FR2896983A1 - SYSTEM FOR TREATING LESIONS ON A BIFURCATION OF BLOOD VESSEL - Google Patents

Abstract

A system for treating lesions on a blood vessel bifurcation having a first limb (B1) and a second limb (B2) comprising: - a first stent (100) adapted to be positioned in the first limb; second stent (200) adapted to be placed in the second limb (B2) by engagement through an orifice (140) of the first stent (100) after it is expanded, and, - a delivery instrument (400) having a longitudinal axis (1), and comprising: - a first balloon (500) adapted to be introduced into the second leg through the orifice (140) of the first stent (100) and to expand said orifice (140); second balloon (600), aligned with the first balloon (500) along the longitudinal axis (1), adapted to receive the second stent (200) and expand it.

Description

The present invention relates to the field of

  lesions on bifurcations of blood vessels. The present invention more specifically relates to a stent delivery system for this purpose.

  The treatment of stenoses detected on coronary arteries is conventionally known by placing endoprostheses formed of tubular bodies openwork in mesh and expandable, thanks to a guide, on the stenosed site. Most often the expansion of these stents is caused by inflating a balloon inside the stents, the balloon being subsequently removed. This system of usual installation of a stent has already rendered great services. However, it does not give complete satisfaction. In particular, the Applicant has found that it is not fully satisfactory when, as is common, the stenosis is located at a blood vessel bifurcation. Indeed, in this case, the arrangement of two distinct stents intended to be placed respectively in the various branches of the bifurcation and whose relative positioning must be adjusted as closely as possible to cover at least the bifurcation zone requires the use of two separate delivery systems in two parallel procedures. These two distinct procedures increase the risk of crossing the guides placing the stents on the bifurcation zone, thus making the treatment of stenotic sites on the bifurcations of blood vessels difficult. A primary object of the present invention is to improve the stent delivery systems to facilitate and improve the treatment of stenosis on the bifurcations of blood vessels. A second object of the present invention is to provide a stent delivery system which allows the operator to place either one or two stents in the bifurcation area of a blood vessel during the same procedure. Another object of the invention is to provide a delivery system limiting the risk of crossing guides between two laying instruments associated with two stents each for a branch of a vessel bifurcation.

  It is also desirable to provide a stent delivery system simple to use and manufacturing while maintaining maximum efficiency. These objects are achieved within the scope of the present invention by a blood vessel bifurcation lesion treatment system comprising a first limb and a second limb, the system being characterized by comprising a first adapted stent to be positioned partly in the first branch of the bifurcation; a second stent adapted to be placed in the second branch of the bifurcation and to be introduced into this second branch by engagement through an orifice of the first stent once it has expanded and a laying instrument having a first axis; longitudinal, said delivery instrument comprising: - a first balloon adapted to be introduced into the second leg through the orifice of the first stent and to expand this orifice; a second balloon, aligned with the first balloon along the first longitudinal axis, adapted to receive the second endoprosthesis and to expand it. The invention will be better understood and other advantages and features will appear on reading the following description given by way of nonlimiting example and with the appended drawings in which: FIG. 1 illustrates a schematic lateral view of a delivery instrument associated with a main stent dedicated to a first branch of a bifurcation of a blood vessel; Figure 2 illustrates a schematic side view of a dual balloon delivery instrument associated with a secondary stent dedicated to a second branch of a bifurcation of a blood vessel; FIGS. 3a and 3b illustrate sectional views, respectively, of a main stent dedicated to a first branch of a bifurcation of a blood vessel and of a beveled secondary stent dedicated to a second branch of the bifurcation; Figure 4 illustrates a perspective view of the stents of Figures 3a and 3b disposed at the bifurcation of a blood vessel; FIG. 5a illustrates a side view of a stent delivery system according to the invention comprising the double balloon laying instrument of FIG. 2 cooperating with the laying instrument of FIG. 1 in an endoprosthesis; FIG. 5b illustrates a side view of the installation of a stent delivery system according to the invention comprising the double balloon laying instrument of FIG. 2 co-operating with the laying instrument of FIG. 1; FIG. 5c illustrates a side view of the deployment of the stent carried by the laying instrument of FIG. 1, by inflation of a first balloon of the double balloon laying instrument of FIG. 2; FIG. 5d illustrates a side view of the deployment of the stent carried by the laying instrument of FIG. 1, by deployment of the latter's balloon; Fig. 5e illustrates a side view of the placement of the secondary stent by the associated dual balloon delivery instrument in a branch of the bifurcation of a blood vessel; FIG. 5f illustrates a variant of FIG. 5c with the deployed secondary stent; FIGS. 6a, 6b, 6c illustrate the coordinated relative movements of the two laying instruments of a delivery system according to the invention during the placement of stents at the bifurcation of a blood vessel. 1. Stent Delivery System for the Treatment of Lesions on Bifurcations of Vessels A stent delivery system for the treatment of lesions on bifurcations of blood vessels in accordance with the present invention will first be described.

  at. The Installation System Instruments This delivery system will allow either one or two stents to be installed, depending on the needs of the V vessel to be treated, in a single procedure. It comprises, on the one hand, a first laying instrument 300 presenting a main balloon 310 intended to expand a so-called main endoprosthesis 100 intended to be placed in a first branch B15 of the bifurcation and a main section P, upstream of the bifurcation of a blood vessel V to be treated, as seen in particular in Figure 4. This main balloon 310 is associated with a guide lumen 323 can receive a first guide element 800 for directing the balloon in the first branch B1 of the bifurcation. On the other hand, the delivery system comprises a second dual-balloon delivery instrument 400 dedicated to the possible placement of a so-called secondary endoprosthesis 200 in the second branch B2 of the bifurcation of the blood vessel V to be treated. This second laying instrument 400 is adapted to cooperate with the first. It comprises a first balloon 500 adapted to be introduced into the second branch B2 through an orifice 140 of the main stent 100, the first balloon 500 being also adapted to dilate the orifice 140 of the main stent 100. It comprises also a second balloon 600 adapted to receive the secondary stent 200 and to dilate it, said stent being intended to be introduced into the second branch (B2) by engagement through the orifice (140) of the first stent (100), a once this one dilated. On the other hand, it advantageously comprises receiving means 530 which can partially receive the first guide element 800 of the first laying instrument 300 so as to hold the two laying instruments 300 and 400 together during the progression of the system. laying to the bifurcation of the V vessel to be treated. We will now describe, more precisely, the structure of the second double-balloon laying instrument 400, shown in FIG. 2. Essentially, this laying instrument 400, having a longitudinal axis 1, comprises the first 500 and the second one. second balloons 600, the most proximal, arranged in a row along this axis 1. These two balloons 500 and 600 are preferably formed, respectively, of tubular elements 510 and 610 elongated generally cylindrical, centered on the axis 1 and whose respective ends 511, 512 and 611, 612 are generally rounded. More precisely, these balls 500 and 600 are, respectively, fixed on two hollow inner tubes 520 and 620 extending parallel to the axis 1 and axially passing through said balloons 500 and 600. They comprise, respectively, at least one light of 522,622 guide receiving a guiding element guide type 700 flexible metal angioplasty. The balloons 500 and 600 extend, respectively, at their proximal ends 511 and 611 by two respective inflation tubes 521 and 621 extending substantially along the axis 1 and adapted to inflate the balloons. Preferably, these inflation tubes 521 and 621 surround the guide 700. Specifically, preferably, each of them comprises two lumens: a first lumen 524, 624 which receives the metal guide 700 and opens into the guiding light associated inner tube 520 and 620 and a second lumen 525, 625 used 6 for inflation which opens into the inner volume of the balloons 500 and 600. It is noted that the inner tubes 520 and 620 and first lights 524 and 624 above are isolated from the inner volume of the balloons 5 500 and 600. On the other hand, the first and second balloons 500 and 600, aligned along the axis 1, are separated by the inflation tube 521 of the first balloon 500, on a length of a few mm. In addition, this inflation tube 521 is extended and opens into the inner tube 620 associated with the second balloon 600, itself extending into the inflation tube 621 thereof. Thus, the inflation tube 621 of the most proximal balloon 600 is composed, more precisely, of three lumens: a guide lumen 624 common to the two balloons 500 and 600, which receives the metal guide 700, a first inflation lumen 525 the first balloon 500 which opens into the associated inner tube 520 and a second lumen 625 used to inflate the second balloon 600 which opens into the internal cavity of the balloon 600. Therefore, the two inflation tubes 521 and 621 associated with the two balloons 500 and 600 are attached together at the proximal end 611 of the second balloon 600 over a large part of their length. Preferably, they are welded together. They then form a common element 410 having three respective slots 430, 440, 450 in respective connection with the tubes 25 and more specifically the guide lights 624 and inflation 525, 625 mentioned above. Thus, the two balloons 500 and 600 are integral, joined on the greater part of their inflation tubes 521 and 621 and they have a common guide light 624 receiving the metal guide 700 directing the assembly in the second branch B2 of the bifurcation. They will, therefore, move together during a possible procedure of installation of the secondary stent 200.

  Furthermore, the common element 410 of the second delivery instrument 400 is provided at its proximal end, opposite to the second balloon 600, two connection systems 445 and 455 with fluid sources and in respective connection with the inflation lights 440 and 450 for expanding the balloons 500 and 600. It also has reversible fastening means and, more particularly, a connection system 435 with a torquer T and in connection with the guide light 430 for fixing the guide 700.

  These connection systems 430, 440 and 450 may be, for example, of the type known as luer lock. Alternatively, the connection means 445 and 455 for inflating the aforementioned balloons may be adapted to receive a conventional inflation syringe tip.

  It is important that the aforementioned connecting means 445 and 455 allow separate expansion of the two balloons 500 and 600. In its proximal part close to the connection systems, the common element 410 has a color marker R1 which will be used to place in good position the secondary stent 600 in the second branch B2 of the bifurcation. This reference R1, of a length of the order of 20 mm, is placed so as to correspond, during the movements of the second laying instrument 400, with the marks located on the first laying instrument 300 as will be described later. in relation to FIGS.

  In addition, each of the two balloons 500 and 600 is preferably provided with opaque radio markers. More specifically, the first balloon 500 has a mark 540 carried by its inner tube 520 and placed midway thereof while the second balloon 600 has a mark 640 located at the proximal end 611 of the balloon 600 and carried by the tube internal 620 associated. Furthermore, advantageously, the inner tube 520 of the first balloon 500 extends out of it, at its distal end 512, 8

  opposed to the inflation tube 521, by a tube called nose 523 of the balloon 500 extending along the axis 1. The guide light 522 associated with the inner tube 520 opens into the nose 523 of the first balloon 500 and the guide 700 emerges from the nose 523 through its free and open distal end 526. This nose 523 of the first balloon 500 also has, at this end 526, receiving means capable of receiving the first guide element 800 guiding the first laying instrument 300. The two laying instruments 300 and 400 of the stents 100 and 200 will then be able to cooperate together during the respective placement of the latter in the branches B1 and B2 of the bifurcation as will be described below in connection with FIGS. 5. These reception means comprise a so-called auxiliary tube 530 hollow, centered on a axis 5. It extends along the axis 5 of the distal end 526 of the nose 523 of the first balloon 500 to the first balloon 500 in a direction slightly inclined relative to the axis 1. It has one end distal 531 bevel, the bevel being defined by a plane parallel to the axis 1 and perpendicular to the plane of the sheet. From this distal end 531, it is fixed, by gluing or welding, to the free end 523 of the nose of the first balloon 500 along the length of the bevel. This length is of the order of a few mm. On the other hand, this auxiliary tube 530 is adapted to receive, at its proximal end 532, an end of the mandrel 800 or of the metal guide guiding the first laying instrument 300. Concerning this first laying instrument 300, illustrated on Figure 1, it comprises a main balloon 310 centered on an axis 2 associated with an inner tube 320, an inflation tube 322 and a nose 321 30 substantially identical to those described in connection with Figure 2 for the first balloon 500. Thus , the first laying instrument 300 comprises a guiding light 323 common to the various tubes 320 and 322 and the nose 321 adapted to receive the mandrel 800 guiding the laying instrument 300 during its progression in the coronary artery to the first branch B1 of the bifurcation. This mandrel 800 opens out of the laying instrument 300, at the free end 327 of the nose 321 of the balloon 310 and is placed in the auxiliary tube 530 of the second delivery instrument 400. To allow the attachment of the mandrel 800 in the auxiliary tube 530, the inflation tube 322 of the main balloon 310 is provided at its proximal end with reversible attachment means and more precisely. of a connection system 325 with a torter T2 and in connection with the guiding light 323. The respective laying instruments 300 and 400 of the two main stents 100 and 200 are then integral, secured together at their nose 321 and 523 respectively. Furthermore, the first laying instrument 300 also includes a connection system 326 with luer-lock fluid sources and in connection with an inflation lumen 324 for expanding the main balloon 310. In addition, it comprises, on its inflation tube 322 two color marks 20 of R3 and R2 separated by a few tens of mm used as marks when placing the secondary stent 200 in the second branch B2. The reference R3, the most distal, and the R2 mark each extend over a length of the order of 20 mm and are separated by a distance of, for example, 27 mm. The main balloon 310 also has two opaque radio markers 313 and 314 carried by its inner tube 320 and disposed respectively at each of its two ends 312 and 311. These marks 313 and 314 extend over a length of 30 cm. order of 2 mm. According to a particular embodiment, of course not limiting, the two laying instruments 300 and 400 respectively of the main stents 100 and 200 have the following dimensions: 10 - The first and second balloons 500 and 600 have a length adapted to take position in the second branch B2 of the bifurcation of the vessel V while the main balloon 310 has a length adapted to take position in the first branch B1 and the main section P of the vessel V; The first and second balloons 500 and 600 have a respective length of 14 mm and 12 mm and have a diameter in the inflated state of the order of 2.0 mm to 3.0 mm; The main balloon 310 has a length of the order of 20 mm and an external diameter in the inflated state of the order of 2.5 to 4 mm; - The external caliber of the laying instruments 400 and 300 integral in the collapsed state of the balloons 500 and 600 is preferably adapted to progress in a guide catheter 6F; The guide lights 624, 524 and 323 of the two laying instruments 400 and 300 have a length of the order of 110 to 135 cm and an internal diameter adapted to receive a flexible guide or metal mandrel with a diameter of 0.014 inches; - The first balloon 500 is separated from the second 600 by its inflation tube 521 over a distance of 30 to 34 mm; The first balloon 500 has a nose with a length of 10.5 to 11 mm while the nose 321 of the main balloon 310 extends over a length of the order of 3 mm; - The auxiliary tube 530 is fixed to the nose 522 of the first balloon 500 over a length of about 6 mm. The stents The two stents intended to be placed at the bifurcation zone will now be described, as can be seen in particular in FIG. 4.

  Regarding the secondary stent 200, illustrated in Figures 3b and 4, and possibly intended to be disposed in the second branch B2 of the bifurcation of the V vessel to be treated, it comprises a tubular section 220 centered on an axis 4.

  Preferably, the section 220 is formed of a tubular element 221 perforated mesh so that the structure of the section 220 allows expansion in cross section thereof. The mesh design of the section may be subject to various variants. This may be, for example, a diamond-shaped or hexagon-shaped drawing, as shown respectively in FIGS. 3b and 4 giving a roasting appearance when they are expanded by the second internal balloon 600, on the inner wall of FIG. branch B2 of the bifurcation.

  The basic structure of such expandable tubular members 221 and the material constituting them are known to those skilled in the art, these arrangements will not be described in detail later. As illustrated in FIG. 3b, the proximal end 202 of the section 220 intended to be placed at the origin of the second branch B2 of the bifurcation, at the hull of the bifurcation, is provided on its peripheral zone with a bevel 240. This bevel 240 may be defined by a plane inclined relative to the axis 4 and perpendicular to the plane of the sheet. Thus, the angular opening of the wall of the section increases from the proximal end 202 until it covers 360, that is to say a complete tubular shape around the axis 4 at the opposite end 201. a particular embodiment, given by way of non-limiting example, the length of the bevel 240 is of the order of 7 to 9 mm and the internal diameter of the secondary stent 200 of the order of 2.0 to 3.0 mm. An alternative embodiment provides a secondary stent 200 comprising several bevels at its proximal end 202. On the other hand, at this end 202, the endoprosthesis 200 has an opaque radio mark 230. This is placed at the end 241 of the bevel 240, the end closest to the distal end 201 of the section 220 and intended to be placed near the hull of the bifurcation. In the developed position, as illustrated in FIG. 4, when the stent 200 is placed in the second branch B2, the chamfered proximal end 202 comes into place harmoniously at the orifice 140 of the endoprosthesis main 100 located at the entrance of the second branch B2, to cover as much as possible the bifurcation zone.

  About the main stent 100, illustrated in Figures 3a and 4, it comprises a tubular section 110 extending along an axis 3 and centered on the latter. This section 110 is formed of two coaxial distal 130 and proximal 120 portions intended to be engaged, respectively, in the first branch B1 and in the main section P of the vessel V. At a longitudinal end 113 parallel to the axis 3 , upstream of the distal portion, the section 110 has the orifice 140 designed so that it realizes the shape of the entrance of the second branch B2 at which it will come to be placed. It is, for example, in the form of a half circular arc 141 opening outwardly of the section 110. Advantageously, it is formed of a particular mesh. This mesh is wider than the mesh defining the tubular element 101 perforated mesh forming the section 110. Such element 101 having already been described with reference to Figure 3b for the secondary stent 200, it will not be described in detail thereafter. In the developed position, when the main stent 100 is placed at the bifurcation of the vessel V, the orifice 140 is placed opposite the second branch B2, ready to receive the second delivery instrument 400. More specifically, the particular mesh of the orifice 140 is designed so that it can receive the first balloon 500 of the second instrument 400 and open widely without deforming during the expansion of this first balloon 500 to entry of the second branch B2 of the bifurcation. On the other hand, it is designed to adapt to the shape of the secondary stent 200 set on the second balloon 600 of the delivery instrument 400, said stent 200 to engage in said open mesh. in front of the entrance of the second branch B2 of the bifurcation and cross it before being arranged in the branch B2, as will be described in connection with FIGS. 5. Furthermore, an opaque radio marker 102, having a length of approximately 1 mm, is fixed on the orifice 140. It can be placed on the periphery of the latter. For example, in FIG. 3a, it is situated in the middle of the circular arc 141. In general, this radiopaque marker 102 is placed so as to correspond during the installation of the two stents 100 and 200 in both branches of the bifurcation with the mark 230 radio opaque disposed on the bevel 240 of the secondary stent 200.

  In a non-limiting example of the invention, the section 110 of the main stent 100 has a length of the order of 17 to 18 mm and the orifice 140 has an internal diameter of about 3 mm. Preferably, the main endoprosthesis 100 is a cobalt chromium type endoprosthesis. 2. Method of implementing the stent delivery system for the treatment of lesions on bifurcations of vessels A method of implementing the delivery system in accordance with the invention and, more particularly, the placement of one or two stents by this system_

  a.Installation of the stent delivery system First, the delivery instrument 400 of the secondary stent 200 is placed in the main stent 100 carried by the main balloon 310. More precisely, with reference to the 5a, the nose 523 of the first balloon 500 of the second delivery instrument 400 is introduced at the proximal end 112 of the proximal portion 120 of the main stent 100 and then engages out of the main stent 100, through the mesh of the orifice 140, to mid length of the inner tube 520 of the first balloon 500.

  Then, by its distal end, the mandrel 800 is placed in the guiding lumen 323 of the first laying instrument 300 until it opens out of the nose 321 of the main balloon 310. Comrne illustrated in FIGS. 5a and 5b, this mandrel 800 is then introduced into the auxiliary tube 530 of the second laying instrument 400, the assembly being fixed by screwing the corrugator T2 to the connection system 325 associated with the guiding light 323. The two noses 523 and 321 of the balloon 310 and the first balloon 500 of the two laying instruments 300 and 400 are thus secured to one another. It will be noted, moreover, that the two laying instruments 300 and 400 are thus substantially located in a row and the overall diameter of the entire delivery system is reduced in the coronary artery. The two integral delivery instruments 300 and 400 and the stents 100 and 200 which they carry are then introduced into the associated guide catheter. The flexible guide 700, previously placed in the second branch B2 of the bifurcation, is then introduced by its proximal end into the free end 526 of the nose 523 of the first balloon 500 25 of the second delivery instrument 400. The assembly comprising the two Layers 300 and 400 solidaires progresses on the guide 700 through the guide catheter and the main section P of the blood vessel V to be treated until reaching the bifurcation. Thus, the removable auxiliary tube assembly 530 / mandrel 800 holding the two noses 522 and 321 of the first balloon 500 and the main balloon 310 together during their progression on the single guide 700 towards the bifurcation makes it possible to eliminate the risk of crossing guides. .

  The progress of the installation system is stopped at the hull of the bifurcation and the nose 523 is released from the first balloon 500 retained by the rigid mandrel 800. For this, in a first step, it becomes the torter T2 of the connection system 325 of the inflation tube 322 of the main balloon 310, the mandrel 800 is then free of movement. This mandrel 800 is then removed from the auxiliary tube 53C), releasing the two noses 523 and 321 of the two balloons 310 and 500. It is then replaced in the guide lumen 323 associated with the main balloon 100 by a flexible guide which is pushed into the first branch B1 of the bifurcation. We then push on each of the two pre-positioned guides in the two branches B1 and B2 of the bifurcation. The two balls 500 and 310, free from each other, and the poseassociated instruments 400 and 300 advance on their respective flexible guide and separate respectively in the two branches B1 and B2 of the bifurcation. Following this movement, on the one hand, the distal portion 130 of the main stent 100 is located in the first branch B1, the stent 100 having advanced on its guide until the orifice 140 is placed at the entrance of the second branch B2 of the bifurcation. On the other hand, the nose 523 and a first half of the first balloon 500 passing through the orifice 140 are engaged in the second branch B2 of the bifurcation while the second half of the first balloon 500 and the remainder of the second laying instrument 400 placed in the proximal portion 120 of the main stent 100 are located in the main section P of the blood vessel V. This precise position is marked by the correspondence of the opaque radio marks 540 and 102 respective of the first balloon 500 and the port 140 located at the hull of the bifurcation. The delivery system is now in place and ready to treat the bifurcation lesions. 16 b. Deployment of the stent delivery system Until then, all the balloons remained in the deflated state. As the position of the orifice 140 and the first balloon 500 at the hull of the bifurcation has been provided through opaque radio marks 102 and 540, it is possible to inflate the balloons. To deploy the system, in a first step, the first balloon 500 of the second delivery instrument 400 is inflated via its inflation tube 521.

  As illustrated in FIG. 5c, its swelling makes it possible, on the one hand, to expand the mesh of the orifice 140 through which it passes and to shape the latter at the entrance to the second branch B2 of the bifurcation. On the other hand, it also makes it possible to dilate the proximal portion 120 of the main stent 100. This balloon 500 is then deflated.

  In a second step, as illustrated in FIG. 5d, the inflation of the main balloon 310 makes it possible to fully deploy the associated main stent 100, which is well open. The main balloon 310 is then deflated. At this level, the mesh of the tubular element 101 of the main stent 100 comes to cover the first branch Bi of the bifurcation and the main section P of the vessel and is placed opposite the second branch by its orifice 140 by presenting a expanded mesh traversed by the first balloon 500 of the second laying instrument 400.

  In a third step, knowing the distance separating the two color markers R1 and R2, respectively carried by the common element 410 of the second laying instrument 400 and by the inflation tube 322 of the first laying instrument 300, the balloon is removed. main 310 so that the color mark R2 coincides with the color mark R1 of the common element 410, fixed as shown in Figures 6a and 6b. An angiographic control is then performed.

  If the result of the installation of the main stent 100 is satisfactory and optimal at the two branches Bi and B2 of the bifurcation, it is not necessary to provide the deployment of the secondary stent 200 in the second branch B2. The two laying instruments 300 and 400 are simply removed then and the procedure is completed. In the opposite case, if the result is not optimal in the second branch B2, the second insertion instrument 400 is displaced so that the second balloon 600 carrying the secondary stent 200 10 is placed in the second branch B2 after having through the orifice 140 of the main stent 100. Advantageously, as shown in Figure 5e, the linear arrangement of the two balloons 500 and 600 of the second laying instrument 400 facilitates the refraction of the mesh of the orifice 140 by the second balloon 600 for implanting the secondary stent 200. Knowing the distance separating the two colored markers R3 and R2 carried by the inflation tube 322 of the first laying instrument 300, this movement is carried out by pushing back the second laying instrument 400 to match the color mark R1 to the mark R3 as shown in Figure 6c. The position of the second balloon 600 is also controlled by the correspondence of the two opaque radio marks 102 and 230 placed respectively on the orifice 140 and on the bevel 202 of the main stents 100 and 200, as shown in FIGS. 5e and 5f.

After verifying that the second balloon 600 was properly placed, it is inflated to deploy the secondary stent 200. This one conforms, on the one hand, to the wall of the second branch B2 and on the other hand, comes to marry at its bevelled end the dilated orifice 140 of the main stent 100.

As shown in FIGS. 4 and 5f, the primary and secondary stents 200 and 200 are then deployed to cover the two branches B1 and B2 of the bifurcation and the main section P of the V vessel treated.

The treatment of lesions at the bifurcation is thus complete. A final angiographic check is performed to verify that the disposition and deployment of both stents 100 and 200 are optimal. If so, the two delivery instruments 300 and 400 are withdrawn at the same time and the treatment of the lesions of the bifurcation of the blood vessel V with the delivery system according to the invention is completed. If not, it is also possible to remake a new swelling of the main balloon 310 and the first balloon 500, together, by a known technique known as kissing balloon technique which will not be described here. Those skilled in the art will appreciate an angioplasty system for the treatment of lesions on bifurcations of blood vessels which, in comparison with known prior art devices, have a delivery system which permits in place an endoprosthesis in a first branch Bi of the bifurcation and leaves the choice to the operator to ask a second, in the second branch B2, if necessary, during the same procedure.

In addition, such a delivery system can be used simply, reliably and efficiently without the risk of crossing the metal guides directing the two stents 100 and 200 in the respective branches B1 and B2 of the bifurcation. Naturally, the present invention is not limited to the particular embodiments which have just been described but extends to any variant within its spirit. In particular, the present invention is not limited to the accompanying drawings. The specific references illustrated in the preceding paragraphs are non-limiting examples of the invention.

Claims (15)

  A system for treating lesions on a blood vessel bifurcation comprising a first limb (B1) and a second limb (B2), the system characterized by comprising: a first stent (100) adapted to be positioned part in the first branch (B1) of the bifurcation; - a second stent (200) adapted to be placed in the second branch (B2) of the bifurcation and be introduced into this second branch (B2) by engagement through an orifice (140) of the first stent (100) after the one it is dilated and, - a laying instrument (400) having a longitudinal axis (1), said laying instrument (400) comprising: - a first balloon (500) adapted to be introduced into the second branch (B2) through the orifice (140) of the first stent (100) and expanding said orifice (140); - A second balloon (600), aligned with the first balloon (500) along said longitudinal axis (1), adapted to receive the second stent (200) and expand it.   2. System according to the preceding claim characterized in that the first and second balloons (500,600) comprise a first common guiding light (624) extending along the longitudinal axis (1) of the laying instrument ( 400), said first guide light being adapted to receive a guide element (700) associated with the second stent (200) and intended to direct all of the two balloons (500, 600) into the second branch (B2) of the bifurcation .   3. System according to the preceding claim characterized in that the first and second balloons (500,600) each extend, at a proximal end (511,611), by an inflation tube (521,621) capable of inflating the balloon (500,600) and comprising a guide lumen (524,624) adapted to receive said guide member (700) associated with the second stent (200), said inflation tubes (521,621) extending substantially parallel to said longitudinal axis (1) of the pose (400), being fixed together over part of their length.   4. System according to the preceding claim characterized in that the inflation tubes (521,621) are welded together over part of their length.   5. System according to one of the preceding claims characterized in that the first stent (100) is associated with an additional laying instrument (300) comprising at least one main balloon (310) adapted to carry and expand the first stent (100). ), said main balloon (310) being extended at a proximal end by an inflation tube (322) adapted to inflate said balloon (310) and comprising a guide lumen (323) adapted to receive a guide member (800) associated with the first stent (100) and for directing the main balloon (310) into the first branch (B1) of the bifurcation.   6. System according to the preceding claim characterized in that said laying instrument (400) has receiving means (530) adapted to partially receive said guide member (800) associated with the first stent (100) and said instrument additional pose (300) has reversible fixing means (325) of said guide element (800) associated with the first stent (100) to the receiving means (530) so as to hold the two laying instruments (300, 400) together advancing on said guide member (700) associated with the second stent (200) to the bifurcation.   7. System according to the preceding claim characterized in that the receiving means (530) comprises a hollow auxiliary tube adapted to receive at a proximal end (532) said guide element (800) associated with the first stent (100) and, for attaching at a distal end (531) to a so-called nose tube (523) comprising the first guide lumen, said nose (523) extending the first balloon (500) from its distal end parallel to said longitudinal axis (1) said laying instrument (400).   8. System according to one of claims 6 to 7 preceding characterized in that the reversible fixing means (325) comprise a connection system with a torquer (T2) and in connection with the guide light (323) of the tube inflating (322) said additional delivery instrument (300) to secure said guide member (800) associated with the first stent (100) to the receiving means (530).   9. System according to one of claims 5 to 8, characterized in that said guide element (800) associated with the first stent (100) is a mandrel.   10. System according to one of claims 7 to 9 preceding characterized in that the auxiliary tube (530) is a tube extending from the nose (523) in a direction inclined relative to the longitudinal axis (1) said laying instrument (400) to the first balloon (500).   11. System according to one of claims 7 to 10 above characterized in that the auxiliary tube (530) comprises a distal end (531) beveled to be fixed by gluing or welding to the nose (523).   12. System according to one of the preceding claims characterized in that the orifice (140) has a mesh adapted to receive the first balloon (500) and open widely without deforming during its expansion and able to comply with the shape of the second stent (200) carried by the second balloon (600) which passes through the entrance of the second branch (B2) of the bifurcation.   13. System according to one of the preceding claims characterized in that the second endoprosthesis (200) has a proximal end (202) having at least one bevel (240).   14. System according to the preceding claim characterized in that the inflation tubes (621,322) comprise color markers.   15. System according to one of the preceding claims characterized in that each balloon (500,600) and each stent (100,200) has at least one opaque radio mark.20.