MXPA06009450A - Intragastric balloon with improved forming means and increased mechanical strength - Google Patents

Abstract

The invention relates to an expandable intragastric balloon which is intended to be implanted in the stomach of a patient for the treatment of obesity. The inventive balloon comprises an outer casing (2) which is sufficiently flexible in order to change from a reduced volume configuration to an expanded configuration, thereby imparting the balloon (1) with its functional shape. The balloon is characterised in that it comprises means (3) for forming the outer casing (2), which are structurally integrated into the balloon (1), but which, for the most part, are separate from the outer casing (2). According to the invention, once the balloon (1) has been implanted, the aforementioned forming means (3) can be actuated in order to:(i) exert a sufficient driving pressure on the outer casing (2) such as to force the deployment thereof, and (ii) occupy a sufficient volume inside the outer casing (2) in order to produce the deployment of the outer casing (2) from the reduced volume configuration to the expanded configuration thereof. The invention is suitable for intragastric balloons.

Description

INTRAGASTRICQ GLOBE WITH ENHANCED TRAINING MEDIA AND INCREASED MECHANICAL RESISTANCE 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 implants capable of artificially 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 in the stomach of a patient for the treatment of obesity, and comprising an outer coating that is sufficiently flexible to move from a reduced volume configuration to an expanded configuration, imparting this shape the balloon * with its functional form. The intragastric balloons used for the treatment of obesity are generally in the form of a flexible bag that forms the outer lining of the balloon and is capable of being filled with a fluid to inflate, in particular air, once the balloon is implanted into the stomach. , to impart to the balloon its functional form, that is, an operative volume and shape that allow occupying a large function of the space available for food.

Although it has many advantages, linked in particular to its manufacturing facility, such balloons nevertheless suffer from several disadvantages. In particular, known intragastric balloons often have a certain degree of porosity, which will allow gradual leakage of the fluid contained within the balloon (gas or liquid), and will carry out the gradual reduction in the volume of the balloon, and thus the therapeutic effectiveness of it. In this way, when the volume of the balloon no longer corresponds to the volume desired for the treatment of obesity, the latter no longer creates the desired sensation of satiety in the patient. That problem proves to be particularly critical in the case where the outer coating of the balloon is filled only with gas. In certain extreme cases, the reduction in the volume of the balloon can cause the latter to pass through the pylorus into the intestinal tract, which causes serious complications in the patient. The properties or characteristics of the intragastric balloon, such as its leak tightness, which are responsible for keeping the balloon in its functional configuration over time, thus seem to be essential parameters of control which makes it possible to improve the effectiveness of medical treatment .

Therefore, there is an entirely obvious interest in producing a balloon designed to preserve its volume and functional configuration over time, and even when the outer coating which is subjected to external stresses and, in particular, to digestive juices, deteriorates and it gradually becomes porous. In addition, the intragastric balloons generally found in the same way suffer from a certain degree of brittleness, which, in particular, comes from the fact that the bag containing the gas to be inflated (or the liquid) also forms the outer shell of the balloon. In this way, the bag is subjected directly to external stresses, which increase the risk of perforation, particularly when the balloon is being handled by the medical practitioner. Therefore, there is a totally obvious interest in producing an intragastric balloon which, while it is sufficiently elastic, is equally sufficient and mechanically resistant and is protected from external stresses. Consequently, the objects assigned to the invention have as their objective to remedy the various disadvantages listed in the foregoing and to provide a new expandable intragastric balloon for the treatment of obesity, which does not have the disadvantages listed above and which, once placed inside the stomach in its functional configuration, it has very slight variations in volume over time. Another object of the invention is to propose a new intragastric balloon whose leak tightness is improved, and whose losses of fluid to inflate, in particular gas, are limited, thereby increasing the therapeutically effective lifespan of the balloon. Another object of the invention aims to propose a new intragastric balloon which, while having good elastic properties, is sufficient and mechanically resistant and protects against external stresses. Another object of the invention is to propose a new intragastric balloon whose formation and expansion is simplified and is particularly rapid. Another object of the invention is to propose a new intragastric balloon which, although it has a considerable volume, is sufficiently light, atraumatic and well tolerated by the patient. The objects assigned to the invention are achieved with the help of an expandable intragastric balloon designed to be implanted in the stomach of a patient for the treatment of obesity and comprising an outer coating that is sufficiently flexible to move from a reduced volume configuration to a expanded, thus imparting to the balloon its functional form, characterized in that it comprises means for forming the outer coating, which are structurally integrated into the balloon and are mainly separated from the outer coating, the formation means being capable of being activated, once that the balloon has been implanted, on the other hand, so as to be able to exert a sufficient impulsion pressure on the outer skin to force it to deploy and, on the other hand, to occupy a sufficient volume inside the outer skin to ensure the deployment of the outer skin of the skin. your volume configuration reduced to your configuration expa loss. BRIEF DESCRIPTION OF THE DRAWINGS Other objects and advantages of the invention will become more apparent with the reading of the following description, as well as with the help of the attached drawings, given for illustrative and non-limiting purposes only, in which: - The Figure 1 is a cross-sectional view showing an intragastric balloon according to the invention, in its maximum expansion position. - Figure 2 is a cross-sectional view showing an intragastric balloon according to the invention, in its unexpanded position. The intragastric balloon according to the invention will now be described although with reference to Figures 1 and 2.

The intragastric balloon 1 according to the invention is designed to be implanted in the stomach of a patient for the treatment of obesity. The intragastric balloon 1 can be expanded, and for this purpose, it comprises an outer coating 2 that is sufficiently flexible to move from a reduced volume configuration (shown in Figure 2) to an expanded configuration (shown in Figure 1). The reduced volume configuration, for example, may correspond to a configuration in which the balloon is not in a folded position on itself occupying a reduced volume, thereby facilitating the insertion of balloon 1 into the esophagus. In fact, the implantation of the intragastric balloon according to the invention is generally carried out in a conventional manner well known to those skilled in the art, when passing through the oral-esophageal route in its compressed or loose folded form. . 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. Thus, it is in its expanded configuration that the balloon 1 will allow to occupy a considerable volume within the gastric cavity (not shown), the so-called expanded configuration then imparts to the balloon with its functional form. In this way, the expression "functional form" refers, on the other hand, to the volume and, on the other hand, to the therapeutic operative form of the balloon for the treatment of obesity. Thus, by occupying a portion of the internal volume of the stomach, the intragastric value 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 ingested food. According to the invention, the intragastric balloon 1 comprises means for forming the outer coating 2. These forming means 3 are structurally integrated into the balloon, that is, they are part of the balloon even before the latter is implanted within the gastric cavity. More precisely, the forming means 3 are integrated into the balloon 1 during its manufacture, thus forming a portion of the functional components of the balloon. According to the invention, once the balloon 1 has been implanted or placed inside the stomach, the means for forming the outer coating 2 are capable of being activated: on the other hand, to be able to exert a sufficient delivery pressure in the outer liner 2 to force it to be deployed, and on the other hand, to be able to occupy a sufficient volume within the outer liner 2 to ensure the deployment of the outer liner 2 from its reduced volume configuration to its expanded configuration. In this way, the forming means 3 are advantageously dimensioned to exert tension on the outer coating 2 with an intensity substantially greater than the strength of resistance able to be opposed by the outer coating 2. Within the meaning of the invention, the outer skin 2 designates the outer wall of the intragastric balloon 1 defined internally by an inner surface 21 and an outer surface 2E that forms the contact surface of the balloon 1 with the stomach. In a particularly advantageous way, the means 3 are formed and designed to exert substantially normal and centrifugal attention on the outer liner 2, to push the latter to the direction of the arrows Fl a F6 shown in Figure 1. In a particularly advantageous manner, the tension is exerted on substantially all of the inner surface 21 of the outer sheath 2, i.e. substantially in each direction in space. The forming means 3 advantageously separates from the outer sheath 2, and is designed to occupy an increasing volume within the outer sheath 2 to produce the deployment thereof. More precisely, the forming means 3 are mainly separated from the outer sheath 2, with the result that, when the balloon 1 is in a non-expanded or bent configuration, shown in Figure 2, the forming means 3 is not necessarily in contact with - the outer covering 2 over the entire inner surface 21 thereof. The forming means 3 in this way are advantageously mounted inside the outer covering 2 with a possibility of being able to move relative to it. The forming means 3 in this way are advantageously designed to occupy a sufficient volume within the outer covering 2 with the result that the latter is able to obtain its expanded configuration. Preferably, the forming means 3 have flexibility and elasticity properties, and are particularly valuable in this field of application. The design of the balloon 1 according to the invention, and particularly the use of the training means 3 described in the above, thus makes it possible to obtain an intragastric balloon 1 capable of retaining its functional form over time, even when the outer lining 2 gradually deteriorates. According to a first possible embodiment of the invention, not shown in the figures, the forming means may advantageously consist of a viscoelastic memory foam having sufficient elastic memory properties in a centrifugal direction to deploy the outer coating of the balloon, when the latter is in its initial reduced volume configuration within the stomach. In this first embodiment, the fluidic communication can be established, by means of a catheter, for example, between the interior of the outer cladding and the atmosphere, so that the foam is able to expand while at the same time compelling the outer cladding to unfold, the air it is then gradually removed from the lining due to expansion of the foam. According to a preferred embodiment of the invention, shown in Figure 1, the forming means 3 consist of an inflation chamber 4, which is different from the outer shell 2, and which is accommodated therein to ensure the formation of the outer shell 2 by introducing a fluid to inflate the inflation chamber 4. The term "inflation chamber" here means an inflatable unit that is mounted within the outer casing 2 and that defines an interior volume capable of being filled with a fluid to be inflated. Preferably, the inflation chamber 4 and the outer jacket 2 are mainly separated and advantageously connected or made integral with each other by a valve-type connection means 10 allowing connection of the inflation chamber 4 to a fluid reservoir, so as to to fill the inflation chamber 4. The inflation chamber 4 is thus able to be activated by inflation, with the aid of a fluid such as a gas (or a liquid). When inflated, the inflation chamber 4 will therefore expand and exert tension on the outer liner 2, specifically on the inner surface 21 thereof, tending to propel it in a centrifugal direction, as shown by the arrows Fl a F6 in the Figure 1, and until the outer skin 2 obtains its expanded and functional configuration. The inflation chamber 4 and the outer covering 2 of this form are adapted in such a way that, during the inflation operation, the outer covering 2 exerts only a slight resistance with respect to the pressure exerted on its internal surface 21 by the chamber 4. of inflation. In this way, the inflation chamber 4 constitutes an impermeable barrier between the inflating fluid it contains and the outer lining 2, thus preventing the fluid to inflate from migrating towards the outer lining 2 of the balloon 1, whose leak tightness is weaker than inflation chamber 4. further, the outer covering 2 that separates and is independent of the formation means 6, of the inflation chamber 4 specifically, is able to effectively ensure the mechanical protection thereof. For this purpose, the outer liner 2 is preferably made of flexible, elastic materials having good mechanical strength properties. In a particularly advantageous manner, the inflation chamber 4 in the outer lining 2 is formed such that, when the inflation chamber 4 occupies its expanded position, the outer lining 2 substantially coincides with the shape of the inflation chamber 4. In this so-called expanded position, the inflation chamber 4 can inflate excessively, that is, fill with a quantity of fluid substantially greater than the amount of fluid it is normally able to contain without undergoing additional elastic deformation or extension of its wall.

Preferably, the inflation chamber 4 and the outer skin 2 are shaped so that, during the inflation operation, a slight gap remains between the external surface 4E of the inflation chamber and the inner surface 21 of the outer skin 2, this space J is sufficient to allow a certain relative mobility between the inflation chamber 4 and the outer jacket 2. Such mobility therefore makes it possible, on the other hand, to prevent the outer lining 2 from interfering with the inflation of the inflation chamber 4, and on the other hand, prevents the deformation of the folds in the outer lining 2. Advantageously, the inflation chamber 4 consists of an inner bag 5 which is sufficiently flexible to move from a reduced volume position to an expanded position. The inner bag 5 preferably consists of an elastomeric material having a sufficient degree of elasticity to allow excessive inflation of the inner bag 5. Advantageously, the inflation chamber 4, specifically the inner bag 5, is designed to be filled with a gas that forms the fluid to be inflated. Quite obviously, the inflation fluid can be a liquid, and without thereby exceeding the scope of the invention. In this way, together with the inflation chamber 4 (or the inner bag 5) and the outer coating 2 which constitute an outer bag, the intragastric balloon 1 forms a double-bag balloon. Advantageously, the inner bag 5 is defined by a wall 6, different and mainly separated from the outer skin 2, comprising at least a shield substantially gas-tight, in order to improve the general leak tightness of the balloon. In this way, the wall 6 may advantageously consist of a multilayer film, the shield then forms one of the film layers, or a single layer film, in which case the shield forms the single layer of film. In a particularly advantageous form, the shield includes in its composition at least one polymer that has a gas barrier effect. The term "polymer having a gas barrier effect" designates polymers having a gas permeability. clearly lower than that of silicone, and specifically an oxygen permeability '(02) less than about ten times that of silicone. Thus, the shield can consist of one or more thermoplastic polymers that have a gas barrier effect, such as ethylene vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polyacrylonitrile (PAN), polyamide (PAS) ), bioriented polyamide, poly (ethylene terephthalate) (PET), bioriented poly (ethylene terephthalate), and thermoplastic elastomeric polyurethane. According to a preferred alternative of the invention, the inner bag 5 consists of one or more films, for example, two films of thermoplastic elastomeric polyurethane, the films being able to become integral with each other, for example, by gumming, or being mobile in relation to each other. Among other valuable properties, polyurethane has a slightly adhesive effect, which facilitates the folding and also the memory properties of formation. As an illustrative example, the oxygen permeability (02) of polyurethane is in the order of 350cm3.60μm / m2.24h.bar at 1, 600cm3.100μm / m2.24h. lbar, while the permeability of the silicone is in the order of 130,000cm3.100μm / m2.24h.bar (measurements taken at 37 ° C and 90% relative humidity). A material such as this also has elastic properties that allow excessive inflation of the inner bag 5, while at the same time providing satisfactory mechanical strength. Advantageously, the inflation chamber 4 is designed to have a substantially spherical shape in its expanded position. For this purpose, the inner bag 5 is preferably manufactured using a heat sealing process, heat welding or heat forming. More precisely, the method to manufacture the bag The interior comprises an assembly step, during the course of which one or more sheets (for example two sheets) are assembled by welding or gumming along a peripheral welding line, the sheets are of a predetermined shape and are made of a substantially gas-impermeable material, such as thermoplastic elastomeric polyurethane which has been preformed, for example, by heat formation, to impart a hemispherical shape thereto. Each sheet may consist of a single polyurethane film, but preferably consists of several, and, for example, two super-imposed polyurethane films, the films being capable of being made integral with each other, for example, by gumming, or be mobile in relation to each other. As for the outer coating 2, it is preferably done by means of an injection molding process. In a particularly advantageous manner, the inflation chamber 4 and the outer coating 2 are substantially concentric and spherical, the spherical shape of the outer coating 2 therefore imparts an atraumatic property to the intragastric balloon 1. According to a particularly advantageous feature of the invention, the outer coating consists of a biocompatible material capable of being well tolerated by the patient. Thus, the outer skin 2 may consist of a silicone-type elastomeric material, a material such as this one having in particular, valuable properties of elastic and mechanical strength. The outer coating 2 advantageously has radiological opacity properties. Furthermore, according to a preferred alternative of the invention, the silicone used to form the outer coating 2 advantageously is white when treated with barium sulfate. Preferably, the thickness of the inner bag 5 will be smaller than the thickness of the outer coating 2, the latter then providing a mechanical protection function with respect to the inner bag 5, thereby limiting the risks of deterioration and / or perforation of the bag 5 inside. In this way, the design of the balloon 1 according to the invention makes it possible to use two different materials to produce the inner bag 5 and the outer coating 2, and also to produce an inner bag 5 with a particularly small thickness, which makes it possible, in particular, limiting the space occupied by the balloon 1 when it is in its reduced volume configuration to be implanted in the stomach of a patient. In a particularly advantageous manner, and in order to be able to further improve the overall leak tightness of the balloon, it is possible to cover the outer skin 2 with parylene. Similarly, inflation chamber 4 can also be covered with parylene. A measure like this also has the advantage of reducing the adhesive effect of silicone. According to an even more preferred alternative of the invention, the intragastric balloon 1 comprises ballasting means consisting of solid and dense bodies 8, preferably made of tungsten, designed to substantially overload the balloon 1. In reality, when the camera 4 of inflation is filled only with gas, balloon 1 may have a tendency to rise towards the upper portion of the stomach and prevent penetration of the food into the gastric cavity. The use of the ballasting means in this way makes it possible to improve the placement of the balloon 1 within the stomach, and at the same time, eliminate an important source of discomfort for the patient.

In a particularly advantageous manner, the bodies 8 solid and dense are joined together by portions 9 of strand, to form a chain, which is substantially accommodated within the inflation chamber 4 and preferably attached to the valve 10. The final placement of the intragastric balloon 1 according to the invention now it will be described. Prior to implantation, the intragastric balloon 1 according to the invention is in a form bent over itself, or even compressed to facilitate its insertion into and passage through the oral passages of the patient, and in particular the esophagus. Advantageously, the balloon 1 may also be bent over itself within a containment cover designed to facilitate balloon implantation. In this case, the balloon is inserted into the gastric cavity along with its cover and then released, and then the cover is removed. Once placed inside the patient's stomach, the intragastric balloon 1 must undergo several operations by the medical practitioner to be able to operate it, that is, to give it a sufficient volume to occupy a portion of the space of the gastric cavity reserved for food. . In the case of the balloon shown in Figure 1, the medical practitioner connects the valve 10 to a source of fluid, preferably air, for example, by means of a catheter extended by an inflation needle, in order to be able to inflate the chamber 4 of inflation. The purpose of this operation is to allow the. expansion of the inflation chamber 4, which will exert tension on the outer lining 2, thus tending to propel it gradually towards a centrifugal direction along the arrows Fl a F6. The inflation operation continues in this way until the outer covering 2 obtains its expanded and functional configuration. When this configuration has been obtained, the medical practitioner can remove from the patient's body all the material required to inflate, particularly the catheter and inflation needle, the purpose of this operation is to release the balloon. The system by the association of the inflation chamber 4 with the outer jacket 2 in this way has several characteristics in common with the pair of conventional air-chamber covers, particularly in terms of flexibility and elasticity, but also in terms of resistance mechanics and system protection of external voltages. The intragastric balloon 1 according to the invention is therefore advantageously designed to retain its functional shape and volume over time, although the outer coating 2 may deteriorate gradually. Another advantage of the intragastric balloon according to the invention is that it has particularly valuable properties of mechanical strength due, in particular, to the outer coating 2 which forms a mechanical protection means for the balloon. Another advantage of the intragastric balloon 1 according to the invention is that it has an improved leak tightness compared to known balloons. Another advantage of the intragastric balloon 1 according to the invention is that it is sufficiently strong to allow easy handling by the medical practitioner. 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 in the stomach of a patient for the treatment of obesity and comprising an outer coating that is visibly flexible to move from a reduced volume configuration to an expanded configuration, thereby imparting to the balloon with its functional form, characterized in that it comprises means for forming an outer coating, which are structurally integrated in the balloon and are mainly separated from the outer coating, the forming means are capable of being activated, once the balloon has been implanted, on the other side, to exert a sufficient push pressure on the outer skin to force it to deploy, and on the other hand, to occupy a sufficient volume within the outer skin to ensure deployment of the outer skin from its reduced volume configuration to its expanded configuration.
2. 2. The intragastric balloon according to claim 1, characterized in that the formation means consists of an inflation chamber that is different from the outer coating and which is accommodated therein to ensure its formation by the introduction of a fluid of inflation in the inflation chamber.
3. 3. The intragastric balloon according to claim 2, characterized in that the inflation chamber and the outer coating are shaped so that, when the inflation chamber occupies its expanded position, the outer coating substantially coincides with the shape of the chamber of inflation. inflation.
4. 4. The intragastric balloon according to claim 2 or 3, characterized in that the inflation chamber consists of an inner bag that is sufficiently flexible to move from a reduced volume position to an expanded position.
5. 5. The intragastric balloon according to claim 4, characterized in that the inner bag consists of an elastomeric material.
6. 6. The intragastric balloon according to claim 4 or 5, characterized in that the inner bag is defined by a wall that includes at least one shield that is substantially impermeable to gases.
7. 7. The intragastric balloon according to claim 6, characterized in that the shield includes in its composition at least one polymer that has a barrier effect against the gas.
8. 8. The intragastric balloon according to claim 7, characterized in that the shield consists of one or more thermoplastic polymers having a gas barrier effect.
9. 9. The intragastric balloon according to claim 8, characterized in that the shield consists of one or more polymers selected from the group of polymers having a gas barrier effect, such as ethylene vinyl alcohol (EVOH), polyvinylidene chloride ( PVDC), polyacrylonitrile (PAN), polyamide (PAS), bioriented polyamide, poly (ethylene terephthalate) (PET), bioriented poly (ethylene terephthalate), and thermoplastic elastomeric polyurethane.
10. The intragastric balloon according to one of claims 4 to 9, characterized in that the inner bag consists of at least one thermoplastic elastomeric polyurethane film.
11. The intragastric balloon according to one of the preceding claims, characterized in that the outer coating consists of a biocompatible material.
12. The intragastric balloon according to one of the preceding claims, characterized in that the outer coating consists of an elastomeric material.
13. 13. The intragastric balloon according to claim 12, characterized in that the outer coating is made of silicone.
14. 14. The intragastric balloon according to claim 13, characterized in that the silicone is white when treated with barium sulfate.
15. 15. The intragastric balloon according to one of the preceding claims, characterized because the. Exterior cladding is covered with parylene.
16. 16. The intragastric balloon according to one of claims 2 to 15, characterized in that the inflation fluid is a gas.
17. 17. The intragastric balloon according to one of claims 2 to 16, characterized in that the inflation chamber is designed to have a substantially spherical shape, in its expanded position.
18. 18. The intragastric balloon according to one of claims 2 to 17, characterized in that the inflation chamber and the outer coating are substantially movable in relation to each other.
19. The intragastric balloon according to one of claims 2 to 18, characterized in that the inflation chamber and the outer coating are substantially concentric.
20. 20. The intragastric balloon according to one of claims 2 to 19, characterized in that the inflation chamber is covered with parylene.