Self-expanding intragastric balloon and its application

Abstract

The present invention provides a self-expanding intragastric balloon and its application, relating to the field of medical device technology. A reaction valve is provided within the balloon body. When the self-expanding intragastric balloon enters the body, the water-soluble filler material dissolves, and the elastic member within the reaction valve drives the support adjustment member to move axially within the valve body shell. The raised portion on the support adjustment member blocks the through-hole. During the movement of the support adjustment member, the through-hole enters the second reaction chamber from the second outlet cavity, connecting the inner chamber A and the inner chamber B of the second reaction chamber. This allows the materials in the inner chambers A and B to contact and react to generate gas. The gas overflows from the air vents on the first guide member and then enters the balloon body through the outlet holes on the outlet end surface of the valve body shell, causing the balloon body to self-expand. This eliminates the need for additional auxiliary equipment to implant or fill the intragastric balloon, thereby improving the convenience of use of the intragastric balloon.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a self-expanding intragastric balloon and applications thereof. Background Art

[0002] Obesity and overweight are significant risk factors for chronic diseases such as cardiovascular disease and diabetes. In recent decades, the prevalence of obesity has skyrocketed worldwide, making it a significant health issue contributing to the socioeconomic burden of contemporary society. The World Health Organization's latest projections suggest that by 2030, nearly 60% of the global population may be overweight or obese. Traditional treatments for obesity include dietary changes, lifestyle interventions, and medications, but these rarely achieve long-term, significant weight loss. Surgery has proven to be the only long-term effective method for weight loss and improving obesity-related comorbidities. However, the invasiveness, safety, and potential postoperative adverse reactions of surgery mean that less than 1% of the obese population undergoes surgery. In recent years, some regions have gradually shifted toward non-invasive weight loss methods. With the increasing prevalence of overweight and obesity, the design and development of convenient, non-invasive weight loss medical devices holds significant social and commercial value.

[0003] Existing non-invasive weight loss methods primarily involve intragastric balloons. Once implanted, these balloons create a sense of fullness and other sensations, resulting in excellent weight loss. Typically, within four to six months of implantation, they can achieve a weight loss rate of 10-15%. However, the current intragastric balloon implantation and removal procedures require at least endoscopy, and the injection of media (such as water and gas) required to inflate the balloon requires an additional catheter, significantly reducing operational convenience.

[0004] In view of this, the present invention is proposed. Summary of the Invention

[0005] The purpose of the present invention is to provide a self-expanding intragastric balloon and its application, which can achieve self-expansion in the stomach without the assistance of an endoscope or other equipment, thereby improving the convenience of use of the intragastric balloon.

[0006] The embodiment of the present invention is achieved as follows:

[0007] In a first aspect, the present invention provides a self-expanding intragastric balloon comprising a balloon body and a reaction valve, wherein the reaction valve is accommodated in the balloon body.

[0008] The reaction valve includes a valve body shell, a support adjustment member, an elastic member and a first guide member.

[0009] The two opposite ends of the valve body shell are the reaction end and the gas outlet end respectively. The end face of the reaction end is provided with a through hole, and the end face of the gas outlet end is provided with an gas outlet hole. The end face of the gas outlet end is also provided with an elastic part mounting groove extending into the interior of the reaction valve, and an elastic part is fixed in the elastic part mounting groove.

[0010] The support and adjustment member is accommodated in the valve body shell, and the support and adjustment member includes a top plate and a support plate that are fixedly connected.

[0011] The edge of the top plate can be selectively slidably connected to the inner wall surface of the valve body shell, dividing the inner cavity of the valve body shell into a first inner cavity and a second inner cavity along the axial direction of the reaction valve. The first inner cavity is formed between the top plate and the inner wall surface of the end face of the reaction end, and the first inner cavity is configured to accommodate a water-soluble filling material.

[0012] A convex portion protruding from the top plate is provided on a surface of one side of the top plate away from the support plate, and the convex portion can be selectively accommodated in the through hole.

[0013] One end of the support plate away from the top plate is fixedly connected to the elastic member, and the elastic member is configured to drive the support adjustment member to move in the valve body shell.

[0014] The first guide member is provided with a first guide hole and a plurality of air holes. The support plate passes through the first guide hole and is sealed so that the support plate can selectively slide relative to the first guide member. The first guide member is fixedly connected to the inner wall surface of the valve body shell on all sides, dividing the second inner cavity into a second reaction cavity and a second air outlet cavity along the axial direction of the reaction valve. The area between the top plate and the first guide member is the second reaction cavity.

[0015] The edge of the support plate contacts the inner wall surface of the valve body shell, dividing the second reaction chamber into inner chamber A and inner chamber B along the radial direction of the reaction valve, and a through groove is radially opened at one end of the support plate close to the elastic member. The through groove can be selectively located in the second gas outlet chamber or the second reaction chamber. When the through groove is located in the second reaction chamber, inner chamber A and inner chamber B are connected, and the materials in inner chambers A and B contact and react to generate gas.

[0016] In a second aspect, the present invention provides a use of a self-expanding intragastric balloon according to any one of the aforementioned embodiments in the preparation of a weight loss product.

[0017] The beneficial effects of the embodiments of the present invention are:

[0018] The present invention provides a self-expanding intragastric balloon and its application. A reaction valve is provided in the balloon body. When the self-expanding intragastric balloon enters the body, a water-soluble filling material dissolves, and an elastic member in the reaction valve can drive a support adjustment member to move axially in the valve body shell. A protrusion on the support adjustment member blocks a through hole. During the movement of the support adjustment member, the through groove enters the second reaction chamber from the second air outlet chamber, connecting the inner cavity A and the inner cavity B of the second reaction chamber, so that the materials in the inner cavities A and B contact and react to generate gas. The gas overflows from the air permeability on the first guide member and then enters the balloon body through the air outlet hole on the air outlet end surface of the valve body shell, thereby achieving self-expansion of the balloon body. Therefore, there is no need to use additional auxiliary equipment to implant or fill the intragastric balloon, thereby improving the convenience of use of the intragastric balloon. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0020] Figure 1 A schematic diagram of the structure of the self-inflating intragastric balloon after expansion provided by an embodiment of the present invention;

[0021] Figure 2 A cross-sectional view of a reaction valve in an initial state provided by an embodiment of the present invention;

[0022] Figure 3 A schematic diagram of the structure of the balloon body after expansion provided by an embodiment of the present invention;

[0023] Figure 4 A front view of a support adjustment member provided in an embodiment of the present invention;

[0024] Figure 5 A partial top view of a support and adjustment member provided in an embodiment of the present invention;

[0025] Figure 6 A schematic structural diagram of a first guide member provided in an embodiment of the present invention;

[0026] Figure 7 A side view of a support adjustment member provided in an embodiment of the present invention;

[0027] Figure 8 A schematic structural diagram of a connector provided in an embodiment of the present invention;

[0028] Figure 9 A schematic diagram of the structural changes of the reaction valve of the self-expanding intragastric balloon provided by an embodiment of the present invention during the expansion process;

[0029] Figure 10 A schematic structural diagram of a balloon body with a degradation function provided by an embodiment of the present invention;

[0030] Figure 11 A schematic structural diagram of a balloon body with a degradation function provided by an embodiment of the present invention;

[0031] Figure 12 Schematic diagram of the structural changes of the reaction valve of the support adjustment member with degradation function during the degradation process provided by an embodiment of the present invention.

[0032] Icons: 10-self-expanding intragastric balloon; 100-balloon body; 110-first air hole; 120-degradable material port; 131-degradable material sheet; 132-non-degradable material sheet; 200-reaction valve; 210-valve body shell; 211-through hole; 212-air outlet; 213-elastic member mounting groove; 220-support adjustment member; 221-top plate; 222-support plate; 2221-elastic member fixing position; 223-protrusion; 224-through groove; 23 0-elastic member; 240-first guide member; 241-first guide hole; 242-ventilation hole; 251-first inner cavity; 2521-second reaction cavity; 2521a-second reaction chamber; 2521b-top plate limiting cavity; 2522-second air outlet cavity; 2523-A inner cavity; 2524-B inner cavity; 260-water-soluble filling material; 270-waterproof breathable membrane; 280-second guide member; 300-connecting member; 310-connecting section; 320-straight section. DETAILED DESCRIPTION

[0033] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings herein can be arranged and designed in various different configurations.

[0034] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but rather merely represents selected embodiments of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort shall fall within the scope of protection of the present invention.

[0035] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0036] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" and the like indicate positions or locations based on the positions shown in the accompanying drawings, or the positions or locations in which the inventive product is typically placed when in use. These terms are intended solely to facilitate the description of the present invention and to simplify the description, and are not intended to indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third," etc., are used solely to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0037] Furthermore, terms such as "horizontal" and "vertical" do not necessarily mean that a component must be absolutely horizontal or overhanging, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but rather that it can be slightly tilted.

[0038] In the description of the present invention, it should also be noted that, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; they may refer to mechanical connections or electrical connections; they may refer to direct connections or indirect connections through an intermediate medium; and they may refer to internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0039] Please refer to Figure 1 Some embodiments of the present invention provide a self-expanding intragastric balloon 10 , comprising a balloon body 100 and a reaction valve 200 , wherein the reaction valve 200 is housed in the balloon body 100 .

[0040] The structure of the reaction valve 200 can realize the inflation of the balloon body 100. Therefore, in actual application, it is only necessary to swallow the self-inflating intragastric balloon 10 (uninflated structure), and then the balloon body 100 is automatically inflated in the stomach through the reaction valve 200.

[0041] In some embodiments, in order to ensure that the self-inflating intragastric balloon 10 expands after entering the stomach, the self-inflating intragastric balloon 10 can be encapsulated in a capsule when not inflated. When the capsule decomposes in the digestive tract, the self-inflating intragastric balloon 10 can realize its self-inflation function, thereby assisting in achieving a weight loss effect.

[0042] Specifically, the specific structure of the reaction valve 200 to achieve the self-expansion effect is as follows:

[0043] Please refer to Figure 2The reaction valve 200 includes a valve body shell 210 , a support adjustment member 220 , an elastic member 230 and a first guide member 240 . The support adjustment member 220 , the elastic member 230 and the first guide member 240 are all accommodated in the valve body shell 210 .

[0044] In some embodiments, the reaction valve 200 is in the shape of a cylinder, a prism, or a pyramid, such as a triangular prism, a quadrangular prism, a hexagonal prism, or a quadrangular pyramid.

[0045] Preferably, the reaction valve 200 is cylindrical in shape. Therefore, the following description will be made using the cylindrical reaction valve 200 as an example. When the reaction valve 200 has other shapes, the shape of the structure cooperating therewith may be changed accordingly.

[0046] Since the reaction valve 200 is cylindrical in shape, the valve housing 210 is a cylindrical housing. Since the valve housing 210 contains the support adjustment member 220, the elastic member 230, and the first guide member 240, the valve housing 210 is a hollow cylindrical housing.

[0047] The two opposite ends of the valve body shell 210 are a reaction end and an air outlet end respectively. In this embodiment, the surfaces of the reaction end and the air outlet end are both circular surfaces.

[0048] Please refer to Figure 3 The end face of the reaction end is provided with a through hole 211, the end face of the gas outlet end is provided with a gas outlet hole 212, and the end face of the gas outlet end is also provided with an elastic member mounting groove 213 extending into the interior of the reaction valve 200, and an elastic member 230 is fixed in the elastic member mounting groove 213.

[0049] Please refer to Figure 4 The support adjustment member 220 is accommodated in the valve body shell 210, and the support adjustment member 220 includes a top plate 221 and a support plate 222 that are fixedly connected. The cross-section of the structure formed by the top plate 221 and the support plate 222 is "T"-shaped. The top plate 221 is arranged along the horizontal direction of the reaction valve 200, and the support plate 222 is arranged along the axial direction of the reaction valve 200.

[0050] Please continue to refer to Figure 2 The edge of the top plate 221 can be selectively slidably connected to the inner wall surface of the valve body shell 210, dividing the inner cavity of the valve body shell 210 into a first inner cavity 251 and a second inner cavity along the axial direction of the reaction valve 200. The first inner cavity 251 is formed between the top plate 221 and the inner wall surface of the end face of the reaction end, and the second inner cavity is formed between the top plate 221 and the inner wall surface of the end face of the gas outlet end. The first inner cavity 251 is configured to accommodate a water-soluble filling material 260.

[0051] A protrusion 223 protruding from the top plate 221 is provided on a surface of one side of the top plate 221 away from the support plate 222 . The protrusion 223 can be selectively received in the through hole 211 .

[0052] Please refer to Figure 5 An elastic member fixing position 2221 is provided at one end of the support plate 222 away from the top plate 221. The support plate 222 is fixedly connected to the elastic member 230 at the elastic member fixing position 2221. The elastic member 230 is configured to drive the support adjustment member 220 to move within the valve body housing 210. Since the elastic member 230 is fixed in the elastic member mounting groove 213 and one end is connected to the support plate 222, the support plate 222 and the top plate 221 are integrally formed. Therefore, when the elastic member 230 drives the support plate 222 to move, it can drive the support adjustment member 220 formed by the support plate 222 and the top plate 221 to move as a whole. The support adjustment member 220 is within the valve body housing 210. Therefore, the elastic member 230 can drive the support adjustment member 220 to move within the valve body housing 210.

[0053] Please continue to refer to Figure 2 Based on this, since the first inner cavity 251 is filled with the water-soluble filling material 260, when the first inner cavity 251 is filled with the water-soluble filling material 260, the top plate 221 will continue to move downward due to the squeezing effect of the water-soluble filling material 260, thereby compressing the elastic member 230. At this time, due to the physical separation effect of the water-soluble filling material 260, the protrusion 223 is not in the through hole 211, but is located in the first inner cavity 251.

[0054] Please refer to Figure 1 After the self-inflating intragastric balloon 10 enters the stomach, the water-soluble filling material 260 will gradually dissolve, or the water-soluble filling material 260 can be quickly dissolved by drinking water (generally 100 to 200 mL of water is sufficient). After the water-soluble filling material 260 dissolves, the squeezing force of the water-soluble filling material 260 on the top plate 221 gradually disappears, or disappears quickly, and the compressive force received by the elastic member 230 disappears, so it has a tendency to stretch, thereby driving the support adjustment member 220 to slide toward the end face of the reaction end, and the top plate 221 gradually moves upward until the protrusion 223 is accommodated in the through hole 211.

[0055] Furthermore, the expansion process of the balloon body 100 also requires the filling of the interior of the balloon body 100 with a medium. The specific structure and process are as follows:

[0056] Please refer to Figure 6The first guide member 240 is provided with a first guide hole 241 and a plurality of air holes 242. The support plate 222 passes through the first guide hole 241 and is sealed so that the support plate 222 can selectively slide relative to the first guide member 240. The first guide member 240 is fixedly connected to the inner wall surface of the valve body shell 210 on all sides, dividing the second inner cavity into a second reaction chamber 2521 and a second air outlet chamber 2522 along the axial direction of the reaction valve 200. The area between the top plate 221 and the first guide member 240 is the second reaction chamber 2521, and the area between the first guide member 240 and the end surface of the air outlet end is the second air outlet chamber 2522.

[0057] In this embodiment, the first guide member 240 is a circular plate-shaped structure, and a plurality of air holes 242 are provided on the circular surface.

[0058] Please continue to refer to Figure 2 and cooperate with Figure 7 Since the support plate 222 is arranged along the axial direction of the reaction valve 200, when the edge of the support plate 222 contacts the inner wall surface of the valve body shell 210, the second reaction chamber 2521 can be divided into an inner chamber A 2523 and an inner chamber B 2524 along the radial direction of the reaction valve 200, and a through groove 224 is radially opened at one end of the support plate 222 close to the elastic member 230. The through groove 224 can be selectively located in the second gas outlet chamber 2522 or the second reaction chamber 2521. When the through groove 224 is located in the second reaction chamber 2521, the inner chamber A 2523 and the inner chamber B 2524 are connected, and the materials in the inner chambers A 2523 and B 2524 contact and react to generate gas; when the through groove 224 is located in the second gas outlet chamber 2522, the inner chamber A 2523 and the inner chamber B 2524 are sealed from each other.

[0059] Therefore, it can be understood that when the protrusion 223 has closed the through hole 211, since the elastic member 230 will drive the support adjustment member 220 to move upward in the above process, the through groove 224 will move from the second air outlet chamber 2522 to the second reaction chamber 2521, thereby connecting the A inner chamber 2523 and the B inner chamber 2524, allowing the materials in the A inner chamber 2523 and the B inner chamber 2524 to contact and react to generate gas, and the gas overflows from the air vent 242 on the first guide member 240 into the second air outlet chamber 2522, and then overflows through the air outlet hole 212 on the valve body shell 210 and enters the balloon body 100, causing the balloon body 100 to expand.

[0060] This process only requires swallowing the self-inflating intragastric balloon 10. If necessary, you can drink water to promote the dissolution of the water-soluble filling material 260, so that the automatic expansion of the intragastric balloon can be directly achieved, which greatly improves the operational convenience of the intragastric balloon and has excellent industrial application value.

[0061] In this embodiment, in order to prevent the materials in the inner cavity A 2523 and the inner cavity B 2524 from scattering, a waterproof and breathable membrane 270 is further provided on the surface of the first guide member 240 in the second reaction chamber 2521 .

[0062] It should be noted that for some solid materials with relatively large particles, by controlling the size of the vent holes 242 in the first guide member 240, the materials in the A cavity 2523 and the B cavity 2524 are prevented from scattering. However, considering the tolerance of the self-inflating intragastric balloon 10 provided by the present invention to all materials, a waterproof and breathable membrane 270 can be provided on the upper surface of the first guide member 240, making the self-inflating intragastric balloon 10 provided by the present invention applicable not only to reactions with solid materials but also to reactions with liquid materials.

[0063] For example, in some embodiments, the material in the A inner cavity 2523 may be citric acid, and the material in the B inner cavity 2524 may be potassium bicarbonate. The citric acid is preferably a citric acid solution, more preferably a citric acid solution with a concentration of 60%.

[0064] The reaction formula of citric acid and potassium bicarbonate is:

[0065] C6H8O7+3KHCO3→K3C6H5O7+3H2O+3CO2

[0066] It can be found that carbon dioxide gas can be released during the above reaction process. According to calculations, when the ratio of citric acid solution to potassium bicarbonate is 3mL:4g, 250mL of carbon dioxide gas is produced for every 1mL of citric acid solution, which is conducive to achieving self-inflation of the intragastric balloon.

[0067] Of course, due to the environmental requirements for the use of the self-inflating intragastric balloon 10 provided by the present invention, the materials forming its structure and the materials filled therein need to be food-grade materials or materials that are suitable for human use, and the medium generated by the reaction that causes the intragastric balloon to expand cannot be toxic or harmful.

[0068] For example, the waterproof breathable membrane 270 is made of any one of PTFE, ePTFE, PP or PE; in this embodiment, it is PTFE.

[0069] Preferably, the water-soluble filling material 260 is a solid material, and the water-soluble filling material 260 includes one or more of polyvinyl alcohol, polyethylene glycol, polyvinyl pyrrolidone, polyacrylamide and betaine derivatives.

[0070] In order to ensure the isolation effect of the waterproof breathable membrane 270 , the edge of the waterproof breathable membrane 270 can be fixed to the periphery of the first guide member 240 or the inner wall surface of the valve body shell 210 by adhesive.

[0071] Preferably, the first guide member 240 is fixedly connected to the notch of the elastic member installation groove 213 .

[0072] Since the through groove 224 can move up and down on the first guide member 240, it can be understood that the first guide member 240 can not only guide the support plate 222, but also guide the elastic member 230. When the spring is in a compressed state, the first guide member 240 guides the support plate 222. When the spring rebounds, the first guide member 240 first guides the support plate 222. When the support plate 222 is out of the position of the first guide member 240, the first guide member 240 guides the elastic member 230.

[0073] Since the movement process of the support plate 222 after it detaches from the first guide member 240 may cause the support adjustment member 220 to tilt, in an optional embodiment, a second guide member 280 is also included. The second guide member 280 is horizontally arranged in the second reaction chamber 2521, and the four sides of the second guide member 280 are fixedly connected to the inner wall surface of the valve body shell 210. A second guide hole is provided on the second guide member 280, and the support plate 222 can selectively slide on the second guide member 280 through the second guide hole.

[0074] Due to the provision of the second guide member 280 , the support plate 222 will still be restricted by the second guide member 280 even after it is separated from the first guide member 240 , thereby ensuring that the support adjustment member 220 can move stably without being skewed.

[0075] Further preferably, since the water-soluble filling material 260 will press down the top plate 221, in order to prevent the top plate 221 from continuing to move downward, the second guide member 280 can be located in the second reaction chamber 2521 at one end close to the top plate 221, and the second guide member 280 divides the second reaction chamber 2521 into a second reaction chamber 2521a and a top plate limiting chamber 2521b along the axial direction of the reaction valve 200, and the area enclosed between the top plate 221 and the second guide member 280 is the top plate limiting chamber 2521b.

[0076] By controlling the second guide member 280 to be positioned within the second reaction chamber 2521 at one end near the top plate 221, the second guide member 280 not only guides the support plate 222 but also limits the top plate 221, preventing it from continuously moving downward due to the pressure of the water-soluble filler material 260. Furthermore, the second guide member 280 can also effectively control the volume of the water-soluble filler material 260 that can be accommodated within the self-inflating intragastric balloon 10, preventing excessive water-soluble filler material 260 from causing the top plate 221 to continuously move downward, thereby shortening the service life of the elastic member 230.

[0077] In some embodiments, in order to ensure that the reaction valve 200 can accommodate sufficient material, obtain a self-expanding intragastric balloon 10 with appropriate volume expansion, and ensure that the reaction valve 200 is easy to swallow or easy to put into a capsule, the dimensions of each structure of the reaction valve 200 can be further controlled.

[0078] Preferably, the dimensions of the valve body shell 210 of the reaction valve 200 are: diameter 5 mm to 30 mm, height 10 mm to 30 mm, and wall thickness 0.1 mm to 3 mm.

[0079] Preferably, the diameter of the gas outlet hole 212 on the gas outlet end surface of the reaction valve 200 is 0.1 mm to 1 mm.

[0080] Preferably, the diameter of the through hole 211 on the reaction end surface of the reaction valve 200 is 1 mm to 5 mm.

[0081] Preferably, the reaction valve 200 is made of any one of nylon, polycarbonate, polyoxymethylene, polymethyl methacrylate, acrylonitrile-styrene-butadiene copolymer, polyetheretherketone, polyphenylene sulfide, polyamide, polyimide, polysulfone, polyethylene furandicarboxylate or stainless steel.

[0082] In an optional embodiment, the thickness of the second guide member 280 is 0.1 mm to 3 mm, and the distance between the top plate 221 and the end surface of the reaction end is 0.3 mm to 10 mm.

[0083] Preferably, the thickness of the first guide member 240 is 0.1 mm to 3 mm, the diameter of each vent hole 242 on the first guide member 240 is 0.1 mm to 1 mm, and the height of the second air outlet cavity 2522 is 0.3 mm to 10 mm.

[0084] Preferably, the diameter of the elastic member 230 is 0.5 mm to 10 mm, the length in the natural state is 0.5 mm to 20 mm, and the length in the compressed state is 0.1 mm to 9 mm; the material of the elastic member 230 is any one of stainless steel, nickel titanium wire or titanium alloy.

[0085] Preferably, the top plate 221 has a thickness of 0.1 mm to 3 mm, the support plate 222 has a radial thickness of 0.1 mm to 3 mm, and an axial height of 3 mm to 15 mm.

[0086] Preferably, the thickness of the balloon body 100 is 30 μm to 120 μm; and the volume of the balloon body 100 after being fully expanded is 100 mL to 1500 mL.

[0087] Preferably, the balloon body 100 is made of non-degradable materials such as polyether polyurethane, liquid silicone rubber, polyethylene nylon blend, etc.

[0088] In an optional embodiment, the diameter of the top plate 221 is substantially identical to the inner diameter of the valve housing 210 to achieve edge sealing; the raised portion 223 is substantially identical in size to the through-hole 211 to achieve sealing; and the dimensions of the first guide hole 241 are substantially identical to those of the support plate 222 to achieve sealing. The overall material of the support and adjustment member 220 is the same as that of the reaction valve 200. Furthermore, the contact area between the top plate 221 and the valve housing 210 can be coated with silicone to further enhance sealing.

[0089] Please refer to Figure 8 In order to facilitate the fixed connection between the balloon body 100 and the reaction valve 200, in an optional embodiment, the self-inflating intragastric balloon 10 further includes a connector 300, the connector 300 including a connecting section 310 and a straight section 320, the connecting section 310 is provided with an opening, the straight section 320 protrudes from the connecting section 310 along the opening, the balloon body 100 is provided with a first air hole 110, the first air hole 110, the opening on the connecting section 310 and the through hole 211 are arranged in sequence, the opening of the connecting section 310 is bonded to the inner surface of the balloon body 100, the reaction valve 200 is accommodated in the straight section 320, and the outer surface of the reaction valve 200 is sealed and fitted with the inner surface of the straight section 320, and the reaction end of the valve body shell 210 is close to the connecting section 310.

[0090] Preferably, the reaction end of the valve body shell 210 is flush with the connecting section 310 , so that the gastric fluid can contact the water-soluble filling material in the first inner cavity 251 .

[0091] The reaction valve 200 and the connecting piece 300 can be bonded together by adhesive, and ensure that there is no gap between the outer wall of the reaction valve 200 and the inner wall of the straight section 320, and then the connecting section 310 can be connected to the balloon body 100.

[0092] In an optional embodiment, the connection between the connecting segment 310 and the balloon body 100 includes solvent bonding, adhesive bonding, welding, and the like.

[0093] Preferably, the diameter of the first air hole 110 on the balloon body 100 is 8.0 mm to 50 mm.

[0094] Preferably, the diameter of the straight section 320 is 5 mm to 30 mm, and the height is 10 mm to 30 mm. The diameter and height of the straight section 320 are preferably just enough to accommodate the reaction valve 200.

[0095] In this embodiment, to facilitate manufacturing and ensure structural stability of reaction valve 200, protrusion 223 is located at the center of top plate 221, through-hole 211 is located at the center of the end surface of the reaction end, and the point where top plate 221 connects to support plate 222 is also located at the center of top plate 221. Elastic member mounting groove 213 is located at the center of the end surface of the gas outlet end. Therefore, elastic member 230 can stably drive support adjustment member 220 to block through-hole 211.

[0096] The working principle of the self-inflating intragastric balloon 10 provided in the embodiment of the present invention is as follows:

[0097] Please refer to Figure 9 The inner cavity of the valve body shell 210 is divided into four cavities along the axial direction from top to bottom through the top plate 221, the second guide member 280 and the first guide member 240 (and the waterproof breathable membrane 270). The four cavities are the first inner cavity 251, the top plate limiting cavity 2521b, the second reaction cavity 2521a and the second air outlet cavity 2522 from top to bottom.

[0098] Among them, the first inner cavity 251 is used to accommodate the water-soluble filling material 260; the top plate limiting cavity 2521b is used to limit the top plate 221 to prevent the top plate 221 from moving downward indefinitely. Therefore, when the amount of water-soluble filling material 260 added is sufficient, the top plate 221 will eventually contact the second guide member 280, and at this time the top plate limiting cavity 2521b does not exist; the second reaction chamber 2521a is used to react and generate a medium that can expand the balloon body 100; the second air outlet cavity 2522 is used to discharge the medium generated in the second reaction chamber 2521a to the balloon body 100.

[0099] Since the reaction process in the second reaction chamber 2521a needs to be controlled and the reaction cannot occur at any time and place, the second reaction chamber 2521a is radially divided into an inner chamber A 2523 and an inner chamber B 2524 by the support plate 222. In the initial state, the inner chamber A 2523 and the inner chamber B 2524 are completely separated and the materials inside cannot contact each other. When the water-soluble filling material 260 dissolves, the elastic member 230 drives the support plate 222 to move upward, so that the through groove 222 on the support plate 222 is opened. The balloon is moved from the second air outlet cavity 2522 into the second reaction chamber 2521a, connecting the inner cavity A 2523 and the inner cavity B 2524 of the second reaction chamber 2521a. The materials in the inner cavities A 2523 and B 2524 react to produce a medium, such as carbon dioxide, that can expand the balloon body 100. The carbon dioxide then passes through the waterproof breathable membrane 270, the air holes 242, and the air outlet 212 and enters the balloon body 100, causing it to expand. After the treatment period is complete, the balloon can be punctured and removed using forceps through a gastroscope.

[0100] In order to further optimize the intragastric balloon, after the above-mentioned structure of the present invention realizes the self-expansion of the intragastric balloon, how to remove the intragastric balloon non-invasively and more conveniently, the present invention provides the following further improvements.

[0101] In an optional embodiment, the material of the balloon body 100 and / or the support adjustment member 220 is a degradable material.

[0102] When the material of the balloon body 100 is a degradable material, the balloon body 100 can be made entirely of degradable materials, or a composite material of degradable and non-degradable materials can be used to make the balloon body 100. Figure 10 As shown, a degradable material port 120 can be opened on the balloon body 100. The degradable material port 120 is made of degradable material. When the degradable material of the degradable material port 120 degrades, the balloon body 100 is deflated, and the deflated self-inflating intragastric balloon 10 can be directly excreted from the body.

[0103] Or, as Figure 11 As shown, the balloon body 100 is composed of multiple sheets of material, including a degradable material sheet 131 and a non-degradable material sheet 132. When the degradable material sheet 131 degrades, the balloon body 100 is deflated, and the deflated self-inflating intragastric balloon 10 can be directly discharged from the body.

[0104] The degradable material of the balloon body 100 includes at least one of polylactide, polycaprolactone, polytrimethylene carbonate or polyglycolide.

[0105] like Figure 12 As shown, when the support and adjustment member 220 is made of a degradable material, after the self-inflating intragastric balloon 10 has been used for a period of time, the material of the support and adjustment member 220 degrades, and the protrusion 223 loses its blocking effect on the through-hole 211. The gas in the self-inflating intragastric balloon 10 can be directly discharged from the through-hole 211 and the first air hole 110, and the balloon body 100 is deflated. The deflated self-inflating intragastric balloon 10 can be directly discharged from the body.

[0106] The degradable material of the support adjustment member 220 includes polylactide, polyglycolide, and copolymers or blends thereof.

[0107] Furthermore, the present invention also provides a preparation method and assembly process of the self-expanding intragastric balloon 10, which are as follows:

[0108] The reaction valve 200 is prepared by injection molding, machining, or 3D printing.

[0109] The balloon body 100 can be manufactured by any one of solution coating molding, hot pressing molding, injection molding or tape casting molding.

[0110] The solution coating molding includes attaching the raw polymer solution of the balloon body 100 to the inner wall of a tooling with a balloon structure, and then demolding the material after the solvent evaporates or the solution solidifies.

[0111] For example, when the raw polymer of the balloon body 100 is polyurethane, the concentration of the polyurethane solution is 7% to 30%, and the solvent is one or more of chloroform, dichloromethane, hexafluoroisopropanol, trifluoroacetic acid, and tetrahydrofuran.

[0112] When the raw polymer of the balloon body 100 is silicone rubber, the hardness of the silicone rubber is 50A to 80A.

[0113] When the raw material polymer of the balloon body 100 is polyether polyurethane, the hardness of the polyether polyurethane is 85A-95A or 45D-65D.

[0114] In order to reduce the escape of gas or liquid in the balloon body 100 and ensure the expansion effect of the balloon body 100, the surface of the obtained balloon body 100 may be coated with a polyparaxylene coating or a silicon dioxide coating.

[0115] When the raw material polymer of the balloon body 100 is a homopolymer, copolymer or blend of a biodegradable material such as polylactide, polycaprolactone, polytrimethylene carbonate and polyglycolide, the solvent for dissolving the above polymers is one or more of chloroform, dichloromethane and hexafluoroisopropanol.

[0116] Furthermore, the thermoforming includes placing polymer particles in a thermoforming machine, first preparing a polymer film by thermoforming, and then welding or bonding two or more polymer films together to form a balloon;

[0117] The tape casting method is to prepare a film of desired thickness from the raw polymer of the balloon body 100 through a tape casting machine, and then prepare the balloon body 100 through welding or bonding.

[0118] The welding methods involved include laser welding, ultrasonic welding, radio frequency welding, thermal welding, and high-frequency welding; the bonding methods include adhesive bonding and polymer solution bonding.

[0119] The preparation of the connector 300 includes obtaining a "T"-shaped connector 300 by vacuum or positive pressure adsorption of the same polymer material as the balloon body 100 near its softening temperature.

[0120] Example 1

[0121] This embodiment provides a self-expanding intragastric balloon 10, including a balloon body 100, a connector 300 and a reaction valve 200. The specific structure is as follows: Figures 1 to 9 shown.

[0122] The raw material of the balloon body 100 is polyether polyurethane (hardness 90A), which is prepared by the casting method to obtain a 50μm thick film, and finally the film is welded into a balloon body 100 with a volume of 500mL by hot pressing, wherein a first air hole 110 with a diameter of 30mm is cut out on one side of the sphere.

[0123] The connector 300 is made of the same polyether polyurethane film as the balloon body 100 and is vacuum-adsorbed near its softening temperature to obtain a "T"-shaped structure, wherein the straight section 320 has a diameter of 15 mm and a height of 25 mm.

[0124] The reaction valve 200 is manufactured by 3D printing. The valve body shell 210 and the support plate 222 of the reaction valve 200 are made of nylon.

[0125] Among them, the dimensions of the valve body shell 210 are 15 mm in diameter, 25 mm in height, and 1.0 mm in wall thickness; the diameter of each air outlet 212 is 0.5 mm; the thickness of the first guide member 240 is 1.0 mm, the diameter of each air vent 242 is 0.5 mm, and the height of the second air outlet cavity 2522 is 4.0 mm; the thickness of the second guide member 280 is 1.0 mm, and the distance between the second guide member 280 and the end face of the reaction end is 7.0 mm; the diameter of the through hole 211 is 2.0 mm.

[0126] The support plate 222 has a thickness of 2.0 mm and a total height of 12 mm; the through slot 224 has a width of 2.0 mm and a height of 11 mm.

[0127] The elastic member 230 is a spring with a diameter of 2.0 mm, a height of 7 mm in a natural state, and a height of 2.0 mm in a compressed state, and is made of 304 stainless steel. The spring is connected to the bottom of the support plate 222 by adhesive bonding.

[0128] The waterproof breathable membrane 270 is made of PTFE and is bonded to the first guide member 240 using an adhesive.

[0129] The filling material is polyvinyl alcohol (brand 1788), which is filled into the first inner cavity 251 in powder form until the spring is in a compressed state.

[0130] The A inner cavity 2523 in the second reaction chamber 2521a is filled with 2 mL of 60% citric acid solution, and the B inner cavity 2524 is filled with 2.7 g of potassium bicarbonate.

[0131] Assembly process: Place the reaction valve 200 into the straight section 320, use adhesive to tightly fit the two, and then use adhesive to bond the connecting section 310 and the balloon body 100 together. Finally, fold the assembled balloon and place it into a gelatin capsule.

[0132] Example 2

[0133] This embodiment provides a self-inflating intragastric balloon 10, which differs from Example 1 only in that the raw material of the balloon body 100 is poly(lactide-caprolactone) copolymer. The preparation method of the balloon body 100 includes dissolving the poly(lactide-caprolactone) copolymer in chloroform to prepare a solution with a mass concentration of 15%, then using a film coater to prepare a film with a thickness of 50 μm. Finally, the film is welded by hot pressing to form the balloon body 100 with a volume of 500 mL. A first air hole 110 with a diameter of 30 mm is cut on one side of the balloon body 100.

[0134] Since the self-inflating intragastric balloon 10 provided in this embodiment is made of a degradable material, the balloon body 100 degrades approximately 150 days after the self-inflating intragastric balloon 10 enters the human body, and the self-inflating intragastric balloon 10 can be directly excreted from the body, eliminating the need to go to the hospital for removal of the self-inflating intragastric balloon 10.

[0135] Comparative Example 1

[0136] The intragastric balloon provided in Example 1 of patent CN201680048150.7.

[0137] Experimental Example 1

[0138] The self-inflating intragastric balloons 10 of Examples 1 and 2 were placed in a dry 3000 mL beaker. 200 mL of purified water was poured into the beaker. The self-inflating intragastric balloons 10 were observed to see if they could naturally expand. The time it took for natural expansion to complete was recorded. The total volume of the expanded intragastric balloons was then measured using the water displacement method. The results are shown in Tables 1 and 2.

[0139] The intragastric balloon provided in Comparative Example 1 was placed in an opaque silicone bag with a thickness of 10 cm. A cylindrical strong magnetic magnet was held outside the silicone bag to control the magnet switch in the intragastric device, simulating the self-expansion state of the intragastric balloon of Comparative Example 1 in the digestive tract. The time for natural expansion to complete was recorded, and the total volume of the intragastric balloon after expansion was measured using the water displacement method. The results shown in Tables 1 and 2 were obtained.

[0140] The above experiment was conducted on 8 intragastric balloons randomly selected from Examples 1 and 2 and Comparative Example 1. The natural expansion completion time refers to the time within which the volume of the intragastric balloon no longer expands within 3 minutes.

[0141] Table 1 Self-expansion completion time of intragastric balloon (min)

[0142] Number of groups / pieces 1 2 3 4 5 6 7 8 average Example 1 5 5 4 6 6 7 6 7 5.75 Example 2 5 7 6 6 5 6 6 4 5.75 Comparative Example 1 22 18 24 10 34 27 10 19 20.5

[0143] Table 2 Total volume after intragastric balloon inflation (mL)

[0144] Number of groups / pieces 1 2 3 4 5 6 7 8 average Example 1 479 491 466 483 502 514 481 473 486.13 Example 2 467 473 486 512 507 489 484 494 489 Comparative Example 1 470 486 497 486 479 508 493 516 491.88

[0145] As can be seen from Tables 1 and 2, the self-inflating intragastric balloon 10 provided by the present invention has excellent self-inflating ability, and can achieve full inflation of the intragastric balloon in approximately 5 minutes. In Comparative Example 1, since the expansion process of the intragastric balloon requires magnetic attraction to control, the inflation speed of the intragastric balloon can be increased by observing and confirming the position of the magnetic poles during the experimental stage. However, once the intragastric balloon enters the human body, i.e., under the experimental simulation conditions provided by the present invention (opaque silicone bag), the position of the magnetic poles inside the intragastric balloon cannot be observed, so repeated attempts on the surface of the opaque silicone bag are required, resulting in a longer time for full inflation of the intragastric balloon.

[0146] Meanwhile, under the experimental conditions of the present invention, the expansion state of the intragastric balloon can be observed by opening the opaque silicone bag. However, during the actual use of the intragastric balloon in Comparative Example 1, it is impossible to determine whether the intragastric balloon is fully inflated. Therefore, it is possible that the user uses the magnet to move the body in the front, back, left, or right directions near the digestive tract, but cannot fully inflate the intragastric balloon due to uncertainty about the position of the intragastric balloon and the position of the magnet inside the intragastric balloon, resulting in poor weight loss effect.

[0147] In addition, the total volume of the self-inflating intragastric balloon 10 provided in Examples 1 and 2 of the present invention after full inflation is comparable to that of the intragastric balloon of Comparative Example 1. The self-inflating process of the self-inflating intragastric balloon 10 provided in the embodiments of the present invention is rapid and reliable, and the self-exhausting intragastric balloon can also be prepared, which greatly simplifies the use of the intragastric balloon and has excellent application value.

[0148] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A self-expanding intragastric balloon, characterized in that: It comprises a balloon body and a reaction valve, wherein the reaction valve is accommodated in the balloon body; The reaction valve comprises a valve body shell, a support adjustment member, an elastic member and a first guide member; The two opposite ends of the valve body shell are respectively a reaction end and an air outlet end, the end surface of the reaction end is provided with a through hole, the end surface of the air outlet end is provided with an air outlet hole, and the end surface of the air outlet end is also provided with an elastic member mounting groove extending toward the interior of the reaction valve, and the elastic member is fixed in the elastic member mounting groove; The support adjustment member is accommodated in the valve body shell, and the support adjustment member includes a top plate and a support plate that are fixedly connected; The edge of the top plate is selectively slidably connected to the inner wall surface of the valve body shell, dividing the inner cavity of the valve body shell into a first inner cavity and a second inner cavity along the axial direction of the reaction valve. The first inner cavity is formed between the top plate and the inner wall surface of the end surface of the reaction end, and the second inner cavity is formed between the top plate and the inner wall surface of the end surface of the gas outlet end. The first inner cavity is configured to accommodate a water-soluble filling material. A protrusion protruding from the top plate is provided on a side surface of the top plate away from the support plate, and the protrusion can be selectively accommodated in the through hole; One end of the support plate away from the top plate is fixedly connected to an elastic member, and the elastic member is configured to drive the support adjustment member to move in the valve body shell; The first guide member is provided with a first guide hole and a plurality of air holes. The support plate passes through the first guide hole and is sealed so that the support plate can selectively slide relative to the first guide member. The first guide member is fixedly connected to the inner wall surface of the valve body shell on all sides, dividing the second inner cavity into a second reaction cavity and a second air outlet cavity along the axial direction of the reaction valve. The area between the top plate and the first guide member serves as the second reaction cavity. The edge of the support plate contacts the inner wall surface of the valve body shell, dividing the second reaction chamber into an inner chamber A and an inner chamber B along the radial direction of the reaction valve, and a through groove is radially opened at one end of the support plate close to the elastic member, and the through groove can be selectively located in the second gas outlet chamber or the second reaction chamber. When the through groove is located in the second reaction chamber, the inner chamber A and the inner chamber B are connected, and the materials in the inner chambers A and B contact and react to generate gas.

2. The self-expanding intragastric balloon according to claim 1, characterized in that A waterproof and breathable membrane is further provided on the surface of the first guide member in the second reaction chamber.

3. The self-expanding intragastric balloon according to claim 2, characterized in that The waterproof breathable membrane is made of any one of PTFE, ePTFE, PP or PE.

4. The self-expanding intragastric balloon according to claim 2, characterized in that The first guide member is fixedly connected to the notch of the elastic member installation slot.

5. The self-expanding intragastric balloon according to claim 1, characterized in that It also includes a second guide member, which is arranged in the second reaction chamber, and the four sides of the second guide member are fixedly connected to the inner wall surface of the valve body shell. The second guide member is provided with a second guide hole, and the support plate passes through the second guide hole and can selectively slide on the second guide member.

6. The self-expanding intragastric balloon according to claim 5, characterized in that The second guide member is located in the second reaction chamber at one end close to the top plate, and the second guide member divides the second reaction chamber into a second reaction chamber and a top plate limiting chamber along the axial direction of the reaction valve. The area enclosed between the top plate and the second guide member is the top plate limiting chamber.

7. The self-expanding intragastric balloon according to claim 6, characterized in that The reaction valve has a shape of any one of a cylinder, a prism or a pyramid.

8. The self-expanding intragastric balloon according to claim 6, characterized in that The reaction valve is cylindrical in shape, and the surfaces of the reaction end and the gas outlet end are both circular; The dimensions of the valve body shell of the reaction valve are: diameter 5 mm to 30 mm, height 10 mm to 30 mm, and wall thickness 0.1 mm to 3 mm; The diameter of the outlet hole on the outlet end face of the reaction valve is 0.1 mm to 1 mm; The diameter of the through hole on the reaction end face of the reaction valve is 1 mm to 5 mm.

9. The self-expanding intragastric balloon according to claim 1, characterized in that The reaction valve is made of any one of nylon, polycarbonate, polyoxymethylene, polymethyl methacrylate, acrylonitrile-styrene-butadiene copolymer, polyetheretherketone, polyphenylene sulfide, polyamide, polyimide, polysulfone, polyethylene furandicarboxylate or stainless steel.

10. The self-expanding intragastric balloon according to claim 8, characterized in that The thickness of the second guide member is 0.1 mm to 3 mm, and the distance between the top plate and the end surface of the reaction end is 0.3 mm to 10 mm; The thickness of the first guide member is 0.1 mm to 3 mm, the diameter of each of the air holes on the first guide member is 0.1 mm to 1 mm, and the height of the second air outlet cavity is 0.3 mm to 10 mm; The diameter of the elastic member is 0.5 mm to 10 mm, the length in the natural state is 0.5 mm to 20 mm, and the length in the compressed state is 0.1 mm to 9 mm; the material of the elastic member is any one of stainless steel, nickel titanium wire or titanium alloy; The thickness of the top plate is 0.1 mm to 3 mm, the thickness of the support plate is 0.1 mm to 3 mm, and the height is 3 mm to 15 mm; The thickness of the balloon body is 30 μm to 120 μm; the volume of the balloon body after being fully expanded is 100 mL to 1500 mL.

11. The self-expanding intragastric balloon according to claim 1, characterized in that The material in the inner cavity A is citric acid; The material in the inner cavity B is potassium bicarbonate.

12. The self-expanding intragastric balloon according to claim 1, characterized in that The material in the inner cavity A is 60% citric acid solution.

13. The self-expanding intragastric balloon according to claim 1, characterized in that The water-soluble filling material is a solid material, and the water-soluble filling material includes one or more of polyvinyl alcohol, polyethylene glycol, polyvinyl pyrrolidone, polyacrylamide and betaine derivatives.

14. The self-expanding intragastric balloon according to claim 1, characterized in that The protrusion is located at the center of the top plate, and the through hole is located at the center of the end surface of the reaction end; The top plate and the support plate are in a "T" shape, and the elastic member mounting groove is located at the center of the end surface of the air outlet end.

15. The self-expanding intragastric balloon according to any one of claims 2 to 14, characterized in that: It also includes a connecting piece, which includes a connecting section and a straight section. The connecting section is provided with an opening, and the straight section protrudes from the connecting section along the opening; the balloon body is provided with a first air hole, and the first air hole, the opening on the connecting section and the through hole are arranged correspondingly in sequence, and the opening of the connecting section is bonded to the inner surface of the balloon body. The straight section accommodates the reaction valve, and the outer surface of the reaction valve is sealed and fitted with the inner surface of the straight section, and the reaction end of the valve body shell is close to the connecting section.

16. The self-expanding intragastric balloon according to claim 15, characterized in that The reaction end of the valve body shell is flush with the connecting section.

17. The self-expanding intragastric balloon according to claim 15, characterized in that The diameter of the first air hole on the balloon body is 8.0 mm to 50 mm; The straight tube section has a diameter of 5 mm to 30 mm and a height of 10 mm to 30 mm.

18. The self-expanding intragastric balloon according to claim 15, characterized in that The material of the balloon body and / or the support adjustment member is a degradable material; The degradable material of the balloon body includes at least one of polylactide, polycaprolactone, polytrimethylene carbonate or polyglycolide.

19. Use of the self-expanding intragastric balloon according to any one of claims 1 to 18 in the preparation of a weight loss product.

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