JP2006334991A - Method for injection molding fine needle - Google Patents
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- JP2006334991A JP2006334991A JP2005164334A JP2005164334A JP2006334991A JP 2006334991 A JP2006334991 A JP 2006334991A JP 2005164334 A JP2005164334 A JP 2005164334A JP 2005164334 A JP2005164334 A JP 2005164334A JP 2006334991 A JP2006334991 A JP 2006334991A
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Abstract
Description
本発明は、少なくとも１つの突起部を有する微細針を射出成形する方法に関する。 The present invention relates to a method for injection molding a fine needle having at least one protrusion.
昨今のマイクロマシン技術のめざましい発展により、特許文献１に記載されているように、マイクロマシン技術を用いてシリコン基板上に任意の形状を有する微細針の鋳型を形成することができるようになった。そして、こうした鋳型に任意の樹脂材料を充填することにより、任意の形状および寸法を有する微細針を製造することが可能となった。 With recent remarkable development of micromachine technology, as described in Patent Document 1, a microneedle mold having an arbitrary shape can be formed on a silicon substrate using micromachine technology. And it became possible to manufacture the fine needle | hook which has arbitrary shapes and dimensions by filling arbitrary resin materials in such a casting_mold | template.
しかし一般的な熱可塑性樹脂材料（ポリプロピレン（ＰＰ）、ポリスチレン（ＰＳ）、ポリアミド（ＰＡ）、ポリエチレンテレフタレート（ＰＥＴ）、ポリエステル（ＰＥ）、ポリテトラフロロエチレン（ＰＴＦＥ）など）を用いた従来式の成形プロセスによれば、数μｍオーダの樹脂バリが発生することは不可避であって、本明細書の文脈における微細針の太さが１０２μｍオーダでることを考えれば、微細針を製造するために従来式の成形プロセスを採用することはできない。すなわち、通常サイズの製品で許容される樹脂バリが微細針においては致命的欠陥となり得る。 However, conventional thermoplastic resin materials (polypropylene (PP), polystyrene (PS), polyamide (PA), polyethylene terephthalate (PET), polyester (PE), polytetrafluoroethylene (PTFE), etc.) are used. According to the molding process, the number [mu] m order of resin burrs an unavoidable, given that the thickness of the microneedles in the context of this specification out 10 2 [mu] m order, for the manufacture of a microneedle The conventional molding process cannot be adopted. In other words, resin burrs that are allowed in normal-size products can be fatal defects in fine needles.
また微細針は、突起部などの複雑な外形形状を有し、その外形形状に固有の効果が期待されるのであるから、樹脂材料を鋳型の先端まで十分に（隅々まで）充填して、微細針の外形形状が完全に再現されなければ、微細針としての本来の効果を発揮し得ない。 In addition, the fine needle has a complicated outer shape such as a protrusion, and since an effect specific to the outer shape is expected, the resin material is sufficiently filled (to every corner) to the tip of the mold, If the external shape of the fine needle is not completely reproduced, the original effect as a fine needle cannot be exhibited.
さらに、微細針を鋳型から離型する際、体積力に比べて表面力の影響が大きくなるため、微細針と鋳型との間で表面固着力の影響を受けて、微細針を鋳型から離型することが困難となる。 Furthermore, when the fine needle is released from the mold, the influence of the surface force is larger than the volume force. Therefore, the fine needle is released from the mold due to the influence of the surface fixing force between the fine needle and the mold. Difficult to do.
これらの問題点を解決するためには、微細針の強度（曲げ強度、引っ張り強度）が離型時の固着力以上である必要があり、すなわち微細針を太く、または短くする必要があるが、微細針の寸法に対する要請とは相反することとなってしまう。したがって、寸法を変更することなく、強度が改善された微細針を開発・提供することに対する要求は高い。 In order to solve these problems, the strength of the fine needle (bending strength, tensile strength) needs to be equal to or greater than the fixing force at the time of mold release, that is, the fine needle needs to be thicker or shorter, This contradicts the requirements for the dimensions of the fine needles. Therefore, there is a high demand for developing and providing fine needles with improved strength without changing dimensions.
これに対し、ステンレスやセラミックス製に匹敵するほどの初期強度を有する生分解性ポリマ製の円柱状の骨治療用具、および押出成形によるその製造方法が特許文献２に提案されている。 On the other hand, Patent Document 2 proposes a cylindrical bone treatment tool made of a biodegradable polymer having an initial strength comparable to that of stainless steel or ceramics, and a method for producing the same by extrusion molding.
しかしながら、特許文献２に記載の押出成形によれば、成形物の外形形状はダイス２の出力断面により決定され、ダイス２の出力断面が、例えば円断面であれば、成形物は円柱状に成形される。すなわち、特許文献２に記載の製造方法によれば、突起部を有するような任意の複雑な外形形状を有する微細針を成形することはできない。 However, according to the extrusion molding described in Patent Document 2, the outer shape of the molded product is determined by the output cross section of the die 2, and if the output cross section of the die 2 is, for example, a circular cross section, the molded product is molded into a cylindrical shape. Is done. That is, according to the manufacturing method described in Patent Document 2, it is not possible to mold a fine needle having any complicated outer shape having a protrusion.
そこで本発明の１つの態様は、このような問題を解決しようとするためになされたもので、少なくとも１つの突起部を有する微細針の射出成形方法を提供し、とりわけ樹脂バリが形成されることなく、離型しやすく、その複雑な外形形状を厳密に再現できる射出成形方法を提供することを目的とする。 Accordingly, one aspect of the present invention has been made in order to solve such problems, and provides an injection molding method of a fine needle having at least one protrusion, and in particular, a resin burr is formed. An object of the present invention is to provide an injection molding method that can be easily released and can accurately reproduce its complicated outer shape.
本発明に係る１つの態様によれば、少なくとも１つの突起部を有する微細針の射出成形方法が提供され、この射出成形方法は、微細針を構成する樹脂材料の温度をガラス転移温度以上、融点以下に維持するステップと、１００ＭＰａ以上の射出圧で樹脂材料を気密封止された鋳型に射出するステップとを有することを特徴とする。 According to one aspect of the present invention, there is provided an injection molding method of a fine needle having at least one protrusion, and the injection molding method has a temperature of a resin material constituting the fine needle equal to or higher than a glass transition temperature and a melting point. And a step of injecting a resin material into an airtightly sealed mold at an injection pressure of 100 MPa or more.
また、射出ステップは、１ｋＰａ以下の真空雰囲気中で行われることが好ましい。 The injection step is preferably performed in a vacuum atmosphere of 1 kPa or less.
さらに、樹脂材料は、生分解性材料であることが好ましい。 Furthermore, the resin material is preferably a biodegradable material.
本発明に係る１つの態様による微細針の射出成形方法によれば、樹脂バリが形成されず、微細針を離型しやすく、その複雑な外形形状を忠実に再現することができる。 According to the injection molding method for fine needles according to one aspect of the present invention, resin burrs are not formed, the fine needles can be easily released, and the complicated outer shape can be faithfully reproduced.
図１〜図５を参照しながら、本発明に係る微細針の射出成形方法について以下説明する。
本発明に係る射出成形方法で成形された微細針１は、概略、図１（ａ）〜（ｃ）に示すように、ホルダ部２とニードル部３を有する。ニードル部３は、これに限定されないが、例えば、ピラミッド状の外形形状（ギザギザ形状）を有する１つまたはそれ以上の突起部を有する。この微細針１は任意の適当な支持装置（図示せず）を用いて、ホルダ部２を支持した上で、ニードル部３を患者の皮膚などに突き刺すことにより、患者の血液を採取する。なお、この微細針１は、任意の樹脂材料で形成することができるが、好適には、生適合性材料またポリ乳酸などの生分解性材料で構成される。
The method for injection molding of fine needles according to the present invention will be described below with reference to FIGS.
The fine needle 1 molded by the injection molding method according to the present invention generally has a holder portion 2 and a needle portion 3 as shown in FIGS. Although not limited to this, the needle part 3 has, for example, one or more protrusions having a pyramidal outer shape (a jagged shape). The microneedle 1 collects the blood of the patient by supporting the holder portion 2 using any appropriate support device (not shown) and then piercing the needle portion 3 into the patient's skin or the like. The fine needle 1 can be made of any resin material, but is preferably made of a biocompatible material or a biodegradable material such as polylactic acid.
また、本発明に係る射出成形方法で用いられる微細針１の鋳型４は、図２に示すように、エッチングプロセスを用いてシリコン基板５上に形成されたキャビティ（凹部）６を有している。このキャビティ６は、微細針１のニードル部３のギザギザ形状と相補関係にある複雑な形状を有しており、微細針１のニードル部３およびこれに対応するシリコン基板５上のキャビティ６を図３および図４に示す。 Further, the mold 4 of the fine needle 1 used in the injection molding method according to the present invention has a cavity (concave portion) 6 formed on the silicon substrate 5 by using an etching process, as shown in FIG. . The cavity 6 has a complicated shape that is complementary to the jagged shape of the needle portion 3 of the fine needle 1, and the cavity 6 on the silicon substrate 5 corresponding to the needle portion 3 of the fine needle 1 is illustrated in FIG. 3 and FIG.
ここで図５を参照しながら、本発明に係る実施形態による微細針の射出成形機について以下説明する。
本発明の射出成形機１０は、概略、キャビティ６を含む鋳型４と、鋳型４を収容するための収容部１１を有する下型（下金型）１２と、キャビティ６内に樹脂材料を搬送・注入するためのランナ部１３および射出口１５を有する上型（上金型）１４と、ランナ部１３内の樹脂材料を加圧するプランジャ１６とを備える。また射出成形機１０は、下型１２を支持するための下型取り付けガイド板１８と、上型１４および下型１２の温度を調整・制御するための上型温調板２０および下型温調板２２と、上側および下側断熱板２４，２６を介して上型温調板２０および下型温調板２２を支持する上型板２８および下型板３０とを有する。上型温調板２０および下型温調板２２は、上型１４および下型１２を加熱するための電気抵抗式ヒータと、冷却するための水冷（または空冷）冷却器と、ヒータおよび冷却器を自動的に制御するコンピュータ（図示せず）とを有する。なお、上型温調板２０、上側断熱板２４および上型板２８には、プランジャ１６の上方に開口部が設けられている。
A fine needle injection molding machine according to an embodiment of the present invention will be described below with reference to FIG.
The injection molding machine 10 of the present invention generally includes a mold 4 including a cavity 6, a lower mold (lower mold) 12 having a housing portion 11 for housing the mold 4, and a resin material in the cavity 6. An upper mold (upper mold) 14 having a runner portion 13 and an injection port 15 for injecting, and a plunger 16 that pressurizes the resin material in the runner portion 13 are provided. The injection molding machine 10 also includes a lower mold mounting guide plate 18 for supporting the lower mold 12, and an upper mold temperature control plate 20 and a lower mold temperature control for adjusting and controlling the temperatures of the upper mold 14 and the lower mold 12. It has the board 22, and the upper mold | type board 28 and the lower mold | type board 30 which support the upper mold | type temperature control board 20 and the lower mold | type temperature control board 22 via the upper and lower heat insulation boards 24 and 26. FIG. The upper mold temperature control plate 20 and the lower mold temperature control plate 22 are an electric resistance heater for heating the upper mold 14 and the lower mold 12, a water-cooled (or air-cooled) cooler for cooling, a heater and a cooler. And a computer (not shown) for automatically controlling. The upper mold temperature adjusting plate 20, the upper heat insulating plate 24 and the upper mold plate 28 are provided with openings above the plunger 16.
さらに、射出成形機１０は、図示しない第１および第２の油圧機構を有し、第１の油圧機構は、上型板２８と下型板３０を垂直方向に型締力Ｆで型締めし、第２の油圧機構は、ランナ部１３内の樹脂材料が射出圧Ｐまで加圧されるように、上型温調板２０、上側断熱板２４および上型板２８の開口部を介して、プランジャ１６を下方へ押圧する。 Further, the injection molding machine 10 has first and second hydraulic mechanisms (not shown). The first hydraulic mechanism clamps the upper mold plate 28 and the lower mold plate 30 in the vertical direction with a mold clamping force F. The second hydraulic mechanism is configured so that the resin material in the runner 13 is pressurized to the injection pressure P through the openings of the upper mold temperature adjusting plate 20, the upper heat insulating plate 24, and the upper mold plate 28. The plunger 16 is pressed downward.
この射出成形機１０は、図５の破線で概略的に図示したように、真空容器３２内に配設され、１ｋＰａ以下、好適には数１００Ｐａ、さらに好適には数１０Ｐａ）の真空状態を実現することができる。 This injection molding machine 10 is disposed in a vacuum vessel 32 as schematically shown by the broken line in FIG. 5 and realizes a vacuum state of 1 kPa or less, preferably several hundreds Pa, more preferably several tens Pa). can do.
次に、本発明の射出成形機１０による動作について説明する。ただし、理解しやすくするために、本発明の微細針１がポリ乳酸で構成される場合について説明するが、微細針１を構成する樹脂材料により本発明は限定されるものではない。 Next, operation | movement by the injection molding machine 10 of this invention is demonstrated. However, for ease of understanding, the case where the fine needle 1 of the present invention is made of polylactic acid will be described, but the present invention is not limited by the resin material constituting the fine needle 1.
まず、鋳型４を下型１２の収容部１１に収容し、図示しない固定手段で固定する。択一的には、鋳型４を収容部１１と同一形状を有するように加工することにより、鋳型４を収容部１１内に固定してもよい。 First, the mold 4 is accommodated in the accommodating portion 11 of the lower mold 12 and fixed by a fixing means (not shown). Alternatively, the mold 4 may be fixed in the housing part 11 by processing the mold 4 to have the same shape as the housing part 11.
そして、下型１２に上型１４を重ね合わせ、第１の油圧機構を用いて型締圧力Ｆ（例えば、１．５６ｋＮ）で上型１４および下型１２を型締めする。このとき、鋳型４と上型１４の間のキャビティ６が実質的に気密封止され、上型１４の射出口１５は、鋳型４のキャビティ６に対向している。 Then, the upper die 14 is overlaid on the lower die 12, and the upper die 14 and the lower die 12 are clamped with a clamping pressure F (for example, 1.56 kN) using the first hydraulic mechanism. At this time, the cavity 6 between the mold 4 and the upper mold 14 is substantially hermetically sealed, and the injection port 15 of the upper mold 14 faces the cavity 6 of the mold 4.
さらに、上型温調板２０および下型温調板２２を用いて、上型１４および下型１２の温度を樹脂材料（ポリ乳酸）の溶融温度ＴＦ（約１７２℃）より小さく、ガラス転移温度Ｔｇ（約７０℃）より高い温度（例えば、約１６０℃）に設定し、成形プロセス中、一定となるように制御する。 Furthermore, using the upper mold temperature control plate 20 and the lower mold temperature control plate 22, the temperature of the upper mold 14 and the lower mold 12 is smaller than the melting temperature T F (about 172 ° C.) of the resin material (polylactic acid), and the glass transition It is set to a temperature (for example, about 160 ° C.) higher than the temperature T g (about 70 ° C.) and controlled to be constant during the molding process.
ここで、ポリ乳酸ペレット３４（以下、単に「ペレット」という。）を上型１４のランナ部１３に搬送して、高温の上型１４で加熱することにより、ペレット３４（樹脂材料）を低流動性および高粘性を有するような固体状態に維持する。 Here, the polylactic acid pellets 34 (hereinafter simply referred to as “pellets”) are conveyed to the runner portion 13 of the upper die 14 and heated by the upper die 14 at a high temperature, whereby the pellets 34 (resin material) are flowed low. To maintain a solid state with high viscosity and high viscosity.
最後に、加熱された低流動性ペレット３４を極めて高い射出圧Ｐ（約１００ＭＰａ〜約７００ＭＰａ、好適には３９０Ｍｐａ）でキャビティ６内に射出して、成形物としての微細針１を得る。 Finally, the heated low-flow pellets 34 are injected into the cavity 6 at an extremely high injection pressure P (about 100 MPa to about 700 MPa, preferably 390 MPa) to obtain the fine needle 1 as a molded product.
このように、ペレット３４は溶融温度ＴＦより低い温度で維持されているので、射出された成形物の密度を増大させることにより、材料の強度（ヤング率）を向上させるとともに、離型時に加わる力に十分耐え得る頑健な微細針１を成形することができる。その結果、信頼性が高く、歩留まりの高い微細針１の射出成形方法を実現することができる。
また、上型１４および下型１６は非常に大きい型締圧力Ｆで互いに押圧され、射出されたペレット３４が高い粘性を有するため、上型１４と鋳型４の間に生じ得る樹脂バリを実質的に抑制または解消することができる。
さらに、射出成形機１０全体を真空状態に維持して、ペレット３４を射出するので、キャビティ６内に存在していた空気によるボイドを回避し、微細針１の適正な外形形状を忠実に再現することができる。
加えて、気密封止された鋳型４（キャビティ６）内に樹脂材料を射出するので、キャビティ６の形状を任意に変えることにより、任意の外形形状を有する微細針１を得ることができる。
Thus, since the pellet 34 is maintained at a temperature lower than the melting temperature TF , the density of the injected molded product is increased, thereby improving the strength (Young's modulus) of the material and adding it at the time of mold release. A robust fine needle 1 that can sufficiently withstand force can be formed. As a result, it is possible to realize an injection molding method of the fine needle 1 with high reliability and high yield.
Further, the upper mold 14 and the lower mold 16 are pressed against each other with a very large mold clamping pressure F, and the injected pellets 34 have a high viscosity, so that there is substantially no resin burr that can occur between the upper mold 14 and the mold 4. Can be suppressed or eliminated.
Further, since the pellet 34 is injected while maintaining the entire injection molding machine 10 in a vacuum state, voids due to air existing in the cavity 6 are avoided, and the appropriate outer shape of the fine needle 1 is faithfully reproduced. be able to.
In addition, since the resin material is injected into the hermetically sealed mold 4 (cavity 6), the microneedle 1 having an arbitrary outer shape can be obtained by arbitrarily changing the shape of the cavity 6.
１ 微細針、２ ホルダ部、３ ニードル部、４ 突起部、５ シリコン基板、６ キャビティ（凹部）１０ 射出成形機、１１ 収容部、１２ 下型（下金型）、１３ ランナ部、１４ 上型（上金型）、１５ 射出口、１６ プランジャ、１８ 取り付けガイド板、２０ 上型温調板、２２ 下型温調板、２４ 上側断熱板、２６ 下側断熱板、２８ 上型板、３０ 下型板、３２ 真空容器、３４ ペレット（樹脂材料）。
DESCRIPTION OF SYMBOLS 1 Fine needle, 2 Holder part, 3 Needle part, 4 Protrusion part, 5 Silicon substrate, 6 Cavity (recessed part) 10 Injection molding machine, 11 Storage part, 12 Lower mold (lower mold), 13 Runner part, 14 Upper mold (Upper die), 15 injection port, 16 plunger, 18 mounting guide plate, 20 upper mold temperature control plate, 22 lower mold temperature control plate, 24 upper heat insulation plate, 26 lower heat insulation plate, 28 upper mold plate, 30 lower Template, 32 vacuum vessel, 34 pellets (resin material).
Claims (3)
微細針を構成する樹脂材料の温度をガラス転移温度以上、融点以下に維持するステップと、
１００ＭＰａ以上の射出圧で樹脂材料を気密封止された鋳型に射出するステップとを有することを特徴とする射出成形方法。 A method for injection molding a fine needle having at least one protrusion,
Maintaining the temperature of the resin material constituting the fine needle above the glass transition temperature and below the melting point;
And a step of injecting a resin material into a hermetically sealed mold at an injection pressure of 100 MPa or more.
The injection molding method according to claim 1, wherein the resin material is a biodegradable material.
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| KR101811513B1 (en) | 2015-11-25 | 2017-12-20 | 주식회사 파이안에스테틱스 | Micro spicule, Mold for Producing the Same and Method for Producing the Same |
| JP2019048096A (en) * | 2012-12-18 | 2019-03-28 | アルキオーネ・ライフサイエンシズ・インコーポレイテッドＡｌｃｙｏｎｅ Ｌｉｆｅｓｃｉｅｎｃｅｓ， Ｉｎｃ． | System and method for reducing or suppressing backflow in transmission system |
| CN113183399A (en) * | 2021-04-01 | 2021-07-30 | 深圳市泰兴源科技有限公司 | Bent pipe forming die |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JP2019048096A (en) * | 2012-12-18 | 2019-03-28 | アルキオーネ・ライフサイエンシズ・インコーポレイテッドＡｌｃｙｏｎｅ Ｌｉｆｅｓｃｉｅｎｃｅｓ， Ｉｎｃ． | System and method for reducing or suppressing backflow in transmission system |
| US11260201B2 (en) | 2012-12-18 | 2022-03-01 | Alcyone Lifesciences, Inc. | Systems and methods for reducing or preventing backflow in a delivery system |
| KR101811513B1 (en) | 2015-11-25 | 2017-12-20 | 주식회사 파이안에스테틱스 | Micro spicule, Mold for Producing the Same and Method for Producing the Same |
| CN113183399A (en) * | 2021-04-01 | 2021-07-30 | 深圳市泰兴源科技有限公司 | Bent pipe forming die |
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