (68) capable of at least partially surrounding said first catheter to be guided by it and a second channel (60) d activation of said angioplasty instrument, said second catheter being placed in said artery being guided by said first catheter.
2. Dispositif d'angioplastie selon la revendication 1, caractérisé en ce qu'une portion (A) dudit premier cathéter (10) proche de sa première extrémité comprend depuis sa première extrémité ledit ballonnet gonflable (12), une zone libre (A2) de mise en place dudit instrument angioplastique (20) et une zone perforée (A3), sur toute la longueur de ladite portion ledit canal de guidage (46) ne débouchant pas dans la paroi latérale dudit premier cathéter, ledit canal de guidage étant muni, dans sa zone perforée, d'ouvertures (48) faisant communiquer ledit canal de guidage avec l'extérieur du cathéter, ledit canal de guidage se prolongeant au-delà dudit ballonnet (12) et étant ouvert à sa première extrémité (46a), ledit canal de guidage étant fendu sur toute sa longueur en dehors de ladite portion de cathéter pour laisser libre ledit fil de guidage (32). 2. Angioplasty device according to claim 1, characterized in that a portion (A) of said first catheter (10) close to its first end comprises from its first end said inflatable balloon (12), a free zone (A2) placing said angioplastic instrument (20) and a perforated area (A3), over the entire length of said portion, said guide channel (46) not opening into the side wall of said first catheter, said guide channel being provided, in its perforated area, openings (48) communicating said guide channel with the outside of the catheter, said guide channel extending beyond said balloon (12) and being open at its first end (46a), said guide channel being slit over its entire length outside said catheter portion to leave free said guide wire (32).
3. Dispositif d'angioplastie selon l'une quelconque des revendications 1 et 2, caractérisé en ce que ledit raccord (14) du premier cathéter (10) est muni de moyens par clapet anti-retour (54) pour obturer la deuxième extrémité du premier canal d'inflation (44) lorsque lesdits moyens de gonflage sont déconnectés dudit raccord.3. Angioplasty device according to any one of claims 1 and 2, characterized in that said connector (14) of the first catheter (10) is provided with means by non-return valve (54) for closing the second end of the first inflation channel (44) when said inflation means are disconnected from said connector.
4. Dispositif d'angioplastie selon l'une quelconque des revendications 1 à 3, caractérisé en ce que ledit instrument d'angioplastie est un deuxième ballonnet gonflable (20) raccordé audit deuxième canal (60) dudit deuxième cathéter. 4. Angioplasty device according to any one of claims 1 to 3, characterized in that said angioplasty instrument is a second inflatable balloon (20) connected to said second channel (60) of said second catheter.
5. Dispositif d'angioplastie selon l'une quelconque des revendications 1 à 4, caractérisé en ce que ledit premier canal de guidage (68) du deuxième cathéter (18) n'existe que sur une longueur réduite à proximité de la première extrémité dudit deuxième cathéter. 5. Angioplasty device according to any one of claims 1 to 4, characterized in that said first guide channel (68) of the second catheter (18) exists only over a reduced length near the first end of said second catheter.
PCT/FR1996/000875 1995-06-16 1996-06-10 Angioplasty device WO1997000093A1 (en)

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EP96922088A EP0831952A1 (en) 1995-06-16 1996-06-10 Angioplasty device
AU63086/96A AU6308696A (en) 1995-06-16 1996-06-10 Angioplasty device

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FR95/07204 1995-06-16
FR9507204A FR2735373A1 (en) 1995-06-16 1995-06-16 ANGIOPLASTY DEVICE

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US9649436B2 (en) 2011-09-21 2017-05-16 Bayer Healthcare Llc Assembly method for a fluid pump device for a continuous multi-fluid delivery system
US10507319B2 (en) 2015-01-09 2019-12-17 Bayer Healthcare Llc Multiple fluid delivery system with multi-use disposable set and features thereof

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EP0277367A1 (en) * 1987-01-06 1988-08-10 Advanced Cardiovascular Systems, Inc. Perfusion type balloon dilatation catheter and apparatus
EP0362146A1 (en) * 1988-09-27 1990-04-04 Schneider (Europe) Ag Dilatation catheter for stretching occlusions
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US9649436B2 (en) 2011-09-21 2017-05-16 Bayer Healthcare Llc Assembly method for a fluid pump device for a continuous multi-fluid delivery system
US9700672B2 (en) 2011-09-21 2017-07-11 Bayer Healthcare Llc Continuous multi-fluid pump device, drive and actuating system and method
US10507319B2 (en) 2015-01-09 2019-12-17 Bayer Healthcare Llc Multiple fluid delivery system with multi-use disposable set and features thereof
US11491318B2 (en) 2015-01-09 2022-11-08 Bayer Healthcare Llc Multiple fluid delivery system with multi-use disposable set and features thereof

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AU6308696A (en) 1997-01-15
EP0831952A1 (en) 1998-04-01
FR2735373A1 (en) 1996-12-20

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