Gastric retention device for oral administration

Abstract

The present invention relates to a gastric administration device, and discloses a gastric retention device for oral administration, comprising a resilient center comprising a plurality of alloy members and at least one fixing portion, the plurality of alloy members being connected at the fixing portion, the plurality of alloy members together forming at least three ribs, the ribs are fixed in the polymer outer surface layer; at least one extension arm is a medicine carrying arm, and the medicine carrying arm is loaded with an active substance; each of the plurality of extension arms is connected to the elastic center via a connecting member; the gastric retention device comprises a folded configuration and an unfolded configuration, the gastric retention device is converted between the folded configuration and the unfolded configuration due to elastic deformation or phase change of the elastic center, and the connecting component is degraded, dissolved, dissociated or mechanically weakened, so that the gastric retention device loses the shape of the unfolded configuration. Through the structural design of the alloy part, the mechanical strength of the elastic center is effectively improved.

Description

Technical Field

[0001] The present invention relates to a gastric drug delivery device, in particular to a gastric retention device for oral drug delivery. Background Art

[0002] The gastric retention device is designed to be administered into the patient's stomach, usually in the form of a capsule that is swallowed or introduced into the stomach through other methods of administration (e.g., a feeding tube or a gastric tube). After the capsule in the stomach dissolves, the gastric retention device expands or unfolds to a certain size, which is retained in the stomach and resists passing through the pyloric sphincter during the required residence period (e.g., three days, seven days, two weeks, etc.). This requires maintaining mechanical stability during the required residence period while releasing one or more active drugs, and the gastric retention device should be discharged from the stomach at the end of the required residence time and easily discharged from the patient's body. At present, the gastric retention device is usually provided with a connecting component that undergoes a strength weakening process such as degradation, dissolution, dissociation or mechanical weakening in the gastric environment, so that part of the expansion arm is separated from the elastic central component or the expansion arm can be folded relative to the elastic central component in the gastrointestinal tract, and finally the elastic central component and the expansion arm can be discharged from the body.

[0003] During storage, the current gastric retention devices are in a folded state, with stress concentration in the elastic center and low creep resistance in the elastic center, which shortens the effective storage period of the gastric retention devices. Furthermore, after entering the gastric cavity, the gastric retention devices are difficult to remain in the stomach for a long time. Summary of the invention

[0004] Therefore, it is necessary to provide a gastric retention device for oral administration to solve the problem that the mechanical strength of the gastric retention device is too weak.

[0005] To achieve the above object, the present invention provides a gastric retention device for oral administration, comprising:

[0006] an elastic center, the elastic center comprising a plurality of alloy pieces and at least one fixing portion, the plurality of alloy pieces being connected at the fixing portion, the plurality of alloy pieces together forming at least three ribs, the ribs being fixed in the polymer outer layer;

[0007] A plurality of extension arms, at least one of which is a drug-carrying arm, wherein the drug-carrying arm is loaded with an active substance,

[0008] a plurality of connecting parts, each of the plurality of extension arms is connected to the elastic center via a connecting part,

[0009] The gastric retention device includes a folded configuration and an expanded configuration, the elastic center undergoes elastic deformation or phase change so that the gastric retention device is converted between the folded configuration and the expanded configuration, and the connecting component is degraded, dissolved, dissociated or mechanically weakened, thereby causing the gastric retention device to lose the shape of the expanded configuration.

[0010] In some embodiments, the alloy piece has a bending angle, two ends of the bending angle of the alloy piece form ribs respectively, and the bending angles of multiple alloy pieces are overlapped and fixed to form the fixing portion.

[0011] In some embodiments, one end of the alloy piece is fixed to the fixing portion, and the other end of the alloy piece extends outward to form the rib.

[0012] In some embodiments, the plurality of alloy members are welded, bonded with adhesives or fasteners to form a fixed portion.

[0013] In some embodiments, the ends of the ribs have connectors for connecting the ribs to the polymer outer layer.

[0014] In some embodiments, the connector is selected from protrusions, hooks, or any other structure capable of interlocking with the polymeric outer layer.

[0015] Another aspect of the present invention provides a gastric retention device for oral administration, comprising:

[0016] a resilient core, the resilient core comprising a single alloy piece, the single alloy piece forming at least three ribs, the ribs being fixed within the polymer outer layer;

[0017] A plurality of extension arms, at least one of which is a drug-carrying arm, wherein the drug-carrying arm is loaded with an active substance,

[0018] a plurality of connecting parts, each of the plurality of extension arms is connected to the elastic center via a connecting part,

[0019] The gastric retention device includes a folded configuration and an expanded configuration, and the elastic center undergoes elastic deformation or phase change so that the gastric retention device is converted between the folded configuration and the expanded configuration.

[0020] The connecting components degrade, dissolve, dissociate, or mechanically weaken, thereby causing the gastric retention device to lose the shape of the deployed configuration.

[0021] In some embodiments, the center of the alloy piece extends outward to form a rib.

[0022] In some embodiments, the alloy member is an alloy wire, and a single alloy wire is formed to form all the ribs.

[0023] In some embodiments, the ends of the ribs have connectors for connecting the ribs to the polymer outer layer.

[0024] In some embodiments, the connector is selected from protrusions, hooks, or any other structure capable of interlocking with the polymeric outer layer.

[0025] Another aspect of the present invention provides a gastric retention device for oral administration, comprising:

[0026] An elastic center, the elastic center includes a plurality of alloy pieces, each of the alloy pieces is shaped to form at least one rib, a plurality of the alloy pieces are connected to form a total of at least three ribs, and the ribs are fixed in the polymer outer layer;

[0027] A plurality of extension arms, at least one of which is a drug-carrying arm, wherein the drug-carrying arm is loaded with an active substance,

[0028] a plurality of connecting parts, each of the plurality of extension arms is connected to the elastic center via a connecting part,

[0029] The gastric retention device includes a folded configuration and an expanded configuration, and the elastic center undergoes elastic deformation or phase change so that the gastric retention device is converted between the folded configuration and the expanded configuration.

[0030] The connecting components degrade, dissolve, dissociate, or mechanically weaken, thereby causing the gastric retention device to lose the shape of the deployed configuration.

[0031] In some embodiments, the alloy piece is an alloy wire, a single alloy wire is shaped to form at least one rib, and a plurality of alloy wires are interconnected to form the elastic center.

[0032] In some embodiments, the ends of the ribs have connectors for connecting the ribs to the polymer outer layer.

[0033] In some embodiments, the connector is selected from protrusions, hooks, or any other structure capable of interlocking with the polymeric outer layer.

[0034] Another aspect of the present invention provides a gastric retention device for oral administration, comprising:

[0035] An elastic center, the elastic center includes a plurality of alloy pieces, the alloy pieces are bent to form two branches, the two branches of every two alloy pieces constitute the rib, the plurality of alloy pieces together form at least three ribs, and the two branches of the alloy pieces of each rib are fixed in the polymer outer layer;

[0036] A plurality of extension arms, at least one of which is a drug-carrying arm, wherein the drug-carrying arm is loaded with an active substance,

[0037] a plurality of connecting parts, each of the plurality of extension arms is connected to the elastic center via a connecting part,

[0038] The gastric retention device includes a folded configuration and an expanded configuration, and the elastic center undergoes elastic deformation or phase change so that the gastric retention device is converted between the folded configuration and the expanded configuration.

[0039] The connecting component degrades, dissolves, dissociates, or mechanically weakens, thereby causing the gastric retention device to lose the shape of the deployed configuration.

[0040] In some embodiments, the ends of the ribs have connectors for connecting the ribs to the polymer outer layer.

[0041] In some embodiments, the connector is selected from protrusions, hooks, or any other structure capable of interlocking with the polymeric outer layer.

[0042] Another aspect of the present invention provides a use of a gastric retention device for oral administration, wherein the gastric retention device is used for preparing a gastric retention device having an effective storage period of at least 6 months.

[0043] In some embodiments, the gastric retention device has an effective shelf life of at least 12 months.

[0044] In some embodiments, the gastric retention device has an effective shelf life of at least 24 months.

[0045] The above technical solution has the following beneficial effects:

[0046] On the one hand, the present invention has an elastic center composed of multiple alloy parts, and the fixing part can quickly complete the positioning and fixation of the alloy parts. The ribs of the elastic center can be formed by bending or radially extending the alloy parts. The use of multiple alloy parts effectively enhances the mechanical strength of the elastic center, which is beneficial to improving the retention time of the gastric retention device.

[0047] On the other hand, the elastic center of the present invention can be composed of a single alloy piece, and the single alloy piece can extend from the center to the circumference to form multiple ribs to ensure the consistency of mechanical strength of the multiple ribs of the elastic center. The elastic center can also be formed by folding a single alloy wire.

[0048] On the other hand, in the elastic center of the present invention, each rib can be composed of branches of two different alloy parts and fixed by a polymer outer layer. When a rib is folded by external force, the two independent alloy parts jointly bear the external force, effectively improving the mechanical strength of the elastic center. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figure 1A Shown is a schematic diagram of the gastric retention device of Example 1 in an expanded configuration.

[0050] Figure 1B Shown Figure 1A Schematic diagram of a gastric retention device in a folded configuration.

[0051] Figure 1C Shown Figure 1A Schematic diagram of a gastric retention device in a storage configuration.

[0052] Figure 1D Shown Figure 1B Schematic diagram of the alloy part in the elastic center.

[0053] Figure 2 Shown is a schematic diagram of the alloy part in Example 2.

[0054] Figure 3A Shown is a schematic diagram of an unassembled alloy member in Example 3.

[0055] Figure 3B Shown is a schematic diagram of the alloy part in Example 3.

[0056] Figure 4A Shown is a schematic diagram of the alloy part in Example 4.

[0057] Figure 4B Shown is a schematic diagram of the alloy part in Example 4.

[0058] Figure 5 Shown is a schematic diagram of the alloy part in Example 5.

[0059] Figure 6 Shown is a schematic diagram of the alloy part in Example 6.

[0060] Figure 7 Shown is a schematic diagram of the alloy part in Example 8.

[0061] Description of reference numerals:

[0062] 1. Elastic center; 11. Alloy part; 111. Rib; 12. Polymer outer layer; 13. Fixing part; 131. Fixing part; 132. Fixing hole; 14. Bending angle; 15. Connector; 16. Branch;

[0063] 2. Extension arm; 3. Connecting parts. DETAILED DESCRIPTION

[0064] A gastric retention device for oral administration, comprising:

[0065] a resilient core, the resilient core comprising at least one alloy member, the at least one alloy member collectively forming at least three ribs, the ribs being secured within the polymeric outer layer;

[0066] A plurality of extension arms, at least one of which is a drug-carrying arm, wherein the drug-carrying arm is loaded with an active substance, wherein the active substance is a therapeutic agent or a diagnostic agent,

[0067] a plurality of connecting parts, each of the plurality of extension arms is connected to the elastic center via a connecting part,

[0068] The gastric retention device includes a folded configuration and an expanded configuration, and the elastic center undergoes elastic deformation or phase change so that the gastric retention device is converted between the folded configuration and the expanded configuration.

[0069] The connecting component degrades, dissolves, dissociates, or mechanically weakens, thereby causing the gastric retention device to lose the shape of the deployed configuration.

[0070] In some embodiments, the alloy piece is selected from a superelastic alloy, and the superelastic alloy includes at least one material selected from the following group: nitinol (Ni-Ti), brass (Cu-Zn), copper aluminum nickel (Cu-Al-Ni) alloy, gold cadmium (Au-Cd) alloy, gold copper zinc (Au-Cu-Zn) alloy, indium thallium (In-Tl) alloy, cobalt nickel aluminum (Co-Ni-Al) alloy, cobalt nickel gallium (Co-Ni-Ga) alloy, copper aluminum beryllium zirconium (Cu-Al-Be-Zr), copper aluminum beryllium chromium (Cu-Al-Be-Cr) alloy, copper aluminum beryllium gadolinium (Cu-Al-Be-Gd) alloy, copper aluminum nickel hafnium (Cu-Al-N) alloy. Superelastic alloys include nickel-iron-gold (Ni-Hf) alloys, copper-tin (Cu-Sn) alloys, copper-zinc-silicon (Cu-Zn-Si) alloys, copper-zinc-aluminum (Cu-Zn-Al) alloys, copper-zinc-tin (Cu-Zn-Sn) alloys, iron-manganese-silicon (Fe-Mn-Si) alloys, iron-platinum (Fe-Pt) alloys, manganese-copper (Mn-Cu) alloys, nickel-iron-gallium (Ni-Fe-Ga) alloys, nickel-titanium-hafnium (Ni-Ti-Hf) alloys, nickel-titanium-palladium (Ni-Ti-Pd) alloys, nickel-manganese-gallium (Ni-Mn-Ga) alloys, nickel-manganese-gallium-copper (Ni-Mn-Ga-Cu) alloys, nickel-manganese-gallium-copper (Ni-Mn-Ga-Co) alloys, and titanium-niobium (Ti-Nb) alloys. The superelastic alloy undergoes elastic deformation to convert the gastric retention device from a folded configuration to an expanded configuration.

[0071] The alloy piece may also be made of a shape memory alloy, which may include at least one material selected from the following group: Ni-Ti, Ni-Ti-Hf, Ni-Ti-Pd, Ni-Fe-Ga, Ni-Mn-Ga, Ni-Mn-Ga-Cu, Ni-Mn-Ga-Co, Ag-Cd, Co-Ni-Al, Co-Ni-Ga, Cu-Al-Be-X (X: Zr, B, Cr, Gd), Cu-Al-Ni, Cu-Al-Ni-Hf, Cu-Sn, Cu-Zn, Cu-Zn-X (X = Si, Al, Sn), Fe-Mn-Si, Fe-Pt, Mn-Cu, Ti-Nb. The shape memory alloy undergoes a phase transformation from a martensite phase to an austenite phase in its crystal structure, thereby enabling the gastric retention device to be transformed from a folded configuration to an expanded configuration.

[0072] The polymer outer layer comprises a soft, foldable material and is selected from the group consisting of polypropylene, polystyrene, polyvinyl chloride, synthetic rubber, phenolic resin (or phenolic resin), neoprene, nylon, polyacrylonitrile, PVB, silicone, acrylonitrile-butadiene-styrene, high-density polyethylene, polycarbonate, nylon, acrylic, polyethylene terephthalate, polybutylene terephthalate, acetal, polyimide, polyurethane and epoxy resin.

[0073] The primary function of the polymer outer layer is to adhere the extension arms. In one embodiment, at least 80% of the folding force is provided by the elastic core, while the remaining less than 20% of the folding force is provided by the polymer outer layer.

[0074] In one embodiment, the polymer outer layer is formed by applying a polymer to a superelastic alloy wire by injection molding or a metal mold. It should be noted that the alloy piece is not limited to the shape of the alloy wire, and the ribs may include other shapes, such as ribbons or strips. The polymer outer layer can be overmolded on the ribs of any of these shapes so that the ribs are firmly fixed in the polymer outer layer.

[0075] In some embodiments, the elastic center includes a plurality of alloy pieces and at least one fixing portion, the plurality of alloy pieces are connected and fixed at the fixing portion, and the plurality of alloy pieces together form at least three ribs.

[0076] In some embodiments, the fixing portion is located at the center of the alloy piece, a plurality of alloy pieces cross each other at the fixing portion, and the ribs are formed at both ends of the alloy piece.

[0077] In some embodiments, the alloy piece has a bending angle, two ends of the bending angle of the alloy piece form ribs respectively, and the bending angles of multiple alloy pieces are overlapped and fixed to form the fixing portion.

[0078] In some embodiments, one end of the alloy piece is fixed to the fixing portion, and the other end of the alloy piece extends outward to form the rib.

[0079] In some embodiments, the plurality of alloy pieces are bonded by welding or adhesive to form the fixing portion.

[0080] In some embodiments, the fixing part is a fixing piece, and the alloy piece is fixed to the fixing piece. The fixing piece is used to assemble and fix the alloy piece, which facilitates the positioning and installation of multiple alloy pieces, and after positioning and installation, the fixing piece and the alloy piece can be further welded or bonded.

[0081] In some embodiments, the elastic center comprises a single alloy piece that forms at least three ribs.

[0082] In some embodiments, all of the ribs are formed from a single alloy piece extending radially outward from a center.

[0083] In some embodiments, the alloy piece is an alloy wire, and the alloy wire is shaped to form all ribs. The ribs are formed by bending and folding a single alloy piece, which strengthens the integrity of the elastic center and is also conducive to strengthening the anti-bending property of the gastric retention device.

[0084] In some embodiments, the elastic center includes a plurality of alloy pieces, wherein the alloy pieces are alloy wires, a single alloy wire is shaped to form at least one rib, and two ends of a plurality of the alloy wires are interconnected to form the elastic center.

[0085] In some embodiments, the elastic center includes a plurality of alloy pieces, the alloy pieces are bent to form two branches, and two branches of every two alloy pieces constitute the rib, and the branches of the two alloy pieces of each rib are fixed by a polymer outer layer.

[0086] Each rib is composed of two branches from two alloy parts, which strengthens the rib's anti-bending ability.

[0087] In some embodiments, the elastic center has a hollow area in the center.

[0088] In the above embodiment, a connector may be provided at the end of the rib, and the connector is used to connect the rib and the polymer outer layer.

[0089] In some embodiments, the connector is selected from protrusions, hooks or any other structure that can interlock with the polymer outer layer. The connection structure with a protruding structure can increase the connection strength between the rib and the outer part, so that the polymer outer layer can firmly fix the alloy part.

[0090] In the present invention, the gastric retention device is used for preparing a gastric retention device having an effective storage period of at least 6 months.

[0091] In the present invention, the gastric retention device is used for preparing a gastric retention device having an effective storage period of at least 12 months.

[0092] In the present invention, the gastric retention device is used for preparing a gastric retention device having an effective storage period of at least 24 months.

[0093] The gastric retention device of the present invention has a high creep resistance, so that the self-expansion mechanism can rebound from the folded configuration to its expanded configuration after long-term storage. The "effective storage period" of the present invention refers to the period during which the gastric retention device can be normally expanded after the gastric retention device is stored in the folded configuration until oral administration.

[0094] In some embodiments, the opening diameter of the gastric retention device in the effective storage period in the expanded configuration can be at least 2 cm, such as 2 cm, 2.1 cm or 2.2 cm. The opening diameter is the diameter or diagonal of the largest cross section of the gastric retention device in the expanded configuration.

[0095] In some embodiments, in the fully expanded configuration of the gastroretention device, all ribs lie in a common plane, which can be defined by an expansion angle of 0°. The gastroretention device in effective storage has an expansion angle of no more than 45°, such as 5°, 6°, 7°, 8°, 9°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, or 45°.

[0096] In some embodiments, the effective storage period of the gastric retention device can be, for example, at least 6 months, at least 9 months, at least 10 months, at most 11 months, at least 1 year, or at least 2 years.

[0097] In some embodiments, the gastric retention device is stored at a storage temperature of, for example, less than 20°C, 21°C, 22°C, 23°C, 24°C, 25°C, 26°C, 27°C, 28°C, 29°C, 30°C, 31°C, 32°C, 33°C, 34°C, 35°C, 36°C, 37°C, 38°C, 39°C, 40°C, 41°C, 42°C, 43°C, 44°C, or 45°C.

[0098] In order to explain the technical content, structural features, achieved objectives and effects of the technical solution in detail, the following is a detailed description in conjunction with specific embodiments and accompanying drawings.

[0099] Example 1

[0100] See also Figures 1A-1D This embodiment discloses a gastric retention device, which includes an elastic core 1 and six extension arms 2 radially connected to the elastic core 1. Figure 1B As shown, the elastic core 1 includes a polymer outer layer 12 and three alloy members 11. In this embodiment, the alloy members 11 are superelastic alloy wires. The gastric retention device also includes six connecting members 3 for connecting each extension arm 2 to the polymer outer layer 12. These superelastic alloy wires are separate components and are independent of each other during assembly. Figure 1D As shown, three superelastic alloy wires cross each other and are bonded or welded at the center of the superelastic alloy wires to form a fixing portion 13, and six ribs 111 are formed at both ends of the three superelastic alloy wires.

[0101] Example 2

[0102] See also Figure 2This embodiment discloses a gastric retention device. Compared with the embodiment 1, the elastic center 1 has a different structure, specifically including: Figure 2 As shown, the elastic center 1 includes six alloy pieces 11 and a fixing portion 13. The alloy piece 11 is a superelastic alloy wire. The fixing portion 13 is a fixing disk. A fixing hole is provided on the side of the fixing disk. One end of the superelastic alloy wire is inserted into the corresponding fixing hole to facilitate the positioning and installation of the alloy piece 11. A plurality of alloy pieces 11 are fixed in the fixing hole by welding or adhesive to form the elastic center 1. The other end of the superelastic alloy wire extends radially to form a rib 111.

[0103] In this embodiment, the fixing member 131 may be made of metal, alloy or polymer.

[0104] Example 3

[0105] See also Figure 3A-3B This embodiment discloses a gastric retention device. Compared with the embodiment 1, the elastic center structure is different, specifically including: Figure 3A-3B As shown, the elastic center includes three alloy pieces 11, the alloy pieces 11 are superelastic alloy wires, each alloy piece 11 is bent at the center to form a bending angle 14, and ribs 111 are formed at both ends of the bending angle 14 of the alloy piece 11, as shown in FIG. Figure 3B As shown, the bending corners 14 of a plurality of alloy parts 11 are overlapped and fixed to each other to form the fixing portion 13 . After the bending corners 14 overlap each other, they are fixed by welding or adhesive.

[0106] Example 4-

[0107] See also Figures 4A-4B This embodiment discloses a gastric retention device. Compared with the embodiment 1, the elastic center 1 has a different structure, specifically including: Figure 4A and Figure 4B As shown, the elastic center includes six alloy pieces 11, the alloy piece 11 is a superelastic alloy wire, the fixing part 13 is a fixing plate, and the fixing plate is provided with evenly distributed fixing holes 132. One end of the superelastic alloy wire is inserted into the fixing hole 132 and fixed in the fixing hole 132 by welding or adhesive to form the elastic center. The other end of the superelastic alloy wire is extended in a radial direction of the central fixing plate to form a rib 111. A connector 15 is provided at the end of the rib 111. The connector 15 is configured to firmly connect the superelastic alloy wire and the polymer outer layer. In this embodiment, the connector 15 is in the shape of a hook, as shown in FIG. Figure 4A and Figure 4B As shown, the connector 15 can be a hook bent in different directions. Optionally, the central fixing plate can be circular or annular. Optionally, the hook-shaped end of the superelastic alloy wire can be bent in a direction parallel to or perpendicular to the plane where the central fixing plate is located.

[0108] Example 5

[0109] See also Figure 5 , this embodiment discloses a gastric retention device, compared with embodiment 1, the elastic center structure is different, specifically including: the elastic center includes a single alloy member 11, and the single alloy member 11 includes six ribs 111 extending outward from the center. The connector 15 is disposed at the tail end of the rib 111 and is configured to firmly connect the rib 111 and the polymer outer layer. In this embodiment, the connector 15 is a protrusion. In other embodiments, the connector 15 may have other shapes, such as a hook, a convex structure, or any other structure that can interlock with the polymer outer layer. In this embodiment, the alloy member 11 is a superelastic alloy plate, which can be stamped, cut, and tailored to obtain the desired shape.

[0110] Example 6

[0111] See also Figure 6 This embodiment discloses a gastric retention device. Compared with the embodiment 1, the elastic center structure is different, specifically including: the elastic center includes a single alloy member 11, the alloy member 11 is a superelastic alloy wire, and the single alloy member 11 is bent and shaped to form all ribs 111, and the superelastic alloy wire is connected at both ends after being bent and formed. Figure 6 The connector 15 is disposed at the rear end of the rib 111. The rib 111 and the connector 15 are formed by bending a single alloy piece 11. The connector 15 is configured to firmly connect the rib 111 and the polymer outer layer. In this embodiment, the connector 15 is a protrusion. In another embodiment, the connector 15 may have other shapes, such as a hook, a convex structure, or any other structure that can interlock with the polymer outer layer.

[0112] Example 7

[0113] This embodiment discloses a gastric retention device. Compared with Example 6, the elastic center includes two alloy pieces, the alloy pieces are superelastic alloy wires, and a single alloy piece is bent and shaped to form three ribs. The two ends of the two superelastic alloy wires are connected to each other to form the six ribs of the elastic center.

[0114] Example 8

[0115] See also Figure 7 This embodiment discloses a gastric retention device. Compared with the embodiment 1, the elastic center structure is different, specifically including: Figure 7 As shown, the elastic center includes three alloy pieces 11, which are superelastic alloy wires, and each alloy piece 11 is bent to form two branches 16. Two adjacent branches 16 of every two alloy pieces 11 constitute the rib 111, and the two branches 16 of each rib 111 are fixed in the polymer outer layer 12.

[0116] In Examples 6 and 8, the alloy member 11 has a hollow area at the center of the elastic center, which reduces the concentration of stress when the gastric retention device is in the folded configuration.

[0117] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or terminal device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or terminal device. In the absence of further restrictions, the elements defined by the sentence "include..." or "comprise..." do not exclude the existence of other elements in the process, method, article or terminal device including the elements. In addition, in this article, "greater than", "less than", "exceed" and the like are understood to exclude the number itself; "above", "below", "within" and the like are understood to include the number itself.

[0118] Although the above embodiments have been described, once those skilled in the art know the basic creative concepts, they can make additional changes and modifications to these embodiments. Therefore, the above description is only an embodiment of the present invention and does not limit the patent protection scope of the present invention. Any equivalent structure or equivalent process transformation made by using the contents of the specification and drawings of the present invention, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. A gastric retention device for oral administration, comprising: an elastic center, the elastic center comprising a plurality of alloy pieces and at least one fixing portion, the plurality of alloy pieces being connected at the fixing portion, the plurality of alloy pieces together forming at least three ribs, the ribs being fixed in the polymer outer layer; A plurality of extension arms, at least one of which is a drug-carrying arm, and the drug-carrying arm is loaded with an active substance; a plurality of connecting members, each of the plurality of extension arms being connected to the elastic center via a connecting member; The gastric retention device includes a folded configuration and an expanded configuration, the elastic center undergoes elastic deformation or phase change so that the gastric retention device is converted between the folded configuration and the expanded configuration, and the connecting component is degraded, dissolved, dissociated or mechanically weakened, thereby causing the gastric retention device to lose the shape of the expanded configuration.

2. The gastric retention device for oral administration according to claim 1, characterized in that The alloy piece has a bending angle, two ends of the bending angle of the alloy piece form ribs respectively, and the bending angles of a plurality of alloy pieces are overlapped and fixed to form the fixing portion.

3. The gastric retention device for oral administration according to claim 1, characterized in that One end of the alloy piece is fixed to the fixing portion, and the other end of the alloy piece extends outward to form the rib.

4. The gastric retention device for oral administration according to any one of claims 1, characterized in that: The plurality of alloy members are bonded by welding, adhesive or fixing members to form a fixing portion.

5. The gastric retention device for oral administration according to any one of claims 1 to 4, characterized in that: The ends of the ribs have connectors for connecting the ribs to the outer polymer layer.

6. The gastric retention device for oral administration according to claim 5, characterized in that The connectors are selected from protrusions, hooks or any other structure capable of interlocking with the polymeric outer layer.

7. A gastric retention device for oral administration, comprising: a resilient core, the resilient core comprising a single alloy piece, the single alloy piece forming at least three ribs, the ribs being fixed within the polymer outer layer; A plurality of extension arms, at least one of which is a drug-carrying arm, wherein the drug-carrying arm is loaded with an active substance, a plurality of connecting parts, each of the plurality of extension arms is connected to the elastic center via a connecting part, The gastric retention device includes a folded configuration and an expanded configuration, and the elastic center undergoes elastic deformation or phase change so that the gastric retention device is converted between the folded configuration and the expanded configuration. The connecting components degrade, dissolve, dissociate, or mechanically weaken, thereby causing the gastric retention device to lose the shape of the deployed configuration.

8. The gastric retention device for oral administration according to claim 7, characterized in that The center of the alloy piece extends outward to form a rib.

9. The gastric retention device for oral administration according to claim 7, characterized in that The alloy piece is an alloy wire, and a single piece of the alloy wire is shaped to form all the ribs.

10. The gastric retention device for oral administration according to any one of claims 7 to 9, characterized in that: The ends of the ribs have connectors for connecting the ribs to the outer polymer layer.

11. The gastric retention device for oral administration according to claim 10, characterized in that The connectors are selected from protrusions, hooks or any other structure capable of interlocking with the polymeric outer layer.

12. A gastric retention device for oral administration, comprising: An elastic center, the elastic center includes a plurality of alloy pieces, each of the alloy pieces is shaped to form at least one rib, a plurality of the alloy pieces are connected to form a total of at least three ribs, and the ribs are fixed in the polymer outer layer; A plurality of extension arms, at least one of which is a drug-carrying arm, wherein the drug-carrying arm is loaded with an active substance, a plurality of connecting parts, each of the plurality of extension arms is connected to the elastic center via a connecting part, The gastric retention device includes a folded configuration and an expanded configuration, and the elastic center undergoes elastic deformation or phase change so that the gastric retention device is converted between the folded configuration and the expanded configuration. The connecting components degrade, dissolve, dissociate, or mechanically weaken, thereby causing the gastric retention device to lose the shape of the deployed configuration.

13. The gastric retention device for oral administration of medicine according to claim 12, characterized in that: The alloy piece is an alloy wire, a single alloy wire is shaped to form at least one rib, and a plurality of alloy wires are interconnected to form the elastic center.

14. The gastric retention device for oral administration according to any one of claims 11 to 12, characterized in that: The ends of the ribs have connectors for connecting the ribs to the outer polymer layer.

15. The gastric retention device for oral administration of medicine according to claim 14, characterized in that The connectors are selected from protrusions, hooks or any other structure capable of interlocking with the polymeric outer layer.

16. A gastric retention device for oral administration, comprising: An elastic center, the elastic center includes a plurality of alloy pieces, the alloy pieces are bent to form two branches, the two branches of every two alloy pieces constitute the rib, the plurality of alloy pieces together form at least three ribs, and the two branches of the alloy pieces of each rib are fixed in the polymer outer layer; A plurality of extension arms, at least one of which is a drug-carrying arm, wherein the drug-carrying arm is loaded with an active substance, a plurality of connecting parts, each of the plurality of extension arms is connected to the elastic center via a connecting part, The gastric retention device includes a folded configuration and an expanded configuration, and the elastic center undergoes elastic deformation or phase change so that the gastric retention device is converted between the folded configuration and the expanded configuration. The connecting component degrades, dissolves, dissociates, or mechanically weakens, thereby causing the gastric retention device to lose the shape of the deployed configuration.

17. The gastric retention device for oral administration of medicine according to claim 16, characterized in that The ends of the ribs have connectors for connecting the ribs to the outer polymer layer.

18. The gastric retention device for oral administration of medicine according to claim 17, characterized in that The connectors are selected from protrusions, hooks or any other structure capable of interlocking with the polymeric outer layer.

19. Use of a gastric retention device for oral administration according to any one of claims 1 to 18, characterized in that: The gastric retention device is used for the preparation of a gastric retention device having an effective storage period of at least 6 months.

20. The use of a gastric retention device for oral administration according to claim 19, characterized in that: The gastric retention device has an effective shelf life of at least 12 months.

21. The use of a gastric retention device for oral administration according to claim 19, characterized in that: The gastric retention device has an effective shelf life of at least 24 months.

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