Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F5/003—Implantable devices or invasive measures inflatable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F5/0036—Intragastrical devices
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T29/00—Metal working
  • Y10T29/49—Method of mechanical manufacture
  • Y10T29/4998—Combined manufacture including applying or shaping of fluent material

Definitions

• 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, in particular of morbid obesity, and more particularly to the field of 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 the treatment of obesity comprising an outer envelope sufficiently flexible to pass from a first configuration in which the balloon occupies a reduced volume, called introduction configuration, to a second configuration, said expanded configuration, in which the balloon has its functional form and occupies a substantially larger volume.
• the present invention also relates to a method of manufacturing an intragastric balloon as defined in the preceding paragraph.
• Such balloons usually comprise a flexible bag, made of a bio-compatible elastomeric material which forms the surface envelope of the balloon and which can be filled, once the balloon has been implanted inside the stomach, with a inflation fluid, such as saline or air.
• a inflation fluid such as saline or air.
• the balloon acquires its functional form, that is to say a volume and shape such that it allows it to occupy a large part of the space normally available for food, prevent it from be evacuated by the digestive tract and make it substantially atraumatic vis-à-vis the stomach walls.
• Such intragastric balloons if they provide interesting results in terms of weight loss, since they reduce the kinetics of passage of food and actually help to quickly generate a feeling of satiety in the patient, nevertheless suffer from disadvantages non negligable.
• the flexible bag is in the form of an entanglement of substantially shapeless material that makes the seizure and manipulation of the balloon difficult by an endoscopic instrument.
• the large amount of material to extract tends to cause an obstruction of the pathways through which the balloon during its extraction, so that the latter has a significant mechanical resistance to its path, especially through the esophagus, which increases the risk of tearing the flexible bag under the action of clamping and traction exerted by the endoscopic clamp.
• 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 which has a lower resistance to extraction while maintaining the same volume. and the same geometry useful when deployed in the stomach as the devices of the prior art.
• Another object of the invention is to propose a novel intragastric balloon, the configuration of which facilitates its path through the natural pathways, in particular the esophagus.
• Another object of the invention is to propose a new intragastric balloon whose handling and extraction are facilitated.
• Another object of the invention is to propose a novel intragastric balloon that is sufficiently resistant and mechanically protected from external aggression.
• Another object of the invention is to propose a novel method of manufacturing an intragastric balloon for the treatment of obesity which makes it possible to obtain an intragastric balloon whose extraction is facilitated.
• intragastric balloon intended to be implanted in, then removed from the stomach of a patient by natural means, as part of a treatment of obesity, said intragastric balloon having an outer envelope sufficiently flexible to pass from a first configuration in which the balloon occupies a reduced volume, called "introduction configuration", to a second configuration, called ".
• said intragastric balloon being characterized in that it comprises extraction configuration means capable of exerting on said balloon intra- gastric a constraint to move the latter of said deployed configuration to a third contracted configuration of substantially lower volume, called “extraction configuration", by acting on the outer shell so that said outer shell substantially, or tends towards a predetermined shape corresponding to said extraction pattern.
• the objects assigned to the invention are also achieved by means of a method of manufacturing an intragastric balloon intended to be implanted in and then removed from the stomach of a patient by the natural routes in the context of a treatment of obesity, said manufacturing method comprising a step (a) for producing an outer envelope in which an outer envelope is made flexible enough to pass from a first configuration in which the balloon occupies a reduced volume , called “introduction configuration”, to a second configuration, called “deployed configuration", in which the balloon has its shape functional and occupies a substantially larger volume, characterized in that said step (a) for producing an outer envelope comprises a sub-step (b) of molding during which said envelope is molded into a shape that makes it possible to obtain a shape memory effect that tends to recall said balloon from its deployed configuration to a third contracted configuration, said extraction configuration, of substantially lower volume.
• FIG. 1 illustrates in a schematic view the extraction by the esophageal route of an intragastric balloon according to the invention with the aid of an endoscopic clamp.
• FIG. 2 illustrates, in a cross-sectional view, an intragastric balloon according to the invention in its introduction configuration.
• FIG. 3 illustrates, in a cross-sectional view, an intragastric balloon according to the invention in its deployed configuration.
• FIG. 4 illustrates, in a cross-sectional view, an intragastric balloon according to the invention in its extraction configuration.
• FIG. 5 illustrates, in a half-sectional view, an intragastric balloon according to the invention in an alternative extraction configuration.
• the intragastric balloon 1 according to the invention is intended to be implanted in the stomach 2 of a patient as part of a treatment for obesity.
• this implantation can be achieved by passage of the balloon in the natural pathways, generally esophageal.
• the balloon is usually conditioned by means of introduction, such as a cover, which force it to have a shape that facilitates its introduction, for example by stretching or otherwise compressing it.
• the balloon is rid of its possible packaging and is in an initial configuration, usually loose, called "introductory configuration", in which it occupies a reduced volume.
• the balloon 1 according to the invention is preferably in its introduction configuration, in an ovoid shape substantially elliptical profile.
• the practitioner then passes the intragastric balloon 1 of its introduction configuration to a second configuration, called “deployed configuration", wherein said balloon has its functional form and occupies a substantially larger volume.
• the expressions designating the various configurations can be applied indifferently to the balloon 1 as to the component parts thereof considered in the corresponding states.
• the term “functional form” refers on the one hand to the volume and on the other hand to the shape which are conferred on the balloon to endow it with the therapeutic capacity expected in the context of a treatment of obesity.
• the balloon 1 must normally occupy a significant volume in the gastric cavity in order to create in the patient a rapid sensation of satiety which is accompanied by a decrease in the amount of food ingested.
• the geometrical, physical and chemical properties of said balloon 1 must contribute to minimizing the traumatic impact thereof on the stomach walls.
• the balloon is designed to adopt a substantially spherical shape in its deployed configuration, as illustrated in FIG.
• the intragastric balloon 1 for the treatment of obesity is expandable and comprises an outer envelope 3 flexible enough to pass from a first configuration in which the balloon occupies a reduced volume called “introduction configuration”, a second configuration called “deployed configuration", wherein the balloon has its functional form and occupies a substantially larger volume.
• the outer envelope 3 is preferably made of a flexible material of the elastomer type, for example silicone.
• the material constituting said outer envelope 3 could be subject to constitutional variations, in particular to be subject to treatments intended to modify its properties such as its transparency, its color, its tightness or its elasticity without departing from the scope of the invention.
• the balloon 1 also comprises shaping means 4 capable of passing it from its introduction configuration to its deployed configuration.
• said forming means 4 comprise an inflation bag 5.
• inflation bag here designates an inflatable member which has a membrane 6 delimiting a substantially variable internal volume, which is mounted inside the outer casing 3 and which can be filled with a fluid of Inflating 7.
• the inflation bag 5 is intended to receive a fluid 7, and more particularly to contain it in a sealed enclosure.
• the intragastric balloon 1 also comprises a connection means, preferably formed by an inflation valve 8, for example made at the using a self-sealing membrane.
• the valve 8 is assembled with the inflation bag 5 and with the outer casing 3.
• the inflation bag 5 is preferably predominantly, or totally, distinct from the outer casing 3, to which it can be attached mechanically to the valve level.
• the outer casing / inflation bag arrangement may thus have a certain analogy with a tire / air chamber assembly.
• the balloon 1 may also comprise additional fixing and / or reinforcing elements 9, for example in the form of flexible disks.
• the practitioner injects an inflation fluid into the bag 5 through the valve 8, for example by means of a cannula, so that the expansion of the pocket 5 leads the latter to exert on the outer shell 3 a stress which tends to push said outer shell in substantially centrifugal directions.
• the inflation pouch 5 and the outer casing 3 are substantially disjoint.
• the transmission of the driving stress of the inflation bag 5 to the outer casing 3 takes place when the outer surface 6A of the membrane 6 substantially comes into contact with the inner surface 3A of the outer casing.
• the outer shell 3 preferably substantially conforms to the shape of the inflation pocket 5 in the deployed configuration.
• the inflation bag 5 has, before inflation, overall dimensions substantially smaller than those of the outer shell 3.
• said membrane 6 is preferably ductile and has a mechanical resistance to deformation sufficiently small to allow its distension during the injection of the pressurized inflation fluid.
• the ratio between the surface, in particular the surface, of the inflation pouch 5 in configuration deployed and the surface thereof in the introduction configuration is such that the transition from the introduction configuration to the deployed configuration induces a residual plastic deformation of the said pocket 5.
• residual plastic deformation is meant a deformation likely to subsist at least partially after removal of the inflation stress, especially during the purge of the balloon.
• the volume of the inflation bag 5 considered in deployed configuration may be substantially greater than the initial volume of said inflation bag, and preferably substantially equal to the total volume occupied by the balloon 1 in the stomach 2.
• the ratio between the surface of the inflation bag 5 and / or the membrane 6, in deployed configuration and the surface of said pocket, respectively of said membrane, in the introduction configuration may be substantially between 2 and 5, and preferably substantially equal to 3.3.
• a needle-type endoscopic instrument can be introduced into the balloon 1 by stitching to through the envelope 3 and the membrane 6, at any point of said balloon.
• the balloon finds, according to an important characteristic of the invention, a shape that is favorable to its recovery in the stomach and its extraction by natural means using an endoscopic forceps 20.
• the intragastric balloon 1 comprises extraction configuration setting means 10 capable of moving it from the deployed configuration to a third contracted configuration, called the "extraction configuration", of volume significantly lower than it occupied in the deployed configuration, to promote its extraction by natural channels.
• said extraction configuration setting means 10 are able to exert on said intragastric balloon 1 a constraint to move it from the deployed configuration to the extraction configuration, by acting on the outer envelope 3 such that said outer shell 3 substantially, or tends toward, a predetermined shape corresponding to said extraction pattern.
• the extraction configuration setting means 10 prevent the balloon, by deflating, from forming a mass of disordered material randomly distributed, particularly capable of forming thick beads hindering its extraction.
• the extraction configuration setting means exert a positive action on the balloon during its deflation, and more specifically on the outer shell 3, so as to organize in a substantially predictable manner the material constituting said outer envelope, and more generally of said balloon, in an arrangement conducive to recovery and extraction by endoscopy.
• the extraction configuration therefore corresponds to a state of the balloon in which the latter has not only a relatively small volume, but also a particular disposition of its constituent material.
• the extraction configuration setting means 10 may comprise elements of recall 11 pseudo-elastics which are constrained when the outer envelope 3 is in deployed configuration and tend to contract it to its extraction configuration.
• pseudo-elastic qualifies recall elements 11 which are capable of deforming and / or deforming the balloon 1 but whose behavior is not necessarily strictly elastic, nor necessarily completely reversible, nor absolutely deterministic.
• the pseudoelastic return elements 11 can in particular induce a simple tendency to refold or constrict without returning the balloon in an extraction configuration which is for example strictly identical to its configuration. introduction.
• said return elements 11 are not necessarily in a state of rest free of any mechanical stress, particularly internal, when the balloon is in the extraction configuration.
• the extraction configuration setting means 10 may in particular be able to act on the outer envelope 3 to give it a substantially elongated shape.
• said extraction setting means 10 are also capable of facilitating the purging of the balloon 1 by exerting on this, and especially on the inflation bag 5, a constraint that tends to force the inflation fluid outside said balloon, contributing for example to drive said fluid through the cannula used by the practitioner to perform the puncture.
• the extraction configuration setting means 10 and the shaping means 4 can in particular be substantially antagonistic.
• the extraction configuration setting means 10 are formed by the outer envelope 3 itself and the pseudoelastic return elements 11 are formed by the membranous structure of the latter. this.
• said outer envelope 3 has a memory of intrinsic shape, preferably imparted by its constituent material, which tends to recall it spontaneously from its deployed configuration to its extraction configuration.
• shape memory is meant the ability to find substantially, or to tend towards, a shape or a dimension which has been predetermined, for example by a dimensioning and / or a particular manufacturing process.
• the outer casing 3 can be made at least partly in a silicone-type elastomeric material.
• the silicone envelope will have a substantially ovoid shape and even more preferably substantially elliptical.
• the extraction configuration setting means 10 are preferably arranged so as to give the outer casing 3, when it is in the extraction configuration, a substantially tapered shape having two vertices 12, 14.
• the return elements 11 may be formed for example by ribs secured to the outer casing 3 and arranged "umbrella" around the tops of the tapered shape, or by constriction rings, or by one or more spiral springs. Said return elements may in particular form a kind of substantially ovoid reinforcement or cage conforming to the shape of the outer envelope 3.
• the balloon 1 may have a shape more or less contracted, and particularly an elliptical shape more or less flattened, in extraction configuration.
• the valve 8 can be arranged at one of the vertices 12, 14, in the extension of the tapered shape. More generally, the more rigid and / or thicker zones of the balloon, such as those comprising valves, elements offering a reinforced grasping grip, reinforcement elements or joining elements can advantageously be located at the level of the vertices 12, 14 of the tapered shape.
• the sequencing of the constitutive material of the balloon in the extraction configuration advantageously tends to bring out the elements or zones that are the most mechanically resistant, and therefore the most capable of being grasped and handled.
• This highlighting areas conducive to seizure, and more particularly the more rigid and / or thick elements such as inflation valve or fixing element and / or reinforcement, also facilitates the identification and seizure of said zones by endoscopy.
• “Material constituting the balloon” is understood to mean, in a nonlimiting manner, all the various constituent elements of the balloon 1, such as the outer envelope 3, the inflation bag 5, the valves 8 or the other fastening elements and / or reinforcement 9, considered indistinguishable as an aggregate cluster of material having a volume and shape that can be changed, in particular depending on the presence of inflation fluid 7 or fluid residue inflation.
• the substantially thick and / or rigid elements that form part of the constitution of the balloon 1, such as inflation valve 8 and fastening and / or reinforcing elements 9, will preferably be located in the longitudinal extension of said balloon 1, c that is, oriented so that they have, in a section normal to the longitudinal axis (XX ') of said balloon, in the extraction configuration, their smallest dimension and / or their least mechanical strength.
• said rigid or thick elements which come into the constitution of the balloon 1, such as the valves 8, will preferably be located at the vertices 12, 14 of the outer envelope 3, and thus distributed and ordered substantially along an axis of preferential extension (XX ') in extraction configuration.
• said rigid elements are likely to be engaged in a row in the natural channels during the extraction and conveying of the balloon 1 through the esophagus 17. Aligning said rigid elements in the direction of movement will in particular limit the risk that they will not cling to the walls of the esophagus and they oppose too much resistance to the movement of said balloon.
• the passage in the extraction configuration has the effect of rearranging the arrangement of the material constituting the balloon, to distribute it so that it is under an approach that facilitates its frontal engagement in the balloon.
• esophagus 17 and its course in a row through it as illustrated in Figure 1.
• the substantially “tapered" tapered shape of the balloon 1 in the extraction configuration allows a gradual engagement of the increasing diameter sections thereof in the esophagus 17, which facilitates the crushing and regular distribution of the material. constituent of the balloon, especially at the level of the neck created by the cardia 18.
• the material constituting the balloon 1 in the extraction configuration is capable of passing without becoming wedged through any oesophageal section of the patient in the stomach of which said balloon 1 has been implanted, in particular through a substantially tubular whose diameter D is approximately 18 mm.
• the inflation bag 5 is able to be plastically distended in a substantially homogeneous manner under the constraint of inflation fluid 7, during the passage from the introduction configuration to the deployed configuration, so as to be able to present, in the extraction configuration, that is to say after the release of said stress and the purging of said fluid, a thickness of its membrane 6 substantially lower than it was in the introduction configuration.
• the inflation bag 5 can retain a residual plastic deformation in the extraction configuration which results in dimensional modifications thereof.
• the inflation pouch 5 has a substantially longer elongated shape and a wider perimeter than the introduction configuration, and therefore a smaller thickness over the entire length.
• the material constituting the membrane 6 is re-arranged by plastic deformation, preferably so that said membrane 6 is thinner and its inner 6B and outer 6A surfaces are wider in the extraction configuration than they were not in the introductory configuration.
• the total cumulative material thicknesses of the inflation bag 5 and the outer envelope 3, measured in a direction orthogonal to the longitudinal axis (XX ') of the balloon 1, is substantially lower in the extraction configuration. what it was in introductory configuration.
• this reduction in thickness of the material constituting the inflation bag 5 allows the extraction setting means 10 to act more efficiently, especially when they crush or chase a part of the material constituent of the balloon.
• the inflation bag 5, after plastic deformation has a mechanical resistance to deformation, especially to folding or compression, less than it would have been if its membrane 6 had been thicker, especially substantially as thick as in the introductory configuration.
• the relaxation of the inflation bag 5 following the distension thereof tends to facilitate the folding of said bag under the effect of the extraction setting means 10.
• Said method for manufacturing an intragastric balloon intended for the treatment of obesity comprises a step (a) of producing an external envelope in the course of which an outer envelope 3 is made which is sufficiently flexible to pass from a first configuration in which the balloon occupies a reduced volume, said introduction configuration, to a second configuration, said expanded configuration, in which the balloon has its functional form and occupies a substantially larger volume.
• said step (a) of producing an outer envelope comprises a substep (b) of molding said envelope in a form that makes it possible to obtain a shape memory effect that tends to recall said balloon of its configuration deployed to a third contracted configuration, said extraction configuration, of substantially lower volume.
• the outer casing 3 is made by injection molding of a silicone elastomer.
• the characteristics of the injection mold such as the shape and the distribution of the thicknesses of the impression will be chosen to give the outer envelope 3 a shape memory.
• the sub-step (b) of molding comprises the production of an outer envelope 3 whose shape is substantially elongated, and, even more preferably, tapered and having two vertices 12, 14 .
• an outer casing 3 molded in an ovoid shape of substantially elliptical sagittal section will give the balloon a tendency to fold on itself, at least partially, during the release of the inflation stress, the vertices 12, 14 of the balloon. ellipse retracting a little like an umbrella that is closed.
• the outer envelope 3 may have at rest a variable thickness, for example a finer median zone conjugated to thicker vertices or vice versa.
• a variable thickness for example a finer median zone conjugated to thicker vertices or vice versa.
• the method of manufacturing the balloon 1 furthermore preferably comprises a step (c) of adding to said outer casing 3 a sealed inflation bag 5 which can be plastically distended when it is filled with a fluid 7. under pressure.
• the inflation bag 5 is preferably made of a polymer having a gas permeability lower than that of silicone, for example thermoplastic polyurethane.
• Said inflation pocket 5 may advantageously be achieved by the joining of at least two polyurethane sheets, for example by welding or gluing along a line or a peripheral solder strip.
• each sheet may be formed by at least two superimposed polyurethane films, said films may or may not be joined together, for example by gluing.
• This stratified constitution notably makes it possible to easily adjust the thicknesses of material and to improve the seal.
• the junction between the sheets has a substantially circular geometry.
• the polyurethane sheets may be previously shaped during a shaping step (d), for example by thermoforming or preferably by stretching, so as to give them a hemispherical shape.
• the inflation bag 5 thus has a substantially spherical geometry.
• the inflation bag 5 is preferably arranged in such a way that it substantially retains its spherical geometry during its expansion, and that the thinning of its membrane 6 is substantially homogeneous.
• substantially homogeneous is meant that the material call created by the distension of the pocket 5 is distributed substantially uniformly in the entire membrane 6, and leads in fact to a refinement roughly evenly distributed.
• the membrane 6 of the inflation bag 5 can be distended during inflation without locally exhibiting excessive necking phenomena that may significantly weaken it or lead to its rupture, in particular by tearing or by bursting.
• the inflation pouch 5 according to the invention is therefore particularly stubborn.
• the inflation bag 5 is also designed to maintain its sealing properties vis-à-vis the inflation fluid, even after being distended.
• a substep (c ') of dimensioning of the inflation bag 5 will be preferably carried out, in particular with respect to the outer envelope 2. and a step (c ") for selecting the constituent material (s) of its membrane (6) so that the deformation experienced by said inflation bag (5) during the transition from the introduction configuration to the deployed configuration is essentially plastic. and that the elastic return of its membrane 6 during the passage from the deployed configuration to the extraction configuration is low, or even substantially negligible.
• the pair of parameters (material, dimension relative to the outer casing 3) of the inflation bag 5 is determined so that it satisfies at least two requirements: the first being that said pocket can deform without significantly weakening or losing its seal to a volume sufficient to confer on the outer envelope that marries its functional form in deployed configuration, the second being that this deformation necessary to achieve said deployed configuration results in a plastic deformation of the membrane 6 as it remains after relaxation of the stress, when the balloon is in the extraction configuration, a residual plastic distension.
• the method of manufacturing a balloon 1 according to the invention may also comprise a step (e) of mounting at least one valve 8, through which fluid transfer systems, such as than cannulas.
• said valve 8 is preferably placed substantially in the extension of the tapered shape imparted by molding to the outer casing 3, even more preferably in one of the vertices 12, 14 thereof.
• the substantially thick and / or rigid elements that come into the composition of the balloon 1 will preferably be placed in the longitudinal extension of said balloon 1, that is to say oriented so that they present, in a normal section longitudinal axis (XX '), their smallest dimension and / or their lower mechanical strength.
• preference will preferably be given to the constructive arrangements contributing to an alignment of the rigid or thick elements according to the predictable direction and direction of extraction of the balloon 1, in order to limit the areas likely to provide a grip and lead to accidental attachment or adhesion to the walls of the extraction channels.
• the outer envelope 3 may be at rest, in particular in the introduction configuration and / or at the end of the molding step (b), in an ovoid or ellipsoid shape whose sagittal section substantially corresponds to an ellipse of major axis L of about 100 mm and minor axis of about 85 mm.
• the inflation bag 5 may be made by joining two sheets each consisting of two films of 100 ⁇ m thick, preformed by stretching and welded to a circular profile of about 70 mm in diameter. This produces a deflated pocket whose membrane 6 has a thickness of about 200 microns in the introduction configuration.
• the balloon 1 can then occupy a functional volume of about 700 cm 3 , substantially in the form of a sphere with a diameter of approximately between 100 mm and 110 mm.
• the volume of the inflation bag 5 deployed configuration will substantially correspond to the functional volume of the balloon 1, or about 700 cm 3 .
• the residual plastic distension of the inflation bag 5 may in this case result in a reduction in the thickness of the membrane 6, said thickness after distension then being substantially between 50 microns to 70 microns.
• the initial thickness of the membrane 6 is likely to be approximately conserved in the immediate vicinity of the weld line joining the two polyurethane sheets.
• this residual extra thickness may be in the form of a wide band of about 1 to 2 mm extending on either side of the junction line.
• a shape memory balloon 1 according to the invention comprising a single pocket, in place of the assembly constituted by the inflation bag 5 and the outer envelope 3. , as well as pockets and / or envelopes with several lobes, for example being substantially in the form of orange segments joined by their vertices, without departing from the scope of the present invention.
• the intragastric balloon 1 in accordance with the invention advantageously makes it possible to spontaneously optimize the distribution of the material inside the patient's stomach, especially at the end of treatment, by reducing the amount of material to be engaged frontally in the esophagus 17.
• the preferential presentation in a row, in an elongated shape with regular substantially atraumatic contours, of the constitutive material of the balloon 1 advantageously facilitates the insertion of said balloon from the stomach 2 into the esophagus 17 and then the path of said balloon through the latter .
• the folding effect, preferably ovalization, obtained by the shape memory imparted to the outer shell 3 is facilitated by the thinning of the membrane 6 which then has a lower resistance to deformation and folding.
• the invention finds its industrial application in the design and manufacture of means for combating obesity, such as intragastric balloons.

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• Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Heart & Thoracic Surgery (AREA)
• Nursing (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biomedical Technology (AREA)
• Obesity (AREA)
• Child & Adolescent Psychology (AREA)
• Engineering & Computer Science (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Surgical Instruments (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Prostheses (AREA)

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  • 2006-02-17 FR FR0601462A patent/FR2897529B1/fr not_active Expired - Fee Related
• 2007
  • 2007-02-16 AU AU2007216387A patent/AU2007216387A1/en not_active Abandoned
  • 2007-02-16 BR BRPI0708445-5A patent/BRPI0708445A2/pt not_active Application Discontinuation
  • 2007-02-16 US US12/279,759 patent/US20090093838A1/en not_active Abandoned
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  • 2007-02-16 WO PCT/FR2007/000285 patent/WO2007093717A2/fr active Application Filing
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