Long-acting gastric residence drug delivery device

Abstract

The utility model relates to medical instrument technical field discloses a long -acting gastric retention drug delivery device, can enter the stomach through the oral self -ingestion mode, further realizes size change through the unfolding of elastic component, and the mechanical strength of elastic component is strengthened through water -induced hard polymer, avoids being extruded deformation and is emptied through the stomach pylorus. The device includes drug loading component, elastic component and connecting component, and the drug loading component includes multiple drug loading pieces, and the drug loading piece all has the drug loading cavity. The elastic component includes multiple elastic pieces, and the first end of multiple elastic pieces is connected with each other to make the elastic component present star -like under the unfolded state. The outer layer of elastic component is covered with reinforcing film, and the reinforcing film is formed by water -induced hard polymer solidification and can gradually transform from flexible to rigid under the aqueous environment. The connecting component includes multiple connecting pieces, and the second end of an elastic piece is connected with a drug loading piece through a connecting piece, and the connecting piece is decomposed under the preset condition, so that the drug loading piece and elastic component are separated and are discharged outside non -invasively.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a long-acting gastric retention drug delivery device. Background Technology

[0002] To address the challenges of long-term medication adherence traps, fluctuating blood drug concentrations, and gaps in personalized treatment for chronic diseases, researchers aim to develop a novel oral long-acting gastroretentive drug delivery system (OGRDDS). OGRDDS utilizes mechanical changes or material properties to achieve prolonged drug retention and continuous release in the stomach, thereby reducing dosing frequency, minimizing blood drug concentration fluctuations, and improving drug efficacy. Currently, a promising strategy is the expandable / expandable OGRDDS, which expands / expands in the stomach to form a shape larger than 2 cm in diameter (the anatomical diameter of the human pylorus), achieving long-acting gastric retention and completing drug release during the retention period. However, due to gastric peristalsis and compression, existing long-acting gastroretentive drug delivery devices still suffer from structural instability, easily leading to deformation after expansion and accidental discharge, resulting in a shorter retention time in the stomach and failing to meet the demand for long-acting drug delivery.

[0003] Therefore, there is an urgent need for a long-acting gastric retention drug delivery device to solve the above problems. Utility Model Content

[0004] The purpose of this invention is to provide a long-acting gastric retention drug delivery device that can increase the retention time of the drug delivery device in the stomach and ensure long-acting drug delivery.

[0005] Based on the above concept, the technical solution adopted by this utility model is as follows:

[0006] A long-acting gastric retention drug delivery device is provided, which can enter the stomach via oral ingestion, the long-acting gastric retention drug delivery device comprising:

[0007] A drug delivery assembly includes multiple drug delivery elements, each of which has a drug delivery cavity and a drug release orifice communicating with the drug delivery cavity. The drug delivery cavity is used to contain a drug, and the drug in the drug delivery cavity can be released from the drug release orifice.

[0008] An elastic component includes a plurality of elastic elements, the first ends of which are connected to each other so that the elastic component is star-shaped in the unfolded state.

[0009] A reinforcing membrane, formed by curing a water-hardening polymer, is capable of gradually transforming from flexible to rigid in an aqueous environment, and is wrapped around the outer layer of the elastic component;

[0010] The connecting component includes multiple connectors. The second ends of the multiple elastic elements are connected one-to-one with the multiple drug-carrying elements through the multiple connectors. The multiple connectors can be disassembled under preset conditions so that the multiple drug-carrying elements can be separated from the elastic component. The separated drug-carrying elements and the elastic component can be discharged from the body non-invasively.

[0011] Optionally, the connector is made of a heat-sensitive material and is capable of melting at a preset temperature to separate the multiple drug-carrying components from the elastic component.

[0012] Optionally, the connecting assembly further includes a connecting cap disposed at the second end of the elastic member, one end of the connecting member being connected to the connecting cap, and the other end of the connecting member being connected to the drug-carrying member.

[0013] Optionally, the connecting cap is provided with a first mounting hole, the drug carrier is provided with a second mounting hole, one end of the connector is threaded to the first mounting hole, and the other end of the connector is threaded to the second mounting hole.

[0014] Optionally, the connecting cap is mated with the drug-carrying component, the first mounting hole communicates with the second mounting hole, and a first mold is fitted at the mating point between the connecting cap and the drug-carrying component;

[0015] The connector cap is provided with a molding hole, which communicates with the first mounting hole. The molding hole is used to inject heat-sensitive material into the first mounting hole and the second mounting hole to form the connector.

[0016] Optionally, the elastic component further includes a central seat, which is a regular polygonal structure. The first ends of the plurality of elastic elements are all connected to the side of the central seat. The elastic elements are triangular prism structures. The portion of the first end of the elastic element located above the top surface of the central seat is provided with an inclined surface. The inclined surface is used to allow the elastic element to avoid the central seat when the elastic component is folded.

[0017] Optionally, in the direction perpendicular to the top surface of the center seat, the height of the center seat is h1, the height of the elastic element is h2, 0.2≤h1 / h2≤0.6, and the angle between the inclined surface and the top surface of the center seat is θ, 10°≤θ≤80°.

[0018] Optionally, the elastic component is integrally formed by 3D printing; and / or,

[0019] The drug-loaded component is integrally formed by 3D printing.

[0020] Optionally, both the elastic element and the drug-carrying element are triangular prism structures, and each edge of the long-acting gastric retention drug delivery device is chamfered.

[0021] Optionally, the long-acting gastric retention drug delivery device further includes a capsule shell, and the drug-carrying component, the connecting component, and the elastic component are connected and can be inserted into the capsule shell, which can be decomposed in the stomach.

[0022] The beneficial effects of this utility model are as follows:

[0023] The long-acting gastric retention drug delivery device proposed in this invention can enter the stomach via oral ingestion. The long-acting gastric retention drug delivery device includes a drug-carrying component, an elastic component, and a connecting component. The drug-carrying component includes multiple drug-carrying elements, each with a drug-carrying cavity for containing the drug. Each drug-carrying element also has a release orifice communicating with the drug-carrying cavity, through which the drug can be released. The elastic component includes multiple elastic elements, the first ends of which are interconnected to form a star-shaped elastic component in its unfolded state. The connecting component includes multiple connectors, the second ends of which are respectively connected to the drug-carrying elements one-to-one. Therefore, after the long-acting gastric retention drug delivery device enters the stomach, the elastic component unfolds into a star shape. The size of the unfolded long-acting gastric retention drug delivery device can be much larger than the anatomical diameter of the human pylorus, thus meeting the physical size requirements for long-acting gastric retention. When the long-acting gastric retention drug delivery device is retained in the stomach, the drug carried by the drug carrier can be slowly released through the drug release orifice to meet the clinical need for slow drug delivery into the stomach for a certain period of time.

[0024] In addition, the outer layer of the elastic component of the long-acting gastric retention drug delivery device is also covered with a reinforcing membrane. The reinforcing membrane is formed by the curing of a water-hardening polymer. The strength of the water-hardening polymer gradually increases in an aqueous environment. That is, when the reinforcing membrane comes into contact with the gastric fluid, its properties will gradually change from flexible to rigid to enhance the stiffness of the elastic component. This makes the elastic component unable to fold. This means that even if the gastric peristalsis and digestion cause pressure on the elastic component, the elastic component will not deform. This ensures that the long-acting gastric retention drug delivery device can remain in the stomach for a certain period of time, ensuring long-acting drug delivery. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the structure of the long-acting gastric retention drug delivery device provided in this embodiment of the utility model;

[0026] Figure 2 This is an exploded view of the structure of the connecting cap, connector, and drug carrier provided in this embodiment of the utility model;

[0027] Figure 3 This is a partial cross-sectional view of the elastic component provided in an embodiment of the present invention;

[0028] Figure 4 This is a performance test curve of the water-induced hardening polymer provided in this embodiment of the utility model;

[0029] Figure 5 This is a comparison diagram of the properties of multiple heat-sensitive materials provided in the embodiments of this utility model;

[0030] Figure 6 This is a comparison diagram of the characteristics of a single heat-sensitive material at different times provided in the embodiments of this utility model.

[0031] In the picture:

[0032] 1. Drug-carrying component; 11. Second mounting hole;

[0033] 2. Connecting assembly; 21. Connector; 211. External thread structure; 22. Connecting cap;

[0034] 3. Elastic component; 31. Elastic element; 311. Inclined surface; 32. Center seat. Detailed Implementation

[0035] To make the technical problem solved by this utility model, the technical solution adopted, and the technical effect achieved clearer, the technical solution of this utility model will be further described below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are merely for explaining this utility model and not for limiting it. Furthermore, it should be noted that, for ease of description, only the parts related to this utility model are shown in the accompanying drawings, not all of them.

[0036] In the description of this utility model, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0037] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0038] In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. In addition, the terms "first" and "second" are only used for distinction in description and have no special meaning.

[0039] The technical solution of this utility model will be further described below with reference to the accompanying drawings and specific embodiments.

[0040] like Figure 1 As shown, this embodiment provides a long-acting gastric retention drug delivery device that can enter the stomach via oral ingestion. The long-acting gastric retention drug delivery device includes a drug-carrying component, an elastic component 3, and a connecting component 2. The drug-carrying component includes multiple drug-carrying elements 1, each with a drug-carrying cavity for containing the drug. Each drug-carrying element 1 also has a release orifice communicating with the drug-carrying cavity, through which the drug can be released. The elastic component 3 includes multiple elastic elements 31, the first ends of which are interconnected to form a star-shaped elastic component 3 in its unfolded state. The connecting component 2 includes multiple connectors 21, the second ends of which are respectively connected one-to-one to the multiple drug-carrying elements 1 via the connectors 21. After the long-acting gastric retention drug delivery device enters the stomach, the elastic component 3 unfolds into a star shape. The connector 21 and the drug-carrying component 1, connected to the second end of the elastic component 31, further extend the size of the star in the radial direction, so that the size of the unfolded long-acting gastric retention drug delivery device can be much larger than the anatomical diameter of the human pylorus, thus meeting the physical size requirements for long-acting gastric retention. When the long-acting gastric retention drug delivery device is retained in the stomach, the drug carried by the drug-carrying component 1 can be slowly released through the drug release orifice to meet the clinical requirement of slowly delivering the drug into the stomach for a certain period of time. When the drug delivery time or amount meets the requirements, or when other situations arise that require termination of drug delivery, the connector 21 can be disassembled to separate the drug delivery component and the drug-carrying component 1. The size of the star-shaped elastic component 3 and the size of the drug-carrying component 1 are both smaller than the anatomical diameter of the human pylorus, meaning that the human body can expel the star-shaped elastic component 3 and the drug-carrying component 1 autonomously.

[0041] The long-acting gastric retention drug delivery device provided in this embodiment is used in the stomach. During peristalsis and digestion, the stomach compresses the long-acting gastric retention drug delivery device. To ensure that the long-acting gastric retention drug delivery device can enter the stomach through oral ingestion, the elastic component 3 needs to be foldable and easily inserted into the capsule shell. That is, the elastic component 3 should have good elasticity and be easily bent. However, if the elastic component 3 is deformed due to stomach peristalsis while unfolded, it may be accidentally expelled, resulting in a short retention time in the stomach. Therefore, the long-acting gastric retention drug delivery device provided in this embodiment also includes a reinforcing membrane. The reinforcing membrane covers the outer layer of the elastic component 3 and is formed by curing a water-hardening polymer. The strength of the water-hardening polymer gradually increases in an aqueous environment; that is, when the reinforcing membrane comes into contact with gastric fluid, its properties gradually change from flexible to rigid. In specific implementation, when the long-acting gastric retention drug delivery device, encased in the capsule shell, enters the stomach, the capsule shell is digested by gastric juice, and the elastic component 3, freed from the constraints of the capsule shell, will extend into a star shape. When the reinforcing membrane covering the elastic component 3 is not in contact with gastric fluid, it remains flexible and does not affect the stretching and folding of the elastic component 3. This allows the elastic component 3 to be folded and inserted into the capsule shell, and to unfold quickly after the capsule shell is disintegrated. However, when the reinforcing membrane comes into contact with gastric fluid, its properties gradually transform into rigidity to enhance the stiffness of the elastic component 3. This makes the elastic component 3 less easily foldable, and even if gastric peristalsis and gastric compression apply external forces to the elastic component 3, it is not easily deformed. This ensures that the long-acting gastric retention drug delivery device can remain in the stomach for a certain period of time, guaranteeing long-acting drug delivery.

[0042] In specific implementation, the material used to make the drug-loaded component 1 includes, but is not limited to, at least one of polycarbonate, polyamide, polyetheretherketone, fluoropolymer, polylactic acid, medical-grade stainless steel, cobalt-chromium alloy, titanium and titanium alloy.

[0043] In specific implementation, the materials used to make the elastic component 3 include, but are not limited to, at least one of the following: polypropylene, polystyrene, polyvinyl chloride, synthetic rubber, phenolic resin, chloroprene rubber, nylon, polyacrylonitrile, PVB, silicone, acrylonitrile-butadiene-styrene, high-density polyethylene, polycarbonate, polycaprolactone, polylactic acid, nylon, acrylic acid, polyethylene terephthalate, polybutylene terephthalate, acetal, polyimide, polyurethane, and epoxy resin.

[0044] In this embodiment, the water-induced hard polymer used to make the reinforcing membrane can be polybenzyl methacrylate-co-polyethylene glycol methacrylate (copolymerized from two monomers, benzyl methacrylate and polyethylene glycol methacrylate), or it can be polybenzyl methacrylate-lithium salt or polyvinylpyrrolidone, all of which are existing materials and will not be described in detail here.

[0045] This embodiment further verifies the changes in material properties of the water-induced hardening polymer in the gastric environment. First, an artificial gastric solution was prepared according to the Chinese Pharmacopoeia 2025, and the pH was measured to be 1.35. Multiple samples of the water-induced hardening polymer (made of polybenzyl methacrylate-co-polyethylene glycol methacrylate) were immersed in the artificial gastric solution and incubated in a 37°C constant temperature incubator. At specific time points (0 min, 30 min, 60 min, 720 min, 1440 min), the corresponding samples were removed, completely dried, and then the stress-strain curves were measured on a testing machine with a tensile force of 2 kN, with the elongation rate fixed at 100 mm / min. (Refer to...) Figure 4 The performance test curves of the water-induced hard polymer show that the water absorption of the water-induced hard polymer sample increases with the extended immersion time in artificial gastric fluid, and the stiffness of the sample also changes significantly.

[0046] In this embodiment, the reinforcing film is a liquid water-hardening polymer that is directly attached to the elastic component 31 after curing, ensuring a tight connection between the reinforcing film and the elastic component 31. First, a mold for combining the reinforcing film and the connector 21 is designed using 3D drawing software, and the mold is fabricated using a high-transmittance quartz sheet. Then, the elastic component 3, manufactured using 3D printing technology, is placed in a specific position within the mold. A pre-prepared water-hardening polymer solution is then injected, with the elastic component 3 positioned in the center of the mold. The solution surrounds the elastic component 3 after injection. Finally, the mold is placed under ultraviolet light for curing, resulting in a smooth reinforcing film that uniformly coats the surface of the elastic component 3. Specifically, the thickness of the reinforcing film can be set to approximately 0.5 mm to ensure its strength enhancement effect on the elastic component 3 in an aqueous environment without affecting the folding of the elastic component 3.

[0047] Optionally, the connector 21 is made of a heat-sensitive material and can melt at a preset temperature. That is, the method provided in this embodiment for separating the drug-carrying component 1 and the elastic component 3 is to change the heating temperature of the connector 21, thereby causing the connector 21 connecting the drug-carrying component 1 and the elastic component 3 to decompose. In specific implementation, when it is necessary to separate the drug-carrying component 1 and the elastic component 3, non-invasive methods such as HIFU (High-Intensity Focused Ultrasound) or magnetocaloric induction can be used to heat the connector 21 to a preset temperature, thereby causing the connector 21 to decompose and detaching the connection between the elastic component 31 and the drug-carrying component 1. In the prior art, there are various heat-sensitive materials that can be used in the field of medical devices, possessing good heat sensitivity and capable of decomposition at temperatures ranging from 40°C to 80°C.

[0048] In this embodiment, the heat-sensitive material is a heat-sensitive alloy, preferably Bi. 45 Pb23 In 19 Sn8Cd5 exhibits superior performance compared to other materials reported in the current literature. The Bi used in this embodiment... 45 Pb 23 In 19 Sn8Cd5( Figure 5 The horizontal axis (thispatent), and other references use PCL2000 ( Figure 5 The horizontal axis of the text is text 1), PCL50000 ( Figure 5 text2 on the horizontal axis), PCL80000 ( Figure 5 The performance of the material on the horizontal axis (literature 3) was compared. First, multiple samples of connector 21 were made using the aforementioned material. All samples were immersed in artificial gastric fluid and incubated in a 37℃ constant temperature incubator. At specific time points (Day 0, Day 1, Day 3, Day 7, Day 14, Day 21), the corresponding group of samples were removed, completely dried, and then tested on a 2kN tensile testing machine. The tensile rate was fixed at 100mm / min. (Refer to...) Figure 5 A comparison chart of the properties of multiple heat-sensitive materials shows that using Bi... 45 Pb 23 In 19 The Sn8Cd5 material samples showed improvements in maximum cohesion force compared to other materials of 43.4 times, 20.3 times, and 9.8 times (compared to Day 0), respectively. (See reference) Figure 6 A comparison of the properties of a single heat-sensitive material at different times; as the immersion time increases, the properties of the material using Bi... 45 Pb 23 In 19 Although the maximum bonding force of the Sn8Cd5 material sample decreased, the bonding force was still greater than 60N, which is much higher than the gastric peristalsis and squeezing force, which are generally less than 0.8N (acting on a surface of 1 square centimeter).

[0049] In other embodiments, the heat-sensitive material may also be polycaprolactone, n-butyl methacrylate, ethylene-vinyl acetate copolymer, polyurethane, etc.

[0050] In other embodiments, the preset decomposition condition of the connector 21 can be changing the pH value of the gastric environment. That is, the connector 21 is made of a pH-degrading material, and the connector 21 can be decomposed by adjusting the pH value of the gastric environment. Alternatively, in other embodiments, the connector 21 can be made of a material with a preset time for decomposition, that is, the connector 21 will decompose autonomously after remaining in the stomach for a certain period of time.

[0051] Optionally, such as Figure 2As shown, the connecting assembly 2 also includes a connecting cap 22, which is disposed at the second end of the elastic member 31. One end of the connecting member 21 is connected to the connecting cap 22, and the other end of the connecting member 21 is connected to the drug-carrying member 1. In a specific implementation, the connecting cap 22 can be fabricated using photosensitive resin material through 3D printing technology, and then fixed to the second end of the elastic member 31 by adhesive bonding. The connecting cap 22 is then connected to the drug-carrying member 1 through the connecting member 21.

[0052] To enhance the connection stability among the elastic component 3, connecting component 2, and drug-carrying component, mounting holes are provided at the connection points of the connecting cap 22 and the drug-carrying component 1 with the connecting component 21. One end of the connecting component 21 extends into the first mounting hole of the connecting cap 22, and the other end extends into the second mounting hole 11 of the drug-carrying component 1. Preferably, an internal thread structure is provided in the first mounting hole to allow the connecting component 21 to be threadedly connected to the connecting cap 22, ensuring a stable connection between the connecting component 21 and the connecting cap 22. An internal thread is provided in the second mounting hole 11 to allow the connecting component 21 to be threadedly connected to the drug-carrying component 1, ensuring a stable connection between the connecting component 21 and the drug-carrying component 1.

[0053] Optionally, the connector 21 is formed by curing a liquid heat-sensitive material, so that both ends of the connector 21 can directly form a matching external thread structure 211 in the first mounting hole and the second mounting hole 11. This is more convenient and faster than first preparing the connector 21 and setting the external thread structure 211 on the connector 21, and then assembling the connector cap 22, the connector 21, and the drug carrier 1. In specific implementation, the end face of the connector cap 22 that connects to the connector 21 is aligned with the end face of the drug carrier 1 that connects to the connector 21, so that the first mounting hole and the second mounting hole 11 are connected. A molding die is fitted at the joint between the connector cap 22 and the drug carrier 1. The molding die surrounds the joint between the connector cap 22 and the drug carrier 1, which can prevent the liquid heat-sensitive material from overflowing. The connecting cap 22 is provided with a molding hole, which is connected to the first mounting hole. Liquid heat-sensitive material can be injected into the first mounting hole through the molding hole, and the liquid heat-sensitive material fills the second mounting hole 11. When the liquid heat-sensitive material solidifies, a connector 21 is formed that is threadedly connected to both the first mounting hole and the second mounting hole 11.

[0054] In practice, a connecting cap 22 with mounting holes and a drug carrier 1 are first designed using 3D drawing software, and then molded using photosensitive resin using 3D technology. In an environment above the phase transition temperature of the heat-sensitive material, it is injected into the first mounting hole of the connecting cap 22 and the second mounting hole 11 of the drug carrier 1. Subsequently, it is transferred to room temperature. The high temperature sensitivity causes the liquid heat-sensitive material to rapidly undergo a phase transition, forming a solid connecting component 21.

[0055] Optionally, such as Figure 2As shown, the elastic component 3 also includes a central base 32, which is a regular polygonal structure. The first ends of multiple elastic elements 31 are all connected to the side of the central base 32. If N elastic elements 31 are provided, the regular polygonal structure becomes a regular N-sided structure, with one elastic element 31 connected to one side of the regular polygonal structure. To reduce the maximum stress experienced by the star-shaped elastic component 3 in the fully folded state when it is unfolded, a clearance structure is also provided at the first end of the elastic element 31. This clearance structure ensures that when multiple elastic elements 31 are moved from a position parallel to the top surface of the central base 32 to a position perpendicular to the top surface of the central base 32, there is still a gap between the first end of the elastic element 31 and the top surface of the central base 32. In this embodiment, the elastic element 31 is configured as a triangular prism structure so that when multiple elastic elements 31 are arranged perpendicular to the top surface of the center seat 32, they can be combined into a columnar structure to facilitate encapsulation in the capsule shell. Moreover, the first end of the elastic element 31 located above the top surface of the center seat 32 is provided with an inclined surface 311. The inclined surface 311 and the top surface of the center seat 32 still have a gap when the elastic component 3 is folded, so as to reduce the stress of the elastic component 3 in the folded state.

[0056] In this embodiment, the structural dimensions of the elastic component 3 are optimized. The elastic component 3 is designed using 3D modeling software, and the height ratio and shear angle are changed. The stress distribution of the elastic component 3 after complete folding is calculated using finite element analysis on simulation software. A sample of the elastic component 3 is obtained through 3D printing. The stress-strain curve of the sample is measured on a tensile testing machine equipped with a 20N sensor. The elongation rate is fixed at 15 mm / min. The elastic modulus is calculated by fitting the data and used to define the material's characteristic parameters in the finite element analysis. It can be concluded that the maximum stress at complete folding is positively correlated with both the height ratio and the shear angle. In this embodiment, as shown... Figure 3 As shown, the height ratio of the elastic component 3 is h1 / h2, where h1 is the height of the center seat 32 in the direction perpendicular to the top surface of the center seat 32, and h2 is the height of the elastic component 31 in the direction perpendicular to the top surface of the center seat 32. The oblique angle of the elastic component 3 is the angle θ formed by the inclined surface 311 and the top surface of the center seat 32. In specific implementations, to reduce the maximum stress of the elastic component 3 in the fully folded state, 0.2≤h1 / h2≤0.6 and 10°≤θ≤80° can be set. Preferably, h1 / h2=0.4 and θ=45°.

[0057] Optionally, since both the elastic element 31 and the drug-carrying element 1 are triangular prism structures, chamfers are provided on each edge of the long-acting gastric retention drug delivery device so that the corners are all rounded surfaces, which helps to reduce damage to the gastric mucosa.

[0058] Optionally, the long-acting gastric retention drug delivery device also includes a capsule shell. The drug-carrying component, connecting component 2, and elastic component 3 are connected and can be inserted into the capsule shell, which is decomposable in the stomach. In specific implementation, the elastic component 3, connecting cap 22, and drug-carrying component 1 are first produced by 3D printing. Then, a reinforcing film is coated on the elastic component 3 by curing, and a connecting component 21 is formed between the connecting cap 22 and the drug-carrying component 1. The connecting cap 22 is then bonded to the elastic component 3 to form a star-shaped drug delivery device body. The drug-carrying cavity contains the drug, and then the drug delivery device body is inserted into the capsule shell.

[0059] In this embodiment, the maximum radial dimension of the elastic component 3 is 13.8 mm, and both the drug carrier 1 and the connecting cap 22 adopt a triangular prism structure, with the maximum circumscribed circle diameter of the triangular prism structure being 3.4 mm. The maximum radial dimension of the long-acting gastric retention drug delivery device in the unfolded state is 49.3 mm, and the maximum radial dimension in the folded state is less than 20 mm.

[0060] The above embodiments merely illustrate the basic principles and characteristics of this utility model. This utility model is not limited to the above embodiments. Various changes and modifications can be made to this utility model without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed utility model. The scope of protection of this utility model is defined by the appended claims and their equivalents.

Claims

1. A long-acting gastric residence drug delivery device capable of being self-ingested orally into the stomach, characterized in that, The long-acting gastric retention drug delivery device includes: A drug delivery assembly includes a plurality of drug delivery elements (1), each of the drug delivery elements (1) having a drug delivery cavity and a drug release hole communicating with the drug delivery cavity, the drug delivery cavity being used to contain a drug, and the drug in the drug delivery cavity being able to be released from the drug release hole; The elastic component (3) includes a plurality of elastic elements (31), the first ends of the plurality of elastic elements (31) being connected to each other so that the elastic component (3) is star-shaped in the unfolded state; The reinforcing membrane is formed by curing a water-hardening polymer and can gradually change from flexible to rigid in an aqueous environment. The reinforcing membrane covers the outer layer of the elastic component (3). The connecting component (2) includes multiple connectors (21). The second ends of the multiple elastic elements (31) are connected one-to-one with the multiple drug-carrying elements (1) through the multiple connectors (21). The multiple connectors (21) can be decomposed under preset conditions so that the multiple drug-carrying elements (1) can be separated from the elastic component (3). The separated drug-carrying elements (1) and the elastic component (3) can be discharged from the body non-invasively.

2. The gastro retentive drug delivery system of claim 1, wherein, The connector (21) is made of a heat-sensitive material and is capable of melting at a preset temperature so that all of the drug-carrying components (1) are separated from the elastic component (3).

3. The gastro retentive drug delivery system of claim 1, wherein, The connecting component (2) further includes a connecting cap (22), which is disposed at the second end of the elastic member (31). One end of the connecting member (21) is connected to the connecting cap (22), and the other end of the connecting member (21) is connected to the drug-carrying member (1).

4. The gastro retentive drug delivery system of claim 3, wherein, The connecting cap (22) is provided with a first mounting hole, the drug carrier (1) is provided with a second mounting hole (11), one end of the connector (21) is threaded to the first mounting hole, and the other end of the connector (21) is threaded to the second mounting hole (11).

5. The gastro retentive drug delivery system of claim 4, wherein, The connecting cap (22) is connected to the drug carrier (1), the first mounting hole is connected to the second mounting hole (11), and a first mold is fitted at the connection point between the connecting cap (22) and the drug carrier (1); The connector cap (22) is provided with a molding hole, which is connected to the first mounting hole. The molding hole is used to inject heat-sensitive material to form the connector (21) into the first mounting hole and the second mounting hole (11).

6. The gastro retentive drug delivery system of claim 1, wherein, The elastic component (3) also includes a center seat (32), which is a regular polygonal structure. The first ends of the multiple elastic elements (31) are all connected to the side of the center seat (32). The elastic element (31) is a triangular prism structure. The portion of the first end of the elastic element (31) located above the top surface of the center seat (32) is provided with an inclined surface (311). The inclined surface (311) is used to allow the elastic element (31) to avoid the center seat (32) when the elastic component (3) is folded.

7. The long-acting gastric retention drug delivery device according to claim 6, characterized in that, The height of the center seat (32) is h1, the height of the elastic element (31) is h2, 0.2≤h1 / h2≤0.6, and the angle between the inclined surface (311) and the top surface of the center seat (32) is θ, 10°≤θ≤80°.

8. The long-acting gastric retention drug delivery device according to claim 6, characterized in that, The elastic component (3) is integrally formed by 3D printing; and / or, The drug-loaded component (1) is integrally formed by 3D printing.

9. The long-acting gastric retention drug delivery device according to claim 1, characterized in that, Both the elastic element (31) and the drug-carrying element (1) are triangular prism structures, and each edge of the long-acting gastric retention drug delivery device is chamfered.

10. The long-acting gastric retention drug delivery device according to claim 1, characterized in that, The long-acting gastric retention drug delivery device also includes a capsule shell. The drug-carrying component, the connecting component (2), and the elastic component (3) are connected and can be inserted into the capsule shell. The capsule shell can be decomposed in the stomach.

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