WO2008015782A1 - Timbre à micro-aiguilles et procédé de production - Google Patents
Timbre à micro-aiguilles et procédé de production Download PDFInfo
- Publication number
- WO2008015782A1 WO2008015782A1 PCT/JP2007/000811 JP2007000811W WO2008015782A1 WO 2008015782 A1 WO2008015782 A1 WO 2008015782A1 JP 2007000811 W JP2007000811 W JP 2007000811W WO 2008015782 A1 WO2008015782 A1 WO 2008015782A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- needle
- patch
- micro
- dollar
- shape
- Prior art date
- Legal status (The legal status 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 status listed.)
- Ceased
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/20—Surgical instruments, devices or methods for vaccinating or cleaning the skin previous to the vaccination
- A61B17/205—Vaccinating by means of needles or other puncturing devices
-
- 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
- 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
- A61M2037/0053—Methods for producing microneedles
Definitions
- Human skin is roughly divided into three layers from the surface: epidermis, dermis and subcutaneous fat.
- the epidermis is the stratum corneum, granule layer, spiny layer and dermis as the outermost layer in contact with the outside world. It consists of a basal layer in contact with.
- the epidermis has an average thickness of about 100 m, excluding palms and wrinkles, and has 500 to 600 Langerhans cells per square millimeter.
- Langerhans cells take up and activate antigens that are present or invaded in the skin, move to the regional lymph nodes, stimulate T cells to differentiate into cytotoxic T cells, and B cells through T cells Antibody is produced by stimulating. Because of this action, Langerhans cells are known to protect living organisms from infection and cancer.
- a device having a needle-like structure capable of administering a drug such as a vaccine material into a living body has been conventionally proposed (for example, see Patent Document 1).
- a thin film film through which the needle part can penetrate is interposed between a needle-like structure having a needle part and a living body, and the needle part is punctured into the skin. Drugs in the thin film can be administered.
- This needle is The length is 2 3 0; U m, and it is a silicon needle structure with 50 lines arranged on the support.
- Patent Document 1 Japanese Patent Laid-Open No. 2 0 00 _ 6 5 7 7 5
- the present invention has been made in view of such circumstances, and can be punctured without the tip of the needle reaching the dermis, from which a microphone mouth needle type capable of administering a drug such as a vaccine material is provided. It is to provide a patch and its manufacturing method.
- a plurality of micro-projection needles are integrally formed on the back surface of the sheet-like patch portion, and the needle is used while the back surface of the patch portion is in close contact with the patient's skin.
- the needle is characterized in that the length dimension from the proximal end to the distal end is approximately 50 to 10 O ⁇ m.
- the invention according to claim 2 is the microneedle type patch according to claim 1, wherein the lengths of the needles are different, and the heights of the needles from the back surface of the patch part are non-uniform. It is characterized by.
- the invention according to claim 3 is the microphone mouth needle type patch according to claim 1 or 2, characterized in that the needle is made of a biodegradable resin that can be decomposed in vivo.
- the invention according to claim 4 is the micro nidle type patch according to any one of claims 1 to 3, wherein the needle has a proximal end diameter of approximately 1 OO m or less. It has a conical shape.
- the invention according to claim 5 is the micro niddle type patch according to any one of claims 1 to 4, wherein the surface of the needle is provided with a fine uneven shape. It is characterized by that.
- the invention according to claim 6 is the microneedle type patch according to any one of claims 1 to 5, wherein the patch portion is made of a flexible member, and the entire back surface of the patch is formed by the patient. It is characterized by being able to closely adhere to the shape of the skin.
- the invention according to claim 7 is that a predetermined resin material having thermoplastic properties is melted in a mold having a plurality of conical holes each having a depth of approximately 50 to 10 Om. After the resin material is cooled and cured, it is released from the mold so that a plurality of micro-projections of needles following the hole shape are integrally formed on the back surface of the sheet-like patch. It is characterized by obtaining a 21 dollar type patch.
- the invention according to claim 9 is the method of manufacturing a microneedle type / touch according to claim 8, wherein the master forms a single block having the needle shape by lathe machining using a byte. It is obtained by arranging a plurality of such blocks in parallel.
- the length of the needle formed on the back surface of the patch portion from the proximal end to the distal end is approximately 50 to 10 Om, The tip can be punctured without reaching the dermis, and drugs such as acupuncture material can be administered from there.
- drugs such as acupuncture material
- the back surface of the patch portion is kept in close contact with the patient's skin.
- the needle is made of a biodegradable resin that can be decomposed in a living body, for example, when the needle is punctured, it breaks and remains in the patient's body.
- the microneedle type patch is discarded, it can be easily disassembled, preventing problems such as environmental destruction.
- the needle since the needle has a conical shape with a proximal diameter of approximately 100 m or less, the pain is prevented from being given to the patient, Better puncture can be made possible.
- the surface of the needle is provided with a fine uneven shape, when the drug is applied to the surface of the needle, the drug continues to be held in the uneven shape, The drug can be successfully administered from the puncture site.
- the patch portion is made of a flexible member, and the entire back surface thereof can closely adhere to the shape of the patient's skin, the puncturing operation can be performed more reliably and satisfactorily. Can do.
- a predetermined resin material having thermoplastic properties is melted in a mold having a plurality of conical holes each having a depth of approximately 50 to 10 Om.
- the mold is obtained by growing the Ni metal layer on the master including the needle shape by electroplating, it is easy to change the needle length and the like. It is possible to obtain a micro two-dollar patch at a lower cost.
- the master 1 is obtained by forming a block having a single needle shape by lathe machining with a byte and arranging a plurality of the blocks in parallel. That you can get a micro two-dollar patch.
- the concave / convex shape is imparted to the surface of the master by the cutting trace by the byte, it is possible to easily obtain the micro two-dollar type patch in which the fine concave / convex shape is imparted to the surface of the needle.
- the microneedle type patch punctures the skin of a patient with a microprojection needle and administers a drug (cancer peptide or the like) from there to activate Langerhans cells to infect the living body. It produces antibodies and cytotoxic T cells to protect against cancer and the like.
- a sheet-like patch portion 1 is integrally formed with the patch portion 1, and the patch portion 1 Mainly composed of a plurality of micro-projection needles 2 formed on the back surface.
- the present microneedle type patch is obtained by forming a biodegradable resin that can be decomposed in a living body and integrating the patch portion 1 and the needle 2 together.
- a biodegradable resin examples thereof include polylactic acid (PLA), aliphatic copolymer polyester, and polyhydroxybutyrate (PHB).
- PLA polylactic acid
- PHB polyhydroxybutyrate
- the needle 2 is made of a biodegradable resin, so that the living body is not affected and is safe.
- the microneedle type patch is discarded, it can be easily disassembled, preventing problems such as environmental destruction.
- thermoplastic properties instead of the above biodegradable resin, other resin materials having thermoplastic properties may be used.
- resin materials having thermoplastic properties
- the patch portion 1 is a flexible member formed by forming the biodegradable resin into a thin film, and the entire back surface (surface on which the needle 2 is formed) It is configured to be able to closely adhere to the shape of the patient's skin. This will cause needle 2 to When the patch part 1 is pressed against the patient's skin to puncture the patient, the patch part 1 bends along the site, so that the patient can adhere well, and the puncture operation can be performed more reliably and satisfactorily.
- the needle 2 has a conical shape with a proximal end (patch 1 side end) diameter of approximately 1 OO m or less, and pain is imparted to the patient when the needle 2 is punctured into the skin. In addition to suppressing this, it is possible to achieve better puncture. It should be noted that the needle 2 may have another shape (such as a quadrangular pyramid or a cylinder) as long as the patient's skin can be punctured satisfactorily.
- the surface of the needle 2 is provided with a fine uneven shape (in this embodiment, a spiral shape), and the surface of the needle 2 was coated with a drug.
- the drug is continuously held in the uneven shape (spiral shape), and the drug can be successfully administered from the puncture site.
- the uneven shape on the surface of the needle 2 is not limited to a spiral shape, but is a shape in which a plurality of recesses or grooves are formed at an arbitrary site, or a streak-like vertical stripe from the tip to the base, and corrugated in the circumferential direction of the cone surface It is good also as what formed the groove
- the needle 2 has a length dimension t from the proximal end to the distal end of approximately 50 to 1 O O m.
- the needle 2 is punctured into the body, and the tip does not reach the dermis, from which the drug is administered. be able to.
- the needle 2 can be punctured better and more reliably.
- the lengths of the respective needles 2 are different, and the heights of the needles 2 from the back surface of the patch portion 1 are non-uniform.
- the length of each needle 2 is varied within a range of about 50 to 100 m.
- needles having large lengths and needles having small lengths may be alternately formed, or may be formed by mixing at regular intervals or irregularly.
- the pressing force is dispersed and punctured Makes needle 2 smooth on the patient's skin It can penetrate and make puncture well.
- a manufacturing method of the microneedle type patch as described above will be described.
- a metal cylindrical member round bar
- its end face is cut by a byte.
- a cylindrical block 3 in which a single micro-projection shape (needle shape 3 a) having a height dimension t of about 50 to 10 Om is formed in the approximate center of the end face.
- the needle shape 3 a is formed by cutting with a lathe of a lathe, a cutting mark (feed mark) by the byte is formed in a spiral shape.
- a plurality of blocks 3 having the needle shape 3a with different height dimensions as described above are prepared, and the blocks 3 are passed through the holes 4a of the structure 4 as shown in FIG. .
- the hole 4 a has an inner diameter substantially equal to the outer diameter of the block 3, and faces the needle shape 3 a from the opening of each hole 4 a.
- a plurality of needle shapes 3 a can be arranged side by side, and a master composed of the structure 4 facing the needle shapes 3 a can be obtained.
- FIG. 6 when a Ni metal layer is grown on the master including the needle shape 3 a by electrical fitting and the Ni metal layer is removed from the master, as shown in FIG. It is possible to obtain a mold 5 having a plurality of holes 5 a having a shape opposite to the needle shape 3 a (manufacture of a mold by an electroplating method). Since the hole 5 a of the mold 5 is formed by transferring the surface shape of the needle shape 3 a, the depth (height) dimension t is approximately 50 to 1 like the needle shape 3 a. Although it is set to OO m, the dimension t is varied to be non-uniform.
- a mold 5 and another mold 6 are arranged to face each other to form a cavity C therein, and a resin material having thermoplastic properties in the cavity C.
- a resin material having thermoplastic properties in the cavity C.
- biodegradable resin is poured in a molten state, and after releasing the cooling effect of the resin material, a microneedle type having a patch portion 1 and a needle 2 as shown in FIG. You can get a patch.
- the needle 2 has a length dimension t of approximately 5 0 to 1 0 0 m.
- a mold made of, for example, a titanium alloy sintered body can be obtained by metal powder injection molding using the master. According to such a mold, since titanium has good releasability from resin, it can be used when forming microneedle type patches. Thus, a release agent or the like can be dispensed with. In addition, due to the fine pores generated in the process of metal powder injection molding, a concavo-convex shape is formed on the surface of the mold, and the concavo-convex shape is transferred to the surface of the needle when the micro two-dollar type patch is formed.
- a semi-molten resin such as nanoimprint (hot press) is pressed against the mold cavity. It may be a molding method using a molding method or a coater (means for pouring molten resin into the mold cavity using a centrifugal force).
- the back surface of the patch 1 is applied to the patient's skin (for example, the skin of the arm or The needle 2 punctures the skin, and the drug applied to the needle 2 is administered into the body by bringing it into close contact with the skin (chest, back, stomach, etc.). Also, without applying the drug to the surface of the needle 2, the back surface of the patch part 1 is in close contact with the skin and the needle 2 is punctured, then the microneedle patch is removed from the skin and the drug is administered from the puncture mark. It may be.
- the tip of the needle 2 can be prevented from reaching the patient's dermis at the time of puncturing.
- the drug can be administered without pain and avoiding the risk of bleeding and secondary infection.
- the vaccine material is administered as a drug, uptake by Langerhans cells is ensured, and the living body is infected.
- Antibodies and cytotoxic T cells can be produced to protect against cancer and cancer.
- the present invention is not limited to this, and in particular, in the case of administering a drug from the puncture mark after puncture with a needle.
- the surface of the needle may not be provided with an uneven shape (such as a spiral shape).
- foreign matters such as salt (magnesium chloride, etc., which is the main component of Nigari) are included, and the foreign matter is removed after molding (in the case of salt, it is dissolved with hot water, etc.) By doing so, an uneven shape may be imparted to the surface of the needle.
- the manufacturing method of the microneedle type patch is not limited to the one in the present embodiment, and the surface of the plate-like member (metal plate or the like) is directly machined or laser processed, and the needle as in the present embodiment.
- a micro two-dollar type patch having the above may be formed. Further, by applying an adhesive to the back surface of the patch part 1 and allowing it to adhere to the skin with the adhesive, the micro two-dollar patch can be kept in close contact for a long time.
- FIG. 1 is a schematic diagram showing a microneedle patch according to an embodiment of the present invention.
- FIG. 3 is a schematic diagram showing a state where the needle is punctured with the micro-bi dollar patch in close contact with the patient's skin.
- FIG. 8 Schematic diagram showing a mold for manufacturing the micro two-dollar patch and a micro one-dollar patch obtained from the mold.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dermatology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Surgical Instruments (AREA)
Abstract
La présente invention concerne un timbre à micro-aiguilles qui, sans que l'extrémité distale des aiguilles ne touche le derme, peut réaliser une perforation de manière à permettre l'administration d'un médicament, tel qu'un vaccin, au travers de ladite perforation, ainsi qu'un procédé de production dudit timbre. La présente invention concerne un timbre à micro-aiguilles constitué d'une partie timbre en forme de feuille (1) et de multiples microprotubérances de type aiguille (2) formant une couche intégrée et superposée à la surface arrière du timbre (2), de telle sorte qu'en collant la surface arrière de la partie timbre (1) sur la peau d'un patient, il est possible de perforer la peau avec les aiguilles (2), lesdites aiguilles (2) ayant une longueur (t), mesurée entre leur extrémité proximale et leur extrémité distale, comprise entre 50 et 100 μm environ.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2006208482A JP2008029710A (ja) | 2006-07-31 | 2006-07-31 | マイクロニードル型パッチ及びその製造方法 |
| JP2006-208482 | 2006-07-31 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2008015782A1 true WO2008015782A1 (fr) | 2008-02-07 |
Family
ID=38996969
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/JP2007/000811 Ceased WO2008015782A1 (fr) | 2006-07-31 | 2007-07-30 | Timbre à micro-aiguilles et procédé de production |
Country Status (2)
| Country | Link |
|---|---|
| JP (1) | JP2008029710A (fr) |
| WO (1) | WO2008015782A1 (fr) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013001480A2 (fr) | 2011-06-28 | 2013-01-03 | Gyoeker Gyula Istvan | Roue de véhicule ferroviaire équipée d'un moteur dans la roue |
| CN103957934A (zh) * | 2011-11-20 | 2014-07-30 | 葛兰素史密丝克莱恩生物有限公司 | 包含tlr-5作为佐剂的用于经皮肤免疫的疫苗 |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009225987A (ja) * | 2008-03-21 | 2009-10-08 | Toppan Printing Co Ltd | 針状体 |
| WO2009130926A1 (fr) * | 2008-04-22 | 2009-10-29 | 南部化成株式会社 | Procédé endermique, organisateur d'aiguille et dispositif d'injecteur endermique |
| JP5668192B2 (ja) | 2010-03-10 | 2015-02-12 | 株式会社ライトニックス | 医療用針及び穿刺具 |
| WO2013057819A1 (fr) | 2011-10-20 | 2013-04-25 | コスメディ製薬株式会社 | Technique de dépôt par micro-aiguille |
| JP5472771B1 (ja) | 2012-09-28 | 2014-04-16 | コスメディ製薬株式会社 | 段差に薬物を保持したマイクロニードル |
| WO2016072350A1 (fr) * | 2014-11-07 | 2016-05-12 | 凸版印刷株式会社 | Ensemble d'aiguilles pour administration transdermique et son procédé de fabrication |
| JP2016195651A (ja) * | 2015-04-02 | 2016-11-24 | 日本写真印刷株式会社 | マイクロニードルシート |
| JP6983162B2 (ja) | 2015-12-28 | 2021-12-17 | エンドダーマ カンパニー リミテッドEndoderma Co., Ltd. | 経皮吸収用マイクロ構造体及びその製造方法 |
| KR101719319B1 (ko) * | 2016-04-05 | 2017-03-23 | 주식회사 엘지생활건강 | 효율적인 피부 천공을 위한 마이크로니들 구조 |
| CN109152914B (zh) * | 2016-05-31 | 2021-06-22 | 日写株式会社 | 微针阵列及其制造方法 |
| EP3563900B1 (fr) | 2016-12-28 | 2023-06-21 | Cosmed Pharmaceutical Co., Ltd. | Réseau de micro-aiguilles revêtu de médicament |
| KR102069091B1 (ko) * | 2017-09-11 | 2020-01-22 | 강명호 | 미세침 롤러 |
| EP4403202A4 (fr) | 2021-09-15 | 2025-10-01 | Cosmed Pharmaceutical Co Ltd | Réseau de micro-aiguilles revêtu de médicament |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001149485A (ja) * | 1999-09-22 | 2001-06-05 | Becton Dickinson & Co | 物質の経皮投与の方法及び装置 |
| US20020082543A1 (en) * | 2000-12-14 | 2002-06-27 | Jung-Hwan Park | Microneedle devices and production thereof |
| JP2002522170A (ja) * | 1998-08-13 | 2002-07-23 | イムプリント ファーマスーティカルス リミテッド | 高速で駆動される1以上の針を揺する物質を供給する装置 |
| JP2004526581A (ja) * | 2001-03-14 | 2004-09-02 | ザ プロクター アンド ギャンブル カンパニー | ソフトリソグラフィ及びフォトリソグラフィを使用して微小針(microneedles)構造を製造する方法 |
| JP2006010421A (ja) * | 2004-06-24 | 2006-01-12 | Gunma Prefecture | 超小型針及びその製造方法 |
| JP2006051361A (ja) * | 2005-07-13 | 2006-02-23 | Nano Device & System Research Inc | 機能性マイクロパイル |
| WO2006075689A1 (fr) * | 2005-01-14 | 2006-07-20 | Fujikura Ltd. | Instrument d'administration de medicament et procede de production associe |
-
2006
- 2006-07-31 JP JP2006208482A patent/JP2008029710A/ja active Pending
-
2007
- 2007-07-30 WO PCT/JP2007/000811 patent/WO2008015782A1/fr not_active Ceased
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002522170A (ja) * | 1998-08-13 | 2002-07-23 | イムプリント ファーマスーティカルス リミテッド | 高速で駆動される1以上の針を揺する物質を供給する装置 |
| JP2001149485A (ja) * | 1999-09-22 | 2001-06-05 | Becton Dickinson & Co | 物質の経皮投与の方法及び装置 |
| US20020082543A1 (en) * | 2000-12-14 | 2002-06-27 | Jung-Hwan Park | Microneedle devices and production thereof |
| JP2004526581A (ja) * | 2001-03-14 | 2004-09-02 | ザ プロクター アンド ギャンブル カンパニー | ソフトリソグラフィ及びフォトリソグラフィを使用して微小針(microneedles)構造を製造する方法 |
| JP2006010421A (ja) * | 2004-06-24 | 2006-01-12 | Gunma Prefecture | 超小型針及びその製造方法 |
| WO2006075689A1 (fr) * | 2005-01-14 | 2006-07-20 | Fujikura Ltd. | Instrument d'administration de medicament et procede de production associe |
| JP2006051361A (ja) * | 2005-07-13 | 2006-02-23 | Nano Device & System Research Inc | 機能性マイクロパイル |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013001480A2 (fr) | 2011-06-28 | 2013-01-03 | Gyoeker Gyula Istvan | Roue de véhicule ferroviaire équipée d'un moteur dans la roue |
| CN103957934A (zh) * | 2011-11-20 | 2014-07-30 | 葛兰素史密丝克莱恩生物有限公司 | 包含tlr-5作为佐剂的用于经皮肤免疫的疫苗 |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2008029710A (ja) | 2008-02-14 |
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Legal Events
| Date | Code | Title | Description |
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