MXPA06009451A - Pouch-equipped intragastric balloon comprising a sealing member which is assembled to the pouches in an improved manner - Google Patents

Abstract

The invention relates to an expandable intragastric balloon consisting of:a first flexible pouch (2) comprising a port;a second pouch (20) which contains the first pouch (2) and which is equipped with a hole (21);and a sealing member (4) which is hermetically fixed to the second pouch (20) and which is intended to seal the port and the hole (21). The invention is characterised in that the first and second pouches (2, 20) are produced from different, non-compatible materials and are assembled with the aid of a fixing element (7). According to the invention, the fixing element is designed to ensure that the sealing member (4) is hermetically fixed to the first pouch (2) inside a passage (6) that is defined by a neck (5) which extends from the port, such that sufficient pressure is exerted on the neck (5) in order for same to be pinched between the sealing member (4) andthe fixing element (7). The invention is suitable for intragastric balloons.

Description

INTRAGASTRICO BALLOON EQUIPPED WITH BAGS THAT COMPRISES A SEALING MEMBER WHICH IS ASSEMBLED IN THE BAGS IN A MODE IMPROVED DESCRIPTION OF THE INVENTION This invention relates to the general technical field of devices that can be implanted in the human body and that are designed to be used for the treatment of obesity, and particularly morbid obesity, and more particularly to implants capable of reducing the volume of the stomach for the particular purpose of producing a feeling of fullness in the patient. This invention relates to an expandable intragastric balloon designed to be implanted within the stomach of a patient for the treatment of obesity and comprising: a first bag that is sufficiently flexible to move from a reduced volume configuration to an expanded configuration, and provided with at least one port, a second bag accommodated to contain the first bag, and provided with at least one hole, - a sealing member held tightly in the second bag and designed to seal the port and the orifice. The invention also relates to a method for manufacturing an expandable intragastric balloon designed to be implanted within the stomach of a patient for the treatment of obesity, where supplies are made for: a step to manufacture at least a first bag that is sufficiently flexible to pass from a reduced volume configuration to an expanded configuration, and which is provided with at least one port, - a step for assembling the first bag together with a second bag, provided with at least one hole, with the result being that the first bag is contained within the second bag, - a step for manufacturing a sealing member designed to seal the port and the orifice, - a step for holding the sealing member on the second bag in a substantially leak-proof manner. The intragastric balloons used for the treatment of obesity generally comprise one or more concentric flexible bags, which are made of the same material, such as silicone, and which are capable of passing from a configuration of reduced volume or folded on itself to an expanded configuration , which imparts to the globe its functional form. The bags are thus frequently filled with an inflating fluid, and for this purpose, comprises a valve-type sealing member designed to ensure its leak tightness. For this purpose, the bags are equipped with a port designed to be sealed by the sealing member, the latter generally being made of the same material as the bags and welded or glued together with the periphery of the hole. Although it has certain advantages, particularly in terms of simplicity and economy of manufacture, the design of these intragastric balloons nevertheless suffers from several disadvantages, associated in particular with the technique of assembling the components (bags and sealing member) by welding or gumming. Thus, although it is relatively easy to weld or gum together materials of the same type, it may prove more difficult to perform this operation for different and incompatible materials for which it is difficult or even impossible to find a common solder or gumming material able to ensure that the balloon is perfectly leak-proof, while at the same time satisfying other criteria (bio-compatibility, etc.). Such is the case, that it may be desirable to produce one of the components of the balloon, for example one of the bags or the sealing member, with a new material, particularly if the latter has better properties (leak tightness, resistance, etc.) for the application under consideration. In a case like this, it is critical to limit the impacts due to the use of this new material on the manufacture of other components of the balloon and its assembly. In the case of intragastric balloons of the prior art, such impacts are difficult to avoid, so that the welding or gumming material must necessarily be compatible, on the one hand, with the material forming the sealing member, and on the other hand, with the material that forms the bags. Consequently, the objects assigned to the invention have as their objective to remedy the various disadvantages listed in the foregoing and to propose a new expandable intragastric balloon for the treatment of obesity, the components of which can be easily assembled while at the same time being made of different materials. Another object of the invention is to provide a new intragastric balloon whose design makes it possible to use a greater variety of materials for its manufacture. Another object of the invention is to propose a new intragastric balloon whose manufacture is particularly simple and fast. Another object of the invention is to provide a new intragastric balloon provided with a sealing member whose leak tightness can be reproduced reliably. Another object of the invention is to provide a new intragastric balloon whose general leak tightness is improved. Another object of the invention is to provide a new intragastric balloon having a generally good degree of mechanical strength. Another object of the invention is to propose a new intragastric balloon whose structure makes it possible to improve the placement of the balloon inside the patient's stomach and limit the undesirable effects of the implant on the functioning of the digestive system. The objects assigned to the invention also aim to propose a new method for manufacturing an expandable intragastric balloon that can be reproduced, and that is simple and quick to implement, while at the same time making it possible to obtain a balloon having an excellent degree of tightness to leaks. Another object of the invention aims to propose a new method for manufacturing an intragastric balloon which makes it possible to guarantee the leak tightness of a sealing member for the balloon, and to do so in a systematic and reproducible manner. The objects assigned to the invention are obtained with the help of an expandable intragastric balloon designed to be implanted within the stomach of a patient for the treatment of obesity, and comprising: a first bag that is sufficiently flexible to pass from a volume configuration reduced to an expanded configuration, and provided with at least one port, a second bag accommodated to contain the first bag, and provided with at least one hole, - a sealing member held on the second bag in a leak-proof manner and designed to seal the port and the orifice. Characterized in that the first and second pouch are made of different non-compatible materials and assembled together with the aid of a fastening element designed to ensure leak-tight fastening of the sealing member on the first pouch, within a passage defined by a neck which extends from the port, by exerting a sufficient amount of pressure on the neck to be able to tighten the sealing member and the fastening element. The objects assigned to the invention are also obtained with the aid of a method for manufacturing an expandable intragastric balloon designed to be implanted within the stomach of a patient for the treatment of obesity, where provisions are made for: - a step to manufacture at least a first bag that is sufficiently flexible to pass from a reduced volume configuration to an expanded configuration, and that is provided with at least one port, - a step to assemble the first bag together with a second bag, provided with at least one a hole, with the result that the first bag is contained within the second bag, a step for manufacturing a sealing member designed to seal the port and the orifice, - a step for holding the sealing member on the second bag in a manner substantially leak-proof, characterized in that in order to assemble the first and the second bag, the nde: - a step for mounting the sealing member within a passage defined by a neck, extending from the port of the first bag, - a step for holding the sealing member on the first bag with the aid of a fastening element suitable when tightening the neck between the sealing member and the fastening element. Other objects and advantages of the invention will be more apparent after reading the following description and consultation of the drawings provided in the appendices, which are given solely for the purpose of illustration and are not in any way limiting, in which: BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a cross-sectional view showing a first embodiment of the intragastric balloon of a single bag according to the invention, in its expanded configuration. Figures 2 and 3 are cross-sectional views showing two embodiments of an intragastric balloon of two bags according to the invention, in their expanded configuration. The intragastric balloon according to the invention will now be described while referring to figures 1 to 3. The intragastric balloon 1 according to the invention is designed to be implanted within the stomach of a patient for the treatment of obesity. The balloon 1 is expandable, and for this purpose, comprises at least a first bag 2 that is flexible enough to pass from a reduced volume configuration to an expanded configuration. The reduced volume configuration, for example, may correspond to a configuration in which the balloon 1 is in a folded position on itself occupying a reduced volume, thus facilitating the insertion of the balloon 1 into the esophagus. In fact, the implantation of the intragastric balloon 1 according to the invention is generally carried out in a conventional manner well known to those of skill in the art, by passing through the oral-esophageal route in its folded form on itself, compressed or loose The expansion, placement and release of the balloon occurs at the end of the gastro-endoscopic operation, when the balloon 1 is correctly placed inside the patient's stomach. In reality, it is in its expanded configuration that balloon 1 will be able to occupy a considerable volume within the gastric cavity (not shown), the expanded configuration thus called then imparts to the balloon its functional form, that is, the form of therapeutic operation of the balloon for the treatment of obesity. In this way, by occupying a portion of the internal volume of the stomach, the intragastric balloon according to the invention makes it possible to create a rapid sensation of satiety in the patient, which is accompanied by a reduction in the amount of food ingested. According to the invention, the first bag 2 comprises at least one port 3, which can result from the method of manufacturing the first bag 2, or in addition is made specifically in the first bag 2, for example, for the purpose of introducing a fluid that inflates in it. According to the invention, the balloon 1 also comprises a sealing member 4 for the first bag 2, designed to seal the port 3. Actually, the first bag 2 is preferably designed to be filled with a fluid that inflates, for example, a gas or a liquid, and the sealing member 4 is designed to ensure the leak tightness of the first bag 2, once it has been inflated it is last. According to the invention, the first bag 2 is provided with a neck 5, which extends from the port 3 in order to define a passage 6 between the inside and the outside of the first bag 2. The passage 6 is thus designed advantageously to receive the sealing member 4. The neck 5 is advantageously formed by a section 2A folded on itself from the wall of the first bag 2, arranged to run substantially and completely around the sealing member 4. According to the invention, the balloon 1 comprises a fastening element 7 designed to ensure the fastening of the sealing member 4 on the first bag 2. For this purpose, the fastening element 7 is designed to exert pressure on the neck 5, which tends to close the latter on the sealing member 4. The fastening element 7 is designed, in particular, to exert sufficient pressure on the neck 5 to be able to tighten it between the sealing member 4 and the fastening element 7, thereby ensuring, on the other hand, the fastening of the sealing member 4 on the first bag 2, and on the other hand, the leakage tightness of the latter in the port area 3. The intragastric balloon 1 thus designed thus allows a simple and reliable assembly of the sealed member 4 on the first bag 2, although these two elements are made of different materials whose conventional assembly by gumming or by using welding lines can prove to be particularly difficult. Assembly in this way makes it possible to produce a strong assembly of the balloon components, and this is done without necessarily using multiple welding lines or gluing operations. Advantageously, the neck 5 comprises an internal wall 51 which defines the passage 6. The holding element 7 is thus advantageously arranged to surround the neck 5 and to exert a substantially uniform pressure on the circumference thereof, so that the The inner wall 51 of the neck 5 substantially adapts to the shape of the sealing member 4, in a leak-proof manner. In a particularly advantageous manner, the pressure exerted by the clamping element 7 is oriented in a centripetal direction (arrows F in Figure 1). Advantageously, the sealing member 4 includes a septum 4A having a self-sealing effect, which is accommodated within the passage 6 substantially opposite the holding element 7. The neck 5 and septum 4A are thus advantageously shaped so that the neck 5 substantially surrounds the septum 4A in its position to seal the first bag 2. In a particularly advantageous form, the fastening element 7 is designed to compress the septum 4A sufficiently to ensure leak tightness thereof, with respect to the fluids that are likely to be contained within the first bag 2. In this way, when exerting pressure on the neck 5, the fastening element 7 thereto time compresses septum 4A to ensure leak tightness. In this way, the clamping element 7 advantageously and simultaneously provides a double function: - on the other hand, it ensures the assembly of the sealing member 4 in the first bag 2, - on the other hand, it imparts to the sealing member 4 its own sealing function, by ensuring compression of septum 4A. For this reason, the pressure exerted by the clamping element 7 on the neck 5 will have to be sufficient to: - on the other hand, ensure the leak tightness between the neck 5 and the sealing member 4, and, on the other hand, ensure the leak tightness of septum 4A. The previously described assembly therefore makes it possible to limit the number of pieces required to provide the same functions. In a particularly advantageous form, the clamping element 7 consists of a ring 8 preferably in the form of a cylindrical tube and accommodated to surround the neck 5. The ring 8 is preferably substantially rigid and is dimensioned to sufficiently compress the septum 4A in a centripetal direction to obtain a leak tight enough of it. The diameter of the ring 8, e? In particular, it must be calculated with respect to the compression ratio of septum 4A that is required in order to obtain adequate leak tightness. In a particularly advantageous manner, the first bag 2 and the sealing member 4 are made of different materials, and preferably of elastomers. Various embodiments of the invention will now be described with reference to Figures 1 to 3. According to a first embodiment of the invention shown in Figure 1, the intragastric balloon 1 comprises only a single bag 2 with a port 3 sealed by a member 4 sealant. In this embodiment of the invention, the sealing member 4 is preferably formed by the septum 4A, which is housed within the neck 5 that extends from the port 3 towards the interior of the bag 2, thus forming a re-entry neck. The bag 2 is preferably made of elastomeric polyurethane, and therefore has good properties of flexibility and elasticity. As for septum 4A, it is preferably made of a silicone base. The fastening element 7, specifically the ring 8, thus surrounds the neck 5 and compresses the septum 4A, thus ensuring on the other hand, that the latter is leak-proof and, on the other hand, that it is clamped over bag 2 in a leak-proof mode, by tightening neck 5 between 'septum 4A and ring 8 (figure 1). Advantageously, septum 4A does not protrude externally from bag 2, thus imparting intragastric balloon 1 with an atraumatic property. According to a second and third embodiment of the invention, shown in Figures 2 and 3, the intragastric balloon 1 advantageously comprises a second flexible bag 20 accommodated to contain the first bag 2, thereby forming the outer coating of the balloon. In a particularly advantageous manner, and as shown in Figures 2 and 3, the fastening element 7 is designed to ensure the assembly of the first inner bag 2 with the second outer bag 20.

For this purpose, the second bag 20 is advantageously provided with at least one hole 21, and the sealing member 4 is designed to seal the hole 21 in a substantially leak-proof manner. Thus, the sealing member preferably comprises a flange 4B designed to allow leak-tight fastening of the sealing member 4 on the second bag 20, for example, by gumming or welding the flange 4B over the periphery of the hole 21. Preferably, the material forming the sealing member 4 is compatible with the material from which the second bag 20 is made, at least in the area of the periphery of the hole 21, to allow the fastening of the sealing member 4 on the second bag 20. , by welding or gumming. The sealing member 4 is thus advantageously held directly on the second bag 20 by welding or gumming. Preferably, the sealing member 4 consists of a material having substantially the same chemical and physical properties as the material forming the second bag 20. Even more preferably, the sealing member 4 and the second bag 20 are made of the same material, such as silicone. According to a possible modality of. the invention, not shown in the figures, the sealing member 4 and the second bag 20 are made integral with each other and form a one-piece unit, capable of being obtained by molding. Advantageously, the flange 4B is arranged to cover the neck 5 of the first bag 2 and the fastening element 7, in order to protect the assembly of the first bag 2 with the sealing member 4 and prevent it from being disconnected, for example, as a result of the movement of the intragastric balloon 1 inside the stomach. In fact, if the neck 5 and / or the holding element 7 protrudes externally from the balloon, repeated movements of the balloon within the patient's stomach can cause the fastening element 7 to gradually loosen, whose flange 4B makes it possible to avoid. The fastening element 7 in this way provides a third function: assembling the first and second bags 2, 20, and doing so in a particularly reliable and reproducible manner, independently of the type of materials that form the bags 2, 20. With this assembly, it is thus possible to use two different materials and not necessarily compatible, in terms of welding or gumming, in order to produce the inner bag and the outer coating, and to do so without any additional manufacturing restrictions. Preferably, the first and second bags 2, 20 are made of different non-compatible materials, the first bag 2 is preferably made of polyurethane, while the second bag 20 is preferably made of silicone. Advantageously, the first inner bag 2 is made of a material having better leak-proof properties than the material forming the second outer bag 20. Due to the good leak-proof properties of the polyurethane, with respect to the gases, it is possible to reduce the thickness of the first bag 2, which has the direct effect of substantially reducing the overall dimensions of the balloon 1 in its reduced volume configuration, facilitating its implementation. In the two modalities shown in figures 2 and 3, the sealing member 4 advantageously consists of a silicone valve, a portion of which consists of the silicone septum 4A, which is designed to fit within the neck 5. A sealing member 4 such as this, thus allows a needle for inflating passes through septum 4A, thereby enabling the filling of the first bag 2, the self-sealing property of the sealing member 4, specifically septum 4A, ensuring the leak tightness of the device when the needle is withdrawn to inflate. According to the third embodiment shown in Figure 3, the neck 5 extends from the port 3 towards the interior of the first bag 2, which thus forms a re-entry neck. Due to this configuration, the second bag 20 is advantageously adapted to the shape of the first bag 2 when the latter is filled with the fluid to be inflated. The balloon then has a substantially compact structure and therefore mechanically more resistant. Totally obvious, it is also possible to produce an intragastric balloon in which the neck 5 of the first bag extends from port 3 towards the exterior of the first bag to form an externally protruding neck (second embodiment shown in figure 2), and to do so without exceeding the scope of the invention. In a particularly advantageous form, the intragastric balloon 1 comprises a ballast means 30 designed to substantially overload the balloon 1 (Figure 3). Thus, when the first bag 2 is filled only with gas, the balloon 1, due to its low weight, may have a tendency to rise toward the upper portion of the stomach, thus preventing the penetration of the food into the gastric cavity. . On the other hand, if the first bag is filled with only the liquid, the intragastric balloon 1 has the risk of being too heavy, and therefore be poorly tolerated by the patient. The use of the ballast means 30 constitutes a compromise that makes it possible to improve the placement of the balloon inside the stomach and at the same time eliminate a source of discomfort for the patient. Advantageously, the ballast means 30 consists of a plurality of solid and dense bodies 31 joined together by portions 32 of strands. Preferably, the ballasting means 30 also comprises spacers 30 arranged between two consecutive solid and dense bodies 31 to avoid collisions, and therefore undesirable noise. The spacers 33 are preferably made of elastomer, for example, silicone. The solid and dense bodies 31 are preferably manufactured from a tungsten base, particularly preferred because of their biocompatible property. In a particularly advantageous manner, and as shown in Figure 3, the ballasting means 30 is preferably accommodated within the first bag 2, and one end of the strand joining the solid and dense bodies 31 together joins firmly to the holding element 7, which makes it possible to restrict the mobility of the ballasting means 30 inside the balloon 1. The holding element 7 can advantageously provide a fourth function, particularly that of a means of attachment and support for the half 30 ballasting.

The invention also relates to a method for manufacturing an expandable intragastric balloon 1 designed to be implanted within the stomach of a patient for the treatment of obesity, wherein the steps are provided: - to manufacture at least a first bag 2, which is sufficiently flexible to move from a reduced volume configuration to an expanded configuration, and that is provided with at least one port 3, - and to manufacture a sealing member 4 for the first bag 2, designed to seal the port 3. Advantageously, the stage for manufacturing the first bag 2 includes a sub-stage where two hemispheres are manufactured, for example, by thermo-forming the edges which are then welded (or gummed) to form a first substantially spherical bag 2 equipped with a neck 5 More accurately, the method for manufacturing the first bag 2 comprises a step during which one or more sheets (eg, two sheets) in a way predetermined, it is made of a material substantially impermeable to gases, such as thermoplastic elastomeric polyurethane, which have been preformed, for example, by thermoforming, to impart a hemispherical shape, are assembled together by welding-or glued throughout of a peripheral welding line.

Each sheet may consist of a single polyurethane film, but preferably consists of several and for example two super-imposed polyurethane films, films that are capable of becoming integral with each other, or being movable in relation to each other. Preferably, each sheet comprises an extension, for example, of rectangular shape. During the assembly of the sheets the extensions superimpose one on the other and are welded together or gummed together along a peripheral welding line (or gummed), to form the neck 5 of the first bag 2. Quite obvious, the step to manufacture the first bag 2 in the same way can result from another process, such as a heat sealing process, and without exceeding the scope of the invention. According to the invention, the method then comprises a step (a) for tightening the neck 5 between the sealing member 4 and a suitable fastening element 7, on the other hand, to ensure the fastening of the sealing member 4 on the first bag 2 , and, on the other hand, leak tightness of the latter. This method makes it possible in this way to advantageously eliminate the conventional step of welding or gumming the sealing member 4 on the first bag 2, thus accelerating the manufacturing operation for the balloon 1.

In addition, this method is particularly advantageous in cases where the first bag 2 and the sealing member 4 are made of non-compatible materials, that is, materials that are difficult or even impossible to assemble by welding or gumming with no guarantee of quality. In a particularly advantageous form, the method comprises a step (b) for turning the neck 5 in such a way that it is placed inside the first bag 2 and forms a re-entry neck. The rotation stage (b) preferably will be carried out before the two aforementioned hemispheres are completely welded together, to retain the access inside the first bag 2. Advantageously, the method then includes a step (c) for mounting the sealing member 4 within a passage 6 formed by the neck 5, followed by a step (d) for mounting a ring 8 around the neck 5, the ring 5 forming the holding element 7, to surround the neck 5 and exerting pressure on the circumference thereof, so that the inner wall 51 of the neck 5 substantially adapts to the sealing member 4, in a leak-proof manner. Advantageously, the method also comprises a step (e) for assembling the first bag 2 with a second bag 20, where the sealing member 4 is held on the second bag 20 in a substantially leak-proof manner. For this purpose, the assembly step (e) comprises a sub-step where the flange 4B of the sealing member 4 is welded or gummed together with the periphery of the hole 21 provided in the second bag 20. A double-bag design 2, 20 such as this it makes it possible to make an intragastric balloon 1 having improved mechanical strength, while at the same time retaining a flexible and elastic structure. In this way then the first bag preferably constitutes an inflation chamber and, in this respect, is designed to be filled with a fluid that inflates, for example, air, the second bag 20 then constitutes the protective outer coating of the balloon 1, the formation and, in particular, the deployment of which is controlled by the first bag 2. In this way, when the first bag 2 is inflated, it will push the wall of the second bag 20, and it will do so until the second bag 20 obtains its Functional form inside the stomach. Due to its particular design, the intragastric balloon 1 according to the invention is able to be easily maintained with the technical developments in the field, and particularly the developments that relate to the materials used in the manufacture of the balloons. Therefore, the invention makes it possible to produce a balloon whose components, particularly the bags and sealing member, can be easily assembled while at the same time being structurally independent from each other and made of separate materials not necessarily compatible. Another advantage of the intragastric balloon according to the invention is that its benefits of good reproducibility, on the other hand, in terms of the assembly of its various components and, on the other hand, in terms of its functional capabilities. In particular, the clamping element 7 is dimensioned to reproducibly guarantee the sealing property of the sealing member 4, and this is achieved by pre-calculating the compression ratio that the clamping element 7 must exert on the septum 4A for be able to ensure leak tightness of the same. Another advantage of the intragastric balloon 1 according to the invention comes from the fact that a single part, particularly the fastening element 7, may be able to provide several different functions, and in particular: / * / * 1) the assembly of the member 4 sealant on the first bag 2 2) the leak tightness of the sealing member 4, specifically the septum 4A, 3) the assembly of the first bag 2 with the second bag 20, 4) the holding of the weighing means 30. Possibility of industrial application The invention finds its industrial application in the design and manufacture of implantable devices to control obesity.

Claims (20)

1. CLAIMS 1. An expandable intragastric balloon designed to be implanted within the stomach of a patient for the treatment of obesity, and comprises: - a first bag that is sufficiently flexible to move from a reduced volume configuration to an expanded configuration, and provided with at least one port, a second bag accommodated to hold the first bag, and provide it with at least one hole, - a sealing member fastened on the second bag in a leak-proof manner, and designed to seal the port and the orifice characterized in that the first and second bags are made of different non-compatible materials and assembled together with the aid of a fastening element designed to ensure leak-proof fastening of the sealing member on the first bag, within a passage defined by a neck that extends from the port, by exerting a sufficient amount of pressure on the neck to be able to tighten it in between the sealing member and the fastening element.
2. 2. The intragastric balloon according to claim 1, characterized in that the sealing member and the second bag are made of compatible materials, and wherein the sealing member is held on the second bag by welding or gumming.
3. The intragastric balloon according to claim 1 or 2, characterized in that the sealing member 4 comprises a flange which allows it to be fastened on the periphery of the orifice in a leak-proof manner, for example by gumming or welding the flange together with the periphery of the hole.
4. 4. The intragastric balloon according to claim 1, 2 or 3, characterized in that the sealing member comprises a septum accommodated within the passage substantially opposite the fastening element.
5. 5. The intragastric balloon according to any of claims 1 to 4, characterized in that the fastening element is designed to sufficiently compress the septum to ensure leak tightness thereof, with respect to the fluids that are likely to be contained within the first bag.
6. 6. The intragastric balloon according to any of the preceding claims, characterized in that the neck extends from the port to the interior of the first bag.
7. The intragastric balloon according to one of the preceding claims, characterized in that the neck comprises an internal wall defining the passage, the fastening element is arranged to move the neck and to exert pressure on the circumference thereof, so that The inner wall of the neck is substantially adapted to the sealing member, in a leak-proof manner.
8. 8. The intragastric balloon according to one of claims 1 to 7, characterized in that the fastening element consists of a ring.
9. The intragastric balloon according to one of claims 1 to 8, characterized in that the first bag is made of polyurethane, the second bag is made of silicone.
10. 10. The intragastric balloon according to one of the preceding claims, characterized in that the sealing member consists of a silicone valve.
11. The intragastric balloon according to one of claims 1 to 10, characterized in that it comprises a ballast means designed to substantially overload the balloon.
12. The intragastric balloon according to claim 11, characterized in that the ballast means consists of a plurality of solid and dense bodies joined together by strand portions.
13. 13. The intragastric balloon according to claim 12, characterized in that the ballast means comprises spacers arranged between two consecutive bodies to avoid shocks.
14. The intragastric balloon according to one of claims 10 to 13, characterized in that the ballast means is supported by the fastening element.
15. 15. The intragastric balloon according to claims 12 to 14, characterized in that one of the ends of the strand joining together the bodies is firmly attached to the fastening element.
16. 16. The intragastric balloon according to one of claims 11 to 15, characterized in that the ballast means is accommodated within the first bag.
17. 17. A method for manufacturing an expandable intragastric balloon designed to be implanted within a patient's stomach for the treatment of obesity, where supplies are made for: - a step to manufacture at least one first bag that is sufficiently flexible to pass from one configuration of reduced volume to an expanded configuration, and that is provided with at least one port, - a step to assemble the first bag together with a second bag, provided with at least one hole, with the result that the first bag is contained within the second bag, - a step for manufacturing a sealing member designed to seal a port and the orifice, - a step for holding the sealing member on the second bag in a substantially leak-proof manner, characterized in that in order to be able to assembling the first and second pouch, the method comprising: - a step for mounting the sealing member within a defined passage r a neck, extending from the port of the first bag, - a step for holding the sealing member on the first bag with the help of a suitable fastening element, by tightening the neck between the sealing member and the fastening element .
18. 18. The method according to claim 17, characterized in that the step for fastening the sealing member on the second bag is carried out by welding or gumming. The method according to claim 17 or 18, characterized in that the sealing member comprises a flange and in that the method comprises a sub-stage where the flange is welded or gummed together with the periphery of the orifice. The method according to one of claims 17 to 19, characterized in that it comprises a step (b) for turning the neck so that it is placed inside the first bag.