WO2018208013A1 - Micro-aiguille - Google Patents

Micro-aiguille Download PDF

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Publication number
WO2018208013A1
WO2018208013A1 PCT/KR2018/003955 KR2018003955W WO2018208013A1 WO 2018208013 A1 WO2018208013 A1 WO 2018208013A1 KR 2018003955 W KR2018003955 W KR 2018003955W WO 2018208013 A1 WO2018208013 A1 WO 2018208013A1
Authority
WO
WIPO (PCT)
Prior art keywords
curvature
skin
microneedle
patch
divided
Prior art date
Application number
PCT/KR2018/003955
Other languages
English (en)
Korean (ko)
Inventor
양승윤
이승수
이강오
Original Assignee
부산대학교 산학협력단
주식회사 에스엔비아
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 부산대학교 산학협력단, 주식회사 에스엔비아 filed Critical 부산대학교 산학협력단
Publication of WO2018208013A1 publication Critical patent/WO2018208013A1/fr

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Classifications

    • 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
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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
    • 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
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0046—Solid microneedles
    • 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
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061—Methods for using microneedles

Definitions

  • the present invention relates to a microneedle patch, and more particularly to a microneedle that can easily prevent the departure when inserted into the skin by improving the shape of the microneedle applied to the patch.
  • the tip is formed on the upper end and the body is formed in a straight line, when inserted into the skin easily detached.
  • U.S. Patent No. 8834423 and U.S. Patent No. 8353861 disclose microneedles having a reverse taper shape. This acts as a notch, weakens the strength and easily breaks.
  • the present invention has been made to solve the problems of the prior art as described above, and an object thereof is to provide a microneedle structure that can prevent the departure from the skin.
  • the present invention comprises a microneedle of the reverse taper form that can easily prevent the departure from the skin, to provide a microneedle structure that can maintain the strength by maintaining a constant overall cross-sectional area relative to the longitudinal direction of the object There is this.
  • the microneedle comprises a patch portion and a plurality of microneedles extending on one surface of the patch portion, wherein the microneedle is a head portion and a conical end portion to facilitate penetration into the skin and the It extends from the head portion to the patch portion, and comprises a body portion which is formed to be concave inward.
  • the microneedle is effective to prevent the departure from the skin.
  • microneedle according to the present invention after insertion into the skin, there is an effect that can be easily broken selectively.
  • microneedle according to the present invention is configured in the form of a reverse tape that can easily prevent the departure from the skin, there is an effect that can maintain the strength by maintaining a constant overall cross-sectional area based on the longitudinal direction.
  • Figure 1 (a) shows a representation of US Patent No. 8834423.
  • Figure 1 (b) shows a representation of US Patent No. 8353861.
  • Figure 2 shows in a perspective view the form applied to the microneedle patch according to the present invention.
  • Figure 3 shows a front cross-sectional view of the recessed type needle according to the present invention.
  • Figure 4 shows a front cross-sectional view of the stapler type needle according to the present invention.
  • Figure 5 (a) shows a front cross-sectional view of the microneedle of the reverse taper shape according to another embodiment of the present invention.
  • Figure 5 (b) shows a side cross-sectional view of the microneedle of the reverse taper type according to another embodiment of the present invention.
  • Figure 5 (c) shows a cross-sectional plan view of the microneedle of the reverse taper shape according to another embodiment of the present invention.
  • the microneedle according to the present invention includes a patch part 1 and a plurality of microneedles 2 extending on one surface of the patch part 1, and the microneedle ( 2) is characterized in that it is provided in the form of a reverse taper of the cross-sectional area increases toward the end.
  • the patch 1 is provided with a plate-like flexible material.
  • the patch 1 may be generally formed in a general form used for patching the microneedle 2, and a film layer having a detachable form may be further formed to protect the surface.
  • microneedles 2 are provided in plural in a form extending from one surface of the patch part 1.
  • the microneedle 2 may be formed to extend from the patch portion 1, the end may be provided in a conical shape to facilitate insertion into the skin.
  • the microneedle 2 is excellent in biocompatibility as an application to be inserted into the skin, and may optionally be composed of a biodegradable material.
  • the microneedle 2 is composed of a head portion 31 and the body portion (32).
  • the head portion 31 is a portion corresponding to the end of the microneedle 2, is formed in a conical shape to facilitate penetration into the skin.
  • the body portion 32 is a portion extending from the head portion 31 to the patch portion 1, and the middle portion is formed to be concave inward with respect to the longitudinal direction.
  • the body portion 32 is formed concave, when the microneedle 2 penetrates the skin by attaching the patch portion 1 to the skin, the body portion is formed concave by elasticity of the skin.
  • the boundary layer of the skin is formed in close contact with 32 to prevent the microneedle 2 from being easily separated.
  • the concave portion of the body portion 32 is not formed in the corner of the corner shape is formed smoothly in the shape of an arch, so that when entering or releasing to the skin, to maintain a sufficient strength to prevent breakage Can be.
  • the concave portion is formed in the middle portion of the body portion 32, as shown in Fig. 1 (a), (b), when formed in an angular shape, the same effect as the notch is formed by itself is angled When the strength of the part is drastically lowered, the injection into the skin is more likely to be broken, so that the injection is difficult, and even after the injection, it may be easily broken, which may make recovery difficult.
  • the microneedle 2 may be intentionally broken after the injection into the skin for the purpose of administering the drug, but as described above, when the angular portion is formed in the body part 32, Penetration into the skin itself is not easy.
  • the body portion 32 is preferably configured so that the angle of the corner shape is not formed.
  • the microneedle 2 according to the present invention can be used for two main purposes, and may be composed of any one of the recessed type needle 3 and the stapler type needle.
  • the immersion type needle (3) after penetrating the microneedle (2) into the skin, and absorbs a portion of the microneedle (2) provided with a biodegradable material with the drug in the skin in the skin to absorb
  • the body is easily broken so that it can remain in the skin.
  • the first-curvature 321 is positioned below the head 31 and has a radius of curvature of 0.65 to 0.75 mm.
  • the first 1-2 curvature portion 322 is located in the lower portion of the first curvature portion when the body portion 32 is divided into four, the radius of curvature is 0.36 ⁇ 0.45mm.
  • the first 1-3 curvature 323 is located below the second curvature, when the body 32 is divided into four, the radius of curvature is 0.30 ⁇ 0.35mm.
  • the first to fourth curvature portions 324 are positioned below the third curvature portion and connected to the patch portion 1, and the radius of curvature is 0.20. It consists of ⁇ 0.29mm.
  • the radius of curvature becomes smaller toward the first-curvature 324 from the first-first curvature 321.
  • the thickness of the first 1-2 curvature 322 to the first 1-3 curvature 323 gradually becomes thin, when the immersion type needle (3) is inserted into the skin, when the lateral pressure is applied In one or more of the 1-2nd curvature 322 and the 1-3th curvature 323 may be easily broken.
  • the stapler type needle (4), the microneedle (2) penetrates into the skin for the purpose of attaching and holding the patch (1) to the skin so as not to open any more open wounds, etc. of the skin After that, it is configured not to be easily detached and configured to prevent the detachment of the patch 1 from the skin.
  • the body portion 42 applied to the stapler type needle 4, as shown in Figure 4 includes a 2-1 curvature portion 421 to 2-4 curvature portion 424 It is configured by.
  • the 2-1nd curvature portion 421 is located below the head portion 41 when the body portion 42 is divided into four parts, and the radius of curvature is 0.15 to 0.25 mm.
  • the second-2 curvature 422 is located below the second-1 curvature 421 when the body 42 is divided into four, and has a radius of curvature of 0.30 to 0.35 mm. It is composed.
  • the 2-3 curvature 423 is located below the second 2-2 curvature 422 and has a radius of curvature of 0.36 to 0.45 mm. It is composed.
  • the second-4 curvature 424 is located in the lower portion of the 2-3 curvature 423 when the body portion 42 is divided into four, and is connected to the patch 1.
  • the radius of curvature is composed of 0.70 to 1.20 mm.
  • the radius of curvature increases from the 2-1st curvature 421 toward the 2-4th curvature 424.
  • the stapler type needle 4 when the stapler type needle 4 is inserted into the skin, the strength is not broken, and at least one of the 2-1 curvature 421 and the 2-2 curvature 422 is maintained.
  • the surface of the skin is caught by the elasticity can be prevented from being easily separated from the skin.
  • the microneedle 2 has a head portion 5 and a patch portion from the head portion 5 forming a conical end portion to facilitate penetration into the skin, as shown in FIG. 5. It extends to (1), but the transverse diameter becomes wider from the upper side to the lower side, and the longitudinal diameter is composed of a body portion 6 in the form of narrowing.
  • FIG. 2A illustrates a front view of the microneedle 2 according to another embodiment
  • FIG. 2B illustrates a side view of the microneedle 2 according to another embodiment. It is shown.
  • FIG. 2 shows a cross section in the plane of A-A ', B-B', C-C 'in plan view.
  • the body portion 6 is configured in an inverted taper shape in which the diameter decreases as the lateral cross section is directed downward, but in the forward cross section, it is preferable that the body portion 6 is configured in a tapered form in which the diameter is increased as it is directed downward.
  • the head portion (5) is configured to not be easily caught off the skin, the cross-sectional area of the body 6 is kept constant To maintain strength.

Landscapes

  • Health & Medical Sciences (AREA)
  • Dermatology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un timbre à micro-aiguilles et, plus spécifiquement, des micro-aiguilles qui sont facilement empêchées de tomber lorsqu'elles sont insérées dans la peau, au moyen de l'amélioration de la forme des micro-aiguilles appliquées à un timbre. Les micro-aiguilles selon la présente invention comprennent : une partie timbre; et une pluralité de micro-aiguilles s'étendant sur une surface de la partie timbre. Les micro-aiguilles sont disposées sous une forme conique inversée dans laquelle la zone de section transversale augmente progressivement vers la partie d'extrémité. Les micro-aiguilles selon la présente invention peuvent être empêchées de tomber de la peau. Les micro-aiguilles selon la présente invention peuvent être facilement et sélectivement rompues après l'insertion dans la peau. Les micro-aiguilles selon la présente invention sont formées sous une forme conique inversée empêchant facilement les micro-aiguilles de tomber de la peau, et la totalité de la zone de section transversale peut être maintenue de manière à être uniforme par rapport à la direction de la longueur et ainsi l'intensité peut être maintenue.
PCT/KR2018/003955 2017-05-08 2018-04-04 Micro-aiguille WO2018208013A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020170057242A KR102014592B1 (ko) 2017-05-08 2017-05-08 마이크로니들
KR10-2017-0057242 2017-05-08

Publications (1)

Publication Number Publication Date
WO2018208013A1 true WO2018208013A1 (fr) 2018-11-15

Family

ID=64105134

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2018/003955 WO2018208013A1 (fr) 2017-05-08 2018-04-04 Micro-aiguille

Country Status (2)

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KR (1) KR102014592B1 (fr)
WO (1) WO2018208013A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110448795A (zh) * 2019-08-22 2019-11-15 优微（珠海）生物科技有限公司 可溶性微针结构
CN114191700A (zh) * 2021-12-17 2022-03-18 北京理工大学 一种可溶性微针及进药装置
CN116474254A (zh) * 2023-05-06 2023-07-25 上海加以科技有限公司 分级微针贴及加工方法

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020256198A1 (fr) * 2019-06-21 2020-12-24 주식회사 에스엔비아 Micro-aiguille à tête en forme de flèche, appareil de fabrication correspondant et procédé de fabrication correspondant
WO2022108184A1 (fr) * 2020-11-19 2022-05-27 한양대학교 산학협력단 Microstructure à faible irritation

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008528192A (ja) * 2005-01-31 2008-07-31 アルザ コーポレイション 低い変動性を有するコーティングマイクロプロジェクション、及びその生成法
JP2010017214A (ja) * 2008-07-08 2010-01-28 Fujifilm Corp ニードルシート及びその製造方法
JP2011083387A (ja) * 2009-10-14 2011-04-28 Kyushu Institute Of Technology 針状体の製造方法並びに針状体および針状体保持シート
KR20120119250A (ko) * 2011-04-21 2012-10-31 (주)마이티시스템 단턱이 형성된 미세바늘
KR101692266B1 (ko) * 2016-08-01 2017-01-03 부산대학교 산학협력단 마이크로니들 패치 및 이의 제조 방법

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8353861B2 (en) 2003-09-18 2013-01-15 Texmac, Inc. Applicator for applying functional substances into human skin
JP5338021B2 (ja) * 2006-07-04 2013-11-13 凸版印刷株式会社 針状体の製造方法
US8834423B2 (en) 2009-10-23 2014-09-16 University of Pittsburgh—of the Commonwealth System of Higher Education Dissolvable microneedle arrays for transdermal delivery to human skin
JP5967595B2 (ja) * 2014-09-08 2016-08-10 株式会社かいわ 穿刺器具

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008528192A (ja) * 2005-01-31 2008-07-31 アルザ コーポレイション 低い変動性を有するコーティングマイクロプロジェクション、及びその生成法
JP2010017214A (ja) * 2008-07-08 2010-01-28 Fujifilm Corp ニードルシート及びその製造方法
JP2011083387A (ja) * 2009-10-14 2011-04-28 Kyushu Institute Of Technology 針状体の製造方法並びに針状体および針状体保持シート
KR20120119250A (ko) * 2011-04-21 2012-10-31 (주)마이티시스템 단턱이 형성된 미세바늘
KR101692266B1 (ko) * 2016-08-01 2017-01-03 부산대학교 산학협력단 마이크로니들 패치 및 이의 제조 방법

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110448795A (zh) * 2019-08-22 2019-11-15 优微（珠海）生物科技有限公司 可溶性微针结构
CN114191700A (zh) * 2021-12-17 2022-03-18 北京理工大学 一种可溶性微针及进药装置
CN114191700B (zh) * 2021-12-17 2022-08-05 北京理工大学 一种可溶性微针及进药装置
CN116474254A (zh) * 2023-05-06 2023-07-25 上海加以科技有限公司 分级微针贴及加工方法

Also Published As

Publication number Publication date
KR20180123260A (ko) 2018-11-16
KR102014592B1 (ko) 2019-08-29

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