Gastric retention apparatus

Abstract

Provided is a gastric retention apparatus, which comprises: an elastic central component (1), a plurality of extension arms (2), and a plurality of connection components (3). Two axial ends of the extension arm (2) are a fixed end (21) and a free end (22); the connection component (3) comprises a first end surface, a second end surface, and an outer side surface connected between the first end surface and the second end surface, the first end surface is adhesively connected to the elastic central component (1), and the second end surface is adhesively connected to the fixed end (21) of the extension arm (2). The connection component (3) comprises a disintegration module (31) and an adhesion module (32); the disintegration module (31) is provided with an exposed region (311) exposed on the outer side surface of the connection component (3), and the adhesion module (32) is provided with a continuous region (323) extending continuously from the first end surface to the second end surface. The breaking force of the extension arm (2) and the elastic central component (1) is effectively improved by means of the adhesion module (32) arranged on the connection component (3), ensuring a sufficient retention period of the gastric retention apparatus in the stomach.

Description

A gastric retention device Technical Field

[0001] The present invention relates to the field of gastric prolonged drug delivery devices, in particular to a gastric retention device. Background Art

[0002] Gastric retention devices are designed to be administered into a patient's stomach, typically in capsule form, to be swallowed or introduced into the stomach via other methods of administration (e.g., feeding tube or nasogastric tube). After the capsule dissolves in the stomach, the gastric retention device expands or unfolds to a size that remains in the stomach and resists passage through the pyloric sphincter for a desired retention period (e.g., three days, seven days, two weeks, etc.). This requires maintaining mechanical stability while releasing one or more active drugs during the desired retention period, and the gastric retention device should be expelled from the stomach at the end of the desired retention time and easily expelled from the patient's body.

[0003] For example, patents CN201680081222.8, CN201680075519.3, and CN201780032420.X disclose gastric retention devices, which generally include a flexible central component, a plurality of extension arms, and a connecting component connecting the two. To ensure that the gastric retention device has a certain retention period, the connecting component includes a time-dependent module and an enteric-coated module. Both modules degrade in a predictable, time-dependent manner under aqueous conditions. For example, while the gastric retention device is retained in the stomach, the time-dependent module is designed to gradually degrade, dissolve, mechanically weaken, or break over time. After achieving the desired retention period, the time-dependent module has degraded, dissolved, dissociated, or mechanically weakened, or has broken, allowing the extension arms to separate from the flexible central component or to fold relative to the flexible central component within the gastrointestinal tract, to the extent that the gastric retention device can pass through the pyloric valve, exit the gastric environment, enter the small intestine, and ultimately be excreted from the body.

[0004] In gastric retention devices, the extended arm is used to load the active drug, and the polymer matrix selected is generally a non-degradable polymer with sufficient mechanical strength.

[0005] The compatibility of the disintegrating materials of the extension arm matrix and the connecting component is quite different, which makes it impossible to ensure the mechanical strength of the weld when the extension arm and the connecting component are melt-welded. This can easily lead to premature rupture of the bonding joint when the gastric retention device is in the stomach, thereby causing the gastric retention device to be expelled prematurely. Summary of the Invention

[0006] Therefore, it is necessary to provide a gastric retention device to solve the problem that the existing connecting parts and the extension arm have low adhesion and the extension arm is prone to premature breakage.

[0007] To achieve the above objectives, the present invention provides a gastric retention device comprising:

[0008] elastic centerpiece;

[0009] A plurality of extension arms, wherein the two axial ends of the extension arms are respectively a fixed end and a free end;

[0010] a plurality of connecting components, each of the connecting components including a first end surface, a second end surface, and an outer side surface connecting the first end surface and the elastic center component, the second end surface being bonded to the fixed end of the extension arm;

[0011] The connecting component includes a disintegration module and an adhesive module, wherein the disintegration module has an exposed area exposed on the outer side of the connecting component, and the adhesive module has a continuous area extending continuously from the first end surface to the second end surface;

[0012] The bonding module is used to increase the bonding force at the bonding point between the connecting component and the extension arm so that the breaking force between the extension arm and the elastic central component is at least 2.5N.

[0013] Furthermore, the exposed area of ​​the disintegration module occupies at least 30% of the area on the outer surface of the connecting component. The sufficient area of ​​the exposed area can ensure that the disintegration module can fully contact the external environment in the gastrointestinal environment, thereby achieving the effect of timed disintegration or safety protection disintegration.

[0014] Furthermore, the bonding module occupies at least 20% of the area on the second end face. The larger the contact area between the bonding module and the fixed end of the extension arm, the better the bonding effect after melt bonding.

[0015] Furthermore, the bonding module and / or the disintegration module are modules of uniform cross-section extending along their axial direction. The axial extension ensures the consistency of the mechanical strength of the connecting component in the axial direction.

[0016] Furthermore, the connecting component includes a central module and a plurality of side modules, wherein the plurality of side modules are circumferentially arranged on the side surfaces of the central module.

[0017] The disintegration module and the bonding module are combined in one of the following ways:

[0018] (A) The disintegration module is a central module, the bonding module is a side module, and the central module has the exposed area exposed on the outer side of the side module;

[0019] (B) The bonding module is a central module, the disintegration module is a side module, and the outer side of the side module is the exposed area.

[0020] Furthermore, in mode (A), the exposed area is exposed on the outer side of the connecting component by one of the following modes:

[0021] (1) The exposed area of ​​the central module is attached to the outer surface of the side module;

[0022] (2) When the plurality of side modules are prepared, they completely cover the side of the central module, and then grooves are opened on the side modules to expose the side of the central module to form the exposed area.

[0023] Furthermore, a side surface of the central module is provided with an inwardly recessed mounting groove, and the side modules are arranged in the mounting groove.

[0024] Furthermore, the bonding module includes two submodules and the continuous area. The two submodules are respectively located on the first end face and the second end face. The disintegration module is arranged between the two submodules. The two submodules are connected through the continuous area.

[0025] Furthermore, the disintegration module has a containing structure, and the continuous area crosses the containing structure.

[0026] Furthermore, the disintegration module includes a time-dependent disintegration module and / or an enteric disintegration module.

[0027] The time-dependent disintegration module can weaken its strength within a predetermined time under aqueous conditions so that the extension arm breaks or becomes bendable relative to the elastic central component, thereby controlling the retention time of the gastric retention device in the stomach. The strength weakening of the time-dependent disintegration module can be gradual degradation, dissolution, dissociation or mechanical weakening over time. After a sufficient number of extension arms break, the gastric retention device can pass through the pyloric valve, leave the gastric cavity and enter the small intestine, and finally be discharged from the body.

[0028] The enteric disintegration module is a pH-dependent disintegration module, which is used to provide an installation mechanism for the gastric retention device. Once the gastric retention device leaves the gastric cavity prematurely and enters the intestine, the enteric disintegration module will quickly complete degradation, dissolution, dissociation or mechanical weakening according to the high pH environment of the small intestine, thereby causing the extension arm to break, avoiding intestinal obstruction, and making it easier for the gastric retention device to pass through the small intestine.

[0029] Furthermore, the disintegration module includes a time-dependent disintegration module and an enteric disintegration module, the time-dependent disintegration module and the enteric disintegration module are arranged axially, the bonding module extends axially, and the bonding module is circumferentially arranged on the sides of the time-dependent disintegration module and the enteric disintegration module.

[0030] The time-dependent disintegration module and the enteric disintegration module are arranged side by side in the axial direction, and the bonding module extends axially on the sides of the time-dependent disintegration module and the enteric disintegration module. The bonding module can bond the time-dependent disintegration module and the enteric disintegration module. Therefore, when preparing the connecting parts, there is no need to pay special attention to the adhesion performance between the time-dependent disintegration module and the enteric disintegration module.

[0031] Furthermore, the bonding module comprises more than 50% bonding material;

[0032] The time-dependent disintegration module comprises less than 30% of a binding material and more than 70% of a time-dependent disintegration material;

[0033] The enteric disintegrating module comprises less than 30% of a bonding material and more than 70% of an enteric disintegrating material.

[0034] The time-dependent disintegration module and the enteric disintegration module both contain some bonding materials for melt bonding with the bonding module.

[0035] Furthermore, the bonding material is the same as the matrix material of the extension arm, and the same material has good melting properties, thereby ensuring the bonding strength between the connecting module and the fixed end of the extension arm.

[0036] Furthermore, the bonding material includes one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide;

[0037] The time-dependent disintegrating material comprises one or more of polylactic acid, polylactic-co-glycolic acid, polyglycolide, polycaprolactone, polyanhydride and polyorthoester;

[0038] The enteric disintegrating material includes one or more of hypromellose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

[0039] Furthermore, the connecting component is prepared and formed by one or more methods selected from the group consisting of melt co-extrusion, melt injection molding, compression molding, secondary sintering molding and three-dimensional printing.

[0040] Another aspect of the present invention discloses a gastric retention device, comprising

[0041] elastic centerpiece;

[0042] A plurality of extension arms, wherein the two axial ends of the extension arms are respectively a fixed end and a free end;

[0043] A plurality of connecting parts, wherein the connecting parts include a plurality of fusion-bonded connecting pieces, including at least one disintegrating connecting piece and end connecting pieces at both ends,

[0044] The connecting sheets all contain adhesive materials, and the difference in mass fraction of the adhesive materials between adjacent connecting sheets does not exceed 50%.

[0045] The disintegrating connecting piece contains more than 60% of disintegrating material,

[0046] The end connecting piece comprises more than 60% of adhesive material and is used to bond the fixed end of the extension arm. The arrangement of multiple connecting pieces on the connecting component ensures that the breaking force between the extension arm and the elastic central component is at least 2.5N.

[0047] Furthermore, the disintegrating connecting tablet includes a time-dependent disintegrating connecting tablet and / or an enteric-coated disintegrating connecting tablet.

[0048] Furthermore, the disintegrating connecting tablets include time-dependent disintegrating connecting tablets and enteric disintegrating connecting tablets.

[0049] The multiple connecting pieces of the connecting component include at least two intermediate connecting pieces located between the time-dependent disintegrating connecting piece and the enteric disintegrating connecting piece, the time-dependent disintegrating connecting piece includes at least 60% time-dependent disintegrating material, the enteric disintegrating connecting piece includes at least 60% enteric disintegrating material, the intermediate connecting piece includes at least 60% adhesive material, the intermediate connecting piece closely attached to the time-dependent disintegrating connecting piece contains no more than 30% time-dependent disintegrating material, and the intermediate connecting piece closely attached to the enteric disintegrating connecting piece contains no more than 30% enteric disintegrating material.

[0050] The time-dependent disintegrating connecting tablet and the enteric disintegrating connecting tablet are buffered by the intermediate connecting tablet to enhance the bonding strength. At the same time, the connecting tablets close to the time-dependent disintegrating connecting tablet and the enteric disintegrating connecting tablet respectively contain part of the corresponding disintegrating material, so that the two are more compatible in the molten state.

[0051] Furthermore, among the at least two intermediate connecting pieces, the intermediate connecting piece closer to the time-dependent disintegrating connecting piece has a higher content of time-dependent disintegrating material, and the intermediate connecting piece closer to the enteric disintegrating connecting piece has a higher content of enteric disintegrating material.

[0052] Furthermore, the bonding material includes one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide;

[0053] The time-dependent disintegrating material comprises one or more of polylactic acid, polylactic-co-glycolic acid, polyglycolide, polycaprolactone, polyanhydride and polyorthoester;

[0054] The enteric disintegrating material includes one or more of hypromellose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

[0055] Furthermore, the bonding material is the same as the matrix material of the extension arm.

[0056] Furthermore, in adjacent connecting sheets, the difference in bonding material does not exceed 40%.

[0057] Another aspect of the present invention discloses a gastric retention device comprising:

[0058] elastic centerpiece;

[0059] A plurality of extension arms, wherein the two axial ends of the extension arms are respectively a fixed end and a free end;

[0060] Multiple connecting parts,

[0061] The connecting component includes a disintegration module and bonding modules located on both sides of the disintegration module. The fixed end of the extension arm and the elastic center component are respectively bonded to the bonding modules on both sides of the disintegration module. The area of ​​the vertical cross-section of the connecting component is S. The bonding point of the disintegration module and the bonding module is provided with a first connecting structure so that the disintegration module and the bonding module have a contact area of ​​at least 1.5S at the bonding point, so that the breaking force between the extension arm and the elastic center component is at least 2.5N.

[0062] Furthermore, the first connection structure includes a matching flange and groove, with the outer side of the flange contacting the inner side of the groove to ensure that the disintegration module and the bonding module have a contact area of ​​at least 1.5S at the bonding point. Both side surfaces and the front side of the flange contact the inner side of the groove, effectively increasing the contact area.

[0063] Furthermore, the flange is extended in a horizontal direction or a vertical direction.

[0064] Furthermore, the maximum thickness of the flange is at least 0.2 mm. The thickness of the flange ensures the mechanical strength of the bonding module and the disintegration module after bonding.

[0065] Furthermore, the width of the flange in the extension direction is d1, the width of the connecting component in the plane where the flange is located is d2, and d1 ≥ 0.5d2.

[0066] Furthermore, the first connection structure includes a plurality of flanges arranged at intervals and staggered on opposite surfaces of the bonding portion of the disintegration module and the bonding module, and the intervals between adjacent flanges on the same side form the groove.

[0067] The flanges on the disintegration module and the bonding module are staggered. During assembly, the flanges are staggered and cross-positioned to match the grooves, and then melt-bonded. The staggered and cross-positioned flanges help improve the bonding effect.

[0068] Furthermore, the disintegration module includes a time-dependent disintegration module and / or an enteric disintegration module.

[0069] Furthermore, the disintegration module includes a time-dependent disintegration module and an enteric disintegration module, and a second connecting structure is provided between the time-dependent disintegration module and the enteric disintegration module so that the time-dependent disintegration module and the enteric disintegration module have a contact area of ​​at least 5S at the bonding point.

[0070] Furthermore, the second connection structure and the first connection structure have the same or different structures.

[0071] Furthermore, the bonding material and the matrix material of the extension arm are the same.

[0072] Furthermore, the bonding module comprises more than 50% of bonding material, and the bonding material is bonded and melted with the matrix material of the extension arm;

[0073] The time-dependent disintegration module comprises less than 30% of a binding material and more than 70% of a time-dependent disintegration material;

[0074] The enteric disintegrating module comprises less than 30% of a bonding material and more than 70% of an enteric disintegrating material.

[0075] Furthermore, the bonding material includes one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide;

[0076] The time-dependent disintegrating material comprises one or more of polylactic acid, polylactic-co-glycolic acid, polyglycolide, polycaprolactone, polyanhydride and polyorthoester;

[0077] The enteric disintegrating material includes one or more of hypromellose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

[0078] Furthermore, the connecting component includes a bonding module, a time-dependent disintegration module, an enteric disintegration module and a bonding module, which are sequentially molded by three-dimensional printing or secondary injection molding and then melt-molded.

[0079] The above technical solution has the following beneficial effects:

[0080] On the one hand, the present invention separately provides a bonding module and a disintegration module, thereby ensuring that the breaking force between the extension arm and the elastic central component is above 2.5N without affecting the mechanical properties of the disintegration module itself, thereby enabling the gastric retention device to remain in the gastric cavity for a sufficient time. The bonding force between the connecting component and the extension arm mainly comes from the bonding module, and the material and formula of the disintegration module can be selected from a wider range. The continuous region continuously extends through the entire connecting component, which is beneficial to enhancing the integrity and mechanical strength of the connecting component.

[0081] On the other hand, the present invention provides a connecting component composed of multiple connecting sheets. The fusion bonding of the multiple connecting sheets helps to improve the bonding strength of the connecting component, and the difference in the adhesive material content between adjacent connecting sheets does not exceed 50%, avoiding excessive difference in material between adjacent connecting sheets, thereby ensuring the mechanical strength of the connecting component, avoiding the occurrence of stress concentration areas on the connecting component, and effectively improving the overall breaking force of the connecting component.

[0082] On the other hand, the connecting component is configured as a disintegration module and a bonding module. The bonding module is bonded to the fixed end of the extension arm to ensure sufficient bonding force between the extension arm and the connecting component. By setting the first connecting structure, the fusion bonding area of ​​the disintegration module and the bonding module is at least 1.5S or more, thereby enhancing the effect of subsequent melt bonding and making the breaking force between the two greater than 2.5N, thereby ensuring that the gastric retention device can be retained in the stomach for a sufficient time. BRIEF DESCRIPTION OF THE DRAWINGS

[0083] FIG. 1 illustrates a gastric retention device according to an embodiment of the present invention in a deployed configuration.

[0084] 2 is a diagram of a gastric retention device in a collapsed configuration according to an exemplary embodiment.

[0085] FIG3 is a schematic diagram of a connecting component according to an embodiment.

[0086] FIG4 is a schematic diagram of a connecting component according to an embodiment.

[0087] FIG5 is a perspective schematic diagram of a connecting component according to an embodiment.

[0088] FIG6 is a schematic diagram of a connecting component according to an embodiment.

[0089] FIG. 7 is a schematic diagram of a connecting component according to an embodiment.

[0090] FIG8 is a schematic diagram of a connecting component according to an embodiment.

[0091] FIG9 is a perspective schematic diagram of a connecting component according to an embodiment.

[0092] FIG. 10 is a schematic diagram of a connecting component according to an embodiment.

[0093] FIG11 is a perspective schematic diagram of a connecting component according to an embodiment.

[0094] FIG12 is a perspective schematic diagram of a connecting component according to an embodiment.

[0095] FIG. 13 is a cross-sectional view of the connecting component along line AA in FIG. 12 .

[0096] FIG14 is a perspective schematic diagram of a connecting component according to an embodiment.

[0097] FIG15 is a perspective schematic diagram of a connecting component according to an embodiment.

[0098] FIG16 is a perspective schematic diagram of a connecting component according to an embodiment.

[0099] FIG17 is a perspective schematic diagram of a connecting component according to an embodiment.

[0100] FIG18 is a perspective schematic diagram of a connecting component according to an embodiment.

[0101] FIG19 is a perspective schematic diagram of a connecting component according to an embodiment.

[0102] FIG20 is a schematic axial cross-sectional view of a connecting component according to an embodiment.

[0103] FIG21 is a perspective schematic diagram of a connecting component according to an embodiment.

[0104] FIG22 is a schematic diagram of the end face of the connecting component in FIG21 .

[0105] FIG23 is a perspective schematic diagram of a connecting component according to an embodiment.

[0106] FIG. 24 is a diagram showing an assembly of connecting components according to an embodiment.

[0107] FIG25 is a perspective schematic diagram of the connecting component in FIG24 .

[0108] FIG26 is a schematic structural diagram of a fracture test device.

[0109] Explanation of the accompanying drawings: 1. Elastic central component; 2. Extension arm; 21. Fixed end; 22. Free end; 3. Connecting component; 31. Disintegration module; 311. Exposed area; 312. Through groove; 313. Time-dependent disintegration module; 314. Enteric disintegration module; 32. Adhesive module; 321. Slot; 322. Submodule; 323. Continuous area; 33. Mounting groove; 34. Disintegration connecting piece; 341. Time-dependent disintegration connecting piece; 342. Enteric disintegration connecting piece; 35. End connecting piece; 36. Middle connecting piece; 37. First connecting structure; 371. Flange; 372. Groove; 38. Second connecting structure; 4. Fracture test device; 41. Fixing table; 42. Lower pressure plate; 43. Test piece. DETAILED DESCRIPTION

[0110] Prior art gastric retention devices are contained in a capsule shell or other container in a compressed, folded configuration that can be swallowed by the patient or that can otherwise be administered to the stomach for patients who are unable to swallow (e.g., via a gastrostomy tube, feeding tube, nasogastric tube, or other route of administration to the stomach).

[0111] Figure 1 shows the deployed configuration of the gastroretentive device. Figure 2 shows the folded configuration of the gastroretentive device. The gastroretentive device comprises an elastic core member 1, a plurality of extension arms 2, and a plurality of connecting members 3. The plurality of extension arms 2 are circumferentially arranged around the elastic core member 1, at least one extension arm 2 is loaded with an active substance, and the extension arms 2 are bonded to the elastic core member 1 via the connecting members 3.

[0112] Once the capsule shell or other container filled with the folded gastric retention device reaches the patient's stomach, the capsule shell dissolves and releases the folded gastric retention device. Upon release, the gastric retention device returns to its expanded configuration. The gastric retention device in the expanded configuration is larger than the pyloric outlet of the stomach, thereby preventing the gastric retention device from exiting the stomach cavity. After the gastric retention device has been in the patient's stomach for a sufficient period of time, the disintegrating material on the connecting member 3 disintegrates, allowing the device to exit the stomach cavity and enter the small intestine.

[0113] When in the stomach, the gastric retention device is compatible with the other normal functions of the digestive gastrointestinal tract. The gastric retention device does not interfere with or prevent chyme (partially digested food) or other gastric contents from being expelled from the stomach through the pyloric sphincter and into the duodenum.

[0114] In some embodiments, the extension arm 2 includes a matrix material, which is used to constitute the main body of the extension arm 2. The active substance loaded on the extension arm 2 is a therapeutic agent or a diagnostic agent.

[0115] In some embodiments, the active substance is selected from doxycycline, donepezil, ivermectin, risperidone, cetirizine, and rosuvastatin, or a pharmaceutically acceptable salt thereof.

[0116] The two ends of the extension arm 2 are a fixed end 21 and a free end 22 , respectively. The fixed end 21 of the extension arm 2 is bonded to the elastic central component 1 through a connecting component 3 .

[0117] In the present invention, the connecting member 3 is configured to undergo degradation, dissolution, dissociation, or mechanical weakening, allowing the extension arms 2 to separate from or bend relative to the elastic core member 1. The oral gastric retention device utilizes the elastic force provided by the elastic core member 1 to transition from a folded configuration to an expanded configuration.

[0118] In some embodiments, the elastic center member 1 is an elastic polymer.

[0119] In some embodiments, the resilient center member 1 comprises a resilient alloy member configured to transform from martensite to austenite to enable the oral gastroretention device to transform from a collapsed configuration to an expanded configuration.

[0120] Compared with the use of elastic polymers, the use of elastic alloy components has a stronger elastic modulus and can better resist the peristaltic force from the stomach in the stomach. At the same time, after the elastic memory alloy enters the body, due to the high temperature of the human body, the memory alloy can naturally transform from martensite to austenite, thereby allowing the extension arm 2 to expand to form an expanded configuration, so that the device can remain in the stomach.

[0121] In the present invention, the connecting component 3 includes a first end face, a second end face and an outer side face connecting the two. The first end face is bonded to the elastic central component 1 , and the second end face is bonded to the fixed end 21 of the extension arm 2 .

[0122] As shown in Figure 3-15, the connecting component 3 includes a disintegration module 31 and a bonding module 32. The disintegration module 31 has an exposed area 311 exposed on the outer side of the connecting component 3, and the bonding module 32 has a continuous area 323 extending continuously from the first end face to the second end face. The material of the bonding module 32 has good melting compatibility with the material of the extension arm 2. The bonding module 32 is used to increase the bonding force at the bonding point between the connecting component 3 and the extension arm 2 so that the breaking force between the extension arm 2 and the elastic center component 1 is at least 2.5N.

[0123] In some embodiments, the material of the bonding module 32 is fully or partially compatible with the matrix material of the extension arm 2 in a molten state.

[0124] In some embodiments, the material of the bonding module 32 is the same as the matrix material of the extension arm 2 , and the same materials have complete melting compatibility.

[0125] In some embodiments, the exposed area 311 of the disintegration module 31 occupies at least 30% of the area on the outer surface of the connecting component 3. The area of ​​the exposed area 311 of the connecting component 3 is used to control the disintegration rate and time of the disintegration module 31, thereby achieving the effect of timed disintegration or safety protection disintegration.

[0126] In a specific embodiment, the exposed area 311 of the disintegration module 31 can occupy 30-40%, 30-60%, 30-80%, 30-100%, 40-50%, 40-50%, 40-80%, 40-100%, 50-60%, 50-80%, 50-100%, 60-70%, 60-80%, 60-100%, 70-80%, 70-90%, 70-100%, 80-90%, 80-100% or 90-100% of the area on the outer surface of the connecting part 3.

[0127] In some embodiments, the bonding module 32 occupies at least 20% of the area on the second end surface. The area occupied by the bonding module 32 on the second end surface is used to enhance the firmness of the melt bonding between the connecting component 3 and the extension arm 2.

[0128] In a specific embodiment, the bonding module 32 occupies at least 20-30%, 20-50%, 20-70%, 20-80%, 20-100%, 30-40%, 30-60%, 30-80%, 30-100%, 40-50%, 40-50%, 40-80%, 40-100%, 50-60%, 50-80%, 50-100%, 60-70%, 60-80%, 60-100%, 70-80%, 70-90%, 70-100%, 80-90%, 80-100% or 90-100% of the area on the second end surface.

[0129] In some embodiments, the bonding module 32 and / or the disintegration module 31 are modules with a uniform cross-section extending along the axial direction thereof. The axial extension ensures the consistency of the mechanical strength of the connecting component 3 in the axial direction.

[0130] As shown in Figures 3-11 and 14-15, in a specific embodiment, both the bonding module 32 and the disintegration module 31 are modules of uniform cross-section extending along their axial direction. The disintegration module 31 and the bonding module 32 can have various other uniform cross-sectional stretched shapes, such as circular, triangular, polygonal, etc. The uniform cross-sectional stretching in the axial direction ensures the consistency of the mechanical strength of the connecting component 3 in the axial direction.

[0131] As shown in FIG3-4 , in some embodiments, the disintegration module 31 and the bonding module 32 are respectively arranged vertically or horizontally.

[0132] In some embodiments, the vertical cross-sections of the connecting component 3 and the extension arm 2 are the same, and may be circular, polygonal or other shapes. In an embodiment of the present invention, the vertical cross-sections of the connecting component 3 and the extension arm 2 are triangular.

[0133] In some embodiments, the connecting component 3 includes a central module and a plurality of side modules, and the plurality of side modules are circumferentially arranged on the sides of the central module.

[0134] As shown in Figures 5-9 and 14-15, the central module is a disintegration module 31, the side modules are bonding modules 32, and the side of the central module has an exposed area 311 exposed on the outer side of the side modules.

[0135] As shown in Figures 5-6, 9 and 14, in the cross-sectional view of the connecting component 3, the exposed area 311 of the central module is inscribed in the surface of the outer side of the side module. In Figures 5-6, the central module is a circle and a hexagon inscribed in the side.

[0136] As shown in Figures 7-8 and 15 , in the cross-sectional views of connecting component 3, the side surfaces of the central module are not tangent to the outer surface of connecting component 3. During preparation, multiple side modules are assembled to cover the sides of the central module. Then, slots 321 are formed in the side modules to expose the sides of the central module, forming exposed areas 311. The size of the exposed area relative to the outer surface of connecting component 3 is determined by the area of ​​slots 321. Disintegration module 31 is located in the center, and bonding module 32 provides some protection and reinforcement for disintegration module 31.

[0137] As shown in FIG5-9 , in some embodiments, the connecting component 3 may configure the disintegration module 31 as a side module and the bonding module 32 as a central module.

[0138] As shown in FIG10 , in some embodiments, the central module is a bonding module 32 , and the side modules can completely cover the sides of the central module. In this case, the exposed area 311 of the disintegration module 31 occupies 100% of the area on the outer surface of the connecting component 3 .

[0139] As shown in FIG11 , in some embodiments, the side of the central module has an inwardly recessed mounting groove 33, and the side modules are disposed within the mounting groove 33. The mounting groove 33 increases the contact area between the central module and the side modules, which helps improve the interaction between the central module and the side modules when preparing the connecting member 3.

[0140] As shown in Figures 12-13, in some embodiments, the bonding module 32 includes two submodules 322 and a continuous region 323. The two submodules 322 are respectively located on the first end face and the second end face. The disintegration module 31 is arranged between the two submodules 322, and the two submodules 322 are connected by a continuous region 323, which crosses the disintegration module 31. The disintegration module 31 has a receiving structure, and the continuous region 323 crosses the receiving structure. The receiving structure can be a through groove 312 on the side of the disintegration module 31 or a through hole that penetrates the disintegration module 31. The cooperation between the receiving structure and the continuous region 323 makes the cooperation between the disintegration module 31 and the bonding module 32 more compact.

[0141] 12-13 , the receiving structure is a through groove 312 located on the side of the disintegration module 31 . The continuous area 323 is adaptively embedded in the through groove 312 , thereby enhancing the overall strength of the disintegration module 31 and the bonding module 32 .

[0142] In some other embodiments, the second end surface has a connection structure that engages with the fixed end 21 of the extension arm 2, and the fixed end 21 of the extension arm 2 and the extension arm 2 are engaged with each other and positioned and then melt-bonded.

[0143] In some embodiments, the disintegration module 31 includes a time-dependent disintegration module 313 and / or an enteric disintegration module 314 .

[0144] The time-dependent disintegration module 313 weakens its strength within a predetermined time under aqueous conditions so that the extension arm 2 breaks or becomes bendable relative to the elastic central component 1, thereby controlling the retention time of the gastric retention device in the stomach. The strength weakening mode of the time-dependent disintegration module 313 can be gradual degradation, dissolution, dissociation or mechanical weakening over time. After a sufficient number of extension arms 2 are broken, the gastric retention device can pass through the pyloric valve, leave the gastric cavity and enter the small intestine, and finally be discharged from the body.

[0145] The enteric disintegration module 314 is a pH-dependent disintegration module, which is used to provide a safety protection mechanism for the gastric retention device. Once the gastric retention device leaves the gastric cavity prematurely and enters the intestine, the enteric disintegration module 314 will quickly complete degradation, dissolution, dissociation or mechanical weakening according to the high pH environment of the small intestine, thereby causing the extension arm 2 to break, avoiding intestinal obstruction and making it easier for the gastric retention device to pass through the small intestine.

[0146] As shown in FIG14 , in some embodiments, the disintegration module 31 includes a time-dependent disintegration module 313 and an enteric disintegration module 314. The time-dependent disintegration module 313 and the enteric disintegration module 314 are arranged axially. The bonding module 32 extends axially and is circumferentially disposed on the sides of the time-dependent disintegration module 313 and the enteric disintegration module 314. The time-dependent disintegration module 313 and the enteric disintegration module 314 are respectively located near the first and second end faces of the connecting component 3.

[0147] The time-dependent disintegration module 313 and the enteric disintegration module 314 are arranged side by side in the axial direction, and the bonding module 32 extends axially on the sides of the time-dependent disintegration module 313 and the enteric disintegration module 314. The bonding module 32 can bond the time-dependent disintegration module 313 and the enteric disintegration module 314. Therefore, when preparing the connecting component 3, there is no need to pay special attention to the bonding performance between the time-dependent disintegration module 313 and the enteric disintegration module 314.

[0148] As shown in Figure 15, in some embodiments, the disintegration module 31 includes a time-dependent disintegration module 313 and an enteric disintegration module 314. The time-dependent disintegration module 313 and the enteric disintegration module 314 are arranged axially. During preparation, a layer of bonding module 32 is first formed on the outer side of the time-dependent disintegration module 313 and the enteric disintegration module 314, and then a groove 321 is opened on the side of the bonding module 32 to form an exposed area 311 on the side of the time-dependent disintegration module 313 and the enteric disintegration module 314.

[0149] In some embodiments, the bonding module 32 includes more than 50% of bonding material, and the bonding material is bonded and melted with the matrix material of the extension arm 2;

[0150] The time-dependent disintegration module 313 includes less than 30% of a binding material and more than 70% of a time-dependent disintegration material;

[0151] The enteric disintegrating module 314 includes less than 30% of a binder material and more than 70% of an enteric disintegrating material.

[0152] The time-dependent disintegration module 313 and the enteric disintegration module 314 both contain some bonding materials for melt-bonding with the bonding module 32 .

[0153] In some other embodiments, the components of the bonding module 32, the time-dependent disintegration module 313 and the enteric disintegration module 314 may further include other additives, and the additives may include plasticizers, solubilizers, dyes and hydrophilic substances (to increase hydrophilicity, such as PEG) or hydrophobic substances and other additives.

[0154] In some embodiments, the adhesive material and the matrix material of the extension arm 2 are the same.

[0155] In some embodiments, the bonding material includes one or more of polycaprolactone (PCL), polylactic acid (PLA), polyglycolide (PGA), polylactic-co-glycolic acid (PLGA), polyhydroxyalkanoates, and modified polysaccharides; the time-dependent disintegrating material includes one or more of polylactic acid (PLA), polylactic-co-glycolic acid (PLGA), polyglycolide PGA (), polycaprolactone (PCL), polyanhydrides, and polyorthoesters (PLGA); and the enteric disintegrating material includes one or more of hydroxypropyl methylcellulose acetate succinate (HPMCAS), acrylate co-polymers, cellulose acetate phthalate, shellac, and polyvinyl acetate phthalate.

[0156] In some embodiments, the disintegration module 31 and the bonding module 32 are prepared by one or more methods selected from the group consisting of melt coextrusion, melt injection molding, compression molding, secondary sintering molding, and three-dimensional printing.

[0157] Among them, the connecting component 3 shown in Figures 3-6, 9-11 can be prepared by melt co-extrusion, melt injection molding, compression molding, secondary sintering molding or three-dimensional printing.

[0158] The connecting component 3 shown in Figures 7-8 is prepared by melt co-extrusion, melt injection molding, compression molding, secondary sintering molding or three-dimensional printing, and then a groove 321 is opened on the outer side of the connecting component 3 to reveal the exposed area 311.

[0159] The connecting component 3 shown in FIG. 11 - 12 and FIG. 14 - 15 can be prepared by melt injection molding, compression molding, secondary sintering molding or three-dimensional printing.

[0160] As shown in Figures 1-2 and 16-17, another aspect of the present invention discloses a gastric retention device, comprising an elastic central component 1, a plurality of extension arms 2 and a plurality of connecting components 3, wherein the axial ends of the extension arms 2 are respectively a fixed end 21 and a free end 22, and the connecting components 3 include a plurality of fusion-bonded connecting pieces, including at least one disintegrating connecting piece 34 and end connecting pieces 35 at both ends.

[0161] The connecting pieces all contain adhesive material, and the difference in mass fraction of the adhesive material between adjacent connecting pieces does not exceed 50%.

[0162] The disintegrating connecting piece 34 contains more than 60% disintegrating material, and the end connecting piece 35 includes more than 60% adhesive material, which is used to bond the fixed end 21 of the extension arm 2. The arrangement of multiple connecting pieces on the connecting part 3 makes the breaking force between the extension arm 2 and the elastic central part 1 at least 2.5N.

[0163] The disintegrating connecting piece 34 of the connecting part 3 is used to control the timed disintegration and rupture or safety protection disintegration of the connecting part 3. When the gastric retention device stays in the stomach for a predetermined time or enters the small intestine environment in advance, the disintegrating connecting piece 34 begins to disintegrate, thereby separating the extension arm 2 and the elastic central part 1.

[0164] In some embodiments, the disintegrating web 34 includes a time-dependent disintegrating web 341 and / or an enteric disintegrating web 342 .

[0165] The time-dependent disintegrating connecting piece 341 weakens in strength within a predetermined time under aqueous conditions so that the extension arm 2 breaks or bends relative to the elastic central component 1, thereby controlling the retention time of the gastric retention device in the stomach. The strength weakening of the time-dependent disintegrating connecting piece 341 can be gradual degradation, dissolution, dissociation or mechanical weakening over time. After a sufficient number of extension arms 2 are broken, the gastric retention device can pass through the pyloric valve, leave the gastric cavity and enter the small intestine, and finally be discharged from the body.

[0166] The enteric disintegrating connecting piece 342 is a pH-dependent disintegrating connecting piece, which is used to provide a safety protection mechanism for the gastric retention device. Once the gastric retention device leaves the gastric cavity prematurely and enters the intestine, the enteric disintegrating module 314 will quickly complete degradation, dissolution, dissociation or mechanical weakening according to the high pH environment of the small intestine, thereby causing the extension arm 2 to break, avoiding intestinal obstruction and making it easier for the gastric retention device to pass through the small intestine.

[0167] In some embodiments, the disintegrating web 34 includes a time-dependent disintegrating web 341 and an enteric disintegrating web 342 .

[0168] The multiple connecting pieces of the connecting component 3 include at least two intermediate connecting pieces 36 located between the time-dependent disintegrating connecting piece 341 and the enteric disintegrating connecting piece 342, the time-dependent disintegrating connecting piece 341 includes at least 60% time-dependent disintegrating material, the enteric disintegrating connecting piece 342 includes at least 60% enteric disintegrating material, the intermediate connecting piece 36 includes at least 60% adhesive material, the intermediate connecting piece 36 close to the time-dependent disintegrating connecting piece 341 contains no more than 30% time-dependent disintegrating material, and the intermediate connecting piece 36 close to the enteric disintegrating connecting piece 342 contains no more than 30% enteric disintegrating material.

[0169] The intermediate connecting piece 36 acts as a buffer between the time-dependent disintegrating connecting piece 341 and the enteric disintegrating connecting piece 342 to enhance the bonding strength. At the same time, the connecting pieces close to the time-dependent disintegrating connecting piece 341 and the enteric disintegrating connecting piece 342 respectively contain part of the corresponding disintegrating material, so that the two are more compatible in the molten state.

[0170] In some embodiments, among the at least two intermediate connecting pieces 36 , the intermediate connecting piece 36 closer to the time-dependent disintegrating connecting piece 341 has a higher content of time-dependent disintegrating material, and the intermediate connecting piece 36 closer to the enteric disintegrating connecting piece 342 has a higher content of enteric disintegrating material.

[0171] As shown in Figure 17, the connecting component 3 is composed of six connecting pieces, including two end connecting pieces 35 located on the end faces, a time-dependent disintegrating connecting piece 341, an enteric disintegrating connecting piece 342 and two intermediate connecting pieces 36. The two end connecting pieces 35 are used to bond to the elastic central component 1 and the extension arm 2 respectively.

[0172] The time-dependent disintegrating connecting sheet 341 includes at least 60% time-dependent disintegrating material and no more than 30% adhesive material, the intermediate connecting sheet 36 closely attached to the time-dependent disintegrating connecting sheet 341 includes at least 60% adhesive material and no more than 30% time-dependent disintegrating material, the enteric disintegrating connecting sheet 342 includes at least 60% enteric disintegrating material and no more than 30% adhesive material, the intermediate connecting sheet 36 closely attached to the enteric disintegrating connecting sheet 342 includes at least 60% adhesive material and no more than 30% enteric disintegrating material.

[0173] In some embodiments, the bonding material includes one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide; the time-dependent disintegrating material includes one or more of polylactic acid, polylactic acid-glycolic acid copolymer, polyglycolide, polycaprolactone, polyanhydride and polyorthoester; the enteric disintegrating material includes one or more of hydroxypropyl methylcellulose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

[0174] In some embodiments, the adhesive material is the same as the matrix material of the extension arm 2 .

[0175] In some embodiments, the bonding material of adjacent connecting sheets differs by no more than 40%.

[0176] In some embodiments, the thickness of each connecting piece can be 0.3-2 mm, and the specific thickness can be 0.3 mm, 0.5 mm, 0.86 mm, 1 mm, 1.28 mm, 1.5 mm or 2 mm. The thickness of the multiple connecting pieces included in the connecting component 3 can be the same or different.

[0177] As shown in Figures 1-2, 18-25, another aspect of the present invention discloses a gastric retention device, comprising an elastic central component 1, multiple extension arms 2 and multiple connecting components 3, the axial ends of the extension arm 2 are respectively a fixed end 21 and a free end 22, the extension arm 2 comprises a matrix material, the connecting component 3 comprises a disintegration module 31 and bonding modules 32 located on both sides of the disintegration module, the fixed end 21 of the extension arm 2 and the elastic central component 1 are respectively bonded to the bonding modules 32 on both sides of the disintegration module, the vertical cross-sectional area of ​​the connecting component 3 is S, and a first connecting structure 37 is provided at the bonding point of the disintegration module 31 and the bonding module 32, so that the disintegration module 31 and the bonding module 32 have a contact area of ​​at least 1.5S at the bonding point, so that the breaking force between the extension arm 2 and the elastic central component 1 is at least 2.5N.

[0178] In some embodiments, the first connecting structure 37 includes a matching flange 371 and a groove 372. The outer side of the flange 371 contacts the inner side of the groove 372, so that the disintegration module 31 and the bonding module 32 have a contact area of ​​at least 1.5S at the bonding point. Both the side surfaces and the front side of the flange 371 contact the inner side of the groove 372, effectively increasing the contact area.

[0179] In some embodiments, the flange 371 may extend in any direction, and the cross-sectional shape of the flange 371 may also be a triangle, a trapezoid, a square, or any other shape.

[0180] In some embodiments, the flange 371 extends in a horizontal direction or a vertical direction.

[0181] As shown in Figure 18, in some embodiments, the first connecting structure 37 includes a plurality of flanges 371 staggered and spaced apart on the opposite surfaces of the bonding point of the disintegration module 31 and the bonding module 32, and the intervals between adjacent flanges 371 on the same side form a groove 372. The wedge-shaped flanges 371 extend horizontally in the width direction, and the plurality of wedge-shaped flanges 371 are arranged at intervals from top to bottom. The flanges 371 and the grooves 372 on the two side surfaces of the disintegration module 31 and the opposite side surfaces of the bonding module 32 complement each other.

[0182] In some embodiments, the maximum thickness of the flange 371 is at least 0.2 mm. The thickness of the flange 371 ensures the mechanical strength of the bonding module 32 and the disintegration module 31 after bonding.

[0183] In a specific embodiment, when the flange 371 is triangular or trapezoidal, the maximum thickness is the length of the base of the flange 371 ; when the flange 371 is square, the maximum thickness is the vertical width of the side of the flange 371 .

[0184] In a specific embodiment, the maximum thickness of the flange 371 can be 0.2 mm, 0.3 mm, 0.5 mm, 0.6 mm, 0.8 mm, 1.0 mm, 1.2 mm, or 1.5 mm.

[0185] As shown in FIG19 , in some embodiments, the disintegration module 31 has square flanges 371 on both sides. The flanges 371 extend horizontally in the width direction and extend horizontally to both sides of the connecting component 3. The bonding module 32 has corresponding grooves 372. In FIG9 , the thickness h of the flanges 371 is at least 0.2 mm.

[0186] As shown in FIG. 20 , in some embodiments, the flange 371 on the disintegration module 31 has a trapezoidal vertical cross-section in the axial direction of the connecting component 3 , and the maximum thickness H of the flange 371 is at least 0.2 mm.

[0187] In some embodiments, the width d1 of the flange 371 in the extension direction and the width d2 of the connecting component 3 on the plane where the flange 371 is located are d1 ≥ 0.5 d2 .

[0188] In a specific embodiment of the present invention, the flange 371 extends in the horizontal direction, and the length d1 of the flange 371 in the extending direction may be 0.5d2, 0.6d2, 0.7d2, 0.8d2, 0.9d2 or d2.

[0189] As shown in Figures 21-22, in some embodiments, a flange 371 is provided on the side of the disintegration module 31. The width of the flange 371 in the extension direction is d1, and the width of the connecting component 3 on the plane where the flange 371 is located is d2, and d1≥0.5d2.

[0190] As shown in FIG. 23 , in some embodiments, three horizontal flanges 371 are provided on the side of the disintegration module 31 , and corresponding side surfaces of the bonding module 32 have grooves 372 of corresponding shapes.

[0191] In some embodiments, the disintegration module 31 includes a time-dependent disintegration module 313 and / or an enteric disintegration module 314 .

[0192] The time-dependent disintegration module 313 weakens its strength within a predetermined time under aqueous conditions so that the extension arm 2 breaks or becomes bendable relative to the elastic central component 1, thereby controlling the retention time of the gastric retention device in the stomach. The strength weakening mode of the time-dependent disintegration module 313 can be gradual degradation, dissolution, dissociation or mechanical weakening over time. After a sufficient number of extension arms 2 are broken, the gastric retention device can pass through the pyloric valve, leave the gastric cavity and enter the small intestine, and finally be discharged from the body.

[0193] The enteric disintegration module 314 is a pH-dependent disintegration module, which is used to provide a safety protection mechanism for the gastric retention device. Once the gastric retention device leaves the gastric cavity prematurely and enters the intestine, the enteric disintegration module 314 will quickly complete degradation, dissolution, dissociation or mechanical weakening according to the high pH environment of the small intestine, thereby causing the extension arm 2 to break, avoiding intestinal obstruction and making it easier for the gastric retention device to pass through the small intestine.

[0194] In some embodiments, the disintegration module 31 includes a time-dependent disintegration module 313 and an enteric disintegration module 314, and a second connecting structure 38 is provided between the time-dependent disintegration module 313 and the enteric disintegration module 314 so that the time-dependent disintegration module 313 and the enteric disintegration module 314 have a contact area of ​​at least 5S at the bonding point.

[0195] In some embodiments, the second connection structure 38 and the first connection structure 37 have the same or different structures.

[0196] As shown in FIG. 24-25 , in some specific embodiments, the connecting component 3 includes two bonding modules 32 located at both ends and a time-dependent disintegration module 313 and an enteric disintegration module 314 located therebetween.

[0197] The first connecting structure 37 and the second connecting structure 38 have the same structure. The bonding module 32, the time-dependent disintegration module 313 and the enteric disintegration module 314 all have multiple wedge-shaped flanges 371. The wedge-shaped flanges 371 extend horizontally in the width direction. The multiple wedge-shaped flanges 371 are arranged at intervals from top to bottom. The intervals between the wedge-shaped flanges 371 are grooves 372. The fixed end 21 of the extension arm 2 is complementary to the shape of the second end face of the connecting component 3.

[0198] In some embodiments, the adhesive material and the matrix material of the extension arm 2 are the same.

[0199] In some embodiments, the bonding module 32 includes more than 50% bonding material, and the bonding material is bonded and melted with the matrix material of the extension arm 2; the time-dependent disintegration module 313 includes less than 30% bonding material and more than 70% time-dependent disintegration material; the enteric disintegration module 314 includes less than 30% bonding material and more than 70% enteric disintegration material.

[0200] In some embodiments, the bonding material includes one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide; the time-dependent disintegrating material includes one or more of polylactic acid, polylactic acid-glycolic acid copolymer, polyglycolide, polycaprolactone, polyanhydride and polyorthoester; the enteric disintegrating material includes one or more of hydroxypropyl methylcellulose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

[0201] In some embodiments, the connecting component 3 includes a bonding module 32, a time-dependent disintegration module 313, an enteric disintegration module 314 and a bonding module 32, which are sequentially molded by three-dimensional printing or secondary injection molding and then melt-molded.

[0202] Preferably, the connecting component 3 is formed by 3D printing and then melt-molded. 3D printing can flexibly set the number and size of the flanges 371 on the first connecting structure 37 and the second connecting structure 38, thereby increasing the contact area between the disintegration module 31 and the bonding module 32.

[0203] In the present invention, the firmness of the connection between the extension arm 2, the connecting member 3 and the elastic center is measured by a break / 90° bend test, and the specific process is as follows:

[0204] A single extension arm 2 is melt-bonded with the elastic center component 1 through the connecting component 3 to form a test piece 43, as shown in Figure 26, and is tested using a fracture test device 4. The fracture test device 4 includes a fixed platform 41 and a lower pressure plate 42. After the elastic center component 1 is fixed by the fixed platform 41, the lower pressure plate 42 presses down the free end 22 of the extension arm 2 to test the downward pressure when the extension arm 2 and the elastic center component 1 are broken or bent 90° relative to each other.

[0205] To fully simulate the environment of the gastric retention device in the stomach, the test piece 43 was immersed in simulated gastric fluid with a pH of 1.2 for 0 days, 7 days, and 10 days, respectively. The test piece 43 was immersed for 2 hours on the 0th day, and then a fracture / 90° bending test was performed. During the test, the forces fed back on the lower pressure plate 42 were recorded as F0, F7, and F10, respectively.

[0206] During the test, generally at 0 days, the disintegrating material has not yet fully dissolved and breaks first during the test. At this time, the measured F0 is the breaking force between the extension arm 2 and the elastic central component 1. After 7 days and 10 days of immersion in the simulated position, the disintegrating material dissolves and the connecting component 3 has a certain degree of flexibility. The extension arm 2 can bend relative to the elastic central component 1. At this time, the measured F7 and F10 are the pressures when the extension arm 2 is bent 90 degrees relative to the elastic central component 1.

[0207] In the present invention, by providing the connecting component 3, the breaking force between the extension arm 2 and the elastic central component 1 is greater than 2.5N at day 0, thereby enabling the gastric retention device to resist the peristaltic pressure of the stomach in the gastric cavity, maintain the expanded configuration, and prevent the gastric retention device from being discharged prematurely.

[0208] In other embodiments, at day 0, the breaking force between the extension arms 2 and the elastic centerpiece 1 is 2.5-15.0N, 3.0-15.0N, 3.5-15.0N, 4.0-15.0N, 4.5-15.0N, 5.0-15.0N, 8-15.0N, 10-15.0N, or 12-15.0N.

[0209] In order to explain the technical content, structural features, achieved objectives and effects of the technical solution in detail, the following is a detailed description in conjunction with specific embodiments and accompanying drawings.

[0210] Example 1

[0211] This embodiment provides a gastric retention device, including an elastic central component 1, six extension arms 2 and six connecting components 3. The elastic central component 1 includes a central elastic metal (not shown in the drawings) and a TPU polymer outer layer wrapping the central elastic metal. The extension arms 2 are made of polycaprolactone.

[0212] As shown in FIG8 , the connecting component 3 includes a time-dependent disintegration module 313 and an adhesive module 32 . The volume ratio of the time-dependent disintegration module 313 to the adhesive module 32 is 4:1. At this time, the adhesive module 32 occupies 20% of the area on the second end surface.

[0213] The time-dependent disintegration module 313 includes 20% polycaprolactone and 80% polylactic acid-glycolic acid copolymer, and the bonding module 32 is 100% polycaprolactone.

[0214] During preparation, the connecting component 3 is prepared by melt injection molding, and the time-dependent disintegration material is first mixed and melted and injected into the first mold to form a time-dependent disintegration module 313. Then, the time-dependent disintegration module 313 is placed in the second mold and the adhesive material is injected. After molding, the adhesive material covers the outer side of the time-dependent disintegration module 313. Finally, a groove 321 is cut on the side to remove part of the adhesive material to reveal the side of the central time-dependent disintegration module 313. In this embodiment, the exposed area 311 of the time-dependent disintegration module 313 is set to occupy 30% of the area of ​​the outer side.

[0215] Examples 2-4

[0216] This embodiment provides a gastric retention device, which is different from the first embodiment in that different connecting components 3 are prepared by controlling the volume ratio of the time-dependent disintegration module 313 and the bonding module 32 .

[0217] Comparative Example 1

[0218] A gastric retention device, which is different from Example 1 in that: the connecting component comprises 36% polycaprolactone and 64% polylactic acid-glycolic acid copolymer, which are completely mixed and then melt-injected to form the connecting component.

[0219] Comparative Example 2

[0220] A gastric retention device, which differs from Example 1 in that: the connecting component includes two adhesive modules, the time-dependent disintegration module is located between the two adhesive modules, the time-dependent disintegration module includes 20% polycaprolactone and 80% polylactic acid-glycolic acid copolymer, and the adhesive module is 100% polycaprolactone. Its structure is shown in Figure 16. The components of the time-dependent disintegration module and the adhesive module are the same as those in Example 1.

[0221] Comparative Example 3

[0222] A gastric retention device, which differs from Example 1 in that the volume ratio of the time-dependent disintegration module and the bonding module is controlled so that the bonding module occupies 15% of the area of ​​the second end surface.

[0223] Example 5

[0224] As shown in FIG15 , this embodiment provides a gastric retention device, which is different from Example 1 in that the central module includes a time-dependent disintegration module 313 and an enteric disintegration module 314 formed in sequence, wherein the enteric disintegration module 314 includes 20% polycaprolactone and 80% hydroxypropyl methylcellulose acetate succinate.

[0225] Comparative Example 4

[0226] This comparative example provides a gastric retention device, which is prepared by preparing two bonding modules, a time-dependent disintegration module, and an enteric disintegration module having the same components as in Example 5. The bonding module, the time-dependent disintegration module, the enteric disintegration module, and the bonding module are melt-bonded in this order to prepare a connecting component, and then the gastric retention device is prepared.

[0227] The test pieces prepared according to the schemes of Examples 1-5 and Comparative Examples 1-4 were subjected to breaking / 90° bending tests, and the breaking force and the bending pressure during 90° bending were recorded.

[0228] The bending test results are shown in Table 1.

[0229] Among them, A is the area of ​​the second end face occupied by the bonding module, B is the area of ​​the side surface of the connecting component occupied by the exposed area, and during the fracture test, the positions on the test piece are: the connecting component body, denoted as W1; the bonding point between the end face of the connecting component and the extension arm, denoted as W2; the bonding point between the time-dependent disintegration module and the bonding module, denoted as W3; the bonding point between the time-dependent disintegration module and the enteric disintegration module, denoted as W4.

[0230] Table 1. Breaking / 90° bending test results.

[0231] As shown in Table 1, the area occupied by the bonding module 32 on the connecting component 3 with a uniform cross-section has a significant impact on the breaking force and bending pressure of the connecting component 3. The higher the volume ratio of the bonding module 32, the higher the breaking force. A comparison between Example 1 and Comparative Example 1 shows that, in connecting components 3 with the same component content, Example 1, due to the bonding module 32 comprising more than 50% of the bonding material, significantly strengthens the bonding strength at the bond point and enhances the breaking force. A comparison between Example 1 and Comparative Example 2 shows that in Example 1, due to the continuous region 323 extending continuously on the connecting component 3, the connecting component 3 of Example 1 has a higher breaking force in the fracture test. A comparison between Example 5 and Comparative Example 4 shows that in Example 5, due to the continuous region 323 extending from the first end face to the second end face between the two bonding modules 32, the overall mechanical strength of the connecting component 3 is improved, and the bonding effect of the time-dependent disintegration module 313 and the enteric disintegration module 314 is also improved.

[0232] Example 6

[0233] This embodiment provides a gastric retention device, including an elastic central component 1, six extension arms 2 and six connecting components 3. The elastic central component 1 includes a central elastic metal and a TPU polymer outer layer wrapping the central elastic metal, and the extension arms 2 are made of polycaprolactone.

[0234] As shown in FIG. 16 , the connecting component 3 includes a time-dependent disintegrating connecting piece 341 and two terminal connecting pieces 35 . The time-dependent disintegrating connecting piece 341 is located between the two terminal connecting pieces 35 .

[0235] The time-dependent disintegrating connecting piece 341 comprises 30% polycaprolactone and 70% polylactic acid-glycolic acid copolymer, and the two end connecting pieces 35 each comprise 70% polycaprolactone and 30% polylactic acid-glycolic acid copolymer.

[0236] During preparation, the materials of different connecting sheets are separated, mixed, melted and extruded to form plastic strips. The corresponding plastic strips are then cut into connecting sheets of corresponding thickness through a slicing device and then melt-bonded.

[0237] Example 7

[0238] This embodiment provides a gastric retention device, which is different from Example 6 in that the time-dependent disintegrating connecting piece 341 includes 30% polycaprolactone, 60% polylactic acid-glycolic acid copolymer and 10% additives, and the terminal connecting piece 35 includes 60% polycaprolactone, 30% polylactic acid-glycolic acid copolymer and 10% additives.

[0239] Example 8

[0240] The difference from Example 6 is that the time-dependent disintegrating connecting piece 341 comprises 40% polycaprolactone and 60% polylactic acid-glycolic acid copolymer, and the terminal connecting piece 35 comprises 60% polycaprolactone and 40% polylactic acid-glycolic acid copolymer.

[0241] Example 9

[0242] This embodiment provides a gastric retention device, which is different from Example 6 in that the time-dependent disintegrating connecting piece 341 includes 20% polycaprolactone, 70% polylactic acid-glycolic acid copolymer and 10% additives, and the terminal connecting piece 35 includes 70% polycaprolactone, 20% polylactic acid-glycolic acid copolymer and 10% additives.

[0243] Example 10

[0244] This embodiment provides a gastric retention device, which differs from Example 6 in that: as shown in Figure 17, the connecting component 3 is composed of six connecting pieces melt-bonded together, which are, in order, the first terminal connecting piece 35, the time-dependent disintegrating connecting piece 341, the first intermediate connecting piece 36, the second intermediate connecting piece 36, the enteric disintegrating connecting piece 342, and the second terminal connecting piece.

[0245] The material compositions of different connecting pieces are as follows:

[0246] First terminal connecting piece 35: 70% polycaprolactone and 30% polylactic acid-glycolic acid copolymer;

[0247] Time-dependent disintegrating connecting tablet 341: 30% polycaprolactone and 70% polylactic acid-glycolic acid copolymer;

[0248] First intermediate connecting sheet 36: 70% polycaprolactone and 30% polylactic acid-glycolic acid copolymer;

[0249] Second intermediate connecting sheet 36: 70% polycaprolactone and 30% hypromellose acetate succinate;

[0250] Enteric disintegrating connecting tablet 342: 30% polycaprolactone and 70% hypromellose acetate succinate;

[0251] Second terminal connecting piece 35: 70% polycaprolactone and 30% hypromellose acetate succinate.

[0252] Comparative Example 5

[0253] This comparative example provides a gastric retention device, which differs from Example 6 in that:

[0254] The time-dependent disintegrating connecting piece comprises 30% polycaprolactone and 70% polylactic acid-glycolic acid copolymer, and the terminal connecting piece comprises 90% polycaprolactone and 10% polylactic acid-glycolic acid copolymer.

[0255] The test pieces prepared according to the schemes of Examples 6-10 and Comparative Examples 2, 4, and 5 were subjected to breaking / 90° bending tests, and the breaking force and the bending pressure at 90° bending were recorded.

[0256] The results are shown in Table 2 below.

[0257] Table 2. Break / 90° bend test results.

[0258] Where C is the number of connecting sheets; D is the maximum difference in the adhesive content between adjacent connecting sheets. For example, in Example 6, the time-dependent disintegrating connecting sheet contains 30% polycaprolactone and the terminal connecting sheet contains 70% polycaprolactone, so D = 70% - 30% = 40%. The following locations on the test piece are used: the bonding point between the time-dependent disintegrating connecting sheet and the terminal connecting sheet is designated as E1; the bonding point between the terminal connecting sheet and the extension arm is designated as E2; the bonding point between the enteric disintegrating connecting sheet and the intermediate or terminal connecting sheet is designated as E3; and the bonding point between the enteric disintegrating connecting sheet and the time-dependent disintegrating connecting sheet is designated as E4.

[0259] It can be seen from Examples 6-9 and Comparative Example 2 that as the amount of adhesive material between adjacent connecting sheets increases, the smaller the difference in the adhesive material content of adjacent connecting sheets, the better the bonding effect. As can be seen from the comparison between Example 10 and Comparative Example 4, two intermediate connecting sheets 36 are provided between the time-dependent disintegrating connecting sheet 341 and the enteric-coated disintegrating connecting sheet 342. The two intermediate connecting sheets 36 provide a good bonding effect between the time-dependent disintegrating connecting sheet 341 and the enteric-coated disintegrating connecting sheet 342, thereby improving the breaking force of the connecting component 3.

[0260] Example 11

[0261] This embodiment provides a gastric retention device, including an elastic central component, six extension arms and six connecting components. The elastic central component includes a central elastic metal and a TPU polymer outer layer wrapping the central elastic metal. The extension arms are made of polycaprolactone.

[0262] As shown in Figure 19, the shape of the vertical cross-section of the connecting component 3 is an equilateral triangle with a side length of 3.3 mm. The connecting component 3 includes an enteric disintegration module 314 and a bonding module 32. Flanges 371 are provided on both sides of the enteric disintegration module 314. The thickness h of the flange 371 is set to 0.2 mm and the width d is set to 1 mm. By controlling the length L of the flange 371 protruding forward, the side of the enteric disintegration module 314 has a surface area of ​​1.5S.

[0263] The enteric disintegrating module 314 includes 20% polycaprolactone and 80% hypromellose acetate succinate, and the bonding module 32 is 100% polycaprolactone.

[0264] Example 12

[0265] The difference from Example 11 is that, as shown in FIG23 , the connecting component 3 includes an enteric disintegration module 314 and an adhesive module 32. Three flanges 371 are provided on both sides of the enteric disintegration module 314. Each flange 371 has a thickness of 0.2 mm. The length and width of the flanges 371 are configured to provide a contact area of ​​3S between the enteric disintegration module 314 and the occupied side of the occupying module. FIG23 shows only the flange 371 on a single side of the enteric disintegration module 314.

[0266] Example 13

[0267] The difference from Example 11 is that, as shown in Figures 24-25, the connecting component 3 includes a bonding module 32, a time-dependent disintegration module 313, an enteric disintegration module 314 and a bonding module 32 which are fused in sequence.

[0268] Multiple flanges 371 are provided on opposite sides of the time-dependent disintegration module 313 and the enteric disintegration module 314 . Flanges 371 are provided on the inner sides of the two bonding modules 32 . The flanges 371 on the opposite sides are staggered and cross-arranged.

[0269] The time-dependent disintegrating module 313 includes 20% polycaprolactone and 80% poly(lactic-co-glycolic acid).

[0270] In this embodiment, since the connecting component 3 itself is relatively small in size, the entire connecting component 3 can be three-dimensionally printed by a 3D printing device. After the 3D printing is completed, in order to further improve the bonding strength between the modules, the connecting component 3 is heated and melted so that the modules are firmly bonded.

[0271] The 3D printing device can flexibly set the structure and form of the flange 371. In this embodiment, as shown in Figures 24-25, the contact area between the first connecting structure 37 and the second connecting structure 38 can be set to 5S through a computer.

[0272] Comparative Example 6

[0273] A gastric retention device, which is different from Example 11 in that: no flange is provided on the side of the enteric disintegration module, and the contact bonding area between the bonding module and the enteric disintegration module is S.

[0274] Comparative Example 7

[0275] A gastric retention device, which differs from Example 13 in that: the second connecting structure between the enteric disintegration module and the time-dependent disintegration module is set so that the contact area between the enteric disintegration module and the time-dependent disintegration module is 3S, and the first connecting structure is the same as the structure of Example 13.

[0276] The test pieces prepared according to the schemes of Examples 11-13 and Comparative Examples 4, 6, and 7 were subjected to breaking / 90° bending tests, and the breaking force and bending pressure at 90° bending were recorded. The results are shown in Table 3 below.

[0277] Table 3. Break / 90° bend test results.

[0278] Wherein, S1 represents the contact area between the enteric disintegration module and the bonding module, S2 represents the contact area between the enteric disintegration module and the time-dependent disintegration module, and the positions on the test piece are: the bonding point between the enteric disintegration module and the bonding module, denoted as F1; the bonding point between the bonding module and the extension arm, denoted as F2; ​​and the bonding point between the enteric disintegration module and the time-dependent disintegration module, denoted as F3.

[0279] When the test piece 43 made of the connecting component 3 of Comparative Example 7 was immersed in the simulated gastric fluid for the third day, the enteric disintegration module 314 and the time-dependent disintegration module 313 of the connecting component 3 were broken and separated.

[0280] From the comparison between Examples 11-12 and Comparative Example 6, it can be seen that the provision of the flange 371 on the connecting component 3 can effectively enhance the bonding effect between the disintegration module and the bonding module 32 and improve the mechanical strength.

[0281] From the comparison between Example 13 and Comparative Example 7, it can be seen that the flange 371 increases the bonding area between the time-dependent disintegration module 313 and the enteric disintegration module 314, so that the two can still be firmly connected even when the ingredients are greatly different.

[0282] It should be noted that, in this document, relational terms such as first and second, etc., are used solely to distinguish one entity or operation from another, and do not necessarily require or imply any actual relationship or order between these entities or operations. Furthermore, the terms "include," "comprise," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or terminal device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or terminal device. Without further limitation, elements defined by the phrase "include..." or "comprising..." do not exclude the presence of additional elements in the process, method, article, or terminal device comprising the elements. Furthermore, in this document, "greater than," "less than," "exceeding," etc., are understood to exclude the number itself; "above," "below," "within," etc., are understood to include the number itself.

[0283] Although the above embodiments have been described, those skilled in the art may make additional changes and modifications to these embodiments once they know the basic creative concepts. Therefore, the above descriptions are merely embodiments of the present invention and do not limit the scope of patent protection of the present invention. Any equivalent structure or equivalent process transformation made using the contents of the present invention's description and drawings, or directly or indirectly applied in other related technical fields, are also included in the scope of patent protection of the present invention.

Claims

1. A gastric retention device, characterized in that include: elastic centerpiece; A plurality of extension arms, wherein the two axial ends of the extension arms are respectively a fixed end and a free end; a plurality of connecting components, each of the connecting components including a first end surface, a second end surface, and an outer side surface connecting the first end surface and the elastic center component, the second end surface being bonded to the fixed end of the extension arm; The connecting component includes a disintegration module and an adhesive module, wherein the disintegration module has an exposed area exposed on the outer side of the connecting component, and the adhesive module has a continuous area extending continuously from the first end surface to the second end surface; The bonding module is used to increase the bonding force at the bonding point between the connecting component and the extension arm so that the breaking force between the extension arm and the elastic central component is at least 2.5N.

2. The gastric retention device according to claim 1, wherein The exposed area of ​​the disintegration module occupies at least 30% of the area on the outer side of the connecting component.

3. The gastric retention device according to claim 1, wherein The bonding module occupies at least 20% of the area on the second end surface.

4. The gastric retention device according to claim 1, wherein The bonding module and / or the disintegration module is a module with a constant cross-section extending along its axial direction.

5. The gastric retention device according to claim 4, wherein The connecting component includes a central module and a plurality of side modules, wherein the plurality of side modules are circumferentially arranged on the side surfaces of the central module. The disintegration module and the bonding module are combined in one of the following ways: (A) The disintegration module is a central module, the bonding module is a side module, and the central module has the exposed area exposed on the outer side of the side module; (B) The bonding module is a central module, the disintegration module is a side module, and the outer side of the side module is the exposed area.

6. The gastric retention device according to claim 5, wherein In mode (A), the exposed area is exposed on the outer side of the connecting component by one of the following modes: (1) The exposed area of ​​the central module is attached to the outer surface of the side module; (2) When the plurality of side modules are prepared, they completely cover the side of the central module, and then grooves are opened on the side modules to expose the side of the central module to form the exposed area.

7. The gastric retention device according to claim 5, wherein The side surface of the central module is provided with an inwardly recessed mounting groove, and the side modules are arranged in the mounting groove.

8. The gastric retention device according to claim 1, wherein The bonding module includes two submodules and the continuous area. The two submodules are respectively located on the first end surface and the second end surface. The disintegration module is arranged between the two submodules. The two submodules are connected through the continuous area.

9. The gastric retention device according to claim 8, wherein The disintegration module is provided with a containing structure, and the continuous area crosses the containing structure.

10. The gastric retention device according to claim 1, wherein The disintegration module includes a time-dependent disintegration module and / or an enteric disintegration module.

11. The gastric retention device according to claim 10, wherein The disintegration module includes a time-dependent disintegration module and an enteric disintegration module, which are arranged axially. The bonding module extends axially and is circumferentially arranged on the sides of the time-dependent disintegration module and the enteric disintegration module.

12. The gastric retention device according to claim 11, wherein The bonding module includes more than 50% bonding material; The time-dependent disintegration module comprises less than 30% of a binding material and more than 70% of a time-dependent disintegration material; The enteric disintegrating module comprises less than 30% of a bonding material and more than 70% of an enteric disintegrating material.

13. The gastric retention device according to claim 12, wherein The adhesive material is the same as the matrix material of the extension arm.

14. The gastric retention device according to claim 11, wherein The bonding material includes one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide; The time-dependent disintegrating material comprises one or more of polylactic acid, polylactic-co-glycolic acid, polyglycolide, polycaprolactone, polyanhydride and polyorthoester; The enteric disintegrating material includes one or more of hypromellose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

15. The gastric retention device according to claim 1, wherein The connecting component is prepared and formed by one or more methods selected from the group consisting of melt co-extrusion, melt injection molding, compression molding, secondary sintering molding and three-dimensional printing.

16. A gastric retention device, characterized in that include: elastic centerpiece; A plurality of extension arms, wherein the two axial ends of the extension arms are respectively a fixed end and a free end; A plurality of connecting parts, wherein the connecting parts include a plurality of fusion-bonded connecting pieces, including at least one disintegrating connecting piece and end connecting pieces at both ends, Each of the connecting sheets comprises an adhesive material, and the difference in mass fraction of the adhesive material between adjacent connecting sheets does not exceed 50%; The disintegrating connecting piece contains more than 60% of disintegrating material; The end connecting piece comprises more than 60% of adhesive material and is used to bond the fixed end of the extension arm. The arrangement of multiple connecting pieces on the connecting component ensures that the breaking force between the extension arm and the elastic central component is at least 2.5N.

17. The gastric retention device according to claim 16, wherein The disintegrating connecting tablets include time-dependent disintegrating connecting tablets and / or enteric disintegrating connecting tablets.

18. The gastric retention device according to claim 17, wherein The disintegrating connecting tablets include time-dependent disintegrating connecting tablets and enteric disintegrating connecting tablets. The connecting component further includes at least two intermediate connecting pieces located between the time-dependent disintegrating connecting piece and the enteric disintegrating connecting piece. The time-dependent disintegrating connecting piece comprises at least 60% of a time-dependent disintegrating material, The enteric disintegrating connecting tablet comprises at least 60% enteric disintegrating material, The intermediate connecting sheet comprises at least 60% adhesive material, The intermediate connecting piece next to the time-dependent disintegrating connecting piece contains no more than 30% of a time-dependent disintegrating material, and the intermediate connecting piece next to the enteric disintegrating connecting piece contains no more than 30% of an enteric disintegrating material.

19. The gastric retention device according to claim 18, wherein Among the at least two intermediate connecting pieces, the intermediate connecting piece closer to the time-dependent disintegrating connecting piece has a higher content of time-dependent disintegrating material, and the intermediate connecting piece closer to the enteric disintegrating connecting piece has a higher content of enteric disintegrating material.

20. The gastric retention device of claim 18, wherein The bonding material includes one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide; The time-dependent disintegrating material comprises one or more of polylactic acid, polylactic-co-glycolic acid, polyglycolide, polycaprolactone, polyanhydride and polyorthoester; The enteric disintegrating material includes one or more of hypromellose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

21. The gastric retention device of claim 16, wherein: The adhesive material is the same as the matrix material of the extension arm.

22. The gastric retention device of claim 16, wherein: The difference in bonding material between adjacent connecting pieces does not exceed 40%.

23. A gastric retention device, characterized in that include: elastic centerpiece; A plurality of extension arms, wherein the two axial ends of the extension arms are respectively a fixed end and a free end; Multiple connecting parts, the connecting parts include a disintegration module and bonding modules located on both sides of the disintegration module, the fixed end of the extension arm and the elastic center part are respectively bonded to the bonding modules on both sides of the disintegration module, the area of ​​the vertical cross-section of the connecting part is S, and a first connecting structure is provided at the bonding point of the disintegration module and the bonding module, the first connecting structure is used to make the disintegration module and the bonding module have a contact area of ​​at least 1.5S at the bonding point, so that the breaking force between the extension arm and the elastic center part is at least 2.5N.

24. The gastric retention device of claim 23, wherein: The first connection structure includes a matching flange and a groove, wherein the outer side of the flange contacts the inner side of the groove so that the disintegration module and the bonding module have a contact area of ​​at least 1.5S at the bonding point.

25. The gastric retention device of claim 24, wherein: The flange is extended in a horizontal direction or a vertical direction.

26. The gastric retention device of claim 24, wherein: The maximum thickness of the flange is at least 0.2 mm.

27. The gastric retention device of claim 24, wherein: The width of the flange in the extension direction is d1, the width of the connecting component in the plane where the flange is located is d2, and d1 ≥ 0.5d2.

28. The gastric retention device of claim 24, wherein The first connection structure includes a plurality of flanges that are staggered and spaced apart on opposite sides of the disintegration module and the bonding module, and the intervals between adjacent flanges on the same side form the groove.

29. The gastric retention device of claim 23, wherein: The disintegration module includes a time-dependent disintegration module and / or an enteric disintegration module.

30. The gastric retention device of claim 29, wherein The disintegration module includes a time-dependent disintegration module and an enteric disintegration module. A second connection structure is provided between the time-dependent disintegration module and the enteric disintegration module so that the time-dependent disintegration module and the enteric disintegration module have a contact area of ​​at least 5S at the bonding point.

31. The gastric retention device of claim 30, wherein: The second connection structure and the first connection structure may have the same or different structures.

32. The gastric retention device of claim 30, wherein: The adhesive material is the same as the matrix material of the extension arm.

33. The gastric retention device of claim 30, wherein: The bonding module comprises more than 50% of bonding material, and the bonding material is bonded and melted with the matrix material of the extension arm; The time-dependent disintegration module comprises less than 30% of a binding material and more than 70% of a time-dependent disintegration material; The enteric disintegrating module comprises less than 30% of a bonding material and more than 70% of an enteric disintegrating material.

34. The gastric retention device of claim 33, wherein: The bonding material includes one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide; The time-dependent disintegrating material comprises one or more of polylactic acid, polylactic-co-glycolic acid, polyglycolide, polycaprolactone, polyanhydride and polyorthoester; The enteric disintegrating material includes one or more of hypromellose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

35. The gastric retention device of claim 30, wherein When preparing the connecting component, the bonding module, the time-dependent disintegration module, the enteric disintegration module and the bonding module are first formed in sequence by three-dimensional printing or secondary injection molding, and then melt-molded.

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