WO2022108184A1 - Low-irritation microstructure - Google Patents

Low-irritation microstructure Download PDF

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Publication number
WO2022108184A1
WO2022108184A1 PCT/KR2021/015703 KR2021015703W WO2022108184A1 WO 2022108184 A1 WO2022108184 A1 WO 2022108184A1 KR 2021015703 W KR2021015703 W KR 2021015703W WO 2022108184 A1 WO2022108184 A1 WO 2022108184A1
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Prior art keywords
region
microstructure
needle body
support wing
support
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PCT/KR2021/015703
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French (fr)
Korean (ko)
Inventor
김용희
라히지샤얀 파크레이
Original Assignee
한양대학교 산학협력단
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Priority claimed from KR1020210102891A external-priority patent/KR102685381B1/en
Application filed by 한양대학교 산학협력단 filed Critical 한양대학교 산학협력단
Publication of WO2022108184A1 publication Critical patent/WO2022108184A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin

Definitions

  • the present invention relates to a microstructure, and more particularly, to a hypoallergenic microstructure capable of minimizing irritation during skin penetration.
  • Administration routes for delivering drugs to the body include oral, injection, transdermal, and the like.
  • Oral administration is a convenient administration that can increase patient compliance, and the active ingredient is delivered to the body in the form of capsules, tablets, or syrups.
  • active ingredients may be inactivated due to first-pass metabolism in the liver, and in fact, the absorption rate of biopharmaceuticals is relatively low. Therefore, in order to express the precise and rapid efficacy of drugs and therapeutic agents, they are administered to the human body by piercing the skin barrier in the form of injections.
  • When delivered in the form of injection there is an advantage in that the activity of the active ingredient is maintained, but there are disadvantages such as the risk of infection, incorrect dose administration, phobia, and pain.
  • microstructures are mainly manufactured in the form of biodegradable/dissolving, solid, coating, and hollow.
  • the biodegradable microstructure is a transdermal delivery that can deliver drugs without pain by formulating various substances including polymers and active ingredients (API/cosmetics or pharmaceuticals) in the form of fine needles, and by dissolving the loaded substances by body fluids after skin insertion it is a system
  • the existing microstructure is composed of a base film and a microneedle, and the microneedle is mainly provided in the form of a cone or polygonal pyramid.
  • microneedles gradually increase in width as they are adjacent to the base film, they cause great irritation when penetrating the skin.
  • the microneedle is broken or cannot be accurately inserted into the skin depending on the direction and magnitude of the force.
  • the present invention provides a hypoallergenic microstructure that minimizes skin irritation and enables quantitative drug delivery.
  • the microstructure according to the present invention includes a base film; and a plurality of microneedles formed on one surface of the base film, wherein the microneedles have a columnar first area protruding from one surface of the base film to a predetermined height, and extending from the first area and the end thereof It includes a needle body having a second area that gradually decreases in width toward the .
  • the width of the first region may be 10 ⁇ m to 750 ⁇ m, and a tip having an angle between 10 degrees and 60 degrees may be formed at the end of the second region.
  • microneedle may further include support wings arranged in plurality around the needle body, connecting the outer surface of the needle body and the base film, and having a thickness thinner than that of the first region.
  • an upper end of the support wing may be positioned lower than an upper end of the first region.
  • the upper end of the support wing may be located at the same height as the upper end of the first region.
  • the upper end of the support wing may be located at the same height as the end of the second region.
  • the support wing may gradually decrease in thickness as it moves away from the center of the needle body.
  • the outer edge of the support wing may include a first corner region extending from the upper end at a first angle, and a second corner region extending from the first corner region at a second angle different from the first angle.
  • the support wing is a first support wing located on one side of the needle body; and a second support wing positioned on the opposite side of the first support wing with respect to the needle body, wherein the first support wing and the second support wing may have different thicknesses.
  • the microneedle can minimize the width of the needle body by providing the support wings, the occurrence of irritation during skin insertion can be minimized. And since the microstructure can maintain a state in close contact with the skin, the microstructure can be dissolved and penetrate the skin within a short time, enabling quantitative drug delivery. In addition, since the support wings connect the needle body and the base film, breakage of the microneedle can be prevented in the process of being separated from the mold or penetrating the skin.
  • FIG. 1 is a perspective view showing a microstructure according to an embodiment of the present invention.
  • FIG. 2 is an enlarged view of the microneedle shown in FIG. 1 .
  • 3 to 5 are views showing microneedles according to various embodiments of the present invention.
  • FIG. 6 and 7 are views showing a microneedle according to another embodiment of the present invention.
  • FIG. 8 is a view showing a needle body according to another embodiment of the present invention.
  • FIG. 9 is a view showing a cross-section of a support wing according to various embodiments of the present disclosure.
  • FIG. 10 is a view showing a cross-section of a support wing according to various embodiments of the present invention.
  • FIG. 11 is a cross-sectional view illustrating an arrangement of support wings according to various embodiments of the present disclosure.
  • FIG. 12 is an image showing a microstructure and a microneedle manufactured according to an embodiment of the present invention.
  • FIG. 13 is a view showing a process of penetrating the microstructure into the skin according to an embodiment of the present invention.
  • FIG. 14 is a view showing a process of penetrating the microstructure according to a comparative example into the skin.
  • the microstructure according to the present invention includes a base film; and a plurality of microneedles formed on one surface of the base film, wherein the microneedles have a columnar first area protruding from one surface of the base film to a predetermined height, and extending from the first area and the end thereof It includes a needle body having a second area that gradually decreases in width toward the .
  • first, second, third, etc. are used to describe various components, but these components should not be limited by these terms. These terms are only used to distinguish one component from another. Accordingly, what is referred to as a first component in one embodiment may be referred to as a second component in another embodiment.
  • a first component in one embodiment may be referred to as a second component in another embodiment.
  • Each embodiment described and illustrated herein also includes a complementary embodiment thereof.
  • 'and/or' is used in the sense of including at least one of the components listed before and after.
  • connection is used in a sense including both indirectly connecting a plurality of components and directly connecting a plurality of components.
  • microstructure according to various embodiments of the present invention may be loaded with a drug to deliver the drug through the skin of the body.
  • a drug means a broad concept, and includes energy, nano-components, cosmetic ingredients (eg, wrinkle improvement agents, skin aging inhibitors and skin whitening agents), cell culture solutions, as well as therapeutic agents for therapeutic purposes in a narrow sense.
  • cosmetic ingredients eg, wrinkle improvement agents, skin aging inhibitors and skin whitening agents
  • cell culture solutions as well as therapeutic agents for therapeutic purposes in a narrow sense.
  • the therapeutic agent includes chemical drugs, protein/peptide drugs, peptide drugs, nucleic acid molecules for gene therapy, and the like.
  • protein/peptide drugs include hormones, hormone analogs, enzymes, enzyme inhibitors, signal transduction proteins or parts thereof, antibodies or parts thereof, single-chain antibodies, binding proteins or binding domains thereof, antigens, adhesion proteins, structural proteins, regulatory proteins, Toxin proteins, cytokines, transcriptional regulatory factors, blood coagulation factors and vaccines may be included.
  • the protein / peptide drug is insulin, IGF-1 (insulin-like growth factor 1), growth hormone, erythropoietin, G-CSFs (granulocyte-colony stimulating factors), GM-CSFs (granulocytes) /macrophagecolony stimulating factors), interferon alpha, interferon beta, interferon gamma, interleukin-1 alpha and beta, interleukin-3, interleukin-4, interleukin-6, interleukin-2, EGFs (epidermal growth factors), calcitonin, ACTH (adrenocorticotropic hormone), TNF (tumor necrosis factor), atobisban, buserelin, cetrorelix, deslorelin, desmopressin, dynorphin A (1-13), elcatonin, eleidosin, eptifibatide, growth hormone releasing hormone-II (GHRHII), gonadorelin , gose
  • microstructure according to the present invention may be made of a biocompatible or biodegradable material.
  • a biocompatible or biodegradable material is substantially non-toxic to the human body, chemically inert, and non-immunogenic, and has the advantage of being dissolved after finally penetrating into the body.
  • the type of the biocompatible material is not particularly limited, and for example, hyaluronic acid, polyester, polyhydroxyalkanoate (PHAs), poly( ⁇ -hydroxyacid), poly( ⁇ -hydroxyacid) ), poly(3-hydroxybutyrate-co-valerate; PHBV), poly(3-hydroxypropionate; PHP), poly(3-hydroxyhexanoate; PHH), poly(4-hydro hydroxy acid), poly(4-hydroxybutyrate), poly(4-hydroxyvalerate), poly(4-hydroxyhexanoate), poly(esteramide), polycaprolactone, polylactide, poly Glycolide, poly(lactide-co-glycolide; PLGA), polydioxanone, polyorthoester, polyetherester, polyanhydride, poly(glycolic acid-co-trimethylene carbonate), polyphosphoester , polyphosphoester urethane, poly(amino acid), polycyanoacrylate, poly(trimethylene carbonate
  • a drug may be additionally loaded.
  • hypoallergenic microstructures according to various embodiments of the present invention will be described.
  • FIG. 1 is a perspective view illustrating a microstructure according to an embodiment of the present invention
  • FIG. 2 is an enlarged view of the microneedle shown in FIG. 1 .
  • the microstructure 10 includes a base film 100 and a microneedle 200 .
  • the base film 100 is a thin film and is provided with a predetermined width.
  • the base film 100 may be provided as a film having a circular or polygonal shape.
  • a plurality of microneedles 200 are formed on one surface of the base film 100, and are provided in a structure capable of penetrating into the skin and minimizing irritation when penetrating the skin.
  • the microneedle 200 includes a needle body 210 and a support wing 250 .
  • the needle body 210 protrudes from one surface of the base film 100 to a predetermined height.
  • the needle body 210 may have a total height of 100um to 2000um.
  • the needle body 210 has a first region 211 and a second region 212 .
  • the first region 211 has a pillar shape protruding from one surface of the base film 100 , and has a predetermined height h1 and a width w1 .
  • the first region 211 may have a height h1 of 50 ⁇ m to 1000 ⁇ m and a width w1 of 10 ⁇ m to 750 ⁇ m.
  • the lower region of the first region 211 may have a width of 10 ⁇ m to 750 ⁇ m, and the upper region may have a width of 10 ⁇ m to 500 ⁇ m.
  • the first region 211 may have a circular or polygonal cross-section.
  • the second region 212 extends from the upper end of the first region 211 and gradually decreases in width toward the end thereof. According to an embodiment, the second region 212 may have a height of 10 ⁇ m to 1000 ⁇ m. An end of the second region 212 forms a sharp tip. According to an embodiment, the tip of the second region 212 may have a tip angle of 10 degrees to 60 degrees.
  • the region where the first region 211 and the second region 212 are connected may have an outer circumferential surface at a predetermined angle or a curved surface. The curved surface can minimize skin irritation.
  • a plurality of support wings 250 are formed to have a thin thickness, and are disposed to be spaced apart from each other along the periphery of the needle body 210 .
  • Support wings 250 may be disposed at the same angle between the needle body 210 as a center.
  • the support wings 250 may be disposed symmetrically with each other around the needle body 210 .
  • three support blades 250 are formed, and it will be described for example that they are disposed at an angle of 120 degrees with respect to the central axis of the needle body 210 .
  • the number and arrangement of the support wings 250 are not limited thereto, and may be variously changed.
  • the support wing 250 has a triangular shape, and connects the outer surface of the needle body 210 and the base film 100 .
  • the support wing 250 gradually decreases in thickness as it goes away from the center of the needle body 210 , and gradually increases in thickness from the top to the bottom connected to the base film 100 . Accordingly, the support wing 250 may have a triangular cross section.
  • the upper end of the support wing 250 may be positioned lower than the upper end of the first region 211 .
  • a width w2 of the connection region where the lower end of the support wing 250 and the base film 110 are connected may be provided to be the same as the width w2 of the first region 211 .
  • the width w2 of the connection region where the lower end of the support wing 250 and the base film 100 are connected may be 10 ⁇ m to 750 ⁇ m.
  • 3 to 5 are views showing microneedles according to various embodiments of the present invention.
  • the upper end of the support wing 250 may be positioned lower than the upper end of the first region 211 . According to the embodiment, the upper end of the support wing 250 may be located at 1/3 of the first area 211 .
  • the upper end of the support wing 250 may be positioned at the same height as the upper end of the first region 211 .
  • the upper end of the support wing 250 may be positioned at the same height as the tip of the second region 212 .
  • the support wing 250 may have various heights as compared to the needle body 210 .
  • the support wing 250 since the bonding strength of the needle body 210 and the base film 100 is improved, the width of the needle body 210 can be minimized. Minimizing the width of the needle body 210 facilitates skin penetration and minimizes skin irritation.
  • the support wing 250 allows the microstructure 10 to be stably separated without damage to the needle body 210 in the process in which the microstructure 100 is separated from the mold. And in the process of penetrating the needle body 210 into the skin by pressing the microstructure 10 with a finger, the support wing 250 prevents damage to the needle body 210 .
  • FIG. 6 and 7 are views showing a microneedle according to another embodiment of the present invention.
  • the support wings 250 may be provided with different inclination angles of outer corners according to their regions.
  • the first area 251 of the support wing 250 has an outer edge extending from the top at a first angle
  • the second area 252 has an outer edge at a second angle different from the first angle from the first area 251 . is extended
  • the outer edge of the second region 252 of the support wing 250 may have a smaller inclination angle than the outer edge of the first region 251 .
  • an outer edge of the second region 252 of the support wing 250 may extend perpendicularly to one surface of the base film 100 .
  • the shape of the support wing 250 may be selected according to the strength of the microstructure 10 and the degree of hardness of the skin layer into which the microstructure 10 is inserted.
  • FIG. 8 is a view showing a needle body according to another embodiment of the present invention.
  • a fillet 215 may be formed along the circumference of the needle body 210 in a region where the needle body 210 and the base film 100 are connected.
  • the fillet 215 may enhance the strength of the microneedle 200 together with the support wings 250 described above by reinforcing the connection region between the needle body 210 and the base film 100 .
  • FIG. 9 is a view showing a cross-section of a support wing according to various embodiments of the present disclosure.
  • the support wing 250 formed on one side of the support body 210 is referred to as a first support wing 250a
  • the support wing 250 formed on the other side of the support body 210 is referred to as a second support wing 250b.
  • the cross-sections of the first and second support wings 250a and 250b may have various shapes and sizes. According to an embodiment, the cross-sections of the first and second support wings 250a and 250b may have a triangular shape, a quadrangular shape, and a pentagonal shape. The shape and size of the first and second support wings 250a and 250b may be selected according to the insertion site of the skin, such as the thickness of the skin layer and the hardness of the skin layer.
  • FIG. 10 is a view showing a cross-section of a support wing according to various embodiments of the present invention.
  • the first and second support wings 250a and 250b may be provided in various thicknesses. As in (A) and (B), the thickness of the first and second support wings (250a, 250b) may be symmetrical with respect to the needle body (210).
  • the thickness of the first and second support wings (250a, 250b) may be asymmetrical with respect to the needle body (210). Specifically, the second support wing 250b may be thicker than the first support wing 250q. This is because one support wing 250b is thicker than the other support wing 250a depending on the direction of load applied to the needle body 210 in the process of the microstructure 10 being separated from the mold or inserted into the skin. It is possible to stably support the needle body 210 .
  • FIG. 11 is a cross-sectional view illustrating an arrangement of support wings according to various embodiments of the present disclosure.
  • At least two support wings 250 may be provided depending on the shape and size of the needle body 210 , and various numbers may be radially arranged around the needle body 210 .
  • FIG. 12 is an image showing a microstructure and a microneedle manufactured according to an embodiment of the present invention
  • FIG. 13 is a diagram showing a process of penetrating the microstructure according to an embodiment of the present invention into the skin
  • FIG. 14 is a comparative example It is a view showing the process of penetrating the microstructure according to the skin.
  • a conical microneedle 300 was used as the microstructure according to the comparative example.
  • the width of the needle body 210 can be minimized due to the support wing 250, so that the occurrence of irritation during skin penetration is minimized.
  • the microneedle 300 according to the comparative example gradually increases in width as it approaches the base film 100 , and thus a great stimulus may be generated during skin penetration.
  • microstructure according to the present invention can be used for medical and skin care.

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Abstract

A microstructure is disclosed. The microstructure comprises a base film and a plurality of microneedles formed on one surface of the base film, wherein the microneedle comprises a needle body having a columnar first region protruding, at a predetermined height, from one surface of the base film, and a second region extending from the first region and having a width that gradually decreases toward the end thereof.

Description

저자극 마이크로 구조체hypoallergenic microstructure
본 발명은 마이크로 구조체에 관한 것으로, 보다 상세하게는 피부 침투 시 자극을 최소화할 수 있는 저자극 마이크로 구조체에 관한 것이다.The present invention relates to a microstructure, and more particularly, to a hypoallergenic microstructure capable of minimizing irritation during skin penetration.
약물을 신체에 전달하는 투여경로에는 경구형, 주사형, 경피형 등이 있다. 경구형 투여는 환자의 복약 순응도를 높일 수 있는 편리한 투여로 유효성분은 캡슐, 정제, 시럽 형태로 신체에 전달한다. 그러나 간에서의 초회통과대사(first-pass metabolism)등으로 인해 유효성분이 불활성화될 수도 있으며 실제로 바이오 의약품의 흡수율은 비교적 낮다. 때문에, 약물 및 치료제 등의 정확하고 빠른 약효를 발현시키기 위해 주사형으로 피부 장벽을 뚫어서 인체에 투여한다. 주사형으로 전달할 경우, 유효성분의 활성이 유지된다는 장점이 있으나 감염의 위험, 정확하지 않은 용량 투여, 공포증, 고통 등의 단점이 있다.Administration routes for delivering drugs to the body include oral, injection, transdermal, and the like. Oral administration is a convenient administration that can increase patient compliance, and the active ingredient is delivered to the body in the form of capsules, tablets, or syrups. However, active ingredients may be inactivated due to first-pass metabolism in the liver, and in fact, the absorption rate of biopharmaceuticals is relatively low. Therefore, in order to express the precise and rapid efficacy of drugs and therapeutic agents, they are administered to the human body by piercing the skin barrier in the form of injections. When delivered in the form of injection, there is an advantage in that the activity of the active ingredient is maintained, but there are disadvantages such as the risk of infection, incorrect dose administration, phobia, and pain.
기존 경구형과 주사형 경로투여의 한계를 극복하기 위해서 최소 침투 마이크로 니들을 포함한 다양한 마이크로 구조체 경피형 약물전달 시스템이 개발되었다. 마이크로 구조체는 주로 생분해성(Biodegradable/dissolving), 솔리드(solid), 코팅(coating), 할로우(hollow)형태로 제작된다. 생분해성 마이크로 구조체는 고분자와 active ingredient(API/화장품 또는 의약품)를 포함한 다양한 물질을 미세 바늘 형태로 제형화하고, 피부 삽입 후 탑재된 물질이 체액에 의해 용해되어 통증 없이 약물을 전달할 수 있는 경피 전달시스템이다.In order to overcome the limitations of the existing oral and injection routes, various microstructured transdermal drug delivery systems including minimally penetrating microneedles have been developed. Microstructures are mainly manufactured in the form of biodegradable/dissolving, solid, coating, and hollow. The biodegradable microstructure is a transdermal delivery that can deliver drugs without pain by formulating various substances including polymers and active ingredients (API/cosmetics or pharmaceuticals) in the form of fine needles, and by dissolving the loaded substances by body fluids after skin insertion it is a system
기존 마이크로 구조체는 베이스 필름과 마이크로 니들로 구성되며, 마이크로 니들은 주로 원뿔 또는 다각뿔 형태로 제공된다. The existing microstructure is composed of a base film and a microneedle, and the microneedle is mainly provided in the form of a cone or polygonal pyramid.
이러한 마이크로 니들은 베이스 필름에 인접할수록 너비가 점차 증가하므로, 피부 침투 시 큰 자극을 발생시킨다. 그리고 피부 삽입 후 이탈 가능성이 커 피부와의 밀착 상태를 안정적으로 유지하지 못한다. 때문에, 정량 약물전달이 쉽지 않고, 약물의 용해 시간이 오래 걸려 가려움, 피부염, 알레르기를 포함한 다양한 피부 질환을 일으킬 수 있다. 또한, 마이크로 구조체를 몰드에서 분리하거나, 손가락으로 마이크로 구조체를 눌러 피부에 삽입하는 경우, 힘의 작용 방향과 크기에 따라 마이크로 니들이 부러지거나, 피부에 정확히 삽입되지 못하는 한계점을 가지고 있다.Since these microneedles gradually increase in width as they are adjacent to the base film, they cause great irritation when penetrating the skin. In addition, it is not possible to maintain a stable state of adhesion with the skin due to the high possibility of detachment after the skin is inserted. Therefore, quantitative drug delivery is not easy, and drug dissolution takes a long time, which can cause various skin diseases including itchiness, dermatitis, and allergies. In addition, when the microstructure is separated from the mold or inserted into the skin by pressing the microstructure with a finger, the microneedle is broken or cannot be accurately inserted into the skin depending on the direction and magnitude of the force.
본 발명은 피부 자극을 최소화하고, 정량 약물 전달이 가능한 저자극 마이크로 구조체를 제공한다. The present invention provides a hypoallergenic microstructure that minimizes skin irritation and enables quantitative drug delivery.
본 발명에 따른 마이크로 구조체는 베이스 필름; 및 상기 베이스 필름의 일 면에 형성된 복수 개의 마이크로 니들을 포함하되, 상기 마이크로 니들은 상기 베이스 필름의 일 면으로부터 소정 높이로 돌출되는 기둥 형상의 제1영역과, 상기 제1영역으로부터 연장되며 그 끝단으로 갈수록 너비가 점차 감소하는 제2영역을 갖는 니들 바디를 포함한다.The microstructure according to the present invention includes a base film; and a plurality of microneedles formed on one surface of the base film, wherein the microneedles have a columnar first area protruding from one surface of the base film to a predetermined height, and extending from the first area and the end thereof It includes a needle body having a second area that gradually decreases in width toward the .
또한, 상기 제1영역의 너비는 10um 내지 750um이고, 상기 제2영역의 끝단에는 10도 내지 60도의 사이각을 갖는 팁이 형성될 수 있다.Also, the width of the first region may be 10 μm to 750 μm, and a tip having an angle between 10 degrees and 60 degrees may be formed at the end of the second region.
또한, 상기 마이크로 니들은, 상기 니들 바디를 중심으로 복수 개 배치되며, 상기 니들 바디의 외측면과 상기 베이스 필름을 연결하며, 상기 제1영역보다 얇은 두께를 갖는 지지 날개들을 더 포함할 수 있다.In addition, the microneedle may further include support wings arranged in plurality around the needle body, connecting the outer surface of the needle body and the base film, and having a thickness thinner than that of the first region.
또한, 상기 지지 날개는 상단이 상기 제1영역의 상단보다 낮게 위치할 수 있다.Also, an upper end of the support wing may be positioned lower than an upper end of the first region.
또한, 상기 지지 날개는 상단이 상기 제1영역의 상단과 동일한 높이에 위치할 수 있다.In addition, the upper end of the support wing may be located at the same height as the upper end of the first region.
또한, 상기 지지 날개는 상단이 상기 제2영역의 끝단과 동일한 높이에 위치할 수 있다.In addition, the upper end of the support wing may be located at the same height as the end of the second region.
또한, 상기 지지 날개는 상기 니들 바디의 중심으로부터 멀어질수록 두께가 점차 감소할 수 있다.In addition, the support wing may gradually decrease in thickness as it moves away from the center of the needle body.
또한, 상기 지지 날개의 외곽 모서리는 상단으로부터 제1각도로 연장되는 제1모서리 영역과, 상기 제1모서리 영역으로부터 상기 제1각도와 상이한 제2각도로 연장되는 제2모서리 영역을 포함할 수 있다.In addition, the outer edge of the support wing may include a first corner region extending from the upper end at a first angle, and a second corner region extending from the first corner region at a second angle different from the first angle. .
또한, 상기 지지 날개는 상기 니들 바디의 일 측에 위치하는 제1지지 날개; 및 상기 니들 바디를 중심으로 상기 제1지지 날개의 반대 편에 위치하는 제2지지 날개를 포함하되, 상기 제1지지 날개와 상기 제2지지 날개는 상이한 두께를 가질 수 있다.In addition, the support wing is a first support wing located on one side of the needle body; and a second support wing positioned on the opposite side of the first support wing with respect to the needle body, wherein the first support wing and the second support wing may have different thicknesses.
본 발명에 의하면, 마이크로 니들은 지지 날개의 제공으로 니들 바디의 너비를 최소화할 수 있으므로, 피부 삽입 시 자극 발생이 최소화될 수 있다. 그리고 마이크로 구조체가 피부에 밀착된 상태를 유지할 수 있으므로, 짧은 시간내에 마이크로 구조체가 용해되고 피부에 침투할 수 있어 정량 약물전달이 가능하다. 또한, 지지 날개들이 니들 바디와 베이스 필름을 연결하므로, 몰드로부터 분리되거나 피부에 침투하는 과정에서 마이크로 니들의 파손이 예방될 수 있다.According to the present invention, since the microneedle can minimize the width of the needle body by providing the support wings, the occurrence of irritation during skin insertion can be minimized. And since the microstructure can maintain a state in close contact with the skin, the microstructure can be dissolved and penetrate the skin within a short time, enabling quantitative drug delivery. In addition, since the support wings connect the needle body and the base film, breakage of the microneedle can be prevented in the process of being separated from the mold or penetrating the skin.
도 1은 본 발명의 일 실시 예에 따른 마이크로 구조체를 나타내는 사시도이다.1 is a perspective view showing a microstructure according to an embodiment of the present invention.
도 2는 도 1에 도시된 마이크로 니들을 확대하여 나타낸 도면이다.FIG. 2 is an enlarged view of the microneedle shown in FIG. 1 .
도 3 내지 도 5는 본 발명의 다양한 실시 예에 따른 마이크로 니들을 나타내는 도면이다.3 to 5 are views showing microneedles according to various embodiments of the present invention.
도 6 및 도 7은 본 발명의 또 다른 실시 예에 따른 마이크로 니들을 나타내는 도면이다.6 and 7 are views showing a microneedle according to another embodiment of the present invention.
도 8은 본 발명의 또 다른 실시 예에 따른 니들 바디를 나타내는 도면이다.8 is a view showing a needle body according to another embodiment of the present invention.
도 9는 본 발명의 다양한 실시 예에 따른 지지 날개의 단면을 나타내는 도면이다.9 is a view showing a cross-section of a support wing according to various embodiments of the present disclosure.
도 10은 본 발명의 다양한 실시 예에 따른 지지 날개의 단면을 나타내는 도면이다.10 is a view showing a cross-section of a support wing according to various embodiments of the present invention.
도 11은 본 발명의 다양한 실시 예에 따른 지지 날개들의 배치를 나타내는 단면도이다.11 is a cross-sectional view illustrating an arrangement of support wings according to various embodiments of the present disclosure.
도 12는 본 발명의 실시 예에 따라 제작된 마이크로 구조체와 마이크로 니들을 나타내는 이미지이다.12 is an image showing a microstructure and a microneedle manufactured according to an embodiment of the present invention.
도 13은 본 발명의 실시 예에 따른 마이크로 구조체를 피부에 침투시키는 과정을 나타내는 도면이다.13 is a view showing a process of penetrating the microstructure into the skin according to an embodiment of the present invention.
도 14는 비교 예에 따른 마이크로 구조체를 피부에 침투시키는 과정을 나타내는 도면이다.14 is a view showing a process of penetrating the microstructure according to a comparative example into the skin.
본 발명에 따른 마이크로 구조체는 베이스 필름; 및 상기 베이스 필름의 일 면에 형성된 복수 개의 마이크로 니들을 포함하되, 상기 마이크로 니들은 상기 베이스 필름의 일 면으로부터 소정 높이로 돌출되는 기둥 형상의 제1영역과, 상기 제1영역으로부터 연장되며 그 끝단으로 갈수록 너비가 점차 감소하는 제2영역을 갖는 니들 바디를 포함한다.The microstructure according to the present invention includes a base film; and a plurality of microneedles formed on one surface of the base film, wherein the microneedles have a columnar first area protruding from one surface of the base film to a predetermined height, and extending from the first area and the end thereof It includes a needle body having a second area that gradually decreases in width toward the .
이하, 첨부된 도면들을 참조하여 본 발명의 바람직한 실시 예를 상세히 설명할 것이다. 그러나 본 발명의 기술적 사상은 여기서 설명되는 실시 예에 한정되지 않고 다른 형태로 구체화될 수도 있다. 오히려, 여기서 소개되는 실시 예는 개시된 내용이 철저하고 완전해질 수 있도록 그리고 당업자에게 본 발명의 사상이 충분히 전달될 수 있도록 하기 위해 제공되는 것이다.Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. However, the technical spirit of the present invention is not limited to the embodiments described herein and may be embodied in other forms. Rather, the embodiments introduced herein are provided so that the disclosed content may be thorough and complete, and the spirit of the present invention may be sufficiently conveyed to those skilled in the art.
본 명세서에서, 어떤 구성요소가 다른 구성요소 상에 있다고 언급되는 경우에 그것은 다른 구성요소 상에 직접 형성될 수 있거나 또는 그들 사이에 제 3의 구성요소가 개재될 수도 있다는 것을 의미한다. 또한, 도면들에 있어서, 막 및 영역들의 두께는 기술적 내용의 효과적인 설명을 위해 과장된 것이다. In this specification, when a component is referred to as being on another component, it means that it may be directly formed on the other component or a third component may be interposed therebetween. In addition, in the drawings, thicknesses of films and regions are exaggerated for effective description of technical content.
또한, 본 명세서의 다양한 실시 예 들에서 제1, 제2, 제3 등의 용어가 다양한 구성요소들을 기술하기 위해서 사용되었지만, 이들 구성요소들이 이 같은 용어들에 의해서 한정되어서는 안 된다. 이들 용어들은 단지 어느 구성요소를 다른 구성요소와 구별시키기 위해서 사용되었을 뿐이다. 따라서, 어느 한 실시 예에 제 1 구성요소로 언급된 것이 다른 실시 예에서는 제 2 구성요소로 언급될 수도 있다. 여기에 설명되고 예시되는 각 실시 예는 그것의 상보적인 실시 예도 포함한다. 또한, 본 명세서에서 '및/또는'은 전후에 나열한 구성요소들 중 적어도 하나를 포함하는 의미로 사용되었다.In addition, in various embodiments of the present specification, terms such as first, second, third, etc. are used to describe various components, but these components should not be limited by these terms. These terms are only used to distinguish one component from another. Accordingly, what is referred to as a first component in one embodiment may be referred to as a second component in another embodiment. Each embodiment described and illustrated herein also includes a complementary embodiment thereof. In addition, in this specification, 'and/or' is used in the sense of including at least one of the components listed before and after.
명세서에서 단수의 표현은 문맥상 명백하게 다르게 뜻하지 않는 한 복수의 표현을 포함한다. 또한, "포함하다" 또는 "가지다" 등의 용어는 명세서상에 기재된 특징, 숫자, 단계, 구성요소 또는 이들을 조합한 것이 존재함을 지정하려는 것이지, 하나 또는 그 이상의 다른 특징이나 숫자, 단계, 구성요소 또는 이들을 조합한 것들의 존재 또는 부가 가능성을 배제하는 것으로 이해되어서는 안 된다. 또한, 본 명세서에서 "연결"은 복수의 구성 요소를 간접적으로 연결하는 것, 및 직접적으로 연결하는 것을 모두 포함하는 의미로 사용된다. In the specification, the singular expression includes the plural expression unless the context clearly dictates otherwise. In addition, terms such as "comprise" or "have" are intended to designate that a feature, number, step, element, or a combination thereof described in the specification exists, but one or more other features, number, step, configuration It should not be construed as excluding the possibility of the presence or addition of elements or combinations thereof. In addition, in this specification, "connection" is used in a sense including both indirectly connecting a plurality of components and directly connecting a plurality of components.
또한, 하기에서 본 발명을 설명함에 있어 관련된 공지 기능 또는 구성에 대한 구체적인 설명이 본 발명의 요지를 불필요하게 흐릴 수 있다고 판단되는 경우에는 그 상세한 설명은 생략할 것이다.In addition, in the following description of the present invention, if it is determined that a detailed description of a related well-known function or configuration may unnecessarily obscure the gist of the present invention, the detailed description thereof will be omitted.
본 발명의 다양한 실시 예에 따른 마이크로 구조체는 약물을 탑재하여 신체 피부를 통해 약물을 전달할 수 있다. The microstructure according to various embodiments of the present invention may be loaded with a drug to deliver the drug through the skin of the body.
약물은 광의의 개념을 의미하며, 협의의 치료 목적의 치료제뿐만 아니라, 에너지, 나노 성분, 미용 성분(예컨대, 주름개선제, 피부노화 억제제 및 피부 미백제), 세포 배양액 등을 모두 포함한다.A drug means a broad concept, and includes energy, nano-components, cosmetic ingredients (eg, wrinkle improvement agents, skin aging inhibitors and skin whitening agents), cell culture solutions, as well as therapeutic agents for therapeutic purposes in a narrow sense.
구체적으로, 상기 치료제로는 화학약물, 단백질/펩타이드의 약, 펩타이드의 약，유전자 치료용 핵산 분자 등을 포함한다.Specifically, the therapeutic agent includes chemical drugs, protein/peptide drugs, peptide drugs, nucleic acid molecules for gene therapy, and the like.
예를 들어, 치료제는 항염증제, 진통제, 항관절염제, 진경제, 항우울증제, 항정신병약물, 신경안정제, 항불안제, 마약길항제, 항파킨스질환 약물, 콜린성 아고니스트, 항암제, 항혈관신생억제제, 면역억제제, 항바이러스제, 항생제, 식욕억제제, 진통제, 항콜린제, 항히스타민제, 항편두통제, 호르몬제, 관상혈관, 뇌혈관 또는 말초혈관 확장제, 피임약, 항혈전제, 이뇨제, 항고혈압제, 심혈관질환 치료제 등을 포함할 수 있다. For example, the therapeutic agent is an anti-inflammatory agent, an analgesic agent, an anti-arthritic agent, an antispasmodic agent, an anti-depressant agent, an anti-psychotic agent, a nerve stabilizer, an anti-anxiety agent, an opioid antagonist, an anti-Parkin's disease drug, a cholinergic agonist, an anti-cancer agent, an anti-angiogenesis inhibitor, an immunosuppressant agent , antiviral, antibiotic, appetite suppressant, analgesic, anticholinergic, antihistamine, antimigraine, hormone, coronary, cerebrovascular or peripheral vasodilator, contraceptive, antithrombotic, diuretic, antihypertensive, cardiovascular disease treatment, etc. may include
특히, 단백질/펩타이드 의약은 호르몬, 호르몬 유사체, 효소, 효소저해제, 신호전달단백질 또는 그 일부분, 항체 또는 그 일부분, 단쇄항체, 결합단백질 또는 그 결합도메인, 항원, 부착단백질, 구조단백질, 조절단백질, 독소단백질, 사이토카인, 전사조절 인자, 혈액 응고 인자 및 백신 등을 포함할 수 있다. 보다 상세하게는, 상기 단백질/펩타이드 의약은 인슐린, IGF-1(insulin-like growth factor 1), 성장호르몬, 에리쓰로포이에틴, G-CSFs (granulocyte-colony stimulating factors), GM-CSFs(granulocyte/macrophagecolony stimulating factors), 인터페론 알파, 인터페론 베타, 인터페론 감마, 인터루킨-1 알파 및 베타, 인터루킨-3, 인터루킨-4, 인터루킨-6, 인터루킨-2, EGFs (epidermal growth factors), 칼시토닌(calcitonin), ACTH(adrenocorticotropic hormone), TNF (tumor necrosis factor), 아토비스반(atobisban), 부세레린(buserelin), 세트로렉릭스(cetrorelix), 데스로레린(deslorelin), 데스모프레신(desmopressin), 디노르핀 A(dynorphin A) (1-13), 엘카토닌(elcatonin), 엘레이도신(eleidosin), 엡티피바타이드(eptifibatide), GHRHII(growth hormone releasing hormone-II), 고나도레린(gonadorelin), 고세레린(goserelin), 히스트레린(histrelin), 류프로레린(leuprorelin), 라이프레신(lypressin), 옥트레오타이드(octreotide), 옥시토신(oxytocin), 피트레신(pitressin), 세크레틴(secretin), 신칼라이드(sincalide), 테르리프레신(terlipressin), 티모펜틴(thymopentin), 티모신(thymosine) α1, 트리프토레린(triptorelin), 바이발리루딘(bivalirudin), 카르베토신(carbetocin), 사이클로스포린, 엑세딘(exedine), 란레오타이드(lanreotide), LHRH (luteinizing hormone-releasing hormone), 나파레린(nafarelin), 부갑상선 호르몬, 프람린타이드(pramlintide), T-20(enfuvirtide), 타이말파신(thymalfasin) 및 지코노타이드를 포함할 수 있다.In particular, protein/peptide drugs include hormones, hormone analogs, enzymes, enzyme inhibitors, signal transduction proteins or parts thereof, antibodies or parts thereof, single-chain antibodies, binding proteins or binding domains thereof, antigens, adhesion proteins, structural proteins, regulatory proteins, Toxin proteins, cytokines, transcriptional regulatory factors, blood coagulation factors and vaccines may be included. More specifically, the protein / peptide drug is insulin, IGF-1 (insulin-like growth factor 1), growth hormone, erythropoietin, G-CSFs (granulocyte-colony stimulating factors), GM-CSFs (granulocytes) /macrophagecolony stimulating factors), interferon alpha, interferon beta, interferon gamma, interleukin-1 alpha and beta, interleukin-3, interleukin-4, interleukin-6, interleukin-2, EGFs (epidermal growth factors), calcitonin, ACTH (adrenocorticotropic hormone), TNF (tumor necrosis factor), atobisban, buserelin, cetrorelix, deslorelin, desmopressin, dynorphin A (1-13), elcatonin, eleidosin, eptifibatide, growth hormone releasing hormone-II (GHRHII), gonadorelin , goserelin, histrelin, leuprorelin, lypressin, octreotide, oxytocin, pitressin, secretin , sincalide, terlipressin, thymopentin, thymosine α1, triptorelin, bivalirudin, carbetocin, cyclosporine, exedine, lanreotide, luteinizing hormone-releasing hormone (LHRH), nafarelin, parathyroid hormone, pramlintide, T-20 (enfuvirtide), thymalfasin, and ziconotide.
또한, 본 발명에 따른 마이크로 구조체는 생체적합성 또는 생분해성 물질로 제조될 수 있다. 생체적합성 또는 생분해성 물질은 실질적으로 인체에 독성이 없고 화학적으로 불활성이며 면역원성이 없는 물질로, 최종적으로 체내 침투 후 용해되는 이점을 가진다.In addition, the microstructure according to the present invention may be made of a biocompatible or biodegradable material. A biocompatible or biodegradable material is substantially non-toxic to the human body, chemically inert, and non-immunogenic, and has the advantage of being dissolved after finally penetrating into the body.
이러한 생체적합성 물질의 종류는 특별히 제한되지 않으며, 예를 들어, 히알루론산, 폴리에스테르, 폴리하이드록시알카노에이트(PHAs), 폴리(α-하이드록시액시드), 폴리(β-하이드록시액시드), 폴리(3-하이드로식부티레이트-co-발러레이트; PHBV), 폴리(3-하이드록시프로프리오네이트; PHP), 폴리(3-하이드록시헥사노에이트; PHH), 폴리(4-하이드록시액시드), 폴리(4-하이드록시부티레이트), 폴리(4-하이드록시발러레이트), 폴리(4-하이드록시헥사노에이트), 폴리(에스테르아마이드), 폴리카프로락톤, 폴리락타이드, 폴리글리코라이드, 폴리(락타이드-co-글리코라이드; PLGA), 폴리디옥사논, 폴리오르토에스테르, 폴리에테르에스테르, 폴리언하이드라이드, 폴리(글리콜산-co-트리메틸렌 카보네이트), 폴리포스포에스테르, 폴리포스포에스테르 우레탄, 폴리(아미노산), 폴리사이아노아크릴레이트, 폴리(트리메틸렌 카보네이트), 폴리(이미노카보네이트), 폴리(타이로신 카보네이트), 폴리카보네이트, 폴리(타이로신 아릴레이트), 폴리알킬렌 옥살레이트, 폴리포스파젠스, PHA-PEG, 에틸렌 비닐 알코올 코폴리머(EVOH), 폴리우레탄, 실리콘, 폴리에스테르, 폴리올레핀, 폴리이소부틸렌과 에틸렌-알파올레핀 공중합체, 스틸렌-이소브틸렌-스틸렌 트리블록 공중합체, 아크릴 중합체 및 공중합체, 비닐 할라이드 중합체 및 공중합체, 폴리비닐 클 로라이드, 폴리비닐 에테르, 폴리비닐 메틸 에테르, 폴리비닐리덴 할라이드, 폴리비닐리덴 플루오라이드, 폴리비닐리덴 클로라이드, 폴리플루오로알켄, 폴리퍼플루오로알켄, 폴리아크릴로니트릴, 폴리비닐 케톤, 폴리비닐아로마틱스, 폴리스틸렌, 폴리비닐 에스테르, 폴리비닐 아세테이트, 에틸렌-메틸 메타크릴레이트 공중합체, 아크릴로니트릴-스틸렌 공중합체, ABS 수지와 에틸렌-비닐 아세테이트 공중합체, 폴리아마이드, 알키드 수지, 폴리옥시메틸렌, 폴리이미드, 폴리에테르, 폴리아크릴레이트, 폴리메타크릴레이트, 폴리아크릴산-co-말레산, 키토산, 덱스트란, 셀룰로오스, 헤파린, 알기네이트, 이눌린, 녹말 또는 글리코겐을 사용할 수 있고, 히알루론산, 폴리에스테르, 폴리하이드록시알카노에이트(PHAs), 폴리(α-하이드록시액시드), 폴리(β-하이드록시액시드), 폴리(3-하이드로식부티레이트-co-발러레이트; PHBV), 폴리(3-하이드록시프로프리오네이트; PHP), 폴리(3-하이드록시헥사노에이트; PHH), 폴리(4-하이드록시액시드), 폴리(4-하이드록시부티레이트), 폴리(4-하이드록시발러레이트), 폴리(4-하이드록시헥사노에이트), 폴리(에스테르아마이드), 폴리카프로락톤, 폴리락타이드, 폴리글리코라이드, 폴리(락타이드-co-글리코라이드; PLGA), 폴리디옥사논, 폴리오르토에스테르, 폴리에테르에스테르, 폴리언하이드라이드, 폴리(글리콜산-co-트리메틸렌 카보네이트), 폴리포스포에스테르, 폴리포스포에스테르우레탄, 폴리(아미노산), 폴리사이아노아크릴레이트, 폴리(트리메틸렌 카보네이트), 폴리(이미노카보네이트), 폴리(타이로신 카보네이트), 폴리카보네이트, 폴리(타이로신 아릴레이트), 폴리알킬렌 옥살레이트, 폴리포스파젠스, PHAPEG, 키토산, 덱스트란, 셀룰로오스, 헤파린, 알기네이트, 이눌린, 녹말 및 글리코겐으로 이루어진 그룹으로부터 선택된 하나 이상을 사용할 수 있다. The type of the biocompatible material is not particularly limited, and for example, hyaluronic acid, polyester, polyhydroxyalkanoate (PHAs), poly(α-hydroxyacid), poly(β-hydroxyacid) ), poly(3-hydroxybutyrate-co-valerate; PHBV), poly(3-hydroxypropionate; PHP), poly(3-hydroxyhexanoate; PHH), poly(4-hydro hydroxy acid), poly(4-hydroxybutyrate), poly(4-hydroxyvalerate), poly(4-hydroxyhexanoate), poly(esteramide), polycaprolactone, polylactide, poly Glycolide, poly(lactide-co-glycolide; PLGA), polydioxanone, polyorthoester, polyetherester, polyanhydride, poly(glycolic acid-co-trimethylene carbonate), polyphosphoester , polyphosphoester urethane, poly(amino acid), polycyanoacrylate, poly(trimethylene carbonate), poly(iminocarbonate), poly(tyrosine carbonate), polycarbonate, poly(tyrosine arylate), polyalkyl Rene oxalate, polyphosphazenes, PHA-PEG, ethylene vinyl alcohol copolymer (EVOH), polyurethane, silicone, polyester, polyolefin, polyisobutylene and ethylene-alphaolefin copolymer, styrene-isobutylene- styrene triblock copolymers, acrylic polymers and copolymers, vinyl halide polymers and copolymers, polyvinyl chloride, polyvinyl ether, polyvinyl methyl ether, polyvinylidene halide, polyvinylidene fluoride, polyvinylidene chloride, Polyfluoroalkenes, polyperfluoroalkenes, polyacrylonitrile, polyvinyl ketone, polyvinylaromatics, polystyrene, polyvinyl ester, polyvinyl acetate, ethylene-methyl methacrylate copolymer, acrylonitrile-styrene copolymer Copolymer, ABS resin and ethylene-vinyl acetate copolymer, polyamide, alkyd resin, polyoxymethylene, polyimide, polyether, polyacrylate, polymethacrylate, polyacrylic acid-co-maleic acid, chitosan, dextran, cellulose , heparin, alginate, inulin, starch or glycogen can be used, and hyaluronic acid, polyester, polyhydroxyalkanoates (PHAs), poly(α-hydroxyacid), poly(β-hydroxyacid) ), poly(3-hydro-butyrate-co-valerate; 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, polyglycolide, poly(lactide-co-glycolide; PLGA) , polydioxanone, polyorthoester, polyetherester, polyanhydride, poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acid), polycyano Acrylates, poly(trimethylene carbonate), poly(iminocarbonate), poly(tyrosine carbonate), polycarbonate, poly(tyrosine arylate), polyalkylene oxalate, polyphosphazenes, PHAPEG, chitosan, dextran One or more selected from the group consisting of , cellulose, heparin, alginate, inulin, starch and glycogen may be used.
상기 마이크로 구조체가 생체 적합성 또는 생분해성 물질이 탑재된 솔리드형 마이크로 니들인 경우, 약물을 추가적으로 탑재할 수 있다. When the microstructure is a solid microneedle loaded with a biocompatible or biodegradable material, a drug may be additionally loaded.
아래에서는, 본 발명의 다양한 실시 예에 따른 저자극 마이크로 구조체에 대해 설명한다.Hereinafter, hypoallergenic microstructures according to various embodiments of the present invention will be described.
도 1은 본 발명의 일 실시 예에 따른 마이크로 구조체를 나타내는 사시도이고, 도 2는 도 1에 도시된 마이크로 니들을 확대하여 나타낸 도면이다.1 is a perspective view illustrating a microstructure according to an embodiment of the present invention, and FIG. 2 is an enlarged view of the microneedle shown in FIG. 1 .
도 1 및 도 2를 참조하면, 마이크로 구조체(10)는 베이스 필름(100)과 마이크로 니들(200)을 포함한다. 1 and 2 , the microstructure 10 includes a base film 100 and a microneedle 200 .
베이스 필름(100)은 두께가 얇은 필름으로, 소정 너비로 제공된다. 베이스 필름(100)은 원형 또는 다각 형상의 필름으로 제공될 수 있다.The base film 100 is a thin film and is provided with a predetermined width. The base film 100 may be provided as a film having a circular or polygonal shape.
마이크로 니들(200)은 베이스 필름(100)의 일 면에 복수 개 형성되며, 피부에 침투 가능하고, 피부 침투 시 자극이 최소화될 수 있는 구조로 제공된다. 마이크로 니들(200)은 니들 바디(210)와 지지 날개(250)를 포함한다.A plurality of microneedles 200 are formed on one surface of the base film 100, and are provided in a structure capable of penetrating into the skin and minimizing irritation when penetrating the skin. The microneedle 200 includes a needle body 210 and a support wing 250 .
니들 바디(210)는 베이스 필름(100)의 일 면으로부터 소정 높이로 돌출된다. 실시 예에 의하면, 니들 바디(210)는 전체 높이가 100um 내지 2000um 일수 있다. 니들 바디(210)는 제1영역(211)과 제2영역(212)을 갖는다. 제1영역(211)은 베이스 필름(100)의 일 면으로부터 돌출된 기둥 형상으로, 소정 높이(h1)와 너비(w1)를 갖는다. 실시 예에 의하면, 제1영역(211)은 50um 내지 1000um의 높이(h1)와 10um 내지 750um의 너비(w1)를 가질 수 있다. 이와 달리, 제1영역(211)의 하단 영역은 10um 내지 750um의 너비를 갖고, 상단 영역은 10um 내지 500um의 너비를 가질 수 있다. 제1영역(211)은 원형 또는 다각형의 단면을 가질 수 있다.The needle body 210 protrudes from one surface of the base film 100 to a predetermined height. According to the embodiment, the needle body 210 may have a total height of 100um to 2000um. The needle body 210 has a first region 211 and a second region 212 . The first region 211 has a pillar shape protruding from one surface of the base film 100 , and has a predetermined height h1 and a width w1 . According to an embodiment, the first region 211 may have a height h1 of 50 μm to 1000 μm and a width w1 of 10 μm to 750 μm. Alternatively, the lower region of the first region 211 may have a width of 10 μm to 750 μm, and the upper region may have a width of 10 μm to 500 μm. The first region 211 may have a circular or polygonal cross-section.
제2영역(212)은 제1영역(211)의 상단으로부터 연장되며, 그 끝단으로 갈수록 너비가 점차 감소한다. 실시 예에 의하면, 제2영역(212)은 10um 내지 1000um의 높이를 가질 수 있다. 제2영역(212)의 끝단은 뾰족한 팁(tip)을 형성한다. 실시 예에 의하면, 제2영역(212)의 팁은 10도 내지 60도의 팁 각도(tip angle)를 가질 수 있다. 제1영역(211)과 제2영역(212)이 연결되는 영역은 외주면이 소정 각도를 이루거나, 곡면으로 제공될 수 있다. 곡면은 피부 자극을 최소화할 수 있다.The second region 212 extends from the upper end of the first region 211 and gradually decreases in width toward the end thereof. According to an embodiment, the second region 212 may have a height of 10 μm to 1000 μm. An end of the second region 212 forms a sharp tip. According to an embodiment, the tip of the second region 212 may have a tip angle of 10 degrees to 60 degrees. The region where the first region 211 and the second region 212 are connected may have an outer circumferential surface at a predetermined angle or a curved surface. The curved surface can minimize skin irritation.
지지 날개(250)는 얇은 두께로 복수 개 형성되며, 니들 바디(210)를 둘레를 따라 서로 이격하여 배치된다. 지지 날개(250)들은 니들 바디(210)를 중심으로 동일한 사이 각으로 배치될 수 있다. 지지 날개(250)는 니들 바디(210)를 중심으로 서로 대칭되어 배치될 수 있다. 본 실시 예에서는, 지지 날개(250)가 3개 형성되며, 니들 바디(210)의 중심축을 기준으로 120도의 사이각으로 배치되는 것을 예를 들어 설명한다. 그러나, 지지 날개(250)의 개수 및 배치는 이에 국한되지 않으며, 다양하게 변경될 수 있다.A plurality of support wings 250 are formed to have a thin thickness, and are disposed to be spaced apart from each other along the periphery of the needle body 210 . Support wings 250 may be disposed at the same angle between the needle body 210 as a center. The support wings 250 may be disposed symmetrically with each other around the needle body 210 . In this embodiment, three support blades 250 are formed, and it will be described for example that they are disposed at an angle of 120 degrees with respect to the central axis of the needle body 210 . However, the number and arrangement of the support wings 250 are not limited thereto, and may be variously changed.
지지 날개(250)는 삼각 형상으로, 니들 바디(210)의 외측면과 베이스 필름(100)을 연결한다. 지지 날개(250)는 니들 바디(210)의 중심으로부터 멀어질수록 두께가 점차 감소하고, 상단으로부터 베이스 필름(100)과 연결된 하단으로 갈수록 점차 두께가 증가한다. 이에 의해, 지지 날개(250)는 삼각형의 단면을 가질 수 있다.The support wing 250 has a triangular shape, and connects the outer surface of the needle body 210 and the base film 100 . The support wing 250 gradually decreases in thickness as it goes away from the center of the needle body 210 , and gradually increases in thickness from the top to the bottom connected to the base film 100 . Accordingly, the support wing 250 may have a triangular cross section.
실시 예에 의하면, 지지 날개(250)의 상단은 제1영역(211)의 상단보다 낮게 위치할 수 있다. 지지 날개(250)의 하단과 베이스 필름(110)이 연결되는 연결 영역은 그 너비(w2)가 제1영역(211)의 너비와 동일하게 제공될 수 있다. 실시 예에 의하면, 지지 날개(250)의 하단과 베이스 필름(100)이 연결되는 연결 영역의 너비(w2)는 10um 내지 750um 일 수 있다.According to an embodiment, the upper end of the support wing 250 may be positioned lower than the upper end of the first region 211 . A width w2 of the connection region where the lower end of the support wing 250 and the base film 110 are connected may be provided to be the same as the width w2 of the first region 211 . According to an embodiment, the width w2 of the connection region where the lower end of the support wing 250 and the base film 100 are connected may be 10 μm to 750 μm.
도 3 내지 도 5는 본 발명의 다양한 실시 예에 따른 마이크로 니들을 나타내는 도면이다.3 to 5 are views showing microneedles according to various embodiments of the present invention.
먼저, 도 3을 참조하면, 지지 날개(250)의 상단은 제1영역(211)의 상단보다 낮게 위치할 수 있다. 실시 예에 의하면, 지지 날개(250)의 상단은 제1영역(211)의 1/3지점에 위치할 수 있다. First, referring to FIG. 3 , the upper end of the support wing 250 may be positioned lower than the upper end of the first region 211 . According to the embodiment, the upper end of the support wing 250 may be located at 1/3 of the first area 211 .
도 4를 참조하면, 지지 날개(250)의 상단은 제1영역(211)의 상단과 동일 높이에 위치할 수 있다. Referring to FIG. 4 , the upper end of the support wing 250 may be positioned at the same height as the upper end of the first region 211 .
도 5를 참조하면, 지지 날개(250)의 상단은 제2영역(212)의 팁과 동일 높이에 위치할 수 있다.Referring to FIG. 5 , the upper end of the support wing 250 may be positioned at the same height as the tip of the second region 212 .
이와 같이, 지지 날개(250)는 니들 바디(210)와 비교할 때, 다양한 높이를 가질 수 있다. 지지 날개(250)에 의해, 니들 바디(210)와 베이스 필름(100)의 결합 강도가 향상되므로, 니들 바디(210)의 너비가 최소화될 수 있다. 니들 바디(210)의 너비 최소화는 피부 침투를 용이하게 하고, 피부 자극을 최소화한다. 또한, 지지 날개(250)는 마이크로 구조체(100)가 몰드로부터 분리되는 과정에서 니들 바디(210)의 파손 없이 안정적으로 마이크로 구조체(10)가 분리될 수 있도록 한다. 그리고 지지 날개(250)는 마이크로 구조체(10)를 손가락으로 눌러 니들 바디(210)를 피부에 침투시키는 과정에서, 니들 바디(210)의 파손을 예방한다.As such, the support wing 250 may have various heights as compared to the needle body 210 . By the support wing 250, since the bonding strength of the needle body 210 and the base film 100 is improved, the width of the needle body 210 can be minimized. Minimizing the width of the needle body 210 facilitates skin penetration and minimizes skin irritation. In addition, the support wing 250 allows the microstructure 10 to be stably separated without damage to the needle body 210 in the process in which the microstructure 100 is separated from the mold. And in the process of penetrating the needle body 210 into the skin by pressing the microstructure 10 with a finger, the support wing 250 prevents damage to the needle body 210 .
도 6 및 도 7은 본 발명의 또 다른 실시 예에 따른 마이크로 니들을 나타내는 도면이다.6 and 7 are views showing a microneedle according to another embodiment of the present invention.
도 6 및 도 7을 참조하면, 지지 날개(250)들은 그 영역에 따라 외곽 모서리의 경사 각도가 상이하게 제공될 수 있다. 지지 날개(250)의 제1영역(251)은 상단으로부터 외곽 모서리가 제1각도로 연장되고, 제2영역(252)은 제1영역(251)으로부터 제1각도와 상이한 제2각도로 외곽 모서리가 연장된다.Referring to FIGS. 6 and 7 , the support wings 250 may be provided with different inclination angles of outer corners according to their regions. The first area 251 of the support wing 250 has an outer edge extending from the top at a first angle, and the second area 252 has an outer edge at a second angle different from the first angle from the first area 251 . is extended
도 6을 참조하면, 지지 날개(250)의 제2영역(252)의 외곽 모서리는 제1영역(251)의 외곽 모서리에 비해 경사 각도가 작을 수 있다Referring to FIG. 6 , the outer edge of the second region 252 of the support wing 250 may have a smaller inclination angle than the outer edge of the first region 251 .
도 7을 참조하면, 지지 날개(250)의 제2영역(252)의 외곽 모서리는 베이스 필름(100)의 일 면에 수직하게 연장될 수 있다.Referring to FIG. 7 , an outer edge of the second region 252 of the support wing 250 may extend perpendicularly to one surface of the base film 100 .
이러한 지지 날개(250)의 형상은 마이크로 구조체(10)의 강도와 마이크로 구조체(10)가 삽입되는 피부층의 단단한 정도에 따라 선택될 수 있다.The shape of the support wing 250 may be selected according to the strength of the microstructure 10 and the degree of hardness of the skin layer into which the microstructure 10 is inserted.
도 8은 본 발명의 또 다른 실시 예에 따른 니들 바디를 나타내는 도면이다.8 is a view showing a needle body according to another embodiment of the present invention.
도 8을 참조하면, 니들 바디(210)와 베이스 필름(100)이 연결되는 영역에는 니들 바디(210)의 둘레를 따라 필렛(fillet, 215)이 형성될 수 있다. 필렛(215)은 니들 바디(210)와 베이스 필름(100)의 연결 영역을 보강하여 상술한 지지 날개(250)들과 함께 마이크로 니들(200)의 강도를 향상시킬 수 있다.Referring to FIG. 8 , a fillet 215 may be formed along the circumference of the needle body 210 in a region where the needle body 210 and the base film 100 are connected. The fillet 215 may enhance the strength of the microneedle 200 together with the support wings 250 described above by reinforcing the connection region between the needle body 210 and the base film 100 .
도 9는 본 발명의 다양한 실시 예에 따른 지지 날개의 단면을 나타내는 도면이다. 이하, 설명의 편의를 위하여 지지 바디(210)의 일 측에 형성된 지지 날개(250)를 제1지지 날개(250a)라 하고, 타 측에 형성된 지지 날개(250)를 제2지지 날개(250b)라 한다.9 is a view showing a cross-section of a support wing according to various embodiments of the present disclosure. Hereinafter, for convenience of explanation, the support wing 250 formed on one side of the support body 210 is referred to as a first support wing 250a, and the support wing 250 formed on the other side of the support body 210 is referred to as a second support wing 250b. say
제1 및 제2 지지 날개(250a, 250b)의 단면은 다양한 형상 및 크기를 가질 수 있다. 실시 예에 의하면, 제1 및 제2 지지 날개(250a, 250b)의 단면은 삼각형, 사각형, 오각형을 가질 수 있다. 제1 및 제2 지지 날개(250a, 250b)의 형상과 크기는 피부층의 두께, 피부층의 단단함 등 피부의 삽입 부위에 따라 선택될 수 있다.The cross-sections of the first and second support wings 250a and 250b may have various shapes and sizes. According to an embodiment, the cross-sections of the first and second support wings 250a and 250b may have a triangular shape, a quadrangular shape, and a pentagonal shape. The shape and size of the first and second support wings 250a and 250b may be selected according to the insertion site of the skin, such as the thickness of the skin layer and the hardness of the skin layer.
도 10은 본 발명의 다양한 실시 예에 따른 지지 날개의 단면을 나타내는 도면이다.10 is a view showing a cross-section of a support wing according to various embodiments of the present invention.
도 10을 참조하면, 제1 및 제2 지지 날개(250a, 250b)는 다양한 두께로 제공될 수 있다. (A)와 (B)와 같이, 제1 및 제2 지지 날개(250a, 250b)의 두께는 니들 바디(210)를 기준으로 대칭될 수 있다.Referring to FIG. 10 , the first and second support wings 250a and 250b may be provided in various thicknesses. As in (A) and (B), the thickness of the first and second support wings (250a, 250b) may be symmetrical with respect to the needle body (210).
반면, (C)와 같이, 제1 및 제2 지지 날개(250a, 250b)의 두께는 니들 바디(210)를 기준으로 비대칭 될 수 있다. 구체적으로, 제2지지 날개(250b)는 제1지지 날개(250q)보다 두께가 두꺼울 수 있다. 이는 마이크로 구조체(10)가 몰드에서 분리되거나, 피부에 삽입되는 과정에서 니들 바디(210)에 가해지는 하중 방향에 따라 어느 하나의 지지 날개(250b)가 다른 하나의 지지 날개(250a)보다 두껍게 형성되어 니들 바디(210)를 안정적으로 지지할 수 있다.On the other hand, as shown in (C), the thickness of the first and second support wings (250a, 250b) may be asymmetrical with respect to the needle body (210). Specifically, the second support wing 250b may be thicker than the first support wing 250q. This is because one support wing 250b is thicker than the other support wing 250a depending on the direction of load applied to the needle body 210 in the process of the microstructure 10 being separated from the mold or inserted into the skin. It is possible to stably support the needle body 210 .
도 11은 본 발명의 다양한 실시 예에 따른 지지 날개들의 배치를 나타내는 단면도이다.11 is a cross-sectional view illustrating an arrangement of support wings according to various embodiments of the present disclosure.
도 11을 참조하면, 지지 날개(250)는 니들 바디(210)의 형상 및 크기에 따라 최소 2개 이상 제공될 수 있으며, 다양한 개수로 니들 바디(210)를 중심으로 방사상으로 배치될 수 있다.Referring to FIG. 11 , at least two support wings 250 may be provided depending on the shape and size of the needle body 210 , and various numbers may be radially arranged around the needle body 210 .
도 12는 본 발명의 실시 예에 따라 제작된 마이크로 구조체와 마이크로 니들을 나타내는 이미지이고, 도 13은 본 발명의 실시 예에 따른 마이크로 구조체를 피부에 침투시키는 과정을 나타내는 도면이고, 도 14는 비교 예에 따른 마이크로 구조체를 피부에 침투시키는 과정을 나타내는 도면이다. 비교 예에 따른 마이크로 구조체는 원뿔 형상의 마이크로 니들(300)이 사용되었다.12 is an image showing a microstructure and a microneedle manufactured according to an embodiment of the present invention, FIG. 13 is a diagram showing a process of penetrating the microstructure according to an embodiment of the present invention into the skin, and FIG. 14 is a comparative example It is a view showing the process of penetrating the microstructure according to the skin. As the microstructure according to the comparative example, a conical microneedle 300 was used.
도 12 및 도 13을 참조하면, 본 발명의 실시 예에 따른 마이크로 구조체(10)는 지지 날개(250)로 인해 니들 바디(210)의 너비가 최소화될 수 있어, 피부 침투 시 자극 발생이 최소화될 수 있다. 12 and 13, in the microstructure 10 according to the embodiment of the present invention, the width of the needle body 210 can be minimized due to the support wing 250, so that the occurrence of irritation during skin penetration is minimized. can
반면, 도 14를 참조하면, 비교 예에 따른 마이크로 니들(300)은 베이스 필름(100)과 인접할수록 너비가 점차 커지므로, 피부 침투 시 큰 자극이 발생될 수 있다.On the other hand, referring to FIG. 14 , the microneedle 300 according to the comparative example gradually increases in width as it approaches the base film 100 , and thus a great stimulus may be generated during skin penetration.
이상, 본 발명을 바람직한 실시 예를 사용하여 상세히 설명하였으나, 본 발명의 범위는 특정 실시 예에 한정되는 것은 아니며, 첨부된 특허청구범위에 의하여 해석되어야 할 것이다. 또한, 이 기술분야에서 통상의 지식을 습득한 자라면, 본 발명의 범위에서 벗어나지 않으면서도 많은 수정과 변형이 가능함을 이해하여야 할 것이다.As mentioned above, although the present invention has been described in detail using preferred embodiments, the scope of the present invention is not limited to specific embodiments and should be construed according to the appended claims. In addition, those skilled in the art should understand that many modifications and variations are possible without departing from the scope of the present invention.
본 발명에 따른 마이크로 구조체는 의료 및 피부 미용에 사용될 수 있다.The microstructure according to the present invention can be used for medical and skin care.

Claims (9)

  1. 베이스 필름; 및base film; and
    상기 베이스 필름의 일 면에 형성된 복수 개의 마이크로 니들을 포함하되,Including a plurality of microneedles formed on one surface of the base film,
    상기 마이크로 니들은The microneedle is
    상기 베이스 필름의 일 면으로부터 소정 높이로 돌출되는 기둥 형상의 제1영역과, 상기 제1영역으로부터 연장되며 그 끝단으로 갈수록 너비가 점차 감소하는 제2영역을 갖는 니들 바디를 포함하는 마이크로 구조체.A microstructure comprising a needle body having a columnar first region protruding from one surface of the base film to a predetermined height, and a second region extending from the first region and gradually decreasing in width toward an end thereof.
  2. 제 1 항에 있어서,The method of claim 1,
    상기 제1영역의 너비는 10um 내지 750um이고,The width of the first region is 10um to 750um,
    상기 제2영역의 끝단에는 10도 내지 60도의 사이각을 갖는 팁이 형성된 마이크로 구조체.A tip having an angle between 10 degrees and 60 degrees is formed at the end of the second region.
  3. 제 1 항에 있어서,The method of claim 1,
    상기 마이크로 니들은,The microneedle is
    상기 니들 바디를 중심으로 복수 개 배치되며, 상기 니들 바디의 외측면과 상기 베이스 필름을 연결하며, 상기 제1영역보다 얇은 두께를 갖는 지지 날개들을 더 포함하는 마이크로 구조체.A plurality of microstructures arranged around the needle body, connecting the outer surface of the needle body and the base film, and further comprising support wings having a thinner thickness than the first region.
  4. 제 3 항에 있어서,4. The method of claim 3,
    상기 지지 날개는 상단이 상기 제1영역의 상단보다 낮게 위치하는 마이크로 구조체.The upper end of the support wing is located lower than the upper end of the first area microstructure.
  5. 제 3 항에 있어서,4. The method of claim 3,
    상기 지지 날개는 상단이 상기 제1영역의 상단과 동일한 높이에 위치하는 마이크로 구조체.The upper end of the support wing is located at the same height as the upper end of the first area microstructure.
  6. 제 3 항에 있어서,4. The method of claim 3,
    상기 지지 날개는 상단이 상기 제2영역의 끝단과 동일한 높이에 위치하는 마이크로 구조체.The upper end of the support wing is located at the same height as the end of the second region microstructure.
  7. 제 3 항에 있어서,4. The method of claim 3,
    상기 지지 날개는 상기 니들 바디의 중심으로부터 멀어질수록 두께가 점차 감소하는 마이크로 구조체.The support wing is a microstructure that gradually decreases in thickness as it goes away from the center of the needle body.
  8. 제 3 항에 있어서,4. The method of claim 3,
    상기 지지 날개의 외곽 모서리는 상단으로부터 제1각도로 연장되는 제1모서리 영역과, 상기 제1모서리 영역으로부터 상기 제1각도와 상이한 제2각도로 연장되는 제2모서리 영역을 포함하는 마이크로 구조체.The outer edge of the support wing includes a first corner region extending from the top at a first angle, and a second corner region extending from the first corner region at a second angle different from the first angle.
  9. 제 3 항에 있어서,4. The method of claim 3,
    상기 지지 날개는The support wing is
    상기 니들 바디의 일 측에 위치하는 제1지지 날개; 및a first support wing positioned on one side of the needle body; and
    상기 니들 바디를 중심으로 상기 제1지지 날개의 반대 편에 위치하는 제2지지 날개를 포함하되,Including a second support wing positioned on the opposite side of the first support wing with respect to the needle body,
    상기 제1지지 날개와 상기 제2지지 날개는 상이한 두께를 갖는 마이크로 구조체.The first support blade and the second support blade have different thicknesses.
PCT/KR2021/015703 2020-11-19 2021-11-02 Low-irritation microstructure WO2022108184A1 (en)

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KR1020210102891A KR102685381B1 (en) 2020-11-19 2021-08-05 Hypoallergenic microstructure

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Citations (5)

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Publication number Priority date Publication date Assignee Title
EP2823850A1 (en) * 2012-03-06 2015-01-14 Technical Institute of Physics and Chemistry of the Chinese Academy of Sciences Polymer micro-needle array chip, preparation process and use thereof
KR102014592B1 (en) * 2017-05-08 2019-08-29 주식회사 에스엔비아 Microneedle
US20190358441A1 (en) * 2018-05-28 2019-11-28 Industrial Cosmetic Lab Microneedle patch for transdermal injections
CN111298280A (en) * 2018-12-11 2020-06-19 尹忠 Soft back microneedle and manufacturing method thereof
CN107073210B (en) * 2014-09-03 2020-11-10 新南创新私人有限公司 Microfluidic device and fabrication

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2823850A1 (en) * 2012-03-06 2015-01-14 Technical Institute of Physics and Chemistry of the Chinese Academy of Sciences Polymer micro-needle array chip, preparation process and use thereof
CN107073210B (en) * 2014-09-03 2020-11-10 新南创新私人有限公司 Microfluidic device and fabrication
KR102014592B1 (en) * 2017-05-08 2019-08-29 주식회사 에스엔비아 Microneedle
US20190358441A1 (en) * 2018-05-28 2019-11-28 Industrial Cosmetic Lab Microneedle patch for transdermal injections
CN111298280A (en) * 2018-12-11 2020-06-19 尹忠 Soft back microneedle and manufacturing method thereof

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