ENDOSCOPIC GASTROINTESTINAL DEVICE FOR RESTRICTION AND REDUCING FOOD ABSORPTION WITH A POSITIONING SYSTEM IN THE STOMACH AND EXTENSION TO THE INTESTINE

20220362045 · 2022-11-17

    Inventors

    Cpc classification

    International classification

    Abstract

    For desorptive technique, inhibiting hunger and reducing the amount of food ingested, besides avoiding the contact of the food with part of the intestine, working for the weight reduction of the patient and associated diseases such as type 2 diabetes. For this, a gastrointestinal device (10) formed from an intragastric ring (1) made of malleable and expandable material, extends a tubular sleeve (3) with or without a stent. The gastrointestinal device (10) has its inlet valve (4) attached to a catheter (CA) for gastrointestinal implant, and is directed into the stomach (L) of the patient, where an endoscopic forceps (EP) or the stent directs the tubular sleeve (3) through the pyloric canal (P), into the duodenum (D), and unfolding until it occupies part of the intestine. Therefore, the intragastric ring (1) is positioned near the Pyloric canal (P), inside the stomach (E), and is then inflated and expanded by fluid—liquid, gas or air, assuming the shape of a balloon.

    Claims

    1- “GASTROINTESTINAL ENDOSCOPIC DEVICE FOR FOOD RESTRICTION AND DESORPTION”, for gastrointestinal implant in the treatment of weight reduction and associated diseases such as type 2 diabetes by combining restrictive technique with desorptive technique, being a gastrointestinal device (10) formed from an intragastric ring (1) produced in malleable and expandable material, preferably silicone, characterized by, from its central hollow portion (2), extending a tubular sleeve (3) of the same material, the device being designed to have its intragastric ring (1) positioned and inflated in the stomach of a patient at the same time that it extends its sleeve (3) to the intestine in order to reduce food absorption.

    2- “GASTROINTESTINAL ENDOSCOPIC DEVICE FOR FOOD RESTRICTION AND DESORPTION”, according to claim 1, characterized by the intragastric ring (1) being in a retracted, deflated and compact state, which adopts, anywhere in its expandable body, an inlet valve (4) of the type with outlet blockage and whose nozzle is suitable to receive the tip of a catheter (CA).

    3- “GASTROINTESTINAL ENDOSCOPIC DEVICE FOR FOOD RESTRICTION AND DESORPTION”, according to claim 1, characterized by the tubular sleeve (3) being welded and permanently connected to the ring (1), having its body corrugated in fold ribs (5) to allow its expansion and retraction, with the end of the sleeve (3) connected to the ring (1) coinciding with its central opening (2), from where it extends its tubular body to the opposite end, in a variable length according to the application or anatomy of the patient.

    4- “GASTROINTESTINAL ENDOSCOPIC DEVICE FOR FOOD RESTRICTION AND DESORPTION” according to claim 3, characterized by the tubular sleeve (3) being equipped with a hollow stent (6) of the spiral or rectilinear type.

    5- “GASTROINTESTINAL ENDOSCOPIC DEVICE FOR FOOD RESTRICTION AND DESORPTION” according to claim 4, characterized by the stent (6) having its length extended along the length of the tubular sleeve (3) and having its air, liquid or gas inlet end connected directly to the intragastric ring (1) or being independent when it receives its own valve with catheter inlet.

    6- “POSITIONING SYSTEM IN THE STOMACH AND EXTENSION TO THE INTESTINE”, according to the gastrointestinal device (10) defined in claim 1, which is configured to reside in the stomach and intestine of the patient and resist migration, without the need for clips or ties, inhibiting hunger, allowing the passage of only part of the processed food (AL) and preventing the passage of this part of processed food in part of the intestine, and for its positioning, the device (10) has its inlet valve (4) coupled to a catheter (CA) for gastrointestinal implant, characterized by, when not equipped with a stent (6), an endoscopic forceps (EP) is inserted into the central opening (2) of the ring (1), resting on the sleeve (3), and the gastrointestinal device (10) is then directed into the stomach (L) of the patient, where the endoscopic forceps (EP) directs the tubular sleeve (3) through the Pyloric canal (P), entering the duodenum (D) and unfolding until it occupies part of the intestine and the deflated intragastric ring (1) is positioned next to the Pyloric canal (P) inside the stomach (E); so, when the fluid (liquid, air or gas), air or gas is released through the catheter (CA), it enters from the inlet valve (4), inflating and expanding the intragastric ring (1) above the pyloric canal (P), configuring itself as a balloon that remains in this position, without being able to move, when then the catheter (CA) and the endoscopic forceps (EP) can be removed.

    7- “POSITIONING SYSTEM IN THE STOMACH AND EXTENSION TO THE INTESTINE” according to claim 6, characterized by the positioning of the tubular sleeve (3) in the duodenum and intestine can be performed before or after the inflation of the intragastric ring (1).

    8- “POSITIONING SYSTEM IN THE STOMACH AND EXTENSION TO THE INTESTINE”, according to claim 6, characterized by, when provided with a stent (6) (spiral or rectilinear), the tubular sleeve (3) is only positioned at the entrance of the duodenum (D) when positioning the device (10) in the stomach (E), where the stent (6) connected directly to the valve (4) of the ring (1) also receives the fluid supply—liquid, air or gas—directed to the latter, inflating and assembling its body, extending and positioning the tubular sleeve (3) in the duodenum and intestine, without the need for endoscopic forceps.

    9- “POSITIONING SYSTEM IN THE STOMACH AND EXTENSION TO THE INTESTINE” according to claim 8, characterized in that the stent (6) separated from the ring (1) receives its own catheter, inserted into its valve before the device (10) is inserted into the stomach (E) to, when correctly positioned, before or after the ring (1) is insufflated, it receives its own supply of fluid to assemble its body and unfold the sleeve (3) through the duodenum and part of the intestine.

    Description

    BRIEF DESCRIPTION OF THE FIGURES

    [0016] After a superficial explanation, the invention is now detailed.

    [0017] FIGS. 1, 2 and 3, as already explained, refer to the prior art, shown through patent documents BR 11 2019 006079 0, BR 11 2015 000384 2 and by the images of the “Endobarrier” device.

    [0018] The following figures, from 4 to 14, show the intragastric ring coupled to the intestinal sleeve and its positioning system, reasons for this patent application, to be better detailed through the figures listed below:

    [0019] FIG. 4—illustrates the gastrointestinal device with the corrugated tubular intestinal sleeve;

    [0020] FIG. 5—illustrates the gastrointestinal device in a configuration where the tubular sleeve adopts a spiral type stent;

    [0021] FIG. 6—illustrates the gastrointestinal device in a configuration where the tubular sleeve adopts a rectilinear type stent;

    [0022] FIG. 7—illustrates the gastrointestinal device being directed into the stomach, aided by the catheter, in an endoscopy procedure;

    [0023] FIG. 8—view of the intragastric ring of the device already positioned above the pyloric canal, with the intestinal sleeve being extended through the duodenum and part of the intestine with the help of endoscopic forceps;

    [0024] FIG. 9—illustrates the positioned device, with the ring filling fluid (liquid, air or gas) being injected from the catheter and through the valve, when the intragastric ring is insufflated like a balloon until it takes the shape of the lower stomach walls. With this, the intragastric ring is kept stabilized above the pyloric channel and minimally exposed in the stomach;

    [0025] FIG. 10 illustrates the above positioning, with the ring insufflated, where the catheter is removed and the device is ready to perform its functions;

    [0026] FIG. 11—illustrates the positioning system shown in the previous figures, but with the tubular sleeve equipped with a stent, which is insufflated together with the ring, unfolding the tubular sleeve through the duodenum and part of the intestine without the need for endoscopic forceps;

    [0027] FIG. 12—illustrates the device positioned on the patient, who, when feeding, has the processed food directed by the central nozzle of the inflated ring and directed by the sleeve, where the device acts in a restrictive and desorptive way;

    [0028] FIGS. 13 and 14—show a photo and a detail of the device being held by the inventor, at a top and a front angle, respectively.

    DETAILED DESCRIPTION OF THE INVENTION

    [0029] According to the attached figures, the “ ENDOSCOPIC GASTROINTESTINAL DEVICE FOR RESTRICTION AND REDUCING FOOD ABSORPTION WITH A POSITIONING SYSTEM IN THE STOMACH AND EXTENSION TO THE INTESTINE”, object of this invention patent application, as illustrated in FIGS. 4, 13 and 14, a gastrointestinal device (10) formed from an intragastric ring (1) produced in malleable and expandable material, preferably silicone, where from its central portion (2) extends a tubular sleeve (3), made of the same material.

    [0030] Said device designed to have its intragastric ring (1) positioned and inflated in the stomach of a patient and extend its sleeve (3) to the intestine in order to reduce food absorption.

    [0031] More specifically, the intragastric ring (1) is in a retracted, deflated, and compact state. The ring (1) adopts, at any place of its expandable body, an inlet valve (4), of the type with outlet lock and whose nozzle is suitable to receive the tip of a catheter (CA).

    [0032] More specifically, the tubular sleeve (3) is welded and permanently connected to the ring (1), and has its body corrugated into bending ribs (5) to allow for expansion and retraction. The end of the sleeve (3) connected to the ring (1) coincides with its central opening (2), from where it extends its tubular body to the opposite end, the length of which can vary depending on the application or patient anatomy.

    [0033] The tubular sleeve (3) can be equipped with a hollow stent (6) of the spiral type, as illustrated in FIG. 5, or of the rectilinear type, as illustrated in FIG. 6. This stent (6) has its length extended along the length of the tubular sleeve (3) and can have its air, liquid or gas inlet end connected directly to the intragastric ring (1) or not, where it then receives an independent valve with catheter inlet.

    [0034] Once the gastrointestinal device (10) is formed, it is configured to reside in the stomach and intestine of the patient and resist migration, to effect both a weight reduction treatment and to combat diseases associated with this malady, such as type 2 diabetes.

    [0035] For its positioning system, the gastrointestinal device (10) has its inlet valve (4) attached to a catheter (CA) for gastrointestinal implant, i.e. for introduction into the stomach (E) of a patient. When not equipped with a stent (6), an endoscopic forceps (EP) is inserted into the central opening (2) of the ring (1), resting on the sleeve (3). Therefore, the gastrointestinal device (10) is directed into the stomach of the patient. The reduced thickness of both the sleeve (3) and the intragastric ring (1) allow for introduction into the stomach (E) with minimal discomfort for the patient.

    [0036] As illustrated in FIG. 7, the endoscopic forceps (EP) guides the tubular sleeve (3) through the pyloric canal (P), entering the duodenum (D) and unfolding until it occupies part of the intestine. The intragastric ring (1), deflated, is then positioned next to the pyloric canal (P), inside the stomach (E). Therefore, when the release of fluid (liquid, air or gas) is triggered by the catheter (CA), it enters from the inlet valve (4), as illustrated in FIGS. 9 and 10, inflating and expanding the intragastric ring (1) above the pyloric channel (P), thus configuring itself as a balloon of spherical shape or close to it and free of tips or corners. The intra gastric ring (1) then remains in this position, without the possibility of being moved, and the catheter (OC) and endoscopic forceps (EP) can then be removed.

    [0037] The positioning of the tubular sleeve (3) in the duodenum and intestine can be performed before or after insufflation of the intragastric ring (1).

    [0038] Alternatively, as illustrated in FIG. 11, when equipped with a stent (6) (spiral or rectilinear), the tubular sleeve (3) is only positioned at the entrance of the duodenum (D) when positioning the device (10) in the stomach (E). This way, if the stent (6) is connected directly to the valve (4) of the ring (1), it will also receive the fluid supply—liquid, air or gas—inflating and assembling its body, extending and positioning the tubular sleeve (3) in the duodenum and intestine, without the need for endoscopic forceps. If the stent (6) is separated from the ring (1), a second catheter is inserted into its valve before the device (10) is inserted into the stomach (E). Thus, when correctly positioned, before or after the ring (1) is inflated, it receives its own supply of fluid to arm its body and unfold the sleeve (3) through the duodenum and part of the intestine.

    [0039] In either case, the inflated intragastric ring (1) remains stabilized just above the pyloric canal (P), without the need for the use of clips or ties like in common applications.

    [0040] The intragastric ring (1) thus stabilized, as illustrated in FIG. 12, allows the passage of part of the processed food (AL) in restrictive technique by occupying part of the stomach, inhibiting hunger and reducing the amount of food ingested. The device (10) provides the passage of this part of processed food through the tubular sleeve (3), stabilized along the duodenum and part of the intestine, which results in a desorptive technique, preventing the absorption of the ingested food content in that part of the intestine. Therefore, by combining two techniques in a simplified construction and easy positioning without the need for surgery, the device (10) proves to be extremely effective in the treatment of obesity and diseases associated to excess weight.

    [0041] The gastrointestinal device (10) remains positioned this way and stable, acting in a restrictive and desorptive way (such as a gastric bypass surgery), but without the risk of surgery, and it is also reversible or reapplicable.