Devices for oral administration or intragastric injection

Abstract

This invention discloses a device for oral administration via injection into the digestive tract, comprising a housing, a triggering component, and a drug delivery component. The housing includes a top cover, a central intermediate shell, and a base. The intermediate shell has a lower material density than the base, thus giving the device a self-sustaining shape. The triggering component includes a soluble fixing member, an elastic member, and a transmission member. The drug delivery component includes microneedles and a drug. The device provided by this invention, by incorporating a reservoir, significantly increases the drug loading capacity, theoretically achieving a drug loading of 50 mg, representing a substantial improvement over existing technologies.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and more specifically to a device for administering medication orally or by injection into the digestive tract. Background Technology

[0002] Oral administration is the most common method of drug delivery, with advantages such as convenience and good patient compliance. However, oral formulations are not very suitable for large biological molecules due to factors such as the need to pass through the highly acidic environment of the intestine. At present, large biological molecules such as insulin, peptides, antibodies, and vaccines cannot be delivered orally and are generally administered by injection. However, patient compliance with injection is low, and some patients have a fear of needles. In addition, injection administration generally requires professional medical staff to perform, which is inconvenient and limits the application of such drugs.

[0003] Microneedling is a form of injection that creates drug delivery channels on the skin surface after needle insertion, effectively promoting transdermal drug absorption. Compared to oral administration, which relies on the digestive tract for absorption, microneedling offers faster absorption and higher drug utilization, along with advantages such as being minimally invasive, painless, and convenient. Combining microneedling with oral administration—by embedding microneedles within capsules to achieve the rapid absorption effect of injection via oral administration—is an ideal drug delivery method that has attracted widespread attention in research and clinical applications.

[0004] The biggest drawback of oral capsule microneedles is their low drug loading capacity. In particular, the overall drug loading capacity of solid microneedles is difficult to exceed the milligram level. Liquid microneedles generally only contain the drug liquid in the conical needle tip of the microneedle, and the drug loading capacity is also relatively small. Therefore, there is an urgent need to develop a device that can deliver drugs orally into the digestive tract with a large drug loading capacity. This device can also eliminate injection pain, increase patient compliance, and achieve the absorption efficiency of injection through oral administration. Summary of the Invention

[0005] To address the technical problems in the prior art, the present invention provides a device for oral administration via injection into the digestive tract. Specifically, the present invention mainly includes the following:

[0006] This invention provides a device for oral administration via injection into the digestive tract, comprising a housing (1000), a triggering component (2000), and a drug delivery component (3000), wherein:

[0007] The outer casing (1000) includes a top cover (1100) at its upper part, an intermediate shell (1200) in the middle part, and a base (1300) at its bottom. The material density of the intermediate shell (1200) is less than that of the base (1300), so that the device is roly-poly shaped.

[0008] The triggering component (2000) includes a soluble fixing component (2100), an elastic component (2200), and a transmission component (2300);

[0009] The drug delivery component (3000) includes microneedles (3100) and a drug.

[0010] In some embodiments, the device for oral administration via injection into the digestive tract according to the present invention, wherein the administration component (3000) further includes a reservoir (3200), the top surface of which is connected to the transmission member (2300), the bottom surface of which is connected to a microneedle (3100), and the bottom surface of which is provided with an opening communicating with the microneedle (3100) below it.

[0011] In some embodiments, the device for oral administration via injection into the digestive tract according to the present invention, wherein the top cover (1100) is an arc-shaped cover plate, the top cover (1100) is made of a soluble material, the intermediate shell (1200) is a hollow frustum with an opening at the lower end, the frustum having convex arc-shaped sides around its perimeter, and the base (1300) is a hollow inverted frustum with openings at the top and bottom, the inverted frustum having convex arc-shaped sides around its perimeter.

[0012] In some embodiments, according to the present invention, the device for oral administration via injection into the digestive tract includes a transmission component (2300) comprising an outer cylinder (2310) and a guide post (2320). The outer cylinder (2310) is a hollow cylinder with an open top. The guide post (2320) is vertically disposed at the center of the outer cylinder (2310), and a first through hole (2321) is provided at the upper end of the guide post (2320). The elastic component (2200) is a spring, which is fitted onto the guide post (2320). Two second through holes (1210) are provided on the top surface of the intermediate shell (1200), and the two second through holes (1210) are symmetrically disposed on both sides of the guide post (2320). The fixing component (2100) is a soluble thread, which passes through the first through hole (2321) and the two second through holes (1210) and is bound together.

[0013] In some embodiments, the device for oral administration via injection into the digestive tract according to the present invention, wherein the microneedle (3100) includes a needle hub (3110), a needle tip (3120), and a needle cap (3130), the needle tip (3120) being a hollow frustum or prismatic shape, the needle cap (3130) being fitted under the needle tip (3120) to seal the needle tip (3120), the shape and size of the needle cap (3130) being adapted to the needle tip (3120), and the shape of the needle cap (3130) being a hollow cone or prismatic shape.

[0014] In some embodiments, the device for oral administration via injection into the digestive tract according to the invention, wherein the reservoir (3200) is made of an elastic material, and the pressure A generated by the elastic member, the deformation resistance B of the reservoir (3200) and the resistance C of the microneedle (3100) to penetrate the tissue satisfy the conditions: A>B>C, and A>B+C.

[0015] In some embodiments, the device for oral administration via injection into the digestive tract according to the present invention, wherein an annular adhesive layer (1400) is provided at the bottom of the housing (1000), the annular adhesive layer is fixed to the bottom surface of the base (1300), the shape and size of the adhesive layer (1400) are adapted to the bottom surface of the base (1300), and the material of the adhesive layer includes a viscous polymer and optional adjuvant drugs.

[0016] In some embodiments, the device for oral administration via injection into the digestive tract according to the present invention, wherein a water-resistant membrane (1500) is provided at the bottom of the outer shell (1000), the water-resistant membrane (1500) being an insoluble thin film material, the water-resistant membrane (1500) having a thickness of 50-100 μm.

[0017] In some embodiments, the device for oral administration via injection into the digestive tract according to the present invention, wherein the microneedle (3100) is configured as an integrally formed soluble solid microneedle module, the soluble solid microneedle module being filled with a solid drug or coated with a solid drug, thereby enabling flexible switching between solid and liquid drug administration through a modular design.

[0018] In some embodiments, the device for oral administration via injection into the digestive tract according to the present invention, wherein the needle hub (3110) and needle tip (3120) are insoluble or poorly soluble materials, and the needle cap (3130) is a soluble material selected from at least one of the following: sodium hyaluronate, sodium carboxymethyl cellulose, pullulan, polyvinyl alcohol, water-soluble polysaccharides, hydroxypropyl methylcellulose, carboxymethyl cellulose, dextran, alginate, starch and gelatin blend, polyvinylpyrrolidone-polyvinyl alcohol, poly(methyl vinyl ether-co-maleic anhydride), trehalose, polyethylene glycol diacrylate, polyethylene glycol, methacrylamide gelatin, and methacrylamide hyaluronic acid.

[0019] The beneficial effects of this invention include:

[0020] 1. By setting up a reservoir, the present invention greatly increases the drug loading capacity, theoretically achieving a drug loading capacity of 50mg, which is a significant improvement compared to existing devices that administer drugs orally via injection into the digestive tract;

[0021] 2. By setting a stainless steel base, the center of gravity is lowered as much as possible, similar to a roly-poly toy, ensuring that the bottom of the drug delivery device always faces downwards, thus ensuring safe and reliable drug delivery. Attached Figure Description

[0022] Figure 1 This is a cross-sectional view of the overall structure of a microneedle within a shell, as exemplified by the present invention.

[0023] Figure 2 This is an exemplary cross-sectional view of the overall structure of the present invention when a portion of the microneedles extends outside the outer shell.

[0024] Figure 3 This is a cross-sectional view of the overall structure of a liquid reservoir when it is squeezed, as exemplified by the present invention.

[0025] Figure 4 This is an exploded view of an exemplary overall device of the present invention.

[0026] Figure 5 This is a three-dimensional schematic diagram of an exemplary casing of the present invention.

[0027] Figure 6 This is a three-dimensional schematic diagram of a microneedle exemplified by the present invention.

[0028] Figure 7 This is a three-dimensional schematic diagram of a transmission component exemplified by the present invention.

[0029] Figure 8 This is a three-dimensional schematic diagram of an exemplary intermediate shell of the present invention.

[0030] Figure 9 The pressure field distribution diagrams are for different shaped shells, which are examples of the present invention.

[0031] Figure 10 The velocity field distribution diagrams are for different shaped shells, which are examples of the present invention.

[0032] Figure 11 The diagram shows the velocity field resistance values ​​of shells with different shapes, which are exemplary embodiments of the present invention.

[0033] Figure 12 This is an example of a soluble thread before and after dissolution, showing a comparison before and after dissolution.

[0034] Figure 13 This is a sample image of a high center of gravity device exemplified by the present invention.

[0035] Figure 14 This is a sample image of a low center of gravity device exemplified by the present invention.

[0036] Explanation of reference numerals in the attached figures:

[0037] 1000. Outer shell; 1100. Top cover; 1200. Intermediate shell; 1210. Second through hole; 1220. First step; 1300. Base; 1310. Second step; 1400. Adhesive layer; 1500. Waterproof membrane; 2000. Triggering component; 2100. Fixing component; 2200. Elastic component; 2300. Transmission component; 2310. Outer cylinder; 2320. Guide post; 2321. First through hole; 3000. Drug delivery component; 3100. Microneedle; 3110. Needle seat; 3120. Needle tip; 3130. Needle cap; 3200. Reservoir. Detailed Implementation

[0038] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0039] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that the upper and lower limits of the range and each intermediate value between them are specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, are also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0040] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While only preferred structures and materials have been described herein, any structures and materials similar to or equivalent to those described herein may be used in the implementation or testing of this invention.

[0041] Furthermore, the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., used in the specification and claims to indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are merely for the convenience of describing the invention and simplifying the description, 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, and therefore should not be construed as a limitation of the invention. In addition, terms such as "first," "second," etc., are also used to describe various elements, areas, parts, etc., and do not specifically refer to any order or sequence, and should not be considered as limitations. It should be understood that such terms can be replaced under appropriate conditions, and the embodiments of the invention described herein can operate in orientations other than those described or exemplified herein.

[0042] In this invention, the term "fixed connection" includes both detachable and non-detachable fixed connections. Detachable fixed connections include bolted connections, while non-detachable fixed connections include welding.

[0043] Example

[0044] like Figures 1-8 As shown, this embodiment provides a device for oral administration via injection into the digestive tract, including a housing 1000, a triggering component 2000, and a drug delivery component 3000.

[0045] The outer shell 1000 is a housing that covers the trigger component 2000 and the drug delivery component 3000. To ensure smooth movement of the outer shell 1000 within the digestive tract, three different shapes of the outer shell 1000 were designed for comparison. Resistance calculations and simulations were performed on the three shapes of the outer shell 1000 using CFD (Computational Fluid Dynamics) technology. Figures 9-11 It can be seen that shape 3 has the least resistance. However, since the upper part of shape 3 is a sharp cone, the internal space is small and cannot meet the needs of installing mechanical structures and drugs. Therefore, considering all factors, shape 1 is the optimal solution, that is, an oval or egg-shaped structure with a flat bottom.

[0046] The outer casing 1000 includes a top cover 1100, a middle casing 1200, and a base 1300. The top cover 1100 is located at the top of the outer casing 1000 and is an arc-shaped cover plate with a higher center and lower ends. The middle casing 1200 is located in the middle of the outer casing 1000 and is preferably a hollow frustum-shaped structure with an open bottom. More preferably, the hollow frustum-shaped structure has convex arc-shaped sides around its perimeter. The top cover 1100 and the middle casing 1200 can be fixedly connected or detachably connected. The fixed connection can be adhesive, and the detachable connection can be threaded. The base 1300 is located at the bottom of the outer casing 1000 and is preferably a hollow inverted frustum-shaped structure with open top and bottom. More preferably, the hollow inverted frustum-shaped structure has convex arc-shaped sides around its perimeter.

[0047] The bottom opening of the base 1300 is preferably circular, and the bottom surface of the base has an annular structure. The base 1300 and the intermediate housing 1200 can be movably connected, and the movable connection can be a threaded connection or a snap-fit ​​connection, preferably a threaded connection.

[0048] Furthermore, the height of the outer shell 1000 is preferably 15-20 mm, and the maximum diameter of the middle shell 1200 is preferably 13-18 mm.

[0049] The height of the center of gravity has a decisive influence on the uprightness of the device. Experiments were conducted on various components of the outer shell 1000 using different materials, demonstrating that by lowering the center of gravity of the outer shell 1000 to a lower density than that of the base 1300, the entire device could be quickly uprighted. Figure 14 As shown, the base 1300 of the device is made of stainless steel. Due to its low center of gravity, the device can quickly return to an upright position. Figure 13 As shown, the base 1300 of the device is made of resin material, and due to its high center of gravity, it cannot stand upright on its own. The overall device, through a precisely designed low center of gravity, makes the device similar to a roly-poly toy, ensuring that the base 1300 always faces downwards. This allows the injection microneedles to be automatically positioned on the gastric mucosa, enabling drug delivery through the digestive tract into the stomach.

[0050] The base 1300 is preferably made of stainless steel, more preferably food-grade stainless steel. Food-grade stainless steel will not leach various alloys and harmful substances in acidic or alkaline solutions. Austenitic or ferritic stainless steel can be selected, such as 1Cr18Ni9Ti, 0Cr19Ni9, 1Cr18Ni9, 1Cr17Ni2, etc. The main component of gastric acid is dilute hydrochloric acid. Under normal circumstances, the pH of gastric acid is 1.8-3.5, and it can be as low as 0.9 when fasting for a long time. At a human body temperature of 36.5℃, this concentration of dilute hydrochloric acid is difficult to corrode ordinary stainless steel, and the harmful elements produced are basically negligible.

[0051] The triggering component 2000 includes a fixing component 2100, an elastic component 2200, and a transmission component 2300. The triggering component 2000 is used to drive the drug delivery component 3000 to administer the drug. The fixing component 2100 is made of a soluble material that gradually dissolves upon contact with a liquid. The fixing component 2100 is preferably a soluble thread. The elastic component 2200 is an elastic member, which can be a spring, a sheet, etc. The elastic component 2200 is preferably a cylindrical helical spring. The elasticity of a spring is generally greater than that of a sheet, and a cylindrical helical spring is convenient for fixed installation. The elastic component 2200 is initially in a compressed state when installed. The transmission component 2300 transmits the elastic force of the elastic component 2200 to the drug delivery component 3000, pushing part of the drug delivery component 3000 out of the outer shell 1000 for injection. The spring is placed inside the transmission component 2300. The transmission component 2300 includes an outer cylinder 2310 and a guide post 2320. The outer cylinder 2310 is preferably a hollow cylinder with an open top. Preferably, the outer diameter of the outer cylinder 2310 is slightly smaller than the inner diameter of the intermediate shell 1200, so that the transmission component 2300 can move freely up and down within the outer shell 1000. The guide post 2320 is vertically arranged at the center of the outer cylinder 2310. The guide post 2320 can be in the shape of a cylinder, square prism, polyhedral prism, etc., preferably a cylinder. The outer diameter of the guide post 2320 is slightly smaller than the inner diameter of the spring, so that the spring can be fitted onto the guide post 2320, making the spring less prone to movement and maintaining stability. The height of the guide post 2320 is higher than the height of the outer cylinder 2310, and the height of the guide post 2320 is less than the height of the spring in its natural state. A first through hole 2321 is horizontally arranged at the upper end of the guide post 2320, so that the fixing component 2100 can pass through it.

[0052] Furthermore, the top surface of the intermediate housing 1200 is provided with two second through holes 1210, which penetrate the top surface. The two second through holes 1210 are symmetrically arranged on both sides of the guide post 2320. The second through holes 1210 can be circular, semi-circular, elliptical, etc. The fixing member 2100 passes through the first through hole 2321 and the two second through holes 1210 and is fixed together. The fixing method can be selected according to the structure and material of the fixing member 2100, such as plug-in, snap-fit, or binding. The fixing member 2100 fixes the transmission member 2300 to the intermediate housing 1200, so that the spring is kept in a compressed state.

[0053] Furthermore, an annular first step 1220 is provided on the inner wall of the intermediate shell 1200. Preferably, the inner and outer diameters of the first step 1220 are the same as the inner and outer diameters of the outer cylinder 2310. When the spring is in the initial compressed state, the upper surface of the outer cylinder 2310 abuts against the first step 1220 to keep the spring position stable.

[0054] Furthermore, the soluble filament 2100 is preferably a filament made primarily of PVA, such as... Figure 12As shown, PVA is a water-soluble polymer that is non-toxic and harmless, and has a certain degree of toughness and strength. It can firmly fix the compression spring, and PVA filaments will dissolve when they come into contact with water, thereby quickly releasing the compressed spring.

[0055] Furthermore, the top cover 1100 is made of a soluble material, and its main components are soluble components, including but not limited to modified starch, gelatin, polyvinyl alcohol and other polymer materials. The main function of the top cover 1100 is to protect the soluble thread 2100 from premature dissolution after the drug delivery device is swallowed, and at least to prevent leakage at the top cover before it reaches the stomach. The dissolution time of the top cover 1100 can be set as needed.

[0056] The drug delivery assembly 3000 includes microneedles 3100 and drugs. The microneedles 3100 include a needle hub 3110, a needle tip 3120, and a needle cap 3130. The type of drug can be selected according to the patient's condition. The needle hub 3110 is preferably a cylindrical structure with an open top. One or more needle tips 3120 are disposed on the bottom surface of the needle hub 3110. The needle tip 3120 can be a hollow frustum or prismatic structure. The central channel of the needle tip 3120 serves as a drug flow channel and is connected to the needle hub 3110. Both the needle hub 3110 and the needle tip 3120 can store drug solution, further increasing the drug loading capacity.

[0057] Furthermore, the upper end face of the needle holder 3110 is provided with an annular folded edge. Preferably, the outer diameter of the folded edge of the needle holder 3110 is the same as the outer diameter of the outer cylinder 2310. The inner wall of the bottom end of the base 1300 is provided with a second step 1310 that is adapted to the needle holder 3110. The inner diameter of the second step 1310 is larger than the diameter of the cylindrical hollow cylinder of the needle holder 3110, and the outer diameter of the second step 1310 is larger than the outer diameter of the folded edge of the needle holder 3110, so that the needle holder 3110 can move freely up and down within the outer shell 1000. The inner diameter of the second step 1310 is smaller than the outer diameter of the folded edge of the needle holder 3110, so that the second step 1310 blocks the folded edge of the needle holder 3110 to prevent the microneedle 3100 from sliding out of the outer shell 1000.

[0058] The needle cap 3130 is fitted under the needle tip 3120 to seal the needle tip 3120. The shape and size of the needle cap 3130 are adapted to the needle tip 3120. The shape of the needle cap 3130 can be a hollow cone or pyramid. The pointed end of the needle cap 3130 is used to puncture the tissue. The needle cap 3130 is made of a soluble material, while the needle hub 3110 and the needle tip 3120 are made of insoluble or poorly soluble materials. The middle of the needle tip 3120 is a liquid delivery channel. After the needle cap 3130 punctures the tissue, the drug solution is injected into the tissue through the middle channel of the needle tip 3120. After the acupuncture injection is completed, the needle cap 3130 can dissolve on its own. After dissolution, the entire microneedle 3100 no longer has a sharp head, avoiding damage to the mucous membrane during the expulsion process.

[0059] Needle cap 3130 can be manufactured by molding. The material of needle cap 3130 is a soluble material. The material of needle cap 3130 should meet the following requirements: 1) good biocompatibility and non-toxic, and has been used in clinical practice; 2) stable material properties that do not affect drug activity; 3) sufficient mechanical strength to penetrate the skin without breaking; 4) wide application and strong plasticity; 5) able to dissolve in the skin and control the drug release rate.

[0060] The raw materials for preparing the needle cap 3130 include, but are not limited to, the following: sodium hyaluronate (HA), sodium carboxymethyl cellulose (CMC-Na), pullulan, polyvinyl alcohol (PVA), water-soluble polysaccharides, hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), dextran, alginate, starch and gelatin blend, polyvinylpyrrolidone-polyvinyl alcohol (PVP-PVA), poly(methyl vinyl ether-co-maleic anhydride) (PMVE / MA), trehalose, PEGDA, polyethylene glycol (PEG), methacrylamide gelatin (GELMA), and methacrylamide hyaluronic acid (HAMA). It can be one or a combination of the above materials, with sodium hyaluronate (HA) being preferred. HA is a safe and reliable biomaterial and drug carrier with good biocompatibility, high viscoelasticity, plasticity, and permeability. HA with different relative molecular masses has different mechanical properties, and different relative molecular weights of HA can be selected according to actual needs when preparing microneedles. Currently, HA is widely used in the preparation of microneedles. When microneedles are administered, HA can dissolve rapidly in tissue fluid and undergo biodegradation in vivo.

[0061] The needle hub 3110 and the needle tip 3120 are made of insoluble or poorly soluble materials, and can be selected from at least one or a combination of high-toughness resins, such as polyethylene, polyvinyl chloride, polycarbonate, polystyrene and light-curing adhesives, or metals, such as stainless steel.

[0062] The soluble filament 2100 controls the spring to remain in a compressed state. After the soluble filament melts, the spring releases pressure and pushes the transmission component 2300. The transmission component 2300 pushes the needle holder 3110 downward, thereby pushing the microneedle tip 3120 out of the outer shell 1000 for drug injection.

[0063] The number of needle tips can be one or more, evenly distributed in an array on the needle base. In this embodiment, there are three needle tips. The dissolution time of the needle tips varies from 5 minutes to 24 hours depending on the material used. The needle tip length is preferably 2-3.5 mm, and more preferably 2.5 mm.

[0064] Furthermore, a water-resistant membrane 1500 is provided on the bottom surface of the base 1300 to prevent external liquids from entering the outer shell 1000 and dissolving the needle cap 3130. When the microneedle 3100 moves downward, the needle cap 3130 pierces the water-resistant membrane 1500 and continues to move into the tissue. The material of the water-resistant membrane 1500 includes, but is not limited to, high molecular materials such as polyethylene, paraffin mixture, polytetrafluoroethylene, rubber, and polyolefins. The thickness of the water-resistant membrane 1500 is preferably 50-100 μm.

[0065] Furthermore, the drug delivery assembly 3000 is also equipped with a reservoir 3200, which stores liquid medication, greatly increasing the drug loading capacity of the drug delivery device. The upper end of the reservoir 3200 is connected to the transmission component 2300, and the lower end of the reservoir 3200 is connected to the microneedle seat 3110. The reservoir 3200, transmission component 2300, and microneedle seat 3110 can be fixedly connected or detachably connected. The fixed connection can be adhesive. Preferably, the upper and lower surfaces of the reservoir 3200 are circular. Preferably, the outer diameter of the upper surface of the reservoir 3200 is slightly smaller than the outer diameter of the bottom surface of the transmission component 2300, and the outer diameter of the lower surface of the reservoir 3200 is slightly smaller than the outer diameter of the folded edge of the needle seat 3110, so that the two ends of the reservoir 3200 abut more stably and reliably when compressed and expanded.

[0066] The reservoir 3200 has an opening on its bottom surface, preferably circular. This circular opening allows the medication stored in the reservoir to flow into the microneedle 3100 below, significantly increasing the device's drug loading capacity. The maximum drug loading capacity can reach 50mg, far exceeding that of devices that only store medication within the microneedle. Preferably, the diameter of the opening on the bottom surface of the reservoir 3200 is slightly smaller than the inner diameter of the cylinder of the needle holder 3110, to facilitate smoother flow of the medication from the reservoir into the microneedle.

[0067] Furthermore, the reservoir 3200 is preferably a conical cylinder that is thicker at both ends and thinner in the middle, which provides more compression space, increases the deformation of the reservoir, and facilitates the squeezing of the liquid in the reservoir 3200 into the microneedle 3100.

[0068] The reservoir 3200 is made of an elastic material. Under the compression of the upper spring, it can deform and inject the drug solution inside the reservoir 3200 into human tissue through the lower microneedle channel. The reservoir 3200 is preferably made of medical-grade silicone rubber. Silicone rubber has high elasticity and excellent biocompatibility. It is non-irritating and non-toxic to human tissue. It can maintain its original elasticity and softness during contact with body fluids and tissues and will not be degraded. It is a very stable inert material.

[0069] By analyzing the forces involved in the acupuncture process, it can be seen that the entire acupuncture process involves three forces: the elastic downward pressure of the spring (A), the deformation resistance of the reservoir (B), and the resistance of the microneedle to the tissue (C). To complete the required injection action, it is necessary to ensure that A > B > C and A > B + C. In this embodiment, a precision force measuring device was used to measure and compare the three forces. The data for the three forces are A = 0.741 kgf, B = 0.293 kgf, and C = 0.011 kgf, respectively. It can be seen from the data that the designed device fully meets the required force conditions.

[0070] Furthermore, an annular adhesive layer 1400 is provided at the bottom of the base 1300. The adhesive layer 1400 is fixed to the bottom surface of the base 1300. The shape and size of the adhesive layer 1400 are adapted to the bottom surface of the base 1300. Preferably, the inner and outer diameters of the adhesive layer 1400 are consistent with the inner and outer diameters of the annular opening on the bottom surface of the base 1300.

[0071] The adhesive layer 1400 serves two purposes: 1. as an auxiliary fixation method; 2. the adhesive layer contains hemostatic Chinese medicine components, promoting the healing of acupuncture wounds. In this embodiment, mechanical measurements show that the maximum adhesive force of the adhesive layer is 0.005 kgf, and the weight of the capsule device is 8-10 g. During swallowing, the esophageal wall is in a naturally vertical state. Since the adhesive force is less than the gravity, in positions such as the vertical esophagus, the adhesive force cannot overcome gravity to fix the drug delivery device to the esophageal wall, and the drug easily "slides" into the stomach for adhesion and fixation. Furthermore, the low center of gravity of the base 1300 further ensures that the base of the drug delivery device is fixed to the stomach wall. The fixation of the drug delivery device is mainly achieved by the low center of gravity of the outer shell, which is positioned at the bottom of the stomach by gravity. At the same time, the adhesive layer 1400 assists in fixation. During swallowing, the esophageal wall is always vertical. Without the action of gravity, the adhesive layer 1400 at the bottom alone cannot fix the drug delivery device to the esophageal wall, thus avoiding the device being fixed to the vertical esophageal wall.

[0072] Furthermore, the adhesive layer 1400 material includes, but is not limited to, extracts of traditional Chinese medicines such as Panax notoginseng and Bletilla striata that have anti-inflammatory and hemostatic effects, as well as adhesive polymers such as carbomer and hydroxypropyl methylcellulose.

[0073] As the drug delivery device slides down the esophageal wall into the stomach, due to the low center of gravity of the base 1300, it stops at the lateral bend at the bottom of the stomach. The adhesive layer 1400 adheres to the stomach wall, the top cover 1100 gradually dissolves until tissue fluid enters the outer shell 1000, the soluble filaments 2100 begin to dissolve, the spring 2200 is released, and the spring 2200 pushes the transmission component 2300, the reservoir 3200, and the microneedle 3100 downwards. Until the folded edge of the microneedle hub 3110 abuts against the second step 1310, the microneedle tip 3120 extends beyond the outer shell 1000 and pierces the stomach wall. Since the stomach wall is about 3-4mm thick and the needle tip is about 2.5mm, the needle tip will not pierce the stomach wall, but will only pierce under the mucus layer. Moreover, there are few sensory nerves in the digestive tract, so it will not cause pain to the patient. The spring continues to press the reservoir, thereby deforming the reservoir and squeezing the liquid in the reservoir into the microneedle, thus accelerating the flow rate of the liquid.

[0074] To further expand its applicability, this device can flexibly switch between solid and liquid drug delivery through modular design. The microneedle 3100 can be made into a one-piece molded dissolvable solid microneedle. The dissolvable solid microneedle is filled with solid drug inside or coated with solid drug on the surface. When the microneedle 3100 comes into contact with tissue fluid, it can dissolve and release the drug.

[0075] A common method for fabricating solid microneedles is to first dissolve biological drugs in water to prepare an aqueous solution. Then, dissolve solidifiable and soluble materials, such as hyaluronic acid, gelatin, and modified polyvinyl alcohol, in this drug-containing aqueous solution. The mixture is then poured into a microneedle mold for filling, drying, and demolding, resulting in a soluble drug-containing solid microneedle. After insertion into the skin, the needle, composed of soluble materials, gradually dissolves in the tissue fluid, releasing the drug simultaneously to achieve the therapeutic purpose. Furthermore, the soluble solid microneedle preferably has a pointed tip for easy tissue insertion.

[0076] Because the top surface of the intermediate shell 1200 obstructs the flow, the spring 2200 cannot slide out from the top of the outer shell 1000. Furthermore, the second step 1310 on the inner wall of the base 1300 obstructs the microneedle hub 3110, preventing the spring 2200, transmission component 2300, reservoir 3200, and microneedle hub 3110 inside the outer shell 1000 from sliding out, thus avoiding harm to the human body. Moreover, the needle cap 3130 is soluble and dissolves on its own after injection, without damaging the mucous membrane. Additionally, the entire device has a closed elliptical structure, and the metal components inside the outer shell 1000 do not directly contact tissues. After injection, the entire device is excreted through the digestive tract. Furthermore, some drugs containing metal or even electronic devices have been used clinically without showing any risk of harm to the human body.

[0077] Although the invention has been described with reference to exemplary embodiments, it should be understood that the invention is not limited to the disclosed exemplary embodiments. Various adjustments or changes may be made to the exemplary embodiments described in this specification without departing from the scope or spirit of the invention. The scope of the claims should be interpreted in the broadest possible sense to cover all modifications and equivalent structures and functions.

Claims

1. A device for oral injection administration within the digestive tract, characterized in that, Includes a housing (1000), a triggering component (2000), and a drug delivery component (3000), wherein: The outer casing (1000) includes a top cover (1100) at its upper part, an intermediate casing (1200) in the middle part, and a base (1300) at its bottom. The material density of the intermediate casing (1200) is less than that of the base (1300), so that the device is roly-poly shaped. The triggering component (2000) includes a soluble fixing component (2100), an elastic component (2200), and a transmission component (2300). The transmission component (2300) transmits the elastic force of the elastic component (2200) to the drug delivery component (3000), and the fixing component (2100) fixes the transmission component (2300) to the intermediate shell (1200). The drug delivery assembly (3000) includes microneedles (3100), drug, and reservoir (3200). The top surface of the reservoir (3200) is connected to the transmission component (2300), and the bottom surface of the reservoir (3200) is connected to the microneedle (3100). The bottom surface of the reservoir (3200) is provided with an opening that communicates with the microneedle (3100) below it. The reservoir (3200) is made of elastic material, and the pressure A generated by the elastic component, the deformation resistance B of the reservoir (3200), and the resistance C of the microneedle (3100) to penetrate the tissue satisfy the conditions: A>B>C, and A>B+C. The microneedle (3100) includes a needle base (3110), a needle tip (3120), and a needle cap (3130). The needle cap (3130) is fitted under the needle tip (3120) to seal the needle tip (3120), and the needle cap (3130) is made of a soluble material.

2. The device for oral administration via injection into the digestive tract according to claim 1, characterized in that, The top cover (1100) is an arc-shaped cover plate, the material of the top cover (1100) is a soluble material, the middle shell (1200) is a hollow frustum with an opening at the lower end, and the frustum has convex arc-shaped sides around its perimeter, and the base (1300) is a hollow inverted frustum with openings at the top and bottom, and the inverted frustum has convex arc-shaped sides around its perimeter.

3. The device for oral administration via injection into the digestive tract according to claim 1, characterized in that, The transmission component (2300) includes an outer cylinder (2310) and a guide post (2320). The outer cylinder (2310) is a hollow cylinder with an open top. The guide post (2320) is vertically arranged at the center of the outer cylinder (2310). A first through hole (2321) is provided at the upper end of the guide post (2320).

4. The device for oral administration via injection into the digestive tract according to claim 1, characterized in that, The elastic component (2200) is a spring, which is fitted onto the guide post (2320); two second through holes (1210) are provided on the top surface of the intermediate shell (1200), and the two second through holes (1210) are symmetrically arranged on both sides of the guide post (2320); the fixing component (2100) is a soluble thread, and the fixing component (2100) passes through the first through hole (2321) and the two second through holes (1210) and is tied together.

5. The device for oral administration via injection into the digestive tract according to claim 1, characterized in that, The needle tip (3120) is a hollow frustum or pyramid shape, and the shape and size of the needle cap (3130) are adapted to the needle tip (3120). The shape of the needle cap (3130) is a hollow cone or pyramid shape.

6. The device for oral administration via injection into the digestive tract according to claim 1, characterized in that, The bottom of the outer shell (1000) is provided with an annular adhesive layer (1400), which is fixed on the bottom surface of the base (1300). The shape and size of the adhesive layer (1400) are adapted to the bottom surface of the base (1300).

7. The device for oral administration via injection into the digestive tract according to claim 6, characterized in that, The adhesive layer is made of a viscous polymer and optionally an adjuvant drug.

8. The device for oral administration via injection into the digestive tract according to claim 1, characterized in that, A water-resistant membrane (1500) is provided at the bottom of the outer shell (1000). The water-resistant membrane (1500) is an insoluble thin film material and has a thickness of 50-100 μm.

9. The device for oral administration via injection into the digestive tract according to claim 1, characterized in that, The needle hub (3110) and needle tip (3120) are made of insoluble or poorly soluble materials.

10. The device for oral administration via injection into the digestive tract according to claim 1, characterized in that, The soluble material of the needle cap (3130) is selected from at least one of the following: sodium hyaluronate, sodium carboxymethyl cellulose, pullulan, polyvinyl alcohol, water-soluble polysaccharide, hydroxypropyl methylcellulose, carboxymethyl cellulose, dextran, alginate, starch and gelatin blend, polyvinylpyrrolidone-polyvinyl alcohol, poly(methyl vinyl ether-co-maleic anhydride), trehalose, polyethylene glycol diacrylate, polyethylene glycol, methacrylamide gelatin, and methacrylamide hyaluronic acid.

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