Intragastric balloon release valve, method of making same and intragastric balloon

Abstract

The present application relates to the technical field of medical devices, and discloses an intragastric balloon release valve, a preparation method thereof and an intragastric balloon. The intragastric balloon release valve comprises an arc surface balloon connecting part and a valve body connected to each other, the valve body is located at the inner arc surface side of the arc surface balloon connecting part, the arc surface balloon connecting part has an opening, the valve body has a liquid outlet channel, and the liquid outlet channel is in communication with the opening; the material of the valve body as a whole is a degradable material; or the material of the valve body is a non-degradable material, the end of the valve body away from the opening is a water outlet in communication with the liquid outlet channel, and a closure element made of a degradable material is arranged on the valve body to close the water outlet. The preparation method of the release valve adopts a mold forming method to obtain the release valve with the above structure. The intragastric balloon comprises a balloon body, and a liquid inlet one-way valve and the release valve are arranged on the balloon body. After the release valve is installed on the intragastric balloon, the liquid release time of the balloon is basically not affected by gastric peristalsis and is basically consistent with the preset time.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to an intragastric balloon release valve, its preparation method, and an intragastric balloon. Background Technology

[0002] Over the past few decades, the global obese population has been increasing. However, obesity is often accompanied by conditions such as hypertension, type II diabetes, ischemic heart disease, dyslipidemia, joint degeneration, sleep apnea, and certain cancers. Traditional treatments for obesity include dietary changes, lifestyle interventions, and medication, but these methods 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 concerns, and potential long-term adverse reactions of surgery mean that less than 1% of the suitable population undergoes the procedure. In the past two decades, European and American countries have gradually shifted towards non-invasive weight loss methods. With the increasing number of overweight and obese individuals, the design and development of a convenient, non-invasive weight loss medical device has significant social and commercial value.

[0003] Currently, a swallowable gastric balloon system that requires no endoscopy for both implantation and removal is available on the market abroad. Since the entire treatment process does not require endoscopy, this swallowable gastric balloon system has great potential in the field of weight loss. The balloon is folded and inserted into a swallowable capsule. The balloon is designed with a one-way self-sealing valve and connects to a catheter. After entering the stomach, the capsule disintegrates, and the balloon can be injected externally through the catheter for an appropriate time. Then, the biodegradable material on the surface or inside the balloon degrades and ruptures, breaking the seal and releasing the balloon fluid. The balloon is then naturally expelled from the body through the gastrointestinal tract. Therefore, the implantation time of the balloon in the stomach is mainly controlled by the biodegradable material inside the balloon.

[0004] Chinese patent application CN108852578A discloses another swallowable gastric water balloon, in which the liquid release port is a biodegradable material patch. The disadvantages of this structure are: (1) Since the sphere is mostly made of silicone or polyurethane, while the biodegradable material is aliphatic polyester, the two are different materials and have poor compatibility. Therefore, during the assembly of the pre-formed biodegradable material patch with the sphere, poor adhesion often occurs, and defects such as gaps and detachment are very likely to occur; (2) The mechanical properties and degradation performance of the biodegradable material on the surface of the sphere are greatly affected by the peristalsis of the stomach and the internal environment of the stomach, which may lead to the actual degradation time not matching the expected time.

[0005] In view of this, the present invention is proposed. Summary of the Invention

[0006] The purpose of this invention is to provide an intragastric balloon release valve, its preparation method, and an intragastric balloon.

[0007] This invention is implemented as follows:

[0008] In a first aspect, the present invention provides an intragastric balloon release valve, comprising an arcuate balloon connection portion and a valve body connected to each other, the valve body being located on the inner arcuate side of the arcuate balloon connection portion, the arcuate balloon connection portion having an opening, and the valve body having a liquid outlet channel communicating with the opening.

[0009] The valve body is made of biodegradable material, and the end of the valve body away from the opening is the closed end of the liquid outlet channel.

[0010] Alternatively, the valve body is made of a non-degradable material, and the end of the valve body away from the opening is the outlet connected to the liquid outlet channel. The valve body is equipped with a sealing element made of a degradable material to seal the outlet.

[0011] In an optional embodiment, the closure element is a binding rope, which is tied to the valve body;

[0012] Optionally, the valve body has a recess, and the rope is tied to the recess.

[0013] In an optional embodiment, the closure is a valve body extension, which has a liquid outlet extension channel. One end of the valve body corresponding to the liquid outlet extension channel is an open end, and the other end is a closed end. The open end is connected to the water outlet.

[0014] Optionally, a binding rope is attached to the valve body near the valve body extension.

[0015] In an optional implementation, the non-degradable material is polyurethane or silicone.

[0016] Secondly, the present invention provides a method for preparing an intragastric balloon release valve, which is prepared by molding. The mold includes an arc-shaped portion and a cylindrical portion. The arc-shaped portion has an arc-shaped convex wall, and the arc-shaped convex wall of the arc-shaped portion is connected to one end of the cylindrical portion. The preparation method includes:

[0017] The curved surface of the mold is immersed in a polymer molding solution, allowing the polymer molding solution to adhere to the convex wall of the curved surface. Then, the polymer molding solution adhering to the convex wall of the curved surface is transformed into the first thin film.

[0018] The cylindrical part of the mold is immersed in a biodegradable material solution, so that the biodegradable material solution adheres to the outer wall of the cylindrical part and connects with the first film part. Then, the biodegradable material solution adhering to the outer wall of the cylindrical part is transformed into a second film part. The first film part and the second film part constitute a film part.

[0019] Remove the diaphragm from the mold, and then flip the diaphragm inside and out to obtain the initial product of the release valve. The part formed by the cylindrical part is the valve body, and the part formed by the arc-shaped convex wall is the arc-shaped balloon connection part.

[0020] The end of the valve body away from the arc-shaped ball joint is the water outlet; the water outlet is sealed by immersing the valve body at the corresponding position of the water outlet in a polymer molding solution or a biodegradable material solution and then drying it; or, the water outlet is sealed by laser welding.

[0021] Optionally, the polymer molding solution is a polyurethane solution or a silicone solution, and the method for converting the polymer molding solution adhering to the mold surface into a thin film is air drying or drying.

[0022] Alternatively, the method for removing the formed film part from the mold is to apply talcum powder to the edge of the film part, and continue to apply talcum powder while peeling the film part until the film part is completely peeled off.

[0023] Thirdly, the present invention provides a method for preparing an intragastric balloon release valve, which is prepared by molding. The mold includes an arc-shaped portion and a cylindrical portion. The arc-shaped portion has an arc-shaped convex wall, and the arc-shaped convex wall of the arc-shaped portion is connected to one end of the cylindrical portion. The preparation steps include:

[0024] The curved surface of the mold is immersed in a polymer molding solution, which is then applied to the convex wall of the curved surface. The polymer molding solution applied to the convex wall of the curved surface is then transformed into a thin film.

[0025] Remove the film part from the mold, and then flip the film part inside and out to obtain the arc-shaped balloon connector;

[0026] Two films made of biodegradable material are welded together to form a valve body with a liquid outlet channel. One end of the valve body corresponding to the liquid outlet channel is welded closed, and the other end is open. The arc-shaped balloon connection part is welded to the end of the valve body corresponding to the open liquid outlet channel to obtain an intragastric balloon release valve.

[0027] Optionally, the polymer molding solution is a polyurethane solution or a silicone solution, and the method for converting the polymer molding solution adhering to the mold surface into a thin film is air drying or drying.

[0028] Alternatively, the method for removing the formed film part from the mold is to apply talcum powder to the edge of the film part, and continue to apply talcum powder while peeling the film part until the film part is completely peeled off.

[0029] Fourthly, the present invention provides a method for preparing an intragastric balloon release valve, which is prepared by molding. The mold includes an arc-shaped part and a cylindrical part. The arc-shaped part has an arc-shaped convex wall, and the arc-shaped convex wall of the arc-shaped part is connected to one end of the cylindrical part.

[0030] The preparation steps include:

[0031] The curved part of the mold and a cylindrical part connected to the curved part are immersed in a polymer molding solution, so that the polymer molding solution adheres to the curved convex wall, and then the polymer molding solution attached to the curved convex wall is transformed into the first film part.

[0032] The remaining portion of the cylindrical part is immersed in a biodegradable material solution, so that the biodegradable material solution adheres to the outer wall of the cylindrical part and connects with the first film. Then, the biodegradable material solution adhering to the outer wall of the cylindrical part is transformed into a second film. The first film and the second film constitute a film.

[0033] Remove the film part from the mold, and then flip the film part inside and out to obtain the initial product of the release valve. The part formed by the polymer molding solution and corresponding to the columnar part is the valve body, the part corresponding to the arc-shaped convex wall is the arc-shaped balloon connection part, and the part formed by the biodegradable material solution and corresponding to the columnar part is the valve body extension part.

[0034] The end of the valve body extension away from the arc-shaped balloon connection is the water outlet; the water outlet is sealed by immersing the valve body extension corresponding to the water outlet in a polymer molding solution or a biodegradable material solution, and then air-drying or drying; or, the water outlet is sealed by laser welding; optionally, the polymer molding solution is a polyurethane solution or a silicone solution, and the method to transform the polymer molding solution adhering to the mold surface into a thin film is by air-drying or drying.

[0035] Alternatively, the method for removing the formed film part from the mold is as follows: apply talcum powder to the edge of the film part, and continue to apply talcum powder while peeling the film part until the film part is completely peeled off.

[0036] Optionally, a biodegradable rope can be tied to the valve body.

[0037] Fifthly, the present invention provides a method for preparing an intragastric balloon release valve, comprising:

[0038] The mold is prepared by molding. The mold includes an arc-shaped part and a cylindrical part. The arc-shaped part has an arc-shaped convex wall, and the arc-shaped convex wall of the arc-shaped part is connected to one end of the cylindrical part.

[0039] The preparation steps include:

[0040] The mold is immersed in a polymer molding solution, so that the polymer molding solution adheres to the surface of the mold. After the polymer molding solution on the surface of the mold is transformed into a thin film, the molded thin film is removed from the mold. The molded thin film is then turned inside out to obtain the initial product of the release valve. The part formed by the cylindrical part is the valve body, and the part formed by the arc-shaped convex wall is the arc-shaped balloon connection part.

[0041] The valve body is secured with a biodegradable rope.

[0042] Optionally, a groove is provided on the peripheral wall of the cylindrical part, so that a recess is formed on the valve body of the obtained release valve prototype, and a biodegradable binding rope is tied to the recess.

[0043] Optionally, the polymer molding solution is a polyurethane solution or a silicone solution, and the method for converting the polymer molding solution adhering to the mold surface into a thin film is air drying or drying.

[0044] Alternatively, the method for removing the formed film part from the mold is to apply talcum powder to the edge of the film part, and continue to apply talcum powder while peeling the film part until the film part is completely peeled off.

[0045] In a sixth aspect, the present invention provides a method for preparing an intragastric balloon release valve, which is prepared by vacuum molding secondary molding. The mold used includes an arc-shaped part and a cylindrical part. The arc-shaped part has an arc-shaped convex wall, and the arc-shaped convex wall of the arc-shaped part is connected to one end of the cylindrical part.

[0046] The preparation steps include:

[0047] The mold is placed in the molding and shaping equipment, and a polyurethane flat film is wrapped around the outside of the mold. After heating to 140-170℃, vacuuming or applying positive pressure is used to make the polyurethane film completely adhere to the mold. After cooling and shaping, the inside and outside are flipped to obtain the initial product of the release valve. The part formed by the cylindrical part is the valve body, and the part formed by the arc-shaped convex wall is the arc-shaped balloon connection part.

[0048] Tie biodegradable ropes to the valve body;

[0049] Optionally, a groove is provided around the periphery of the cylindrical part, so that a recess is formed on the valve body of the resulting release valve prototype, and a biodegradable binding rope is tied to the recess.

[0050] In a seventh aspect, the present invention provides an intragastric balloon, comprising a balloon body, an inlet one-way valve provided on the balloon body, and a release valve mounting port on the balloon body. The intragastric balloon release valve of any of the foregoing embodiments or the intragastric balloon release valve prepared by any of the foregoing embodiments is installed at the release valve mounting port, and the valve body is located inside the balloon body.

[0051] The present invention has the following beneficial effects:

[0052] The gastric balloon release valve provided in this embodiment of the invention consists of an arc-shaped balloon connector and a valve body. The valve body is located on the inner arc side of the arc-shaped balloon. After the arc-shaped balloon connector is connected to the balloon body, the valve body is located inside the gastric balloon. Since the valve body is made of a biodegradable material or has a sealing component made of a biodegradable material, it can be degraded after the valve body is in the liquid inside the balloon or in contact with gastric juice for a period of time, thereby realizing the release of the liquid inside the balloon.

[0053] The gastric balloon release valve provided in this invention places a component made of biodegradable material inside the balloon body, and the degradation time is largely unaffected by gastric peristalsis. Therefore, the degradation time of the biodegradable material is accurate; generally, the actual degradation time is the same as the designed degradation time. Therefore, compared to existing solutions that place the biodegradable material on the balloon wall, this gastric balloon release valve, after being installed on the balloon body, has the valve body located inside the balloon body, resulting in higher accuracy in predicting its actual release time. Attached Figure Description

[0054] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0055] Figure 1 This is a schematic diagram of the mold used in Example 1;

[0056] Figure 2 This is a schematic diagram of the gastric balloon release valve prepared in Example 1;

[0057] Figure 3 This is a schematic diagram of the mold used in Example 2;

[0058] Figure 4 This is a schematic diagram of the gastric balloon release valve prepared in Example 2;

[0059] Figure 5 This is a schematic diagram of the mold used in Example 3;

[0060] Figure 6 This is a schematic diagram of the gastric balloon release valve prepared in Example 3;

[0061] Figure 7 Photograph of the stomach wall of a pig approximately 10 days before excretion, after the release valve of Example 1 was made into a balloon and implanted into the pig's stomach;

[0062] Figure 8Photograph of the stomach wall of a pig approximately 10 days before excretion, after the release valve of Example 2 was made into a balloon and implanted into the pig's stomach.

[0063] Icons: 100-Gastric balloon release valve; 110-Arc-shaped balloon connection; 111-Opening; 120-Valve body; 122-Valve body extension; 123-Recess; 124-Closed end; 130-Tied cord; 10-Mold; 11-Arc-shaped surface; 12-Cylindrical part; 13-Scale line; 14-Groove. Detailed Implementation

[0064] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0065] The following is a detailed description of the gastric balloon release valve 100 and its preparation method, as well as the gastric balloon, provided in the embodiments of the present invention.

[0066] The intragastric balloon release valve 100 provided in this embodiment of the invention includes an arc-shaped balloon connecting part 110 and a valve body 120 connected to each other. The valve body 120 is located on the inner arc side of the arc-shaped balloon connecting part 110. The arc-shaped balloon connecting part 110 has an opening 111, and the valve body 120 has a liquid outlet channel that communicates with the opening 111.

[0067] The valve body 120 is made of biodegradable material, and the end of the valve body 120 away from the opening 111 is the closed end 124 that closes the liquid outlet channel.

[0068] Alternatively, the valve body 120 may be made of a non-degradable material, with the end of the valve body 120 away from the opening 111 serving as an outlet connected to the liquid outlet channel, and the valve body 120 may be equipped with a sealing element made of a degradable material for sealing the outlet.

[0069] The gastric balloon release valve 100 provided in this embodiment of the invention is composed of an arc-shaped balloon connecting part 110 and a valve body 120. The valve body 120 is disposed on the inner arc side of the arc-shaped balloon. After the arc-shaped balloon connecting part 110 is connected to the balloon body, the valve body 120 is located inside the gastric balloon. Since the valve body 120 is made of a biodegradable material, or the valve body 120 is provided with a sealing part made of a biodegradable material, the valve body 120 can be degraded after being in the liquid inside the balloon or in contact with gastric juice for a period of time, thereby realizing the release of the liquid inside the balloon.

[0070] The gastric balloon release valve 100 provided in this embodiment of the invention incorporates a component made of biodegradable material inside the balloon body, and the degradation time is largely unaffected by gastric peristalsis. Therefore, the degradation time of the biodegradable material is accurate; generally, the designed degradation time is the actual degradation time. Thus, compared to existing solutions that place the biodegradable material in the balloon wall, this solution's gastric balloon release valve 100, after being installed on the balloon body, has the valve body 120 located inside the balloon body, resulting in higher accuracy in predicting its actual release time.

[0071] Specifically, three specific structures and corresponding preparation methods for the release valves are provided below.

[0072] Example 1

[0073] This embodiment provides an intragastric balloon release valve 100 and its preparation method.

[0074] The gastric balloon release valve 100 has the following specific structure:

[0075] It includes an arc-shaped balloon connecting part 110 and a valve body 120 connected to each other. The valve body 120 is located on the inner arc side of the arc-shaped balloon connecting part 110. The arc-shaped balloon connecting part 110 has an opening 111, and the valve body 120 has a liquid outlet channel that communicates with the opening 111.

[0076] The valve body 120 is made of biodegradable material, and the end of the valve body 120 away from the opening 111 is the closed end 124 that closes the liquid outlet channel.

[0077] The gastric balloon release valve 100 provided in this embodiment releases the liquid inside the balloon after the valve body 120 degrades.

[0078] Its preparation method is as follows:

[0079] like Figure 1 As shown, the mold is prepared by molding with a mold 10. The mold 10 includes an arc-shaped part 11 and a cylindrical part 12. The arc-shaped part 11 has an arc-shaped convex wall, and the arc-shaped convex wall of the arc-shaped part 11 is connected to one end of the cylindrical part 12.

[0080] The preparation steps include:

[0081] The arc-shaped part 11 of the mold 10 is immersed in a polymer molding solution, so that the polymer molding solution adheres to the arc-shaped convex wall. Then, the polymer molding solution adhering to the arc-shaped convex wall is dried to transform it into a first film part (corresponding to the arc-shaped balloon connection part 110).

[0082] The cylindrical part 12 of the mold 10 is immersed in a biodegradable material solution, so that the biodegradable material solution adheres to the outer wall of the cylindrical part 12 and connects with the first film. Then, the biodegradable material solution adhering to the outer wall of the cylindrical part 12 is transformed into a second film (corresponding to the valve body 120) through a drying process. The first film and the second film constitute a film.

[0083] The diaphragm is removed from the mold 10, and then the diaphragm is flipped inside and out to obtain the initial product of the release valve; the part formed by the cylindrical part 12 is the valve body 120, and the part formed by the arc-shaped convex wall is the arc-shaped balloon connecting part 110.

[0084] The end of the valve body 120 furthest from the arc-shaped balloon connection 110 is the water outlet; the water outlet is sealed by immersing the valve body 120 at the position corresponding to the water outlet in a polymer molding solution or a biodegradable material solution, and then air-drying or drying; alternatively, the water outlet can be sealed by laser welding, thus obtaining the intragastric balloon release valve 100, as shown below. Figure 2 As shown.

[0085] Optionally, the polymer molding solution is a polyurethane solution or a silicone solution, and the method for converting the polymer molding solution adhering to the surface of the mold 10 into a thin film is air drying or drying.

[0086] Furthermore, when the polymer molding solution is a silicone solution, the method for transforming the polymer molding solution adhering to the surface of the mold 10 into a thin film is to dry and cure it at 80-110°C.

[0087] Furthermore, the method for removing the formed film part from the mold 10 is as follows: apply talcum powder to the edge of the film part, and continue to apply talcum powder while peeling the film part until the film part is completely peeled off.

[0088] Preferably, the polymer molding solution can be, for example, a polyurethane solution with a mass concentration of 10%. The polyurethane solution can be prepared by dissolving polyurethane ions in tetrahydrofuran, and then mixing it thoroughly to obtain the polymer molding solution.

[0089] Optionally, the biodegradable material solution may be, for example, a biodegradable polylactide solution with a mass concentration of 10%. The preparation method of the biodegradable polylactide solution may be, for example, dissolving the biodegradable polylactide in chloroform, and obtaining the biodegradable material solution after complete dissolution and thorough mixing.

[0090] It should be noted that another method for preparing the gastric balloon release valve 100 provided in this embodiment can also be:

[0091] The arc-shaped surface 11 of the mold 10 is immersed in a polymer molding solution, so that the polymer molding solution adheres to the arc-shaped convex wall, and then the polymer molding solution adhering to the arc-shaped convex wall is transformed into a thin film.

[0092] Remove the film part from the mold 10, and then flip the film part inside and out to obtain the arc-shaped balloon connection part 110;

[0093] Two films made of biodegradable material are welded together to form a valve body 120 with a liquid outlet channel. One end of the valve body 120 corresponding to the liquid outlet channel is welded closed (closed end 124), and the other end is open. The arc-shaped balloon connecting part 110 (its opening 111) is welded to the valve body 120 corresponding to the open end of the liquid outlet channel to obtain the gastric balloon release valve 100.

[0094] The gastric balloon release valve 100 provided in this embodiment is made into a gastric balloon and placed inside the human stomach. After liquid is injected into the balloon through a one-way water inlet valve, the liquid fills the balloon, occupying space in the stomach and creating a feeling of fullness. Since the valve body 120 is not located on the side wall of the balloon body, its degradation is minimally affected by gastric peristalsis. Therefore, the gastric balloon produced by installing the gastric balloon release valve 100 on the balloon body in this embodiment has the characteristic that the actual liquid release time is basically matched with the preset time.

[0095] Example 2

[0096] This embodiment provides an intragastric balloon release valve 100 and its preparation method.

[0097] The gastric balloon release valve 100 has the following specific structure:

[0098] It includes an arc-shaped balloon connecting part 110 and a valve body 120 connected to each other. The valve body 120 is located on the inner arc side of the arc-shaped balloon connecting part 110. The arc-shaped balloon connecting part 110 has an opening 111, and the valve body 120 has a liquid outlet channel that communicates with the opening 111.

[0099] The valve body 120 is made of a non-degradable material. The end of the valve body 120 away from the opening 111 is the outlet that is connected to the liquid outlet channel. The valve body 120 is provided with a sealing element made of a degradable material for sealing the outlet.

[0100] The gastric balloon release valve 100 provided in this embodiment releases the liquid inside the balloon after the sealing element degrades.

[0101] Furthermore, in this embodiment, the sealing element is a binding rope 130, which is tied to the valve body 120 to seal the outlet. When the binding rope 130 degrades, its sealing effect on the outlet is lost, and the liquid inside the balloon is released.

[0102] Optionally, the valve body 120 has a recess 123, and the binding rope 130 is tied to the recess 123.

[0103] The recess 123 is provided so that the rope 130 can be tied here to prevent it from slipping after being tied.

[0104] Its preparation method is as follows:

[0105] like Figure 3 As shown, the mold is prepared by molding with a mold 10. The mold 10 includes an arc-shaped part 11 and a cylindrical part 12. The arc-shaped part 11 has an arc-shaped convex wall, and the arc-shaped convex wall of the arc-shaped part 11 is connected to one end of the cylindrical part 12.

[0106] The preparation steps include:

[0107] The mold 10 is immersed in a polymer molding solution, so that the polymer molding solution adheres to the surface of the mold 10. After the polymer molding solution on the surface of the mold 10 is transformed into a thin film, the molded thin film is removed from the mold 10. The molded thin film is then flipped inside out to obtain the initial product of the release valve. The part formed by the cylindrical part 12 is the valve body 120, and the part formed by the arc-shaped convex wall is the arc-shaped balloon connection part 110.

[0108] A gastric balloon release valve 100 is obtained by binding the valve body 120 with a biodegradable rope 130. Figure 4 As shown.

[0109] Optionally, a groove 14 is provided on the peripheral wall of the cylindrical part 12, so that a recess 123 is formed on the valve body 120 of the obtained release valve prototype, and a biodegradable binding rope 130 is tied to the recess 123.

[0110] Optionally, the polymer molding solution is a polyurethane solution or a silicone solution, and the method for converting the polymer molding solution adhering to the surface of the mold 10 into a thin film is air drying or drying.

[0111] Alternatively, the method for removing the formed film part from the mold 10 is as follows: apply talcum powder to the edge of the film part, and continue to apply talcum powder while peeling the film part until the film part is completely peeled off.

[0112] It should be noted that another method for preparing the gastric balloon release valve 100 provided in this embodiment can also be:

[0113] The material is prepared by vacuum molding and secondary forming. The mold 10 used includes an arc-shaped part 11 and a cylindrical part 12. The arc-shaped convex wall of the arc-shaped part 11 is connected to one end of the cylindrical part 12.

[0114] The preparation steps include:

[0115] The mold 10 is placed in the molding and shaping equipment, and the polyurethane flat film is wrapped around the mold 10. After heating to 140-170℃, vacuuming or applying positive pressure is used to make the polyurethane film smooth and completely adhere to the mold 10. After cooling and shaping, the inside and outside are flipped to obtain the initial product of the release valve. The part formed by the columnar part 12 is the valve body 120, and the part formed by the arc-shaped convex wall is the arc-shaped balloon connection part 110.

[0116] Tie the rope 130 to the valve body 120.

[0117] Optionally, a groove 14 is provided on the peripheral wall of the cylindrical part 12, so that a recess 123 is formed on the valve body 120 of the obtained release valve prototype, and a biodegradable binding rope 130 is tied to the recess 123.

[0118] The gastric balloon release valve 100 provided in this embodiment is made into a gastric balloon and placed in the human stomach. After liquid is injected into the balloon through the water inlet check valve, the binding rope 130 is completely immersed in the liquid environment inside the balloon. The only factor affecting the degradation of the binding rope 130 is the liquid inside the balloon. The preset degradation time is reliable. Therefore, the gastric balloon equipped with the gastric balloon release valve 100 provided in this embodiment has the characteristic that the actual liquid release time is basically matched with the preset time.

[0119] Example 3

[0120] This embodiment provides an intragastric balloon release valve 100 and its preparation method.

[0121] The gastric balloon release valve 100 has the following specific structure:

[0122] It includes an arc-shaped balloon connecting part 110 and a valve body 120 connected to each other. The valve body 120 is located on the inner arc side of the arc-shaped balloon connecting part 110. The arc-shaped balloon connecting part 110 has an opening 111, and the valve body 120 has a liquid outlet channel that communicates with the opening 111.

[0123] The valve body 120 is made of a non-degradable material. The end of the valve body 120 away from the opening 111 is the outlet that is connected to the liquid outlet channel. The valve body 120 is provided with a sealing element made of a degradable material for sealing the outlet.

[0124] The gastric balloon release valve 100 provided in this embodiment releases the liquid inside the balloon after the sealing element degrades.

[0125] Furthermore, in this embodiment, the sealing element is a valve body extension 122, which has a liquid outlet extension channel. One end of the valve body 120 corresponding to the liquid outlet extension channel is an open end 111, and the other end is a closed end 124. The open end 111 is connected to the water outlet.

[0126] Its preparation method is as follows:

[0127] like Figure 5 As shown, the mold is prepared by molding with a mold 10. The mold 10 includes an arc-shaped part 11 and a cylindrical part 12. The arc-shaped part 11 has an arc-shaped convex wall, and the arc-shaped convex wall of the arc-shaped part 11 is connected to one end of the cylindrical part 12.

[0128] The mold is prepared by forming a mold 10, which includes an arc-shaped part 11 and a cylindrical part 12. The arc-shaped convex wall of the arc-shaped part 11 is connected to one end of the cylindrical part 12.

[0129] The arc-shaped part 11 of the mold 10 and a portion of the cylindrical part 12 connected to the arc-shaped part 11 are immersed in a polymer molding solution, so that the polymer molding solution adheres to the arc-shaped convex wall, and then the polymer molding solution attached to the arc-shaped convex wall is transformed into a first film part (the component corresponding to the arc-shaped balloon connection part 110 and the valve body 120).

[0130] The remaining portion of the cylindrical part 12 is immersed in a biodegradable material solution, so that the biodegradable material solution adheres to the outer wall of the cylindrical part 12 and connects with the first film member. Then, the biodegradable material solution adhering to the outer wall of the cylindrical part 12 is transformed into a second film member (corresponding to the valve body extension 122). The first film member and the second film member constitute a film member.

[0131] The film is removed from the mold 10, and then the film is flipped inside and out to obtain the initial product of the release valve. The part formed by the polymer molding solution and corresponding to the column part 12 is the valve body 120, the part corresponding to the arc-shaped convex wall is the arc-shaped balloon connection part 110, and the part formed by the biodegradable material solution and corresponding to the column part 12 is the valve body extension part 122.

[0132] The end of the valve body extension 122 away from the arc-shaped balloon connection 110 is the water outlet; the water outlet is sealed by immersing the valve body extension 122 at the position corresponding to the water outlet in a polymer molding solution or a biodegradable material solution, and then air-drying or drying; or, the water outlet is sealed by laser welding to obtain the gastric balloon release valve 100.

[0133] Optionally, the polymer molding solution is a polyurethane solution or a silicone solution, and the method for converting the polymer molding solution adhering to the surface of the mold 10 into a thin film is air drying or drying.

[0134] Alternatively, the method for removing the formed film part from the mold 10 is as follows: apply talcum powder to the edge of the film part, and continue to apply talcum powder while peeling off the film part until the film part is completely peeled off.

[0135] Optionally, a biodegradable binding rope 130 is tied to the valve body 120. The binding rope 130 forms a double safety structure, which avoids the risk of the release port being loosely tied or prematurely released, and the safe retention time of the release port in the body can be adjusted as needed.

[0136] Taking biodegradable polylactide as an example, biodegradable materials are often harder than polyurethane. When biodegradable polylactide is used to form the valve body extension 122, a step will be formed between the valve body extension 122 and the valve body 120. When the binding rope 130 is tied to the valve body 120, it will not slip off due to the blocking effect of the step.

[0137] Optionally, a scale line 13 is provided in the middle of the cylindrical portion 12 of the mold 10 to indicate the degree to which the cylindrical portion 12 is immersed in the polymer molding solution or the biodegradable material solution. For example, with the curved portion 11 as the upper part and the cylindrical portion 12 as the lower part, and the scale line 13 as the boundary, the portion above the scale line 13 is immersed in the polymer molding solution, and the portion below the scale line 13 is immersed in the biodegradable material solution.

[0138] The working principle of this embodiment is as follows:

[0139] For example, the designed valve body extension 122 degrades (component breakage occurs) in physiological saline (pH=7) for 10 months and in gastric juice (pH=1.0-2.0) for 4 months. The binding cord 130 degrades in physiological saline for 4 months. When the gastric balloon release valve 100 is placed inside the balloon for 4 months, the absorbable suture breaks, and gastric juice from the environment enters through the channel portion at the umbrella surface (opening 111 of the arc-shaped balloon connection portion 110), thereby contacting the biodegradable polylactide portion. After about 2 months of contact and degradation by gastric juice, the biodegradable polylactide portion breaks, and the water inside the balloon is released.

[0140] Alternatively, the designed valve body extension 122 degrades (component breakage occurs) in physiological saline (pH=7) for 4 months. The binding rope 130 also degrades in physiological saline for 4 months. When the release valve is placed inside the sphere for 4 months, both the absorbable suture and the biodegradable polylactide portion break, releasing water from the sphere.

[0141] Alternatively, the designed valve body extension 122 degrades (breaks) in gastric juice (pH = 1.0-2.0) for 4 months. The binding rope 130 is not used. Gastric juice from the environment enters through the channel portion at the umbrella surface (opening 111 of the arc-shaped balloon connection portion 110), thereby contacting the biodegradable polylactide portion. When the balloon with this release port is placed in the body for 4 months, the biodegradable polylactide portion undergoes acid corrosion degradation and breaks, releasing water from the balloon.

[0142] Experimental Example 1

[0143] The gastric balloon release valve 100 was prepared according to the method provided in Example 1. The polymer molding solution used was a 10% polyurethane solution with tetrahydrofuran as the solvent, and the biodegradable polylactide solution used was a 10% poly(lactic acid-caprolactone) solution (molar ratio 70:30) with chloroform as the solvent.

[0144] The gastric balloon release valve 100 is connected to a balloon body with a liquid inlet check valve to form a gastric balloon. The preset degradation time of the balloon is 120 days. The gastric balloon is implanted into the pig's stomach. Starting from day 110, the pig's feces are observed daily to see if the balloon is expelled. The time when the balloon is expelled is the time when the liquid in the balloon is released.

[0145] There were 10 experimental groups, and the actual release time of each group was recorded in Table 1 below.

[0146] Table 1 Actual degradation time for each experimental group

[0147]

[0148] Comparing the actual average degradation time with the preset degradation time, the error was found to be only 1-3 days. This demonstrates that the release valve provided in Embodiment 1 of the present invention can achieve an effect where the preset time and the actual degradation time are essentially consistent. Comparing 10 experimental groups, the release time of each group was basically the same, with a maximum difference of only 3 days between groups. This indicates that after the release valve provided in this embodiment of the present invention is installed inside the balloon, the balloon liquid release time is basically consistent with the preset time.

[0149] Experiment Example 2

[0150] The gastric balloon release valve 100 was prepared according to the method provided in Example 2, wherein the polymer molding solution used was a polyurethane solution with a mass concentration of 10% and the solvent was tetrahydrofuran, and the binding cord 130 used was made of poly(p-dioxanone).

[0151] The gastric balloon release valve 100 is connected to a balloon body with a liquid inlet check valve to form a gastric balloon. The preset degradation time of the balloon is 100 days. The gastric balloon is implanted into the pig's stomach. Starting from 90 days, the pig's feces are observed every day to see if the balloon is expelled. The time when the balloon is expelled is the time when the liquid in the balloon is released.

[0152] There were 10 experimental groups, and the actual release time of each group was recorded in Table 1 below.

[0153] Table 2 Actual degradation time for each experimental group

[0154]

[0155] Comparing the actual average degradation time with the preset degradation time, the error was found to be only 1-3 days. This demonstrates that the release valve provided in Embodiment 2 of the present invention can achieve an effect where the preset time and the actual degradation time are essentially consistent. Comparing 10 experimental groups, the release time of each group was basically the same, with a maximum difference of only 3 days between groups. This indicates that after the release valve provided in this embodiment of the present invention is installed inside the balloon, the balloon liquid release time is basically consistent with the preset time.

[0156] Experimental Example 3

[0157] An intragastric balloon release valve 100 was prepared according to the method provided in Example 3. The release valve is provided with a valve body extension 122 and a binding cord 130. The polymer molding solution used is an 8% polyurethane solution with tetrahydrofuran as the solvent, and the biodegradable polylactide solution used is a 10% poly(lactic-co-lactide) solution (molar ratio 60:40) with chloroform as the solvent. The binding cord 130 is made of poly(lactic-co-caprolactone) (molar ratio 85:15).

[0158] The gastric balloon release valve 100 is connected to a balloon body with a one-way inlet valve to form a gastric balloon. The binding cord 130 degrades in physiological saline at pH 7 for 120 days; the valve body extension 122 degrades in physiological saline at pH 7 for 120 days, and then degrades again after being exposed to gastric juice for 35 days. After the binding cord 130 degrades, the gastric juice in the environment comes into contact with the valve body extension 122, and the valve body extension 122 gradually degrades under the corrosion of the gastric juice. Therefore, in this embodiment, the preset liquid release time of the balloon is 160 days. The gastric balloon is implanted in the stomach of a pig, and starting from 150 days, the pig feces are observed daily to see if the balloon is expelled. The time when the balloon is expelled is the liquid release time of the balloon.

[0159] There were 10 experimental groups, and the actual release time of each group was recorded in Table 1 below.

[0160] Table 3 Actual degradation time for each experimental group

[0161]

[0162] Comparing the actual average degradation time with the preset degradation time, the error was found to be only 1-3 days. This demonstrates that the release valve provided in Embodiment 3 of the present invention can achieve an effect where the preset time and the actual degradation time are essentially consistent. Comparing 10 experimental groups, the release time of each group was basically the same, with a maximum difference of only 4 days between groups. This indicates that after the release valve provided in this embodiment of the present invention is installed inside the balloon, the balloon liquid release time is basically consistent with the preset time.

[0163] Experiment Example 4

[0164] This experimental example provides a control group, which differs from Example 1 only in that it provides a gastric balloon without a release valve. The balloon wall, coinciding with the sphere's meridian, is made of a biodegradable poly(lactic acid-caprolactone) material (molar ratio 70:30). This biodegradable material degrades in the gastric fluid environment in 90 seconds, meaning the balloon's preset release time is 90 seconds. The gastric balloon was implanted into the pig's stomach. Considering that this balloon structure is significantly affected by gastric peristalsis, some groups might experience premature release. Starting at 60 days, the pigs were observed daily to see if the balloon was expelled through feces. The time when the balloon was expelled was considered the release time of the fluid within the balloon.

[0165] There were 10 experimental groups, and the actual release time of each group was recorded in Table 4 below.

[0166] Table 4. Actual degradation time for each experimental group

[0167]

[0168] The table above shows that there are significant differences between the actual release time and the preset release time for each group. This indicates that using biodegradable materials on the balloon wall to release balloon fluid after a period of time results in significant differences between the preset degradation time and the actual release time due to individual differences (possibly influenced by factors such as pig feeding and drinking, as well as individual differences in the gastric environment).

[0169] Experimental Example 5

[0170] Safety tests:

[0171] Taking the release valves of Examples 1 and 2 as examples, they were made into balloons and implanted into the stomach of pigs. The damage to the stomach wall after the balloon was implanted was observed by gastroscopy, as shown below. Figure 7 and Figure 8 As shown.

[0172] Figure 7 and Figure 8 These are photographs of the stomach wall observed 10 days before the release valves of Examples 1 and 2 were implanted into the stomach. The stomach wall appears smooth, and no adverse effects of the balloon on the stomach wall were observed.

[0173] This invention also provides an intragastric balloon, including a balloon body, a one-way valve for inlet fluid is provided in the balloon body, the balloon body also has a release valve mounting port and an intragastric balloon release valve 100 provided in this invention embodiment, the intragastric balloon release valve 100 is installed at the release valve mounting port, and the valve body 120 is located inside the balloon body.

[0174] The catheter is inserted into the inlet guide valve. After the gastric balloon is implanted into the stomach, liquid (such as saline) is injected into the catheter. The liquid fills the balloon and occupies space in the stomach, which reduces the volume of the stomach and increases the feeling of fullness. After a preset time, the biodegradable parts in the release valve degrade and the release valve opens, releasing the liquid in the balloon.

[0175] The gastric balloon provided in this embodiment of the invention is equipped with a gastric balloon release valve 100, so the actual release of the liquid in the balloon is basically consistent with the preset time.

[0176] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A gastric balloon release valve, characterized in that, The device includes an interconnected arc-shaped balloon connector and a valve body. The valve body is located on the inner arc side of the arc-shaped balloon connector. The arc-shaped balloon connector has an opening, and the valve body has a liquid outlet channel that communicates with the opening. The valve body is made of a non-degradable material. The end of the valve body away from the opening is a water outlet that communicates with the liquid outlet channel. The valve body is provided with a sealing element made of a degradable material for sealing the water outlet. The closure is a valve body extension, which has a liquid outlet extension channel. One end of the liquid outlet extension channel is an open end, and the other end is a closed end. The open end is connected to the water outlet. A biodegradable rope is tied to the valve body near the extension of the valve body.

2. The gastric balloon release valve according to claim 1, characterized in that, The valve body has a recess, and the binding rope is tied to the recess.

3. The gastric balloon release valve according to claim 1, characterized in that, The non-degradable material is polyurethane or silicone.

4. A method for preparing an intragastric balloon release valve, characterized in that, The mold is prepared by a molding method. The mold includes an arc-shaped part and a cylindrical part. The arc-shaped part has an arc-shaped convex wall, and the arc-shaped convex wall of the arc-shaped part is connected to one end of the cylindrical part. The preparation steps include: The arc-shaped part of the mold and a portion of the cylindrical part connected to the arc-shaped part are immersed in a polymer molding solution, so that the polymer molding solution adheres to the arc-shaped convex wall, and then the polymer molding solution attached to the arc-shaped convex wall is transformed into a first film. The remaining portion of the cylindrical part is immersed in a biodegradable material solution, so that the biodegradable material solution adheres to the outer wall of the cylindrical part and connects with the first film. Then, the biodegradable material solution adhering to the outer wall of the cylindrical part is transformed into a second film. The first film and the second film constitute a film. The film is removed from the mold, and then the film is flipped inside out to obtain a release valve prototype. The part formed by the polymer molding solution and corresponding to the cylindrical part is the valve body, the part corresponding to the arc-shaped convex wall is the arc-shaped balloon connection part, and the part formed by the biodegradable material solution and corresponding to the cylindrical part is the valve body extension part. The end of the valve body extension away from the arc-shaped balloon connection is the water outlet; the water outlet is sealed by immersing the valve body extension corresponding to the water outlet in the polymer molding solution or the biodegradable material solution, and then air-drying or drying; or, the water outlet is sealed by laser welding. A biodegradable rope is tied to the valve body.

5. The preparation method according to claim 4, characterized in that, The polymer molding solution is a polyurethane solution or a silicone solution, and the method for transforming the polymer molding solution adhering to the mold surface into a thin film is air drying or drying.

6. The preparation method according to claim 4, characterized in that, The method for removing the formed film from the mold is as follows: apply talcum powder to the edge of the film, and continue to apply talcum powder while peeling the film until the film is completely peeled off.

7. The preparation method according to claim 4, characterized in that, A groove is provided on the peripheral wall of the cylindrical part, so that a recess is formed on the valve body of the obtained release valve prototype, and the biodegradable material binding rope is tied to the recess.

8. A gastric balloon, characterized in that, The device includes a balloon body, on which a one-way valve for inlet is provided. The balloon body also has a release valve mounting port and an intragastric balloon release valve as described in any one of claims 1 to 3 or an intragastric balloon release valve prepared by the preparation method described in any one of claims 4 to 7. The intragastric balloon release valve is installed at the release valve mounting port, and the valve body is located inside the balloon body.

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