JP2009045312A - Formation method and production method of needle-like body, and needle-like body - Google Patents

Formation method and production method of needle-like body, and needle-like body Download PDF

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JP2009045312A
JP2009045312A JP2007215669A JP2007215669A JP2009045312A JP 2009045312 A JP2009045312 A JP 2009045312A JP 2007215669 A JP2007215669 A JP 2007215669A JP 2007215669 A JP2007215669 A JP 2007215669A JP 2009045312 A JP2009045312 A JP 2009045312A
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JP5034777B2 (en
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Kazuhiko Shiomitsu
一彦 塩満
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Toppan Inc
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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
    • 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
    • A61M2037/0053—Methods for producing microneedles

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a production method of a fine needle-like body having an intended length and an acute distal end and controlling a side wall state in a simple process. <P>SOLUTION: This formation method of the needle-like body is provided with (1) a process for forming a working base plate consisting of at least two types of materials having qualities of different etching characteristics, (2) a process for uniformly working the working base plate into a needle shape to form a needle-like preparatory body, and (3) a process for selectively etching the needle-like preparatory body to form the needle-like body. This production method of the needle-like body is characterized in forming a duplicate plate using the needle-like body formed by the method as a matrix and executing a transcription molding using the duplicate plate. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

本発明は、微細な針状体の作製方法ならびに製造方法及びそれによる針状体に関するものである。   The present invention relates to a method for producing and manufacturing a fine needle-like body and a needle-like body thereby.

皮膚上から薬剤を浸透させ体内に薬剤を投与する方法である経皮吸収法は、人体に痛みを与えることなく簡便に薬剤を投与することが出来る方法として用いられているが、薬剤の種類によっては経皮吸収法で投与が困難な薬剤が存在する。これらの薬剤を効率よく体内に吸収させる方法として、ミクロンオーダーの微細な針状体（マイクロニードル）を用いて皮膚を穿孔し、皮膚内に直接薬剤を投与する方法が注目されている。この方法によれば、投薬用の特別な機器を用いることなく、簡便に薬剤を皮下投薬することが可能となる（特許文献１参照）。   The percutaneous absorption method, which is a method of infiltrating a drug from the skin and administering the drug into the body, is used as a method that can be easily administered without causing pain to the human body. There are drugs that are difficult to administer by transdermal absorption. As a method for efficiently absorbing these drugs into the body, a method of perforating the skin using micron-sized fine needles (microneedles) and administering the drug directly into the skin has attracted attention. According to this method, it is possible to easily administer a drug subcutaneously without using a special medication device (see Patent Document 1).

この際に用いるマイクロニードルの形状は、皮膚を穿孔するための十分な細さと先端角、および皮下に薬液を浸透させるための十分な長さを有していることが必要とされ、マイクロニードルの直径は数μｍから数百μｍ、マイクロニードル長さは皮膚の最外層である角質層を貫通し、かつ神経層へ到達しない長さ、具体的には数十μｍから数百μｍ程度のものであることが望ましいとされている。また、マイクロニードルを構成する材料としては、仮に破損したニードルが体内に残留した場合でも、人体に悪影響を及ぼさない材料であることが必要であり、この材料としては医療用シリコン樹脂や、マルトース、ポリ乳酸、デキストラン等の生体適合樹脂が有望視されている（特許文献２参照）。   The shape of the microneedle used at this time is required to have a sufficient fineness and tip angle for piercing the skin, and a sufficient length for allowing the drug solution to penetrate subcutaneously. The diameter is from several μm to several hundred μm, and the microneedle length penetrates through the stratum corneum, which is the outermost layer of the skin, and does not reach the nerve layer, specifically, several tens μm to several hundred μm. It is considered desirable. In addition, the material constituting the microneedle needs to be a material that does not adversely affect the human body even if a broken needle remains in the body, such as medical silicone resin, maltose, Biocompatible resins such as polylactic acid and dextran are considered promising (see Patent Document 2).

このような微細構造を低コストかつ大量に製造するためには、射出成型法、インプリント法、キャスティング法等に代表される転写成型法が有効であるが、いずれの方法においても成型を行うためには所望の形状を凹凸反転させた原型が必要であり、マイクロニードルのようなアスペクト比（構造体の幅に対する高さ、もしくは深さの比率）が高く、先端部の先鋭化が必要である構造体を形成するためには、その製造工程が非常に複雑となる。   In order to produce such a fine structure at a low cost and in large quantities, a transfer molding method represented by an injection molding method, an imprinting method, a casting method, etc. is effective. However, in any method, molding is performed. Requires an original with the desired shape reversed, and has a high aspect ratio (height or depth ratio to the width of the structure) like a microneedle, and requires sharpening of the tip. In order to form the structure, the manufacturing process becomes very complicated.

上述した構造体を形成する方法として、特許文献３および４では、シリコンの単結晶材料の結晶面方位ごとのエッチングレート差を利用した製造方法が提案されている。   As a method for forming the above-described structure, Patent Documents 3 and 4 propose a manufacturing method using a difference in etching rate for each crystal plane orientation of a silicon single crystal material.

また、直接生体適合材料を用いた作製方法として、特許文献５では、熱溶融を用い材料を引き伸ばす操作を２回行う事で、括れ部を設けた２種類の材質で構成された針状体の作製方法が提案されている。
米国特許第６，１８３，４３４号明細書 特開２００５−２１６７７号公報 特開２００２−７９４９９号公報 特開２００５−１９９３９２号公報 特開２００６−３４６１２７号公報 In addition, as a production method using a biocompatible material directly, in Patent Document 5, an operation of stretching a material by using heat melting is performed twice, so that a needle-like body composed of two kinds of materials provided with a constricted portion is obtained. A manufacturing method has been proposed.
US Pat. No. 6,183,434 Japanese Patent Laid-Open No. 2005-21677 JP 2002-79499 A JP 2005-199392 A JP 2006-346127 A

しかしながら、前記特許文献３および４で提案される従来の方法は、結晶面方位ごとのエッチングレート差を利用するものであり、針状体を製造するには高度に精製された単結晶材料を必要とし、針状体のテーパー角度、先端角度は単結晶材料の物性により規定される。また、高アスペクト比のニードル形状を得るために、高精度のアライメントを有するダイシング、マイクロニードル側壁保護膜の形成、多種の薬液処理等の多数の工程が必要となる。また、先端部の先鋭化には、異方性ウエットエッチングの厳密な時間制御が必要となり、各工程に高度な加工技術が必要となる。また、エッチングが進むことにより脱落したマスクが周辺を汚染するという問題が発生する。   However, the conventional methods proposed in Patent Documents 3 and 4 make use of the etching rate difference for each crystal plane orientation, and a highly purified single crystal material is required to produce needles. The taper angle and tip angle of the needle-like body are defined by the physical properties of the single crystal material. Moreover, in order to obtain a needle shape with a high aspect ratio, a number of steps such as dicing with high-precision alignment, formation of a microneedle sidewall protective film, and various types of chemical treatments are required. In addition, sharpening of the tip requires strict time control of anisotropic wet etching, and advanced processing techniques are required for each process. In addition, there is a problem that the mask that has fallen off as the etching progresses contaminates the periphery.

また、前記特許文献５で開示されている技術では、針状体を構成する材料を溶融させ、引き伸ばす事で針状体を作製でき、溶融材料を二種類使用することで、括れ部を持った、穿刺後に先端部が選択的に皮膚内に残留する構造を持った針状体を作製することができる。しかしながら、この方法では作製する材料は溶融可能なことが必須であり、針の高さ・形状等を変更するために、該当する材料の性質を変化させる必要がある。また、括れ部を設ける位置にも制限が存在する。   Further, in the technique disclosed in Patent Document 5, the needle-shaped body can be produced by melting and stretching the material constituting the needle-shaped body, and by using two types of molten materials, a constricted portion is provided. A needle-like body having a structure in which the tip portion selectively remains in the skin after puncturing can be produced. However, in this method, it is essential that the material to be produced can be melted, and in order to change the height and shape of the needle, it is necessary to change the properties of the corresponding material. There is also a restriction on the position where the constricted portion is provided.

そこで、本発明は、上述した問題を解決するためになされたものであり、簡便な工程で、所望の長さを有し、先端が先鋭であり、側壁状態を制御可能な針状体の製造方法を提供することを目的とする。   Therefore, the present invention has been made to solve the above-described problems, and is a simple process that produces a needle-like body having a desired length, a sharp tip, and a controllable side wall state. It aims to provide a method.

本発明の請求項１に係る発明は、微細な針状体の製造方法において、（１）少なくとも二種類のエッチング特性の異なる材質の材料で構成された加工基板を作成する工程と、（２）前記加工基板を、前記異なる材質の材料に対して、均等に針状に加工して針状準備体を作成する工程と、（３）前記針状準備体を、前記異なる材質の材料の一方に対して、選択的にエッチング加工して針状体を作成する工程と
を備えたことを特徴とする針状体の作製方法である。 The invention according to claim 1 of the present invention is the method for producing a fine needle-like body, in which (1) a step of creating a processed substrate made of materials of materials having different etching characteristics, and (2) A step of processing the processed substrate uniformly into a needle shape with respect to the material of the different material to create a needle-shaped preparation body; and (3) the needle-shaped preparation body as one of the materials of the different material. On the other hand, a method for producing a needle-like body comprising a step of selectively etching and creating a needle-like body.

また本発明の請求項２に係る発明は、前記エッチング特性の異なる材質の材料が、層状に構成された加工基板を用いて加工することを特徴とする、請求項1に記載の針状体の作製方法である。   The invention according to claim 2 of the present invention is the needle-shaped body according to claim 1, wherein the materials having different etching characteristics are processed by using a processing substrate having a layered structure. This is a manufacturing method.

また本発明の請求項３に係る発明は、前記エッチング特性の異なる材質の材料が、3種以上の材質で層状に構成された加工基板を用いて加工することを特徴とする、請求項２に記載の針状体の作製方法である。   Further, the invention according to claim 3 of the present invention is characterized in that the materials having different etching characteristics are processed using a processing substrate configured in layers with three or more kinds of materials. It is a manufacturing method of the acicular body of description.

また本発明の請求項４に係る発明は、請求項１〜３のいずれかに記載の針状体の作製方法で作製した針状体を母型とし、前記母型から複製版を作製し、前記複製版を用いて転写加工成形を行うことを特徴とする針状体の製造方法である。   The invention according to claim 4 of the present invention is a needle-shaped body produced by the method for producing a needle-shaped body according to any one of claims 1 to 3 as a matrix, and a duplicate plate is fabricated from the matrix. It is a method for producing a needle-like body, wherein transfer processing molding is performed using the duplicate plate.

また本発明の請求項５に係る発明は、請求項１〜３のいずれかに記載の針状体の作製方法、または、請求項４に記載の針状体の製造方法によって製造された針状体である。   Further, the invention according to claim 5 of the present invention is the needle shape manufactured by the method for manufacturing the needle-shaped body according to any one of claims 1 to 3 or the method for manufacturing the needle-shaped body according to claim 4. Is the body.

本発明の針状体の製造方法は、まず、エッチング特性の異なる少なくとも二種類の材質の材料で構成された加工基板を作成する。次に、この加工基板に対して、切削、エッチング等で均等に加工して針状準備体を作成する。その後、一方の材料を選択的にエッチング加工することで、針状体を作製することを特徴とする。すなわち、少なくとも二種類の材質の材料を含む加工基板を、例えば切削などで区別無く加工する。その後、一方の材料のみに働く、例えばウエットエッチングを行うことで、一方の材料のみが加工され、側壁の
一部が内側に凹み括れたような構造や、外側に凸な構造を持つ針状体を作製することが可能となる。 In the method for manufacturing a needle-like body of the present invention, first, a processed substrate made of at least two kinds of materials having different etching characteristics is created. Next, the processed substrate is uniformly processed by cutting, etching, or the like to create a needle-shaped preparation. Thereafter, one of the materials is selectively etched to produce a needle-like body. That is, a processed substrate containing at least two kinds of materials is processed without distinction, for example, by cutting. After that, it works only on one material, for example, wet etching is performed, so that only one material is processed and a part of the side wall is recessed inside, or a needle-like body having a convex structure on the outside Can be produced.

またこの時、エッチング時間を調整することで、形状の制御が可能となる。例えば長時間エッチングを行うことで、括れの程度が大きくなりより折れやすい形状にするといったことが簡便に行える。   At this time, the shape can be controlled by adjusting the etching time. For example, by performing etching for a long time, it is possible to easily form a shape that increases the degree of constriction and easily breaks.

またこの時、他方の材料を選択的にエッチングすることで、例えば一方のプロセスで凸型を作製でき、他方のプロセスでは凹型を作製するといったようなことが簡便に行える。   At this time, by selectively etching the other material, for example, a convex mold can be produced by one process, and a concave mold can be produced by the other process.

また本発明の針状体の他の作製方法は、３種以上の材質を層状に配置した基板を用いて、まず均等に針状に加工した後、それぞれの材質に選択的な加工を施すことで、返しと括れ両方を設けた、針の抜け落ちを防ぎかつ、所望の場所で折れるような針状体を作製することが可能となる。   Another method for producing the needle-shaped body according to the present invention is to first process the needles evenly using a substrate in which three or more kinds of materials are arranged in layers, and then selectively process each material. Thus, it is possible to produce a needle-like body that is provided with both a barb and a neck and prevents the needle from falling off and can be broken at a desired location.

また、針状体の先端部を構成している材料が、例えばドライエッチングに対応した材質であれば、等方的なドライエッチングを行う事で、複雑な側壁形状を持ち、かつ先端形状が鋭利な針状体を作製することが可能となる。   In addition, if the material constituting the tip of the needle-shaped body is a material that is compatible with dry etching, for example, isotropic dry etching has a complicated sidewall shape and the tip shape is sharp. It becomes possible to produce a needle-like body.

本発明の針状体の製造方法は、作製した針状体を母型とし、この母型から作製した複製型を用いて転写加工成形を行うことを特徴とする。これにより、様々な材料に製造された針状体の形状を転写することが出来る。このため、例えば、生体適合樹脂（医療用シリコン樹脂や、マルトース、ポリ乳酸、デキストラン等）に転写することで、生体に低負荷の材料を用いた針状体を製造することが可能となる。   The method for producing a needle-like body of the present invention is characterized in that the produced needle-like body is used as a mother die, and transfer processing molding is performed using a replica die produced from the mother die. Thereby, the shape of the needle-shaped body manufactured in various materials can be transferred. For this reason, for example, it becomes possible to manufacture a needle-like body using a material having a low load on a living body by transferring it to a biocompatible resin (medical silicone resin, maltose, polylactic acid, dextran, etc.).

以下、本発明の針状体の作製方法及び製造方法の一実施形態について、図面を用いて説明を行う。   Hereinafter, an embodiment of a method for producing and manufacturing a needle-like body of the present invention will be described with reference to the drawings.

まず、図１（ａ）に示すように、最終的に得るべき針状体を形成すべき箇所に対応した、複数の材質の材料１１，１２からなる加工基板１０１を作成する。   First, as shown in FIG. 1A, a processed substrate 101 made of a plurality of materials 11 and 12 corresponding to a portion where a needle-like body to be finally obtained is to be formed is formed.

このとき、加工基板の材料としては、加工性の異なる二種類以上の材質で構成され、切削、プラズマエッチングなどの広い意味でのエッチング法で加工可能なものであれば良く、加工法に適する材料を適宜選択することが出来る。例えば具体的には、シリコンを母材として酸化物層を挟んだもの、あるいはSiGeを挟んだものを用いても良い。   At this time, the material of the processed substrate may be any material that is composed of two or more kinds of materials having different processability and that can be processed by a wide range of etching methods such as cutting and plasma etching. Can be appropriately selected. For example, specifically, a material in which an oxide layer is sandwiched using silicon as a base material or a material in which SiGe is sandwiched may be used.

また、３種以上の材質の材料を用いても良い。図２（ａ）に示すように、３種の材質の材料２１，２２，２３を層状に組み合わせた加工基板２０１を使用しても良い。   Further, three or more kinds of materials may be used. As shown in FIG. 2A, a processed substrate 201 in which three types of materials 21, 22, and 23 are combined in layers may be used.

次に、複数種の材質の材料から構成される加工基板を、図１（ｂ）に示すように、均等に針状準備体に加工する。   Next, as shown in FIG.1 (b), the process board | substrate comprised from the material of a multiple types of material is processed into a needle-shaped preparation body equally.

加工する手段としては、複数種の材質の材料から構成される加工基板を均等に針状準備体に加工できればよく、テーパーブレードを用いた切削、ワイヤー加工、エッチングマスクを厚み方向に変化させたエッチング、サンドブラスト等を用いても良い。   As a means of processing, it is only necessary to uniformly process a processing substrate composed of a plurality of types of materials into a needle-like preparation, cutting using a taper blade, wire processing, etching by changing the etching mask in the thickness direction. Sand blasting or the like may be used.

次に、選択的な加工手段としては、特定の物質に選択的に働く方法であればよく、等方的なドライエッチング、ウエットエッチング等を用いても良い。   Next, as a selective processing means, any method that selectively works on a specific substance may be used, and isotropic dry etching, wet etching, or the like may be used.

このとき、図１（c）のように根元付近に括れを設けることで、穿刺時に折れやすい針状体１０４を作製することができる。   At this time, as shown in FIG. 1 (c), by providing a constriction near the base, the needle-like body 104 that is easily broken at the time of puncture can be produced.

また、選択的に加工するターゲットを変えることで凹凸を反転させる事が可能となる。このとき、図１（d）に示すように、根元近傍に凸部を設けることで、穿刺後に針が抜け落ちることを防止する、針の返しのような構造を持つ針状体１０５を作製することができる。   Further, it is possible to reverse the unevenness by changing the target to be selectively processed. At this time, as shown in FIG. 1 (d), a needle-like body 105 having a structure like a needle return that prevents the needle from falling off after puncture is provided by providing a protrusion near the root. Can do.

さらにまた、図２に示すように、３種以上の材質を組み合わせ、それぞれに選択的な加工を施す事で、例えば返しとくぼみを設けた、針の抜け落ちを防ぎかつ、所望の場所で折れるような針状体２０６を作製する事ができる。   Furthermore, as shown in FIG. 2, by combining three or more kinds of materials and performing selective processing on each of them, for example, a barb and a dent are provided to prevent the needle from falling off and to be folded at a desired place. A needle-like body 206 can be produced.

次に、図４を用いて針状体の転写加工成形について説明を行う。上述した作製方法により得られた針状体４０１を母型とし、鋳型層４０２を形成し、複製版４０３を形成する。   Next, needle-shaped transfer processing molding will be described with reference to FIG. The needle-like body 401 obtained by the above-described manufacturing method is used as a mother mold, the template layer 402 is formed, and the duplicate plate 403 is formed.

まず、針状体４０１が形成された面に、複製版４０３を形成するための鋳型層４０２を形成する（図４（ａ））。鋳型層４０２の材質については、特に制限されず、複製版として機能するだけの形状追従性、後述する転写加工成形における転写性、耐久性および離型性を考慮した材質を選択することが出来る。例えば、鋳型層４０２の材質としてニッケルを用いても良い。この場合、ニッケル膜の形成方法としては、メッキ法、ＰＶＤ法、ＣＶＤ法などが挙げられる。   First, a template layer 402 for forming the duplicate plate 403 is formed on the surface on which the needle-like body 401 is formed (FIG. 4A). The material of the mold layer 402 is not particularly limited, and a material can be selected in consideration of shape followability that functions as a duplicate plate, transferability in transfer processing molding described later, durability, and releasability. For example, nickel may be used as the material of the mold layer 402. In this case, examples of the method for forming the nickel film include a plating method, a PVD method, and a CVD method.

次に、図４（ｂ）に示すように、針状体４０１と鋳型層４０２を分離し、複製版４０３を得る。   Next, as shown in FIG. 4B, the needle-like body 401 and the template layer 402 are separated to obtain a duplicate plate 403.

針状体４０１と鋳型層４０２を分離する方法としては、物理的な剥離力による分離または選択性エッチング法を用いることが出来る。   As a method for separating the needle-like body 401 and the template layer 402, separation by a physical peeling force or a selective etching method can be used.

次に、図４（ｃ）に示すように、複製版４０３に針状体材料を充填する。針状体材料は特に制限されないが、生体適合性材料である医療用シリコン樹脂や、マルトース、ポリ乳酸、デキストラン等を用いることで、生体に適用可能な針状体を形成出来る。針状体材料の充填方法についての制限は無いが、生産性の観点から、インプリント法、ホットエンボス法、射出成形法、押し出し成形法およびキャスティング法を好適に用いることが出来る。   Next, as shown in FIG. 4C, the replica plate 403 is filled with the needle-shaped body material. The needle-shaped body material is not particularly limited, but a needle-shaped body applicable to a living body can be formed by using a medical silicone resin, maltose, polylactic acid, dextran, or the like which is a biocompatible material. Although there is no restriction | limiting about the filling method of needle-shaped body material, From a viewpoint of productivity, the imprint method, the hot embossing method, the injection molding method, the extrusion molding method, and the casting method can be used suitably.

次に、針状体材料を複製版４０３から離型し、図４（ｄ）に示すように、転写成形された針状体４０４を得る。   Next, the needle-shaped body material is released from the replica plate 403 to obtain a transfer-molded needle-shaped body 404 as shown in FIG.

このとき、複製版４０３の剥離性を向上させるために、針状体材料の充填前に、複製版４０３の表面上に離型効果を増すための離型層を形成してもよい（図示せず）。離型層としては、例えば広く知られているフッ素系の樹脂を用いることが出来る。また、離型層の形成方法としては、ＰＶＤ法、ＣＶＤ法、スピンコート法、ディップコート法等の薄膜形成手法を好適に用いることができる。   At this time, in order to improve the peelability of the duplicate plate 403, a release layer for increasing the mold release effect may be formed on the surface of the duplicate plate 403 before filling with the needle-shaped material (not shown). ) As the release layer, for example, a well-known fluorine-based resin can be used. Moreover, as a formation method of a mold release layer, thin film formation methods, such as PVD method, CVD method, a spin coat method, a dip coat method, can be used suitably.

以上より、針状体の転写加工成形を実施することが出来る。一体成形された機械的強度の高い複製版を作成することにより、同一の複製版で多量の針状体を製造することが出来るため、生産コストを低くし、生産性を高めることが可能となる。   From the above, transfer processing molding of the needle-like body can be performed. By producing a replica plate with high mechanical strength that is integrally molded, a large amount of needle-like bodies can be manufactured with the same replica plate, which makes it possible to reduce production costs and increase productivity. .

以下に、本発明の具体的実施例を説明する。   Hereinafter, specific examples of the present invention will be described.

＜実施例１＞
基底部近傍に括れを設けた、針状体の製造方法についての実施例を説明する。まず、基板として上部Ｓｉ厚さ１００μｍ、埋め込みＳｉＯ2層（Ｂｕｒｉｅｄ Ｏｘｉｄｅ）厚さ１０μｍのＳＯＩ（Ｓｉｌｉｃｏｎ ｏｎ Ｉｎｓｕｌａｔｏｒ）ウエハ（厚み：５２５μｍ）を用意した。 <Example 1>
An embodiment of a method for manufacturing a needle-like body provided with a constriction near the base will be described. First, an SOI (Silicon on Insulator) wafer (thickness: 525 μm) having an upper Si thickness of 100 μm and a buried SiO 2 layer (Buried Oxide) thickness of 10 μm was prepared as a substrate.

まず、先端を加工した研削刃による切削加工で、ＳＯＩ基材の表面に溝を形成した。その後、基板を平行移動させ前記溝のテーパー面に重なるように研削刃で溝を形成した。（図３（ｂ）、（ｃ））ここで先端を加工した研削刃による切削加工とは、厚みが１ｍｍの研削刃を用い、先端面が幅２００μｍとなり、研削刃側壁面と傾斜面とのなす角が１７０°となるような研削刃を使用した。傾斜面の傾斜角度は、最終的に形成される針状体の基底部の形状を決定する。図示しないが、最終的に形成される角錐形状の針状体先端角度を２０°とするために、本実施例における研削刃先端部の傾斜面の傾きは１７０°を選択した。   First, a groove was formed on the surface of the SOI base material by cutting with a grinding blade whose tip was processed. Thereafter, the substrate was moved in parallel, and grooves were formed with a grinding blade so as to overlap the tapered surface of the grooves. (FIG. 3 (b), (c)) Here, the cutting with the grinding blade with the tip processed is a grinding blade with a thickness of 1 mm, the tip surface has a width of 200 μm, and the grinding blade side wall surface and the inclined surface A grinding blade having an angle of 170 ° was used. The inclination angle of the inclined surface determines the shape of the base portion of the needle-like body that is finally formed. Although not shown in the drawings, the inclination of the inclined surface of the tip of the grinding blade in this example was selected to be 170 ° in order to set the tip end angle of the pyramidal needle to be finally formed to 20 °.

上記操作を複数回行う事で、三角断面形状を有する凸部を５本持つ基材を得た。（図３（ｄ））
次に、前記基材を９０°回転させ、同様の研削加工を行い、アレイ上に並んだ正四角錐、高さ２００μｍ、根元幅７１μｍの針状準備体を得た。（図示せず）
次に、針状準備体を含む前記加工基板を、バッファードフッ酸（４％ＨＦ／２０％ＮＨ4Ｆ）に１５分浸漬し、基板ＳｉＯ2層をエッチングしたところ、高さ２００μｍ、根元幅７１μｍ、基底部より１００μｍ上方に幅１０μｍ、内側に１０μｍ括れた部位を持つ、図１（ｃ）に示すような形状を得た。 By performing the above operation a plurality of times, a base material having five convex portions having a triangular cross-sectional shape was obtained. (Fig. 3 (d))
Next, the substrate was rotated by 90 °, and the same grinding process was performed to obtain a needle-shaped preparation having a regular quadrangular pyramid, a height of 200 μm, and a root width of 71 μm arranged on the array. (Not shown)
Next, when the processed substrate including the needle-shaped preparation was immersed in buffered hydrofluoric acid (4% HF / 20% NH 4 F) for 15 minutes and the substrate SiO 2 layer was etched, the height was 200 μm and the base width was A shape as shown in FIG. 1C was obtained, having a portion of 71 μm, a width of 10 μm above the base and a width of 10 μm and an inner side of 10 μm.

＜実施例２＞
転写加工成形による針状体の製造法の実施例について説明する。上述した実施例１で作製された針状体に、蒸着法により膜厚３００ｎｍのニッケル層を形成し、このニッケル層をシード層としてメッキ法によりニッケルを１ｍｍ形成した。次に、濃度２５ｗｔ％、液温９０℃の水酸化カリウム水溶液を用いてシリコン基板を溶解させ、ニッケルからなる複製版を作製した。 <Example 2>
An embodiment of a method for producing a needle-like body by transfer processing molding will be described. A nickel layer having a thickness of 300 nm was formed on the needle-shaped body manufactured in Example 1 described above by vapor deposition, and 1 mm of nickel was formed by plating using this nickel layer as a seed layer. Next, a silicon substrate was dissolved using a potassium hydroxide aqueous solution having a concentration of 25 wt% and a liquid temperature of 90 ° C. to produce a replica plate made of nickel.

この複製版を用いマルトース、デキストラン、ポリ乳酸を材料としてインプリント法により転写成型したところ、それぞれ原版と同形状の針状体が形成されていることを確認した。   When this duplicate plate was used for transfer molding by the imprint method using maltose, dextran, and polylactic acid as materials, it was confirmed that needles having the same shape as the original plate were formed.

本発明の針状体の製造方法は、医療のみならず、微細な針状体を必要とする様々な分野に適用可能であり、例えばＭＥＭＳデバイス、創薬、化粧品などに用いる微細な針状体の製造方法としても有用である。   The method for producing a needle-shaped body according to the present invention can be applied not only to medical treatment but also to various fields that require a fine needle-shaped body. For example, a fine needle-shaped body used for MEMS devices, drug discovery, cosmetics, and the like. It is also useful as a production method.

本発明の針状体の作製方法の一実施形態を断面でしめす概略図である。It is the schematic which shows one Embodiment of the production method of the acicular body of this invention in a cross section. 本発明における針状体の作製方法の他の実施形態を断面でしめす概略図である。It is the schematic which shows other embodiment of the production method of the acicular body in this invention in a cross section. 実施例１での溝加工を説明する概略図である。FIG. 3 is a schematic diagram illustrating groove processing in Example 1. 本発明における転写加工成形を用いた針状体の製造方法を説明する概略断面図である。It is a schematic sectional drawing explaining the manufacturing method of the acicular body using the transfer process shaping | molding in this invention.

符号の説明Explanation of symbols

１１，１２・・・（材質の異なる）材料
２１、２２、２３・・・（材質の異なる）材料
３１，３２・・・（材質の異なる）材料
１０１、２０１、３０１・・・・・加工基板
１０３、２０４、３０４・・・針状準備体
１０４・・・凹部を設けた針状体 １０５、２０５・・・・・凸部を設けた針状体
２０６・・・・・凹部と凸部を設けた針状体
３０３・・・・・ダイシングソー
４０１・・・針状体（母型） ４０２・・・鋳型層 ４０３・・・複製版 ４０４・・・針状体 11, 12 ... (different materials) materials 21, 22, 23 ... (different materials) materials 31, 32 ... (different materials) materials 101, 201, 301 ... processed substrates 103, 204, 304 ... acicular preparation 104 ... acicular body provided with recesses 105, 205 ... acicular body 206 provided with projections ... Needle-shaped body 303... Dicing saw 401... Needle-shaped body (matrix) 402... Mold layer 403.

Claims (5)

微細な針状体の製造方法において、
（１）少なくとも二種類のエッチング特性の異なる材質の材料で構成された加工基板を作
成する工程と
（２）前記加工基板を、前記異なる材質の材料に対して、均等に針状に加工して針状準備
体を作成する工程と
（３）前記針状準備体を、前記異なる材質の材料の一方に対して、選択的にエッチング加
工して針状体を作成する工程と
を備えたことを特徴とする針状体の作製方法。 In the method for producing fine needles,
(1) a step of creating a processed substrate composed of at least two kinds of materials having different etching characteristics; and (2) processing the processed substrate equally into needles with respect to the different materials. A step of creating a needle-shaped preparation, and (3) a step of selectively etching the needle-shaped preparation with respect to one of the different materials to create a needle-shaped body. A method for producing a needle-like body. 前記エッチング特性の異なる材質の材料が、層状に構成されたことを特徴とする、請求項1に記載の針状体の作製方法。   2. The method for producing a needle-like body according to claim 1, wherein the materials having different etching characteristics are configured in a layered manner. 前記エッチング特性の異なる材質の材料が、3種以上の材質で層状に構成された加工基板を用いて加工することを特徴とする、請求項２に記載の針状体の作製方法。   3. The method for producing a needle-like body according to claim 2, wherein the materials having different etching characteristics are processed using a processing substrate configured in a layer form with three or more kinds of materials. 請求項１〜３のいずれかに記載の針状体の作製方法で作製した針状体を母型とし、前記母型から複製版を作製し、前記複製版を用いて転写加工成形を行うことを特徴とする針状体の製造方法。   A needle-shaped body produced by the method for producing a needle-shaped body according to any one of claims 1 to 3 is used as a mother die, a duplicate plate is produced from the mother die, and transfer processing molding is performed using the duplicate plate. A method for producing a needle-like body characterized by the above. 請求項１〜３のいずれかに記載の針状体の作製方法、または、請求項４に記載の針状体の製造方法によって製造された針状体。   The acicular body manufactured by the manufacturing method of the acicular body in any one of Claims 1-3, or the manufacturing method of the acicular body of Claim 4.
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WO2004078668A1 (en) * 2003-03-03 2004-09-16 Nippon Sheet Glass Company, Limited Method of manufacturing article with recess and protrusion
JP2005246595A (en) * 2004-03-05 2005-09-15 Ritsumeikan Microneedle array and method of producing the same

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WO2004078668A1 (en) * 2003-03-03 2004-09-16 Nippon Sheet Glass Company, Limited Method of manufacturing article with recess and protrusion
JP2005246595A (en) * 2004-03-05 2005-09-15 Ritsumeikan Microneedle array and method of producing the same

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107405477A (en) * 2015-03-18 2017-11-28 凸版印刷株式会社 The manufacture method of Agent Administration device and Agent Administration device

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