WO2018208013A1 - Microneedle - Google Patents

Microneedle 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
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WO
WIPO (PCT)
Prior art keywords
curvature
skin
microneedle
patch
divided
Prior art date
Application number
PCT/KR2018/003955
Other languages
French (fr)
Korean (ko)
Inventor
양승윤
이승수
이강오
Original Assignee
부산대학교 산학협력단
주식회사 에스엔비아
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Application filed by 부산대학교 산학협력단, 주식회사 에스엔비아 filed Critical 부산대학교 산학협력단
Publication of WO2018208013A1 publication Critical patent/WO2018208013A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0046Solid microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061Methods 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.

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  • 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

The present invention relates to a microneedle patch and, more specifically, to microneedles which are easily prevented from falling off when inserted into the skin, by means of enhancing the shape of the microneedles applied to a patch. Microneedles according to the present invention comprise: a patch portion; and a plurality of microneedles extending on one surface of the patch portion. The microneedles are provided in a reverse taper form in which the cross-sectional area gradually increases toward the end part. The microneedles according to the present invention can be prevented from falling off the skin. The microneedles according to the present invention can easily and selectively be broken off after the insertion into the skin. The microneedles according to the present invention are formed in a reverse taper form easily preventing the microneedles from falling off the skin, and the entire cross-sectional area can be maintained to be uniform with respect to the length direction and thus the strength can be maintained.

Description

마이크로니들Microneedle
본 발명은 마이크로니들패치에 관한 것으로, 더욱 상세하게는 패치에 적용되는 마이크로니들의 형상을 개선하여 피부에 삽입 시, 이탈을 용이하게 방지할 수 있는 마이크로니들에 관한 것이다.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.
마이크로니들패치에 적용되는 마이크로니들은, 상단부에 팁이 형성되고 몸체가 직선으로 형성되어 피부에 삽입 시, 쉽게 이탈하였다. Microneedle applied to the microneedle 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.
일반적으로, 피부가 찢어지거나 베였을 시, 벌어지는 것을 간단히 방지하기 위해 스테플러를 이용하여 이를 방지하였으나 부착이 용이한 마이크로니들패치 붙임으로 인해, 상처를 깊게 내지 않으며 벌어지는 피부를 고정할 수 있다. 하지만 이를 위해서는 피부로부터 마이크로니들이 쉽게 이탈하는 문제를 해결해야 한다.In general, when the skin is torn or cut, it is prevented by using a stapler to easily prevent the opening, but due to the microneedle patch attaching easy to attach, it is possible to fix the opening without deepening the wound. However, this requires solving the problem of microneedles detaching easily from the skin.
이와 관련하여, 종래의 기술을 살펴보면, 도 1에 나타낸 바와 같이, 미국등록특허 제8834423호, 미국등록특허 제8353861호에 역테이퍼 형태의 마이크로니들이 개시되고 있으나, 이는 바디부에 모서리진 각이 형성되어 이것이 노치로 작용하여 강도가 약해져 쉽게 파단되는 등의 문제점이 있다.In this regard, referring to the prior art, as shown in FIG. 1, 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.
따라서, 본 발명은 상기한 바와 같은 종래 기술의 문제점을 해결하기 위해 안출된 것으로, 피부로부터 이탈을 방지할 수 있는 마이크로니들 구조를 제공하는데 그 목적이 있다.Accordingly, 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.
또한, 본 발명은 마이크로니들을 피부에 삽입 후, 선택적으로 쉽게 파단시킬 수 있는 마이크로니들 구조를 제공하는데 또 다른 목적이 있다.It is another object of the present invention to provide a microneedle structure that can be easily broken after insertion of the microneedle into the skin.
또한, 본 발명은 피부로부터 이탈을 용이하게 방지할 수 있는 역테이퍼 형태의 마이크로니들을 구성하되, 길이방향을 기준으로 전체적인 단면적을 일정하게 유지하여 강도를 유지할 수 있는 마이크로니들 구조를 제공하는데 그 목적이 있다.In addition, 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.
본 발명이 해결하고자 하는 과제들은 이상에서 언급한 과제로 제한되지 않으며, 여기에 언급되지 않은 본 발명이 해결하고자 하는 또 다른 과제들은 아래의 기재로부터 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자에게 명확하게 이해될 수 있을 것이다.The problem to be solved by the present invention is not limited to the above-mentioned problem, another problem to be solved by the present invention not mentioned here is those skilled in the art to which the present invention pertains from the following description Will be clearly understood.
본 발명에 마이크로니들은, 패치부 및 상기 패치부 일면에 연장 형성되는 복수개의 마이크로니들을 포함하여 구성되고, 상기 마이크로니들은, 피부로 침투가 용이하도록 원뿔형태의 단부를 형성하는 헤드부 및 상기 헤드부로부터 상기 패치부까지 연장 마련되되, 내측으로 오목하게 형성되는 바디부를 포함하여 구성된다.In the present invention, 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.
본 발명에 마이크로니들은, 피부로부터 이탈을 방지할 수 있는 효과가 있다.In the present invention, the microneedle is effective to prevent the departure from the skin.
또한, 본 발명에 따른 마이크로니들은, 피부에 삽입 후, 선택적으로 쉽게 파단 시킬 수 있는 효과가 있다.In addition, the microneedle according to the present invention, after insertion into the skin, there is an effect that can be easily broken selectively.
또한, 본 발명에 따른 마이크로니들은, 피부로부터 이탈을 용이하게 방지할 수 있는 역테이퍼 형태로 구성되되, 길이방향을 기준으로 전체적인 단면적을 일정하게 유지하여 강도를 유지할 수 있는 효과가 있다.In addition, the 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.
도 1의 (a)는 미국등록특허 제8834423호의 대표도를 나타낸 것이다.Figure 1 (a) shows a representation of US Patent No. 8834423.
도 1의 (b)는 미국등록특허 제8353861호의 대표도를 나타낸 것이다.Figure 1 (b) shows a representation of US Patent No. 8353861.
도 2는 본 발명에 따른 마이크로니들이 패치에 적용된 형태를 사시도로 나타낸 것이다.Figure 2 shows in a perspective view the form applied to the microneedle patch according to the present invention.
도 3은 본 발명에 따른 함입타입니들의 정단면도를 나타낸 것이다.Figure 3 shows a front cross-sectional view of the recessed type needle according to the present invention.
도 4는 본 발명에 따른 스테이플러타입니들의 정단면도를 나타낸 것이다.Figure 4 shows a front cross-sectional view of the stapler type needle according to the present invention.
도 5의 (a)는 본 발명의 또 다른 실시예에 따른 역테이퍼 형태의 마이크로니들의 정단면도를 나타낸 것이다.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.
도 5의 (b)는 본 발명의 또 다른 실시예에 따른 역테이퍼 형태의 마이크로니들의 측단면도를 나타낸 것이다.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.
도 5의 (c)는 본 발명의 또 다른 실시예에 따른 역테이퍼 형태의 마이크로니들의 평면 단면도를 나타낸 것이다.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.
이상과 같은 본 발명에 대한 해결하고자 하는 과제, 과제의 해결수단, 발명의 효과를 포함한 구체적인 사항들은 다음에 기재할 실시예 및 도면들에 포함되어 있다. 본 발명의 이점 및 특징, 그리고 그것들을 달성하는 방법은 첨부되는 도면과 함께 상세하게 후술되어 있는 실시예들을 참조하면 명확해질 것이다.Specific matters including the problem to be solved, the solution to the problem, and the effects of the present invention as described above are included in the embodiments and drawings to be described below. Advantages and features of the present invention and methods for achieving them will be apparent with reference to the embodiments described below in detail with the accompanying drawings.
본 발명에 다른 마이크로니들은, 도 2에 도시된 바와 같이, 패치부(1) 및 상기 패치부(1) 일면에 연장 형성되는 복수개의 마이크로니들(2)을 포함하여 구성되고, 상기 마이크로니들(2)은, 단부로 향할수록 단면적이 증가하는 형태의 역테이퍼 형태로 마련되는 것을 특징으로 한다.As shown in FIG. 2, 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.
먼저, 상기 패치부(1)는, 판상의 유연소재로 마련된다.First, the patch 1 is provided with a plate-like flexible material.
상기 패치부(1)는, 일반적으로 마이크로니들(2) 패치에 사용되는 일반적인 형태로 구성될 수 있고, 표면의 보호를 위해 탈부착 가능한 형태의 필름층이 더 형성될 수 있다.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.
다음으로, 상기 마이크로니들(2)은, 상기 패치부(1) 일면에 연장 형성되는 형태로 복수개 마련된다.Next, the microneedles 2 are provided in plural in a form extending from one surface of the patch part 1.
구체적으로, 상기 마이크로니들(2)은, 상기 패치부(1)로부터 연장 형성될 수 있고, 단부는 피부에 삽입이 용이하도록 원뿔 형태로 마련될 수 있다.Specifically, 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.
상기 마이크로니들(2)은 피부에 삽입 되는 용도로서 생체적합성이 우수하고, 선택적으로 생분해성 재료로 구성될 수 있다.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.
구체적으로, 상기 마이크로니들(2)은, 헤드부(31) 및 바디부(32)로 구성된다.Specifically, the microneedle 2 is composed of a head portion 31 and the body portion (32).
상기 헤드부(31)는, 상기 마이크로니들(2)의 단부에 해당하는 부분으로, 피부로 침투가 용이하도록 원뿔 형태로 형성된다.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.
다음으로, 상기 바디부(32)는, 상기 헤드부(31)로부터 상기 패치부(1)까지 연장 마련되는 부분으로, 길이방향을 기준으로 중간부가 내측으로 오목하게 형성된다.Next, 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.
상기 바디부(32)가 오목하게 형성됨으로 인해, 피부에 상기 패치부(1)를 부착하여 상기 마이크로니들(2)이 상기 피부에 침투되면, 피부의 탄력에 의해, 오목하게 형성되는 상기 바디부(32)에 상기 피부의 경계층이 밀착 형성되어 상기 마이크로니들(2)이 쉽게 이탈되는 것을 방지할 수 있다. Since 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.
또한, 상기 바디부(32)의 오목하게 형성되는 부분은 모서리형태의 각이 형성되지 않고, 아치 형태로 매끄럽게 구성되므로 상기 피부에 투입하거나 해제할 시, 충분한 강도를 유지하여 파단 되는 결함을 방지할 수 있다.In addition, 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.
상기 바디부(32)의 중간부에 오목하게 형성되는 부분이 도 1의 (a), (b)에 도시된 바와 같이, 각진 형태로 구성되면, 그 자체로 노치와 같은 효과가 형성되어 상기 각진 부분의 강도가 급격히 낮아져 상기 피부로의 투입이시, 파손될 가능성이 높아져 투입이 어렵고, 투입 후에도 쉽게 부러질 수 있어 회수가 어려운 문제점이 발생할 수 있다.If 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.
상기 마이크로니들(2)은 상기 피부에 투입 후에는 내제된 약물을 투여하기 위한 목적으로 고의로 파단을 시킬 수도 있으나 상기한 바와 같이, 상기 바디부(32)에 각진 부분이 형성되면 급격히 낮아진 강도로 인해 상기 피부로의 침투 자체가 용이하지 않다.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.
따라서 상기 바디부(32)에 모서리 형태의 각이 형성되지 않도록 구성되는 것이 바람직하다.Therefore, the body portion 32 is preferably configured so that the angle of the corner shape is not formed.
본 발명에 따른 상기 마이크로니들(2)은 크게 2가지 목적으로 사용될 수 있는데, 함입타입니들(3) 및 스테이플러타입니들 중 어느 하나로 구성될 수 있다.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.
먼저, 상기 함입타입니들(3)은, 상기 마이크로니들(2)을 피부에 침투시킨 후, 상기 피부속에 약물과 함께 생분해성 재질로 마련되는 상기 마이크로니들(2)의 일부를 상기 피부속에 남겨 흡수 되도록 하기 위한 것으로, 상기 피부에 상기 마이크로니들(2)을 투입 후, 측방향 압력이 가해질 시, 용이하게 몸체가 파단되어 상기 피부 속에 남을 수 있도록 구성된다.First, 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 In order to ensure that, after the microneedle (2) is put into the skin, when the lateral pressure is applied, the body is easily broken so that it can remain in the skin.
구체적으로, 상기 함입타입니들(3)에 적용되는 바디부(32)는, 도 3에 도시된 바와 같이, 제 1-1 곡률부(321) 내지 제 1-4 곡률부(324)를 포함하여 구성된다.Specifically, the body portion 32 applied to the recessed type needle 3, as shown in Figure 3, including a 1-1 curvature 321 to 1-4 curvature 324 It is composed.
먼저, 상기 제 1-1 곡률부(321)는, 상기 바디부(32)를 4등분 했을 때, 상기 헤드부(31)의 하부에 위치하고, 곡률반경이 0.65~0.75mm로 구성된다.First, when the first-first curvature 321 is divided into four equal parts, the first-curvature 321 is positioned below the head 31 and has a radius of curvature of 0.65 to 0.75 mm.
다음으로, 상기 제 1-2 곡률부(322)는, 상기 바디부(32)를 4등분 했을 때, 상기 제 1 곡률부의 하부에 위치하고, 곡률반경이 0.36~0.45mm로 구성된다.Next, 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.
다음으로, 상기 제 1-3 곡률부(323)는, 상기 바디부(32)를 4등분 했을 때, 상기 제 2 곡률부의 하부에 위치하고, 곡률반경이 0.30~0.35mm로 구성된다.Next, 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.
다음으로, 상기 제 1-4 곡률부(324)는, 상기 바디부(32)를 4등분 했을 때, 상기 제 3 곡률부의 하부에 위치하여 상기 패치부(1)에 연결되고, 곡률반경이 0.20~0.29mm로 구성된다.Next, when the body portion 32 is divided into four portions, 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.
결론적으로, 상기 제 1-1 곡률부(321)로부터 상기 제 1-4 곡률부(324)로 향할수록 곡률반경이 작아지는 형태로 구성된다.In conclusion, the radius of curvature becomes smaller toward the first-curvature 324 from the first-first curvature 321.
이로 인해, 상기 제 1-2 곡률부(322) 내지 상기 제 1-3 곡률부(323)의 두께가 점차적으로 얇아져 상기 피부에 상기 함입타입니들(3)을 삽입 후, 측방향 압력을 가할 시, 상기 제 1-2 곡률부(322) 및 제 1-3 곡률부(323) 중 어느 하나 이상에서 파단이 용이하게 발생할 수 있다.For this reason, 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.
다음으로, 상기 스테이플러타입니들(4)은, 피부의 벌어진 상처 등을 더 이상 벌어지지 않도록 상기 패치부(1)를 피부에 부착하여 잡아주기 위한 목적으로 상기 마이크로니들(2)이 상기 피부에 침투 후, 용이하게 이탈되지 않도록 구성되어 상기 피부로부터 상기 패치부(1)의 이탈을 방지할 수 있게 구성된다.Next, 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.
구체적으로, 상기 스테이플러타입니들(4)에 적용되는 상기 바디부(42)는, 도 4에 도시된 바와 같이, 제 2-1 곡률부(421) 내지 제 2-4 곡률부(424)를 포함하여 구성된다.Specifically, 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.
먼저, 상기 제 2-1 곡률부(421)는, 상기 바디부(42)를 4등분 했을 때, 상기 헤드부(41)의 하부에 위치하고, 곡률반경이 0.15~0.25mm로 구성된다.First, 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.
다음으로, 상기 제 2-2 곡률부(422)는, 상기 바디부(42)를 4등분 했을 때, 상기 제 2-1 곡률부(421)의 하부에 위치하고, 곡률반경이 0.30~0.35mm로 구성된다.Next, 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.
다음으로, 상기 제 2-3 곡률부(423)는, 상기 바디부(42)를 4등분 했을 때, 상기 제 2-2 곡률부(422)의 하부에 위치하고, 곡률반경이 0.36~0.45mm로 구성된다.Next, when the body portion 42 is divided into four parts, 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.
다음으로, 상기 제 2-4 곡률부(424)는, 상기 바디부(42)를 4등분 했을 때, 상기 제 2-3 곡률부(423)의 하부에 위치하여 상기 패치부(1)에 연결되고, 곡률반경이 0.70~1.20mm로 구성된다.Next, 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.
결론적으로, 상기 제 2-1 곡률부(421)로부터 상기 제 2-4 곡률부(424)로 향할수록 곡률반경이 증가하는 형태로 구성된다.In conclusion, the radius of curvature increases from the 2-1st curvature 421 toward the 2-4th curvature 424.
이로 인해, 상기 피부에 상기 스테이플러타입니들(4)이 삽입되었을 시, 부러지지 않는 강도를 유지하며, 상기 제 2-1 곡률부(421) 및 제 2-2 곡률부(422) 중 어느 하나 이상에서 상기 피부의 표면이 탄력에 의해 걸림이 형성되어 상기 피부로부터 용이하게 이탈하는 것을 방지할 수 있다.For this reason, 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.
또 다른 실시예로, 상기 마이크로니들(2)은 도 5에 도시된 바와 같이, 피부로 침투가 용이하도록 원뿔형태의 단부를 형성하는 헤드부(5) 및 상기 헤드부(5)로부터 상기 패치부(1)까지 연장 마련되되, 상부에서 하방으로 향할수록 횡방향 직경은 넓어지고, 종방향 직경은 좁아지는 형태의 바디부(6)로 구성된다.In another embodiment, 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.
구체적으로, 도 2의 (a)는 또 다른 실시예에 따른 상기 마이크로니들(2)의 정면도를 나타낸 것이고, 도 2의 (b)는 또 다른 실시예에 따른 상기 마이크로니들(2)의 측면도를 나타낸 것이다.Specifically, FIG. 2A illustrates a front view of the microneedle 2 according to another embodiment, and FIG. 2B illustrates a side view of the microneedle 2 according to another embodiment. It is shown.
도 2의 (c)는 A-A’, B-B’, C-C’ 순으로 나타낸 단면을 평면으로 나타낸 것이다.(C) of FIG. 2 shows a cross section in the plane of A-A ', B-B', C-C 'in plan view.
상기 바디부(6)는, 측방향 단면이 하방으로 향할수록 직경이 줄어드는 역테이퍼 형태로 구성되되, 정방향 단면은 하방으로 향할수록 직경이 늘어나는 테이퍼 형태로 구성되는 것이 바람직하다.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.
상기와 같이 구성됨으로 인해, 상기 마이크로니들(2)이 피부에 투입 시, 상기 헤드부(5)가 상기 피부에 걸려 이탈이 용이하지 않도록 구성되되, 상기 바디부(6) 전체적인 단면적은 일정하게 유지되어 강도를 유지할 수 있다.Due to the configuration as described above, when the microneedle (2) is put into the skin, 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.
이와 같이, 상술한 본 발명의 기술적 구성은 본 발명이 속하는 기술분야의 당업자가 본 발명의 그 기술적 사상이나 필수적 특징을 변경하지 않고서 다른 구체적인 형태로 실시될 수 있다는 것을 이해할 수 있을 것이다.As such, the technical configuration of the present invention described above can be understood by those skilled in the art that the present invention can be implemented in other specific forms without changing the technical spirit or essential features of the present invention.
그러므로 이상에서 기술한 실시예들은 모든 면에서 예시적인 것이며 한정적인 것이 아닌 것으로서 이해되어야 하고, 본 발명의 범위는 상기 상세한 설명보다는 후술하는 특허청구범위에 의하여 나타나며, 특허청구범위의 의미 및 범위 그리고 그 등가 개념으로부터 도출되는 모든 변경 또는 변형된 형태가 본 발명의 범위에 포함되는 것으로 해석되어야 한다.Therefore, the above-described embodiments are to be understood as illustrative and not restrictive in all respects, and the scope of the present invention is indicated by the following claims rather than the detailed description, and the meaning and scope of the claims and their All changes or modifications derived from an equivalent concept should be construed as being included in the scope of the present invention.
[부호의 설명][Description of the code]
1 : 패치부1 patch
2 : 마이크로니들2: microneedle
3: 함입타입니들3: immersion type needle
31 : 헤드부31: head
32 : 바디부32: body part
321 : 제 1-1 곡률부321: first curvature
322 : 제 1-2 곡률부322: first 1-2 curvature
323 : 제 1-3 곡률부323: first to third curvature
324 : 제 1-4 곡률부324: 1-4 the curvature
4 : 스테이플러타입니들4: Stapler Type Needle
41 : 헤드부41: head
42 : 바디부42: body part
421 : 제 2-1 곡률부421 second curvature
422 : 제 2-2 곡률부422: 2-2 curvature
423 : 제 2-3 곡률부423: second 2-3 curvature
424 : 제 2-4 곡률부424: 2-4nd curvature
5 : 헤드부5: head
6 : 바디부6: body part

Claims (5)

  1. 패치부;Patch portion;
    상기 패치부 일면에 연장 형성되는 복수개의 마이크로니들;을 포함하고,Includes; a plurality of microneedles extending on one surface of the patch portion,
    상기 마이크로니들은,The microneedle,
    피부로 침투가 용이하도록 원뿔형태의 단부를 형성하는 헤드부; 및A head portion which forms a conical end portion to facilitate penetration into the skin; And
    상기 헤드부로부터 상기 패치부까지 연장 마련되되, 내측으로 오목하게 형성되는 바디부;를 포함하는 것을 특징으로 하는 마이크로니들.And a body portion extending from the head portion to the patch portion, the body portion being concave inwardly.
  2. 제 1 항에 있어서,The method of claim 1,
    상기 마이크로니들은, The microneedle,
    피부에 침투 후, 파단되어 상기 피부속에 남아있는 형태의 함입타입니들; 및After penetrating the skin, the break-in type needle that is broken and remaining in the skin; And
    피부에 침투 후, 상기 피부로부터 용이하게 이탈되지 않도록 구성되어 파손된 피부의 고정을 위한 스테이플러타입니들; 중 어느 하나로 구성될 수 있는 것을 특징으로 하는 마이크로니들.A stapler type needle configured to fix the damaged skin so as not to be easily separated from the skin after penetration into the skin; Microneedle, characterized in that can be configured to any one of.
  3. 제 2 항에 있어서,The method of claim 2,
    상기 함입타입니들에 적용되는 상기 바디부는,The body portion applied to the recessed type needle,
    상기 바디부를 4등분 했을 때, 상기 헤드부의 하부에 위치하는 제 1-1 곡률부;A first-first curvature part disposed below the head part when the body part is divided into four parts;
    상기 바디부를 4등분 했을 때, 상기 제 1 곡률부의 하부에 위치하는 제 1-2 곡률부;When the body portion is divided into four, the first 1-2 curvature portion located below the first curvature portion;
    상기 바디부를 4등분 했을 때, 상기 제 2 곡률부의 하부에 위치하는 제 1-3 곡률부;When the body portion is divided into four portions, the first to third curvature portions positioned under the second curvature portion;
    상기 바디부를 4등분 했을 때, 상기 제 3 곡률부의 하부에 위치하여 상기 패치부에 연결되는 제 1-4 곡률부;를 포함하고,When the body portion is divided into four, 1-4 curvature portion which is located below the third curvature portion and connected to the patch portion;
    상기 제 1-1 곡률부로부터 상기 제 1-4 곡률부로 향할수록 곡률반경이 줄어드는 형태로 구성되어, 상기 피부에 상기 함입타입니들이 삽입 시, 상기 제 1-2 곡률부 및 제 1-3 곡률부 중 어느 하나 이상에서 파단이 용이하게 발생되는 것을 특징으로 하는 마이크로니들.The radius of curvature decreases as it goes from the first-first curvature to the first-fourth curvature, and when the recessed type needle is inserted into the skin, the first-two curvature and the first-three curvature Microneedle, characterized in that the breakage occurs easily in any one or more of the.
  4. 제 2 항에 있어서,The method of claim 2,
    상기 스테이플러타입니들에 적용되는 상기 바디부는,The body portion applied to the stapler type needle,
    상기 바디부를 4등분 했을 때, 상기 헤드부의 하부에 위치하는 제 2-1 곡률부;A second-first curvature part disposed below the head part when the body part is divided into four parts;
    상기 바디부를 4등분 했을 때, 상기 제 2-1 곡률부의 하부에 위치하는 제 2-2 곡률부;A second-2 curvature part disposed below the second-1 curvature part when the body part is divided into four parts;
    상기 바디부를 4등분 했을 때, 상기 제 2-2 곡률부의 하부에 위치하는 제 2-3 곡률부;A second 2-3 curvature portion disposed below the second-2 curvature portion when the body portion is divided into four parts;
    상기 바디부를 4등분 했을 때, 상기 제 2-3 곡률부의 하부에 위치하여 상기 패치부에 연결되는 제 2-4 곡률부;를 포함하고,When the body portion is divided into four, the 2-4 curvature portion which is located under the 2-3 curvature portion and connected to the patch portion;
    상기 제 2-1 곡률부로부터 상기 제 2-4 곡률부로 향할수록 곡률반경이 증가하여, 상기 피부에 상기 스테이플러타입니들이 삽입 시, 상기 제 2-1 곡률부 및 제 2-2 곡률부 중 어느 하나 이상에서 상기 피부에 걸림이 형성되어 상기 피부로부터의 이탈이 어려운 것을 특징으로 하는 마이크로니들.The radius of curvature increases from the 2-1 curvature to the 2-4 curvature, so that when the stapler type needle is inserted into the skin, any one of the 2-1 curvature and the 2-2 curvature The microneedle, characterized in that the hook is formed on the skin from the above it is difficult to escape from the skin.
  5. 제 1 항에 있어서,The method of claim 1,
    상기 마이크로니들은,The microneedle,
    피부로 침투가 용이하도록 원뿔형태의 단부를 형성하는 헤드부; 및A head portion which forms a conical end portion to facilitate penetration into the skin; And
    상기 헤드부로부터 상기 패치부까지 연장 마련되되, 상부에서 하방으로 향할수록 횡방향 직경은 넓어지고, 종방향 직경은 좁아지는 형태의 바디부;로 구성되는 것을 특징으로 하는 마이크로니들. The body is provided extending from the head portion to the patch portion, the transverse diameter becomes wider and the longitudinal diameter becomes narrower from the top toward the lower portion; microneedle, characterized in that consisting of.
PCT/KR2018/003955 2017-05-08 2018-04-04 Microneedle WO2018208013A1 (en)

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KR1020170057242A KR102014592B1 (en) 2017-05-08 2017-05-08 Microneedle

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