JP2022155251A - Microneedle manufacturing method and microneedle manufacturing device - Google Patents

Microneedle manufacturing method and microneedle manufacturing device Download PDF

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JP2022155251A
JP2022155251A JP2021058664A JP2021058664A JP2022155251A JP 2022155251 A JP2022155251 A JP 2022155251A JP 2021058664 A JP2021058664 A JP 2021058664A JP 2021058664 A JP2021058664 A JP 2021058664A JP 2022155251 A JP2022155251 A JP 2022155251A
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plastic material
pressing
projection
supporting
protrusion
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JP7008854B1 (en
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洋佑 高麗
Yosuke Koma
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Lintec Corp
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Lintec Corp
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Abstract

To provide a projection-bearing body manufacturing method and a projection-bearing body manufacturing device capable of filling the deepest parts of recesses with a plastic material to the extent possible.SOLUTION: Provided is a projection-bearing body manufacturing device EA for manufacturing projection-bearing bodies CB having projections CV formed thereon, comprising: material supporting means 20 for executing a material supporting step of supporting a base material BM containing a plastic material PM by using a supporting member 22 having a supporting surface 22A in which recesses 22B corresponding to projections CV are formed; pressing means 30 for executing a pressing step of forming the projections CV for forming a projection-bearing body from the plastic material PM by pressing the base material BM in a direction of facing the supporting surface 22A to fill the recesses 22B with a plastic material PM; and pressure reducing means 90 for executing a pressure reduction step that performs compression by the pressing means 30 under reduced-pressure atmosphere.SELECTED DRAWING: Figure 1

Description

本発明は、突起保有体の製造方法および突起保有体の製造装置に関する。 The present invention relates to a projection holder manufacturing method and a projection holder manufacturing apparatus.

針状の突起部が形成された突起保有体の製造技術は公知である(例えば、特許文献1参照)。 A technique for manufacturing a projection holder having needle-like projections is known (see Patent Document 1, for example).

特開2019-170795号公報JP 2019-170795 A

特許文献1で開示された突起保有体の製造技術では、熱可塑性樹脂3(可塑性材料)を押圧して当該可塑性材料を凹版2(支持部材)の凹部に充填させる際、凹部に空気溜りができてしまうので、凹部の最深部にまで可塑性材料を充填させることができず、所望形状の突起保有体を形成することができなくなるという不都合を発生する。 In the technology for manufacturing the protrusion holder disclosed in Patent Document 1, when the thermoplastic resin 3 (plastic material) is pressed to fill the recesses of the intaglio 2 (supporting member) with the plastic material, air pockets are formed in the recesses. As a result, the plastic material cannot be filled up to the deepest part of the recess, resulting in the inconvenience that a desired shape of the projection holding body cannot be formed.

本発明の目的は、凹部の最深部にまで極力可塑性材料を充填させることができる突起保有体の製造方法および突起保有体の製造装置を提供することにある。 SUMMARY OF THE INVENTION It is an object of the present invention to provide a method for manufacturing a projection holder and an apparatus for manufacturing a projection holder that can fill the deepest part of the recess with a plastic material as much as possible.

本発明は、請求項に記載した構成を採用した。 The present invention employs the configurations described in the claims.

本発明によれば、押圧工程での押圧を減圧雰囲気で行うため、凹部に空気溜りができることが低減され、凹部の最深部にまで極力可塑性材料を充填させることができる。 According to the present invention, since the pressing in the pressing step is performed in a reduced pressure atmosphere, it is possible to reduce the formation of air pockets in the recesses and fill the deepest part of the recesses with the plastic material as much as possible.

(A)~(D)は、本発明の一実施形態に係る突起保有体の製造装置の説明図および同装置の動作説明図。(E)~(G)は、変形例の説明図。(A) to (D) are an explanatory diagram of a projection holding body manufacturing apparatus according to an embodiment of the present invention and an explanatory diagram of the operation of the same apparatus. (E) to (G) are explanatory diagrams of modifications.

以下、本発明の一実施形態を図面に基づいて説明する。
なお、本実施形態におけるX軸、Y軸、Z軸は、それぞれが直交する関係にあり、X軸およびY軸は、所定平面内の軸とし、Z軸は、前記所定平面に直交する軸とする。さらに、本実施形態では、Y軸と平行な図1中手前方向から観た場合を基準とし、図を指定することなく方向を示した場合、「上」がZ軸の矢印方向で「下」がその逆方向、「左」がX軸の矢印方向で「右」がその逆方向、「前」がY軸と平行な図1中手前方向で「後」がその逆方向とする。なお、方向を示す矢印を記載していない図1(B)~(G)は、全て図1(A)と同じ方向から観た図とする。
An embodiment of the present invention will be described below with reference to the drawings.
Note that the X-axis, Y-axis, and Z-axis in this embodiment are orthogonal to each other, and the X-axis and Y-axis are axes within a predetermined plane, and the Z-axis is an axis orthogonal to the predetermined plane. do. Furthermore, in the present embodiment, when viewed from the front in FIG. 1 parallel to the Y-axis, when the direction is indicated without designating the drawing, "up" is the direction of the arrow of the Z-axis and "down". is the opposite direction, "left" is the arrow direction of the X axis, "right" is the opposite direction, "front" is the direction parallel to the Y axis in FIG. 1, and "rear" is the opposite direction. Note that FIGS. 1B to 1G, which do not include arrows indicating directions, are views viewed from the same direction as FIG. 1A.

本発明の突起保有体の製造装置(以下、単に「製造装置」ともいう)EAは、突起部CVが形成された突起保有体CBの製造方法を実施する装置であって、可塑性材料PMを含んだ母材BMを搬送する材料搬送工程を実施する材料搬送手段10と、突起部CVに対応した凹部22Bが形成された支持面22Aを有する支持部材22で、母材BMを支持する材料支持工程を実施する材料支持手段20と、母材BMを支持面22Aへ向かう方向に押圧して可塑性材料PMを凹部22Bに充填させ、当該可塑性材料PMから突起部CVを形成して突起保有体CBを形成する押圧工程を実施する押圧手段30と、可塑性材料PMを加熱する加熱工程を実施する加熱手段40と、支持面22Aに対する支持シートBSの位置決めを行う位置決め工程を実施する位置決め手段50と、突起保有体CBを支持部材22から離間させる離間工程を実施する離離間手段60と、可塑性材料PMを冷却する冷却工程を実施する冷却手段70と、可塑性材料PMを浸出媒体としての水WTに浸すことで、可塑性材料PMを多孔質体とする浸出工程を実施する浸出手段80と、押圧手段30での押圧を減圧雰囲気で行う減圧手段90とを備え、BMの供給を行う母材供給工程を実施する母材供給手段PSの近傍に配置されている。
なお、母材BMは、支持シートBSの一方の面に可塑性材料PMが積層されている。また、本実施形態の支持シートBSは、液体および気体のうち少なくとも一方を透過可能な透過性を有する透過部材としての紙によって構成されている。さらに、可塑性材料PMは、ポリ乳酸(PLA)が主成分とされることで熱可塑性を有し、水WTに浸出する浸出材料としてのポリエチレングリコールPG(図1(D)の拡大図参照)を含有している。本実施形態の可塑性材料PMは、ポリ乳酸とポリエチレングリコールPGとの2つの成分の混合物とされ、それらの割合が重量比で5対5とされたものが採用されている。
A projection holder manufacturing apparatus (hereinafter also simply referred to as "manufacturing apparatus") EA of the present invention is an apparatus for carrying out a method for manufacturing a projection holder CB having projections CV formed thereon, and includes a plastic material PM. A material supporting process for supporting the base material BM with a material conveying means 10 for carrying out a material conveying process for conveying the base material BM and a supporting member 22 having a supporting surface 22A formed with recesses 22B corresponding to the protrusions CV. and the base material BM is pressed in the direction toward the support surface 22A to fill the recesses 22B with the plastic material PM, and the protrusions CV are formed from the plastic material PM to form the protrusion holders CB. pressing means 30 for performing a pressing step for forming; heating means 40 for performing a heating step for heating the plastic material PM; positioning means 50 for performing a positioning step for positioning the support sheet BS with respect to the support surface 22A; Separating means 60 for performing a separating step of separating the holder CB from the support member 22, cooling means 70 for performing a cooling step of cooling the plastic material PM, and immersing the plastic material PM in water WT as a leaching medium. is equipped with a leaching means 80 for performing a leaching step of making the plastic material PM into a porous body, and a depressurizing means 90 for performing pressing by the pressing means 30 in a decompressed atmosphere, and performing a base material supplying step for supplying the BM. It is arranged in the vicinity of the base material supplying means PS.
The base material BM is formed by laminating a plastic material PM on one surface of the support sheet BS. Further, the support sheet BS of the present embodiment is made of paper as a permeable member that is permeable to at least one of liquid and gas. Furthermore, the plastic material PM has thermoplasticity due to its main component being polylactic acid (PLA), and polyethylene glycol PG (see the enlarged view of FIG. 1(D)) as a leaching material that leaches into the water WT. contains. The plastic material PM of this embodiment is a mixture of two components, polylactic acid and polyethylene glycol PG, in a weight ratio of 5:5.

材料搬送手段10は、複数のアームによって構成され、その作業範囲内において、作業部である先端アーム11Aで支持したものを何れの位置、何れの角度にでも変位可能な駆動機器としての所謂多関節ロボット11と、先端アーム11Aに支持され、減圧ポンプや真空エジェクタ等の図示しない減圧手段(保持手段)によって吸着保持が可能な保持面12Aを有する保持板12とを備え、可塑性材料PMを支持面22Aに当接させて母材BMを支持部材22上に載置する構成となっている。 The material conveying means 10 is composed of a plurality of arms, and within its working range, a so-called multi-joint driving device capable of displacing what is supported by the tip arm 11A, which is the working part, to any position and any angle. It comprises a robot 11 and a holding plate 12 having a holding surface 12A supported by a distal arm 11A and capable of being held by suction by a decompression means (holding means) (not shown) such as a decompression pump or a vacuum ejector. 22A, and the base material BM is placed on the support member 22. As shown in FIG.

材料支持手段20は、段部21Aが形成された基台21と、段部21A内に嵌め込まれて支持され、支持面22Aに凹部22Bが形成された支持部材22とを備えている。 The material support means 20 includes a base 21 having a stepped portion 21A formed thereon, and a support member 22 which is fitted and supported in the stepped portion 21A and has a support surface 22A formed with a recessed portion 22B.

押圧手段30は、駆動機器としての直動モータ31と、その出力軸31Aに支持された押圧部材32とを備えている。本実施形態では、押圧部材32は透明な素材で構成されている。 The pressing means 30 includes a direct-acting motor 31 as a driving device, and a pressing member 32 supported by its output shaft 31A. In this embodiment, the pressing member 32 is made of a transparent material.

加熱手段40は、基台21の内部に配置されたコイルヒータやヒートパイプの加熱側等からなる加熱機器41を備えている。 The heating means 40 includes a heating device 41 such as a coil heater and a heating side of a heat pipe arranged inside the base 21 .

位置決め手段50は、カメラや投影機等の撮像手段や、光学センサや超音波センサ等の各種センサ等で構成され、ブラケット51Aを介して押圧部材32に支持された検知機器51と、駆動機器としてのXYテーブル52と、当該XYテーブル52の出力台52Aに支持され、出力軸53Aで基台21を支持する駆動機器としての回動モータ53とを備え、支持部材22をXY平面内で直線移動または曲線移動させるとともに、当該支持部材22をXY平面内で回転移動させる構成となっている。 The positioning means 50 includes imaging means such as a camera and a projector, various sensors such as an optical sensor and an ultrasonic sensor, and the like. and a rotating motor 53 as a driving device that is supported by an output table 52A of the XY table 52 and supports the base 21 with an output shaft 53A, and linearly moves the support member 22 within the XY plane. Alternatively, the support member 22 is configured to be rotated in the XY plane while being curvedly moved.

離間手段60は、複数のアームによって構成され、その作業範囲内において、作業部である先端アーム61Aで支持したものを何れの位置、何れの角度にでも変位可能な駆動機器としての所謂多関節ロボット61と、先端アーム61Aに支持され、減圧ポンプや真空エジェクタ等の図示しない減圧手段(保持手段)によって吸着保持が可能な保持面62Aを有する保持板62とを備えている。 The separating means 60 is composed of a plurality of arms, and is a so-called articulated robot as a driving device capable of displacing an object supported by the tip arm 61A, which is a working part, to any position and any angle within its working range. 61, and a holding plate 62 having a holding surface 62A which is supported by the tip arm 61A and can be held by suction by a decompression means (holding means) (not shown) such as a decompression pump or a vacuum ejector.

冷却手段70は、保持板62の内部に設けられたペルチェ素子やヒートパイプの冷却側等からなる冷却機器71を備えている。 The cooling means 70 includes a cooling device 71 including a Peltier element provided inside the holding plate 62, a cooling side of a heat pipe, and the like.

浸出手段80は、水WTと、水WTを受容する容器81とを備えている。 The brewing means 80 comprises water WT and a container 81 for receiving the water WT.

減圧手段90は、駆動機器としての直動モータ91と、その出力軸91Aに支持され、上面92Aで直動モータ31を支持する上蓋92と、底面93AでXYテーブル52を支持し、上蓋92とで密閉空間SPを形成する下蓋93と、密閉空間SPを減圧する減圧ポンプや真空エジェクタ等の減圧機器94とを備えている。 The decompression means 90 includes a linear motion motor 91 as a driving device, an upper lid 92 supported by an output shaft 91A of the linear motion motor 91 and supporting the linear motion motor 31 on an upper surface 92A, and an upper lid 92 supporting an XY table 52 on a bottom surface 93A. and a decompression device 94 such as a decompression pump and a vacuum ejector for decompressing the hermetically sealed space SP.

以上の突起保有体の製造装置EAの動作を説明する。
先ず、図1(A)中実線で示す初期位置に各部材が配置された製造装置EAに対し、当該製造装置EAの使用者(以下、単に「使用者」という)または多関節ロボットやベルトコンベア等の図示しない搬送手段が、同図のように母材供給手段PS上に母材BMを供給した後、使用者が操作パネルやパーソナルコンピュータ等の図示しない操作手段を介して自動運転開始の信号を入力する。すると、材料搬送手段10が多関節ロボット11および図示しない減圧手段を駆動し、保持板12を移動させて保持面12Aを支持シートBSに当接させ、当該保持面12Aで母材BMを吸着保持し、母材BMを支持部材22の支持面22A上に載置した後、図示しない減圧手段の駆動を停止して保持板12を初期位置に復帰させる。次いで、減圧手段90が直動モータ91を駆動し、上蓋92を下降させて下蓋93とで密閉空間SPを形成した後、減圧機器94を駆動し、密閉空間SP内を減圧する。その後、押圧手段30が直動モータ31を駆動し、押圧部材32を下降させ、図1(B)に示すように、当該押圧部材32で母材BMを支持面22Aへ向かう方向に押圧し、可塑性材料PMを凹部22B内に充填させる。この際、加熱手段40が加熱機器41を駆動し、可塑性材料PMを加熱して軟化させ、当該可塑性材料PMを凹部22B内に充填させ易くする。次に、位置決め手段50が検知機器51を駆動し、支持シートBSの位置を検出し、この検出結果を基にして位置決め手段50がXYテーブル52および回動モータ53を駆動し、支持シートBSの所定の位置に凹部22B(突起部CV)が配置されるように支持部材22を移動させる。これにより、可塑性材料PMから突起部CVと当該突起部CVを支える土台FDとが形成され、支持シートBSに突起部CVが形成された突起保有体CBが形成される。そして、減圧手段90が密閉空間SP内を大気圧にした後、押圧手段30および減圧手段90が直動モータ31、91を駆動し、押圧部材32および上蓋92をそれぞれ初期位置に復帰させ、加熱手段40が加熱機器41の駆動を停止する。
The operation of the projection holding body manufacturing apparatus EA will be described.
First, a user of the manufacturing apparatus EA (hereinafter simply referred to as a "user"), an articulated robot, or a belt conveyor is assigned to the manufacturing apparatus EA in which each member is arranged at the initial position indicated by the solid line in FIG. 1(A). After feeding the base material BM onto the base material supply means PS as shown in FIG. Enter Then, the material conveying means 10 drives the articulated robot 11 and the decompression means (not shown) to move the holding plate 12 to bring the holding surface 12A into contact with the support sheet BS, and the holding surface 12A adsorbs and holds the base material BM. Then, after the base material BM is placed on the support surface 22A of the support member 22, the drive of the decompression means (not shown) is stopped to return the holding plate 12 to the initial position. Next, the decompression means 90 drives the direct-acting motor 91 to lower the upper lid 92 to form the closed space SP together with the lower lid 93, and then drives the decompression device 94 to reduce the pressure in the enclosed space SP. After that, the pressing means 30 drives the direct-acting motor 31 to lower the pressing member 32, and as shown in FIG. The recess 22B is filled with a plastic material PM. At this time, the heating means 40 drives the heating device 41 to heat and soften the plastic material PM, thereby facilitating the filling of the recess 22B with the plastic material PM. Next, the positioning means 50 drives the detection device 51 to detect the position of the support sheet BS. The support member 22 is moved so that the recess 22B (projection CV) is arranged at a predetermined position. As a result, the protrusions CV and the base FD for supporting the protrusions CV are formed from the plastic material PM, and the protrusion holders CB in which the protrusions CV are formed on the support sheet BS are formed. Then, after the decompressing means 90 reduces the pressure in the sealed space SP to the atmospheric pressure, the pressing means 30 and the decompressing means 90 drive the direct-acting motors 31 and 91 to return the pressing member 32 and the upper lid 92 to their initial positions, respectively, and heat the air. The means 40 stop driving the heating device 41 .

次いで、離間手段60および冷却手段70が多関節ロボット61および冷却機器71を駆動し、図1(C)に示すように、保持板62を突起保有体CBに当接させ、可塑性材料PMを冷却する。これにより、図1(C)の拡大図に示すように、可塑性材料PMが縮んで凹部22Bとの間に隙間CLが形成され、凹部22Bから突起部CVを抜き取り易くなる。この際、離間手段60が保持板62で可塑性材料PMを加圧しながら冷却手段70が可塑性材料PMを冷却することで、可塑性材料PMと支持シートBSとの接着を良好にすることができる。その後、冷却手段70が冷却機器71の駆動を停止し、可塑性材料PMの冷却を終了すると、離間手段60が多関節ロボット61および図示しない減圧手段を駆動し、保持板62の保持面62Aで突起保有体CBを吸着保持して当該突起保有体CBを支持部材22から離間させた後、図1(D)に示すように、突起保有体CBを水WT内に浸す。これにより、可塑性材料PMに含有しているポリエチレングリコールPGが水WTに浸出し、図1(D)の拡大図に示すように、当該ポリエチレングリコールPGがあった部位に孔HLが形成されて空洞化し、可塑性材料PMが多孔質体となる。次に、離間手段60が多関節ロボット61を駆動し、孔HLが形成された突起保有体CBを図示しない次工程に搬送して図示しない減圧手段の駆動を停止し、当該突起保有体CBから保持板62を切り離し、切り離した保持板62を初期位置に復帰させ、以降上記同様の動作が繰り返される。 Next, the separating means 60 and the cooling means 70 drive the articulated robot 61 and the cooling device 71, and as shown in FIG. do. As a result, as shown in the enlarged view of FIG. 1(C), the plastic material PM shrinks to form a gap CL between it and the recess 22B, making it easier to remove the protrusion CV from the recess 22B. At this time, the cooling means 70 cools the plastic material PM while the separating means 60 presses the plastic material PM with the holding plate 62, so that the adhesion between the plastic material PM and the support sheet BS can be improved. After that, when the cooling means 70 stops driving the cooling device 71 and finishes cooling the plastic material PM, the separating means 60 drives the articulated robot 61 and the decompression means (not shown), and the holding surface 62A of the holding plate 62 protrudes from the holding surface 62A. After holding the holding bodies CB by suction and separating the projection holding bodies CB from the supporting member 22, the projection holding bodies CB are immersed in water WT as shown in FIG. 1(D). As a result, the polyethylene glycol PG contained in the plastic material PM is leached into the water WT, and as shown in the enlarged view of FIG. , and the plastic material PM becomes a porous body. Next, the separating means 60 drives the multi-joint robot 61 to transport the projection holding body CB with the hole HL formed thereon to the next process (not shown), stop the driving of the decompression means (not shown), and remove the projection holding body CB from the projection holding body CB. The holding plate 62 is separated, the separated holding plate 62 is returned to the initial position, and the same operation as described above is repeated thereafter.

以上のような実施形態によれば、押圧工程での押圧を減圧雰囲気で行うため、凹部22Bに空気溜りができることが低減され、凹部22Bの最深部にまで極力可塑性材料PMを充填させることができる。 According to the embodiment as described above, since the pressing in the pressing step is performed in a reduced pressure atmosphere, the formation of air pockets in the recess 22B is reduced, and the plastic material PM can be filled to the deepest part of the recess 22B as much as possible. .

本発明における手段および工程は、それら手段および工程について説明した動作、機能または工程を果たすことができる限りなんら限定されることはなく、まして、前記実施形態で示した単なる一実施形態の構成物や工程に全く限定されることはない。例えば、材料支持工程は、突起部に対応した凹部が形成された支持面を有する支持部材で、可塑性材料を含んだ母材を支持する工程であればどんな工程でもよく、出願当初の技術常識に照らし合わせてその技術範囲内のものであればなんら限定されることはない(その他の手段および工程も同じ)。 The means and steps in the present invention are not limited in any way as long as they can perform the operations, functions or steps described for those means and steps. The process is not limited at all. For example, the material supporting process may be any process as long as it is a process of supporting a base material containing a plastic material with a support member having a support surface on which recesses corresponding to the protrusions are formed, and it is the common general knowledge at the time of filing. There is no limitation as long as it is within the technical scope in comparison (other means and processes are the same).

材料搬送手段10は、多関節ロボット11を採用することなく多関節ロボット61を離間手段60と共有し、母材BMを搬送する構成としてもよいし、保持板12に代えてまたは併用して、吸着パッド等を採用してもよいし、本発明の突起保有体の製造装置EAに備わっていてもよいし、備わっていなくてもよく、備わっていない場合は、他の装置や人手で母材BMを搬送すればよい。 The material conveying means 10 may share the articulated robot 61 with the separating means 60 without adopting the articulated robot 11 to convey the base material BM. A suction pad or the like may be employed, and the apparatus EA for manufacturing a protrusion holder of the present invention may or may not be provided with the base material. The BM should be transported.

材料支持手段20は、基台21に段部21Aがなくてもよいし、支持部材22を保持する減圧ポンプや真空エジェクタ等の減圧手段やチャックモータ等の支持部材保持手段を設けてもよいし、基台21がなく、支持部材22のみで構成されていてもよい。
支持部材22は、金属、樹脂、シリコーン材、ゴム材、木材、紙、陶器等、何で構成されていてもよいし、凹部22Bの数が1でもよいし複数でもよいし、突起保有体CBを支持部材22から離間させ易くするために、フッ素やシリコーン等の剥離性向上部材が支持面22Aや凹部22Bにコーティングされていたり、塗布されていたり、積層されていたりしてもよい。
In the material supporting means 20, the base 21 may not have the stepped portion 21A, or decompression means such as a decompression pump or a vacuum ejector for holding the support member 22, or support member holding means such as a chuck motor may be provided. , the base 21 may be eliminated and only the support member 22 may be provided.
The support member 22 may be made of any material such as metal, resin, silicone material, rubber material, wood, paper, ceramics, etc. The number of the recesses 22B may be one or more, and the projection holding bodies CB may be provided. In order to facilitate the separation from the support member 22, the support surface 22A and the concave portion 22B may be coated, applied, or laminated with a peelability improving member such as fluorine or silicone.

押圧手段30は、押圧部材32を移動させることなくまたは、押圧部材32を移動させつつ、支持部材22を移動させ、母材BMを支持面22Aへ向かう方向に押圧して突起部CVを形成してもよいし、押圧部材32が半透明でもよいし、透明でなくてもよいし、直動モータ31および押圧部材32を採用することなく多関節ロボット11および保持板12を材料搬送手段10と共有したり、多関節ロボット61および保持板62を離間手段60と共有したりして、保持板12や保持板62を介して母材BMを支持面22Aへ向かう方向に押圧して突起部CVを形成してもよいし、直動モータ31を採用することなく多関節ロボット11を材料搬送手段10と共有したり、多関節ロボット61を離間手段60と共有したりして、押圧部材32を介して母材BMを支持面22Aへ向かう方向に押圧して突起部CVを形成してもよい。 The pressing means 30 moves the supporting member 22 without moving the pressing member 32 or while moving the pressing member 32, and presses the base material BM in the direction toward the supporting surface 22A to form the projections CV. Alternatively, the pressing member 32 may be translucent or non-transparent, and the articulated robot 11 and the holding plate 12 may be combined with the material conveying means 10 without adopting the direct-acting motor 31 and the pressing member 32. By sharing the multi-joint robot 61 and the holding plate 62 with the separating means 60, the base material BM is pressed in the direction toward the support surface 22A via the holding plate 12 and the holding plate 62 to press the protrusion CV. may be formed, the articulated robot 11 may be shared with the material conveying means 10 without adopting the linear motion motor 31, or the articulated robot 61 may be shared with the separating means 60, and the pressing member 32 The protrusions CV may be formed by pressing the base material BM in the direction toward the support surface 22A.

加熱手段40は、基台21の外部に配置されてもよいし、支持部材22の内部や押圧部材32の内部に配置されてもよいし、押圧手段30での押圧前に可塑性材料PMを加熱してもよいし、押圧手段30での押圧中に可塑性材料PMを加熱してもよいし、押圧手段30での押圧後に可塑性材料PMを加熱してもよいし、本発明の突起保有体の製造装置EAに備わっていてもよいし、備わっていなくてもよい。 The heating means 40 may be arranged outside the base 21, inside the support member 22, or inside the pressing member 32, and heat the plastic material PM before being pressed by the pressing means 30. Alternatively, the plastic material PM may be heated while being pressed by the pressing means 30, or the plastic material PM may be heated after being pressed by the pressing means 30. It may or may not be provided in the manufacturing apparatus EA.

位置決め手段50は、支持部材22および押圧部材32のうち少なくとも一方をXY平面内で直線移動または曲線移動させたり回転移動させたりしてもよいし、例えば、支持部材22をX方向(またはY方向)に直線移動または曲線移動させ、押圧部材32をY方向(X方向)に直線移動または曲線移動させてもよいし、支持部材22や押圧部材32をX方向またはY方向以外の方向に直線移動または曲線移動させてもよいし、支持部材22や押圧部材32をXY平面内で直線移動または曲線移動させるだけでもよいし、支持部材22や押圧部材32をXY平面内で回転移動させるだけでもよい。
検知機器51は、1体でもよいし2体以上でもよいし、押圧部材32の側方から支持面22Aに対する支持シートBSの位置を検知してもよいし、基台21や支持部材22を透明または半透明なもので構成し、それら基台21や支持部材22を透視して支持面22Aに対する支持シートBSの位置を検知してもよいし、押圧部材32に支持されていなくてもよい。
位置決め手段50は、支持面22Aに対する可塑性材料PMの位置決めを行ってもよいし、支持面22Aに対する支持シートBSおよび可塑性材料PMの両方の位置決めを行ってもよいし、本発明の突起保有体の製造装置EAに備わっていてもよいし、備わっていなくてもよい。
The positioning means 50 may move at least one of the support member 22 and the pressing member 32 linearly, curvilinearly, or rotationally within the XY plane. ), the pressing member 32 may be moved linearly or curvedly in the Y direction (X direction), or the support member 22 and the pressing member 32 may be linearly moved in the X direction or in directions other than the Y direction. Alternatively, the support member 22 and the pressing member 32 may be moved in a curved line, or the support member 22 and the pressing member 32 may be simply moved linearly or curvedly within the XY plane, or the support member 22 and the pressing member 32 may be rotationally moved within the XY plane. .
The detection device 51 may be one or two or more, and may detect the position of the support sheet BS with respect to the support surface 22A from the side of the pressing member 32. Alternatively, the support sheet BS may be configured with a translucent material, and the position of the support sheet BS with respect to the support surface 22A may be detected by seeing through the base 21 and the support member 22, or the support sheet BS may not be supported by the pressing member 32.
The positioning means 50 may position the plastic material PM with respect to the support surface 22A, may position both the support sheet BS and the plastic material PM with respect to the support surface 22A, or may position the projection holder of the present invention. It may or may not be provided in the manufacturing apparatus EA.

離間手段60は、多関節ロボット61を採用することなく多関節ロボット11を材料搬送手段10と共有し、突起保有体CBを支持部材22から離間させる構成としてもよいし、剥離用テープを突起保有体CBに貼付し、当該剥離用テープに張力を付与して突起保有体CBを支持部材22から離間させる構成でもよいし、バイブレータや超音波振動装置等の振動手段を採用し、突起保有体CBに振動を加えて当該突起保有体CBを支持部材22から離間し易くしてもよいし、突起保有体CBを遠心分離させてもよいし、突起保有体CBを水WTに浸した際、当該突起保有体CBを移動させたり振動させたりしてポリエチレングリコールPGを水WTに浸出させ易くしてもよいし、本発明の突起保有体の製造装置EAに備わっていてもよいし、備わっていなくてもよく、備わっていない場合は、他の装置や人手で突起保有体CBを支持部材22から離間させればよい。 The separating means 60 may share the multi-joint robot 11 with the material conveying means 10 without adopting the multi-joint robot 61, and may be configured to separate the protrusion holder CB from the support member 22. It may be attached to the body CB, and tension may be applied to the peeling tape to separate the projection holding body CB from the support member 22. Alternatively, a vibrating means such as a vibrator or an ultrasonic vibration device may be used to remove the projection holding body CB. may be easily separated from the support member 22 by applying vibration to the projection holding body CB, the projection holding body CB may be centrifuged, or when the projection holding body CB is immersed in water WT, the The protrusion holder CB may be moved or vibrated to facilitate the leaching of the polyethylene glycol PG into the water WT. If it is not provided, the projection holder CB may be separated from the support member 22 by another device or manually.

冷却手段70は、押圧部材32の内部やその近傍に冷却機器71を設け、当該押圧部材32で母材BMを押圧した状態で可塑性材料PMを冷却してもよいし、母材BMを押圧することなく可塑性材料PMを冷却してもよいし、保持板62の外部に設けられてもよいし、基台21や支持部材22の内部に設けられてもよいし、水や混合液等の液体、エタノールやアセトン等の有機溶剤または、鉱物油や化学合成油等のオイル等の冷却媒体に可塑性材料PMを浸して当該可塑性材料PMを冷却する構成でもよいし、大気や冷風等を可塑性材料PMに当てて当該可塑性材料PMを冷却する構成でもよいし、冷却機器71を採用することなく水WTを浸出手段80と共有し、可塑性材料PMを冷却する構成でもよいし、本発明の突起保有体の製造装置EAに備わっていてもよいし、備わっていなくてもよい。 The cooling means 70 may be provided with a cooling device 71 inside or near the pressing member 32, and the plastic material PM may be cooled while the base material BM is pressed by the pressing member 32, or the base material BM may be pressed. The plastic material PM may be cooled without cooling, may be provided outside the holding plate 62, may be provided inside the base 21 or the support member 22, or may be provided in a liquid such as water or a mixed liquid. Alternatively, the plastic material PM may be cooled by immersing it in a cooling medium such as an organic solvent such as ethanol or acetone or an oil such as mineral oil or synthetic oil. The water WT may be shared with the leaching means 80 without adopting the cooling device 71 to cool the plastic material PM, or the protrusion holder of the present invention may or may not be provided in the manufacturing apparatus EA.

浸出手段80は、浸出媒体として、水や混合液等の液体、エタノールやアセトン等の有機溶剤または、鉱物油や化学合成油等のオイル等、母材BMに含有している浸出材料を浸出させることができるものであれば何が採用されてもよいし、浸出媒体を移動、循環、振動、撹拌させて浸出材料を浸出媒体に浸出し易くしてもよいし、本発明の突起保有体の製造装置EAに備わっていてもよいし、備わっていなくてもよい。 The leaching means 80 leaches a leaching material contained in the base material BM, such as a liquid such as water or a mixed liquid, an organic solvent such as ethanol or acetone, or an oil such as mineral oil or chemically synthesized oil, as a leaching medium. Anything can be adopted as long as it can be used, and the leaching medium may be moved, circulated, vibrated, or agitated to facilitate leaching of the leaching material into the leaching medium. It may or may not be provided in the manufacturing apparatus EA.

減圧手段90は、例えば、材料搬送手段10、材料支持手段20および押圧手段30を含んだ領域を減圧雰囲気としたり、材料搬送手段10、押圧手段30、位置決め手段50および離間手段60を含んだ領域を減圧雰囲気としたり、突起保有体の製造装置EA全てを含んだ領域を減圧雰囲気としたりしてもよく、押圧手段30での押圧を減圧雰囲気で行うことができれば、どの領域を減圧雰囲気としてもよいし、例えば、上蓋92および下蓋93を採用することなく、上面に開口部を有するケースと、当該ケースに蝶番を介して支持されたケース蓋とで密閉空間SPを形成してもよいし、密閉空間SP内の減圧加減は、使用者が任意に決定することができ、真空としてもよい。 The decompression means 90, for example, creates a decompressed atmosphere in a region including the material conveying means 10, the material supporting means 20 and the pressing means 30, or creates a region containing the material conveying means 10, the pressing means 30, the positioning means 50 and the spacing means 60. may be set to a reduced pressure atmosphere, or an area including all of the projection holding body manufacturing apparatus EA may be set to a reduced pressure atmosphere. Alternatively, for example, without using the upper lid 92 and the lower lid 93, the closed space SP may be formed by a case having an opening on the upper surface and a case lid supported by the case via a hinge. , the degree of pressure reduction in the closed space SP can be arbitrarily determined by the user, and may be a vacuum.

母材供給手段PSは、単なる台でもよいし、ベルトコンベアでもよいし、自走式の搬送台等でもよいし、本発明の突起保有体の製造装置EAに備わっていてもよいし、備わっていなくてもよい。 The base material supply means PS may be a simple stand, a belt conveyor, a self-propelled carriage, or the like, and may or may not be provided in the projection holding body manufacturing apparatus EA of the present invention. It doesn't have to be.

突起保有体の製造装置EAは、例えば、単体ガスや複合ガス等のガス、水や混合液等の液体、エタノールやアセトン等の有機溶剤または、鉱物油や化学合成油等のオイル等の流体雰囲気の中で、母材BMを支持面22Aへ向かう方向に押圧して突起部CVを形成してもよい。 The projection holding body manufacturing apparatus EA is, for example, a gas such as a single gas or a composite gas, a liquid such as water or a mixed liquid, an organic solvent such as ethanol or acetone, or a fluid atmosphere such as oil such as mineral oil or chemically synthesized oil. Among them, the projections CV may be formed by pressing the base material BM in the direction toward the support surface 22A.

支持シートBSは、透過部材として、例えば、布、不織布、樹脂、メッシュ材、木材等の他、貫通孔が形成された金属、樹脂、シリコーン材、ゴム材、木材、紙、陶器等、液体および気体のうち少なくとも一方を透過可能なものであればどのようなものが採用されていてもよいし、例えば、金属、樹脂、シリコーン材、ゴム材、木材、紙、陶器等、液体および気体を透過不可能なもの(透過部材でないもの)が採用されていてもよい。 The support sheet BS can be made of, for example, cloth, non-woven fabric, resin, mesh material, wood, metal having through holes formed therein, resin, silicone material, rubber material, wood, paper, pottery, etc., liquid and Any material can be used as long as at least one of the gases can be permeable. For example, metals, resins, silicone materials, rubber materials, wood, paper, pottery, etc. Impossible ones (those that are not transmissive members) may be employed.

可塑性材料PMは、熱や圧力等のエネルギーを加えることで変形し、その後元の形状に戻らないもの、例えば、金属、粘土、樹脂等が例示でき、樹脂の場合、例えば、PET、ポリプロピレン、ポリエチレン、ポリ塩化ビニル、ポリ(ラクチド-co-グリコリド)共重合体(PLGA)等、可塑性を有するものであれば何でもよいし、単一の成分からなるものでもよいし、複数の成分からなるものでもよいし、可塑性を有するもののみによって構成されていてもよいし、可塑性を有するものと可塑性を有しないものとで構成されていてもよいし、熱可塑性を有していなくてもよいし、浸出材料を含有していなくてもよいし、熱可塑性を有する材料として熱可塑性樹脂を含んだものが採用されてもよい。
可塑性材料PMと浸出材料との割合は、5対5以外に例えば、8対2や1対9等どのような割合であってもよいし、それらの比の基準は、重量比以外に例えば、質量比、体積比、モル比等どのような基準でもよい。
浸出材料は、例えば、塩化ナトリウム、硝酸カリウム、ミョウバン、ポリビニルアルコール等、浸出媒体に浸出するものであればどのようなものでもよい。
母材BMは、支持シートBSのない可塑性材料PMのみで構成されていてもよいし、支持シートBSおよび可塑性材料PMの他に他のものが積層されていてもよいし、可塑性材料PMの量が凹部22Bの容量と同じ量でもよいし、凹部22Bの容量以上でもよい。
突起部CVの高さは、100nm~3mmでもよいし、100nm以下でもよいし、3mm以上でもよい。特に所謂マイクロニードルとして使用する場合には、突起部CVの高さは、100μm~1.5mmとするとよい。
突起部CVの先端は、尖っていてもよいし、尖っていなくてもよいし、丸まっていてもよいし、矢尻形状でもよいし、二股または三股以上に分岐していてもよい。
突起部CVの形状は、円錐、角錐、円柱、角柱、それらを組み合わせた形状でもよい。
Examples of the plastic material PM include materials that are deformed by applying energy such as heat and pressure and do not return to their original shape afterward, such as metals, clays, and resins. In the case of resins, examples include PET, polypropylene, and polyethylene. , Polyvinyl chloride, poly (lactide-co-glycolide) copolymer (PLGA), etc., may be anything as long as it has plasticity, may consist of a single component, or may consist of a plurality of components. It may be composed only of materials with plasticity, may be composed of materials with plasticity and materials without plasticity, may not have thermoplasticity, and may be leached. It may contain no material, or a material containing a thermoplastic resin may be employed as a material having thermoplasticity.
The ratio of the plastic material PM to the leaching material may be any ratio other than 5:5, such as 8:2 or 1:9. Any standard such as mass ratio, volume ratio, molar ratio, etc. may be used.
The leaching material can be, for example, sodium chloride, potassium nitrate, alum, polyvinyl alcohol, etc., as long as it leaches into the leaching medium.
The base material BM may be composed only of the plastic material PM without the support sheet BS, or may be laminated with other materials in addition to the support sheet BS and the plastic material PM, or the amount of the plastic material PM may be may be the same amount as the capacity of the recess 22B, or may be greater than or equal to the capacity of the recess 22B.
The height of the protrusion CV may be 100 nm to 3 mm, 100 nm or less, or 3 mm or more. Especially when used as a so-called microneedle, the height of the projection CV is preferably 100 μm to 1.5 mm.
The tip of the protrusion CV may be sharp, not sharp, rounded, arrowhead-shaped, or bifurcated or trifurcated.
The shape of the protrusion CV may be a cone, a pyramid, a cylinder, a prism, or a combination thereof.

突起保有体CBは、図1(E)に示すように、可塑性材料PMから突起部CVのみが形成され、当該突起部CVが直接支持シートBSに支持されたものでもよいし、図1(F)に示すように、可塑性材料PMから突起部CVと土台FDとが形成され、当該土台FDが支持シートBSに埋め込まれた(浸透した)状態のものでもよいし、図1(G)に示すように、可塑性材料PMから突起部CVと土台FDとが形成され、支持シートBSに支持されていないものでもよい。 As shown in FIG. 1(E), the protrusion holding body CB may be formed by forming only the protrusions CV from the plastic material PM, and the protrusions CV may be directly supported by the support sheet BS. ), the protrusion CV and the base FD may be formed from the plastic material PM, and the base FD may be embedded (penetrated) in the support sheet BS, or as shown in FIG. 1(G). Thus, the projecting portion CV and the base FD may be formed from the plastic material PM and may not be supported by the support sheet BS.

前記実施形態における駆動機器は、回動モータ、直動モータ、リニアモータ、単軸ロボット、2軸または3軸以上の関節を備えた多関節ロボット等の電動機器、エアシリンダ、油圧シリンダ、ロッドレスシリンダおよびロータリシリンダ等のアクチュエータ等を採用することができる上、それらを直接的又は間接的に組み合せたものを採用することもできる。
前記実施形態において、押圧ローラや押圧ヘッド等の押圧手段や押圧部材といった被押圧物を押圧するものが採用されている場合、上記で例示したものに代えてまたは併用して、ローラ、丸棒、ブレード材、ブラシ状部材の他、大気やガス等の気体の吹き付けによるものを採用してもよいし、押圧するものをゴム、樹脂、スポンジ等の変形可能な部材で構成してもよいし、金属や樹脂等の変形しない部材で構成してもよいし、支持(保持)手段や支持(保持)部材等の被支持部材(被保持部材)を支持(保持)するものが採用されている場合、メカチャックやチャックシリンダ等の把持手段、クーロン力、接着剤(接着シート、接着テープ)、粘着剤(粘着シート、粘着テープ)、磁力、ベルヌーイ吸着、吸引吸着、駆動機器等で被支持部材を支持(保持)する構成を採用してもよい。
The drive device in the above embodiment includes a rotating motor, a linear motor, a linear motor, a single-axis robot, an electric device such as a multi-joint robot having two or more joints, an air cylinder, a hydraulic cylinder, and a rodless robot. Actuators such as cylinders and rotary cylinders can be used, and combinations thereof directly or indirectly can also be used.
In the above embodiment, when a pressing means such as a pressing roller or a pressing head or a pressing member for pressing an object to be pressed is employed, a roller, a round bar, In addition to a blade material and a brush-like member, a material that blows gas such as air or gas may be adopted, and the pressing material may be made of a deformable member such as rubber, resin, sponge, etc. It may be composed of a non-deformable member such as metal or resin, or a support (holding) means or support (holding) member that supports (holds) a member to be supported (member to be held) is adopted. , gripping means such as mechanical chucks and chuck cylinders, Coulomb force, adhesives (adhesive sheets, adhesive tapes), adhesives (adhesive sheets, adhesive tapes), magnetic force, Bernoulli adsorption, suction adsorption, drive equipment, etc. A configuration for supporting (holding) may be adopted.

EA…突起保有体の製造装置
20…材料支持手段
22…支持部材
22A…支持面
22B…凹部
30…押圧手段
80…浸出手段
90…減圧手段
BM…母材
CB…突起保有体
CV…突起部
PG…ポリエチレングリコール(浸出材料)
PM…可塑性材料
WT…水(浸出媒体)
EA...Protrusion holding body manufacturing apparatus 20...Material supporting means 22...Supporting member 22A...Support surface 22B...Recessed part 30...Pressing means 80...Exuding means 90...Decompressing means BM...Base material CB...Protrusion holding body CV...Protrusion part PG …polyethylene glycol (leaching material)
PM: plastic material WT: water (leaching medium)

本発明は、マイクロニードルの製造方法およびマイクロニードルの製造装置に関する(以下、本明細書ではマイクロニードルを「突起保有体」と称する。)The present invention relates to a microneedle manufacturing method and a microneedle manufacturing apparatus (hereinbelow, a microneedle is referred to as a "projection holder" in this specification) .

Claims (3)

突起部が形成された突起保有体の製造方法であって、
前記突起部に対応した凹部が形成された支持面を有する支持部材で、可塑性材料を含んだ母材を支持する材料支持工程と、
前記母材を前記支持面へ向かう方向に押圧して前記可塑性材料を前記凹部に充填させ、当該可塑性材料から前記突起部を形成して前記突起保有体を形成する押圧工程とを実施し、
前記押圧工程での押圧を減圧雰囲気で行う減圧工程を実施することを特徴とする突起保有体の製造方法。
A method for manufacturing a protrusion holder having a protrusion, comprising:
a material supporting step of supporting a base material containing a plastic material with a support member having a support surface on which recesses corresponding to the protrusions are formed;
a pressing step of pressing the base material in a direction toward the supporting surface to fill the recesses with the plastic material, and forming the protrusions from the plastic material to form the protrusion holders;
A method for manufacturing a protrusion holder, characterized in that a depressurizing step is performed in which the pressing in the pressing step is performed in a depressurized atmosphere.
前記可塑性材料は、浸出媒体に浸出する浸出材料を含有し、
前記押圧工程の後段で前記可塑性材料を前記浸出媒体に浸すことで、前記可塑性材料を多孔質体とする浸出工程を実施することを特徴とする請求項1に記載の突起保有体の製造方法。
the plastic material contains a leaching material that leaches into the leaching medium;
2. The method of manufacturing a protrusion holder according to claim 1, wherein the leaching step of making the plastic material porous is performed by immersing the plastic material in the leaching medium after the pressing step.
突起部が形成された突起保有体の製造装置であって、
前記突起部に対応した凹部が形成された支持面を有する支持部材で、可塑性材料を含んだ母材を支持する材料支持手段と、
前記母材を前記支持面へ向かう方向に押圧して前記可塑性材料を前記凹部に充填させ、当該可塑性材料から前記突起部を形成して前記突起保有体を形成する押圧手段とを備え、
前記押圧手段での押圧を減圧雰囲気で行う減圧手段を備えていることを特徴とする突起保有体の製造装置。
An apparatus for manufacturing a projection holder having projections formed thereon,
material support means for supporting a base material containing a plastic material with a support member having a support surface on which recesses corresponding to the protrusions are formed;
pressing means for pressing the base material in a direction toward the support surface to fill the recesses with the plastic material, and forming the protrusions from the plastic material to form the protrusion holders;
An apparatus for manufacturing a protrusion holding body, comprising depressurizing means for performing pressing by the pressing means in a depressurized atmosphere.
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JP2011078618A (en) * 2009-10-08 2011-04-21 Toray Eng Co Ltd Method for producing stamper for microneedle
JP2013111104A (en) * 2011-11-25 2013-06-10 Dainippon Printing Co Ltd Method for manufacturing microneedle device
JP2014501547A (en) * 2010-10-19 2014-01-23 トラスティーズ オブ タフツ カレッジ Silk fibroin-based microneedle and method for producing the same

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JP2008110494A (en) * 2006-10-27 2008-05-15 Mitsubishi Kagaku Media Co Ltd Method for producing member having uneven surface
JP2011078617A (en) * 2009-10-08 2011-04-21 Toray Eng Co Ltd Stamper for microneedle sheet, and manufacturing method for the same, and manufacturing method for microneedle using the same
JP2011078618A (en) * 2009-10-08 2011-04-21 Toray Eng Co Ltd Method for producing stamper for microneedle
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