Gastric retention device

Abstract

The present application relates to the field of gastric prolonged administration device, disclose a kind of gastric retention device, including elastic center component, multiple extension arms and multiple connecting components, the two ends of extension arm axial are fixed end and free end respectively;Connecting component includes first end face, second end face and the outer side surface between the connection of both, first end face is bonded with elastic center component, and second end face is bonded with the fixed end of extension arm;Connecting component includes disintegration module and bonding module, disintegration module has exposed area exposed on the outer side surface of connecting component, and bonding module has continuous area continuously extended from first end face to second end face, in the present application, the fracture force of extension arm and elastic center component is effectively improved by being provided on connecting component, to ensure that gastric retention device can have sufficient retention period in stomach.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of gastric extended release devices, in particular to a gastric residence device. BACKGROUND

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

[0003] Gastric residence devices are disclosed in patents CN201680081222.8, CN201680075519.3, CN201780032420.X, etc., generally comprising a generally elastic central part, a plurality of elongated arms and a connecting part between the two, in order to make the gastric residence device have a certain residence period, the connecting part comprises a time-dependent module and an enteric module, which degrades in a predictable time-dependent manner under aqueous conditions, for example, when the gastric residence device is retained in the stomach during the residence period, the time-dependent module is designed to gradually degrade, dissolve, mechanically weaken or break over time. After reaching the desired residence period, the time-dependent module has degraded, dissolved, dissociated or mechanically weakened, or has broken, so that the elongated arms are separated from the elastic central part or so that the elongated arms can be folded relative to the elastic central part in the gastrointestinal tract to such an extent that the gastric residence device can pass through the pyloric valve, leave the stomach environment and enter the small intestine, and eventually be expelled from the body.

[0004] In the gastric residence device, the elongated arms are used for the loading of active drugs, and the polymer matrix selected generally is a non-degradable polymer with sufficient mechanical strength.

[0005] The solubility of the disintegration material of the elongated arm matrix and the connecting part is quite different, so that when the elongated arm and the connecting part are fusion welded, the mechanical strength of the welded part cannot be guaranteed, which easily leads to the premature breakage of the bonded part when the gastric residence device is in the stomach, thereby causing the gastric residence device to be expelled prematurely. SUMMARY

[0006] Therefore, it is necessary to provide a gastric residence device to solve the problem of low adhesion of the existing connecting part and elongated arm, and the premature breakage of the elongated arm.

[0007] To achieve the above-mentioned purpose, the present application provides a gastric residence device, comprising:

[0008] an elastic central part;

[0009] a plurality of extension arms, each of which has a fixed end and a free end at two axial ends thereof;

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

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

[0012] the bonding module is used to increase the bonding force at the bonding position of the connecting component and the extension arm, so that the breaking force between the extension arm and the elastic center component is at least 2.5 N or more.

[0013] Further, 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 be in sufficient contact with the external environment in the gastrointestinal environment, thereby playing a role of timed disintegration or safety protection disintegration.

[0014] Further, the bonding module occupies at least 20% of the area on the second end surface. The greater the contact area of the bonding module with the fixed end of the extension arm, the better the bonding effect after fusion bonding.

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

[0016] Further, the connecting component comprises a center module and a plurality of side modules, the plurality of side modules being circumferentially arranged on the side surface of the center module,

[0017] the combination mode of the disintegration module and the bonding module is one of the following modes:

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

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

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

[0021] (1) the exposed area of the center module is attached to the surface where the outer surface of the side module is located;

[0022] (2) The plurality of side modules completely cover the side of the central module when the side modules are prepared, and then the side modules are provided with slots to expose the side of the central module to form the exposed area.

[0023] Further, the side of the central module has an inwardly recessed mounting groove, and the side module is arranged in the mounting groove.

[0024] Further, the adhesive module comprises two sub-modules and the continuous area, the two sub-modules are respectively located at the first end face and the second end face, and the disintegration module is arranged between the two sub-modules, and the two sub-modules are connected through the continuous area.

[0025] Further, the disintegration module has a receiving structure, and the continuous area passes through the receiving structure.

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

[0027] The time-dependent disintegration module weakens in strength in a predetermined time under aqueous conditions, so that the extension arm is broken or bendable relative to the elastic central part, thereby controlling the retention time of the gastric retention device in the stomach, and the time-dependent disintegration module can be gradually degraded, dissolved, dissociated or mechanically weakened over time, and after a sufficient number of extension arms are broken, the gastric retention device can pass through the pyloric valve, leave the stomach cavity and enter the small intestine, and finally be excreted from the body.

[0028] The enteric disintegration module, i.e. the pH-dependent disintegration module, is used to provide a mounting mechanism for the gastric retention device, and once the gastric retention device prematurely leaves the stomach cavity and enters the intestine, the enteric disintegration module will rapidly complete degradation, dissolution, dissociation or mechanical weakening according to the high pH environment of the small intestine, thereby causing the extension arm to break and avoiding intestinal obstruction, so that the gastric retention device can easily pass through the small intestine.

[0029] Further, the disintegration module comprises a time-dependent disintegration module and an enteric disintegration module, the time-dependent disintegration module and the enteric disintegration module are arranged in an axial direction, the adhesive module extends in an axial direction, and the adhesive module is arranged on the side of the time-dependent disintegration module and the enteric disintegration module in a circumferential direction.

[0030] The time-dependent disintegration module and the enteric disintegration module are arranged side by side in an axial direction, the adhesive module extends in an axial direction on the side of the time-dependent disintegration module and the enteric disintegration module, and the adhesive module can bond the time-dependent disintegration module and the enteric disintegration module, so that when the connecting part is prepared, the adhesion performance between the time-dependent disintegration module and the enteric disintegration module does not need to be specially considered.

[0031] Further, the adhesive module comprises more than 50% adhesive material;

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

[0033] The enteric disintegration module comprises less than 30% adhesive material and more than 70% enteric disintegration material.

[0034] Both the time-dependent disintegration module and the enteric disintegration module contain part of adhesive material for fusion bonding with the adhesive module.

[0035] Further, the adhesive material and the matrix material of the extension arm are the same. The same material has good melting property, which ensures the bonding force of the connection between the module and the fixed end of the extension arm.

[0036] Further, the adhesive material comprises one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide;

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

[0038] The enteric disintegration material comprises one or more of hydroxypropyl methyl cellulose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

[0039] Further, the connection component is prepared by one or more of melt co-extrusion, melt injection molding, compression molding, secondary sintering molding and three-dimensional printing.

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

[0041] The elastic central component;

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

[0043] A plurality of connection components, the connection component comprises a plurality of fusion-bonded connection pieces, wherein at least one disintegration connection piece and two end terminal connection pieces are included,

[0044] The connection pieces all contain adhesive material, and the mass fraction percentage difference of the adhesive material between adjacent connection pieces is not more than 50%,

[0045] The disintegration connection piece contains more than 60% disintegration material,

[0046] The end connecting piece comprises more than 60% adhesive material for bonding the fixed end of the extension arm, and the arrangement of multiple connecting pieces on the connecting component makes the breaking force between the extension arm and the elastic center component at least 2.5N.

[0047] Further, the disintegrating connecting piece comprises a time-dependent disintegrating connecting piece and / or an enteric disintegrating connecting piece.

[0048] Further, the disintegrating connecting piece comprises a time-dependent disintegrating connecting piece and an enteric disintegrating connecting piece,

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

[0050] The buffering of the intermediate connecting piece between the time-dependent disintegrating connecting piece and the enteric disintegrating connecting piece enhances the bonding strength, and the connecting pieces close to the time-dependent disintegrating connecting piece and the enteric disintegrating connecting piece respectively contain part of the corresponding disintegrating material, so that they have better compatibility in the molten state.

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

[0052] Further, the adhesive material comprises 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 acid-glycolic acid copolymer, polyglycolide, polycaprolactone, polyanhydride and polyorthoester;

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

[0055] Further, the adhesive material is the same as the matrix material of the extension arm.

[0056] Further, among the adjacent connecting pieces, the difference between the adhesive materials is not more than 40%.

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

[0058] a resilient central member;

[0059] a plurality of elongated arms, each of which has a fixed end and a free end at two axial ends;

[0060] a plurality of connecting members,

[0061] the connecting member comprises a disintegration module and an adhesive module on both sides of the disintegration module, the fixed end of the elongated arm and the resilient central member are respectively bonded to the adhesive modules on both sides of the disintegration module, the vertical cross-sectional area of the connecting member is S, and the bonding part of the disintegration module and the adhesive module is provided with a first connecting structure, so that the disintegration module and the adhesive module have a contact area of at least 1.5S at the bonding part, thereby making the breaking force between the elongated arm and the resilient central member at least 2.5N.

[0062] Further, the first connecting structure comprises a matching flange and groove, the outer side surface of the flange is in contact with the inner side surface of the groove to make the disintegration module and the adhesive module have a contact area of at least 1.5S at the bonding part. The two side surfaces and the front surface of the flange are in contact with the inner side surface of the groove, effectively improving the contact area.

[0063] Further, the flange is arranged in the horizontal direction or the vertical direction.

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

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

[0066] Further, the first connecting structure comprises a plurality of flanges arranged in a staggered manner on the opposite surfaces of the bonding part of the disintegration module and the adhesive module, and the space between the flanges on the same side forms the groove.

[0067] The flanges on the disintegration module and the adhesive module are arranged in a staggered manner, and during assembly, the staggered and crossed flanges are positioned to match the groove, and then fusion bonding is performed. The staggered and crossed flanges help to improve the bonding effect.

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

[0069] Further, the disintegration module comprises a time-dependent disintegration module and an enteric disintegration module, and a second connecting structure is arranged 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 position.

[0070] Further, the second connecting structure and the first connecting structure are the same or different in structure.

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

[0072] Further, the bonding module comprises more than 50% of the bonding material, and the bonding material is bonded and fused with the matrix material of the extension arm.

[0073] The time-dependent disintegration module comprises less than 30% of the bonding material and more than 70% of the time-dependent disintegration material.

[0074] The enteric disintegration module comprises less than 30% of the bonding material and more than 70% of the enteric disintegration material.

[0075] Further, the bonding material comprises one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide.

[0076] The time-dependent disintegration material comprises one or more of polylactic acid, polylactic acid-glycolic acid copolymer, polyglycolide, polycaprolactone, polyanhydride and polyorthoester.

[0077] The enteric disintegration material comprises one or more of hydroxypropyl methyl cellulose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

[0078] Further, the connecting component comprises the bonding module, the time-dependent disintegration module, the enteric disintegration module and the bonding module which are sequentially formed by three-dimensional printing or secondary injection molding, and then fused and formed.

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

[0080] In the present application, the bonding module and the disintegration module are separately arranged, which ensures that the breaking force between the extension arm and the elastic center component is more than 2.5N without affecting the mechanical properties of the disintegration module, so that the gastric retention device can remain in the stomach cavity for a sufficient time, and the bonding force between the connecting component and the extension arm mainly comes from the bonding module, the material and formula of the disintegration module can be selected in a wider range, and the continuous area continuously extends through the entire connecting component, which is beneficial to strengthen the integrity and mechanical strength of the connecting component.

[0081] The connecting component is provided by a plurality of connecting pieces, the plurality of connecting pieces are fused and bonded, which helps to improve the bonding strength of the connecting component, and the content of bonding material between adjacent connecting pieces differs by no more than 50%, so that the mechanical strength of the connecting component is ensured, and the area of stress concentration on the connecting component is avoided, and the overall breaking force of the connecting component is effectively improved.

[0082] The connecting component is provided as a disintegration module and a bonding module, the bonding module is bonded with the fixed end of the extension arm to ensure sufficient bonding force between the extension arm and the connecting component, and the bonding area of the disintegration module and the bonding module is at least 1.5S or more through the provision of the first connecting structure, so as to strengthen the effect of subsequent fusion bonding, so that the breaking force between the two is 2.5N or more, so as to ensure that the gastric retention device can be retained in the stomach for a sufficient time. BRIEF DESCRIPTION OF DRAWINGS

[0083] Figure 1 The gastric retention device in the expanded configuration is described for the specific embodiment.

[0084] Figure 2 The gastric retention device in the folded configuration is described for the specific embodiment.

[0085] Figure 3 The schematic diagram of the connecting component is described for one embodiment.

[0086] Figure 4 The schematic diagram of the connecting component is described for one embodiment.

[0087] Figure 5 The schematic diagram of the connecting component is described for one embodiment.

[0088] Figure 6 The schematic diagram of the connecting component is described for one embodiment.

[0089] Figure 7 The schematic diagram of the connecting component is described for one embodiment.

[0090] Figure 8 The schematic diagram of the connecting component is described for one embodiment.

[0091] Figure 9 The schematic diagram of the connecting component is described for one embodiment.

[0092] Figure 10 The schematic diagram of the connecting component is described for one embodiment.

[0093] Figure 11 The schematic diagram of the connecting component is described for one embodiment.

[0094] Figure 12 Perspective view of a connecting member according to an embodiment.

[0095] Figure 13 Perspective view of a connecting member according to an embodiment. Figure 12 Cross-sectional view of a connecting member along line A-A.

[0096] Figure 14 Perspective view of a connecting member according to an embodiment.

[0097] Figure 15 Perspective view of a connecting member according to an embodiment.

[0098] Figure 16 Perspective view of a connecting member according to an embodiment.

[0099] Figure 17 Perspective view of a connecting member according to an embodiment.

[0100] Figure 18 Perspective view of a connecting member according to an embodiment.

[0101] Figure 19 Perspective view of a connecting member according to an embodiment.

[0102] Figure 20 Axial cross-sectional view of a connecting member according to an embodiment.

[0103] Figure 21 Perspective view of a connecting member according to an embodiment.

[0104] Figure 22 Perspective view of a connecting member according to an embodiment. Figure 21 Schematic view of an end face of a connecting member.

[0105] Figure 23 Perspective view of a connecting member according to an embodiment.

[0106] Figure 24 Combined view of a connecting member according to an embodiment.

[0107] Figure 25 Perspective view of a connecting member according to an embodiment. Figure 24 Schematic view of a connecting member.

[0108] Figure 26 Schematic view of a breaking test device.

[0109] BRIEF DESCRIPTION OF THE DRAWINGS

[0110] 1. elastic central member

[0111] 2. elongated arm; 21. fixed end; 22. free end

[0112] 3. Connecting components; 31. Disintegration module; 311. Exposed area; 312. Through groove; 313. Time-dependent disintegration module; 314. Enteric disintegration module; 32. Adhesive module; 321. Groove; 322. Sub-module; 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. Intermediate connecting piece; 37. First connecting structure; 371. Flange; 372. Groove; 38. Second connecting structure;

[0113] 4. Fragmentation test device; 41. Fixing platform; 42. Lower pressure plate; 43. Test piece. Detailed Implementation

[0114] In the prior art, gastric retention devices are contained in a capsule shell or other container in a compressed, folded configuration, which can be swallowed by a patient or otherwise administered to the stomach for patients who cannot swallow (e.g., via a gastrostomy tube, feeding tube, gastric tube, or other route of administration to the stomach).

[0115] like Figure 1 The diagram shows the deployed configuration of the gastric retention device. (As shown) Figure 2 The diagram shows the folded configuration of the gastric retention device. The gastric retention device includes an elastic central component 1, multiple extension arms 2, and multiple connecting components 3. The multiple extension arms 2 are arranged circumferentially around the elastic central component 1, and at least one extension arm 2 is loaded with an active substance. The extension arm 2 is bonded to the elastic central component 1 through the connecting components 3.

[0116] 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 unfolded configuration. The unfolded gastric retention device is larger than the pyloric outlet of the stomach, thus preventing the gastric retention device from exiting the gastric cavity. After the gastric retention device has been retained for a sufficient time, the disintegrating material on the connecting member 3 disintegrates, allowing the device to leave the gastric cavity and enter the small intestine.

[0117] While in the stomach, the gastric retention device is compatible with other normal functions of the digestive tract. The gastric retention device does not interfere with or impede the passage of chyme (partially digested food) or other gastric contents emptied from the stomach through the pyloric sphincter into the duodenum.

[0118] In some embodiments, the extension arm 2 includes a matrix material for constituting the body of the extension arm 2, and the active substance loaded on the extension arm 2 is a therapeutic agent or a diagnostic agent.

[0119] In some embodiments, the active substance is selected from doxycycline, donepezil, ivermectin, risperidone, cetirizine, and rosuvastatin or pharmaceutically acceptable salts thereof.

[0120] The two ends of the extension arm 2 are a fixed end 21 and a free end 22, respectively, and the fixed end 21 of the extension arm 2 is bonded to the elastic center component 1 through the connecting component 3.

[0121] In the present application, the connecting component 3 is configured to separate the extension arm 2 from the elastic center component 1 or to be relatively bendable after a degradation, dissolution, dissociation or mechanical weakening process. The oral gastric retention device is transformed from the folded configuration to the unfolded configuration by the elastic force provided by the elastic center component 1.

[0122] In some embodiments, the elastic center component 1 is an elastic polymer.

[0123] In some embodiments, the elastic center component 1 includes an elastic alloy component configured to be transformed from martensite to austenite to transform the oral gastric retention device from the folded configuration to the unfolded configuration.

[0124] Compared with using an elastic polymer, using an elastic alloy component 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, so that the extension arm 2 is unfolded to form the unfolded configuration, so that the device can be retained in the stomach.

[0125] In the present application, 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 center component 1, and the second end face is bonded to the fixed end 21 of the extension arm 2.

[0126] As shown in Figures 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 face of the connecting component 3, and the bonding module 32 has a continuous area 323 continuously extending from the first end face to the second end face, the material of the bonding module 32 has good melt compatibility with the material of the extension arm 2, and the bonding module 32 is used to increase the bonding force at the bonding position of 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 or more.

[0127] In some embodiments, the material of the bonding module 32 is selected to be completely compatible or partially compatible with the matrix material of the extension arm 2 in a molten state.

[0128] In some embodiments, the material of the bonding module 32 is selected to be the same material as the matrix material of the extension arm 2, and the same material has complete melt compatibility.

[0129] 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 member 3. The area of ​​the exposed area 311 of the connecting member 3 is used to control the disintegration rate and time of the disintegration module 31, thereby achieving the function of timed disintegration or safe disintegration protection.

[0130] In a specific embodiment, the exposed area 311 of the disintegration module 31 may 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 side of the connecting component 3.

[0131] In some embodiments, the bonding module 32 occupies at least 20% of the area on the second end face. The area occupied by the bonding module 32 on the second end face is used to enhance the strength of the fusion bonding between the connecting member 3 and the extension arm 2.

[0132] In a specific embodiment, the adhesive 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 face.

[0133] In some embodiments, the bonding module 32 and / or the disintegration module 31 are uniform cross-section modules extending axially. The axial extension ensures the consistency of the mechanical strength of the connecting parts 3 in the axial direction.

[0134] like Figures 3-11 As shown in Figures 14-15, in a specific embodiment, both the bonding module 32 and the disintegration module 31 are uniform cross-section modules extending along their axial direction. The disintegration module 31 and the bonding module 32 can be circular, triangular, polygonal, or other various uniform cross-section stretched shapes. The uniform cross-section stretching in the axial direction can ensure the consistency of the mechanical strength of the connecting parts 3 in the axial direction.

[0135] like Figures 3-4 As shown, in some embodiments, the disintegration module 31 and the bonding module 32 are respectively arranged vertically or horizontally.

[0136] In some embodiments, the connecting component 3 and the extension arm 2 have the same vertical cross-section, which can be a circle, a polygon, or other shapes. In the embodiments of the present invention, the vertical cross-sections of the connecting component 3 and the extension arm 2 are triangular.

[0137] In some embodiments, the connecting component 3 includes a central module and a plurality of side modules, with the plurality of side modules circumferentially disposed on the sides of the central module.

[0138] like Figures 5-9 As shown in Figures 14-15, the central module is a disintegration module 31, the side module is an adhesive module 32, and the side of the central module has an exposed area 311 that is visible on the outer side of the side module.

[0139] like Figures 5-6 As shown in Figures 9 and 14, in the cross-sectional view of the connecting component 3, the exposed area 311 of the central module is fitted and inscribed within the surface of the outer side surface of the side module. Figures 5-6 The central module is a circle and a hexagon inscribed in the side.

[0140] like Figures 7-8 As shown in Figure 15, in the cross-sectional view of the connecting component 3, the side of the central module is not tangent to the outer side of the connecting component 3. During fabrication, multiple side modules are combined to first cover the side of the central module, and then slots 321 are opened on the side modules to expose the side of the central module, forming an exposed area 311. The size of the exposed area on the outer side of the connecting component 3 can be determined by the area of ​​the slots 321. The disintegration module 31 is located in the center, and the bonding module 32 plays a certain role in protecting and reinforcing the disintegration module 31.

[0141] like Figures 5-9 In some embodiments, the connecting component 3 may configure the disintegration module 31 as a side module and the adhesive module 32 as a center module.

[0142] like Figure 10 As shown, in some embodiments, the central module is an adhesive module 32, in which case the side modules can completely cover the sides of the central module, and the exposed area 311 of the disintegration module 31 occupies 100% of the area on the outer side of the connecting component 3.

[0143] like Figure 11 As shown, in some embodiments, the center module has an inwardly recessed mounting groove 33 on its side, and the side module is disposed within the mounting groove 33. The mounting groove 33 increases the contact area between the center module and the side module, which helps to improve the interaction effect between the center module and the side module when the connecting component 3 is fabricated.

[0144] like Figures 12-13As shown, in some embodiments, the bonding module 32 comprises two sub-modules 322 and a continuous region 323, the two sub-modules 322 are respectively located at the first end face and the second end face, the disintegration module 31 is arranged between the two sub-modules 322, the continuous region 323 is connected between the two sub-modules 322 and crosses the disintegration module 31. The disintegration module 31 has a containing structure, and the continuous region 323 crosses the containing structure. The containing structure can be a through slot 312 on the side of the disintegration module 31 or a through hole penetrating through the disintegration module 31. The cooperation of the containing structure and the continuous region 323 makes the cooperation of the disintegration module 31 and the bonding module 32 more compact.

[0145] Specifically, as shown in the figure, Figures 12-13 The containing structure is a through slot 312 on the side of the disintegration module 31. The continuous region 323 is adapted to be embedded in the through slot 312, which enhances the overall strength of the disintegration module 31 and the bonding module 32.

[0146] In some other embodiments, the second end face has a connecting structure that is engaged with the fixed end 21 of the extension arm 2, and the fixed end 21 of the extension arm 2 is fused and bonded after being engaged and positioned with the extension arm 2.

[0147] In some embodiments, the disintegration module 31 comprises a time-dependent disintegration module 313 and / or an enteric disintegration module 314.

[0148] The time-dependent disintegration module 313 weakens in strength under aqueous conditions within a predetermined time, so that the extension arm 2 is broken or bendable relative to the elastic center part 1, thereby controlling the retention time of the gastric retention device in the stomach. The weakening of the strength of the time-dependent disintegration module 313 can be gradual degradation, dissolution, dissociation or mechanical weakening over time. After a sufficient number of the extension arm 2 is broken, the gastric retention device can pass through the pyloric valve, leave the stomach cavity and enter the small intestine, and finally be excreted from the body.

[0149] 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 prematurely leaves the stomach cavity and enters the intestine, the enteric disintegration module 314 will rapidly 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 the gastric retention device easy to pass through the small intestine.

[0150] As shown in the figure, Figure 14As shown, in some embodiments, the disintegration module 31 includes a time-dependent disintegration module 313 and an enteric disintegration module 314, which are arranged axially. An adhesive 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 end face and the second end face of the connecting component 3.

[0151] The time-dependent disintegration module 313 and the enteric disintegration module 314 are arranged side by side along the axial direction. The adhesive module 32 extends axially on the side of the time-dependent disintegration module 313 and the enteric disintegration module 314. The adhesive module 32 can bond the time-dependent disintegration module 313 and the enteric disintegration module 314. Therefore, when preparing the connecting part 3, there is no need to pay special attention to the adhesive performance between the time-dependent disintegration module 313 and the enteric disintegration module 314.

[0152] like Figure 15 As shown, in some embodiments, the disintegration module 31 includes a time-dependent disintegration module 313 and an enteric disintegration module 314, which are arranged axially. During preparation, an adhesive module 32 is first formed on the outer surface 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 adhesive module 32 to form an exposed area 311 on the side of the time-dependent disintegration module 313 and the enteric disintegration module 314.

[0153] In some embodiments, the bonding module 32 includes more than 50% adhesive material, which is bonded and fused to the matrix material of the extension arm 2;

[0154] The time-dependent disintegration module 313 comprises less than 30% adhesive material and more than 70% time-dependent disintegration material;

[0155] The enteric disintegration module 314 comprises less than 30% adhesive material and more than 70% enteric disintegration material.

[0156] Both the time-dependent disintegration module 313 and the enteric disintegration module 314 contain a portion of adhesive material for fusion bonding with the adhesive module 32.

[0157] In some other embodiments, the components of the adhesive module 32, the time-dependent disintegration module 313, and the enteric disintegration module 314 may also include other additives, which may include plasticizers, solubilizers, dyes, and hydrophilic substances (such as PEG) or hydrophobic substances.

[0158] In some embodiments, the adhesive material and the matrix material of the extension arm 2 are the same.

[0159] In some embodiments, the adhesive material includes one or more of polycaprolactone (PCL), polylactic acid (PLA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (PLGA), polyhydroxyalkanoates, and modified polysaccharides; the time-dependent disintegration material includes one or more of polylactic acid (PLA), polylactic acid-glycolic acid copolymer (PLGA), polyglycolic acid PGA, polycaprolactone (PCL), polyanhydrides, and polyorthoesters (PLGA); the enteric disintegration material includes one or more of hydroxypropyl methylcellulose acetate succinate (HPMCAS), acrylate copolymers, cellulose acetate phthalate, shellac, and polyvinylacetate phthalate.

[0160] In some embodiments, the disintegration module 31 and the bonding module 32 are prepared by one or more of the following methods: melt co-extrusion, melt injection molding, compression molding, secondary sintering molding, and 3D printing.

[0161] Among them, such as Figures 3-6 , Figures 9-11 The connecting component 3 shown can be prepared by melt co-extrusion, melt injection molding, compression molding, secondary sintering molding or 3D printing.

[0162] Figures 7-8 The connecting component 3 shown is prepared by melt co-extrusion, melt injection molding, compression molding, secondary sintering or 3D printing. Then, a groove 321 is opened on the outer side of the connecting component 3 to expose the exposed area 311.

[0163] Figures 11-12 , Figures 14-15 The connecting component 3 shown can be prepared by melt injection molding, compression molding, secondary sintering molding or 3D printing.

[0164] like Figures 1-2 As shown in Figures 16-17, another aspect of the present invention discloses a gastric retention device, including an elastic central component 1, a plurality of extension arms 2 and a plurality of connecting components 3. The two ends of the extension arms 2 in the axial direction are a fixed end 21 and a free end 22, respectively. The connecting components 3 include a plurality of connecting pieces that are fused together, including at least one disintegrating connecting piece 34 and end connecting pieces 35 at both ends.

[0165] The connecting pieces each comprise a bonding material, and the percentage mass fraction difference of the bonding material between adjacent connecting pieces is not more than 50%.

[0166] The disintegrating connecting piece 34 comprises more than 60% of disintegrating material, and the end connecting piece 35 comprises more than 60% of bonding material for bonding the fixed end 21 of the elongated arm 2. The arrangement of the plurality of connecting pieces on the connecting member 3 makes the breaking force between the elongated arm 2 and the elastic central member 1 at least 2.5 N.

[0167] The disintegrating connecting piece 34 of the connecting member 3 is used for controlling the timed disintegration breaking or safety protection disintegration of the connecting member 3. When the gastric retention device enters the small intestine environment after a predetermined time of retention in the stomach or in advance, the disintegrating connecting piece 34 starts to disintegrate, so that the elongated arm 2 and the elastic central member 1 are separated.

[0168] In some embodiments, the disintegrating connecting piece 34 comprises a time-dependent disintegrating connecting piece 341 and / or an enteric disintegrating connecting piece 342.

[0169] The time-dependent disintegrating connecting piece 341 weakens in strength in an aqueous condition within a predetermined time, so that the elongated arm 2 is broken or bendable relative to the elastic central member 1, thereby controlling the retention time of the gastric retention device in the stomach. The weakening of the strength of the time-dependent disintegrating connecting piece 341 can be gradual degradation, dissolution, dissociation or mechanical weakening over time. After a sufficient number of the elongated arm 2 is broken, the gastric retention device can pass through the pyloric valve, leave the stomach cavity and enter the small intestine, and finally be excreted from the body.

[0170] 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 stomach cavity in advance and enters the intestinal tract, the enteric disintegrating module 314 will rapidly complete degradation, dissolution, dissociation or mechanical weakening according to the high pH environment of the small intestine, thereby causing the elongated arm 2 to break, avoiding intestinal obstruction, and making the gastric retention device easy to pass through the small intestine.

[0171] In some embodiments, the disintegrating connecting piece 34 comprises a time-dependent disintegrating connecting piece 341 and an enteric disintegrating connecting piece 342.

[0172] The connecting piece 3 includes at least two intermediate connecting pieces 36 located between the time-dependent disintegration connecting piece 341 and the enteric disintegration connecting piece 342. The time-dependent disintegration connecting piece 341 includes at least 60% time-dependent disintegration material, the enteric disintegration connecting piece 342 includes at least 60% enteric disintegration material, the intermediate connecting piece 36 includes at least 60% adhesive material, the intermediate connecting piece 36 adjacent to the time-dependent disintegration connecting piece 341 contains no more than 30% time-dependent disintegration material, and the intermediate connecting piece 36 adjacent to the enteric disintegration connecting piece 342 contains no more than 30% enteric disintegration material.

[0173] The time-dependent disintegration connecting piece 341 and the enteric disintegration connecting piece 342 are buffered by the intermediate connecting piece 36 to enhance the bonding strength. At the same time, the connecting pieces that are in close contact with the time-dependent disintegration connecting piece 341 and the enteric disintegration connecting piece 342 each contain a portion of the corresponding disintegration material, which makes the two more compatible in the molten state.

[0174] In some embodiments, among at least two intermediate connecting pieces 36, the intermediate connecting piece 36 closer to the time-dependent disintegration connecting piece 341 has a higher content of time-dependent disintegration material, and the intermediate connecting piece 36 closer to the enteric disintegration connecting piece 342 has a higher content of enteric disintegration material.

[0175] like Figure 17 As shown, the connecting component 3 consists of six connecting pieces, including two end connecting pieces 35 located on the end face, a time-dependent disintegration connecting piece 341, an enteric disintegration connecting piece 342, and two intermediate connecting pieces 36. The two end connecting pieces 35 are used to bond to the elastic center component 1 and the extension arm 2, respectively.

[0176] The time-dependent disintegration connector 341 comprises at least 60% time-dependent disintegration material and no more than 30% adhesive material; the intermediate connector 36, which is closely attached to the time-dependent disintegration connector 341, comprises at least 60% adhesive material and no more than 30% time-dependent disintegration material; the enteric disintegration connector 342 comprises at least 60% enteric disintegration material and no more than 30% adhesive material; and the intermediate connector 36, which is closely attached to the enteric disintegration connector 342, comprises at least 60% adhesive material and no more than 30% enteric disintegration material.

[0177] In some embodiments, the adhesive material includes one or more of polycaprolactone, polylactic acid, polyglycolic acid, polylactic-co-glycolic acid copolymer, polyhydroxyalkanoate, and modified polysaccharides; the time-dependent disintegration material includes one or more of polylactic acid, polylactic-co-glycolic acid copolymer, polyglycolic acid, polycaprolactone, polyanhydride, and polymethyl methacrylate; and the enteric disintegration material includes one or more of hydroxypropyl methylcellulose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac, and polyvinyl acetate phthalate.

[0178] In some embodiments, the adhesive material is the same as the matrix material of the extension arm 2.

[0179] In some embodiments, the adhesive materials of adjacent connecting pieces differ by no more than 40%.

[0180] In some embodiments, the thickness of each connecting piece can be 0.3-2 mm, specifically 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.

[0181] like Figures 1-2 18-25, another aspect of the present invention discloses a gastric retention device, including an elastic central component 1, a plurality of extension arms 2 and a plurality of connecting components 3. The two ends of the extension arms 2 in the axial direction are a fixed end 21 and a free end 22, respectively. The extension arms 2 include a matrix material. The connecting components 3 include a disintegration module 31 and adhesive modules 32 located on both sides of the disintegration module. The fixed end 21 and the elastic central component 1 of the extension arms 2 are respectively bonded to the adhesive modules 32 on both sides of the disintegration module. The area of ​​the vertical cross section of the connecting components 3 is S. A first connecting structure 37 is provided at the bonding joint of the disintegration module 31 and the adhesive module 32 so that the disintegration module 31 and the adhesive module 32 have a contact area of ​​at least 1.5S at the bonding joint, thereby making the breaking force between the extension arms 2 and the elastic central component 1 at least 2.5N.

[0182] In some embodiments, the first connection structure 37 includes a matching flange 371 and a groove 372, the outer side of the flange 371 contacting the inner side of the groove 372 such that the disintegration module 31 and the bonding module 32 have a contact area of ​​at least 1.5S at the bonding point. Both sides and the front side of the flange 371 are in contact with the inner side of the groove 372, effectively increasing the contact area.

[0183] In some embodiments, the flange 371 can extend in any direction, and the cross-sectional shape of the flange 371 can be triangular, trapezoidal, square, or any other shape.

[0184] In some embodiments, the flange 371 extends in a horizontal or vertical direction.

[0185] like Figure 18 As shown, in some embodiments, the first connection structure 37 includes a plurality of flanges 371 that are staggered and spaced apart on the opposite surfaces of the bonding joint of the disintegration module 31 and the bonding module 32. The gap between adjacent flanges 371 on the same side forms a groove 372. The wedge-shaped flanges 371 extend horizontally in the width direction. 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 sides of the disintegration module 31 and the opposite sides of the bonding module 32 are complementary.

[0186] In some embodiments, the maximum thickness of flange 371 is at least 0.2 mm. The thickness of flange 371 ensures the mechanical strength of the bonded module 32 and the disintegration module 31 after bonding.

[0187] 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.

[0188] In a specific embodiment, the maximum thickness of the flange 371 can be 0.2mm, 0.3mm, 0.5mm, 0.6mm, 0.8mm, 1.0mm, 1.2mm, or 1.5mm.

[0189] like Figure 19 As shown, in some embodiments, the disintegration module 31 has square flanges 371 on both sides, the flanges 371 extend horizontally in the width direction, and the flanges 371 extend horizontally to both sides of the connecting component 3. The bonding module 32 has corresponding grooves 372. Figure 9 The thickness h of the central flange 371 is at least 0.2 mm.

[0190] like Figure 20 As shown, in some embodiments, the flange 371 on the disintegration module 31 has a trapezoidal vertical cross section in the axial direction of the connecting member 3, and the maximum thickness H of the flange 371 is at least 0.2 mm.

[0191] In some embodiments, the width d1 of the flange 371 in the extending direction is d2, and the width of the connecting member 3 on the plane where the flange 371 is located is d2, where d1 ≥ 0.5d2.

[0192] In a specific embodiment of the present invention, the flange 371 extends in a horizontal direction, and the length d1 of the flange 371 in the extension direction can be 0.5d2, 0.6d2, 0.7d2, 0.8d2, 0.9d2 or d2.

[0193] like Figures 21-22As shown, in some embodiments, the disintegration module 31 has a flange 371 on its side, the flange 371 has a width d1 in the extending direction, and the connecting member 3 on the plane where the flange 371 is located has a width d2, where d1≥0.5d2.

[0194] like Figure 23 As shown, in some embodiments, the disintegration module 31 has three horizontal flanges 371 on its side, and the adhesive module 32 has grooves 372 with corresponding shapes on its corresponding side.

[0195] In some embodiments, the disintegration module 31 includes a time-dependent disintegration module 313 and / or an enteric disintegration module 314.

[0196] The time-dependent disintegration module 313 weakens in strength within a predetermined time under aqueous conditions, so that the extension arm 2 breaks or becomes flexible relative to the elastic central component 1, thereby controlling the retention time of the gastric retention device in the stomach. The weakening method 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 break, the gastric retention device can pass through the pyloric valve, leave the gastric cavity and enter the small intestine, and finally be expelled from the body.

[0197] The enteric disintegration module 314 is a pH-dependent disintegration module used to provide a safety protection mechanism for the gastric retention device. Once the gastric retention device leaves the stomach cavity in advance and enters the intestine, the enteric disintegration module 314 will rapidly 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.

[0198] In some embodiments, the disintegration module 31 includes a time-dependent disintegration module 313 and an enteric disintegration module 314, with a second connection structure 38 between the time-dependent disintegration module 313 and the enteric disintegration module 314, such that the time-dependent disintegration module 313 and the enteric disintegration module 314 have a contact area of ​​at least 5 seconds at the bonding point.

[0199] In some embodiments, the second connection structure 38 and the first connection structure 37 may have the same or different structures.

[0200] like Figures 24-25 As shown, in some specific embodiments, the connecting component 3 includes two adhesive modules 32 located at both ends and a time-dependent disintegration module 313 and an enteric disintegration module 314 located between the two.

[0201] The first connecting structure 37 and the second connecting structure 38 are the same structure, and the bonding module 32, the time-dependent disintegration module 313 and the enteric disintegration module 314 all have a plurality of wedge-shaped flanges 371 on them, the wedge-shaped flanges 371 extend horizontally in the width direction, the plurality of wedge-shaped flanges 371 are arranged in intervals from top to bottom, the intervals between the wedge-shaped flanges 371 are grooves 372, and the fixed end 21 of the extension arm 2 is in shape complementarity with the second end face of the connecting component 3.

[0202] In some embodiments, the bonding material is the same as the matrix material of the extension arm 2.

[0203] In some embodiments, the bonding module 32 includes more than 50% of the bonding material, the bonding material is bonded and fused with the matrix material of the extension arm 2; the time-dependent disintegration module 313 includes less than 30% of the bonding material and more than 70% of the time-dependent disintegration material; and the enteric disintegration module 314 includes less than 30% of the bonding material and more than 70% of the enteric disintegration material.

[0204] In some embodiments, the bonding material includes one or more of polycaprolactone, polylactic acid, polyglycolide, polylactic-glycolic acid copolymer, polyhydroxyalkanoate and modified polysaccharide; the time-dependent disintegration material includes one or more of polylactic acid, polylactic-glycolic acid copolymer, polyglycolide, polycaprolactone, polyanhydride and polyorthoester; and the enteric disintegration material includes one or more of hydroxypropyl methyl cellulose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac and polyvinyl acetate phthalate.

[0205] In some embodiments, the connecting component 3 includes the bonding module 32, the time-dependent disintegration module 313, the enteric disintegration module 314 and the bonding module 32 which are sequentially formed by three-dimensional printing or secondary injection molding, and then fused and formed.

[0206] Preferably, the connecting component 3 is formed by 3D printing, and then fused and formed, and the number and size of the flanges 371 on the first connecting structure 37 and the second connecting structure 38 can be flexibly set by using 3D printing, thereby increasing the contact area between the disintegration module 31 and the bonding module 32.

[0207] In the present application, the firmness of the extension arm 2, the connecting component 3 and the elastic center component 1 is determined by the breaking / 90° bending test, and the specific process is as follows:

[0208] After a single extension arm 2 is fused and bonded with the connecting component 3 and the elastic center component 1, a test piece 43 is formed, as shown in Figure 26As shown, the test is performed using a break test device 4, which includes a fixed table 41 and a lower pressing plate 42. After the elastic central component 1 is fixed by the fixed table 41, the lower pressing plate 42 presses the free end 22 of the elongated arm 2, and the pressing force is tested when the elongated arm 2 is broken or bent by 90° relative to the elastic central component 1.

[0209] In order to fully simulate the environment of the gastric retention device in the stomach, the test piece 43 is soaked in simulated gastric juice with a pH of 1.2 for 0d (days), 7d (days), and 10d (days), respectively. The test piece 43 is soaked for 2h in 0d, and then the break / 90° bending test is performed. The force fed back on the lower pressing plate 42 during the test is recorded as F0, F7, and F10, respectively.

[0210] During the test, generally, at 0d, the disintegration material has not been fully dissolved, and the test is first performed by breaking. At this time, F0 measured is the breaking force between the elongated arm 2 and the elastic central component 1. After being soaked for 7d and 10d, the disintegration material is dissolved, and the connecting component 3 has a certain softness. At this time, F7 and F10 measured are the pressing forces when the elongated arm 2 is bent by 90° relative to the elastic central component 1.

[0211] In the present application, the breaking force between the elongated arm 2 and the elastic central component 1 is 2.5N or more at 0d, so that the gastric retention device can resist the peristaltic pressure of the stomach in the stomach cavity, maintain the unfolded configuration, and avoid the gastric retention device being discharged too early.

[0212] In other embodiments, the breaking force between the elongated arm 2 and the elastic central component 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 at 0d.

[0213] In order to describe the technical content, structural features, and purposes and effects of the technical scheme in detail, the following will be described in detail in combination with specific embodiments and the accompanying drawings.

[0214] Embodiment 1

[0215] The present embodiment provides a gastric retention device, which includes an elastic central component 1, six elongated 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 elongated arm 2 is prepared using polycaprolactone.

[0216] As shown in FIG. 1, the gastric retention device includes an elastic central component 1, six elongated arms 2, and six connecting components 3. Figure 8As shown, the connecting component 3 comprises a time-dependent disintegration module 313 and a bonding module 32, and the volume ratio of the time-dependent disintegration module 313 and the bonding module 32 is 4:1, and at this time, the bonding module 32 occupies 20% of the area of the second end face.

[0217] The time-dependent disintegration module 313 comprises 20% polycaprolactone and 80% polylactic acid-glycolic acid copolymer, and the bonding module 32 is 100% polycaprolactone.

[0218] In the preparation, the connecting component 3 is prepared by melt injection molding. The time-dependent disintegration material is first mixed and melt injected into a first mold to form the time-dependent disintegration module 313. Then, the time-dependent disintegration module 313 is placed into a second mold, and the bonding material is injected. After molding, the bonding material covers the outer side of the time-dependent disintegration module 313. Finally, a slot 321 is opened on the side to remove part of the bonding material to expose the side of the central time-dependent disintegration module 313. In this embodiment, the exposed area 311 of the time-dependent disintegration module 313 occupies 30% of the outer side.

[0219] Example 2-4

[0220] This embodiment provides a gastric retention device, which is different from Example 1 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.

[0221] Comparative Example 1

[0222] 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, and is completely mixed and then melt injection molded to form the connecting component.

[0223] Comparative Example 2

[0224] A gastric retention device, which is different from Example 1 in that the connecting component comprises two bonding modules, and the time-dependent disintegration module is located between the two bonding modules. The time-dependent disintegration module comprises 20% polycaprolactone and 80% polylactic acid-glycolic acid copolymer, and the bonding module is 100% polycaprolactone. The structure is as shown in Figure 16 As shown, the components of the time-dependent disintegration module and the bonding module are the same as in Example 1.

[0225] Comparative Example 3

[0226] A gastric retention device, which is different from Example 1 in that the bonding module occupies 15% of the area of the second end face by controlling the volume ratio of the time-dependent disintegration module and the bonding module.

[0227] Example 5

[0228] As Figure 15 In this embodiment, a gastric residence device is provided, which is different from that of embodiment 1 in that the center module comprises a time-dependent disintegration module 313 and an enteric disintegration module 314 which are sequentially formed, wherein the enteric disintegration module 314 comprises 20% polycaprolactone and 80% hydroxypropyl methyl cellulose acetate succinate.

[0229] Comparative Example 4

[0230] This comparative example provides a gastric residence device, two adhesive modules, a time-dependent disintegration module and an enteric disintegration module with the same components as in embodiment 5 are prepared, sequentially melt-bonded to prepare a connecting component in the order of adhesive module, time-dependent disintegration module, enteric disintegration module, adhesive module, and then the gastric residence device is prepared.

[0231] The test pieces prepared according to the schemes of embodiments 1-5 and comparative examples 1-4 are subjected to breakage / 90° bending tests, and the breaking force and bending pressure at 90° bending are recorded.

[0232] The bending test results are shown in Table 1 below.

[0233] Wherein, A is the area of the adhesive module occupying the second end surface, B is the area of the exposed region occupying the side surface of the connecting component, and the positions on the test piece during the breakage test are as follows: the connecting component body, denoted as W1; the adhesive joint between the connecting component end surface and the extension arm, denoted as W2; the adhesive joint between the time-dependent disintegration module and the adhesive module, denoted as W3; and the adhesive joint between the time-dependent disintegration module and the enteric disintegration module, denoted as W4.

[0234] Table 1: Breakage / 90° bending test results.

[0235] Scheme A(％) B(％) [F0(N)] Breaking point [F7(N)] F 10 (N)]]> Example 1 20 30 4.7 W1 2.1N 1.5 Example 2 30 30 5.6 W1 2.2 1.6 Example 3 40 30 6.1 W1 2.5 1.8 Example 4 50 30 6.5 W1 2.7 2.0 Example 5 30 30 4.4 W4 2.0 - Comparative Example 1 — — 2.3 W2 - - Comparative Example 2 100 30 1.7 W3 - - Comparative Example 3 15 30 2.1 W2 - - Comparative Example 4 100 30 1.2 W4 - -

[0236] As can be seen from Table 1, in the connecting component 3 with equal cross-section extension, the area occupied by the adhesive module 32 has a greater impact on the breaking force and bending pressure of the connecting component 3, and the higher the volume ratio of the adhesive module 32, the higher the breaking force. As can be seen from the comparison between embodiment 1 and comparative example 1, in the connecting component 3 with the same component content, embodiment 1 has a separate adhesive module 32 with adhesive material greater than 50%, which greatly strengthens the adhesion of the adhesive joint and increases the breaking force. As can be seen from the comparison between embodiment 1 and comparative example 2, in embodiment 1, the adhesive module 32 has a continuous region 323 extending continuously on the connecting component 3, so that the connecting component 3 of embodiment 1 has a higher breaking force in the breakage test. As can be seen from the comparison between embodiment 5 and comparative example 4, in embodiment 5, the two adhesive modules 32 have a continuous region 323 from the first end surface to the second end surface, which improves the overall mechanical strength of the connecting component 3 and also improves the adhesion effect of the time-dependent disintegration module 313 and the enteric disintegration module 314.

[0237] Example 6

[0238] The present example provides a gastric residence device comprising a resilient central member 1, six elongated arms 2 and six connecting members 3, the resilient central member 1 comprising a central resilient metal and a TPU polymer outer layer surrounding the central resilient metal, the elongated arms 2 being made of polycaprolactone.

[0239] As shown in Figure 16 connecting members 3 comprise a time-dependent disintegration connecting piece 341 and two end connecting pieces 35, the time-dependent disintegration connecting piece 341 being located between the two end connecting pieces 35.

[0240] The time-dependent disintegration 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.

[0241] In the preparation, the materials of different connecting pieces are separated, mixed, melt-extruded to form plastic strips, and then the plastic strips are cut into connecting pieces of corresponding thicknesses by a slicing device, and then melt-bonded.

[0242] Example 7

[0243] The present example provides a gastric residence device, which is different from Example 6 in that the time-dependent disintegration connecting piece 341 comprises 30% polycaprolactone, 60% polylactic acid-glycolic acid copolymer and 10% additive, and the end connecting piece 35 comprises 60% polycaprolactone, 30% polylactic acid-glycolic acid copolymer and 10% additive.

[0244] Example 8

[0245] The present example provides a gastric residence device, which is different from Example 6 in that the time-dependent disintegration connecting piece 341 comprises 40% polycaprolactone and 60% polylactic acid-glycolic acid copolymer, and the end connecting piece 35 comprises 60% polycaprolactone and 40% polylactic acid-glycolic acid copolymer.

[0246] Example 9

[0247] The present example provides a gastric residence device, which is different from Example 6 in that the time-dependent disintegration connecting piece 341 comprises 20% polycaprolactone, 70% polylactic acid-glycolic acid copolymer and 10% additive, and the end connecting piece 35 comprises 70% polycaprolactone, 20% polylactic acid-glycolic acid copolymer and 10% additive.

[0248] Example 10

[0249] The present example provides a gastric residence device, which is different from Example 6 in that, asFigure 17 As shown, the connecting member 3 is composed of six connecting pieces fused and bonded together in the order of a first end connecting piece 35, a time-dependent disintegration connecting piece 341, a first middle connecting piece 36, a second middle connecting piece 36, an enteric disintegration connecting piece 342, and a second end connecting piece.

[0250] The material compositions of the different connecting pieces are as follows:

[0251] The first end connecting piece 35: 70% polycaprolactone and 30% polylactic acid-glycolic acid copolymer;

[0252] The time-dependent disintegration connecting piece 341: 30% polycaprolactone and 70% polylactic acid-glycolic acid copolymer;

[0253] The first middle connecting piece 36: 70% polycaprolactone and 30% polylactic acid-glycolic acid copolymer;

[0254] The second middle connecting piece 36: 70% polycaprolactone and 30% hydroxypropyl methylcellulose acetate succinate;

[0255] The enteric disintegration connecting piece 342: 30% polycaprolactone and 70% hydroxypropyl methylcellulose acetate succinate;

[0256] The second end connecting piece 35: 70% polycaprolactone and 30% hydroxypropyl methylcellulose acetate succinate.

[0257] Comparative Example 5

[0258] This comparative example provides a gastric residence device, which is different from Example 6 in that:

[0259] wherein the time-dependent disintegration connecting piece comprises 30% polycaprolactone and 70% polylactic acid-glycolic acid copolymer, and the end connecting piece comprises 90% polycaprolactone and 10% polylactic acid-glycolic acid copolymer.

[0260] The test pieces prepared according to the schemes of Examples 6-10 and Comparative Examples 2, 4, and 5 were subjected to breakage / 90° bending tests, and the breaking force and bending pressure at 90° bending were recorded,

[0261] The results are shown in Table 2 below.

[0262] Table 2. Breakage / 90° bending test results.

[0263] Scheme C (tablet) D(％) [F0(N)] Breaking point [F7(N)] F 10 (N)]]> Example 6 3 40 3.3 E1 2.2 - Example 7 3 30 3.7 E1 3.1 2.1 Example 8 3 20 4.3 E1 3.5 2.3 Example 9 3 50 3.1 E1 2.1 - Example 10 6 40 3.5 E3 2.3 - Comparative Example 2 3 80 1.7 E1 - - Comparative Example 4 4 80 1.2 E4 - - Comparative Example 5 3 60 2.3 E1 - -

[0264] Wherein, C is the number of connecting pieces; D is the maximum difference of the content of the adhesive material between adjacent connecting pieces. For example, in Example 6, the time-dependent disintegration connecting piece contains 30% polycaprolactone, and the terminal connecting piece contains 70% polycaprolactone, so D = 70% - 30% = 40%. The positions on the test piece: the adhesive joint of the time-dependent disintegration connecting piece and the terminal connecting piece, marked as E1; the adhesive joint of the terminal connecting piece and the extension arm, marked as E2; the adhesive joint of the enteric disintegration connecting piece and the intermediate connecting piece or the terminal connecting piece, marked as E3; the adhesive joint of the enteric disintegration connecting piece and the time-dependent disintegration connecting piece, marked as E4.

[0265] As can be seen from Examples 6-9 and Comparative Example 2, the smaller the difference in the content of the adhesive material between adjacent connecting pieces, the better the effect of the adhesion. As can be seen from the comparison between Example 10 and Comparative Example 4, the two intermediate connecting pieces 36 arranged between the time-dependent disintegration connecting piece 341 and the enteric disintegration connecting piece 342 make the time-dependent disintegration connecting piece 341 and the enteric disintegration connecting piece 342 have a good adhesion effect, thereby improving the breaking force of the connecting component 3.

[0266] Example 11

[0267] This example provides a gastric retention device, which comprises an elastic central component, six extension arms and six connecting components. The elastic central component comprises a central elastic metal and a TPU polymer outer layer wrapping the central elastic metal, and the extension arms are made of polycaprolactone.

[0268] As shown in Figure 19 , the shape of the vertical section of the connecting component 3 is a triangle similar to an equilateral triangle, and the side length of the triangle is 3.3 mm. The connecting component 3 comprises an enteric disintegration module 314 and an adhesive module 32. The two side edges of the enteric disintegration module 314 are provided with flanges 371. The thickness h of the flanges 371 is 0.2 mm, and the width d is 1 mm. By controlling the length L of the flanges 371 protruding forward, the side surface of the enteric disintegration module 314 has a surface area of 1.5S.

[0269] Wherein, the enteric disintegration module 314 comprises 20% polycaprolactone and 80% hydroxypropyl methyl cellulose acetate succinate, and the adhesive module 32 is 100% polycaprolactone.

[0270] Example 12

[0271] The difference from Example 11 is that, as shown in Figure 23As shown, the connecting component 3 comprises an enteric disintegration module 314 and an adhesive module 32, and the two side edges of the enteric disintegration module 314 are provided with three flanges 371, each with a thickness of 0.2 mm. The length and width of the flanges 371 are set to make the enteric disintegration module 314 have a contact area of 3S with the occupying side of the occupying module. Figure 23 Only the flanges 371 on a single side of the enteric disintegration module 314 are shown in the figure.

[0272] Example 13

[0273] The difference from Example 11 is that, as shown, the connecting component 3 comprises an adhesive module 32, a time-dependent disintegration module 313, an enteric disintegration module 314, and an adhesive module 32 in sequence. Figures 24-25

[0274] The time-dependent disintegration module 313 and the enteric disintegration module 314 are each provided with a plurality of flanges 371 arranged at intervals on the opposite sides, and the inner sides of the two adhesive modules 32 are provided with flanges 371. The flanges 371 on the opposite sides are arranged in staggered and intersecting manner.

[0275] The time-dependent disintegration module 313 comprises 20% polycaprolactone and 80% polylactic acid-glycolic acid copolymer.

[0276] In this embodiment, the connecting component 3 has a small volume, and the entire connecting component 3 can be formed by 3D printing equipment. After 3D printing, the connecting component 3 is heated and melted to further improve the adhesion between the modules.

[0277] The 3D printing equipment can flexibly set the structure and form of the flanges 371. In this embodiment, as shown, the contact area of the first connecting structure 37 and the second connecting structure 38 can be set to 5S by computer. Figures 24-25

[0278] Comparative Example 6

[0279] A gastric retention device, different from Example 11 is that: no flanges are arranged on the side of the enteric disintegration module, and the contact and adhesion area of the adhesive module and the enteric disintegration module is S.

[0280] Comparative Example 7

[0281] A gastric retention device, different from Example 13 is that: the second connecting structure between the enteric disintegration module and the time-dependent disintegration module is set to make the contact area of the enteric disintegration module and the time-dependent disintegration module be 3S, and the first connecting structure is the same as that of Example 13.

[0282] ​​The test pieces prepared according to the schemes of Examples 11-13 and Comparative Examples 4, 6, 7 were subjected to the breaking / 90° bending test, and the breaking force and the bending pressure at 90° bending were recorded, with the results shown in Table 3 below.

[0283] Table 3. Breaking / 90° bending test results.

[0284] S1 S2 [F0(N)] Breaking point [F7(N)] F 10 (N)]]> Example 11 1.5S - 2.7 F1 2.1 - Example 12 3S - 4.7 F1 3.2 2.2 Comparative Example 6 S - 1.4 F1 - - Example 13 5S 5S 6.7 F1 3.8 2.4 Comparative Example 7 Comparative Example 8 5S 3S 2.5 F3 - -

[0285] Wherein S1 represents the contact area of the enteric disintegration module and the adhesive module, S2 is the contact area of the enteric disintegration module and the time-dependent disintegration module, the position on the test piece: the adhesive joint of the enteric disintegration module and the adhesive module, denoted as F1; the adhesive joint of the adhesive module and the extension arm, denoted as F2; the adhesive joint of the enteric disintegration module and the time-dependent disintegration module, denoted as F3.

[0286] The test piece 43 made of the connecting component 3 of Comparative Example 7 broke and separated between the enteric disintegration module 314 and the time-dependent disintegration module 313 of the connecting component 3 on the 3rd day of immersion in simulated gastric fluid.

[0287] As can be seen from the comparison of Examples 11-12 and Comparative Example 6, the provision of the flange 371 on the connecting component 3 can effectively enhance the adhesive effect of the disintegration module and the adhesive module 32, and improve the mechanical strength.

[0288] As can be seen from the comparison of Example 13 and Comparative Example 7, the increase in the adhesive area between the time-dependent disintegration module 313 and the enteric disintegration module 314 through the flange 371 can enable the two to be firmly connected even in the case of a large difference in composition.

[0289] It should be noted that, in the present text, relational terms such as first and second are used only to distinguish one entity or operation from another, and do not necessarily require or imply that there is any such actual relationship or order between these entities or operations. Moreover, the terms “include”, “contain” or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or terminal device including a series of elements not only includes those elements, but also includes other elements not explicitly listed or inherent to such a process, method, article or terminal device. Without further limitation, the elements defined by the statement “include” or “contain” do not exclude the presence of additional elements in the process, method, article or terminal device including the elements. In addition, in the present text, “greater than”, “less than”, “exceed” and the like are understood as not including the number itself; “above”, “below”, “within” and the like are understood as including the number itself.

[0290] Although the above-mentioned embodiments have been described, those skilled in the art can make further changes and modifications to the embodiments once they know the basic inventive concept, and therefore the above-mentioned embodiments are only examples of the present application, and are not intended to limit the patent protection scope of the present application, and any equivalent structure or equivalent process transformation made by using the content of the present application specification and drawings, or directly or indirectly applied to other related technical fields, are also included in the patent protection scope of the present application.

Claims

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

2. The gastric retention device according to claim 1, characterized in that, 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, characterized in that, The bonding module occupies at least 20% of the area on the second end face.

4. The gastric retention device according to claim 1, characterized in that, The bonding module and / or disintegration module are equal-section modules extending along their axial direction.

5. The gastric retention device according to claim 4, characterized in that, The connecting component includes a central module and multiple side modules, with the multiple side modules circumferentially arranged on the sides of the central module. The combination of the disintegration module and the bonding module can be one of the following methods: (A) The disintegration module is a central module, the bonding module is a side module, and the central module has the exposed area that is 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, characterized in that, In method (A), the exposed area is exposed on the outer side of the connecting member in one of the following ways: (1) The exposed area of ​​the central module is attached to the outer side surface of the side module; (2) When the multiple side modules are prepared, they completely cover the side of the central module. Then, slots are opened on the side modules to expose the side of the central module and form the exposed area.

7. The gastric retention device according to claim 5, characterized in that, The central module has an inwardly recessed mounting groove on its side, and the side module is disposed in the mounting groove.

8. The gastric retention device according to claim 1, characterized in that, The bonding module includes two sub-modules and the continuous region. The two sub-modules are located on the first end face and the second end face, respectively. The disintegration module is disposed between the two sub-modules, and the two sub-modules are connected by the continuous region.

9. The gastric retention device according to claim 8, characterized in that, The disintegration module has a containment structure, and the continuous region traverses the containment structure.

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

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

12. The gastric retention device according to claim 11, characterized in that, The bonding module comprises more than 50% adhesive material; The time-dependent disintegration module comprises less than 30% adhesive material and more than 70% time-dependent disintegration material; The enteric disintegration module comprises less than 30% adhesive material and more than 70% enteric disintegration material.

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

14. The gastric retention device according to claim 12, characterized in that, The adhesive material includes one or more of polycaprolactone, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxy fatty acid ester, and modified polysaccharides; The time-dependent disintegrating material includes one or more of polylactic acid, polylactic acid-glycolic acid copolymer, polyglycolic acid, polycaprolactone, polyanhydride, and polyoxyethylene ester; The enteric disintegrating material includes one or more of hydroxypropyl methylcellulose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac, and polyvinyl acetate phthalate.

15. The gastric retention device according to claim 1, characterized in that, The connecting component is prepared by one or more of the following methods: melt co-extrusion, melt injection molding, compression molding, secondary sintering molding, and 3D printing.

16. A gastric retention device, characterized in that, include: Elastic central component; Multiple extension arms, wherein the two ends of the extension arms in the axial direction are a fixed end and a free end, respectively; Multiple connecting components, each comprising multiple phase-fused connecting pieces, including at least one disintegrating connecting piece and end connecting pieces at both ends. Each of the connecting pieces contains adhesive material, and the difference in the mass fraction percentage of adhesive material between adjacent connecting pieces does not exceed 50%. The disintegrating connecting piece contains more than 60% disintegrating material; The end connecting piece comprises more than 60% 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, characterized in that, The disintegration linker includes time-dependent disintegration linkers and / or enteric disintegration linkers.

18. The gastric retention device according to claim 17, characterized in that, The disintegration linkers include time-dependent disintegration linkers and enteric disintegration linkers. The connecting component also includes at least two intermediate connecting pieces located between the time-dependent disintegration connecting piece and the enteric disintegration connecting piece. The time-dependent disintegration connector comprises at least 60% time-dependent disintegration material. The enteric-disintegrating connective tissue comprises at least 60% enteric-disintegrating material. The intermediate connecting piece includes at least 60% adhesive material. The intermediate linker adjacent to the time-dependent disintegration linker contains no more than 30% time-dependent disintegration material, and the intermediate linker adjacent to the enteric disintegration linker contains no more than 30% enteric disintegration material.

19. The gastric retention device according to claim 18, characterized in that, Of the at least two intermediate connecting pieces, the intermediate connecting piece closer to the time-dependent disintegration connecting piece has a higher content of time-dependent disintegration material, and the intermediate connecting piece closer to the enteric disintegration connecting piece has a higher content of enteric disintegration material.

20. The gastric retention device according to claim 18, characterized in that, The adhesive material includes one or more of polycaprolactone, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxy fatty acid ester, and modified polysaccharides; The time-dependent disintegrating material includes one or more of polylactic acid, polylactic acid-glycolic acid copolymer, polyglycolic acid, polycaprolactone, polyanhydride, and polyoxyethylene ester; The enteric disintegrating material includes one or more of hydroxypropyl methylcellulose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac, and polyvinyl acetate phthalate.

21. The gastric retention device according to claim 16, characterized in that, The adhesive material is the same as the matrix material of the extension arm.

22. The gastric retention device according to claim 16, characterized in that, In adjacent connecting pieces, the adhesive material differs by no more than 40%.

23. A gastric retention device, characterized in that, include: Elastic central component; Multiple extension arms, wherein the two ends of the extension arms in the axial direction are a fixed end and a free end, respectively; Multiple connecting components are provided, each including a disintegration module and adhesive 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 adhesive modules on both sides of the disintegration module. The vertical cross-sectional area of ​​the connecting component is S. A first connecting structure is provided at the bonding joint between the disintegration module and the adhesive module. The first connecting structure is used to ensure that the disintegration module and the adhesive module have a contact area of ​​at least 1.5S at the bonding joint, thereby ensuring that the breaking force between the extension arm and the elastic center component is at least 2.5N.

24. The gastric retention device according to claim 23, characterized in that, 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 according to claim 24, characterized in that, The flange extends in either a horizontal or vertical direction.

26. The gastric retention device according to claim 24, characterized in that, The maximum thickness of the flange is at least 0.2 mm.

27. The gastric retention device according to claim 24, characterized in that, The flange has a width d1 in the extending direction, and the connecting component of the plane where the flange is located has a width d2, wherein d1 ≥ 0.5d2.

28. The gastric retention device according to claim 24, characterized in that, 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 gap between adjacent flanges on the same side forms the groove.

29. The gastric retention device according to claim 23, characterized in that, The disintegration module includes a time-dependent disintegration module and / or an enteric disintegration module.

30. The gastric retention device according to claim 29, characterized in that, The disintegration module includes a time-dependent disintegration module and an enteric disintegration module, and 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 5 seconds at the bonding point.

31. The gastric retention device according to claim 30, characterized in that, The second connection structure may be the same as or different from the first connection structure.

32. The gastric retention device according to claim 30, characterized in that, The bonding module comprises more than 50% adhesive material, which is bonded and fused to the matrix material of the extension arm; The time-dependent disintegration module comprises less than 30% adhesive material and more than 70% time-dependent disintegration material; The enteric disintegration module comprises less than 30% adhesive material and more than 70% enteric disintegration material.

33. The gastric retention device according to claim 32, characterized in that, The adhesive material is the same as the matrix material of the extension arm.

34. The gastric retention device according to claim 33, characterized in that, The adhesive material includes one or more of polycaprolactone, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxy fatty acid ester, and modified polysaccharides; The time-dependent disintegrating material includes one or more of polylactic acid, polylactic acid-glycolic acid copolymer, polyglycolic acid, polycaprolactone, polyanhydride, and polyoxyethylene ester; The enteric disintegrating material includes one or more of hydroxypropyl methylcellulose acetate succinate, acrylate copolymer, cellulose acetate phthalate, shellac, and polyvinyl acetate phthalate.

35. The gastric retention device according to claim 30, characterized in that, The connecting component is first formed sequentially by 3D printing or secondary injection molding of the bonding module, time-dependent disintegration module, enteric disintegration module and bonding module, and then melt-molded.

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