FR2862525A1 - Intra-gastric balloon for treating obesity has inner inflatable pouch covered by gas impermeable screen containing at least one gas barrier polymer - Google Patents

Abstract

The balloon (1) has at least one primary pouch (2) that can be inflated from an initial reduced volume. The pouch has a covering (5) comprising at least one screen that is virtually impermeable to gas and contains at least one gas barrier thermoplastic polymer. An independent claim is included for a process for making the balloon.

Description

INTRA-GASTRIC BALL WITH A BARRIER SCREEN

  GAS PROCESS, PROCESS FOR MANUFACTURING THE SAME AND

  USE OF POLYMERS WITH GAS BARRIER EFFECT

TO MANUFACTURE SUCH A BALLOON

  The present invention relates to the general technical field of implantable devices in the human body intended to be used in the context of a treatment of obesity, and in particular of morbid obesity, and more particularly to implants able to reduce artificially the volume of the stomach, in particular to produce a feeling of satiety in the patient.

  The present invention relates to an expandable intragastric balloon for implantation within the stomach of a patient to reduce stomach volume as part of a treatment for obesity. balloon being provided with at least a first pocket capable of passing from a reduced volume position to an expanded position by introduction of a first inflation fluid.

  The invention also relates to a method of manufacturing an expandable intragastric balloon, said balloon being intended to be implanted inside the stomach of a patient to reduce the volume of the stomach as part of a treatment obesity, and having a first pocket.

  The invention also relates to a new use of polymers with a gas barrier effect.

  The intragastric balloons used for the treatment of obesity generally comprise a flexible pouch able to move from a reduced volume position to an expanded position when an inflation fluid is introduced into the pocket. For this purpose, the latter generally has sufficient flexibility to move from the reduced volume position to the expanded position, and is provided with an orifice closed by a valve through which the inflation can be performed using a inflation fluid, and in particular a gas.

  It is also known to make double-bag balloons, ie balloons having two pockets, namely an inner bag, which generally contains a gas, and an outer bag, which contains the inner bag and liquid, this last filling the chamber separating the two pockets.

  The intragastric balloons generally encountered, whether of single-pocket or double-pocket type, are generally made from elastomeric materials, of the silicone type.

  Such intragastric balloons, if they have certain advantages, such as their good general mechanical strength, nevertheless suffer from several disadvantages.

  In particular, the known intragastric balloons generally have a certain porosity, which will allow the progressive leakage of the fluid contained in the balloon (gas or liquid), and thus gradually reduce the volume of the balloon, and therefore the therapeutic efficacy of this balloon. latest.

  Thus, when the volume of the balloon no longer corresponds to the desired volume for the treatment of obesity, it no longer creates the feeling of satiety desired in the patient. This problem is particularly significant in the case of intragastric balloons filled with gas.

  However, it is desirable, in order to minimize the discomfort generated by the balloon, to reduce the weight of the latter, filling it mainly with gas.

  The tightness of the intragastric balloon within the stomach therefore appears as an essential parameter whose control makes it possible to improve the effectiveness of the treatment and to increase its duration.

  The objects assigned to the invention therefore aim to remedy the various disadvantages listed above and to propose a new expandable intragastric balloon for the treatment of obesity, the sealing of which is improved, and making it possible to limit the losses of fluids. inflation, in particular of gas, thus increasing the duration of effectiveness of the balloon.

  Another object of the invention is to provide a novel intragastric balloon whose manufacture and implantation, and in particular the folding and expansion, are simplified and fast.

  Another object of the invention is to propose a novel intragastric balloon with good general mechanical strength.

  Another object of the invention is to provide a novel intragastric balloon which, although having a significant volume, is sufficiently light, atraumatic and well supported by the patient.

  The objects assigned to the invention are also intended to provide a novel method of manufacturing an expandable intragastric balloon which is particularly simple and quick to implement, while allowing to obtain a balloon having excellent sealing. not,

  The objects assigned to the invention also aim at proposing a new use of polymers having a gas barrier effect in the medical field.

  The objects assigned to the invention are achieved by means of an expandable intragastric balloon intended to be implanted inside the stomach of a patient to reduce the volume of the stomach, as part of a treatment of obesity, said balloon being provided with at least a first bag capable of passing from a reduced volume position to an expanded position by introduction of a first inflation fluid, characterized in that said first bag is delimited by an envelope comprising at least one screen substantially impervious to gases, said screen comprising in its composition at least one gas barrier polymer.

  The objects assigned to the invention are also achieved by means of a method of manufacturing an expandable intragastric balloon, said balloon being intended to be implanted inside the stomach of a patient to reduce the volume of the stomach as part of a treatment for obesity, and comprising a first pouch, characterized in that said first pouch is manufactured by gluing and / or welding the edges of one or more sheets of forms predetermined devices comprising at least one screen substantially impervious to gases, said screen being composed of at least one gas barrier polymer.

  The objects assigned to the invention are also achieved by using the use of one or more gas-barrier polymers to produce a substantially gas-impermeable screen forming at least a portion of the envelope defining a pocket. intragastric balloon.

  Other objects and advantages of the invention will appear better on reading the description which follows, as well as with the aid of the accompanying drawings, given purely by way of illustration and without limitation, in which: FIG. 1 illustrates, according to a side view, a first embodiment of an intragastric balloon according to the invention in its expansion position.

  - Figure 2 illustrates, in a side cutaway view, a second embodiment of an intragastric balloon according to the invention.

  - Figure 3 illustrates, in a cross-sectional view, a third embodiment of an intragastric balloon according to the invention.

  - Figure 4 illustrates, in a cross-sectional view, a first embodiment of a substantially gas-impermeable film according to the invention.

  - Figure 5 illustrates, in a cross-sectional view, a second embodiment of a substantially gas-impermeable film according to the invention.

  - Figure 6 illustrates, in a cross-sectional view, a third embodiment of a substantially gas-impermeable film according to the invention.

  - Figure 7 illustrates, in a perspective side view, a step of manufacturing the expandable intragastric balloon according to the invention.

  - Figure 8 illustrates, in a cross-sectional view, a dual-pocket intragastric balloon according to the invention, and its components.

  Figures 1 to 3 illustrate three embodiments of an intragastric balloon 1 according to the invention.

  The intragastric balloon 1 according to the invention is expandable. For this purpose, it is provided with at least a first pocket 2 capable of passing from a reduced volume position to an expanded position by introduction of a first inflation fluid. The reduced volume position may for example correspond to a position in which the balloon 1 is deflated and is in a folded position occupying a reduced volume, facilitating the introduction of the balloon into the esophagus.

  Implantation of the intragastric balloon 1 according to the invention is in fact generally performed, conventionally and well known to those skilled in the art, by passage into the oral and oesophageal in its folded or loose form. The expansion, placement and release of the balloon occur at the end of the gastro-endoscopic operation, when the intragastric balloon 1 is correctly positioned in the patient's stomach.

  Thus, it is in its so-called expanded position that the balloon will be able to occupy a non-negligible volume of the gastric cavity (not shown), the so-called expanded position then giving the balloon its functional shape. The intragastric balloon 1 according to the invention is indeed intended to be implanted inside the stomach of a patient to reduce the volume of the stomach as part of a treatment for obesity. Thus, by occupying part of the volume of the stomach, the intragastric balloon 1 according to the invention makes it possible to create in the patient a rapid sensation of satiety, which is accompanied by a reduction in the amount of food ingested.

  According to a first embodiment of the invention, and as shown in FIG. 1, the intragastric balloon 1 is formed by the only first pocket 2. The latter then advantageously comprises a connection member 4 enabling the connection to be made. from the balloon 1 to a first source of fluid, so as to allow the filling of said first bag 2 with the inflation fluid, and preferably a gas such as air. The connecting member 4 is preferably formed by a first valve 4A preferably self-sealing, for example a septum, allowing the introduction of an inflation needle (not shown) and sealing the first pôche 2 when said needle is removed. For this purpose, the valve 4A is advantageously structured such that when the inflation needle is removed, it closes automatically.

  Thus, after its introduction into a reduced volume position inside the patient's stomach, the intragastric balloon 1 according to the invention can be inflated by filling the first bag 2 with the aid of the needle. inflation, which is connected to the first source of fluid through a catheter (not shown).

  According to this first embodiment of the invention, the first pocket 2 advantageously has a shape that is not necessarily spherical and for example padded or cylindrical, preferably atraumatic, so as not to damage the inner wall of the gastric cavity. Indeed, according to the invention, the first pocket 2 is delimited by an envelope 5, which forms, in the first embodiment of the invention, the outer wall of the intragastric balloon 1, and is therefore likely to come into contact with the inner wall of the gastric cavity.

  According to a second and a third embodiment of the invention shown in FIGS. 2, 3 and 8, the intragastric balloon 1 advantageously comprises a second bag 3 provided with a second closure valve 4B, said second bag 3 being, as well as the first pocket 2, adapted to move from a reduced volume position to an expanded position, by introducing a second inflation fluid.

  In the context of the invention, a greater number of pockets (for example three, four or more) can be provided, each pocket being inflatable with a different fluid.

  It is thus possible, in the case of the two-pocket balloons shown in FIGS. 2 and 3, to inflate one bag with water or physiological fluid, the other bag being inflated with lower density, for example air. This makes it possible, for the same total overall volume of the intragastric balloon 1, to obtain a weight that is lower than that of conventional one-bag balloons.

  According to the second embodiment of the invention shown in FIGS. 2 and 8, the first pocket 2 is preferentially disposed inside the second pocket 3, which has, in an expanded position, a volume substantially greater than that of the first pocket 2.

  Thus, FIG. 2 illustrates, in a cut-away side view, the first pocket 2 located inside the cavity formed by the second pocket 3.

  According to the third embodiment of the invention shown in Figure 3, the second pocket 3 is disposed inside the first pocket 2, which has, in the expanded position, a volume substantially greater than that of the second pocket 3 .

  According to the invention, and whatever the embodiment chosen, the envelope 5 of the first pocket 2 comprises at least one screen E substantially impervious to gases such as oxygen (O 2), nitrogen (N 2), carbon dioxide (002) and, more generally, air (FIGS. 4 to 6 and 8). The screen E can thus advantageously be in the form of a thin layer of one or more materials extending over a portion or over the entire surface of the envelope 5.

  However, in order to obtain the best possible seal for the balloon 1, the screen E will preferably extend over the entire surface of the envelope 5 (in dashed lines in FIG. 3).

  According to the invention, the screen E comprises in its composition at least one gas-barrier polymer, and this in proportions sufficient to obtain the desired barrier effect. The screen E thus makes it possible to significantly increase the duration of effectiveness of the balloon 1 according to the invention with respect to the balloons generally encountered. Indeed, because of its particular composition, the screen E reduces the loss of inflation fluids when the balloon 1 is in the operating position inside the stomach.

  According to a preferred variant of the invention, the screen E is advantageously composed of one or more thermoplastic polymers with a gas barrier effect. The latter generally have a gas porosity that is substantially lower than elastomeric materials such as silicone.

  Even more preferably, the screen E is composed of one or more polymers chosen from the group of polymers with a gas barrier effect such as ethylene vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), poly acrylonitrile (PAN), polyamide (PA), bi-oriented polyamide, polyethylene terephthalate (PET) and bi-oriented polyethylene terephthalate.

  The screen E may advantageously be integrated with the structure of the envelope 5 of the balloon, and for example be placed between two layers of materials such as silicone. The envelope 5 may also be formed substantially integrally by the screen E. According to a preferred variant of the invention, the envelope 5 is formed by a multilayer film 7 comprising a first layer 6 of polymers having a gas barrier effect forming the E screen, and a second layer 8 of polypropylene (PP) or polyethylene (PE) (Figure 4).

  According to another variant of the invention shown in FIG. 5, the envelope 5 is advantageously formed by a multilayer film 7 comprising a first layer 6 of ethylene vinyl alcohol (EVOH) forming the screen E, interposed between a second layer 8 and a third layer 9 of polyethylene (PE). In comparison with other barrier polymers, ethylene vinyl alcohol has the best properties with respect to transmission to gases such as oxygen, nitrogen and carbon dioxide.

  The use of ethylene vinyl alcohol thus makes it possible to produce films of sufficiently low thickness to maintain a certain flexibility, this flexibility being a particularly important parameter because it makes it possible to fold the balloon facilitating its introduction into the esophagus. .

  Thus, the ethylene vinyl alcohol films, even if they have a thickness of a few microns, generally give good results in terms of gas tightness. The determination of the optimum thickness of the ethylene vinyl alcohol layer therefore results from a compromise between, on the one hand, the need to have a sufficiently small thickness of the film so that it retains its flexibility, and on the other hand the need to have a sufficiently tight film, it being understood that the greater the thickness of the EVOH layer, and the lower its permeability in time.

  To obtain the desired effect, the thickness of the first layer 6 of ethylene vinyl alcohol can thus be about 10 microns.

  As an illustrative example, the oxygen permeability (02) of the EVOH is of the order of 4 to 60 cm3. pm / m2. 24. bar, while the permeability of the silicone is 19,000 cm3. mm / m2. 24. bar (measured at 23 ° C and 0% relative humidity on a 25 m thick sample).

  According to a still more preferred embodiment of the invention, and as shown in FIG. 6, the multilayer film 7 advantageously comprises an outer layer 10 of polyamide (PA) covering the second and / or third layers 8, 9 of polyethylene.

  The polyamide, thus disposed on the periphery of the film 7, allows the attachment of two sheets 15, 16 of multilayer film to each other by heat-sealing, and preferably using a thermal pulse welding (Figure 7).

  The outer layer 10 of polyamide may advantageously cover the two faces of the film 7 or, according to the preferred variant shown in FIG. 6, a single face of the film 7.

  According to this preferred embodiment, the polyamide layer is preferably disposed in contact with the apparatus to be welded. Thus, the melting temperature of the polyamide being higher than that of the polyethylene, the film can be more easily detached from the welding apparatus when the welds are made.

  It is of course conceivable to replace the outer layer 10 of polyamide with a layer based on other materials, which are well known to those skilled in the art, which also make it possible to facilitate the thermo-welding operations and are likely to have other interesting features, for example improving the flexibility or the resistance of the film.

  The film 7 thus advantageously forms a sandwich material in which the first layer 6 of ethylene vinyl alcohol is protected from moisture by the second and third layers 8, 9 of polyethylene.

  Of course, the polyethylene can be replaced by polypropylene, the latter also having good impermeability properties with respect to water vapor. Indeed, EVOH is particularly sensitive to moisture and must therefore preferably be isolated from the latter in order to avoid its degradation.

  Preferably, the second and third layers 8, 9 will be based on low density polyethylene or metallocene polyethylene.

  It is of course conceivable to make one of the second and third layers 8, 9 from polyethylene, the other layer being based on polypropylene, or by any other material substantially impermeable to moisture.

  According to the second and third embodiments of the invention, the second bag 3 may have a composition substantially identical to that of the first bag 2. Thus, the second bag 3 may also be formed by a multilayer film having substantially the same structure and the same composition as the film 7 used to make the first pocket 2.

  According to a preferred variant of the invention, the second bag 3 is formed by an elastomeric material, of the silicone type. This variant embodiment is particularly suitable in the second embodiment of the invention, in which the second pocket 3 contains the first pocket 2 and therefore forms the outer part of the balloon 1. For this reason, it is particularly advantageous to realize the second bag 3 with an elastomeric material, which will be able to withstand the various shocks to which the balloon 1 is likely to be subjected.

  However, it is also conceivable, as shown in FIG. 3, to produce an intragastric balloon 1 in which the second bag 3 is disposed inside the first bag 2, which is formed by the film 7. multilayer described above. The second pocket 3 advantageously has an inner face 31 and an outer face 3E which, when said second pocket 3 is made of an elastomeric material such as silicone, are preferably covered, at least partially, by parylene, in order to improve the sealing of said second pocket 3 (Figures 2 and 3).

  In addition, in the second embodiment shown in FIG. 2, where the second bag 3 forms the outer part of the balloon 1, covering said second bag 3 with parylene makes it easier to handle the intragastric balloon 1. by the operator. Parylene can thus advantageously replace the use of talc.

  According to the second and third embodiments of the invention shown in FIGS. 2 and 3, the first inflation fluid is preferably a gas G, for example air, the second inflation fluid being preferentially a liquid L, for example example of water or physiological fluid.

  It is of course conceivable to reverse the previous configuration, the first inflation fluid becoming a liquid filling the first bag 2, and the second inflation fluid becoming a gas filling the second bag 3.

  It is also conceivable to inflate the first and second pockets 2, 3 with the aid of the same inflation fluid, and preferably a gas.

  According to the second and third embodiments of the invention, the first and second pockets 2, 3 are advantageously substantially movable relative to each other. This means in particular that the two pockets 2, 3 are preferably free to move relative to each other and are not integral.

  However, it is of course conceivable to secure them to one another, for example by means of spacers 30 now and fixing the position of the two pockets 2, 3 at a distance from each other ( Figure 8).

  According to the second and third embodiments of the invention, the intragastric balloon 1 according to the invention advantageously has an internal pocket Pi and an external pocket Pe (FIGS. 2 and 3).

  In the second embodiment of the invention, the first pocket 2 forms the inner pocket Pi, the second pocket 3 then forming the outer pocket Pe (Figures 2 and 8).

  On the contrary, in the third embodiment of the invention, the first pocket 2 forms the outer pocket Pe, the second pocket 3 then forming the inner pocket Pi (FIG. 3).

  The volume of the inner bag Pi is preferably of the order of 400 to 500 cm 3, the volume of the outer bag Pe then being preferably of the order of 600 cm 3.

  Due to the small difference in volume between the inner pocket Pi and the outer pocket Pe, the relative mobility of the inner and outer pockets Pi, Pe, although existing, is relatively small. This relative mobility further decreases when the inner bag Pi is formed by the first bag 2, which preferably has a shape cushion or cylinder. Thus, the particular shape of the first pocket 2 further reduces its mobility within the second pocket 3.

  According to the second and third embodiments shown in FIGS. 2 and 3, the first and second pockets 2 and 3 are preferably substantially concentric, thus conferring on the intragastric balloon 1 a good mechanical balance.

  According to the first and third embodiments of the invention shown respectively in FIGS. 1 and 3, the envelope 5 is able to come into contact with the inner wall of the gastric cavity, so that in these embodiments of the invention, the shape of the envelope 5 will be preferably atraumatic.

  The intragastric balloon 1 according to the invention thus makes it possible, by virtue of its improved sealing, to reduce the losses of fluids, which has the effect of increasing the therapeutic effectiveness of the balloon.

  The invention also relates to a method of manufacturing an expandable intragastric balloon 1, said balloon 1 being intended to be implanted inside the stomach of a patient to reduce the volume of the stomach in the context a treatment of obesity, and having a first pocket 2.

  According to the invention and as shown in FIGS. 7 and 8, the method comprises a step where the first bag 2 is manufactured from one or more sheets 15, 16 of predetermined shapes, said sheet or sheets (s) 15, 16 comprising at least one substantially gas-impermeable screen E, said screen E being composed of at least one gas-barrier polymer, to obtain a first pocket 2 with at least one orifice 31.

  Thus, the first pocket 2 can be made by folding a single sheet of predetermined shape (for example rectangular), then by joining, and for example by welding and 1 or gluing the edges facing each other. It is also possible to manufacture the first pocket 2 by using several sheets 15, 16 precut and secured, by welding or gluing, to each other by their edges 15A, 15B, 15C, 15D, 16B, 16C, 16D according to one or several welding lines 20 (FIGS. 7 and 8). The welds may in particular be made using thermal pulses, but it is of course conceivable to use other welding processes without departing from the scope of the invention.

  The first pocket 2 thus manufactured may for example have a substantially cubic shape, cylindrical or pad. It is also possible, by welding a plurality of pre-cut sectors, to form a substantially spherical pocket. But this procedure requires a large number of welds, which may not only increase the probability of rupture of the seal of the bag but also make the surface condition of the latter more aggressive.

  According to an alternative embodiment of the invention, the first bag 2 may be manufactured using a step of thermoforming said sheet or sheets 15, 16.

  This step advantageously consists in placing a barrier film sheet, that is to say having at least the screen E, vertically to a mold of predetermined shape, for example spherical or hemispherical. When the film, after a pre-heating step, has reached a

  pre-established sufficient temperature, a suction system comes to apply the film against the mold, said film then substantially conforming to the shape of the mold. Once cooled, the film can be removed from the mold while retaining the shape given by the latter.

  It is thus conceivable to carry out, by thermoforming, two hemispherical halfpipes which can then be, at a later stage, joined together, for example by welding them and / or gluing them together. preferably along a single substantially median weld line.

  Such a method thus makes it possible to produce a pouch of substantially spherical shape, and therefore atraumatic, which may be particularly advantageous in the field of implantable devices in the human body.

  Another advantage of the thermoforming process is that it respects the integrity of the various polymer layers forming the film.

  Another variant consists in stretching, on a punch (for example in the form of a half-sphere), one or more preheated barrier film sheets, said punch then penetrating into said sheet or sheets to give them its shape.

  According to the invention, the method also comprises a step in which a first valve 4A is mounted in said orifice 31 (FIG. 8), said valve being preferentially a self-sealing valve. The first pocket 2, thus provided with said valve 4A, advantageously defines, in the expanded position, a closed and substantially sealed volume.

  According to a preferred variant of the invention, the manufacturing method also comprises a step in which a second bag 3 is manufactured, for example by injection of an elastomeric material, of the silicone type, in a mold, said second bag 3 having dimensions substantially greater than those of the first bag 2, so as to contain the latter, and being provided with at least one opening 32 for receiving a second valve 4B, the kind of lip valve.

  The manufacturing method advantageously comprises an additional step in which the first bag 2 is introduced inside the second bag 3 by positioning the opening 32 of the second bag 3 substantially opposite the first valve 4A, and in that the second valve 4B is mounted in said opening 32, for example by gluing at the peripheral edge 32B of the opening 32 (FIG. 8). This method thus makes it possible to obtain an intragastric balloon 1 according to the second embodiment shown in FIG. 2.

  To obtain an intragastric balloon 1 according to the third embodiment shown in FIG. 3, it suffices, after constitution of the first bag 2, to introduce the second bag 3 provided with the second valve 4B inside the first pocket 2, positioning the second valve 4B substantially opposite the orifice 31 of the first pocket 2, then to mount the first valve 4A in said orifice 31.

  The invention also relates to a new use of one or more polymers with a gas barrier effect for producing a substantially gas-impermeable screen E forming at least part of the envelope 5 delimiting a first bag 2 of intragastric balloon 1.

  Advantageously, the gas-barrier polymer or polymers used are thermoplastic polymers.

  Even more preferably, the gas-barrier polymer or polymers are chosen from the group comprising ethylene vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), poly-acrylonitrile (PAN), polyamide (PA ), bi-oriented polyamide, polyethylene terephthalate (PET) and bi-oriented polyethylene terephthalate.

  Terminal placement of the intragastric balloon 1 according to the invention will now be described.

  Before implantation, the intragastric balloon 1 according to the invention is preferably in a folded form, or compressed, so as to facilitate its introduction and its passage into the oral pathways of the patient, and in particular the esophagus.

  We therefore see the value of making a balloon having one or more pockets 2, 3 of the finest thickness possible to allow its folding.

  Once positioned inside the patient's stomach, the intragastric balloon 1 must undergo several operations on the part of the surgeon in order to make it functional, that is to say to give it a sufficient volume to occupies part of the space of the gastric cavity reserved for food.

  In the case of the single bag balloon shown in Figure 1, the surgeon preferably connects the first valve 4A to a source of fluid, preferably air, to inflate the balloon 1 until it occupies the desired volume.

  In the case of the double-bagged balloon shown in FIGS. 2 and 8, the surgeon preferably starts by filling the inner bag Pi with a first inflation fluid, preferably a gas. For this purpose, it connects, for example by means of a catheter, the first valve 4A of the internal bag Pi to the first source of fluid. An inflation needle (not shown) is introduced so as to pass firstly the first shutter valve 4A (for example the septum) of the internal bag Pi, and secondly the second valve 4B shutter the external pocket Pe. The thus mounted needle also ensures the relative immobility of the pockets Pi, Pe relative to each other, and maintain the two valves 4A, 4B facing one another.

  When the inner bag Pi is inflated, the surgeon inflates the outer bag Pe, preferably with a second fluid, for example water or physiological fluid. The second fluid then preferably comes to substantially completely cover the inner bag Pi. The surgeon can use another inflation needle, or even exert a simple pull on the needle already in place, in order to position the end of said needle in the gap separating the inner pocket Pi from the outer pocket Pe. When the inflation needle is connected to the second fluid source, the surgeon can inflate the outer pouch Pe.

  When the two bags Pi, Pe are inflated, the surgeon can remove from the body of the patient all the equipment necessary for inflation, namely the catheter and the inflation needle, this operation having the effect of releasing the balloon.

Claims (22)

  1 - Expandable intra-gastric balloon (1) intended to be implanted inside the stomach of a patient to reduce the volume of the stomach as part of a treatment for obesity, said balloon (1 ) being provided with at least a first pocket (2) capable of passing from a reduced volume position to an expanded position by introduction of a first inflation fluid, characterized in that said first pocket (2) is delimited by a envelope (5) comprising at least one screen (E) substantially impervious to gases, said screen (E) comprising in its composition at least one gas barrier polymer.   2 - intragastric balloon according to claim 1 characterized in that the screen (E) is composed of one or more thermoplastic polymers with a gas barrier effect.   3 - intragastric balloon according to claim 1 or 2 characterized in that the screen (E) is composed of one or more polymers selected from the group of gas barrier polymers such as ethylene vinyl alcohol (EVOH ), polyvinylidene chloride (PVDC), polyacrylonitrile (PAN), polyamide (PA), bi-oriented polyamide, polyethylene terephthalate (PET) and bioriented polyethylene terephthalate.   4 - intragastric balloon according to claim 1, 2 or 3 characterized in that the casing (5) is formed by a multilayer film (7) comprising a first layer (6) of gas barrier polymer, forming the screen (E), and a second layer (8) of polypropylene (PP) or polyethylene (PE).   - Intra-gastric balloon according to claim 3 characterized in that the casing (5) is formed by a multilayer film (7) comprising a first layer (6) of ethylene vinyl alcohol (EVOH), forming the screen (E ), interposed between a second and a third layer (8, 9) of polyethylene (PE) or polypropylene (PP).   6 - intragastric balloon according to claim 5 characterized in that the film (7) multilayer comprises an outer layer (10) of polyamide (PA) covering the second and I or the third layer (s) (8, 9).   7 - intragastric balloon according to one of claims 4 to 6 characterized in that the polyethylene is high density polyethylene or metallocene polyethylene.   8 - intragastric balloon according to any one of claims 1 to 7 characterized in that it comprises a second pocket (3) adapted to move from a reduced volume position to an expanded position by introduction of a second fluid inflation.   9 - intragastric balloon according to claim 8 characterized in that the first pocket (2) is disposed inside the second pocket (3) which has, in the expanded position, a volume substantially greater than that of said first pocket (2).   10 - intragastric balloon according to claim 8 characterized in that the second pocket (3) is disposed inside the first pocket (2) which has, in the expanded position, a volume substantially greater than that of said second pocket (3).   11 - intragastric balloon according to claim 9 or 10 characterized in that said second pocket (3) has a composition substantially identical to that of said first pocket (2).   12 - intragastric balloon according to claim 9 or 10 characterized in that said second pocket (3) is formed by an elastomeric material of the silicone type.   13-intragastric balloon according to claim 12 characterized in that said second pocket has an inner face (31) and / or an outer face (3E) covered (s) of parylene.   14 - intra-gastric balloon according to one of claims 8 to 13 characterized in that the first inflation fluid is a gas G, the second inflation fluid being a liquid L. - Intragastric balloon according to one of claims 8 to 14 characterized in that said first and second pockets (2, 3) are substantially movable relative to each other.   16-intragastric balloon according to one of claims 8 to 15 characterized in that said first and second pockets (2, 3) are substantially concentric.   17 - A method of manufacturing an expandable intragastric balloon (1), said balloon (1) being intended to be implanted inside the stomach of a patient to reduce the volume of the stomach in the frame a treatment of obesity and comprising a first pocket (2) characterized in that said first pocket (2) is manufactured from one or more sheets (15, 16) of predetermined shapes comprising at least one screen (E) substantially impervious to gases, said screen (E) being composed of at least one gas barrier polymer, to obtain a first pocket (2).   18 - Manufacturing method according to claim 17 characterized in that the manufacture of said first pocket (2) comprises a step of thermoforming said sheet or sheets (15,16).   19 -Procédé method according to claim 17 characterized in that the manufacture of said first pocket (2) comprises a step in which the edges (15A, 15B, 15C, 15D, 16B, 16C, 16D) of said one or more leaves (15, 16).   20-manufacturing method according to one of claims 17 to 19 characterized in that makes a second bag (3), for example by injection of an elastomeric material in a mold, said second pocket (3) having dimensions substantially greater than those of the first pocket (2) and being provided with at least one opening (32) for receiving a second valve (4B).   21 - Manufacturing method according to claim 20 characterized in that introduces the first pocket (2) inside the second pocket (3) by positioning the opening (31) of the second pocket (3) substantially in view of the first valve (4A) and in that the second valve (4B) is mounted in said opening (32), for example by gluing.   22 - Use of one or more polymers having a gas barrier effect for producing a screen (E) substantially impervious to gases forming at least part of the envelope (5) delimiting a first pocket (2) of balloon (1) intra -gastric.   23 - Use according to claim 22 characterized in that the one or more polymers with a gas barrier effect are thermoplastic polymers.   24 - Use according to claim 22 or 23 characterized in that the gas-barrier polymer (s) is (are) chosen from the group comprising ethylene vinyl alcohol (EVOH), polyvinylidene chloride (PVDC) , poly-acrylonitrile (PAN), polyamide (PA), bi-oriented polyamide, polyethylene terephthalate (PET) and bi-oriented polyethylene terephthalate.