MXPA06002647A - Intragastric balloon assembly. - Google Patents

Abstract

The invention relates to an intragastric balloon assembly. The invention combines three medico-surgical elements, namely: (i) an intragastric balloon, (ii) a valve for regulating postoperative inflation and the percutaneous gastronomy technique with endoscopic control, and (iii) a novel means for fixing the assembly that prevents the migration of the balloon. The inventive intragastric balloon assembly comprises a silicon balloon which is provided with a fixed inflation catheter and an attachment consisting of a silicon tube which is bigger at the balloon inlet. Said silicon tube acts as a tension support and is fixed to the aponeurosis by means of a plate that can be adjusted as required, said adjustable plate being secured to the aponeurosis with suture points or metal clips. Once said elements have been secured, the support is cut and the catheter is connected to an inflation valve which is placed under the skin and which is secured to the aponeurosis with points or clips.

Description

INTRAGASTRICO BALL SET Field of the Invention The present invention relates to the type of medical devices used to reduce the dietary intake of people with overweight problems, especially in people with morbid obesity.

Background of the Invention Exogenous obesity, which has been termed as morbid or other adjectives, generally means an increase in weight in an important proportion according to height, age, etc., and which can put life at risk due to the problems that the very overweight produces. Given this medical circumstance, the various medical treatments available for weight reduction generally fail, so in the vast majority of cases, surgical procedures have remained the only possibility of treatment with real effectiveness. The problem of obesity is so important in developed countries that has come to be considered a public health problem, so the most important objective of all therapy is to try to solve this condition with more effective treatments and involving fewer complications, morbi-mortality, and costs. In the sixties and seventies, surgical experiences were made and reported to try to reduce overweight by creating shunts that produced the effect of a short bowel with generally disastrous results, since morbi-mortality was so high that they motivated almost total abandonment, until the appearance of surgical implements such as staplers, which arrived in our country in the late seventies and early eighties, thus initiating a series of works published around the world, especially gastroplasties and referrals with multiple variations, whose results were good in terms of control and weight reduction, but implied open surgery, with surgical risks, anesthetics, etc., as well as high costs. More recently, about 5 years ago, a new surgical technique appeared that consists of placing, via laparoscopy, an inflatable band around the stomach in its upper portion, by means of a subcutaneous valve, which can be controlled by radiology and / or endoscopy. With this technique there is a gastric reduction and decrease in intake that results in a significant weight loss, practically equal to that obtained in open surgery with staplers, but with less morbidity and mortality and the advantages of laparoscopic surgery. , this is with less pain and quick post-operative recovery. However, the most important problem with this surgical technique is the increase in cost, since it is still a hospital, surgical and laparoscopic procedure combined with the cost of the band, and which also requires specialized and experienced surgeons. At the beginning of the 1980s, the first reports of the use of intragastric balloons for the treatment of obesity appeared, which partially fill the stomach to induce a feeling of satiety in patients and thus help to reduce food intake and adopt new eating habits. Since then and for the next 10 years or so publications have appeared in the scientific literature of different countries with different experiences on the use of balloons of different materials, most of them reporting failures or very low percentages of success, due to the multiple complications and difficulties They are presented both in their placement and in their management and monitoring during the treatment time, so the method was losing credibility and in many cases abandoned, except isolated experiences reported in various publications. Currently the company Bioenterics Corporation, manufactures and distributes an intragastric balloon called BIES® System, which is little used since the same company recommends it only as an alternative in short programs of limited reduction or in some cases prior to definitive surgery, for which they recommend surgery to reduce gastric capacity, by laparoscopy using a gastric band that the same company produces. The most important problems that have arisen in the use of intragastric balloons are on the one hand the material from which they were manufactured, since at the beginning elements that were easily destroyed by gastric juices were used, so they should be replaced frequently, however, this has now been solved by using silicone resistant materials that can remain up to several months inside the patient. Other important difficulties are the rupture of the balloon, which results in the migration of the same to the intestine, eventually causing the intestinal blockage that requires surgery, and also the migration of the inflated balloon that also causes the blockage of the esophagus or pylorus. . Moreover, with the balls available on the market, there is a great technical difficulty for its endoscopic placement and maintenance or modification of the inflation, once placed inside the stomach. There are several documents describing intragastric balloons with improvements that aim to overcome some of these disadvantages, among which are those described in the US Patent No. 5,259,399 of Alan Brown, which consists of a balloon that is placed in the fundus of the stomach through a percutaneous gastrostomy and it is placed right up to the foot! of the patient, with a thick semirigid or rigid attachment, through which a balloon is inserted which is inflated and deflated with solutions, and controlled by sensors placed on the patient's body, and an electric pump operated with batteries, which is placed outside the host's body. This device has the disadvantage that the patient must support a catheter or thick catheter outside the skin of the abdomen and that probe or catheter must be connected to the equipment for inflation and deflation each time that food is ingested, which is extremely important. uncomfortable for the patient. On the other hand, US Pat. No. 5,234,454 by Roger G. Bangs, describes an intragastric balloon placed through a surgical gastrostomy previously performed (several weeks before), to then place the balloon, which implies prior surgery. Additionally, the probe used is very thick, approximately 1 cm in diameter or more, and is external, which means that the patient must remain with a probe on the outside of his body through a hole in the abdominal wall, which in addition to the inconveniences found in the case of Alan Brown's American patent causes constant pain and discomfort to the patient. The device Bangs has two balloons one for inflation and to keep the stomach attached to the abdominal wall inside and another more distal balloon that serves for the purpose of filling the stomach. The Mexican patent application No. PA / a / 2000/00 922 corresponding to the application of US Patent No. 2001/0037127 A1 of Andrés de Hoyos Garza describes a percutaneous intragastric balloon catheter for the treatment of obesity consisting of a modification to the endoscopic percutaneous gastrostomy tube that has been modified at its proximal or gastric end, being provided with a balloon that is inflated with air at different volumes through an external or extragastric valve by means of a manometer or syringe. The advantage described by de Hoyos in relation to what is already known is that said balloon neither moves in the stomach nor moves even when there is rupture since it is fixed, and its filling capacity can be controlled externally at any time. The disadvantage found with this system is that it is fixed on the outer side of the stomach wall on the skin, this causes the patient to carry external elements, this can be very uncomfortable for the same. On the other hand, Hoyos does not describe or disclose the way to fix the system and something very important does not contemplate or resolve the leakage of gastric fluid or possible infections of the stomach wall. Also, U.S. Patent Application No. 2002/0055757 of Roger de la Torre et al. They describe a method and a device for use in the placement of an intragastric device of minimal invasion, said device describes an expandable component and fasteners such as sutures, this device is partially extended through the stomach wall and fastened or anchored in the stomach of the patient. The device can be expanded out or removed by a transesophageal approach and / or through a combination of transesophageal or transabdominal approaches. In this invention the balloon is fixed to the stomach and the abdominal wall by means of sutures, which can cause tissue necrosis and in a few days leaks, infections or even perforation of the stomach, and also once the system has been installed inside the stomach. Inflation control is not resolved. Moreover, US Pat. No. 5,993,473 to Young C. Chang and Mei H. Chan, discloses an expandable body device for the gastric cavity that includes an expandable elastic body, a rigid, sealed delivery tube connected to the expandable body and It has a fastener and a valve on the base of the filling tube. The device proposed by Chang and Chan includes some elements arranged outside the abdominal wall with a rigid and wide catheter, which causes greater discomfort to the patient and additionally does not resolve the fixation technique in the abdominal wall. Therefore, there is a need to have a means for the treatment of morbid obesity that allows to reduce the surgical and post-operative risks, easy to handle and install by means of a surgical technique of minimal invasiveness, without laparoscopic surgery or any other type, with less anesthesia or surgical trauma, that has a control of inflammation, that produces a controlled and significant weight reduction, similar to the current surgical procedures of gastroplasia surgeries and band placement, substantially eliminate the patient's discomfort and also reduce the costs of another surgical treatment.

SUMMARY OF THE INVENTION The present invention therefore aims to provide an intragastric balloon set that remains fixed to the abdominal wall, to prevent movement and therefore any possibility of resultant injury to the gastric wall as a result of such movements as well. as any obstruction or blockage caused by the breaking of the ball Further, the balloon assembly of the invention aims to avoid both the discomfort caused by external elements, and to make less apparent the presence of the elements of the set in the body of the patient.

A further objective of the invention is to cause the patient less anesthetic-surgical trauma during the implantation of the intragastric balloon. Thus, it is also an object of the invention to provide the elements for controlling the amount of inflation of the intragastric balloon at any time after its placement. It is also an object of the invention to reduce the cuts in the patient's tissue as well as to reduce the number of fixed elements of the intragastric balloon assembly within the patient's body. Also, another objective of the invention is to provide a ball that can be made in various forms and that has a greater capacity than those currently available, since some people tend to develop larger stomachs. In addition, the invention aims to reduce the risks of open surgery, as well as the risks of hospitalization and costs, by performing ambulatory or short-stay surgery. Another additional and significant objective of the present invention is to provide a means to prevent the leakage of gastric fluid into the cavity or abdominal wall at the balloon fixation site, thus eliminating any possibility of contamination or infection, this would result in the need for Remove the system These and other objects are carried out by the present invention which combines a new set of intragastric balloon that remains fixed inside the patient without visible external elements; a fixing means that prevents the migration of the balloon; elements for inflating the balloon when placed inside the patient's stomach and for modifying its volume at any later time; as well as a percutaneous gastrostomy technique with endoscopic control that eliminates the high costs of laparoscopic surgery and those related to hospitalization, general anesthesia, etc. The intragastric balloon assembly of this invention consists of a balloon, preferably made of silicone or other material that is not corrosive to the gastric juices and a rigid support fixedly attached thereto, preferably formed integrally with the balloon, which will serve as a means of traction to transport the balloon into the gastric cavity and also as a tension support. Said rigid support is fixed to the aponeurosis by means of a fixation plate that can be secured with stitches or metal staples. In this way, external elements on the skin of the abdomen are avoided, such as thin probes or trocars that are uncomfortable for the patient and are also difficult to control and susceptible to infection. The invention also contemplates providing a means of inflating the balloon, consisting of an inflation catheter fixedly attached to the balloon at a point adjacent to the rigid support and preferably attached to said support along its length releasably, to supply a fluid to the balloon to inflate it to a predetermined volume. Said catheter is separated from the rigid support once the intragastric balloon is disposed within the stomach and then connected to an inflation valve that is fixed subcutaneously and secured to the aponeurosis with sutures or staples, said inflation valve controls the size of the intragastric balloon after placing it. One of the objectives of the invention is to reduce the cuts in the patient's body, as well as the fastening elements of the intragastric balloon assembly and considering that the embodiment of the invention described above contemplates that the rigid support is attached to a subcutaneously fixed plate while the inflation catheter is also connected to the valve subcutaneously and placed separately to through it or another incision in the abdominal wall. In a further embodiment of the invention there is provided an element that allows to integrate the fixing plate and the inflation valve in such a way that in the preferred embodiment a tubular device is disposed in the center of the valve to pass the rigid support through of the same, also having a flange on the upper side of the plate that allows to suture and fix the rigid support to the plate under a certain tension. In a further effort to reduce the fasteners in the intragastric balloon assembly of the present invention, a third embodiment contemplates disposing the inflation catheter detachably attached to the balloon in a distal position from the rigid support, preferably in a diametrically position. opposite, where a self-sealing inflation valve is also provided on the balloon. In this way the balloon is initially inflated through the catheter, in a manner similar to currently available balloons, but once the balloon has been fixed in the stomach by means of the rigid support and the fixation plate, in the manner previously described, easy handling of the balloon is allowed for any subsequent inflation or deflation process during the course of treatment, being done through endoscopy through the esophagus, therefore such processes are carried out in a rapid manner, which causes minor inconveniences to the patient. In order to fulfill the objective of preventing leakage of the gastric contents into the tissues, in a further embodiment of the invention, a means is provided to promote fibrosis and scarring of the stomach wall at the point of perforation for fixation of the balloon, thus promoting the union of the assembly to the abdominal wall in the peritoneum layer, said means consists of a layer of a material that promotes fibrosis and scarring such as gorotex, mersilene or similar, applied on the rigid support and the base of the ball, this is the place where the support emerges, which is in contact with the wall of the stomach and the abdominal wall, above the aponeurosis. Furthermore, to allow a better adhesion of the balloon to the stomach and stomach to the abdominal wall, a further embodiment of the present invention is contemplated which provides a circular reinforcement made of the same material as the balloon, arranged adjacent to the base of the balloon. ball, that is, the point where the rigid support emerges, formed integrally with the ball, said circular reinforcement consists of a disc having reliefs formed and distributed radially therein and on the edge thereof, with the purpose of not interrupting the blood circulation of the tissue that is in contact with the intragastric balloon and other elements of the set, avoiding any possibility of necrosis in that area of the stomach. Also, in a further preferred embodiment of the invention, the intragastric balloon assembly also includes a circular folding plastic screen, made of a material such as soft silicone, disposed on and integrally made with the rigid support, which extends outwardly within the abdominal cavity, very similar to an umbrella, said screen being deposited on the outer wall of the stomach and on the peritoneum, adhered in a circular area on one side of the base of the balloon, perfectly sealing the area of the hole made in the stomach. This plastic screen forms a layer that avoids leaks of the gastric juice that can cause greater complications, such as a bacterial infection, both in the cavity and in the abdominal wall.

Brief Description of the Drawings. Figure 1 shows the intragastric balloon assembly of the present invention according to a first embodiment; Figure 2 shows a flat top view of the fixing plate of the present invention; Figure 3 is a diagram showing how the balloon of the present invention is implanted. Figures 4A and 4B, shows a perspective view and a planar top view, respectively, of an arrangement of the inflation valve integrated with the fixing plate of the intragastric balloon assembly according to a second embodiment of the invention; Figures 5A and 5B are a perspective side view and a planar top view, respectively, of a second arrangement of the inflation valve integrated with the fixation plate of the intragastric balloon assembly according to the second embodiment of the invention; Figure 6 shows a diagram of how the intragastric balloon assembly has been implanted according to the second embodiment of the invention; Figure 7 shows the balloon assembly of the invention, deflated according to a third embodiment of the invention; Figure 8 shows the intragastric balloon assembly of Figure 7 in its deflated form with the inflated catheter; Figure 9 shows a diagram illustrating how the intragastric balloon assembly of Figure 7 has been implanted; Figure 10 shows the base of the balloon of the intragastric balloon assembly in the inflated state according to the fourth embodiment of the invention; Figure 11 shows a diagram of how the intragastric balloon assembly has been implanted according to the fourth embodiment of the invention; Figure 12 is a cross-sectional view of the scheme of Figure 11, at the point where the balloon is attached to the stomach wall showing the arrangement of the reliefs on the balloon; and Figures 13 to 15, illustrate the surgical technique for implanting the intragastric balloon assembly of the present invention.

Detailed Description of the Invention The intragastric balloon of the invention, illustrated in Figure 1, is constituted by a balloon 1, which is preferably made of compliant elastic silicone, with an approximate capacity between 200 to 1000 ce. and can present a form either circular (as shown in Figure 1) or bilobed or kidney-shaped. Said balloon 1, is provided with a rigid support 2, which serves as a guide and support thereof, consisting of an elongated element such as a solid tube made preferably of silicone, which is fixed unitary to the balloon 1 and which presents a diameter that is greater at the end joined to the balloon 1 and is reduced towards its opposite end, in which it has a handle 3 for holding. Likewise, said rigid support 2 has a notch (not shown) that extends through its length from the end attached to the balloon 1 to approximately 15 cm forward, which serves to receive the inflation catheter 4, which is attached to support 2 and which can easily be detached therefrom. Said inflation catheter 4 has a diameter between approximately 1.5 to 2.0 mm and a length of approximately 20 cm. Likewise, the invention contemplates the provision of an inflation valve 5 which is a safety valve of plastic or silicone firm of approximately 2 cm in diameter and 1 cm in height, which is readily available in the market, and which presents two or three eyebrows for fixing (not shown). Said inflation valve 5 is attached to the inflation catheter and fixed to the aponeurosis. In addition, the balloon assembly of the invention includes a fixing plate 6, shown in greater detail in Figure 2, which is a plate of approximately 1 to 1.5 mm in thickness, and is preferably made of silicone or inert plastic of greater hardness, which is illustrated with a rectangular shape rounded by its ends, but this can vary either circular, ovoid, etc. and whose diameter is preferably between 4 to 5 cm. Said fixing plate 6, has a first hole 7 which has a circular rim 8 which fits and fixes the rigid support 2 and a second hole 9, through which passes the inflation catheter 4, and also includes several holes of fixing 0, preferably 4 of these holes. The implantation of the intragastric balloon assembly of the present invention, (figures 12, 13 and 14) is made to be introduced with a flexible central endoscope 14 through the patient's mouth to identify the stomach, which is inflated with air by means of the endoscope later on the bottom of the gastric body is pressed against the greater curvature with the endoscope, to identify the puncture site to locate the light through the abdominal wall, then a trocar 11 is introduced at the puncture site, perforating all the layers of the abdominal wall and perforating the stomach, observing the operation through the endoscope, in such a way that a space for the traction of the rigid support 2 is formed together with the catheter 4 and the balloon 1, which is taken to outside with the help of a suture strand 15 is introduced through trocar 11, once the indicated mandrin has been removed from trocar 11 and is taken out by the end tweezers. oscope 14, as illustrated in figure 13, and then pulled out through the endoscope through the oral cavity, where it is secured to a handle 3 of the rigid support 2 (see figure 14). The pulling of the suture 15 is then started by pulling it through the abdominal wall so that the rigid support 2 together with the catheter 4 and the balloon 1 are brought from the digestive tract to the stomach of the patient, the rigid support being taken 2 and the inflation catheter 4 through the gastric wall and the abdominal wall. Fixation and placement of the intragastric balloon is initiated to separate the catheter 4 from the rigid support 2, then the rigid support 2 is inserted into the hole 7 of the fixation plate 6 having a handle 3 that is removed; the balloon 1 is inflated through the catheter 4 to a predetermined volume. The catheter 4 is fixed by passing it through the hole 9 of the fixation plate 6 and joining it to the inflation valve 5, fixing it at the same time to the fixation plate and the inflation valve to the anterior aponeurosis of the abdomen with stitches or staples. Additionally, in order to reduce the number of incisions in the patient's body as well as the fastening elements of the intragastric balloon assembly, a second embodiment of the invention is contemplated, simplifying the way of fixing the rigid support 2 and catheter 4, which consists of in providing an integrated fixing plate 6 'having a hole T for fixing the rigid support 2 and an inflation valve 5' fixedly disposed therein, eliminating the need to have two fixing elements arranged subcutaneously. A first arrangement of the integrated plate 6 'is shown in the figures 4A and 4B, comprising a fixation plate 6 'having a hole 7' with a circular rim 8 'formed therein and a valve 51 disposed contiguously thereon, such that the inflation catheter 4 fixed by the bottom side of the plate 6 'to the valve 5' and the rigid support 2 is passed through the hole T and fixed to the circular flange 8 '. Moreover, a wider bilobate fixing plate is contemplated in this arrangement such that one of the parts will serve to fix the plate and the other is integrated with the inflation valve 5 '. A second arrangement of the integrated fixing plate 6"is shown in Figures 5A and 5B, which additionally includes a tubular element 18 disposed in the center of the valve 5" so that the rigid support 2 passes through said element. tubular 18, said plate 6"having a flange 8" on the upper side thereof, for suturing and fixing the rigid support 2 to the plate 6"under a certain tension In a third embodiment of the invention, the intragastric balloon assembly includes a balloon 1 and a rigid support 2 as in the modalities described above, which serves as a guide and support for the balloon 1, which consists of an elongated element such as a solid tube preferably made of silicone, which is fixed in a unitary manner. ball 1 and having a larger diameter at the end attached to the balloon 1, which becomes smaller toward the opposite end where a handle 3 is formed. Moreover, the balloon 1 is provided with a self-sealing valve 16 attached at fixed to the balloon 1 and connected to the catheter 17 for an initial inflation of the balloon 1, said catheter being removably attached to the balloon 1 in order to be detached from the balloon 1, after it is inflated, when these are available of the stomach and before fixing the balloon 1 to the abdominal wall. The valve 16 is disposed at a point distant from the rigid support 2, preferably at a point diametrically opposite the rigid support 2, as best seen in Figure 8. Likewise, the third embodiment of the intragastric balloon assembly is provided with a plate fixing 6 similar to that shown in figure 2, which is a plate with a thickness of approximately 1 to 1.5 mm, and is preferably made of silicone or inert plastic of greater hardness and having a diameter preferably between 4 to 5 cm. Said fixing plate 6 has a first hole 7 having a circular edge 8, which fits and is fixed to the rigid support 2 and also includes some fixing holes 10, 4 of said holes being preferably arranged. The implantation of the intragastric balloon assembly according to the third embodiment of the invention is carried out by introducing a flexible central endoscope 14 through the mouth of the patient to identify the stomach which is inflated with air by means of the endoscope, then the bottom of the gastric body is pressed against the greater curvature with the endoscope, to identify the puncture site by locating the light through the abdominal wall, then a puncture trocar 11 is inserted into the puncture site, perforating all layers of the puncture site. the abdominal wall and perforating the stomach, observing this operation through the endoscope, such that a gap is formed for the traction of the rigid support 2 together with the catheter 4 and the balloon 1, which is carried out with the help of a thread of suture 15 that is introduced through trocar 11, once the mandrin with tip of trocar 11 is removed and is taken by the tweezers of endoscope 14, as shown in FIG. illustrated in Figure 13. And then pulled through the endoscope through the oral cavity where the handle 3 of the rigid support 2 is secured (see Figure 14). The pulling of the suture 15 is then started by pulling it through the abdominal wall so that the rigid support 2 together with the balloon 1 and the catheter 17 are brought through the digestive tract to the stomach of the patient, bringing the rigid support 2 to through the gastric wall and the abdominal wall. Initial inflation is then started through the detachable catheter 17, which is partially exposed at that moment through the patient's mouth. This inflation may not be the end but a partial or temporary, with approximately 200 to 300 ce. of air or other fluid that allows to exert tension between the rigid support 2 and the inflated balloon 1 so that the wall of the perforated stomach is close to the peritoneal and parietal layer. The rigid support 2 is then pulled so that the balloon 1 adheres perfectly to the gastric wall and, at the same time, the gastric wall adheres to the abdominal wall in the peritoneal layer to avoid leakage of the gastric contents towards the abdominal wall. After this, the fixation plate 6 is inserted by introducing the rigid support 2 through the greater hole 7, which is secured to the circular flange 8 and the fixation plate 6 is fixed to the anterior aponeurosis of the abdomen with suture and finally the tissue Subcutaneous cellular and skin are closed. To prevent leakage of gastric contents to the abdominal wall which may result in infection, in a fourth embodiment of the invention, illustrated in figures 10 to 12, it is contemplated to provide the balloon 1 with a circular reinforcement 19, formed integrally with the balloon and made of the same material as the balloon 1, arranged adjacent to the base of the balloon 1, this is around the point where the rigid support 2 emerges, said reinforcement 9 having a plurality of reliefs 20 formed therein radially distributed in the edge thereof with the purpose of not interrupting the blood circulation of the tissue in contact with the intragastric balloon 1 and the elements that make up the whole, avoiding any possibility of necrosis in that area of the stomach. This embodiment of the invention also contemplates the provision of a foldable plastic screen 21 made of a flexible material such as soft silicone, arranged around the rigid support 2 and separated from the balloon 1, formed integrally with the rigid support 2. Said screen 21 it is initially in a folded position, shown in Figure 10, that is before inserting the balloon assembly into the stomach and unfolding once it has traversed the wall of the stomach in a similar manner to an umbrella, said screen resting on the outer wall of the stomach and joining thereto to seal the area of the hole formed in the stomach and thus provide together with the circular reinforcement 19 an internal and external sealing system that prevents the gastric juices from leaking, which could cause a great complication, such as a bacterial infection. In a further embodiment of the invention there is provided a means to promote fibrosis and scarring of the stomach wall at the point of perforation, thereby promoting the union of the assembly to the abdominal wall in the peritoneal layer, said means consisting of a layer of a material that promotes fibrosis and scarring such as gorotex, mersilene, or the like, applied on the rigid support 2 and the base of the balloon 1, this is where the rigid support 2 emerges, which they are in contact with the wall of the stomach and the abdominal wall until the aponeurosis so that said tissues adhere to the elements of the balloon assembly thus avoiding the leakage of gastric juices and related complications. Said fibrosis-promoting and healing material is applied to the base of the balloon 1 and to the rigid support 2 once they have been taken to the patient's stomach. It will be evident to those skilled in the art that various modifications or variations may be made to the invention described herein without departing from the spirit and scope of the same, so it should be understood that what is described and illustrated here is merely illustrative of the invention and not limiting Of the same.

Claims (23)

18 CLAIMS 1. Set of intragastric balloon to reduce the food intake of a person suffering from obesity, characterized because it comprises: a balloon; an elongate element formed unitarily with the balloon for attaching the balloon to the gastric wall of the person's stomach, which includes a first end attached to the balloon and a second end attached to a handle. an inflation catheter attached to the balloon, arranged to inflate the balloon, an inflation valve connected to the inflation catheter. 2. An intragastric balloon assembly according to claim 1, characterized in that the capacity of the balloon is from about 200 to 1000 ce. 3. An intragastric balloon assembly according to claim 1, characterized in that the balloon has a generally circular shape. 4. An intragastric balloon assembly according to claim 1, characterized in that the balloon has a generally bilobed shape. 5. An intragastric balloon assembly according to claim 1, characterized in that the balloon is made of a silicone resistant to corrosion by gastric acids. 6. - An intragastric balloon assembly according to claim 1, characterized in that the elongate element is made of silicone. 7. The intragastric balloon assembly according to claim 1, characterized in that the elongated element is arranged adjacent to the inflation catheter. 8. The intragastric balloon assembly according to claims 1 and 7, characterized in that a first end of the catheter is connected to the balloon and a second end of the catheter is connected to the inflation valve. 9. Intragastric balloon assembly according to claim 1, 19 characterized in that it comprises a fixing plate for securing the elongated element to a portion of the abdominal wall. 10. The intragastric balloon assembly according to claim 9, characterized in that the fixation plate is a plate of approximately 1 to 1.5 mm thick. 11. The intragastric balloon assembly according to claim 9, characterized in that the fixation plate is formed integrally with the inflation valve. The intragastric balloon assembly according to claim 9, characterized in that the fixing plate integrated with the inflation valve comprises a tubular element disposed at the center of the inflation valve through which the elongate element is passed and fixed to the upper flange of the tubular element. 13. - Intragastric balloon assembly according to claim 1, characterized in that the inflation valve is fixedly arranged in the balloon and the inflation catheter is removably attached to the balloon to allow the catheter to be separated from the balloon after inflation . 14. The intragastric balloon assembly according to claim 13, characterized in that the inflation valve is arranged in the balloon at a point diametrically opposite to that of the elongated element. 15. The intragastric balloon assembly according to claim 1, characterized in that the elongate element is partially covered with a layer of a material that promotes fibrosis and healing in the region that has contact with the tissues. 16. The intragastric balloon assembly according to claim 15, characterized in that the material that promotes fibrosis and scarring is selected between goretex and mersilene. 17. The intragastric balloon assembly according to claim 1, characterized in that it further comprises a circular reinforcement disposed 20 adjacent to the base of the balloon, at the site emerging the elongate element, integrally formed with said balloon and having formed a plurality of reliefs formed thereon radially distributed at the edge thereof, said circular reinforcement being configured for Adhere to the inner wall of the stomach when the balloon is placed in the stomach, such that it seals the hole formed in the stomach. 18. Intragastric balloon assembly according to claim 17, characterized in that the circular reinforcement is made of the same material as the balloon. 19. Intragastric balloon assembly according to claim 1, characterized in that it further comprises a plastic screen arranged around the elongated element, separated from the balloon and formed integrally with the elongate element, said plastic screen being capable of being initially arranged in a folded position, before inserting the balloon assembly into the stomach and unfolding after it crosses the wall of the stomach, said screen being configured to rest on the outer wall of the stomach to prevent the leakage of gastric juices. 20. Intragastric balloon assembly according to claim 19, characterized in that the plastic screen is made of silicone. 21. Method for placing an intragastric balloon assembly in the stomach of a patient comprising the steps of: providing an intragastric balloon assembly that includes an elongate element having a first end attached to the balloon and a second end attached to a handle, an inflation catheter releasably attached to the balloon and an inflation valve fixedly attached to the balloon, connected to the inflation catheter; identify the stomach using an endoscope inserted through the patient's mouth; identify a puncture site on an outer portion of the patient's abdominal wall. twenty-one pierce all the layers of the abdominal wall at the puncture site and perforate the stomach to introduce a first end of a suture into the stomach take the first end of the suture with the endoscope and pull the endoscope and the first end of the suture to through the mouth of the patient joining the first end of the suture to the handle of the elongated element of the intragastric balloon assembly pull a second end of the suture so that the first end of the suture with the intragastric balloon assembly is pulled towards the The stomach of the patient and the tubular member is carried through the gastric wall and the abdominal wall while the catheter remains through the digestive tract and the patient's mouth; inflate the balloon with a fluid through the catheter; fixing the tubular member to the abdominal wall with a fixation plate; detach the catheter from the intragastric balloon assembly, withdrawing it from the patient. 22. Method according to claim 21, characterized in that it also comprises the step of applying a layer of material that promotes fibrosis and healing on the elongate element and the balloon in the regions that have contact with the tissues once the assembly has been removed. of balloon to the stomach of the patient. Method according to claim 21, taken in combination with the balloon assembly of claims 17 to 20, characterized in that it also comprises the step of unfolding the folding screen once the elongated element has crossed the stomach wall so that the The screen rests on the outer wall of the stomach and joins it, sealing the area of the hollow formed in the stomach to prevent the leakage of gastric juices.