FR2743302A1 - DEVICE FOR THE PLACEMENT OF AN AORTO-ILIAC ENDOPROSTHESIS - Google Patents

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

 The present invention relates to a bag device for the placement of an aortoiliac stent by the endoluminal route.

 Devices of this type are known which comprise a pocket or balloon which can be deformed axially by means of a pressurized liquid injected into a sealed sheath. In the first place, the devices were used to dilate the coronaries or the peripheral arteries when the latter saw their light narrowing or becoming 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 bag device allows the introduction of a stent or prosthesis consisting of a metal ring with shape memory which expands using the bag when the latter receives the liquid under pressure so that the ring keep apart the walls of the coronaries or arteries. As soon as the memory ring is removed, the device is removed having previously deflated the pocket to leave the coronary or artery in a so-called nor .- .. operating position.

 The device according to the present invention comprises improvements which allow the placement by enacuminal route of an aorto-iliac endoprosthesis made up of two identical tubes.

 The device according to the present invention comprises a first pocket called "distal pocket" cooperating in a sealed manner with a first sheath which is connected with first supply means to allow the radial deformation of said distal pocket, and a second pocket called "pocket "proximal" tightly secured to a second sheath which communicates with other means of supply independent of the first to achieve the radial deformation of 1 ~ alite proximal pocket, while sealed means allow the proximal pocket integral with its sheath and its feed means to slide on the first sheath to adjust the distance between the distal and proximal pockets.

The appended drawing, given by way of example, will allow a better understanding of the invention, the characteristics which it has 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 aorto-iliac endoprosthesis 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 aortoiliac endoprosthesis.

 - Figure 6 is a view showing one of the pockets of the device according to the present invention in the inflated position to allow attachment of one end of the tube of the aorto-iliac stent.

 Cn has been shown diagrammatically in FIG. 1 the silhouette of a human body C and of an abdominal aorta 1 in which is attached a stent 2 by means of a pocket device 3.

the abdominal aorta 1 separates into a first artery called the "left primary iliac artery" and into a second artery ld called "the right primary iliac artery". The abdominal aorta: has above the iliac arteries la and lb a lower mesenteric artery lc, a left renal artery ld and a right renal artery le
We have shown an example of an aneurysm profile 1f of the abdominal aorta 1 which is located below the renal arteries ld and le and which can extend on each primary iliac artery la and lb.

 The left primary iliac artery la is extended by a left external iliac artery lc and an internal left iliac artery li. The right primary iliac artery lb is extended by a right external iliac artery lh and an internal right iliac artery li.

 The aortoiliac stent 2 consists of two identical tubes 2a which are introduced respectively, for example, by the left external iliac artery lq and right 1h or the corresponding common femoral by means of a bag device 3. The Aortoiliac endoprosthesis 2 is described in a patent application belonging to the Applicant.

 It is noted that each tube 2a has a conical profile so that the upper or distal ends 2b are of a larger diameter than that of the lower or proximal ends 2c. The upper ends 2b cooperate with a mesh sleeve 2d, while the lower ends 2c are adapted to receive a mesh sleeve 2e, of diameter smaller than that of said sleeves 2d.

 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 installation of the two tubes 2a, constituting 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 lf aneurysm.

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

 Note that the sheath 3d and the tube 3q 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 3i 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 3l to inflate the distal pocket 3f for the 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 sealed means 3u such as for example an O-ring which is in contact with the sheath 3d to allow a sealed sliding between said 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 32 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 sealed pocket 3s called "proximal pocket".

 The internal part of the proximal pocket 3s communicates with the free space 3p by means of holes 3t formed 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 lb.

 It is easily understood that if the tube 31 is connected to a syringe 5 injecting a fluid under pressure inside the second connector 3k, said fluid penetrates inside the free space 32 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 3q is designed to receive a wire 7 allowing the device 3 to be guided inside the external iliac artery lq, 1h from the primary iliac artery la, lb and this as far as the abdominal aorta 1 , as we will see better below.

 In Figure 5, there is 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 if, it is necessary to introduce a device 3 into each external iliac artery lq, 1h or the 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 the device 3 is inserted inside the abdominal aorta 1 and the primary iliac artery la, lb.

 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 1b or in 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 femoral corresponding municipality.

It is easy to understand the operation of the device 3 according to the description 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 lq and 1h or of 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 id, the. The wire 7 allows the establishment and 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 the common femoral until the upper or distal end 2b and the distal pocket 3f for example depending on the operating case are placed below the left renal artery ld, while the other lower or proximal end 2c and the proximal pocket 3s are arranged either inside the left primary iliac artery la, or in the external iliac artery lq.

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

 The devices 3 are introduced by the fact that each wire 7 penetrates inside the corresponding tube 3q.

 - 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 la, lb or inside the artery external iliac lq, lh, it can, by acting on the second connector 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 male 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 the 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.

 - It then proceeds to the simultaneous swelling of the two proximal pockets 3s of each device 3 so that the lower end 2c, integral with the screened sleeve 2e, deforms and press against the internal wall of the primary iliac artery la, lb or against the internal wall of the external iliac artery lq, 1h depending on the operating case (Figure 6).

 - 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 stent 2 inside the abdominal aorta 1 and the primitive iliac arteries 1a. , lb or the external iliac arteries la, 1h to relieve the aneurysm lf.

 - It finally sutures the wound at the level of the introduction of each device 3.

 Note that the placement of a stent 2 by means of pocket 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 3f and proximal 3s pockets of each device 3 once deformed are sufficient for the mesh sleeves 2d, 2e to come into contact perfectly against the internal wall of the abdominal aorta 1 and against the wall internal primitive iliac arteries la, lb or external iliac arteries 1g, lh.

 It should moreover be understood that the foregoing 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 (5)

 1. Pouch device for the establishment of an aorto-iliac endoprosthesis by the endoluminal route, characterized in that it comprises a first pocket (3f) called "dis tale pocket" cooperating tightly 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) called "proximal pocket" tightly secured with a second sheath (3n) which communicates with other supply means (5) independent of the first to achieve radial deformation of said proximal pocket (3s), while sealed means (3r, 3u) allow the proximal pocket (3s), integral its sheath (3n) and its supply means, slide on the first sheath (3d) to adjust the distance between the distal (3f) and proximal (3s) pockets.  2. Pouch device according to claim 1, characterized in that it comprises a first connector (3a) cooperating with the supply means (4) of the distal pocket (3f), a first sheath (3d) integral with the connector (3a) and in which a tube (3q) is arranged co-axially, making it possible to delimit a free space (31) for feeding the distal pocket (3f), a second connector (3k) operating with the second means 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 co-axially to define another free space (3g) for the feeding 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 pockets distal (3f) and proximal (3s).  3. Device according to claim 1, characterized in that a tube (2a) of an aortoiliac endoprosthesis (2) is arranged around the device (3) so that its upper ends (2bi and lower (2c) are respectively above and coaxially arranged on the distal (3f) and proximal (3s) pockets, while a protective envelope (8) covers the tube (2a) and the device (3).  4. 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. Device according to claim 4, characterized in that the protective cover (8) is tearable or peelable.