Intragastric space filler

[0001] The present disclosure relates generally to implantable weight control devices. More specifically, the present disclosure relates to a device that fills the intragastric space, which can be implanted in a removable manner to the patient, providing improved fixation, stabilization and the associated natural advantages of the immediate-operating system structure.

BACKGROUND OF THE DISCLOSURE [0002] In the current state of the art, fillers of intragastric space are known to be used to lose the weight of extremely obese persons. All intragranular space fillers used for this purpose operate in such a way that an empty bag or space filler is placed in the stomach through the esophagus. Then, the bag or space filler is filled (completely or partially) with a suitable insufflation fluid, e.g. saline, by means of a filling tube or catheter that is inserted into the stomach through the mouth or nose. The space filler takes up space in the stomach, thus leaving less space available for food and creating a feeling of satiety in an obese person. Clinical experience regarding the current state of the art has shown that in many obese patients, fillers in the intragastric space significantly help in controlling appetite and achieving weight loss. One of the types of intragastric bags and space fillers described in the current state of technology remains connected to the filling tube at all times when the space filler is in the stomach. The tube is inserted into the patient's stomach through the nostrils. Such an intragastric filler is described, for example, in US Pat. No. 4,133,315. in which the space filler is in the stomach. The tube is inserted into the patient's stomach through the nostrils. Such an intragastric filler is described, for example, in US Pat. No. 4,133,315. in which the space filler is in the stomach. The tube is inserted into the patient's stomach through the nostrils. Such an intragastric filler is described, for example, in US Pat. No. 4,133,315.

[0003] US patents 4 416 267 and 4 899 747 (Garren et al.) Disclose a gastric insert for treating obesity in humans by reducing the volume of the stomach and containing an elastic filled filler in the shape of a torus with a central opening extending through it. At least a portion of the space filler comprises a self-sealing substance, which makes it easier to puncture it with a needle to fill the space filler and seal the opening after removing the needle. The method includes placing a space filler within the stomach of a person being treated for obesity, thereby reducing the volume of the stomach. The gastric insert developed by Garren and others satisfactorily fulfills the function of controlling appetite. The insert can, however, unexpectedly be emptied and collapsed, which results in blockage from blocking the pylorus or small intestine. It is desirable to develop a space filler system that provides some noticeable warning and indicates the need to remove the implant from the patient's body at the right time.

[0004] Several surgical techniques have been attempted to circumvent the absorbent surface of the small intestine or to reduce the size of the stomach by bypassing or dividing it. It turned out that these treatments are both dangerous to perform in patients suffering from morbid obesity, as well as cause numerous life-threatening postoperative complications. Such operations are often difficult to reverse.

[0005] Non-operative approaches to the treatment of obesity include a voluntary diet that is often ineffective because most people do not have enough willpower to limit food intake. Other approaches include the use of gastric fillers such as methylcellulose, which are often taken in the form of tablets. Methylcellulose expands in the stomach, leaving it feeling full. Pouch and tube assemblies have also been proposed in which the bag is introduced into the stomach by ingestion, and the tube attached thereto is used to periodically refill the bag, especially immediately before the meal or during the meal. After eating the meal the bag can be completely emptied immediately or it can be emptied gradually over a few hours,

[0006] U.S. Patent No. 4,133,315, issued January 9, 1979, discloses an assembly of a refilled bag and tube. The tubes remain attached to the bag and are located inside the esophagus to be treated. These tubes are often the cause of erosions and oesophageal ulceration. The patent also discloses a diet in which a fixed tube used to fill the stomach bag extends through an opening formed in the stomach wall as well as through an opening formed in the abdomen.

[0007] US Patent No. 4,246,893, issued January 27, 1981, discloses an inflatable bag and tube assembly that is surgically placed outside and near the stomach. After filling the bag, the upper part of the abdomen expands and the stomach is compressed, which ensures the generation of a feeling of nourishment that reduces the desire to take food.

[0008] The entire content of the US patent 4 598 699 of 8 July 1996 relates to a disclosed endoscopic device for removing a filled stomach liner of a subject undergoing treatment of obesity comprising an elongated flexible tube containing channels and a holding device at the distal end of the flexible tube which is constructed and placed so as to grip and stabilize the filled gastric insert. [0009] In the state of the art, for example in US 6 826 428, a device for stimulating the stomach to stimulate neuromuscular gastric tissue is also disclosed.

[0010] US patent 4 694 827 of September 22, 1987 discloses a balloon that can be placed in the stomach and filled in it to suppress the patient from receiving food, where it is filled, containing a plurality of convex protrusions with a smooth surface disposed as so that the balloon can be hooked against the stomach wall only in remote locations, which aims to minimize the mechanical damage caused to the stomach wall by the balloon.

[0011] US Patent No. 6,746, 460 of June 8, 2004 discloses an expandable device inserted into the stomach of a patient and held therein by affixing or otherwise affixing an expandable device to the stomach walls. Such expandable devices include attachment areas for attachment to one or more attachment elements that can be configured to at least partially extend through one or more folds of the patient's stomach wall. Such fastening elements can be made in many different shapes, e.g. spiral, elongated, annular or tick, and can also be configured to be non-piercing.

[0012] It has therefore been found that a reduction in the size of the stomach chamber can cause a significant percentage of people to cause weight loss, and the subject of the present disclosure is a device that in a non-operable manner reduces the size of the stomach chamber and which can be easily removed. In one aspect of the present disclosure, a device is disclosed that fills the intragastric space with a programmed volume, which can be adjusted and sent to warn of a potential device failure.

SUMMARY OF THIS DISCLOSURE [0013] According to features of the present disclosure, a device is disclosed that fills an intragastric space to reduce stomach volume comprising a filled space filler and a security element attached to said space filler, the security element comprising a mechanism for generating a noticeable signal to remove said filler.

[0014] According to preferred embodiments of the present disclosure, certain aspects of the disclosure relate to an intragastric space filling system for treating obesity in a patient by reducing the stomach volume comprising at least two flexible infillatory space fillers attached to each other, the first space filler being filled to a certain volume inside the stomach and is not fluidly connected to other remaining space fillers, and at least a portion of the first space filler is made of biodegradable material. In an embodiment, the gastrointestinal filling device of the present disclosure is characterized in that the patient has small or minimal effects of intestinal obstruction from obstruction, erosion, perforation and infection.

[0015] According to an embodiment of the present disclosure, the space filling system comprises a pressure sensor element for transmitting to the receiver or driver of internal pressure readings in one space filler. In a further embodiment, the pressure sensor element is mounted on the first of at least two space fillers of the intragastric space filling system to measure the internal pressure in the first space filler. In a further embodiment, the pressure sensor element further comprises a transmitter for wirelessly transmitting a signal indicative of the measured internal pressure to the receiver outside the patient's body. The measured internal pressure is compared with a predetermined pressure threshold to signal removal of the filling system. In embodiments, the pressure sensor element can be replaced by a pH sensor, a flow sensor, a temperature sensor, an electrolyte sensor or the like.

[0016] In embodiments, two of the at least two space fillers of the intragastric space filling system are configured to be a tandem in the interior of the stomach cavity, or are configured to be substantially parallel to each other.

[0017] According to another embodiment of the present disclosure, at least one of the two space fillers of the intragastric space filling system is affixed to the inner stomach wall. In a further embodiment, the fastening operation is designed and configured so that the fastening mechanism is activated when the space filler is filled and comes into contact with the inner wall of the stomach, and the fastening mechanism is released when the filler is emptied.

[0018] According to embodiments of the present disclosure, at least a portion of at least two space fillers are visible using ultrasound. One way of visualization is to use an air bubble visible from the ultrasound located on or on a part of the space filler. Another way is to place the contrast agent visible with ultrasound at or on the part of the space filler.

[0019] In an embodiment, the intragastric space filling device is configured to be inserted through the patient's esophagus. In another embodiment, at least a part of the outer surface of the space filler is treated with an acid-protecting substance, a corrosion preventive or a release-preventing substance, the substance comprising polytetrafluoroethylene, inert material or other biocompatible biological material (such as albumin, melatonin). , phosphorylcholine or protein). The surface treatment methods include coating, painting, dipping, impregnation and the like.

[0020] In aspects of the disclosure, there is provided a device for filling an intra-gastric space for treating obesity in a patient by reducing the volume of the stomach, containing a filled space filler and a security element attached to the space filler, the security element comprising a mechanism for generating a noticeable signal to cause removal of the space filler. [0021] In aspects of the present disclosure, there is provided a device for filling the intragastric space for treating obesity in a patient by reducing the volume of the stomach, containing the filled space filler with the first reference shape in the filled state and the solution ensuring essential keeping in the emptied state of the first reference shape. In an embodiment, the solution ensuring essential keeping in the emptied state of the first reference shape is to place a spiral protrusion on the space filler, the spiral protrusion being made of a similar material as the space filler. In a further embodiment, the solution ensuring substantially maintaining the first reference shape in the emptied state is to place the space of many crossbars in the interior space of the filler.

[0022] In some aspects of the disclosure, there is provided a device for filling the intragastric space for treating obesity in a patient by reducing the volume of the stomach, containing a filled space filler having a first circumference cross-section in a filled state, and a solution to keep the second circumference cross section of at least 75 in the empty state. percent of the first circumference of the cross-section.

[0023] In an embodiment, each of the at least two space fillers of the intragastric space filling system comprises a central opening extending through it. In another embodiment, one of the at least two space fillers is made from a polyurethane sheet material. In yet another embodiment, the polyurethane sheet material is monolayer. For this purpose, another sheet-like polymeric material, elastic (e.g. silicone or Nylon) or non-elastic (e.g. polyethylene or polytetrafluoroethylene) may also be suitable.

[0024] In an embodiment, the biodegradable material for the intragastric space filling system is selected from the group consisting of polymers or copolymers of lactide, glycolide, caprolactone, polydioxane, trimethylene carbonate, poly (orthoesters) and ethylene peroxide). In another embodiment, one of the at least two space fillers is made of a non-biodegradable material selected from the group consisting of polyester, polypropylene, Nylon, polyethylene, copolymers and similar materials.

[0025] In aspects of the present disclosure, a method of treating obesity in a patient that causes minimal nausea and includes implementing a device that fills the intragastric space coated with a nausea-preventing agent is provided. [0026] According to a feature of the present disclosure, there is disclosed an intragastric space filling device for reducing gastric volume comprising a filled space filler and a security element affixed to said space filler, the security element comprising a mechanism for generating a noticeable signal to remove said space filler.

BRIEF DESCRIPTION OF THE DRAWINGS [0027] The additional objects and features of the disclosure will become more apparent, and the invention itself will become clearer upon reading the following detailed description of exemplary embodiments made with reference to the accompanying drawings.

Fig. 1 shows an embodiment of a device for filling the intragastric space with two space fillers attached to each other and parallel to each other.

Fig. 2 shows an embodiment of the first space filler of the two space fillers shown in Fig. 1 through which the central channel passes.

Fig. 3 shows an embodiment of a device filling the intragastric space with two space fillers attached to each other and constituting a tandem.

Fig. 4 shows an embodiment of a device for filling the intragastric space comprising a filled space filler with its supporting mechanism.

Fig. 5 is a cross-sectional view of an embodiment of the support mechanism shown in Fig. 4.

Fig. 6 shows an embodiment of one embodiment of a device for filling the intragastric space with two expandable elements connected to one another.

Fig. 7 shows an example of an illustration of the device for filling the intragastric space shown in Fig. 6 that is in the body of the device.^cs.

Fig. 8 shows an embodiment of a device for filling the intragastric space comprising a shape retaining mechanism.

Fig. 9 is a perspective view of a device for filling the intragastric space shown in Fig. 8.

Fig. 10 shows an embodiment of an adjustable device for filling the intragastric space.

Fig. 11 shows an embodiment of an adjustable device for filling the intragastric space.

Fig. 12 shows an embodiment of the insertion device for inoperable implantation of an intragastric space filling device.

Fig. 13 shows an embodiment of one embodiment of removing from a patient's body a device filling the intragastric space.

Fig. 14 illustrates an embodiment of a pressure sensor element mounted on the space filler in accordance with the principles of the present disclosure.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS [0028] Embodiments of the disclosure described below relate in particular to an intragastric space filling device comprising at least one filler for a stomach volume space and one space filler made of a biodegradable material, wherein the biodegradable material (i.e. at least a part the space filler is made of a biodegradable material) is used as a warning signal to ensure that the device that fills the intragastric space is removed at the right time. The description provides specific details of various embodiments, but it should be understood that this description is illustrative only and should not be construed as limiting this disclosure.

[0029] The stomach is a "J" shaped organ with very active muscles. The muscles of the stomach dilate and contract depending on how much food is in the stomach. This shrinkage provides mechanical crumbling of food. The purpose of grinding is to increase the surface area available for food-sensitive chemicals. Gastric glands secrete enzymes ensuring chemical breakdown of food and partial digestion of proteins. The enzyme that breaks down the proteins is pepsin. The gastric gland also secretes hydrochloric acid, which kills almost all bacteria found in food. It also secretes mucus that protects the stomach wall against the effects of hydrochloric acid. During the mechanical and chemical grinding and decomposing of food, it becomes a semi-liquid substance,

[0030] The structure of the stomach is completely unique. It can be divided into four areas: groove, bottom, body and pylorus. The gullet is the area closest to the heart where the esophagus connects to the stomach. The bottom is an area bending over the rest of the stomach (considering the standing person). The stomach's body is the central area and forms the majority of the organ. The pyloric is an area that is connected to the small intestine. The gullet and pylorus contain sphincter muscles that regulate the movement of food and fluids.

[0031] The volume of the human stomach is different in different people. Human stomachs usually have a volume of around one liter. Because the stomach can expand, it can reach up to four liters.

[0032] The device of the present disclosure aims at providing mechanisms to prevent or avoid displacements, intestinal obstruction from obstruction, bleeding disorders, erosions, gastric perforations or any internal organs and similar phenomena. Some complications are acceptable if the benefits of constructing the device far outweigh the dangers, for example, minor complications related to the access site, some discomfort to the patient due to the presence of the device or problems with access, nausea, flatulence and the like.

[0033] The intragastric filling device can fill up to 95% of the stomach and is self-regulating or portable. It can be set or programmed so that the space filler can be adjusted in accordance with input signals associated with pressure, volume, pH, temperature, size, electrolytic properties, etc. In an embodiment, the device for filling the intragastric space is also equipped with a mechanism for detecting a failure, e.g. detecting bleeding / ulcer, displacement limiter, etc. According to embodiments, the adjustable device filling the intragastric space is removable.

[0034] In some aspects of the disclosure, a method is provided for measuring fluid pressure in a patient's body or in a space filler comprising: (a) providing a wireless capacitive sensor with a microelectromechanical system (MEMS) comprising an induction coil and spaced apart capacitor plates forming an inductance-capacitive circuit; wherein the pressurized fluid contacts one of the capacitive plates; (b) excitation of mutual inductance using an external signal transmitted to the sensor, the purpose of which is to obtain a resonance frequency response constituting the internal signal transmitted by the sensor; and (c) determining, on the basis of the internal fluid pressure signal in the patient's body, the function of the resonance frequency response sent by the sensor as a result of changing the capacitance of the sensor due to a change in the distance between the plates caused by the pressure of the fluid flowing out of the sensor due to a change in series resistance. The pressure sensor element and methods of using it are well known to those skilled in the art, for example the MEMS assembly disclosed in US 6 890 300 or US Patent 6,939,299.

[0035] In aspects of the present disclosure, a device is provided for filling an intra-gastric space to treat a patient's obesity by reducing the volume of the stomach, containing a filled space filler and a security element attached to the space filler, the security element generating a noticeable signal to cause removal of the space filler, and at least a portion the outer surface of the device filling the intragastric space is processed using melatonin.

[0036] In some aspects of the disclosure, there is provided a pressure sensor element for mounting on a first of at least two space fillers of an intragastric space fill device for measuring the interior pressure in a first space filler. In an embodiment, the pressure sensor element is mounted on the biodegradable filler of the space of the device 19 filling the intragastric space. In another embodiment, the pressure sensor element is mounted on any or each of the at least two space fillers of the present disclosure.

[0037] Figs. 1 - 14 show embodiments of an intragastric space filling device 19 and an insertion device for implanting and removing an intragastric space filling device 19 according to the present disclosure. Fig. 1 shows an intragastric balloon or device 19 filling the intragastric space with two space fillers 21A, 21B attached to each other and parallel to each other.

[0038] In an embodiment, the intragastric space filling device 19 comprises two space fillers 21A, 21B, the second space filler 21B being in the first space filler 21A, and at least a portion of the first space filler 21A is made of biodegradable material, optionally with an element a pressure sensor (see, e.g., FIG. 14) for measuring the pressure in the first space filler 21A. In a further embodiment, the device 19 that fills the intragastric space comprises two space fillers 21A, 21B, the second space filler 21B being in the first space filler 21A, and at least a portion of the first space filler 21A is made of a biodegradable material with a sensing element to measure one or more of the first content space filler properties, where the properties include pH, temperature, electrolyte type, electrolyte concentration and the like. In another embodiment, the space between the first space filler 21A and the second space filler 21B is filled with a fluid or saline solution comprising a dye or odor generating mechanism to provide early detection of damage to, emptying or leaking the first space filler 21A. electrolyte concentration and the like. In another embodiment, the space between the first space filler 21A and the second space filler 21B is filled with a fluid or saline solution comprising a dye or odor generating mechanism to provide early detection of damage to, emptying or leaking the first space filler 21A. electrolyte concentration and the like. In another embodiment, the space between the first space filler 21A and the second space filler 21B is filled with a fluid or saline solution comprising a dye or odor generating mechanism to provide early detection of damage to, emptying or leaking the first space filler 21A.

[0039] In an embodiment, the connecting elements 26A, 26B are made of a flexible or resilient material. In another embodiment, the connection elements 26A, 26B are made of a solid material allowing to ensure a lack of fluid connection between the space fillers 21A, 21B. According to an embodiment, a movable spindle is used to eject a device 19 to fill the intragastric space from the light of the insertion device. In an alternative embodiment, the plunger of the inserter comprises a forward pulling mechanism that is located at a distal end relative to the intragastric space filling device 19. During the insertion phase, the device 19 filling the intragastric space is in axial extension (i.e.

[0040] In aspects of the present disclosure, plurality of connection elements 26A, 26B are arranged between the second space filler 21B and the first space filler 21A that is connected to the infusion tube 23 via a sealed inlet 20. Figure 2 shows an embodiment of the first space filler 21A 1 in which the central canal 33 extends. In an embodiment, the intragastric space filling device 19 comprises a plurality of channels extending therein, some of the channels being connected to each other. In an embodiment, the at least one connecting element 26A comprises a unidirectional check valve or a seal that allows fluid to flow from the first space filler 21A to the second space filler 21B,

[0041] In an embodiment, the device 19 filling the intragastric space is made of a polyurethane sheet material, wherein the sheet polyurethane material is monolayer. In another embodiment, the intragastric space filling device 19 is made of non-biodegradable material selected from polyester, polypropylene, Nylon, polyethylene, silicone, latex, polyethylene and copolymers thereof. In an embodiment, the device 19 filling the intragastric space is a permanent implant. In another embodiment, the useful durability of the intragastric filling device 19 of the present disclosure is about 3 to 12 months.

[0042] According to yet another embodiment, the intragastric space filling device 19 is designed to provide a safe use of a filled balloon made of a biodegradable material selected from the group consisting of polymers or copolymers of lactide, glycolide, caprolactone, polydioxane, trimethylene carbonate, poly (orthoesters) ) and poly (ethylene oxide). Alternatively, the biodegradable material is collagen, chitosan, elastin, gelatin or combinations thereof.

[0043] Fig. 3 shows a device 19 filling the intragastric space with two space fillers 22A, 22B attached to each other and constituting a tandem. During the insertion phase or the insertion phase of the device (see, for example, FIG. 7), both fillers 22A, 22B of the space of the intragastric space filling device 19 are emptied, sunken and retracted in the catheter shield. The intragastric space filling device 19 includes a plurality of connecting elements between the second space filler 22B and the first space filler 22A, the first space filler 22A being connected to the infusion tube 23 via a sealed inlet.

[0044] According to embodiments of the present disclosure, a device is provided for filling the intragastric space for treating patient obesity by reducing the volume of the stomach, comprising at least two elastic filled fillers 22A, 22B fixed to each other, wherein each space filler 22A, 22B can be filled to a certain volume in the interior of the stomach 40, between the first space filler 22A and the remaining space fillers 22B have a one-way fluid connection, and at least a portion of the first space filler 22A is made of biodegradable material. In an embodiment, the non-return valve allows fluid to flow in only one direction from the first space filler 22A through the channel to the second space filler 22B.

[0045] In accordance with the embodiment shown in Fig. 4, a device 19 is provided for filling the intragastric space with an embodiment of the filled filler 27 and a plurality of radially expandable support elements provided thereon, each support member 29A incorporating a non-contacting portion 29A. with suspended space filler and part 29B in contact with the space filler. The radially expandable support elements 29 may be attached to each other by means of a crossbar 31 or other connection mechanisms.

Figure 5 is a cross-section of an exemplary support member 29 shown in Figure 4. According to an embodiment, the support member 29 includes a mesh expandable structure 38 wrapped or encapsulated in biocompatible elastomeric material 39, such as silicone, polyurethane, latex and the like. similar. In an embodiment, the elastomeric material has a high content of voids or micropores, such as in the case of a sponge or foam. In an embodiment, the mesh expandable structure 38 is similar to a vasodilator that is either self-expanding or expanded with a balloon. In an embodiment, the mesh expanded structure 38 can be mechanically compressed or it can be made of a temperature-sensitive shape memory material named Nitinol.

[0047] FIG. 6 shows a device 19 that fills the intragastric space with two connected expandable elements 48, 49. The same embodiment is shown in FIG. 7 where it is located in the patient's stomach. The first expandable element 48 connects to the second expandable element 49 via a plurality of connection elements 47. In an embodiment, the first expandable element 48 and the second expandable element 49 are not fluidly connected to one another. According to an embodiment, an infusion port 46 is used for introducing a fluid, e.g. saline solution, or other substances into the intragastric space filling device 19. The infusion port 46 should be known and understood by those with basic knowledge in the field. In another embodiment, at least one of the connection elements 47 has a light providing a fluid communication between the expandable element 48 and the expandable element 49. At least one of the expandable elements 48, 49 further comprises a central passage 45 for moving the food. [0048] According to the embodiment shown in Figures 6 and 7, the sizes and configuration of the intragastric space filling device 19 are adapted to fill the stomach up to 90% (effectively 95%) of the available stomach volume. In an embodiment, the edge surface 44A of the first expandable element 48 or the edge surface 44B of the second expandable element 49 has a corrugated shape, thereby contacting the inner wall of the stomach 40 along separate lines (one-dimensional) of the pleats, not in the contact areas (two-dimensional). In an embodiment, the size and shape of the second expandable element 49 ensure its expansion into the interior stomach wall 40 at a location remote from the pyloric sphincter region 43. In an embodiment, the second expandable element 49 comprises a plurality of convex projections with a smooth surface arranged to allow the filler 19 of the intragastric space to engage the stomach wall only at remote locations, so as to minimize mechanical damage to the stomach wall due to the presence of the intragastric space filler. In an embodiment, the size and shape of the second expandable element 49 ensure its expansion into the interior stomach wall 40 at a location remote from the pyloric sphincter region 43. In an embodiment, the second expandable element 49 comprises a plurality of convex projections with a smooth surface arranged to allow the filler 19 of the intragastric space to engage the stomach wall only at remote locations, so as to minimize mechanical damage to the stomach wall due to the presence of the intragastric space filler. In an embodiment, the size and shape of the second expandable element 49 ensure its expansion into the interior stomach wall 40 at a location remote from the pyloric sphincter region 43. In an embodiment, the second expandable element 49 comprises a plurality of convex projections with a smooth surface arranged to allow the filler 19 of the intragastric space to engage the stomach wall only at remote locations, so as to minimize mechanical damage to the stomach wall due to the presence of the intragastric space filler.

[0049] Figs. 8 and 9 show a device 19 filling the intragastric space with a shape retaining mechanism made of a material other than the material of the filler being filled. In an embodiment, the device 19 filling the intragastric space comprises two toroidal space fillers 73, 74. In another embodiment, the first toroidal filler 73 of space and the second toroidal filler 74 of space become one general balloon-like filler that is wrapped around a shape retaining mechanism 72 and connected thereto by a balloon-closed central section 77.

[0050] As shown in Fig. 9, the shape retaining mechanism 72 may further include a spring-like spiral 75 that is semi-rigid and configured to withstand the compressive pressure exerted by the stomach wall, but is resilient and may be assembled using of the device to be removed by compression, crushing, by string pulling technique (as shown in Figures 10 and 11) or by other mechanical destructive methods that are known and understood by the skilled person. The shape retaining mechanism 72 may be made of Nitinol or another resilient and flexible metal or polymer.

[0051] Balloon-like space fillers are generally made by plunging the plunger in a silicone solution, which is done several times to obtain the desired thickness. In order to combine the balloon-like space filler with another space filler or security element, a silicone-compatible adhesive is usually used, e.g. cold vulcanizing silicone or medium temperature silicone adhesive.

[0052] Fig. 10 shows an embodiment of an intragastric space filling device 19 comprising a mechanism for mechanical net squeezing of an expandable device 38. For a person having basic knowledge in the art, it is known and understood that the embodiment shown in Fig. 10 can be used in devices 19 filling the intragastric space containing more than one filler space. In the first step of the operation, the support element is placed and configured to be circumferentially or radially incised inwardly until a smaller profile is obtained, along with a deferred device 19 filling the intragastric space configured so, that it could be placed in the insertion catheter casing by placing the device 19 filling the intragastric space in the patient's stomach. In the second stage of the operation, the support element automatically expands after it has been released from the catheter cover with the filled device 19 filling the intragastric space, occupying the space within the stomach 40 In the third stage of the operation, during the removal phase, a removal device is inserted into the stomach 40 crushing capabilities to align the support element properly and crush the item to a small size allowing removal in the light of the removal device (e.g., removal catheter sheaths).

[0053] Fig. 10 shows an embodiment of a device 19 filling the intragastric space, while Fig. 11 shows another embodiment of a device 19 filling the intragastric space. In an embodiment, the device 19 that fills the intragastric space comprises a pulling string 60 connected to a plurality of rings 62, 63, 64, which are attached to a device 19 for filling the intragastric space. According to an embodiment, the rings 62, 63, 64 may be an integral part of the intragastric filling device 19. The nib of the pulling string 65 at the distal end has a size larger than the hole of the distal ring 64. The node located at the distal end 65 holds the distal end of the pulling string 60 in a tightly wrapped state around the distal ring 64. When the proximal section of the pulling string 60A is extracted from the intragastric filling device 19 through the proximal ring 62, the intragastral cavity device 19 becomes radially or spirally smaller. In an embodiment, the cone-shaped locking member 61 can move through the ring one way in a ratchet manner as is known to those skilled in the art. The volume of the device 19 filling the intragastric space thus becomes irreversibly smaller each time the cone-shaped locking member 61 is moved through the proximal ring 62.

[0054] Figure 12 shows an embodiment of a catheter of a standard catheter for inserting a device 19 filling the intragastric space into a patient's body, the intragastric space filling device 19 including at least two space fillers, e.g. 22A and 22B, connected to each other using connecting elements 36. The person having the basic knowledge in the field will of course realize and understand that using the standard catheter sheath it is possible to insert any of the fillers disclosed herein, including 21A, 21B, 22A, 22B, 27, 44A, 44B, 73, 74 and other equivalent ones, in any number of configurations of embodiments. In an embodiment, after placing the catheter sheath 40 around the stomach 40, the infusion tube 23 is used as a movable pushing rod to push the device 19 filling the intragastric space into the patient's stomach 40. The intragastric filling device 19 is then filled via an infusion tube 23 from an external source of physiological saline, liquid or other substances, depending on the embodiment. The device of the present disclosure can then be used to treat obesity in patients by: (A) providing an intragastric filling device 19 with an infusion tube 23 connected therewith in a detachable manner inside the elongated catheter sheath, wherein the intragastric space filling device 19 comprises at least two interconnected elastic filled space fillers, e.g. 22A and 22B, as well as an optional security element 22C, wherein the first space filler 22A may be inflated to a volume in the interior of the stomach 40, and the least part of the first space filler 22A is made of biodegradable material; (B) inserting the catheter cover through the mouth into the stomach 40; (C) pushing out the device 19 that fills the intragastric space from the gastric catheter sheath 40; (D) filling the space fillers 22A and 22B through the infusion tube 23 with a suitable amount of liquid, saline solution or other substance to increase their volume;

[0055] The catheter protector or insertion device for the intragastric space filling device 19 is moved through the esophagus 24 and the heart incision 42 into the patient's stomach 40. After introduction into the stomach 40, space fillers, e.g. 22A and 22B, are filled. In an embodiment, at least one of the exemplary space fillers 22A and 22B is inflexible and is inflated to a pressure slightly greater than the local atmospheric pressure or pressure in the stomach 40, preferably to a pressure difference of about 1-20 mmHg, more preferably about 1-5. mm Hg. One of the reasons for the higher pressure in the exemplary space fillers 22A and 22B is to maintain occupying the desired stomach volume, despite

[0056] In the inner and outer layers of the cell membrane, including those in the stomach 40, phosphorylcholine (PC) can be found. It is the main component located in the outer layer of the membrane, and since it has both a positive and a negative charge (it is bipolar), it is both electrically neutral. As a result, the outer layer of the cell membrane does not cause excessive adhesion. If phosphorylcholine is applied to or contained within the material, a reduction in protein and cell adhesion is achieved, a reduction in the inflammatory response and minimization of fibrous capsule formation are achieved. Some aspects of the disclosure relate to a device 19 that fills the intragastric space coated with immobilized antibodies (e.g. CD34 or the like), which pretend to be a biological surface to reduce adhesion and reduce reactivity. Disclosed herein is a method for treating patient obesity with minimal nausea effects comprising implementing a device 19 that fills the intragastric space coated with a nausea-preventing agent, wherein the nauseating agent may be melatonin, albumin or phosphorylcholine to imitate the biological surface.

[0057] According to embodiments, at least part of the outer surface of the intragastric space filling device 19 is treated with an acid protective substance or an anti-stick substance. According to other embodiments, the intragastric space filling device 19 includes a central opening extending therethrough or the size of the intragastric space filling device 19 ensures occupancy of at least 90% of the patient's stomach volume. In a further embodiment, the intragastric space filling device 19 has adjustable capacity and size and is configured to occupy up to 90% (effectively 95%) of the stomach volume of the patient. The device 19 filling the intragastric space should provide the possibility of increasing in size over time using infusion through the port or infusion with re-docking, which should be known to those skilled in the art. The dimensions of the intragastric filling device 19 can be adjusted over time to allow the stomach to initially receive it and increase the volume to achieve the right balance between weight loss and the absence of nausea and vomiting.

[0058] In an embodiment, at least a part of the outer surface of the intragastric space filling device 19 is treated with an acid protective substance, a corrosion preventive or non-stick substance, which substance comprises polytetrafluoroethylene, inert material or other biological material (such as albumin, melatonin, phosphorylcholine, immobilized antibody or proteins) that are biocompatible. The surface treatment methods include coating, painting, dipping, impregnation and the like. In an embodiment, the melatonin or phosphorylcholine coating is located on at least part of the outer surface of the intragastric space filling device 19. In a preferred embodiment, the melatonin or phosphorylcholine coating is located on at least that portion of the outer surface of the intragastric filling device 19 that contacts the gastric wall. The intragastric filling device 19 can also be made or coated with a material belonging to the polyolefin family, such as high density polyethylene, linear low density polyethylene and very high molecular weight polyethylene, fluoropolymer materials such as a fluorinated copolymer of ethylene and propylene, polymethylpentene, polysulphones, or some elastomers, such as thermoplastic polyurethanes and C-Flex block copolymers. which comes into contact with the stomach wall. The intragastric filling device 19 can also be made or coated with a material belonging to the polyolefin family, such as high density polyethylene, linear low density polyethylene and very high molecular weight polyethylene, fluoropolymer materials such as a fluorinated copolymer of ethylene and propylene, polymethylpentene, polysulphones, or some elastomers, such as thermoplastic polyurethanes and C-Flex block copolymers. which comes into contact with the stomach wall. The intragastric filling device 19 can also be made or coated with a material belonging to the polyolefin family, such as high density polyethylene, linear low density polyethylene and very high molecular weight polyethylene, fluoropolymer materials such as a fluorinated copolymer of ethylene and propylene, polymethylpentene, polysulphones, or some elastomers, such as thermoplastic polyurethanes and C-Flex block copolymers.

[0059] Turning back to Figure 1, the inner surface or outer surface of the sheath 25 of the delivery catheter can be treated to give it hydrophilic properties or reduce surface friction. The intragastric space filling device 19 includes a sealed inlet 20 for infusing a fluid or saline solution into the space fillers 21A, 21B via an infusion tube or needle connected to an infusion tube 23 that is connected to an external fluid source. In an embodiment, the sealed inlet 20 is made of a self-sealing substance, which is intended to facilitate piercing it with a needle to fill the space filler 21A, 21B and seal the opening after the needle has been removed. In another embodiment, the sealed inlet 20 is provided with a unidirectional check valve for introducing infusion fluid or saline solution. It will be appreciated by those skilled in the art that these principles can be used in each of the disclosed embodiments as well as in the equivalent ones. [0060] Similarly, administration of melatonin may reduce the nausea associated with the implementation of the intragastric space filling device 19. Melatonin is a hypnotic that affects the regulation of gastrointestinal motility and related sensations. In some previous clinical trials in which 3 mg of melatonin was given before going to sleep for two weeks,

[0061] In the similar security / removal device shown in Fig. 13, mesh struts cross each other in the vicinity of the central mesh section of the expanding device 38. A thread 55 extends alternately from the front side and rear side of each crossing point. The thread 55 is connected to a loop 56, one end of the thread extending through the loop 56 at the other end of the thread and extending slightly beyond its plane by the end of the loop 57. during removal, the end loop 57 is caught or grasped by a removal device (e.g., a device comprising a hook, gripper or similar) and pulled outwards towards the mouth, allowing peripheral crushing of the expanded structure and a significant reduction in its profile for removal from the body.

[0062] According to embodiments, other security solutions are also used. The size and configuration of the biodegradable part of the biodegradable space filler are selected so that it biodegrades after a specified time, the biodegradation of the biodegradable space filler and its subsequent emptying are used as a warning signal indicating the need to remove the device 19 filling the intragastric space. A safety solution is provided when the pressure sensors on the space fillers emit a low pressure signal as a result of the emptying of the space filler. In some aspects of the disclosure, a signal is provided to remove or remove the intragastric filling device 19 in the event of emptying the space filler, e.g. 21A, 21B, or signaling a low pressure. This can prevent a life-threatening or life-threatening blockage / obstruction of the pylorus 41 by a completely emptied device filling the intragastric space. In an embodiment, the intragastric space filling device 19 can be removed after a predetermined time has elapsed since its implementation, e.g. 6 months after implementation. This can prevent a life-threatening or life-threatening blockage / obstruction of the pylorus 41 by a completely emptied device filling the intragastric space. In an embodiment, the intragastric space filling device 19 can be removed after a predetermined time has elapsed since its implementation, e.g. 6 months after implementation. This can prevent a life-threatening or life-threatening blockage / obstruction of the pylorus 41 by a completely emptied device filling the intragastric space. In an embodiment, the intragastric space filling device 19 can be removed after a predetermined time has elapsed since its implementation, e.g. 6 months after implementation.

[0063] In some aspects of the disclosure, there is provided an intragastric space filling device 19 for treating obesity in a patient by reducing the volume of the stomach, containing a filled reference space filler that is substantially maintained after accidental or intentional emptying of the intragastric space filling device. For illustration, maintaining the reference shape of the device 19 that fills the intragastric space is provided by using a relatively stiff spiral support protrusion extending along the inner surface of the device 19 filling the intragastric space. The support protrusion is similar to the spiral reinforcing elements extending along the inner surface of the flexible hose. Sizes (at least one full circumferential circle) and a configuration of the projection provide resistance to the compressive pressure exerted by the stomach wall, but are flexible and can be compressed by a removable device by compression, crumpling, string pulling technique or other mechanical deconstruction methods. . In an embodiment, the projection is made of the same biocompatible material as the device 19 filling the intragastric space. In another embodiment, the projection is an integral part of the device 19 that fills the intragastric space.

[0064] Also for illustration, the apparatus for maintaining the reference shape of the intragastric space filling device 19 includes a plurality of relatively rigid crossbars located in the interior space of the intragastric space filling device 19, all ends of the crossbars being attached to the inner wall of the intragastric space filling device. The sizes and configuration of the cross-braces provide resistance to the compressive pressure exerted by the stomach wall, but they are flexible and can be compressed by the removable device by compression, crushing or other mechanical destructive means. In an embodiment, the crossbar is made of the same biocompatible material as the device 19 filling the intragastric space. Also for illustration, the apparatus for maintaining the reference shape of the intragastric space filling device 19 may comprise foam material within the interior space of the intragastric space filling device 19. The size and shape of the material provide resistance to the compressive pressure exerted by the stomach wall, but it is elastic and can be compressed by a removable device by squeezing, crushing, using a string pulling technique (as shown in Figures 10 and 11) or other mechanical ways.

[0065] Fig. 14 shows an embodiment of a space filler 21A (see, for example, Fig. 2) including a pressure sensor element 51. The pressure sensor elements 51 may preferably be suitable pressure sensors known to those of ordinary skill in the art, e.g. pressure sensor disclosed in US 6 890 300. The pressure sensor element 51 may be mounted on the space filler 21A in accordance with the teachings of this disclosure or in a manner known to those skilled in the art. In an embodiment, the space filler 21A includes a recess 50, the size and configuration of which allows the pressure sensor element 51 to be mounted and mounted. The pressure sensor element 51 is pressure-connected to the interior space 53 via the opening 52.

Returning back to Figure 3, the intragastric filling device 19 may further comprise an elastic filled space filler 22A and a security element 22C that are connected to the space filler 22A, the security element 22C producing a noticeable signal indicating the need to remove the filling device 19. intragastric space. In an embodiment, the security element 22C is in the form of a visible dye, which in the case of damage to the intragastric space filling device 19 causes a visible change in the color of the urine within a short time of rupture of the intragastric space filling device 19. In an embodiment, the security element 22C is in the form of an aroma, which in the case of damage or leakage of the device filling the intragastric space, causes the odor of urine in a short time from the rupture of the device 19 filling the intragastric space. In a further embodiment, the security element 22C has the form of a biodegradable material which in the case of premature biodegradation of the security element 22C generates a signal indicating the necessity to remove the components that have been decomposed / biodegraded. The implementation of the protective element 22C is understood by those skilled in the art who will appreciate the variations and combinations of signaling devices informing patients or physicians of the need to remove the device filling the intragastric space. [0067] The security element 22C may also include a pressure sensor element for measuring the internal pressure of the space filler 22A, as described above. The pressure sensor element may further comprise a transmitter for wireless transmission of the measured internal pressure to the receiver outside the patient's body. In an embodiment, the security element 22C includes a pH sensor element for measuring the pH value in the patient's stomach, wherein the pH sensor element may further comprise a transmitter for wireless sending of the measured pH value to the receiver outside the patient's body. The measured pH or its change over time is compared to historical data or predetermined data to evaluate the performance or integrity of the device.

[0068] The security element 22C may comprise a device for maintaining the shape of the intragastric filling device 19, whereby a defective device 19 filling the intragastric space (by leakage or collapse) does not cause intestinal obstruction from obstruction. The security element 22C may maintain a minimum cross-sectional shape or perimeter after failure of the filler, e.g. as seen in the embodiment shown in FIG. 4. In an embodiment, proper maintenance of size is at least 50% to 75% of the reference value from before damage.

[0069] According to an embodiment, the intragastric filling device 19 and the securing element 22C are configured to be a tandem within the stomach 40 In another embodiment, the intragastric space filling device 19 and the security element 22C are configured to extend substantially parallel relative to each other. In a further embodiment, the safety element 22C or the intragastric space filling device 19 including the protection element 22C are attached to the inner wall of the stomach 40 or through it. Specialists will understand and notice these tips and related implementations.

[0070] In an embodiment, the security element 22C or the space filler (e.g. 21A, 21B) of the intragastric space filling device 19 are visible using ultrasound. In another embodiment, an ultrasound transducer is used to emit an ultrasound signal on the safety element or device 19 that fills the intragastric space.

[0071] Aspects of the present disclosure relate to a mechanism for fixing or restraining an intragastric space filling device 19 that provides attachment only when the intragastric space filling device 19 is adequately filled. In an embodiment, at least one of the space fillers (e.g. 21A, 21B) of the intragastric space filling device 19 is attached to the inner stomach wall 40. In a further embodiment, the attachment is solved and configured so that the securing mechanism (e.g. triggered when the device filling the intragastric space is filled and comes into contact with the inner wall of the stomach 40, and be turned off when the filler is emptied. The filled device 19 filling the intragastric space is maintained or stabilized by attaching or otherwise fixing the expandable device to the stomach walls. In an embodiment, such expandable devices include mounting areas for attachment to one or more attachment elements that can be configured to at least partially extend through one or more folds of the patient's stomach wall as is known to those skilled in the art. Such fastening elements can be made in many different shapes, e.g. spiral, elongated, annular or tick, and can also be configured to be non-piercing.

[0072] The apparatus and method have been described with reference to embodiments that are now considered to be the most practical and advantageous, however, it should be understood that the disclosure is not limited to the disclosed embodiments. It includes various modifications and similar embodiments within the scope of the claims, the scope of which should be considered in its broadest interpretation to cover all such modifications and similar constructions. The present disclosure includes each and all embodiments of the following claims.