WO2023106693A1 - Cartouche de micro-aiguille et son procédé de fabrication - Google Patents

Cartouche de micro-aiguille et son procédé de fabrication Download PDF

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Publication number
WO2023106693A1
WO2023106693A1 PCT/KR2022/018504 KR2022018504W WO2023106693A1 WO 2023106693 A1 WO2023106693 A1 WO 2023106693A1 KR 2022018504 W KR2022018504 W KR 2022018504W WO 2023106693 A1 WO2023106693 A1 WO 2023106693A1
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WO
WIPO (PCT)
Prior art keywords
microneedle
cartridge
base member
base
hole
Prior art date
Application number
PCT/KR2022/018504
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English (en)
Korean (ko)
Inventor
이성경
한궁현
김우익
Original Assignee
쥬빌리바이오텍 주식회사
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
Priority claimed from US17/547,167 external-priority patent/US11969569B2/en
Application filed by 쥬빌리바이오텍 주식회사 filed Critical 쥬빌리바이오텍 주식회사
Publication of WO2023106693A1 publication Critical patent/WO2023106693A1/fr

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    • 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
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body
    • 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 microneedle cartridge and its production method, and more particularly, to a microneedle cartridge that can be interchangeably mounted on a microneedle applicator used to infiltrate the skin, and through different microneedles in one cartridge. It relates to a microneedle cartridge capable of injecting a drug multiple times and a method for producing the same.
  • transdermal drug delivery system In general, injecting drugs through the skin is called a transdermal drug delivery system. Since such a transdermal drug delivery system does not pass through the gastrointestinal tract, it can be administered regardless of the acidity of the gastrointestinal tract, enzymes, food, or movement of the gastrointestinal tract. possible.
  • Transdermal drug delivery devices include ultrasound, jet injection, electroporation, iontophoresis, hypodermic needle, chemical penetration enhancer, and micro needle. This is used
  • a microneedle is a microneedle having a length of several hundred micrometers that passes through the stratum corneum of the skin and delivers a drug ingredient under the skin.
  • Microneedles were developed by Mark Prausnitz in 1998 as a next-generation drug delivery system that eliminates the fear of injections by combining the convenience of conventional syringes and patches.
  • the microneedle can not only deliver macromolecular substances such as proteins or peptides, but also painless drug delivery, recovery of the injection site is faster than general injection, the risk of contamination and infection is low, and the drug efficacy is high, so the dosage can be reduced. A lot of research and development is being done to apply this according to the advantage of reducing it.
  • solid type microneedles were widely used to form micropores in the skin with microneedles and infiltrate drugs through the formed pores. Recently, these solid-type microneedles are manufactured in the form of rollers and are widely used in the cosmetics field.
  • Microneedles for subcutaneous drug injection are coated type that coats the needle surface with drug, dissolving type that forms the needle itself with a substance containing drug ingredients and dissolves the needle in the skin, It is divided into a hollow type that injects drugs through an internal hollow.
  • Microneedles are mostly used in a form attached to the skin by including the microneedle in a patch coated with an adhesive for adhesion to the skin, except for a hollow type in which a drug reservoir is separately provided.
  • microneedles have been mostly used for disposable use only.
  • the present applicant has disclosed a microneedle applicator and a cartridge capable of periodically injecting drugs using a microneedle through International Patent Publication No. WO 2021/167410.
  • the cartridge disclosed in the selection by the present applicant is formed in a disk shape, and microneedle bases are respectively disposed in a plurality of through-holes arranged radially along the circumference. Microneedles are formed on the lower surface of the microneedle base.
  • the pressing part in the applicator moves on the cartridge and is operated in such a way as to press the selected microneedle toward the skin.
  • the configuration of the applicator becomes complicated because the pressing unit moving up and down must be rotated, and when the applicator is manufactured in the form of a wearable device, there is a problem in miniaturizing the size of the applicator.
  • a method of forming a coating layer by immersing the microneedle in a chemical solution is used when the deviation of the drug delivered by the microneedle is tolerable to some extent.
  • the microneedle is located in the through-hole of the cartridge body, and the microneedle bases are pressed and exposed to the outside of the through-hole to immerse the microneedle to coat the drug.
  • the cartridge itself is made of a single injection-molded product, it is difficult to load the chemical solution on the tip of the microneedle using a dispenser after injection. Because, in general, the dispenser moves the nozzle along an orthogonal axis, but in the cartridge of the present invention, since the microneedles are radially arranged, it is difficult to set coordinates to accurately position the nozzle at the tip.
  • An object of the present invention is to provide a microneedle cartridge suitable for an applicator configured such that a pressing unit only moves up and down to pressurize a microneedle and the cartridge rotates.
  • Another object of the present invention is to minimize damage to an invasion site due to repeated microneedle invasion.
  • Another object of the present invention is to provide a microneedle cartridge suitable for securing a waterproof function of a microneedle applicator.
  • Another object of the present invention is to provide a microneedle cartridge capable of disinfecting a microneedle invasion site.
  • Another object of the present invention is to provide a microneedle cartridge capable of injecting an accurate amount of drug through a microneedle.
  • Another object of the present invention is to provide a method for producing a microneedle cartridge capable of loading an accurate amount of drug into a microneedle.
  • microneedle cartridge of the present invention which was devised to achieve the above object,
  • a disk-shaped cartridge body having a rotational force transmission unit receiving rotational force from the applicator
  • microneedle bases on which one or more microneedles are disposed on a lower surface and each positioned within the first through-hole
  • a holding member connecting the first through hole and the microneedle base to hold the microneedle base in the first through hole
  • the microneedle base is characterized in that it is made movable between a first position before being pressed by the pressing part and a second position in a state of maximum pressure by the pressing part.
  • the position of the microneedle disposed on the lower surface of the microneedle base is different from the position of the microneedle disposed on the lower surface of an adjacent microneedle base.
  • the drug delivered by the microneedle is different from the drug delivered by adjacent microneedles.
  • the holding member has an elastic force to return the microneedle base from the second position to the first position.
  • the cartridge further includes a thin film attached to the upper and lower surfaces of the cartridge body to seal the first through-hole.
  • the holding member is a member connecting the inner wall of the first through-hole and the microneedle base.
  • the holding member is a thin film adhered to the upper surface of the cartridge body.
  • the thin film on the upper or lower surface of the cartridge body has elasticity so that the microneedle base can return from the second position to the first position.
  • a disinfectant solution is filled in some of the first through-holes.
  • a wiper is installed between the first through-holes on the lower surface of the cartridge body.
  • the microneedle base is preferably formed by combining a first base member connected to a holding member and a second base member on which microneedles are formed.
  • the coupling of the first and second base members is performed by a locking jaw formed on one of the first and second base members.
  • the coupling of the first and second base members is performed by a through hole formed in the first base member and a protrusion formed in the second base member and inserted into the through hole.
  • a disk-shaped cartridge body having a rotational force transmission unit receiving rotational force from the applicator; a plurality of first through-holes radially disposed with respect to the center of the cartridge body; thin films attached to the upper and lower surfaces of the cartridge body to seal the first through-hole; a plurality of first base members each positioned within the first through hole; a retaining member connecting the first through hole and the first base member to retain the first base member within the first through hole; providing a microneedle cartridge having a second through-hole through which the pressing part of the microneedle applicator passes when moving to seal the microneedle applicator;
  • It is characterized by comprising the step of packaging the microneedle cartridge.
  • the method may further include transferring the second base member to a storage tray and packaging the dried second base member before transporting the second base member to the first base member.
  • Another method for producing a microneedle cartridge is
  • a disk-shaped cartridge body having a rotational force transmission unit receiving rotational force from the applicator; a plurality of first through-holes radially disposed with respect to the center of the cartridge body; thin films attached to the upper and lower surfaces of the cartridge body to seal the first through-hole; a plurality of first base members each positioned within the first through hole; a retaining member connecting the first through hole and the first base member to retain the first base member within the first through hole; providing a microneedle cartridge having a second through-hole through which the pressing part of the microneedle applicator passes when moving to seal the microneedle applicator;
  • It is characterized by comprising the step of packaging the microneedle cartridge.
  • the method further comprises transferring the second base member to a storage tray and packaging the second base member before transporting the second base member processed with the microneedle to the first base member side.
  • microneedle cartridge suitable for an applicator configured such that the cartridge rotates while the pressing unit moves up and down to pressurize the microneedle.
  • the microneedle cartridge of the present invention has an effect suitable for securing the waterproof function of the microneedle applicator.
  • the microneedle cartridge of the present invention can minimize damage to the invasion site due to repeated microneedle invasion, and has an effect of disinfecting the invasion site of the microneedle.
  • an accurate amount of drug can be injected through the microneedle, and the productivity of the process of loading the drug into the microneedle can be improved.
  • 1 is a view showing the shape of the microneedle applicator of the present invention.
  • Figure 2 is an exploded perspective view of the microneedle applicator viewed from the upper side.
  • Figure 3 is an exploded perspective view of the microneedle applicator viewed from the lower side.
  • FIG. 4 is a bottom view of a microneedle cartridge according to another embodiment of the present invention.
  • FIG. 5 is a view showing the relationship between the pressurizing part and the pressurizing part coupling hole of the present invention.
  • 6, 7, and 8 are views showing the mutual relationship between the pressurizing part and the cartridge.
  • FIG. 10 is a diagram showing the action relationship between a disinfectant solution and a wiper.
  • FIG. 11 is a view showing a microneedle base according to an embodiment of the present invention.
  • FIG. 12 is a view showing a microneedle base according to another embodiment of the present invention.
  • FIG. 13 is a view showing a shape in which a second base member is loaded on a tray
  • Cartridge 120 Cartridge Body 122: Torque Transmission Unit 130: Wiper
  • microneedle base 171 first base member
  • microneedle 176 through hole 177: size adjustment groove 178: protrusion
  • FIG. 1 is a perspective view showing the appearance of the microneedle applicator of the present invention
  • FIG. 2 is an exploded perspective view of the microneedle applicator viewed from the top
  • FIG. 3 is an exploded perspective view viewed from the bottom.
  • the microneedle applicator 10 includes an applicator body 20 and a bottom portion 50 detachably coupled to the lower surface of the body 20 .
  • the microneedle cartridge 100 is inserted into the space between the lower surface of the applicator body 20 and the bottom 50 .
  • a control unit for controlling the operation of the applicator, a rechargeable battery unit for supplying power, and a driving unit operating according to the command of the control unit are installed, and the pressing units 24 and 25 are operated according to the operation of the driving unit. ) reciprocates toward the bottom.
  • a cartridge coupling shaft 22 coupled to rotate the cartridge 100 is exposed on the lower surface of the applicator body 20 .
  • a cartridge insertion groove 21 and a charging terminal 26 are provided on the lower surface of the applicator body portion 20, and a sealing portion 23 is provided along the outer edge of the cartridge insertion groove 21.
  • the applicator main body 20 of this embodiment is provided with a strap mounting portion 27 for mounting a strap for wearing the applicator on the wrist.
  • the applicator body portion 20 and the bottom portion 50 are provided with coupling portions 28 and 58 coupled to each other by magnetic force.
  • the bottom portion 50 has a pressurizing portion coupling hole 52 to which the pressing portions 24 and 25 passing through the second through hole 160 of the cartridge 100 are coupled, and the charging terminal 26 is exposed to the outside.
  • a charging terminal hole 56 is provided for
  • a sealing part 23-1 is provided around the pressing part coupling hole 52 to cooperate with the pressing part 24 to prevent water or dust from penetrating into the applicator body part 20.
  • the lower surface of the bottom portion 50 comes into contact with the user's skin when the applicator is worn.
  • the cartridge body 120 is provided with a rotational force transmission unit 122 receiving rotational force from the applicator 10 and has a disk shape.
  • the rotational force transmission unit 122 is formed in the center of the cartridge body 120 to be coupled with the coupling shaft 22, but the side surface forming the circumferential surface of the disc-shaped cartridge body 120. It is provided as a machined gear, and a drive gear capable of applying a rotational force to the cartridge 100 by engaging with the gear instead of the coupling shaft 22 may be provided.
  • a plurality of first through-holes 150 are installed in the cartridge body 120 in a radial manner based on its center.
  • Microneedle bases 170 are disposed in each of the first through-holes 150, and microneedles 175 are disposed on a lower surface of the microneedle base 170.
  • microneedle 175 may be provided in the same number at the same position on the lower surface of each microneedle base 170 . However, as shown in FIG. 4 , microneedles 175 of adjacent microneedle bases 170 may be formed at different positions.
  • the microneedle-invaded skin returns to its original state in about 4 hours, but when the drug is injected by the microneedle within 4 hours, the position of the microneedle is arranged differently as shown in FIG. 4 to avoid skin damage. it is desirable
  • the microneedle base 170 of the present invention and the inner wall of the first through hole 150 are connected by a holding member 180.
  • the holding member 180 serves to keep the microneedle base 170 from being separated from the cartridge 100 when the pressing portion 25 of the applicator presses the microneedle base 170 toward the skin.
  • the holding member 180 can return to its original position (first position) within the first through-hole 150 from the second position where the microneedle base 170 is maximally pressed toward the skin by the pressing part 25. It also serves to provide elasticity.
  • the holding member 180 of this embodiment connects the inner wall of the first through hole 150 and the microneedle base 170.
  • a thin film is adhered to the upper and lower surfaces of the cartridge to prevent the microneedle base 170 and the microneedle 175 in the first through hole 150 from being contaminated.
  • the thin film may be made of various materials such as metal and synthetic resin.
  • the thin film is not shown unless otherwise indicated, but those skilled in the art will be able to understand the attachment position and shape of the thin film.
  • FIG. 7 shows a shape in which the microneedle base 170 is attached to the thin film 191 attached to the upper surface of the cartridge, and when pressed by the pressing unit 25, the thin film 191 is stretched to the second position without tearing. will be. Then, the microneedle base 170 can be returned to the first position by the elastic force of the thin film 191 .
  • FIG. 8 is the same as the embodiment of FIG. 7 in that the microneedle base 170 attached to the thin film 191 attached to the upper surface of the cartridge is pressed by the pressing unit 25 . 8 is different from the embodiment of FIG. 7 in that the thin film 192 attached to the lower surface extends to the second position. 8(b) shows the microneedle base 170 returned to the first position by the elastic force of the thin film 192 attached to the lower surface.
  • FIG. 9 shows a wiper 130 installed between the first through-hole 150 on the lower surface of the cartridge body 120
  • FIG. 10 is a view showing the working relationship between the disinfectant solution 140 and the wiper 130.
  • FIG. 10(a) shows that the disinfectant solution 140 is filled in the first through-hole 150-1 located in the center.
  • the pressurizing parts 24 and 25 descend and pressurize the microneedle base 170 to puncture the thin film 192 on the lower surface of the cartridge 100, the antiseptic solution 140 in the first through-hole 150-1 flows into the skin. spilled to the side (See Fig. 10(b))
  • the microneedle base 170 does not need to be moved to the second position, and is preferably moved only to the extent of perforating the thin film 192 .
  • the microneedle in the first through-hole 150-1 is not coated with a drug in the case of a coating type, and must be formed of a material that is not dissolved by a disinfectant solution in the case of a dissolution type.
  • the wiper 130 cooperates with the disinfectant solution 140 in the coupling hole 52 of the pressing part.
  • the skin surface is disinfected (see Fig. 10(c)).
  • the wiper 130 may be made of a flexible material such as rubber, silicon, or fiber.
  • microneedles 175 of the adjacent first through-holes 150-2 move to the lower side of the pressing parts 24 and 25.
  • the microneedle base 170 is connected to the holding member 180, the first base member 171 and the microneedle 175 are formed on the second base member. (172) to solve the above problems.
  • FIG. 11 shows only the microneedle base 170 and the holding member 180 in the first through-hole.
  • FIG. 11(a) shows the first and second base members combined, and
  • FIG. 11(b) shows the first through-hole. 1,2 It shows the form before the base member is combined.
  • the microneedles 175 are formed in a straight line on the second base member 172 in a row, column or matrix form.
  • the second base member 172 is put into the dispenser singly or arranged in a row, column, or matrix form.
  • the dispenser can grasp the position of the tip of the second base member 172 or the microneedle 175 by an image camera or a position sensor, and accordingly, the dispenser whose nozzle position is controlled according to the Cartesian coordinate system is the microneedle 175 It is possible to accurately and easily move the nozzle to the front end position of the microneedle, and accordingly, it is possible to mount an accurate amount of chemical liquid on the front end of the microneedle.
  • the liquid chemical loaded on the microneedle 175 of the second base member 172 is fixed to the front end of the microneedle through a drying process.
  • the second base member is transported to the side of the first base member to be assembled with the first base member.
  • the coupling of the second base member to the first base member after loading the liquid medicine may be performed within the same production space.
  • mass production is performed.
  • the mass-produced second base member is combined with the first base member and assembled into a finished product, the space occupied by the cartridge increases, and the entire production line required for coupling with the first base member must be managed so as not to be contaminated.
  • the second base member loaded with the chemical solution is sealed and packed in the storage tray 174 as shown in FIG. 13 and stored separately, and when assembled with the first base member, It is also desirable to disassemble and assemble the assembly.
  • the first base member and the second base member may be coupled by a known coupling method, such as adhesion using an adhesive or adhesive tape, fitting through a groove or protrusion, or the like.
  • the second base member is a very small plate material having a width/length/thickness of about 2.0/3.0/0.6 mm in size, and the first base member has a width/length size equal to or greater than these.
  • first and second base members 171 and 172 are engaged with the second base member 172 by the locking jaw 173 formed on the first base member 171 as shown in FIG. 11 . do.
  • a locking jaw 173 facilitates the coupling of the finely sized first and second members 171 and 172 gripped by a jig or a picker.
  • the locking jaw is formed on the second base member.
  • the first and second base members 171 and 172 are formed in the through hole 176 formed in the first base member 171 and the second base member 172, as shown in FIG.
  • the coupling may be achieved by the protrusion 178 formed and inserted into the through hole 176 .
  • the through hole 176 and the protrusion 178 are smoothly coupled to each other by the size adjustment groove 177 provided therein.
  • the present invention is a microneedle cartridge that can be interchangeably mounted on a microneedle applicator used to infiltrate the skin, and a microneedle cartridge that can inject a drug multiple times through different microneedles in one cartridge, and its production used in the method

Abstract

Une cartouche de micro-aiguille de la présente invention comprend : un corps de cartouche qui est formé pour avoir une forme de disque et qui est pourvu d'une unité de transfert de force de rotation qui reçoit une force de rotation provenant d'un applicateur ; une pluralité de premiers trous débouchants qui sont agencés radialement sur la base du centre du corps de cartouche ; des films minces collés aux surfaces supérieure et inférieure du corps de cartouche pour sceller les premiers trous débouchants ; une pluralité de bases de micro-aiguilles qui ont chacune une ou plusieurs micro-aiguilles sur leur surface inférieure et sont respectivement situées dans les premiers trous débouchants ; un élément de maintien qui relie les premiers trous débouchants et les bases de micro-aiguilles afin de maintenir les bases de micro-aiguilles dans les premiers trous débouchants ; et un second trou débouchants à travers lequel passe une unité de presse de l'applicateur de micro-aiguille pour sceller l'applicateur de micro-aiguille, la base de micro-aiguille étant mobile entre une première position de la base de micro-aiguille avant d'être pressée par l'unité de presse et une seconde position de la base de micro-aiguille étant pressée au maximum par l'unité de presse.
PCT/KR2022/018504 2021-12-09 2022-11-22 Cartouche de micro-aiguille et son procédé de fabrication WO2023106693A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US17/547,167 2021-12-09
US17/547,167 US11969569B2 (en) 2021-12-09 2021-12-09 Microneedle cartridge
KR1020210181338A KR102416058B1 (ko) 2021-12-09 2021-12-17 마이크로니들 카트리지
KR10-2021-0181338 2021-12-17
KR20220155235 2022-11-18
KR10-2022-0155235 2022-11-18

Publications (1)

Publication Number Publication Date
WO2023106693A1 true WO2023106693A1 (fr) 2023-06-15

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Application Number Title Priority Date Filing Date
PCT/KR2022/018504 WO2023106693A1 (fr) 2021-12-09 2022-11-22 Cartouche de micro-aiguille et son procédé de fabrication

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH1043296A (ja) * 1996-08-05 1998-02-17 Terumo Corp 薬液注入器具
KR20100135863A (ko) * 2008-04-01 2010-12-27 더 제너럴 하스피탈 코포레이션 생체조직의 냉각방법 및 냉각장치
US20130345638A1 (en) * 2012-06-25 2013-12-26 Flugen, Inc. Multiple drug delivery device
WO2021167410A1 (fr) * 2020-02-20 2021-08-26 쥬빌리바이오텍 주식회사 Applicateur pour l'administration de médicament et timbre à micro-aiguilles utilisé à cet effet
KR20210106388A (ko) * 2020-02-20 2021-08-30 쥬빌리바이오텍 주식회사 약물 주입을 위한 어플리케이터 및 이에 사용되는 마이크로 니들 패치
KR102416058B1 (ko) * 2021-12-09 2022-07-05 쥬빌리바이오텍 주식회사 마이크로니들 카트리지

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH1043296A (ja) * 1996-08-05 1998-02-17 Terumo Corp 薬液注入器具
KR20100135863A (ko) * 2008-04-01 2010-12-27 더 제너럴 하스피탈 코포레이션 생체조직의 냉각방법 및 냉각장치
US20130345638A1 (en) * 2012-06-25 2013-12-26 Flugen, Inc. Multiple drug delivery device
WO2021167410A1 (fr) * 2020-02-20 2021-08-26 쥬빌리바이오텍 주식회사 Applicateur pour l'administration de médicament et timbre à micro-aiguilles utilisé à cet effet
KR20210106388A (ko) * 2020-02-20 2021-08-30 쥬빌리바이오텍 주식회사 약물 주입을 위한 어플리케이터 및 이에 사용되는 마이크로 니들 패치
KR102416058B1 (ko) * 2021-12-09 2022-07-05 쥬빌리바이오텍 주식회사 마이크로니들 카트리지

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