WO1997025091A1

WO1997025091A1 - Device for positioning an aortoiliac endoprosthesis

Info

Publication number: WO1997025091A1
Application number: PCT/FR1997/000006
Authority: WO
Inventors: Jean-Marc Denis
Original assignee: Denis Jean Marc
Priority date: 1996-01-08
Filing date: 1997-01-02
Publication date: 1997-07-17
Also published as: FR2743302B1; FR2743302A1

Abstract

Two identical devices (3) are provided that each include a first or distal body (3f) for shaping a first lattice sleeve (2d) and sealingly engaging a first sheath (3d) connected to first feed means (4) for radially deforming the distal body (3f), and a second or proximal body (3s) for shaping a second lattice sleeve (2e), said proximal body being sealingly secured to a second sheath (3n) communicating with further feed means (5) separate from the first for radially deforming the proximal body (3s). Said second sleeve (2e) has a smaller diameter than the first sleeve (2d), while sealing means (3r, 3u) enable the proximal body (3s) secured to the corresponding sheath (3n) and feed means (5) to slide along the first sheath (3d) in order to adjust the distance between the distal (3f) and proximal (3s) bodies.

Description

DEVICE FOR THE PLACEMENT OF AN AORTO-ILIAC ENDOPROSTHESIS

The present invention relates to a bag device for the establishment of an aortoiliac endoprosthesis by the endoluminal route for the treatment of aortic or aortoiliac aneurysms under renal

Devices of this type are known which comprise a pocket or balloon which can be deformed axially by means of a pressurized tick injected into a sealed sheath.

First, the devices were used to dilate the coronaries or peripheral arteries when the latter saw their lumen narrow or become blocked.

Secondly, the same pouch devices have been used to put in place endoluminal stents to fight against restenosis of the coronaries or arteries when they have undergone dilation as defined above. Indeed, the pocket device allows the introαuction of a stent or prosthesis consisting of a metal ring with shape memory which expands using the pocket when the latter receives the liquid under pressure so that the ring keep the walls of the coronaries or arteries apart. As soon as the shape memory ring is removed, the device is removed having previously deflated the pocket to leave the coronary or the artery in a so-called normal operating position.

The device according to the present invention comprises improvements which allow the placement by endoluminal route of an aortoiliac endoprosthesis consisting of two identical tubes.

The present invention also aims to improve treatments by the endoluminal route in order to facilitate the placement of endoprostheses at the level of the aortic or aorto-bi-iiiac aneurism.

The device according to your present invention comprises two identical devices, each device comprising a first pocket for shaping a first screened sleeve, known as a "distal pocket", cooperating in leaktight fashion with a first sheath which is connected with first supply means. to allow the radial deformation of said distal pocket, and a second shaping pocket of a second mesh sleeve, called "proximal pocket", secured in a sealed manner with a second sheath which communicates with other means of supply independent of the first to achieve radial deformation of said proximal pocket. said second sleeve being of smaller diameter than said first sleeve, while sealed means allow the proximal pocket, integral with its sheath and its supply means, to slide on the first sheath to adjust the distance between the distal and proximal pockets .

The aortoiliac stent according to the present invention comprises two tubes capable of deforming elastically in all directions and each of which end is integral with a mesh sleeve provided with hooking means, while said tubes have a conical profile so that their upper ends are of a larger diameter than that of their lower ends and that said sleeves are made of a material bio-compatible, deformable and shape memory metal.

The appended drawing, given by way of example, will allow a better understanding of the invention, the characteristics which it presents and the advantages which it is capable of providing:

Figure 1 is a schematic view illustrating the establishment of the bag device according to the present invention for the introduction of an aortoiliac stent inside the abdominal aorta of a patient. Figure 2 is a schematic view showing the bag device according to the present invention.

Figure 3 and 4 are longitudinal sections illustrating the bag device of Figure 2 in the rest position.

Figure 5 is a longitudinal section showing the two pockets of the device according to the present invention around which is disposed a tube of the aorto-iliac endoprosthesis illustrated in Figures 7 to 9. Figure 6 is a view showing one of the pockets of the following device ia present invention in the inflated position to allow attachment of one of the ends of the tubes of the aorto-iliac endoprosthesis shown in FIGS. 7 to 9.

Figure 7 is a perspective view illustrating the aortoiliac stent according to the present invention.

Figure 8 is a view showing the positioning of the aortoiliac stent inside the wall of the abdominal aorta. Figure 9 is a section on a larger scale along IX-IX of Figure 8 of the abdominal aorta at the upper fixation of the aorto-iliac endoprosthesis.

The silhouette of a human body C and of an abdominal aorta 1 in which a stent 2 is fixed is represented diagrammatically in FIG. 1 by means of a bag device 3.

The abdominal aorta 1 separates into a first artery 1a called "left primary iliac artery" and into a second artery 1b called "right primary iliac artery". The abdominal aorta 1 comprises above the iliac arteries 1a and 1b a lower mesenteric artery 1c, a left renal artery 1d and a right renal artery 1e. An example of an aneurysm profile 1f of the abdominal aorta 1 has been shown which is located below the renal arteries 1d and 1e and which can extend over the primary iliac arteries 1a and 1b. The left primary iliac artery 1a is extended by a left external iliac artery 1g and by a left internal iliac artery 1i. The right primary iliac artery 1b is extended by a right external iliac artery 1h and a right internal iliac artery 1j. The aortoiliac stent 2 comprises two similar tubes 2a and of the same configuration. Each tube 2a is made of a bio-compatible material to avoid any rejection from neighboring living organs. The tubes 2a are provided with sufficient flexibility and elastically deformable in all their directions. The material preferably used for the manufacture of the tubes may for example be of the type called under the name "DACRON".

It can be seen that the tubes 2a are provided with an adequate length to respond to the treatment of aneurysms of the abdominal aorta 1 situated between the renal arteries 1d, 1e and the primary iliac arteries 1a, 1b.

For this, each tube 2a has a conical profile so that the upper ends 2b, are of a larger diameter than that of the lower ends 2c as shown in Figure 7. The upper ends 2b cooperate respectively with a mesh sleeve 2d. Each lower end 2c is connected to a screened sleeve 2e of diameter smaller than that of the sleeves 2d (FIG. 7).

The sleeves 2d, 2e are provided in a metal alloy with shape memory and comprises, for example, small hooks 2f directed in the direction of the exterior and regularly distributed around the periphery of each sleeve (FIG. 7).

Each mesh sleeve 2d, 2e penetrates inside the upper 2b and lower 2c ends of each tube 2a to extend the latter in their longitudinal direction. The hooks 2f are integral with the free ends of each sleeve 2d, 2e, that is to say those protruding at the end of each tube 2a.

For the sake of clarity and conciseness, we will only proceed to the description of a single device 3, knowing that the second is strictly identical to the first for the positioning of the two tubes 2a of the endoprosthesis 2.

In Figure 2, there is shown the bag device 3 for the establishment of a tube 2a knowing that another device 3 will allow the establishment of another tube 2a for the constitution of the aorto-iliac endoprosthesis 2 inside the abdominal aorta 1 for the treatment of the aneurysm 1f. The device 3 comprises a first hollow connector 3a made of plastic material integral with a tube 3b which communicates with the internal part 3c of said connector. Opposite the tube 3b, the connector 3a is tightly secured to a sheath 3d which communicates with the internal part 3c. The sheath 3d has, near its free end 3e, a fixed waterproof pocket 3f called “distal pocket” which can deform radially under the pressure of a fluid, as will be seen better below.

A tube 3g passes through the connector 3a on the one hand to open near the tube 3b and on the other hand to penetrate co-axially inside the sheath 3d, so that its free end 3h is welded to that 3e of said 3d sheath.

It is noted that the sheath 3d and the tube 3e delimit a free space 3i which communicates with the internal part 3c of the connector 3a and with the internal part of the distal pocket 3f by means of holes 3j made in the sheath 3d.

It is easily understood that if the tube 3b is integral with a syringe 4 injecting a pressurized fluid inside the connector 3a, said fluid penetrates inside the free space 3i to inflate the distal pocket 3f for ia deform radially.

Near the first connector 3a is disposed a second plastic connector 3k which can slide co-axially on the sheath 3d secured to said first connector 3a. The second connector 3k comprises watertight means 3u such as for example an O-ring which is in contact with the sheath 3d to allow a sealed sliding between the sheath 3d and said connector 3k.

The second connector 3k is integral with a tube 31 which opens into the internal part 3m of said second connector 3k. The latter is integral opposite the tube 31 with a second sheath 3n which is crossed co-axially by the first sheath 3d to delimit a second free space 3p which communicates with the internal part 3n of the connector 3k.

The free end 3q of the second sheath 3n comprises sealed means 3r such as for example an O-ring to allow said second sheath 3n to slide on the first sheath 3d. The second sheath 3n is integral with a second waterproof pocket 3s called "proximal pocket".

The internal part of the proximal pocket 3s communicates with the free space 3p by means of holes 3t made in the second sheath 3n.

Inside the distal 3f and proximal 3s pockets are fixed rings 6 on the outer periphery of the sheaths 3d and 3n to allow the radiographic location of said pockets inside the abdominal aorta 1 and the left primary iliac arteries 1a and right 1b. It is easily understood that if the tube 31 is connected to a syringe 5 injecting a pressurized fluid inside the second fitting 3k, said fluid penetrates inside the free space 3p to inflate and radially deform the proximal pocket 3s (figure 6).

It is noted that the device 3 comprises two pockets 3f, 3s, one of which at least 3s can slide to perfectly adjust the distance separating said pockets. Also, the pockets 3f, 3s are deformable radially independently of one another.

It can be seen that the tube 3g is designed to receive a wire 7 allowing the device 3 to be guided inside the external iliac artery 1g, 1h from the primary iliac artery 1a, 1b and this as far as the abdominal aorta 1, as will be seen more clearly below. In Figure 3, we have shown the device 3 described above around which is disposed a tube 2a, constituting a part of the aorto-iliac stent 2. In fact, to constitute the aorto-iliac stent 2 inside of the aneurysm 1f, it is necessary to introduce a device 3 into each external iliac artery 1g, 1h or corresponding common femoral around which is placed a tube 2a.

Thus, a tube 2a is placed around the device 3 so that the upper or distal end 2b secured to the mesh sleeve 2d is disposed around the distal pocket 3f while the lower or proximal end 2c cooperating with another mesh sleeve 2e covers the proximal pocket 3s.

Around the tube 2a and over the entire length of the device 3, that is to say from the end 3e of the sheath 3d to the second connector 3k, a protective envelope 8 is placed which is detachable or peelable to allow its removal as soon as possible. that the device 3 is inserted inside the abdominal aorta 1 and the primary iliac artery 1a, 1b.

It is noted that for the constitution of the aortoiliac endoprosthesis 2, it is necessary to introduce into each of the left external iliac arteries 1a and right 1b or into each of the corresponding common femoral devices 3 as described above provided with 'a tube 2a protected by the envelope 8. It is obvious that the outside diameter of the device 3 provided with the tube 2a and the envelope 8 is very small to be able to easily penetrate inside the external iliac artery or the corresponding common femoral. We easily understand the operation of the device 3 as described above, namely that the surgeon proceeds as follows:

- It incises for example and according to the operating case at the level of the left external iliac arteries 1g, 1h or the corresponding common femoral to allow the introduction of a wire 7 in each of the arteries until it is placed at the level of the aneurysm 1f and that it exceeds the renal arteries 1d, 1e. Wire 7 allows the setting in place and the introduction of a device 3 provided with its tube 2a and its protective envelope 8 up to the level of the aneurysm 1f of the abdominal aorta 1.

- It introduces a first device 3 provided with a tube 2a into the left external iliac artery 1g or common femoral ia until the upper or distal end 2b and the distal pocket 3f for example depending on the operative case are placed below the left renal artery 1d, while the other lower or proximal end 2c and the proximal pocket 3s are arranged either inside the left primary iliac artery 1a, or in the external iliac artery 1g.

- It introduces a second device 3 provided with another tube 2a into the right external iliac artery 1 h or the common femoral until the upper or distal end 2b are placed at the same level as the upper end or distal 2b of the tube 2a previously introduced by means of the first device 3, while the upper or proximal end 2c and the proximal pocket 3s are arranged either in the right primary iliac artery 1b, or in the external iliac artery 1h.

The introduction of the devices 3 is carried out by the fact that each wire 7 penetrates inside the corresponding tube 3g.

- It removes the protective casing 8 in order to be able to check by radiographic means the correct positioning of the distal 3f and proximal pockets 3s of each device 3. In fact, the introduction of each device 3 is checked by radiographic way by means of the rings 6 which are arranged on the 3d and 3n ducts.

In the case where the proximal pocket 3s of each device 3 around which the lower end 2c of the tube 2a is disposed is badly positioned inside the primary iliac artery 1a, 1b or inside the artery external iliac 1g, 1 h, it can, by acting on the second connection 3k of the corresponding device 3 located outside the human body C, move along the sheath 3d said pocket 3s and the lower end 2c of the tube 2a corresponding to vary the distance between the two distal pockets 3f and proximal 3s and therefore the length of the tube 2a between its upper 2b and lower 2c ends. - It inflates simultaneously by injection of a pressurized fluid by means of syringes 4 the distal pockets 3f of each device 3. The radial deformation of the distal pockets 3f makes it possible to conform the mesh sleeves 2d, provided at each upper or distal end 2b of each tube 2a. Thus the external periphery of each tube 2a on the one hand perfectly matches the internal wall of the abdominal aorta 1 and on the other hand is pressed against the external periphery of the other tube 2a to ensure perfect sealing of the stent 2 (Figure 9).

- It then proceeds to the simultaneous swelling of two proximal pockets 3s of each device 3 so that the lower end 2c, secured to the mesh sleeve 2e, deforms and come to press against the internal wall of the primary iliac artery 1a, 1b or against the internal wall of the external iliac artery 1g, 1h depending on the operating case (Figures 6 and 8). - It simultaneously deflates the proximal pockets 3s and then the distal pockets 3f always simultaneously to be able to remove each device 3 and the corresponding wire 7 to be able to leave the endoprosthesis 2 inside the abdominal aorta 1 and the primitive iliac arteries 1a , 1b or the external iliac arteries 1g, 1h to relieve the aneurysm 1f (Figure 8).

- Finally it sutures the wound at the level of the introduction of each device 3.

Note that the placement of a stent 2 by means of bag devices 3 is not binding on the patient since it is a radiographic surgery for a short time.

It goes without saying that the diameters of the distal pockets 3f and proximal 3s of each device 3 once deformed are sufficient for the mesh sleeves 2d, 2e to be pressed perfectly against the internal wall of the abdominal aorta 1 and against the wall internal to the primary iliac arteries 1a, 1b or the external iliac arteries 1g, 1h.

A variant of the stent 2 according to the present invention consists in that the upper end 2b of each tube 2a is integral with a sleeve 2d which is in this case partially engaged inside the corresponding tube 2a.

Indeed, this solution is provided when the aneurysm 1f rises near the renal arteries 1d and 1e, thus removing part of the abdominal aorta 1 for fixing the stent 2. In this case, the sleeves 2d must come fix above the renal arteries 1d and 1e without the upper end 2b of each tube 2a obstructing them (Figure 1).

Thus, the sleeves 2d are deformed in the same manner as above, but the hooks 2f are fixed in the internal wall of the abdominal aorta 1 and above the renal arteries 1d and 1e, while the upper ends 2b of each tube 2a are located below the renal arteries 1d and 1e. The configuration of the sleeves 2d allows the flow of blood flow in the renal arteries 1d and 1e and this without obstructing them.

Likewise, the sleeves 2e of each tube 2a adapted to the lower end 2c may only be partially engaged in order to be able to anchor in the external iliac artery 1g, 1h without preventing the passage of blood flow in the other internal iliac artery 1i, 1d.

Each wire constituting the mesh of the sleeves 2d and 2e has a surface condition suitable for ensuring sufficient anchoring either inside each tube 2a, or inside each artery. It goes without saying that the tubes 2a of the stent 2 can cross without influencing the method of fixing said stent.

It should moreover be understood that the above description has been given only by way of example and that it in no way limits the field of the invention from which one would not depart by replacing the execution details described by all other equivalents.

Claims

1. Pouch device for the establishment of an aortoiliac endoprosthesis by the endoluminal route, characterized in that it comprises two identical devices (3), each device comprising a first pocket (3f) for shaping a first mesh sleeve (2d), called "distal pocket", cooperating in a sealed manner with a first sheath (3d) which is connected with first supply means (4) to allow the radial deformation of said distal pocket (3f), and a second pocket (3s) of conformation of a second screened sleeve (2e), called "proximal pocket", secured in a sealed manner with a second sheath (3n) which communicates with other supply means (5) independent of first to carry out the radial deformation of said proximal pocket (3s), said second sleeve (2e) being of smaller diameter than said first sleeve (2d), while sealed means (3r, 3u) allow the proximal pocket (3s), secured to its sheath (3 n) and its supply means (5), to slide on the first sheath (3d) to adjust the distance between the distal (3f) and proximal (3s) pockets.

2. Bag device according to claim 1, characterized in that it comprises a first connector (3a) cooperating with the supply means (4) of the distafe bag (3f), a first sheath (3d) integral with the connector (3a) and in which a tube (3g) is arranged co-axially, making it possible to delimit a free space (3i) for feeding the distal pocket (3f), a second connector (3k) cooperating with the second means d supply (5) of the proximal pocket (3s) a second sheath (3n) integral with the second fitting (3k) in which the first sheath (3d) is arranged coaxially to define another free space (3p) for the supply of the proximal pocket (3s), and watertight means (3r, 3u) allowing the sliding of the second fitting (3k) and the second sheath (3n) on the first sheath (3d) to adjust the distance between the distal pockets (3f) and proximal (3s).

3. Pouch device according to claim 1, characterized in that a tube (2a) of a stent (2) is arranged around the device (3) so that its upper (2b) and lower (2c) ends are respectively above and coaxially disposed on the distal (3f) and proximal (3s) pockets, while a protective envelope (8) covers the tube (2a) and the device (3).

4. Pouch device according to claim 3, characterized in that the protective envelope (8) is provided from the end (3e) of the sheath (3d) up to the level of the second fitting (3k).

5. Pouch device according to claim 4, characterized in that the protective envelope (8) is tearable or peelable.

6. Aorto-iliac endoprosthesis for the treatment of aneurysms of the abdominal aorta, according to claim 3, characterized in that it comprises two tubes (2a) capable of deforming elastically in all directions and each end of which (2b, 2c) is integral with a mesh sleeve (2d, 2e), said tubes (2a) being of conical profile so that their upper ends (2b) are of a larger diameter than that of their lower ends (2c), while that said sleeves (2d, 2e) are provided with attachment means (2f) for retaining the endoprosthesis and are made of a bio¬ compatible metallic material, deformable and with shape memory.

7. Aorto-iliac endoprosthesis according to claim 6, characterized in that said ends (2b) of larger diameter of said tubes (2a) with conical profile are joined against each other by deformation of said mesh sleeves (2d) of so that the external periphery of each tube (2a), on the one hand, perfectly matches the internal wall of the abdominal aorta (1) and, on the other hand, bears against the external periphery of the other tube to ensure perfect sealing of the stent (2).

8. Aortoiliac endoprosthesis according to claim 6, characterized in that the upper (2b) and lower (2c) ends of each tube (2a) completely cover the corresponding sleeves (2d, 2e) allowing only the hooks ( 2f) for retaining the stent (2) in the internal wall of the abdominal aorta (1) and in the internal wall of the primary iliac artery (1a, 1b).

9. Aortoiliac stent according to claim 6, characterized in that the upper (2b) and lower (2c) ends of each tube (2a) only partially cover the sleeves (2d, 2e) so that the hooks (2f ) are fixed in the internal wall of the abdominal aorta (1) above the renal arteries (1d and 1e) and in the internal wall of the external iliac artery (1g, 1h) to allow the passage of blood flow .

10. Aorto-iliac endoprosthesis according to claim 6, characterized in that the wire constituting the mesh of the sleeves (3, 4) has a surface condition suitable for ensuring sufficient anchoring either inside each tube (2a), either inside 5 of each artery.

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