Self-interlocking microstructure

By designing self-interlocking microstructures, including the base membrane and the support wing structure of the microneedles, the problem of separation and rupture of microstructures during skin penetration was solved, achieving stable drug delivery and improved safety.

CN116472085BActive Publication Date: 2026-05-15KOSAS BIOTECHNOLOGY CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
KOSAS BIOTECHNOLOGY CO LTD
Filing Date
2021-11-02
Publication Date
2026-05-15

AI Technical Summary

Technical Problem

Existing microstructures are prone to separation when penetrating the skin, making it difficult to maintain close contact with the skin. This results in unstable drug delivery and limited drug loading, potentially causing skin diseases and discomfort due to adhesion.

Method used

A microstructure was designed, including a base membrane and multiple microneedles. Each microneedle consists of a needle body and supporting wings. The supporting wings are arranged around the needle body and have a self-interlocking function to ensure close contact between the microstructure and the skin. The supporting wings connect the needle body and the base membrane to prevent the microneedles from breaking during insertion.

Benefits of technology

This technology enables quantitative drug delivery, stable skin penetration, avoids microneedle rupture, improves the accuracy and safety of drug delivery, and reduces the risk of skin diseases.

✦ Generated by Eureka AI based on patent content.

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Abstract

Disclosed is a microstructure. The microstructure includes a base film and a plurality of microneedles formed on one surface of the base film, wherein each of the plurality of microneedles can include: a needle body; and a support wing disposed around the needle body as a plurality, connecting an outer surface of the needle body and the base film, and having a thickness smaller than the needle body.
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Description

Technical Field

[0001] This invention relates to a microstructure, and more specifically, to a microstructure capable of penetrating the skin and delivering a drug. Background Technology

[0002] There are various routes of drug delivery to the human body, including oral, injectable, transdermal, and others. Oral delivery is a convenient method that increases patient compliance, and the active ingredient is delivered to the body in the form of capsules, tablets, and syrups. However, the active ingredient may be inactivated due to first-pass metabolism in the liver, and the absorption rate of biologics is actually relatively low. Therefore, to achieve accurate and rapid medical effects from drugs, therapeutic agents, etc., they are administered to the human body via injectable delivery, which involves piercing the skin barrier. When delivered via injectable delivery, it has the advantage of maintaining the activity of the active ingredient, but also has disadvantages such as the risk of infection, inaccurate dosing, fear, and pain.

[0003] Various microstructured transdermal drug delivery systems, including minimally penetrating microneedles, have been developed to overcome the limitations of existing oral and injectable drug delivery routes. The microstructures are primarily fabricated in biodegradable / dissolvable, solid, coated, and hollow forms. Biodegradable microstructures are transdermal delivery systems in which various materials, including polymers and active ingredients (APIs / cosmetics or pharmaceuticals), are formulated in the form of fine needles and inserted into the skin. The loaded materials are then dissolved by body fluids, allowing for painless drug delivery.

[0004] Existing microstructures consist of a broad base membrane and microneedles with a thin body, primarily arranged in a conical or polygonal pyramidal shape. The limitation of this microneedle shape lies in the high likelihood of separation after insertion into the skin, making it difficult to deliver drugs in a fixed quantity. Furthermore, due to the fine dimensions of the microneedles (tens to hundreds of micrometers) and the limited drug loading capacity, their application is mainly limited to the cosmetic field, as they cannot deliver the desired amount of active ingredient to the human body. Additionally, because the microstructure cannot maintain close contact with the skin, and drug dissolution takes a long time, there are limitations such as the risk of causing various skin conditions (including itching, dermatitis, and allergies) and uncomfortable adhesion. Moreover, when the microstructure is separated from the mold or pressed into the skin with a finger, the following limitations exist: the microneedles may break or fail to insert accurately into the skin depending on the direction and magnitude of the force applied. Summary of the Invention

[0005] Technical issues

[0006] This invention provides a microstructure capable of quantitatively delivering drugs to the skin.

[0007] Technical solution

[0008] The microstructure according to the invention may include: a base film; and a plurality of microneedles formed on a surface of the base film, wherein the plurality of microneedles may include: a needle body; and a plurality of support wings arranged around the needle body, connecting the outer surface of the needle body and the base film, and having a thickness thinner than the thickness of the needle body.

[0009] Furthermore, the support wing may be symmetrical about the center of the needle body.

[0010] Furthermore, the thickness of the support wing can gradually decrease as the support wing moves away from the center of the needle body.

[0011] In addition, the needle body may include: a first region, bonded to the base film; a second region, extending from the first region and the width of the second region gradually increases with increasing distance from the first region; and a third region, extending from the second region and the width of the third region gradually decreases as it reaches the end of the third region, and each of the support wings may be disposed in a segment between the first region and the second region.

[0012] Furthermore, when viewed from above, the region connecting the support wing and the base membrane may have an end located within the maximum radius region of the second region.

[0013] Furthermore, when viewed from above, the region connecting the support wing and the base membrane may have an end located on the same line as the maximum radius region of the second region.

[0014] Furthermore, when viewed from above, the region connecting the support wing and the base membrane may have an end located outside the maximum radius region of the second region.

[0015] Furthermore, the connection region between the second region and the third region may have an outer peripheral surface configured as a curved surface.

[0016] In addition, the needle body includes: a first region, bonded to the base membrane; a second region, extending from the first region and the width of the second region gradually increases with increasing distance from the first region; and a third region, extending from the second region and the width of the third region gradually decreases as it reaches an end of the third region, and each of the support wings extends downward from the end of the third region and is connected to the base membrane.

[0017] Furthermore, the connection area between the support wing and the base membrane can be larger than the maximum radius area of ​​the second region.

[0018] In addition, the support wing may include: a first support wing located on one side of the needle body; and a second support wing located on the opposite side of the first support wing centered on the needle body, and the first support wing and the second support wing may have different thicknesses.

[0019] Furthermore, the thickness of the support wing can gradually increase from the upper end of the support wing to the lower end of the support wing adjacent to the base membrane.

[0020] Beneficial effects

[0021] According to the present invention, a microneedle is provided with a structure combining a needle body and supporting wings, and due to its self-interlocking capability, a stable state of close contact between the microstructure and the skin can be maintained. Therefore, the microstructure is dissolved and can penetrate the skin, thereby enabling quantitative drug delivery. Furthermore, since the supporting wings connect the needle body and the base membrane, the microneedle is prevented from rupturing during separation from the mold or penetration into the skin. Moreover, since the needle body consists of a first region, a second region with a maximum radius region, and a third region forming the tip, a sufficient amount of drug can be loaded. Attached Figure Description

[0022] Figure 1 This is a perspective view showing a microstructure according to an embodiment of the present invention.

[0023] Figure 2 yes Figure 1 The image shows a magnified view of the microneedles.

[0024] Figure 3 It shows the basis Figure 2 A diagram illustrating the optimized size of the microneedles in an embodiment.

[0025] Figure 4 This is a perspective view illustrating a microstructure according to another embodiment of the present invention.

[0026] Figure 5 yes Figure 4 The image shows a magnified view of the microneedles.

[0027] Figure 6 This is a diagram illustrating a microneedle according to another embodiment of the present invention.

[0028] Figure 7 This is a diagram illustrating a microneedle according to another embodiment of the present invention.

[0029] Figure 8 This is a diagram illustrating a microneedle according to another embodiment of the present invention.

[0030] Figure 9 This is a diagram illustrating the process of manufacturing microstructures using molds.

[0031] Figure 10 This is a diagram illustrating the process of inserting a microstructure according to an embodiment of the present invention into the skin.

[0032] Figure 11 This is a diagram illustrating a microneedle according to another embodiment of the present invention.

[0033] Figure 12 This is a diagram illustrating a microneedle according to another embodiment of the present invention.

[0034] Figure 13 and Figure 14 This is a diagram illustrating various shapes of the needle body according to an embodiment of the present invention.

[0035] Figure 15 This is a diagram illustrating the needle body and base film according to an embodiment of the present invention.

[0036] Figure 16 This is a diagram showing a cross-section of a support wing according to various embodiments of the present invention.

[0037] Figure 17 This is a cross-sectional view showing the arrangement of support wings according to various embodiments of the present invention.

[0038] Figure 18 The image shows a microstructure and microneedles manufactured according to an embodiment of the present invention.

[0039] Figure 19 This is a diagram illustrating the process of injecting a drug by penetrating a microstructure according to an embodiment of the invention into the skin.

[0040] Figure 20 This is a diagram illustrating the process of injecting a drug by penetrating the skin through a microstructure according to a comparative example.

[0041] Figure 21 This is a diagram illustrating a microstructure and its microneedles manufactured according to an embodiment of the present invention.

[0042] Figure 22 This is a diagram illustrating a microstructure and its microneedles manufactured according to other embodiments of the present invention.

[0043] Figure 23 This is an enlarged view of a microneedle manufactured according to an embodiment of the present invention.

[0044] Best way to carry out the invention

[0045] The microstructure according to the invention may include: a base film; and a plurality of microneedles formed on a surface of the base film, wherein the microneedles may include: a needle body; and a plurality of support wings arranged around the needle body, connecting the outer surface of the needle body and the base film, and having a thickness thinner than the thickness of the needle body. Detailed Implementation

[0046] Preferred embodiments of the invention will be described in detail below with reference to the accompanying drawings. However, the inventive concept is not limited to the embodiments described herein and may be embodied in other forms. Rather, the embodiments described herein are provided so that the disclosure will be thorough and complete, and the spirit of the invention will be fully conveyed to those skilled in the art.

[0047] In this specification, when an element is referred to as being on another element, it means that it can be formed directly on the other element, or that a third element can be inserted therebetween. Furthermore, in the accompanying drawings, the thickness of the membrane and the region is exaggerated for the purpose of effectively explaining the technical content.

[0048] Furthermore, although terms such as first, second, and third have been used to describe various elements in the various embodiments of this specification, these elements should not be limited by these terms. These terms have only been used to distinguish one element from another. Thus, an element referred to as a first element in one embodiment may be referred to as a second element in another embodiment. Each embodiment described and illustrated herein also includes supplementary embodiments thereof. Additionally, in this specification, "and / or" has been used to indicate the inclusion of at least one of the elements listed before and after.

[0049] In this specification, singular expressions include plural expressions unless the context clearly specifies otherwise. Furthermore, the terms "comprising" or "having" are intended to indicate the presence of the features, quantities, steps, components, or combinations thereof described in the specification, but should not be construed as excluding the possibility of the presence or addition of one or more other features, quantities, steps, components, or combinations thereof. Additionally, in this specification, "connected" is used to mean both indirectly connecting multiple components and directly connecting multiple components.

[0050] Furthermore, in the following description of the invention, a detailed description of a relevant known function or configuration will be omitted if it is determined that such a detailed description may unnecessarily obscure the subject matter of the invention.

[0051] The microstructures according to various embodiments of the present invention can load drugs and deliver drugs through the skin of the human body.

[0052] Drugs are a broad concept, encompassing not only therapeutic agents used for treatment purposes in the narrow sense, but also all energy sources, nano-components, cosmetic ingredients (e.g., anti-wrinkle agents, skin aging inhibitors, and skin brighteners), cell culture media, and so on.

[0053] Specifically, therapeutic agents include chemical drugs, protein / peptide drugs, peptide drugs, and nucleic acid molecules used for gene therapy.

[0054] For example, therapeutic agents may include anti-inflammatory drugs, analgesics, anti-arthritis drugs, antispasmodics, antidepressants, antipsychotics, sedatives, anxiolytics, anesthetic antagonists, anti-Parkinson's drugs, cholinergic agonists, anticancer drugs, anti-angiogenic inhibitors and immunosuppressants, antiviral drugs, antibiotics, appetite suppressants, analgesics, anticholinergics, antihistamines, antimigraine drugs, hormones, coronary vasodilators, cerebral vasodilators or peripheral vasodilators, contraceptives, antithrombotic drugs, diuretics, antihypertensive drugs, and cardiovascular disease treatments, etc.

[0055] Specifically, protein / peptide drugs may include hormones, hormone analogs, enzymes, enzyme inhibitors, signal transduction proteins or portions thereof, antibodies or portions thereof, single-chain antibodies, binding proteins or their binding domains, antigens, attachment proteins, structural proteins, regulatory proteins, toxic proteins, cytokines, transcriptional regulatory factors, coagulation factors, vaccines, etc. More specifically, protein / peptide drugs may include insulin, insulin-like growth factor 1 (IGF-1), growth hormone, erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte / macrophage colony-stimulating factor (GM-CSF), interferon α, interferon β, interferon γ, interleukin-1 α and β, interleukin-3, interleukin-4, interleukin-6, interleukin-2, epidermal growth factor (EGF), calcitonin, adrenocorticotropic hormone (ACTH), tumor necrosis factor (TNF), atorbitan, sesquiterene, and cetrizoline. Cefuroxime, Desmopressin, Dysorcinol A (1-13), Ecalcitonin, Levodoxin, Etibatide, Growth Hormone Releasing Hormone-II (GHRH-II), Gonadorelin, Goserelin, Histamine Relin, Leuprorelin, Lysine Vasopressin, Octreotide, Oxytocin, Vasopressin, Secretin, Sincalli, Terlivasopressin, Thymopentin, Thymosin α1, Triptorelin, Diacerelin, Carbenicillin, Cyclosporine, Exetine, Lanreotide, Luteinizing Hormone Releasing Hormone (LHRH), Nafaline, Parathyroid Hormone, Pramlinide, Enft (T-20), Thymofasin, and Ziconopeptide.

[0056] Furthermore, since the microstructure according to the invention is self-interlocking after insertion into skin tissue, it can be made of biocompatible or biodegradable materials. Biocompatible or biodegradable materials, being substantially non-toxic, chemically inert, and non-immunogenic to the human body, have the advantage of dissolving after ultimately penetrating the human body.

[0057] There are no particular limitations on the type of biocompatible material, and examples may include hyaluronic acid, polyester, polyhydroxyalkanoates (PHAs), poly(α-hydroxy acids), poly(β-hydroxy acids), poly(3-hydroxybutyrate-co-hydroxyvalerate (PHBV), poly(3-hydroxypropionate) (PHP), poly(3-hydroxyhexanoate) (PHH), poly(4-hydroxy acids), poly(4-hydroxybutyrate), poly(4-hydroxyvalerate), poly(4-hydroxyhexanoate), poly(esteramide), polycaprolactone, polylactide, polyglycolic acid, poly(lactide-co-glycolic acid) (PLGA), polydioxanone, polyorthoester, polyether ester, polyanhydride, poly(glycolic acid-co-trimethylene carbonate), polyphosphate, polyphosphate urethane, poly(amino acids), polycyanoacrylate, poly(trimethylene carbonate), poly(imino carbonate), poly(tyrosine carbonate), polycarbonate, poly(tyrosine aryl compounds), poly(alkylene compounds) Oxalates), polyphosphates, phytohemagglutinin-polyethylene glycol (PHA-PEG), ethylene-vinyl alcohol copolymer (EVOH), polyurethanes, silicones, polyesters, polyolefins, polyisobutylene and ethylene-α-olefin copolymers, styrene-isobutylene-styrene triblock copolymers, acrylic polymers and copolymers, ethylene halide polymers and copolymers, polyvinyl chloride, polyvinyl ether, polyvinyl methyl ether, polyvinylidene halide, polyvinylidene fluoride, polyvinylidene chloride, polyfluoroalkane, polyperfluoroalkane, polyacrylonitrile, polyvinyl ketone, polyvinyl aromatic hydrocarbons, polystyrene, polyvinyl ester, polyvinyl acetate, ethylene-methyl methacrylate copolymer, acrylonitrile-styrene copolymer, ABS resin and ethylene-vinyl acetate copolymer, polyamides, alkyd resins, polyoxymethylene, polyimide, polyether, polyacrylate, polymethyl methacrylate, poly(acrylic acid-co-maleic acid), chitosan, dextran, cellulose, heparin, alginate, inulin, starch or glycogen,Alternatively, it may include one or more selected from the group consisting of: hyaluronic acid, polyester, polyhydroxyalkanoates (PHAs), poly(α-hydroxyacid), poly(β-hydroxyacid), poly(3-hydroxybutyrate-co-hydroxyvalerate) (PHBV), poly(3-hydroxypropionate) (PHP), poly(3-hydroxyhexanoate) (PHH), poly(4-hydroxyacid), poly(4-hydroxybutyrate), poly(4-hydroxyvalerate), poly(4-hydroxyhexanoate), poly(esteramide), polycaprolactone, polylactide, polyglycolic acid, poly(lactide). Poly(glycolic acid-co-glycolic acid) (PLGA), polydioxanone, polyorthoesters, polyether esters, polyanhydrides, poly(glycolic acid-co-trimethylene carbonate), polyphosphates, polyphosphate urethanes, poly(amino acids), polycyanoacrylates, poly(trimethylene carbonate), poly(imino carbonate), poly(tyrosine carbonate), polycarbonate, poly(tyrosine aryl compounds), poly(alkylene oxalate), polyphosphates, phytohemagglutinin-polyethylene glycol (PHA-PEG), chitosan, dextran, cellulose, heparin, alginate, inulin, starch, and glycogen.

[0058] When the microstructure is a solid microneedle loaded with biocompatible or biodegradable material, a drug can be loaded additionally.

[0059] Various embodiments of self-interlocking microstructures will be described below.

[0060] Figure 1 This is a perspective view illustrating a microstructure according to an embodiment of the present invention, and Figure 2 yes Figure 1 The image shows a magnified view of the microneedles.

[0061] Reference Figure 1 and Figure 2 The microstructure 10 includes a base membrane 100 and microneedles 200.

[0062] The base film 100 is a film with a thin thickness and is set with a predetermined width. The base film 100 can be set as a circular or polygonal shape.

[0063] Multiple microneedles 200 are formed on one surface of the base membrane 100 and are arranged in a structure that allows them to penetrate the skin and are self-interlocking. Each microneedle 200 includes a needle body 210 and a support wing 250.

[0064] The needle body 210 protrudes from one surface of the base film 100 to a predetermined height. Specifically, the needle body 210 has a first region 211 to a third region 213. The first region 211 is a region bonded to one surface of the base film 100 and has a first width w1. A second region 212 extends from the first region 211, and the width of the second region 212 gradually increases with increasing distance from the first region 211. The maximum width of the cross-section of the second region 212 has a second width w2 greater than the first width w1. A third region 213 extends from the second region 212, and the width of the third region 213 gradually decreases towards its end. The end of the third region 213 forms a sharp tip. A connecting region 215 connecting the second region 212 and the third region 213 has an outer peripheral surface configured as a curved surface.

[0065] Multiple support wings 250 are formed with a thin thickness and are spaced apart from each other along the outer periphery of the needle body 210. The support wings 250 may be arranged at the same included angle with respect to the needle body 210. The support wings 250 may be arranged symmetrically around the needle body 210. In this embodiment, four support wings 250 will be described, for example, and arranged at an angle of 90 degrees relative to the needle body 210. However, the number and arrangement of the support wings 250 are not limited to this and various changes can be made.

[0066] The support wing 250 connects the outer surface of the needle body 210 and the base film 100. The thickness of the support wing 250 gradually decreases as it moves away from the center of the needle body 210, and gradually increases as it moves from its upper end to its lower end connected to the base film 100. Therefore, the support wing 250 may have a triangular cross-section.

[0067] According to this embodiment, the support wing 250 can be disposed in the section between the second region 212 and the first region 211. That is, the upper end of the support wing 250 is located at the same height as the maximum width region of the second region 212, and the lower end of the support wing 250 is connected to the base film 100. Furthermore, when viewed from above, the end of the connection region 251 connecting the lower end of the support wing 250 and the base film 100 can be aligned with the outer corner portion of the maximum width of the second region 212.

[0068] Figure 3 It shows the basis Figure 2 A diagram illustrating the optimized size of the microneedles in an embodiment.

[0069] Reference Figure 3The needle body 210 may have a height h from 10 μm to 2000 μm, the second region 212 may have a height h2 from 5 μm to 1995 μm, and the third region 213 may have a height h3 from 5 μm to 1995 μm. Furthermore, the first region 211 may have a width w1 from 1 μm to 750 μm in the width direction, and the second region 212 may have a maximum width w2 from 1.1 μm to 900 μm in the width direction. The third region 213 may have a width w3 from 0.1 μm to 500 μm in the width direction in the intermediate region from the second region 212 to the end. The third region 213 may have a sharp angle θ from 10 degrees to 60 degrees.

[0070] The support wing 250 can be positioned at a height of 1 μm to 1000 μm, and the width of the support wing 250 connected to the lower end 251 of the base film 100 is 0.1 μm to 750 μm. The width from the end of one support wing 250 to the end of another support wing 250 located on the opposite side of the needle body 210 can be 1.1 μm to 1500 μm.

[0071] Figure 4 This is a perspective view illustrating a microstructure according to another embodiment of the present invention, and Figure 5 yes Figure 4 The image shows a magnified view of the microneedles.

[0072] Reference Figure 4 and Figure 5 The support wing 250, which can be configured with a microstructure, allows the lower end of the support wing 250 to have a length greater than that of the support wing 250. Figure 2 The length of the lower end of the support wing 250 is shown. Therefore, the length of the region connecting the support wing 250 and the base film 100 can be set to be greater than the maximum radius of the second region 212. In addition, the outer corner of the support wing 250 can extend at the same angle as the angle of the inclined surface of the third region 213.

[0073] Figure 6 This is a diagram illustrating a microneedle according to another embodiment of the present invention.

[0074] Reference Figure 6 When viewed from above, the end of the region connecting the support wing 250 and the base film 100 may be located within the maximum width of the second region 212. Furthermore, the outer corners of the support wing 250 may be shaped to slope downwards and inwards so as to be adjacent to the central axis of the needle body 210 when reaching the lower end of the needle body 210.

[0075] Figure 7 This is a diagram illustrating a microneedle according to another embodiment of the present invention.

[0076] Reference Figure 7 The upper end of the support wing 250 can be located below the maximum radius region of the second region 212.

[0077] Figure 8 This is a diagram illustrating a microneedle according to another embodiment of the present invention.

[0078] Reference Figure 8 The support wing 250 extends from the tip region of the needle body 210 and connects to the base film 100. Therefore, the height from the upper end to the lower end of the support wing 250 is the same as the height of the needle body 210. Furthermore, the length of the region connecting the support wing 250 and the base film 100 is set to be greater than the maximum radius of the second region 212.

[0079] As described above, the support wing 250 can be manufactured in various sizes and in various relationships with the needle body 210.

[0080] Figure 9 It is a diagram illustrating the process of manufacturing microstructures using molds, and Figure 10 This is a diagram illustrating the process of inserting a microstructure according to an embodiment of the present invention into the skin.

[0081] Reference Figure 9 and Figure 10 The support wings 250 increase the bonding strength between the needle body 210 and the base membrane 100. Therefore, during the separation of the microstructure 10 from the mold 50, the microstructure 10 can be separated stably without damaging the needle body 210. Furthermore, during the process of penetrating the needle body 210 into the skin 70 by pressing the base membrane 100 with the finger 60, the needle body 210 can be stably inserted into the skin 70 without damage due to the support of the support wings 250.

[0082] Figure 11 This is a diagram illustrating a microneedle according to another embodiment of the present invention.

[0083] Reference Figure 11 The second region 212 and the third region 213 of the needle body 210 have the same heights h2 and h3. Furthermore, a support wing 250 is disposed in the section between the second region 212 and the first region 211. According to an embodiment, the upper end of the support wing 250 is located below the maximum radius region of the second region 212. When viewed from above, the end of the region connecting the support wing 250 and the base film 100 protrudes beyond the outer side of the maximum radius region of the second region 212.

[0084] Figure 12 This is a diagram illustrating a microneedle according to another embodiment of the present invention.

[0085] Reference Figure 12 The second region 212 of the needle body 210 is formed to have a greater height than the third region 213. Therefore, with Figure 3 Compared to the third region 213 of the needle body 210 shown, the third region 213 has a large sharp angle.

[0086] exist Figures 1 to 12 In the microstructure described, the heights of the maximum radius regions of the second region 212 of the needle body 210 are set to be different from each other. Figures 1 to 10 The height of the maximum radius region of the second region 212 described in the text is set to be less than the height of the third region 213. Figure 11 The height of the maximum radius region of the second region 212 described in the text is set to be the same as the height of the third region 213, and Figure 12 The height of the maximum radius region of the second region 212 described herein is set to be greater than the height of the third region 213. Since this varying height of the maximum radius region of the second region 212 is proportional to the interlocking skin layer depth of the microneedles 200, drug delivery can be tailored to the target skin layer.

[0087] Figure 13 and Figure 14 This is a diagram illustrating various shapes of the needle body according to an embodiment of the present invention.

[0088] Reference Figure 13 The needle body 210 can be configured as third regions 213a, 213b, 213c, and 213d with various shapes (such as cones, triangular pyramids, square pyramids, and pentagonal pyramids) and sizes. These various shapes of the needle body 210 can be selected according to the amount and mode of drug delivery.

[0089] Reference Figure 14 ,and Figure 13 The needles connected at a predetermined angle in the second regions 212a, 212b, 212c, and 212d, and the third regions 213a, 213b, 213c, and 213d are different. Figure 14 The needle body may have rounded corners 214a, 214b, 214c, and 214d formed in the connecting region between the second regions 212a to 212d and the third regions 213a to 213d. The rounded corners 214a to 214d connect the second regions 212a to 212d and the third regions 213a to 213d of the needle body using curved surfaces.

[0090] Figure 15 This is a diagram illustrating a needle body and a base film according to an embodiment of the present invention. For ease of description, the support wings are not shown.

[0091] Reference Figure 15 A rounded corner 211a can be formed along the outer periphery of the first region 211 connecting the needle body 210 and the base film 100. The rounded corner 211a can reinforce the connection area between the needle body 210 and the base film 100, thereby improving the strength of the microneedle 200 together with the aforementioned support wing 250.

[0092] Figure 16This is a diagram showing a cross-section of a support wing according to various embodiments of the present invention. In the following, for ease of description, the support wing 250 formed on one side of the first region 211 of the needle body 210 is referred to as the first support wing 250a, and the support wing 250 formed on the other side thereon is referred to as the second support wing 250b.

[0093] The cross-sections of the first support wing 250a and the second support wing 250b can have various shapes and sizes. According to an embodiment, the cross-sections of the first support wing 250a and the second support wing 250b can have triangular, quadrilateral, and pentagonal shapes. The shape and size of the first support wing 250a and the second support wing 250b can be selected according to the insertion site of the skin (e.g., the thickness and hardness of the skin layer).

[0094] According to the example, the first support wing 250a and the second support wing 250b may be symmetrical with respect to the first region 211.

[0095] According to another example, such as Figure 16 As shown in (c), the first support wing 250a and the second support wing 250b may be asymmetrical relative to the first region 211. Specifically, the second support wing 250b may be thicker than the first support wing 250a. This is because, during the process of separating the microstructure 10 from the mold 50 or inserting the microstructure 10 into the skin 70, along the loading direction applied to the needle body 210, either support wing 250b is formed to be thicker than the other support wing 250a, so that the needle body 210 can be stably supported.

[0096] Figure 17 This is a cross-sectional view showing the arrangement of support wings according to various embodiments of the present invention.

[0097] Reference Figure 17 At least two support wings 250 can be provided according to the shape and size of the needle body 210, and can be arranged radially around the needle body 210 in various numbers.

[0098] Figure 18 Images illustrating microstructures and microneedles manufactured according to embodiments of the present invention are shown. Figure 19 This is a diagram illustrating the process of injecting a drug by penetrating a microstructure according to an embodiment of the invention into the skin, and Figure 20 This is a diagram illustrating the process of injecting a drug by penetrating a microstructure according to a comparative example into the skin. In the microstructure 20 according to the comparative example, a tapered microneedle is used.

[0099] Reference Figure 18 and Figure 19Due to the shape of the needle body 210 and the support wings 250 according to an embodiment of the present invention, the microneedle 200 can be inserted, allowing the basement membrane 100 to be in close contact with the skin 70. Furthermore, because the microneedle 200 interlocks with the skin 70, the microstructure 10 can stably maintain close contact with the skin. Approximately 30 minutes after insertion of the microstructure 10, it can be confirmed that the drug has penetrated the skin and that the microstructure 10 has completely decomposed.

[0100] Additionally, refer to Figure 20 The conical microneedles have weak penetration ability into the skin 70, and the penetration state (i.e., interlocking) cannot be stably maintained, preventing the basement membrane from fully adhering to the skin. Therefore, even after 30 minutes, the skin penetration efficiency of the drug is low, because the microneedles and the basement membrane remain intact in the microstructure 20.

[0101] Figure 21 This is a diagram illustrating a microstructure and its microneedles manufactured according to an embodiment of the present invention.

[0102] Reference Figure 21 The base membrane and microneedles can be made using the same materials. Figure 21 (A) shows a microstructure in which the base membrane and microneedles are made of hyaluronic acid, and Figure 21 (B) illustrates a microstructure in which the base membrane and microneedles are made by mixing a blue-based dye and hyaluronic acid. In this way, microstructures can be fabricated such that drugs are loaded onto the entire area of ​​the base membrane and microneedles.

[0103] Figure 22 This is a diagram illustrating a microstructure and its microneedles manufactured according to other embodiments of the present invention.

[0104] Reference Figure 22 The basement membrane and microneedles can be made of different materials. When a drug is loaded onto the basement membrane, there is a possibility that the drug may not be delivered to the skin, and in such cases, it is necessary to selectively load the drug onto the microneedles. The drug can be loaded onto the entire microneedle or its tip. Figure 22 In the microneedle shown, a blue-based dye is loaded onto its tip. This allows for the selective loading of drugs onto the tip of the microneedle.

[0105] Figure 23 This is an enlarged view of a microneedle manufactured according to an embodiment of the present invention.

[0106] The invention has been described in detail above using preferred embodiments, but the scope of the invention is not limited to the specific embodiments and should be interpreted in accordance with the appended claims. Furthermore, those skilled in the art will understand that many modifications and variations are possible without departing from the scope of the invention.

[0107] Industrial applicability

[0108] The microstructures according to the present invention can be used for medical treatment and skin care.

Claims

1. A microstructure for transdermal drug delivery, comprising: Base film; as well as Multiple microneedles are formed on one surface of the base film. The plurality of microneedles include: Needle body; and Multiple support wings are arranged around the needle body, connecting the outer surface of the needle body and the base film, and have a thickness thinner than the needle body. The needle body includes: The first region is bonded to the base membrane; A second region extends from the first region, and the width of the second region gradually increases with increasing distance from the first region; and A third region extends from the second region, and the width of the third region gradually decreases as it reaches its end. Each of the support wings is disposed in the segment between the first region and the second region.

2. The microstructure according to claim 1, wherein, The support wing is symmetrical about the center of the needle body.

3. The microstructure according to claim 1, wherein, The thickness of the support wing gradually decreases as the support wing moves away from the center of the needle body.

4. The microstructure according to claim 1, wherein, When viewed from above, the region connecting the support wing and the base membrane has an end located within the maximum radius region of the second region.

5. The microstructure according to claim 1, wherein, When viewed from above, the region connecting the support wing and the base membrane has an end located on the same line as the maximum radius region of the second region.

6. The microstructure according to claim 1, wherein, When viewed from above, the region connecting the support wing and the base membrane has an end located outside the maximum radius region of the second region.

7. The microstructure according to claim 1, wherein, The connection region between the second region and the third region has an outer peripheral surface configured as a curved surface.

8. The microstructure according to claim 1, wherein, Each of the support wings extends downward from the end of the third region and connects to the base membrane.

9. The microstructure according to claim 8, wherein, The connection area between the support wing and the base membrane is larger than the maximum radius area of ​​the second region.

10. The microstructure according to claim 1, wherein, The support wing includes: A first support wing is located on one side of the needle body; and The second support wing is located on the opposite side of the first support wing, centered on the needle body. Furthermore, the first support wing and the second support wing have different thicknesses.

11. The microstructure according to claim 1, wherein, The thickness of the support wing gradually increases from the upper end of the support wing to the lower end of the support wing adjacent to the base film.