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

Definitions

• the present invention relates to the technical field of medical or surgical devices intended to be implanted in a human or animal body, in particular to implantable devices intended to receive an inflation fluid.
• the invention particularly relates to implantable medical or surgical devices intended to be in contact with tissues, biological organs and / or body fluids surrounding them during implantation.
• the invention relates more specifically to a medical or surgical device implantable in a human or animal body, said device comprising a casing consisting of a multilayer complex of which at least a first layer is mainly composed of a first flexible polymer and at least a second layer is mainly composed of a second flexible polymer, the chemical composition of said first and second flexible polymers not allowing the establishment of chemical bonds between said first and second flexible polymers, said envelope being intended to be filled with an inflation fluid.
• the invention also relates to a method for manufacturing an implantable medical or surgical device in a human or animal body, said method comprising a step of manufacturing an envelope consisting of a multilayer complex, said envelope being intended to be filled with an inflating fluid, said step of manufacturing the envelope comprising a first substep of manufacturing at least a first layer predominantly composed of a first flexible polymer and a second substep of manufacturing at least a second layer mainly composed of a second flexible polymer, the chemical composition of said first and second flexible polymers not allowing the establishment of chemical bonds between said first and second flexible polymers.
• an intragastric balloon intended to reduce gastric volume and / or to limit the flow of food.
• the intragastric balloon is generally introduced by the practitioner into the stomach, without surgical intervention, under simple anesthesia, classically by endoscopy. Indeed, most often, the balloon is inserted, in deflated folded form, by the natural routes of the mouth and then esophageal to the inside of the patient's stomach.
• the intragastric balloon receives an inflation fluid, for example air or physiological saline, through a catheter connecting the balloon to the outside of the patient's body, so that the balloon takes a substantially spherical functional form in which it has a therapeutic efficacy.
• an inflation fluid for example air or physiological saline
• the balloon occupies a space in the stomach that can no longer be occupied by food, which effectively limits the ability of the patient to swallow.
• the presence of the balloon in the patient's stomach significantly slows the flow of food, which also helps to reduce the amount of food ingested.
• an intragastric balloon by simultaneously reducing the space available for food in the stomach and helping to limit the speed of passage of food, promotes the rapid achievement of a feeling of satiety for the patient who ingests food and thus contributes to a loss of weight of the latter.
• the known intragastric balloons comprise, most often, a flexible pouch made of an elastomeric material having flexibility and biocompatibility properties, so as to promote an easier introduction of the balloon into the stomach and a good tolerance of the latter for the patient.
• These balloons have in particular sufficient flexibility to be inflated in the functional position and then deflated prior to extraction at the end of treatment, without risk of bursting or violent deflation of the balloon.
• intragastric balloons have a certain porosity to the inflation fluid and tend, in general, to deflate gradually after a certain period of use, which is even more troublesome than the treatment of the Obesity usually has to last several months.
• Such undesired progressive deflation is particularly problematic because it reduces the volume of the balloon, which limits the effectiveness of the treatment and can sometimes force the practitioner to proceed to a new inflation of the balloon.
• a new intervention presents certain risks and in particular that of over-inflating the balloon because the practitioner does not know precisely the volume of inflation fluid that has actually been discharged from the balloon. This deflation problem Inadvertent is also accentuated in the case where these intragastric balloons are inflated with a gas.
• the gas passes, in general, more easily than a liquid through the wall of the balloon.
• a gas and in particular air as an inflation fluid, makes it possible to obtain a balloon that is more comfortable for the patient because the balloon has a much lower weight in the patient's stomach than the balloon. an inflated balloon with a liquid.
• the design of a balloon that is both light and comfortable for the patient, and secondly through which the leakage of inflation fluid remains limited and without impact on the effectiveness of the treatment, is therefore a real challenge technical.
• the known prior balloons may be porous to the gastric fluid that surrounds them, so that a greater or lesser amount of gastric fluid can then migrate, during treatment, into the balloon.
• This presence of gastric fluid within the balloon can cause a certain number of problems, and in particular that of degrading the polymer constituting the balloon due in particular to the high acidity of the gastric fluid.
• Such degradation of the interior of the balloon may reduce the balloon holding in the stomach, and thereby compel the practitioner to remove the balloon from the patient.
• gastric fluid within the balloon can also cause problems when the balloon is removed.
• the practitioner deflates the balloon, generally with the aid of a needle, so as to extract all the inflation fluid from the balloon so that the balloon returns to its deflated initial shape compatible with atraumatic retraction. and simple of the patient's body.
• the contents of the latter become difficult to completely empty, which lengthens and complicates the extraction operation of the balloon, and may, in certain cases, cause a removal of the balloon complex, even traumatic.
• a balloon consisting of two flexible polymer bags, namely an inner bag disposed inside an external pocket.
• the two pockets are interconnected at a valve that allows inflation of the inner bag with an inflation fluid.
• the inner pocket thus acts as a sort of "air chamber” and the increase of its volume, thanks to a contribution of inflation fluid, causes the concomitant increase in the volume of the second outer pocket, so as to obtain an inflated balloon of substantially spherical shape.
• Such a balloon comprising two flexible polymer bags has the advantage of considerably reducing the porosity of the balloon, particularly because of the need for the fluid to pass through two thicknesses of materials in order to enter or exit the balloon.
• the two pockets can be made of elastomeric materials of different nature, so as to improve the tightness of the ball while maintaining its atraumatism.
• the inner bag is made of polyurethane
• the outer bag is made of silicone.
• Polyurethane indeed has excellent gas tightness, but a certain fragility and a surface appearance that can be aggressive for biological tissues. These relative fragility and potentially traumatic nature are compensated by the external pocket which is, for its part, made of silicone, resistant and atraumatic material.
• This two-pocket balloon solves all the problems raised with a balloon comprising a single flexible bag, but could however be optimized.
• the presence of polymers of different nature for each of the pockets, dictated by the specific functions assigned to each of the pockets, can lead to certain problems at the time of deflation and removal of the balloon.
• the internal pocket may tend not to follow the deformation of the outer pocket and to present a different behavior or independent of the outer pocket. In this case, it may result in creasing or creasing of the inner bag while the outer pocket is positioned correctly in the axis of the esophagus during the extraction of the balloon.
• This wrinkling of the internal pocket has a tendency to modify the volume occupied by the deflated balloon, in particular making it more traumatic for the tissues and resulting, in some cases, a more complicated and more traumatic extraction of the balloon.
• gastric fluid it is possible, under certain conditions, that a quantity of gastric fluid succeeds in migrating inside the balloon and remains locked between the two pockets.
• the presence of gastric fluid between the two bags may, in some cases, cause some difficulties at the time of deflation. Indeed, the complete emptying of the balloon becomes longer and more difficult when gastric fluid is present in the balloon. This presence of gastric fluid between the two pockets can sometimes prevent complete deflation of the balloon and thus make the removal of the balloon from the patient's body more traumatic.
• the objects assigned to the invention therefore aim to remedy the disadvantages mentioned above and to propose a new implantable medical or surgical device Atraumatic and fluid-tight, easy and convenient to put in place, and therefore the use is particularly simple and atraumatic for the patient.
• Another object of the invention is to propose a new implantable medical or surgical device made from inexpensive materials, well known and particularly well tolerated by the body.
• Another object of the invention is to propose a new implantable medical or surgical device of simple design that promotes its atrauma in the body.
• Another object of the invention is to provide a new implantable medical or surgical device having excellent fluid tightness and body fluids that surround it, effectively and reliably throughout the treatment.
• Another object of the invention is to propose a new implantable medical or surgical device that can be easily extracted from the patient's body, in particular by limiting any trauma to the tissues.
• Another object of the invention is to propose a new implantable medical or surgical device whose dimensions confer on said device sealing properties while maintaining its atraumatism and flexibility.
• Another object of the invention is to propose a new implantable medical or surgical device that can be used in the medical, surgical or aesthetic field, in particular as part of a treatment against obesity or as a medical device for sampling and / or fluid supply.
• Another object of the invention is to provide a new method of manufacturing an implantable medical or surgical device comprising easy steps to implement and to obtain a new implantable medical or surgical implantable device atraumatic and fluid-tight, easy and practice to put in place, and whose use is particularly simple and atraumatic for the patient.
• Another object of the invention is to propose a novel method of manufacturing a medical or surgical device comprising a step guaranteeing a reliable and long-lasting seal of said device to the fluids.
• Another object of the invention is to provide a novel method of manufacturing a medical or surgical device comprising an operation for ensuring uniform sealing of said device to the body fluid.
• Another object of the invention is to propose a new method of manufacturing a medical or surgical device comprising easy and simple steps to implement to obtain a non-traumatic device, easy to introduce and remove from the body of the patient .
• Another object of the invention is to propose a novel method of manufacturing a medical or surgical device that can be used in the treatment of morbid obesity.
• a medical or surgical device implantable in a human or animal body, said device comprising an envelope consisting of a multilayer complex of which at least a first layer is mainly composed of a first flexible polymer and at least a second layer is mainly composed of a second flexible polymer, the chemical composition of said first and second flexible polymers not allowing the establishment of chemical bonds between said first and second flexible polymers, said envelope being intended to be filled with an inflation fluid, said device being characterized in that it comprises at least a third layer intended to establish chemical bonds with each of said first and second flexible polymers, so as to secure said first and second layers on substantially all their surface.
• the objects assigned to the invention are also achieved by means of a method of manufacturing a medical or surgical implantable device in a human or animal body, said method comprising a step of manufacturing an envelope consisting of a multilayer complex, said envelope being intended to be filled with an inflation fluid, said step of manufacturing the envelope comprising a first substep of manufacturing at least a first layer mainly composed of a first flexible polymer and a second sub-step of manufacturing at least a second layer consisting mainly of a second flexible polymer, the chemical composition of said first and second flexible polymers not allowing the establishment of chemical bonds between said first and second flexible polymers, said method being characterized in that the manufacturing step comprises a third substep manufacturing step; at least one third layer for establishing chemical bonds with each of said first and second flexible polymers, so as to secure said first and second layers over substantially their entire surface.
• FIG. a schematic view in cross section, an intragastric balloon according to a first embodiment of the invention.
• FIG. 2 illustrates, in a schematic cross-sectional view, a detail A of the intragastric balloon of FIG. 1.
• FIG. 3 illustrates, in a schematic cross-sectional view, an intragastric balloon in a second mode embodiment of the invention.
• FIG. 4 illustrates, in a schematic cross-sectional view, a detail B of the intragastric balloon of FIG. 3.
• the present invention relates to a medical or surgical device implantable 1 in a human or animal body, that is to say to a device 1 that can be introduced, implanted or inserted into the body, in particular such that once implanted said device 1 is no longer accessible directly from outside the body.
• the device 1 is, in particular, designed to come into contact with body fluids during its introduction into the body and once implanted.
• body fluid is meant a liquid or a gas present in the body and with which the device 1 may be in contact, for example blood, mucus, gastric fluid, urine or any other type fluid present in the body.
• the device 1 is put in place during a surgical operation, involving local or general anesthesia, or during an endoscopy or any other conventional surgical and / or medical operation.
• the device 1 of the present invention is introduced into the human body by the natural routes, including the oral and esophageal, during a simple medical operation that does not require surgery. It is quite possible to use this device 1 for different applications, including medical or surgical or aesthetic.
• the device 1 of the present invention constitutes one of the following devices: an intragastric balloon, a plastic surgery implant, a gastric ring or a device for injecting and / or sampling fluid within the patient's body.
• the device 1 constitutes a gastric ring
• it is intended to surround the stomach of a patient to reduce the passage diameter of the stomach for the treatment of obesity, that is to say it is designed to enclose the stomach, for example at the stoma, so that the flow of food and the amount of food that can be ingested are considerably reduced, to allow the patient to lose weight.
• the device 1 of the invention constitutes a device for injecting and / or sampling fluid, it takes for example the form of an "implantable site" or a "port of injection "for repetitive injection of drugs.
• the device 1 constitutes a plastic surgery implant, for example a breast implant filled with silicone gel or saline solution. It is also conceivable, according to other embodiments of the present invention, that the device 1 constitutes an orthopedic or articular implant for the replacement of a defective joint for example, or a urinary sphincter used in the treatment of incontinence. urinary.
• the intragastric balloon 2 of the invention is designed to be introduced as naturally as possible into the stomach, so as to reduce the volume of the stomach for the purpose of slimming the patient.
• the practitioner introduces the balloon 2 into a conformation folded and deflated by the mouth and then the esophagus to reach the stomach where it positions said balloon 2 at the desired location, the balloon 2 being permanently connected to the outside the patient using a flexible tube of bio compatible material, for example a catheter.
• the practitioner fills, with the aid of the catheter, the balloon 2 with a fluid of inflation, so that the balloon 2 is in a substantially spherical form in which it has a therapeutic efficacy.
• the balloon 2 comprises an envelope 3 consisting of a multilayer complex, said envelope 3 being intended to play the role of a single wall of said balloon 2.
• single wall it is meant that the balloon 2 has a single pocket separating the balloon. inside the balloon 2 of the gastric medium.
• the balloon 2 has a behavior similar to that of a balloon comprising a single pocket, that is to say that it has in particular an overall behavior, unitary and monobloc when deflated.
• This envelope 3 comprises an inner face 3A and an outer face 3B, the inner face 3A defining a substantially closed chamber 2A.
• the casing 3 has properties enabling it, on the one hand, to form a balloon 2 of substantially spherical shape, and, on the other hand, to maintain the position, the resistance and the therapeutic efficacy of the balloon 2 in the stomach. of the patient.
• the multilayer complex of the invention comprises a combination of several layers forming a joint assembly of which at least a first layer 4, comprising an inner face 4A and an outer face 4B, is mainly composed of a first flexible polymer and at least a second layer 5, comprising an inner face 5 A and an outer face 5B, is mainly composed of a second flexible polymer. All the layers of the envelope 3 are secured to each other over substantially their entire surface.
• the envelope 3 of the balloon 2 is therefore designed in the form of strata, at least two of which are of a different nature and not chemically compatible, said strata forming layers stacked one on the other, associated, joined or glued to each other over substantially their entire surface and encircling the chamber 2A, so as to form a unitary wall to the balloon 2.
• the layers are superimposed and assembled together on substantially their entire surface so continues without space between each of them, so as to form an envelope 3 in one piece giving the balloon 2 a monobloc behavior substantially identical to that of a single pocket balloon.
• the presence of this single layer 3 multilayer has the advantage of avoiding the inadvertent penetration of gastric fluid between the two layers 4, 5.
• the envelope 3 is intended to be filled with an inflation fluid which is contained in the chamber 2 A delimited by said envelope 3.
• the balloon 2 is inflated, until a functional volume is reached. , effective in the context of a therapeutic treatment, substantially equal to 600 ml.
• a supply of inflation fluid into the envelope 3, in particular within the chamber 2A delimited by the envelope 3 thus makes it possible to pass the envelope 3, and more generally said balloon 2, of a reduced volume configuration. an expanded configuration in which said balloon 2 has its functional form.
• the balloon 2 of the invention is inflated with a gas, for example air, so as to obtain a light and comfortable balloon for the patient.
• a gas for example air
• the balloon 2 is designed to go from a folded configuration at low volume, when introduced into the stomach, to an inflated configuration, it is advantageously made of flexible polymer for introduction, deployment, inflation, deflation and easy removal of the balloon 2.
• the first polymer of the casing 3 is an elastomer, preferably polyurethane
• the second polymer of the casing 3 is also an elastomer, preferably silicone.
• Said envelope 3 is thus preferably predominantly composed of at least two layers 4, 5 of biocompatible elastic polymers and well tolerated by the body. It is of course possible that the envelope 3 comprises more than two layers of elastomer and / or that the nature of the layers is modified, that is to say that the outermost is polyurethane and the innermost layer is silicone.
• the first layer 4 of the envelope 3 is the innermost layer of the balloon 2 and is intended to be in contact with the inflation fluid, the second layer 5 of the envelope 3 being, for its part, the layer more external and being intended to be in contact with a body fluid, here the gastric fluid.
• the first layer 4 deforms, due to its elastic properties, and causes in its deformation the second layer 5 attached thereto.
• the first layer 4 is therefore capable of extending, during a supply of fluid, to take a substantially spherical shape corresponding to the shape of the second layer 5 during a supply of inflation fluid, said second layer 5 having advantageously a substantially spherical shape memory.
• the first layer 4 has a certain fluid tightness that can enter and / or exit the balloon 2.
• the polyurethane is an elastomer less porous to fluids than silicone.
• the first layer 4 thus advantageously has, in addition to its aforementioned spherical shaping function, a natural barrier function limiting the entry and / or the fluid outlet of said balloon 2.
• the second layer 5, preferably mainly composed of silicone, has, for its part, a function of mechanical resistance, of atraumatism and flexibility favoring a good tolerance of the balloon 2 in the body. Indeed, silicone is a material perfectly well tolerated by the body, limiting the risk of infection, resistant to the acidity of the stomach environment and widely used in many medical or surgical applications, inside the body.
• the combination of these two layers 4, 5 made of elastomer in the casing 3 thus has the advantage of limiting the flow of fluids through said casing 3, which considerably improves the efficiency of the balloon 2, in particular avoiding deflation. premature and premature balloon, and limiting the internal degradation of the balloon 2 by the particularly acidic gastric fluid, which could infiltrate to the chamber 2A. This association also makes it possible to obtain a flexible and atraumatic balloon.
• the balloon 2 of the invention comprises on the one hand at least a first inner layer 4 whose main function is to limit the transfer of fluids between the balloon 2 and the gastric medium, in both directions, and on the other hand at least a second outermost layer 5 whose function is to make the balloon 2 both atraumatic and flexible.
• the constituent polymers of said layers 4, 5 are chosen for their properties in relation to these functions that must be fulfilled by said layers 4, 5.
• the sealing properties are, in general, advantageously fulfilled by polyurethane-type polymers whereas the Flexibility and atraumatic properties are preferentially satisfied by silicone-type polymers.
• the balloon 2 also comprises at least a third layer 6, comprising an inner face 6A and an outer face 6B, intended to establish chemical bonds with each of said first and second flexible polymers, so as to secure said first and second layers 4, 5 over substantially their entire surface.
• the third layer 6 is an intermediate layer which is positioned between the first layer 4 and the second layer 5 of the envelope 3.
• This third layer 6 is capable, because of its chemical nature in particular, to establish chemical bonds with each of the first and second layers, over their entire surface.
• the chemical bonds are advantageously strong bonds, preferably covalent bonds, so as to allow solid attachment of the first and second layers 4, 5 between them.
• the third layer 6 of the envelope 3 comprises a single first underlayer 7 mainly composed of at least one biocompatible compound based on silicon, preferably from minus one silicon oxide and / or at least one silane and / or at least one siloxane and / or at least one carbosilicon compound.
• the first sub-layer 7 contributes to improving the tightness of the first layer 4, and more generally of the envelope 3, with the gastric liquid, which contributes to guaranteeing the stability of the balloon 2 throughout the duration of the treatment, in particular attenuating the porous nature of the envelope 3 and constituting an effective barrier for the latter.
• the first subset layer 7 may comprise a compound of formula SiCH and / or a silicon oxide of formula SiO 2 and / or a siloxane with a methyl group of formula SiO (CH 3 ) 3 .
• the first sub-layer 7 of the third layer 6 may comprise several of the above-mentioned compounds, said compounds also being able to be arranged in the form of several layers stacked one on the other, so as to improve the watertightness of the envelope 3 and in particular of the first layer 4.
• the first sub-layer 7 of the third layer 6 of the envelope 3 is intended to establish chemical bonds with the first layer 4 of the envelope 3 on the one hand and with the second layer 5 of the envelope 3 on the other hand.
• the first sub-layer 7 of the third layer 6 establishes chemical bonds, preferably covalent bonds, with the polyurethane and the silicone in order to effectively secure the first and second layers 4, 5 together.
• the thickness of the first sub-layer 7 of the third layer 6 of the envelope 3 is substantially between 50 nm and 2000 nm, and preferably substantially between 50 nm and 300 nm. Such a thickness being sufficient to seal the envelope 3 while maintaining flexibility and atraumatism of said envelope 3.
• the third layer 6 of the envelope 3 advantageously comprises a second sub-layer 8 predominantly composed of at least one biocompatible metal and / or at least one biocompatible ceramic, preferably chosen from the following group: silver, platinum, titanium, aluminum, alumina, zyrcone, titanium oxide.
• the composition of the second sub-layer 8 also contributes to sealing the envelope 3, in particular by preventing the inflation fluid that can escape from the balloon 2.
• the third pocket 6 comprises only a second sub-layer 8, without silicon-based underlayer, comprising one or more strata (s) of metal and / or ceramic.
• the thickness of the second sub-layer 8 of the third layer 6 of the envelope 3 is substantially between 50 nm and 2000 nm, and preferably substantially between 50 nm and 200 nm, preferably substantially equal to 100 nm.
• the third layer 6 of the envelope 3 is mainly composed of at least a first sub-layer 7 and / or a second sub-layer 8, so as to increase the tightness of the envelope 3, more generally of the balloon 2, both to the fluid it contains and to the body fluid.
• the third layer 6 also promotes the assembly of the first and second layers 4, 5.
• the first sub-layer 7 is deposited on the first layer 4 and acts as hooked for the second sub-layer 8 on said first layer 4.
• the silicon-based compound promotes the holding of the metal and / or ceramic constituent ve) of the second sub-layer 8 on the first layer 4.
• adhesion primers are used which are coated on the metal underlayer so as to promote the formation of chemical bonds between the metal and the second layer 5 silicone.
• the third layer 6 of the envelope 3 comprises at least a first underlayer 7, at least a second underlayer 8 and at least a third underlayer 8. layer 9, said first and third sub-layers 7, 9 being of substantially identical composition, the second sub-layer 8 being interposed between said first and third sub-layers 7, 9, so that each of said first and third sub-layers 7, 9 are intended to establish chemical bonds with the first and second layers 4, 5 of the envelope 3 respectively.
• Such a composition of the third layer 6 makes it possible at the same time to perfectly seal the balloon 2 and to ensure a solid connection over substantially all their surface. said first and second layers 4, 5 of the envelope 3 of the balloon 2.
• the third layer 6 thus advantageously plays a role of surface treatment of the first layer 4 to allow the latter to be secured to the second layer 5, preferably silicone.
• the second layer 5 is coated with a silicone-based adhesive, said adhesive allowing the establishment of chemical bonds, preferably covalent bonds, between the third layer 6 and the second layer 5.
• the various layers previously described make it possible to obtain an envelope 3 of thickness substantially between 0.1 and 0.9 mm, advantageously substantially equal to 0.5 mm, and preferably substantially less than 0. , 4 mm.
• the casing 3 thus has the advantage on the one hand to barrier the inflation fluid, in particular gas, and body fluid, for example gastric fluid, and on the other hand to be thin enough to preserve its elasticity and fold properly during deflation to promote the extraction of the balloon 2 by the esophagus.
• the envelope 3 comprises the following layers, from the inside to the outside of the balloon 2:
• a first sub-layer 7 of a third layer 6 comprising at least one silicon-based biocompatible compound, forming a homogeneous and amorphous sub-layer on the first layer 4 and whose thickness is substantially less than 0.3 ⁇ m,
• a second underlayer 8 of a third layer 6 comprising a metal deposit based on at least one biocompatible metal and / or at least one biocompatible ceramic, preferably made of gold.
• the second sub-layer 8 forms a homogeneous sub-layer, compact and integrally secured to the first underlayer
• a third sub-layer 9 of a third layer 6 comprising at least one biocompatible compound based on silicon, forming a homogeneous underlayer and amorphous on the second sub-layer 8 and whose thickness is substantially less than 0.3 ⁇ m,
• This layer superposition configuration advantageously promotes the good performance of the first and second layers 4, 5, while giving the balloon 2 excellent sealing both the inflation fluid, including air, and gastric fluid. Consequently, such a multilayer complex forming the envelope 3 of the balloon 2 has the advantage of guaranteeing bidirectional sealing of the balloon 2, not only to the body fluid likely to enter the balloon 2, but also to the inflation fluid able to exit 2. It is also conceivable to use a greater number of layers or sub-layers, without departing from the scope of the present invention.
• the inner face 4A of the first layer 4 and / or the outer face 5B of the second layer 5 may be covered with one or more sub-layers comprising at least one biocompatible compound based on silicon and / or at least one biocompatible metal and / or at least one biocompatible ceramic, as previously described.
• the present invention also relates, as a whole invention, a medical or surgical device 1 implantable in a human or animal body, said device 1 comprising a casing 3 intended firstly to be filled with an inflation fluid and on the other hand, to be in contact with body fluids, said envelope 3 consisting of a multilayer complex of which at least a first layer 4 is mainly composed of a first polymer having inflation-fluid sealing properties and / or to body fluids and at least a second layer 5 is mainly composed of a second polymer having flexibility and atraumatic properties, said device 1 being characterized in that it comprises at least a third layer 6 intended to establish links with each of said first and second polymers so as to join said first and second layers together s 4, 5 on substantially their entire surface.
• the first and second polymers are preferably elastomers as previously described, especially polyurethane and silicone respectively, not chemically compatible spontaneously or with the use of conventional adhesives.
• the balloon 2 of the invention therefore has the advantage of being, on the one hand, impervious to the inlet and the outlet of the fluid, particularly because of the presence of the first polyurethane layer and the third intermediate layer 6. and on the other hand atraumatic and well tolerated thanks in particular to its second outer silicone layer 5.
• the multilayer conformation of the envelope 3, with, in particular, the presence of a third layer 6 designed to assemble, over substantially their entire surface, said first and second layers 4, 5, which are not naturally chemically compatible, makes it possible to confer on the balloon 2 a behavior of a single pocket balloon.
• the presence of a single casing 3 avoids any risk of entry and stagnation of gastric fluid between the layers of the balloon 2.
• the present invention also relates to a method of manufacturing an implantable medical or surgical device in a human or animal body.
• the following description will focus on a method for producing an intragastric balloon for the treatment of obesity, said balloon being intended to be implanted in the stomach of a patient to reduce the internal volume of the stomach.
• the method can be used for the manufacture of other types of implants and can thus constitute, for example, a method of manufacturing a gastric ring for the treatment of obesity, a urinary sphincter for the treatment of urinary incontinence, a plastic surgery implant or an injection device and / or fluid sampling within the body of the patient.
• Said method comprises a step of manufacturing an envelope 3 consisting of a multilayer complex, said envelope 3 being intended to be filled with an inflation fluid.
• the manufacturing step of the envelope 3 comprises a first substep of manufacturing at least a first layer 4 mainly composed of a first flexible polymer, preferably an elastomer such as for example polyurethane.
• the first layer 4 is manufactured by assembling two polyurethane sheets by high frequency welding and is intended to contain the inflation fluid, preferably a gas.
• This method also comprises a second substep of manufacturing at least a second layer 5 mainly composed of a second flexible polymer, preferably a elastomer such as for example silicone.
• This second sub-step advantageously comprises a molding operation of the second layer 5 in order to obtain a second layer 5 of substantially spherical shape with shape memory, ie after molding the second pocket 5 retains a memory of a substantially spherical shape.
• the chemical composition of said first and second flexible polymers does not allow the establishment of chemical bonds between said first and second flexible polymers, in particular between polyurethane and silicone, the silicone being deemed to be insoluble.
• the manufacturing step of the method of the invention comprises a third substep of manufacturing at least a third layer 6 intended to establish chemical bonds with each of said first and second flexible polymers, so as to secure said first and second layers 4, 5 over substantially their entire surface.
• the third manufacturing substep is performed after the first substep of manufacturing the first layer 4, prior to the second substep of manufacturing the second layer 5.
• the third substep of manufacturing comprises preferably, a first deposition operation of a first sub-layer 7 predominantly composed of at least one biocompatible compound based on silicon, preferably a silicon oxide and / or a silane and / or a siloxane and / or a carbosilicon compound.
• the first deposition operation corresponds to a sealing step and is performed by cold plasma deposition corresponding in particular to a cold chemical vapor deposition "plasma assisted chemical vapor deposition" (PACVD).
• PSVD cold chemical vapor deposition
• This technique consists in sending one or more gases, for example hexamethydisilane (HMDS) and / or tetramethylsilane (TMS) and / or hexamethyldisiloxane (HMDSO), and ionizing said gas or gases.
• gases for example hexamethydisilane (HMDS) and / or tetramethylsilane (TMS) and / or hexamethyldisiloxane (HMDSO)
• the vapor phase deposition operation comprises a grafting of the silicon-based compound on the first layer 4, said grafting making it possible to carry out covalent bonds between the molecules of said silicon-based compound with each other on the one hand, and between the molecules of said silicon-based compound and the molecules of said first layer 4 of said balloon 2 on the other hand.
• the third manufacturing sub-step also comprises a second deposition operation of a second sub-layer 8 mainly composed of at least one biocompatible metal and / or at least one biocompatible ceramic chosen advantageously in the following group : gold, silver, platinum, titanium, aluminum, alumina, zyrcone, titanium oxide.
• the second sub-layer 8 preferably predominantly composed of gold, is also deposited by cold plasma deposition, the first sub-layer 7 beforehand. deposited on the first layer 4 advantageously forming an underlayer for effective holding of the second sub-layer 8 on the first layer 4.
• said first sub-layer 7 thus constitutes an effective adhesion interface
• the third manufacturing sub-step also comprises a third operation of depositing a third sub-layer 9. predominantly composed of at least one silicon-based biocompatible compound as previously defined for the first sub-layer 7.
• the deposition operation of the third sub-layer 9 is preferably performed by a substantially cold plasma deposition technology. identical to that mentioned above.
• the cold plasma deposition makes it possible on the one hand to obtain homogeneous sub-layers 7, 8, 9 and of constant thickness, and on the other hand to establish solid bonds between the deposited silicon-based compound molecules. and, between the molecules of silicon-based compounds and said first and / or second layers 4, 5.
• This technique makes it possible in particular to obtain a crosslinking between the molecules of the first and / or third sublayer 7 , 9 between them and between the first and / or third sub-layer molecules 7, 9 and the first layer 4 and / or the second layer 5 molecules.
• the molecules are bonded to each other monomer by monomer, which promotes the recovery of the pores of the constituent polymer of the first layer 4 and / or the second layer 5 and thus improves the tightness of the balloon 2.
• any other method making it possible to obtain the deposition of the sub-layers 7, 8, 9 of the envelope 3 could be envisaged, for example the deposition by the chemical vapor deposition technique "chemical vapor deposition” (CVD) for depositing on non-heat-sensitive materials.
• CVD chemical vapor deposition
• the manufacture of the third layer 6, by the PACVD process advantageously makes it possible to continuously deposit several alternative strata of compounds based on silicon and / or metal and / or ceramic, following each other, without any change or stop the machine. This technique also avoids the columnar structures of metal that may eventually form.
• the cold plasma deposition is done when the first layer 4 is in an expanded configuration, having a volume at least equal to that which will occupy the balloon 2 in the patient's stomach, in order to avoid possible subsequent risks of cracking of the third layer 6 during inflation of the balloon 2.
• a rotation of the balloon 2 is preferably implemented during the cold plasma deposition of the third layer 6, so as to promote a deposit uniform and of constant thickness.
• the manufacturing step further comprises a bonding operation of the first layer 4, previously covered with the third layer 6, with the second layer 5, the bonding comprising a coating operation of said second layer 5 and / or the third layer 6 with a polymer adhesive which establishes chemical bonds between the third layer 6 and the second layer 5, in order to secure said first and second layers 4, 5.
• the operation bonding occurs after the manufacturing sub-steps of the first and third layers 4, 6 of the casing 3.
• silicone adhesive is deposited, preferably on the internal face 5A of the second silicone layer 5, which is then assembled with the first polyurethane layer 4, the silicone glue making it possible to establish chemical bonds, in particular Si-S type covalent bonds. iO, between the third layer 6 and the second layer 5 in order to secure said first and second layers 4, 5.
• the polymer adhesive is deposited indifferently on one of the sub-layers 7, 8 or 9 of the third layer 6 when said sub-layer is in contact with said second layer 5.
• the manufacturing step comprises a soaking operation of the first layer 4, previously covered with the third layer 6, in a liquid polymer which establishes chemical bonds, in particular Si-SiO type covalent bonds, with the third layer 6, so as to join said first and second layers 4,5.
• a first layer 4 is produced which is covered by the method described above with a third layer 6.
• the jacket 3 is dipped in a liquid polymer. , preferably in liquid silicone, the third layer 6 then forming covalent bonds with the silicon atoms of the liquid silicone, so as to promote the formation and the holding of the second layer 5 made of silicone on the first layer 4.
• soaking operation makes it possible to obtain a second layer 5 of thickness substantially less than 150 ⁇ m, thus favoring obtaining an intragastric balloon 2 comprising a shell 3 of thickness substantially less than the thickness of the two pockets of previous balloons.
• the implementation of the method of the present invention makes it possible to obtain an intragastric balloon 2 comprising a casing 3 forming a single wall, all the layers of which are perfectly fixed on substantially their entire surface. Therefore, this process promotes the production of a fluid-tight balloon 2 with a single wall, easy to use and atraumatic.
• such a method ensures the manufacture of a balloon 2 not likely to wrinkle during its extraction from the stomach and having a general use behavior substantially identical to that of a balloon 2 comprising a single pocket.

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• 2009
  • 2009-12-09 US US13/133,434 patent/US20110276076A1/en not_active Abandoned
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  • 2009-12-09 EP EP09803744A patent/EP2387380A1/fr not_active Withdrawn
  • 2009-12-09 WO PCT/EP2009/066674 patent/WO2010066761A1/fr active Application Filing

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