Long-acting gastric retention drug delivery device

Abstract

The invention relates to the technical field of medical apparatus and instruments, and discloses a long-acting gastric retention drug delivery device which can enter the stomach in an oral self-ingestion mode, further realizes size change through expansion of an elastic assembly, enhances the mechanical strength of the elastic assembly through a water-induced hard polymer, and avoids extrusion deformation and emptying through the pylorus of the stomach. The device comprises a medicine carrying assembly, an elastic assembly and a connecting assembly, the medicine carrying assembly comprises a plurality of medicine carrying pieces, and each medicine carrying piece is provided with a medicine carrying cavity. The elastic assembly comprises a plurality of elastic pieces, and the first ends of the elastic pieces are connected with one another, so that the elastic assembly is in a star shape in the unfolded state. The outer layer of the elastic assembly is coated with a reinforcing film, and the reinforcing film is formed by curing a water-hardened polymer and can be gradually converted into rigidity from flexibility in a water-based environment. The connecting assembly comprises a plurality of connecting pieces, the second end of one elastic piece is connected with one medicine carrying piece through one connecting piece, and the connecting pieces are decomposed under preset conditions, so that the medicine carrying pieces and the elastic assembly are separated and discharged out of the body in a non-invasive mode.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a long-acting gastric retention drug delivery device. Background Art

[0002] To address the pain points of chronic disease long-term medication compliance, blood drug concentration fluctuations, and personalized treatment gaps, researchers hope to develop a new oral long-acting gastroretentive drug delivery system (OGRDDS). OGRDDS uses mechanical changes or material properties to allow drugs to remain in the stomach for a long time and continuously release, thereby reducing the frequency of dosing, reducing blood drug concentration fluctuations, and improving drug efficacy. Currently, the more promising strategy is the expansion / expansion type OGRDDS, which uses its expansion / expansion in the stomach to form a shape with a diameter greater than 2 cm (the anatomical diameter of the human pylorus) to achieve long-term gastric retention and complete drug release during the retention period. However, due to gastric peristalsis and gastric compression, existing long-acting gastroretentive drug delivery devices still have structural instability problems, which can easily cause the deployed long-acting gastroretentive drug delivery device to be squeezed and deformed, resulting in accidental expulsion, resulting in a shorter retention time in the stomach and failing to meet the needs of long-term drug delivery.

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

[0004] The object of the present invention is to provide a long-acting gastric retention drug delivery device, which can increase the retention time of the drug delivery device in the stomach and ensure long-term drug delivery.

[0005] As conceived above, the technical solution adopted by the present invention is:

[0006] Provided is a long-acting gastric retention drug delivery device capable of entering the stomach by oral self-ingestion, the long-acting gastric retention drug delivery device comprising:

[0007] A drug loading assembly, comprising a plurality of drug loading members, each of which has a drug loading cavity and a drug releasing hole communicating with the drug loading cavity, wherein the drug loading cavity is used to hold the drug, and the drug in the drug loading cavity can be released from the drug releasing hole;

[0008] An elastic assembly comprising a plurality of elastic members, wherein first ends of the plurality of elastic members are connected to each other so that the elastic assembly is star-shaped in an expanded state;

[0009] A reinforcing membrane, wherein the reinforcing membrane is formed by curing a water-hardening polymer, the reinforcing membrane can gradually transform from flexible to rigid in an aqueous environment, and the reinforcing membrane is coated on the outer layer of the elastic component;

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

[0011] Optionally, the connecting member is made of a heat-sensitive material, and the connecting member can melt at a preset temperature to separate the plurality of drug carrying members from the elastic component.

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

[0013] Optionally, a first mounting hole is provided on the connecting cap, a second mounting hole is provided on the medicine carrying member, one end of the connecting member is threadedly connected to the first mounting hole, and the other end of the connecting member is threadedly connected to the second mounting hole.

[0014] Optionally, the connecting cap is docked with the drug carrying member, the first mounting hole is communicated with the second mounting hole, and a first mold is sleeved on the docking point between the connecting cap and the drug carrying member;

[0015] A forming hole is provided on the connection cap, the forming hole being communicated with the first mounting hole, and the forming hole is used to inject a heat-sensitive material forming the connection member into the first mounting hole and the second mounting hole.

[0016] Optionally, the elastic component also includes a center seat, which is a regular polygonal structure. The first ends of multiple elastic members are connected to the side of the center seat. The elastic member is a triangular prism structure. The first end of the elastic member is located above the top surface of the center seat and an inclined surface is provided. The inclined surface is used to make the elastic member avoid the center seat when the elastic component is in a folded state.

[0017] Optionally, perpendicular to the top surface of the center seat, the height of the center seat is h1, the height of the elastic member is h2, 0.2≤h1 / h2≤0.6, 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 carrying component is integrally formed by 3D printing.

[0020] Optionally, the elastic member and the drug-carrying member are both 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 comprises a capsule shell, and the drug-carrying component, the connecting component and the elastic component can be loaded into the capsule shell after being connected, and the capsule shell can be decomposed in the stomach.

[0022] The beneficial effects of the present invention are:

[0023] The long-acting gastric-retention drug delivery device proposed in the present invention can enter the stomach through oral self-ingestion. The long-acting gastric-retention drug delivery device includes a drug-carrying assembly, an elastic assembly, and a connecting assembly. The drug-carrying assembly includes multiple drug-carrying parts, each of which has a drug-carrying cavity for containing the drug. The drug-carrying parts also have a drug-releasing hole connected to the drug-carrying cavity, and the drug in the drug-carrying cavity can be released through the drug-releasing hole. The elastic assembly includes multiple elastic parts, the first ends of which are interconnected to form an elastic assembly that is star-shaped in the expanded state. The connecting assembly includes multiple connecting parts, the second ends of which are respectively connected to the multiple drug-carrying parts through the multiple connecting parts. After the long-acting gastric-retention drug delivery device enters the stomach, the elastic assembly expands into a star shape. The size of the expanded long-acting gastric-retention drug delivery device can be much larger than the anatomical diameter of the human pylorus, so as to meet the physical size requirements of long-term 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 hole to meet the clinical requirement of slowly delivering the drug 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, which is formed by solidifying a water-hardening polymer. The strength of the water-hardening polymer will gradually increase in an aqueous environment, that is, when the reinforcing membrane comes into contact with the liquid in the stomach, its performance will gradually change from flexible to rigid, so as to enhance the rigidity of the elastic component, which makes the elastic component unable to fold anymore. Even if the gastric peristalsis and digestion cause squeezing of the elastic component, the elastic component will not be deformed, thereby ensuring that the long-acting gastric retention drug delivery device can be retained in the stomach for a certain period of time, thereby ensuring long-term drug delivery. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 1 is a schematic structural diagram of a long-acting gastric retention drug delivery device provided by an embodiment of the present invention;

[0026] Figure 2 1 is a schematic diagram of the exploded structure of the connecting cap, the connecting member and the drug carrying member provided in an embodiment of the present invention;

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

[0028] Figure 4is a performance test curve diagram of the water-hardening polymer provided by an embodiment of the present invention;

[0029] Figure 5 This is a comparison chart of characteristics of multiple heat-sensitive materials provided by an embodiment of the present invention;

[0030] Figure 6 This is a comparison chart of the characteristics of a single heat-sensitive material at different times provided by an embodiment of the present invention.

[0031] In the picture:

[0032] 1. Medicine carrier; 11. Second mounting hole;

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

[0034] 3. Elastic component; 31. Elastic member; 311. Inclined surface; 32. Center seat. DETAILED DESCRIPTION

[0035] To make the technical problems solved by the present invention, the technical solutions adopted, and the technical effects achieved more clearly, the technical solutions of the present invention are further described below with reference to the accompanying drawings and through specific embodiments. It should be understood that the specific embodiments described herein are merely for the purpose of explaining the present invention and are not intended to limit the present invention. It should also be noted that, for ease of description, the drawings only show portions relevant to the present invention, not all of them.

[0036] In the description of the present invention, unless otherwise expressly specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention in specific circumstances.

[0037] In the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Furthermore, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0038] In the description of this embodiment, terms such as "upper," "lower," "left," and "right" are used to refer to positions or locations based on those shown in the accompanying drawings. These terms are intended solely to facilitate description and simplify operation, and are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first" and "second" are used solely for descriptive purposes and have no special meaning.

[0039] The technical solution of the present invention will be further described below with reference to the accompanying drawings and through specific implementation methods.

[0040] like Figure 1 As shown, this embodiment provides a long-acting gastric retention drug delivery device that can enter the stomach through oral self-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 a plurality of drug-carrying parts 1, each of which has a drug-carrying cavity for containing drugs. The drug-carrying part 1 also has a drug-releasing hole connected to the drug-carrying cavity, and the drug in the drug-carrying cavity can be released from the drug-releasing hole. The elastic component 3 includes a plurality of elastic parts 31, and the first ends of the plurality of elastic parts 31 are interconnected to form an elastic component 3 that is star-shaped in the expanded state. The connecting component 2 includes a plurality of connecting parts 21, and the second ends of the plurality of elastic parts 31 are respectively connected to the plurality of drug-carrying parts 1 through the plurality of connecting parts 21. After the long-acting gastric retention drug delivery device enters the stomach, the elastic component 3 unfolds into a star-shaped shape. The connector 21 connected to the second end of the elastic component 31 and the drug-carrying member 1 further extend in the radial direction of the star shape, allowing the expanded long-acting gastric retention drug delivery device to be significantly larger than the anatomical diameter of the human pylorus, thereby physically meeting the requirements for long-term gastric retention. While the long-acting gastric retention drug delivery device is retained in the stomach, the drug carried by the drug-carrying member 1 can be slowly released through the drug release holes, meeting the clinical requirement of slow drug delivery to the stomach for a certain period of time. When the drug delivery duration or delivery amount meets the requirements, or when other circumstances require drug delivery termination, the connector 21 can be disassembled to separate the drug delivery member and the drug-carrying member 1. The dimensions of the star-shaped elastic component 3 and the drug-carrying member 1 are both smaller than the anatomical diameter of the human pylorus, meaning that the body can expel the star-shaped elastic component 3 and the drug-carrying member 1 on its own.

[0041] The long-acting gastric retentive drug delivery device provided in this embodiment is used in the stomach. During peristaltic digestion, the stomach compresses the long-acting gastric retentive drug delivery device. To ensure that the long-acting gastric retentive drug delivery device can enter the stomach via oral self-ingestion, the elastic component 3 must be foldable and fit within the capsule shell. This means that the elastic component 3 has good elasticity and is easily bent. This could cause the elastic component 3 to be deformed and accidentally expelled from the stomach due to gastric peristalsis when the elastic component 3 is unfolded, resulting in a shorter retention time in the stomach. Therefore, the long-acting gastric retentive drug delivery device provided in this embodiment also includes a reinforcing membrane, which coats the outer layer of the elastic component 3. The reinforcing membrane is formed by curing a hydrohardening polymer. The hydrohardening polymer gradually increases in strength in an aqueous environment. Specifically, upon contact with gastric fluid, the reinforcing membrane's properties gradually transform from flexible to rigid. In practice, when the long-acting gastric retentive drug delivery device enclosed by the capsule shell enters the stomach and the capsule shell is digested by gastric fluid, the elastic component 3 loses the restraint of the capsule shell and expands into a star shape. When the reinforcing membrane wrapped around the elastic component 3 does not come into contact with the liquid in the stomach, the reinforcing membrane is flexible, that is, it will not affect the stretching and folding of the elastic component 3, so that the elastic component 3 can be folded and placed in the capsule shell, and can also be quickly unfolded after the capsule shell is decomposed. After the reinforcing membrane comes into contact with the liquid in the stomach, the characteristics of the reinforcing membrane will gradually transform into rigidity to enhance the stiffness of the elastic component 3, which makes it impossible for the elastic component 3 to be folded easily. Even if gastric peristalsis and gastric compression apply external force to the elastic component 3, the elastic component 3 is not easily deformed, so as to ensure that the long-acting gastric retention drug delivery device can be retained in the stomach for a certain period of time, thereby ensuring long-term drug delivery.

[0042] In specific implementation, the material for making the drug carrier 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 material for making the elastic component 3 includes but is not limited to at least one of 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-hardening polymer for making the enhanced membrane can be polybenzyl methacrylate-co-polyethylene glycol methacrylate (copolymerized from two monomers, benzyl methacrylate and polyethylene glycol methacrylate), or polybenzyl methacrylate-lithium salt or polyvinyl pyrrolidone, all of which are existing materials and will not be described in detail here.

[0045] This example further verifies the changes in the material properties of water-hardening polymers in the gastric environment. First, artificial gastric juice was prepared with reference to the "Chinese Pharmacopoeia 2025", and the pH value was measured to be 1.35 using a pH meter. Multiple samples of water-hardening polymers (made of polybenzyl methacrylate-co-polyethylene glycol methacrylate) were immersed in artificial gastric juice and incubated in a constant temperature incubator at 37°C. The samples of the corresponding groups were taken out at specific time points (0min, 30min, 60min, 720min, 1440min), and after being completely dried, the stress-strain curve was measured on a testing machine loaded with a 2KN tensile force, and the elongation was fixed at 100mm / min. Reference Figure 4 From the performance test curve of the water-hardening polymer, it can be seen that as the immersion time of the water-hardening polymer sample in artificial gastric juice increases, the water absorption increases and the stiffness of the sample also changes significantly.

[0046] In this embodiment, the reinforcement film is made of a liquid, water-hardening polymer that is directly attached to the elastic member 31 after curing, ensuring a tight connection between the reinforcement film and the elastic member 31. A mold for combining the reinforcement film and the connector 21 is first designed using 3D drawing software, and the mold is then fabricated using a highly transparent quartz sheet. The elastic component 3, fabricated using 3D printing technology, is then 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. Once the solution is injected into the mold, it surrounds the elastic component 3. Finally, the mold is placed under ultraviolet light for curing, resulting in a smooth reinforcement film that evenly covers the surface of the elastic component 3. In practice, the reinforcement film can be set to a thickness of approximately 0.5 mm, ensuring that it does not affect the folding of the elastic component 3 while enhancing its strength in an aqueous environment.

[0047] Optionally, the connector 21 is made of a heat-sensitive material, and the connector 21 can melt at a preset temperature, that is, the method of separating the drug-carrying part 1 and the elastic component 3 provided in this embodiment is to decompose the connector 21 connecting the drug-carrying part 1 and the elastic component 3 by changing the heating temperature of the connector 21. In specific implementation, when it is necessary to separate the drug-carrying part 1 and the elastic component 3, the connector 21 can be heated and reach a preset temperature through non-invasive methods such as HIFU (High-Intensity Focused Ultrasound) or magnetic thermal induction, so that the connector 21 is decomposed to release the connection between the elastic part 31 and the drug-carrying part 1. In the prior art, there are many heat-sensitive materials that can be used in the field of medical devices, which have good thermal sensitivity and can be decomposed at temperatures of 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 has better performance than other materials reported in the literature. 45 Pb 23 In 19 Sn8Cd5( Figure 5 This patent in the horizontal axis), and PCL2000 ( Figure 5 The horizontal axis of the literature1), PCL50000 ( Figure 5 The horizontal axis of the literature2), PCL80000 ( Figure 5 First, multiple samples of the connector 21 were made of the above-mentioned material, and the multiple samples were immersed in artificial gastric juice and incubated in a constant temperature incubator at 37°C. At specific time points (Day 0, Day 1, Day 3, Day 7, Day 14, Day 21), the corresponding groups of samples were taken out, completely dried, and then tested on a 2kN tensile testing machine with a fixed tensile rate of 100mm / min. Figure 5 The characteristic comparison chart of multiple heat-sensitive materials shows that Bi 45 Pb 23 In 19 The maximum connection strength of the Sn8Cd5 material samples was 43.4 times, 20.3 times, and 9.8 times higher than that of other materials (compared to Day 0). Figure 6 The characteristics comparison chart of a single heat-sensitive material at different times. As the immersion time increases, Bi 45 Pb 23 In 19 Although the maximum connection force of the sample made of Sn8Cd5 material has decreased, the connection force is still greater than 60N, which is much higher than the gastric peristalsis and extrusion force, which is 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 to change the pH value of the gastric environment, that is, the connector 21 is made of a pH-decomposable material, and the pH value of the gastric environment can be adjusted to cause the connector 21 to decompose. Alternatively, in other embodiments, the connector 21 can be made of a material that decomposes after a preset time, that is, the connector 21 will automatically decompose after being retained in the stomach for a certain period of time.

[0051] Alternatively, as Figure 2As shown, the connecting assembly 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. In a specific implementation, the connecting cap 22 can be formed using a photosensitive resin material using 3D printing technology. The connecting cap 22 is fixed to the second end of the elastic member 31 by bonding, and then connected to the drug carrying member 1 via the connecting member 21.

[0052] To enhance the stability of the connection between the elastic component 3, the connecting component 2, and the drug-carrying component, mounting holes are provided at the connection cap 22 and the location where the drug-carrying component 1 connects to 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 of the connecting component 21 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 two. An internal thread structure 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 two components.

[0053] Optionally, the connector 21 is formed by solidifying a liquid heat-sensitive material, so that the ends of the connector 21 can directly form an adaptive external thread structure 211 within the first mounting hole and the second mounting hole 11. This is more convenient and quicker than first preparing the connector 21 and setting the external thread structure 211 on the connector 21, and then assembling the connecting cap 22, the connector 21, and the drug carrier 1. In a specific implementation, the end face of the connecting cap 22 connected to the connector 21 is connected to the end face of the drug carrier 1 connected to the connector 21, so that the first mounting hole and the second mounting hole 11 are connected, and a forming mold is installed at the junction of the connecting cap 22 and the drug carrier 1. The forming mold surrounds the junction of the connecting cap 22 and the drug carrier 1 to prevent the liquid heat-sensitive material from overflowing. A forming hole is provided on the connecting cap 22, and the forming hole is connected to the first mounting hole. Liquid heat-sensitive material can be injected into the first mounting hole through the forming hole, and the liquid heat-sensitive material fills the second mounting hole 11. When the liquid heat-sensitive material solidifies, a connecting piece 21 that is threadedly connected to both the first mounting hole and the second mounting hole 11 can be formed.

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

[0055] Alternatively, as Figure 2As shown, the elastic assembly 3 also includes a center seat 32, which is a regular polygonal structure. The first ends of multiple elastic members 31 are each connected to the side of the center seat 32. If N elastic members 31 are provided, the regular polygonal structure is a regular N-sided structure, with each elastic member 31 correspondingly connected to one side of the regular polygonal structure. To reduce the maximum stress experienced by the star-shaped elastic assembly 3 in its unfolded state when fully folded, a clearance structure is provided at the first end of the elastic member 31. This clearance structure ensures that when the multiple elastic members 31 are positioned from parallel to the top surface of the center seat 32 to perpendicular to the top surface of the center seat 32, there is still a gap between the first end of the elastic member 31 and the top surface of the center seat 32. In this embodiment, the elastic member 31 is configured as a triangular prism structure, so that when multiple elastic members 31 are arranged perpendicular to the top surface of the center seat 32, they can be combined into a columnar structure to facilitate being wrapped in a capsule shell, and an inclined surface 311 is provided at the portion of the first end of the elastic member 31 located above the top surface of the center seat 32. There is still a gap between the inclined surface 311 and the top surface of the center seat 32 when the elastic component 3 is in the folded state, 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 drawing software, and the two parameters of the height ratio and the bevel angle are changed. The stress distribution of the elastic component 3 after it is fully folded is calculated on the simulation software using the finite element analysis method. A sample of the elastic component 3 is obtained by 3D printing, and the stress-strain curve of the sample is measured on a tensile testing machine equipped with a 20N sensor. The stretching rate is fixed at 15mm / min, and the elastic modulus is fitted and calculated and used to define the characteristic parameters of the material in the finite element analysis. It can be concluded that the maximum stress when fully folded is positively correlated with the height ratio and the bevel angle. In this embodiment, if 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 perpendicular to the top surface of the center seat 32, and h2 is the height of the elastic member 31 perpendicular to the top surface of the center seat 32. The bevel angle of the elastic component 3 is the angle θ formed between the inclined surface 311 and the top surface of the center seat 32. In practice, to reduce the maximum stress of the elastic component 3 in the fully folded state, the ratio can be set to 0.2 ≤ h1 / h2 ≤ 0.6, and 10° ≤ θ ≤ 80°. Preferably, h1 / h2 = 0.4, and θ = 45°.

[0057] Optionally, since both the elastic member 31 and the drug carrying member 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 arc surfaces, which is beneficial to reduce damage to the gastric mucosa.

[0058] Optionally, the long-acting gastric retention drug delivery device further includes a capsule shell. The drug-carrying component, connecting component 2, and elastic component 3 are connected and can be loaded into the capsule shell. The capsule shell is decomposable in the stomach. In specific implementation, the elastic component 3, connecting cap 22, and drug-carrying member 1 are first produced by 3D printing. A reinforcing film is then coated on the elastic component 3 through curing molding, and a connecting member 21 is formed between the connecting cap 22 and the drug-carrying member 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 is then filled with drug, and the drug delivery device body is then loaded into the capsule shell.

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

[0060] The above embodiments merely illustrate the basic principles and features of the present invention. The present invention is not limited to the above embodiments. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. A long-acting gastric retention drug delivery device capable of entering the stomach by oral self-intake, characterized in that: The long-acting gastric retention drug delivery device comprises: A drug carrying assembly comprises a plurality of drug carrying members (1), each of the drug carrying members (1) having a drug carrying cavity and a drug releasing hole communicating with the drug carrying cavity, the drug carrying cavity being used to hold a drug, and the drug in the drug carrying cavity being capable of being released from the drug releasing hole; An elastic component (3) comprising a plurality of elastic members (31), wherein first ends of the plurality of elastic members (31) are connected to each other so that the elastic component (3) is star-shaped in an expanded state; A reinforcement film, the reinforcement film being formed by curing a water-hardening polymer, the reinforcement film being capable of gradually transforming from flexibility to rigidity in an aqueous environment, the reinforcement film being coated on the outer layer of the elastic component (3); The connecting assembly (2) comprises a plurality of connecting members (21), wherein the second ends of the plurality of elastic members (31) are connected to the plurality of drug-carrying members (1) in a one-to-one correspondence via the plurality of connecting members (21), and the plurality of connecting members (21) can be decomposed under preset conditions so that the plurality of drug-carrying members (1) can be separated from the elastic assembly (3), and the separated drug-carrying members (1) and the elastic assembly (3) can be discharged from the body non-invasively.

2. The long-acting gastric retention drug delivery device according to claim 1, characterized in that: The connecting member (21) is made of a heat-sensitive material and can melt at a preset temperature to separate the plurality of drug-carrying members (1) from the elastic component (3).

3. The long-acting gastric retention drug delivery device according to claim 1, characterized in that The connecting assembly (2) further comprises a connecting cap (22), wherein the connecting cap (22) is arranged 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 long-acting gastric retention drug delivery device according to claim 3, characterized in that: A first mounting hole is provided on the connecting cap (22), a second mounting hole (11) is provided on the medicine carrying member (1), one end of the connecting member (21) is threadedly connected to the first mounting hole, and the other end of the connecting member (21) is threadedly connected to the second mounting hole (11).

5. The long-acting gastric retention drug delivery device according to claim 4, characterized in that: The connecting cap (22) is docked with the medicine carrying member (1), the first mounting hole is communicated with the second mounting hole (11), and a first mold is sleeved on the docking position between the connecting cap (22) and the medicine carrying member (1); A forming hole is provided on the connecting cap (22), the forming hole being in communication with the first mounting hole, and the forming hole being used to inject heat-sensitive material forming the connecting piece (21) into the first mounting hole and the second mounting hole (11).

6. The long-acting gastric retention drug delivery device according to claim 1, characterized in that: The elastic component (3) further comprises a center seat (32), the center seat (32) being a regular polygonal structure, the first ends of the plurality of elastic members (31) being connected to the side surface of the center seat (32), the elastic members (31) being a triangular prism structure, the first end of the elastic member (31) being located above the top surface of the center seat (32) and being provided with an inclined surface (311), the inclined surface (311) being used to enable the elastic member (31) to avoid the center seat (32) when the elastic component (3) is in a folded state.

7. The long-acting gastric retention drug delivery device according to claim 6, characterized in that: Perpendicular to the top surface of the center seat (32), the height of the center seat (32) is h1, the height of the elastic member (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 carrying component (1) is integrally formed by 3D printing.

9. The long-acting gastric retention drug delivery device according to claim 1, characterized in that: The elastic member (31) and the drug-carrying member (1) are both 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 further comprises a capsule shell. The drug-carrying component, the connecting component (2) and the elastic component (3) can be loaded into the capsule shell after being connected, and the capsule shell can be decomposed in the stomach.

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