JP2005087519A - Liquid medicine injector - Google Patents

Liquid medicine injector Download PDF

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JP2005087519A
JP2005087519A JP2003326021A JP2003326021A JP2005087519A JP 2005087519 A JP2005087519 A JP 2005087519A JP 2003326021 A JP2003326021 A JP 2003326021A JP 2003326021 A JP2003326021 A JP 2003326021A JP 2005087519 A JP2005087519 A JP 2005087519A
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skin
concave portion
container
needle
wing
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JP4409239B2 (en
JP2005087519A5 (en
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Takeo Ishii
竹夫 石井
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Terumo Corp
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Terumo Corp
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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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

<P>PROBLEM TO BE SOLVED: To provide a liquid medicine injector puncturing a needle into the skin while reducing a pain, surely preventing the needle from coming off from the skin, and percutaneously injecting a sufficient amount of the liquid medicine into the skin. <P>SOLUTION: This liquid medicine injector 1 is provided with a container 11, a retainer body 12 having a recessed part 121 opened to the tip side and retaining the container 11, a plurality of hollow needles 20 communicated with the container 11, penetrating through the retainer body 12 and projecting outward from the inside bottom 123 of the recessed part 121, a pushing element 13 providing a driving force for percutaneously injecting the liquid medicine in the container 11 into the skin via the needle 20, a suction port 125 sucking the air in the recessed part 121 for mutually approachingly moving the inside bottom 123 of the recessed part 121 and the skin to contact them with each other, and an adhesive layer 30 formed on the end face of the retainer body 12 being contactable with the skin and containing an adhesive. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

本発明は、薬液注入装置に関し、より詳しくは、薬液を、人または動物の皮膚表面より、針を介して経皮的に皮内へ注入するための薬液注入装置に関する。   The present invention relates to a chemical solution injection device, and more particularly, to a chemical solution injection device for transdermally injecting a chemical solution from the surface of a human or animal skin through a needle.

近年、バイオテクノロジーの進歩により、インスリン、成長ホルモン、インターフェロン、カルシトニン等に代表される高分子量医薬品の生産量が増大している。これらは蛋白製剤であるため、従来の医薬品のように内服すると消化管内で多くが分解されてしまう。したがって、高分子量医薬品の薬効量を得るためには、消化管内での分解を回避する必要がある。このため、高分子量医薬品を投与する場合には、非経口投与である皮下注射や筋肉注射に頼らざるを得ない。しかし、注射に対する患者の恐怖感は根強いものがあり、注射時の針の穿刺による痛みを軽減する手段が強く要望されている。特に、糖尿病患者のように毎日繰り返しインスリンを投与する必要がある者にとっては、この注射時の針の穿刺による痛みは切実な問題である。   In recent years, production of high molecular weight pharmaceuticals represented by insulin, growth hormone, interferon, calcitonin and the like has increased due to advances in biotechnology. Since these are protein preparations, many of them are decomposed in the gastrointestinal tract when they are taken like conventional pharmaceuticals. Therefore, it is necessary to avoid degradation in the gastrointestinal tract in order to obtain an effective amount of a high molecular weight pharmaceutical product. For this reason, when administering a high molecular weight pharmaceutical, it is necessary to rely on subcutaneous injection or intramuscular injection which is parenteral administration. However, the patient's fear of injection is persistent, and there is a strong demand for means for reducing pain caused by needle puncture at the time of injection. Especially for those who need to repeatedly administer insulin every day, such as diabetic patients, the pain caused by needle puncture at the time of injection is a serious problem.

皮膚は、一般的に、死んだ表皮細胞層からなる角質層、生きた表皮細胞層、真皮層、および皮下脂肪組織層からなり、この皮膚が筋膜を介して筋肉層と接している。最も汎用される注射として皮下注射があるが、この注射方法は、角質層、生きた表皮細胞層、および真皮層を貫いて皮下脂肪組織に薬液を投与するものである。しかし、真皮層や皮下脂肪組織層には痛みの刺激を受容する自由神経終末や血管が豊富にあるため、針先が神経を傷つけたり血管を損傷したりすることによってブラジキニンなどの発痛物質の産生を促し、痛みを引き起こしてしまう。針の穿刺による痛みを軽減する最も簡便な方法は、神経や血管に対する損傷を最小限に抑えることである。具体的には、針を細くすることと、短くすることが有効である。インスリンの自己注射用の針は、時代とともに細く短くなり、最近では、針の外径が０．２５ｍｍ（３１Ｇ針）で長さが５ｍｍのものが登場してきた。しかし、未だ、穿刺痛に関して、患者の満足は十分には得られてはいない。   The skin generally consists of a stratum corneum consisting of a dead epidermal cell layer, a live epidermal cell layer, a dermis layer, and a subcutaneous adipose tissue layer, and this skin is in contact with the muscle layer via the fascia. The most commonly used injection is subcutaneous injection, and this injection method involves administering a drug solution into the subcutaneous adipose tissue through the stratum corneum, the living epidermal cell layer, and the dermis layer. However, since the dermis layer and subcutaneous adipose tissue layer have abundant free nerve endings and blood vessels that accept pain stimuli, the needle tip damages the nerves and damages the blood vessels. It stimulates production and causes pain. The simplest way to reduce pain from needle puncture is to minimize damage to nerves and blood vessels. Specifically, it is effective to make the needle thinner and shorter. Insulin self-injection needles have become thinner and shorter over time, and recently, needles with an outer diameter of 0.25 mm (31 G needle) and a length of 5 mm have appeared. However, patient satisfaction has not yet been fully achieved with respect to puncture pain.

このように針をさらに細くすれば、穿刺痛は軽減される。しかし、針を細くすれば、針体の腰が弱くなるために針が曲がり易くなって刺しづらくなること、および薬液の針内を流れる抵抗が上昇し薬液を押し出しにくくなることといった問題が生じる。このため、インスリン用としては、３１Ｇ針よりも細い一様な針は実現されていない。   If the needle is made thinner in this way, the puncture pain is reduced. However, if the needle is made thinner, the waist of the needle body becomes weak, so that the needle is easily bent and difficult to stab, and the resistance of the drug solution flowing through the needle increases, making it difficult to push out the drug solution. For this reason, a uniform needle thinner than the 31G needle has not been realized for insulin.

かかる問題を解決するために、近年、外径が先端で細く先端から基端に向かって太くされ、内径もそれに応じて変化させた針が提案されている（特許文献１、２参照）。これにより、細い針の腰の弱さと流路抵抗の上昇という問題が同時に解決される。しかし、特許文献２に示されるように、提案された針は、主として全長５ｍｍ以上の単針であり、皮下注射を意図したものである。つまり、特許文献１、２は、薬液を皮内に確実かつ容易に、かつ穿刺痛を軽減しつつ投与する技術を提示するものではない。   In order to solve this problem, in recent years, needles have been proposed in which the outer diameter is thin at the tip and thicker from the tip to the base, and the inner diameter is changed accordingly (see Patent Documents 1 and 2). This simultaneously solves the problems of the weakness of the thin needle and the increase in flow resistance. However, as shown in Patent Document 2, the proposed needle is mainly a single needle having a total length of 5 mm or more, and is intended for subcutaneous injection. That is, Patent Documents 1 and 2 do not present a technique for administering a drug solution into the skin reliably and easily while reducing puncture pain.

一方、針の長さを短くすると新たな問題が生じる。皮膚の表皮および真皮層は、皮下脂肪組織層と異なり、細胞が密で硬い。このため、薬液を表皮あるいは真皮層に投与する場合、１本の針で多量の投与はできない。一般に、皮膚の表皮と真皮層の間、あるいは真皮層へ投与する皮内投与の場合、ツベルクリン反応検査では０．１ｍｌ、アレルゲンテストや抗生物質などの薬物過敏性テストでは０．０２ｍ１の薬液が注入される。しかし、０．１ｍｌ以上の薬液が皮内に注入されると、狭い細胞問隙に基づく薬液収容能力の限界や、血管を通しての生体内への薬液吸収が追いつかないという理由で、皮膚が膨れ上がり、ついには皮膚における針の刺し口から薬液が漏れ出してしまう。このように現行の皮内投与では、薬液の投与量に制限がある。また、皮内に針先を位置させるために、一般的には、長い針を皮膚に略平行に刺さなければならない等の技術的な難しさも存在する。   On the other hand, if the needle length is shortened, a new problem arises. Unlike the subcutaneous adipose tissue layer, the epidermis and dermis layer of the skin are dense and hard. For this reason, when a chemical solution is administered to the epidermis or dermis layer, a large amount cannot be administered with one needle. In general, in the case of intradermal administration between the epidermis and the dermis layer of the skin or into the dermis layer, 0.1 ml is injected for tuberculin reaction test, and 0.02 ml for drug hypersensitivity tests such as allergen test and antibiotics. Is done. However, when 0.1 ml or more of drug solution is injected into the skin, the skin swells up due to the limitation of the drug solution storage capacity based on the narrow cell space and the absorption of the drug solution into the living body through blood vessels Eventually, the drug solution leaks from the needle piercing in the skin. Thus, the current intradermal administration has a limitation on the dose of the drug solution. In addition, in order to position the needle tip in the skin, there are generally technical difficulties such as having to pierce a long needle substantially parallel to the skin.

かかる問題を解決するために、近年、長さが最高１ｍｍ（特に１〜５００μｍ）の中空の複数の針を皮膚面に垂直に刺して電場をかけることによって、薬物を投与する経皮システムが提案されている（特許文献３参照）。しかし、皮膚には弾力があり、さらに前述したように表皮および真皮は細胞が密で硬いため、針を押し付けてもある距離までは刺さらずに凹む傾向がある。このため、上記文献に記載のシステムにおける複数の針は、長さが短いこと、および皮膚との接点が点でないことから、皮膚に刺さりにくいことが予想される。しかも、針が短いため、たとえ刺さっても外れやすい。すなわち投与された多くの薬液が生体内に入らずに漏れてしまう恐れがある。また、上記システムの複数の針は、写真リトグラフィーのようなミクロ領域加工方法により一体的に製造されるものであるため、製造することが技術的に難しいという問題もある。   In order to solve this problem, recently, a transdermal system for administering a drug by applying a plurality of hollow needles with a maximum length of 1 mm (especially 1 to 500 μm) vertically to the skin surface and applying an electric field has been proposed. (See Patent Document 3). However, the skin has elasticity and, as described above, the cells of the epidermis and dermis tend to be dented without being pierced to a certain distance even if the needle is pressed because the cells are dense and hard. For this reason, the plurality of needles in the system described in the above document are expected to be less likely to pierce the skin because of the short length and the point of contact with the skin is not a point. Moreover, since the needle is short, it is easy to come off even if it is stabbed. That is, there is a risk that many of the administered drug solution may leak without entering the living body. In addition, since the plurality of needles of the above system are manufactured integrally by a micro region processing method such as photolithography, there is a problem that it is technically difficult to manufacture.

また、薬液の注入中に装置を皮膚に固着させるために真空を作り出す手段を備えた注入装置が提案されている（特許文献４参照）。しかし、この注入装置は、使用者がプランジャ機構を押圧する動作によって薬液の注入作用と装置の皮膚への固着作用とが発揮される構成とされているため、薬液を注入する間、装置の皮膚への固着を確実に維持することが難しい。このため、複数の針のうち１本でも皮膚から外れると、流路抵抗の低い外れた針から薬液が漏れてしまう恐れがある。
特開２００２−１５９５７６号公報 特開２００２−２９１８８４号公報 特表平１０−５１０１７５号公報 特表平８−５０８９０１号公報 In addition, there has been proposed an injection device provided with means for creating a vacuum in order to fix the device to the skin during the injection of a chemical solution (see Patent Document 4). However, this injection device is configured such that the action of injecting the chemical solution and the effect of fixing the device to the skin are exerted by the action of the user pressing the plunger mechanism. It is difficult to reliably maintain the sticking to. For this reason, if even one of the plurality of needles is detached from the skin, there is a risk that the chemical solution leaks from the detached needle having a low flow resistance.
JP 2002-159576 A JP 2002-291844 A Japanese National Patent Publication No. 10-510175 Japanese National Patent Publication No. 8-508901

本発明は、上述の課題を解決するためになされたものであり、本発明の目的は、痛みを軽減しつつ針を皮膚に穿刺できるとともに、針が皮膚から外れることを確実に防止でき、十分な量の薬液を経皮的に皮内へ注入することが可能な薬液注入装置を提供することである。   The present invention has been made to solve the above-mentioned problems, and the object of the present invention is to puncture the needle into the skin while alleviating the pain, and to reliably prevent the needle from coming off the skin. It is an object of the present invention to provide a chemical solution injection device capable of transdermally injecting a large amount of a chemical solution into the skin.

本発明の目的は、下記する手段により達成される。   The object of the present invention is achieved by the following means.

（１）薬液を収容可能な容器と、先端側に開口する凹状部を備え、前記容器を保持するための保持体と、前記容器内と連通され前記保持体を貫通して前記凹状部の内側底面から外方へ突出する複数の中空の針と、前記容器内の薬液を前記針を介して経皮的に皮内へ注入するための駆動力を提供する薬液駆動手段と、前記凹状部の内側底面と皮膚とを相互に近接移動させて接触させるための接触手段と、前記保持体の皮膚に接触可能な端面に形成された粘着剤を含む粘着層と、を有することを特徴とする薬液注入装置。   (1) A container that can store a chemical solution, a concave portion that opens to the distal end side, a holding body that holds the container, and the inside of the concave portion that communicates with the inside of the container and penetrates the holding body A plurality of hollow needles projecting outward from the bottom surface, a drug solution driving means for providing a driving force for transcutaneously injecting the drug solution in the container into the skin through the needle, and A drug solution comprising contact means for bringing the inner bottom surface and skin into close contact with each other, and an adhesive layer formed on an end surface of the holder that can contact the skin, the adhesive layer including an adhesive. Injection device.

（２）前記粘着層は、前記凹状部の内側底面に形成されていることを特徴とする上記（１）に記載の薬液注入装置。   (2) The chemical injection device according to (1), wherein the adhesive layer is formed on an inner bottom surface of the concave portion.

（３）前記保持体は、前記凹状部内の空気を吸引するための吸引口を有し、前記吸引口から空気を吸引することにより、前記凹状部の内側底面に皮膚を引き寄せて接触させる上記（１）に記載の薬液注入装置。   (3) The holding body includes a suction port for sucking air in the concave portion, and draws air from the suction port so that the skin is brought into contact with the inner bottom surface of the concave portion. The chemical injection device according to 1).

（４）前記保持体は、前記凹状部の開口端近傍の側方に設けられ皮膚に当接可能な翼部を備え、当該翼部は、皮膚面と平行に内側に移動可能な少なくとも一対の翼片を有し、前記翼片が皮膚に当接された状態で当該翼片を内側にずらすことにより、皮膚を当該翼片で挟んで持ち上げ前記凹状部の内側底面に引き寄せて接触させる上記（１）に記載の薬液注入装置。   (4) The holding body includes a wing portion provided on a side near the opening end of the concave portion and capable of contacting the skin, and the wing portion is movable inward in parallel to the skin surface. The wing piece has a wing piece, and the wing piece is shifted inward in a state where the wing piece is in contact with the skin, whereby the skin is sandwiched between the wing pieces and lifted to be brought into contact with the inner bottom surface of the concave portion. The chemical injection device according to 1).

（５）前記保持体は、前記凹状部の開口端近傍の側方に設けられ皮膚に当接可能な翼部を備え、当該翼部は、皮膚面と平行に外側に移動可能な少なくとも一対の翼片を有し、前記翼片が皮膚に当接された状態で当該翼片を外側にずらすことにより、前記凹状部の側壁がつぶれて略平坦になって前記凹状部の内側底面に皮膚を接触させる上記（１）に記載の薬液注入装置。   (5) The holding body includes a wing portion provided on a side near the opening end of the concave portion and capable of contacting the skin, and the wing portion is movable at least a pair of outer sides parallel to the skin surface. When the wing piece is shifted to the outside in a state where the wing piece is in contact with the skin, the side wall of the concave portion is crushed and becomes substantially flat, and the skin is placed on the inner bottom surface of the concave portion. The chemical injection device according to (1), which is brought into contact.

（６）前記針の先端の外径は、０．１ｍｍ以上かつ０．２５ｍｍ以下であり、前記針の基端の外径は、先端の外径よりも大きいことを特徴とする上記（１）〜（５）のいずれか１つに記載の薬液注入装置。   (6) The outer diameter of the distal end of the needle is 0.1 mm or more and 0.25 mm or less, and the outer diameter of the proximal end of the needle is larger than the outer diameter of the distal end. The chemical injection device according to any one of to (5).

（７）前記針は、外径が先端から基端に向かって漸増している部分を有することを特徴とする上記（６）に記載の薬液注入装置。   (7) The liquid injector according to (6), wherein the needle has a portion whose outer diameter gradually increases from the distal end toward the proximal end.

（８）前記針は、基端から前記凹状部の内側底面に対応する位置までの基部と、前記凹状部の内側底面から突出し、生体内に穿刺可能な部分である穿刺部とからなり、前記穿刺部の全長は、１ｍｍ以上かつ２．５ｍｍ以下であることを特徴とする上記（１）〜（７）のいずれか１つに記載の薬液注入装置。   (8) The needle includes a base from a base end to a position corresponding to the inner bottom surface of the concave portion, and a puncture portion that protrudes from the inner bottom surface of the concave portion and is a portion that can be punctured in a living body, The total length of the puncture part is 1 mm or more and 2.5 mm or less, The drug solution injection device according to any one of the above (1) to (7).

（９）前記容器は、当該容器内に薬液を充填するための充填口を有することを特徴とする上記（１）〜（８）のいずれか１つに記載の薬液注入装置。   (9) The said chemical | medical solution injection apparatus as described in any one of said (1)-(8) characterized by the said container having a filling port for filling the chemical | medical solution in the said container.

（１０）前記薬液駆動手段は、前記容器内に挿入されるガスケットに連結され使用者により押され得る押し子、前記容器内の薬液を押圧するための板ばね、前記ガスケットを押圧するためのコイルばね、弾性材料からなるバルーンを利用した機構、電動ポンプ、イオントフォレシス駆動を利用した機構、および高吸水性物質の体積膨張を利用した機構のうちのいずれかを有することを特徴とする上記（１）〜（９）のいずれか１つに記載の薬液注入装置。   (10) The chemical liquid driving means is connected to a gasket inserted into the container and can be pressed by a user, a leaf spring for pressing the chemical liquid in the container, and a coil for pressing the gasket The above, characterized in that it has any one of a spring, a mechanism using a balloon made of an elastic material, an electric pump, a mechanism using iontophoresis drive, and a mechanism using volume expansion of a superabsorbent substance ( 1) The chemical solution injection device according to any one of (9).

（１１）前記針の先端を保護するためのキャップを有することを特徴とする上記（１）〜（１０）のいずれか１つに記載の薬液注入装置。   (11) The chemical injection device according to any one of (1) to (10), further including a cap for protecting the tip of the needle.

（１２）前記保持体は、前記凹状部の開口端近傍の側方に設けられ皮膚に当接可能な翼部を備え、前記粘着層は、前記翼部の端面と前記凹状部の内側底面とに形成され、前記針の先端は、前記翼部の前記粘着層が形成された端面よりも基端側に位置されることを特徴とする上記（１）に記載の薬液注入装置。   (12) The holding body includes a wing portion provided on a side near the opening end of the concave portion and capable of contacting the skin, and the adhesive layer includes an end surface of the wing portion and an inner bottom surface of the concave portion. And the distal end of the needle is positioned on the proximal side of the end surface of the wing portion where the adhesive layer is formed.

（１３）薬液を収容可能な容器と、先端側に開口する凹状部、および当該凹状部の開口端近傍の側方に設けられ皮膚面と平行に内側に移動可能な少なくとも一対の翼片を有する皮膚に当接可能な翼部を備え、前記容器を保持するための保持体と、前記容器内と連通され前記保持体を貫通して前記凹状部の内側底面から外方へ突出する複数の中空の針と、前記容器内の薬液を前記針を介して経皮的に皮内へ注入するための駆動力を提供する薬液駆動手段と、前記翼片が皮膚に当接された状態で当該翼片を内側にずらすことにより、皮膚を当該翼片で挟んで持ち上げ前記凹状部の内側底面に引き寄せて接触させるための接触手段と、を有することを特徴とする薬液注入装置。   (13) A container that can store a chemical solution, a concave portion that opens to the distal end side, and at least a pair of wing pieces that are provided on a side near the opening end of the concave portion and are movable inward in parallel to the skin surface. A wing part capable of contacting the skin, a holding body for holding the container, and a plurality of hollows communicating with the inside of the container and penetrating the holding body and projecting outward from the inner bottom surface of the concave part Needle, a drug solution driving means for providing a driving force for transdermally injecting the drug solution in the container into the skin through the needle, and the wing piece in contact with the wing piece And a contact means for lifting the skin between the wing pieces to bring it into contact with the inner bottom surface of the concave portion by moving the piece inward.

（１４）薬液を収容可能な容器と、先端側に開口する凹状部、および当該凹状部の開口端近傍の側方に設けられ皮膚面と平行に外側に移動可能な少なくとも一対の翼片を有する皮膚に当接可能な翼部を備え、前記容器を保持するための保持体と、前記容器内と連通され前記保持体を貫通して前記凹状部の内側底面から外方へ突出する複数の中空の針と、前記容器内の薬液を前記針を介して経皮的に皮内へ注入するための駆動力を提供する薬液駆動手段と、前記翼片が皮膚に当接された状態で当該翼片を外側にずらすことにより、前記凹状部の側壁がつぶれて略平坦になって前記凹状部の内側底面に皮膚を接触させるための接触手段と、を有することを特徴とする薬液注入装置。   (14) A container that can store a chemical solution, a concave portion that opens to the distal end side, and at least a pair of wing pieces that are provided on the side near the opening end of the concave portion and are movable outward in parallel with the skin surface. A wing part capable of contacting the skin, a holding body for holding the container, and a plurality of hollows communicating with the inside of the container and penetrating the holding body and projecting outward from the inner bottom surface of the concave part Needle, a drug solution driving means for providing a driving force for transdermally injecting the drug solution in the container into the skin through the needle, and the wing piece in contact with the wing piece And a contact means for bringing the skin into contact with the inner bottom surface of the concave portion by squeezing the piece outward to make the side wall of the concave portion flat and flat.

本発明の薬液注入装置によれば、複数の針を使用することにより針を細くして痛みを軽減しつつ皮膚に穿刺できるとともに、針が皮膚から外れることを確実に防止することができる。したがって、十分な量のたとえば経口投与の難しい高分子医薬品などの薬液を、経皮的に皮内へ確実かつ容易に注入することができる。   According to the drug solution injection device of the present invention, by using a plurality of needles, it is possible to puncture the skin while reducing the pain and reducing pain, and it is possible to reliably prevent the needle from coming off the skin. Therefore, a sufficient amount of a drug solution such as a polymer drug that is difficult to administer orally, for example, can be reliably and easily injected into the skin percutaneously.

以下、図面を参照して、本発明の実施の形態を説明する。   Embodiments of the present invention will be described below with reference to the drawings.

図１は、本発明の第１実施形態に係る薬液注入装置を示す図であって、（Ａ）は概略断面図、（Ｂ）はキャップを外した状態の底面図である。図２は、図１に示される針の概略拡大図である。   1A and 1B are diagrams showing a chemical liquid injector according to a first embodiment of the present invention, in which FIG. 1A is a schematic cross-sectional view, and FIG. 1B is a bottom view with a cap removed. FIG. 2 is a schematic enlarged view of the needle shown in FIG.

図１に示されるように、本実施形態に係る薬液注入装置１は、本体１０と針２０とを有している。   As shown in FIG. 1, the chemical liquid injector 1 according to this embodiment includes a main body 10 and a needle 20.

本体１０は、薬液を収容可能な容器１１と、容器１１を保持するための保持体１２と、容器１１内の薬液を針２０を介して経皮的に皮内へ注入するための駆動力を提供する薬液駆動手段としての押し子１３とを有する。   The main body 10 has a container 11 that can store a chemical solution, a holding body 12 for holding the container 11, and a driving force for transdermally injecting the chemical solution in the container 11 into the skin through the needle 20. And a pusher 13 as a chemical liquid drive means to be provided.

本明細書において、皮内とは、真皮層をいい、皮膚の表皮細胞層と真皮層の間の部位も含む。なお、本実施形態の薬液注入装置１は、薬液の皮内投与を意図したものであるが、結果的に皮下等の他の部位に薬液が注入される場合がある装置も含む。   In this specification, intradermal refers to the dermis layer, and includes the site between the epidermal cell layer and the dermis layer of the skin. In addition, although the chemical | medical solution injection device 1 of this embodiment is intended for intradermal administration of a chemical | medical solution, the apparatus which may inject | pour a chemical | medical solution into other site | parts, such as subcutaneously, as a result is also included.

容器１１は、略円筒状を呈しており、押し子１３が容器１１の軸方向に往復動可能に挿入される内部空間１１１を有する。容器１１の保持体１２と反対側（図中上側）には、押し子１３を内部空間１１１に挿入するための開口１１２が形成されている。   The container 11 has a substantially cylindrical shape, and has an internal space 111 into which the pusher 13 is inserted so as to be able to reciprocate in the axial direction of the container 11. An opening 112 for inserting the pusher 13 into the internal space 111 is formed on the side of the container 11 opposite to the holding body 12 (upper side in the figure).

また、容器１１は、当該容器１１の内部空間１１１内に薬液を充填するための充填口１１３を有する。充填口１１３には、チューブ４１を介して、流路を開閉可能なバルブ４２が取り付けられている。バルブ４２には、薬液を供給するための図示しないシリンジ等の薬液供給装置を接続することができる。   Further, the container 11 has a filling port 113 for filling the internal space 111 of the container 11 with a chemical solution. A valve 42 that can open and close the flow path is attached to the filling port 113 via a tube 41. A chemical liquid supply device such as a syringe (not shown) for supplying the chemical liquid can be connected to the valve 42.

保持体１２は、先端側（図中下側）に開口する凹状部１２１を備える。また、凹状部１２１の開口端近傍の側方には、皮膚に当接可能な翼部１２２が設けられている。翼部１２２を設けることにより、薬液注入装置１は皮膚上に安定して支持され得る。ただし、本実施形態では、翼部を省略することも可能である。翼部１２２は、図１（Ｂ）に示されるように楕円板形状を呈しているが、略平板形状であれば任意の形状を採ることができる。   The holding body 12 includes a concave portion 121 that opens to the distal end side (lower side in the figure). In addition, a wing 122 that can contact the skin is provided on the side of the concave portion 121 in the vicinity of the opening end. By providing the wing part 122, the chemical liquid injector 1 can be stably supported on the skin. However, in the present embodiment, the wing portion can be omitted. Although the wing | blade part 122 is exhibiting the elliptical plate shape as FIG. 1 (B) shows, if it is a substantially flat plate shape, it can take arbitrary shapes.

保持体１２の凹状部１２１の内側底面１２３は、先端側に向かって凸形状に形成されることが好ましい。このような構成にすれば、内側底面１２３は後述するように針２０が外方に突出する領域であるため、複数の針２０が皮膚に均等に刺さりかつ刺さった状態を維持し易くなる。内側底面１２３の凸形状は、図１に示すような略円錐形状に限られるものではなく、たとえば球面形状の一部であってもよい。ただし、内側底面１２３は平面であってもよい。   The inner bottom surface 123 of the concave portion 121 of the holding body 12 is preferably formed in a convex shape toward the tip side. With such a configuration, the inner bottom surface 123 is a region in which the needle 20 protrudes outward as will be described later, and therefore, it is easy to maintain a state in which the plurality of needles 20 are evenly stuck and stuck in the skin. The convex shape of the inner bottom surface 123 is not limited to a substantially conical shape as shown in FIG. 1, and may be a part of a spherical shape, for example. However, the inner bottom surface 123 may be a flat surface.

本実施形態においては、容器１１と保持体１２とは、好ましくは、一体成形される。しかし、容器１１と保持体１２とを別部材として形成し、接着あるいは溶着等の手段によって、保持体１２を容器１１の端部に固着することも可能である。あるいは、容器１１を、螺合もしくは嵌合によって、保持体１２に着脱可能に接続する構成を採用することも可能である。   In the present embodiment, the container 11 and the holding body 12 are preferably integrally formed. However, it is also possible to form the container 11 and the holding body 12 as separate members and fix the holding body 12 to the end of the container 11 by means such as adhesion or welding. Alternatively, it is possible to adopt a configuration in which the container 11 is detachably connected to the holding body 12 by screwing or fitting.

保持体１２の皮膚に接触可能な端面には、粘着剤を含む粘着層３０が形成されている。粘着層３０は、凹状部１２１の内側底面１２３と、翼部１２２の端面１２４とに形成されるのが好ましいが、いずれか一方に形成されていてもよい。凹状部１２１の内側底面１２３に粘着層３０を形成することにより、針２０の突出箇所近傍を皮膚にしっかりと粘着させることができ、また、翼部１２２の端面１２４に粘着層３０を形成することにより、薬液注入装置１の保持体１２を皮膚上にしっかりと固定することができる。これにより、穿刺直後や薬液の注入時に針が皮膚から外れることをより確実に防止できる。粘着層３０の外表面には、図示しない剥離シートが貼付されており、使用時に剥がされる。   An adhesive layer 30 containing an adhesive is formed on the end surface of the holder 12 that can contact the skin. The adhesive layer 30 is preferably formed on the inner bottom surface 123 of the concave portion 121 and the end surface 124 of the wing portion 122, but may be formed on either one. By forming the adhesive layer 30 on the inner bottom surface 123 of the concave portion 121, the vicinity of the protruding portion of the needle 20 can be firmly adhered to the skin, and the adhesive layer 30 is formed on the end surface 124 of the wing portion 122. Thereby, the holding body 12 of the chemical injection device 1 can be firmly fixed on the skin. Thereby, it can prevent more reliably that a needle | hook remove | deviates from skin immediately after puncture or at the time of injection | pouring of a chemical | medical solution. A release sheet (not shown) is affixed to the outer surface of the adhesive layer 30 and is peeled off during use.

粘着層３０の粘着剤としては、一般的な粘着剤であれば使用可能であり、たとえば天然ゴム系粘着剤やアクリル系粘着剤が使用され得る。なお、粘着層には、たとえば皮膚を冷却するための物質等、粘着以外の目的の物質が含まれていてもよい。   As the pressure-sensitive adhesive of the pressure-sensitive adhesive layer 30, any general pressure-sensitive adhesive can be used. For example, a natural rubber pressure-sensitive adhesive or an acrylic pressure-sensitive adhesive can be used. The adhesive layer may contain a target substance other than the adhesive, such as a substance for cooling the skin.

また、保持体１２は、凹状部１２１内の空気を吸引するための吸引口１２５を有する。吸引口１２５には、チューブ５１を介して、空気を吸引可能な図示しないシリンジ等の吸引装置を接続するためのコネクタ５２が取り付けられている。吸引口１２５、チューブ５１、コネクタ５２および吸引装置は、凹状部１２１の内側底面１２３と皮膚とを相互に近接移動させて接触させるための接触手段として機能する。具体的には、吸引装置により吸引口１２５から空気を吸引することにより、凹状部１２１の内側底面１２３に皮膚を引き寄せて接触させることが可能となる。したがって、針を皮膚に確実に刺して薬液注入時に針が皮膚から外れることを防止することができる。保持体１２に接続されているチューブ５１には、空気の逆流を防止するための逆止弁が設けられていてもよい。   Further, the holding body 12 has a suction port 125 for sucking the air in the concave portion 121. A connector 52 for connecting a suction device such as a syringe (not shown) capable of sucking air through the tube 51 is attached to the suction port 125. The suction port 125, the tube 51, the connector 52, and the suction device function as contact means for causing the inner bottom surface 123 of the concave portion 121 and the skin to move close to each other and come into contact with each other. Specifically, by sucking air from the suction port 125 by the suction device, it is possible to bring the skin into contact with the inner bottom surface 123 of the concave portion 121. Therefore, it is possible to prevent the needle from coming off the skin when the drug solution is injected by reliably piercing the skin with the needle. The tube 51 connected to the holding body 12 may be provided with a check valve for preventing the backflow of air.

押し子１３の先端には、容器１１に挿入されて内壁に密着するガスケット１３１が取り付けられている。ガスケット１３１は、押し子１３が使用者により押されて保持体１２に向かって移動する際に、薬液が後方に漏れないようにシールし、薬液を前方に押し出す役目を果たす。   A gasket 131 that is inserted into the container 11 and is in close contact with the inner wall is attached to the tip of the pusher 13. When the pusher 13 is pushed by the user and moves toward the holding body 12, the gasket 131 seals the chemical liquid so that it does not leak backward, and serves to push the chemical liquid forward.

ガスケット１３１は、ブチルゴム、シリコンゴム、あるいはエラストマー等の材料を使用する成形加工によって製造される。容器１１、保持体１２、および押し子１３は、ポリプロピレンやポリエチレンなどのプラスチックあるいはガラス等の材料を使用して、成形加工によって製造される。なお、容器１１と保持体１２は、透明なプラスチックが望ましい。   The gasket 131 is manufactured by a molding process using a material such as butyl rubber, silicon rubber, or elastomer. The container 11, the holding body 12, and the pusher 13 are manufactured by molding using a material such as plastic or glass such as polypropylene or polyethylene. The container 11 and the holding body 12 are preferably transparent plastic.

針２０は、容器１１内の内部空間１１１と連通しており、保持体１２を貫通して凹状部１２１の内側底面１２３から外方へ突出している。針２０は、中空形状を呈しており、複数本設けられる。図１（Ｂ）では、５本の針２０が示されている。針の本数は、複数であれば薬液の投与量を効果的に増やすことができるため、２〜１００本の範囲が好ましく、針穿刺の確実性や製造コストの観点を考慮すれば、２〜１０本の範囲がより好ましい。   The needle 20 communicates with the internal space 111 in the container 11 and penetrates the holding body 12 and protrudes outward from the inner bottom surface 123 of the concave portion 121. The needle 20 has a hollow shape, and a plurality of needles 20 are provided. In FIG. 1B, five needles 20 are shown. If the number of needles is plural, the dose of the drug solution can be effectively increased. Therefore, the range of 2 to 100 needles is preferable, and in view of the reliability of needle puncture and the manufacturing cost, 2 to 10 The book range is more preferred.

図２に示すように、針２０の先端の外径Ｄ１は、０．１ｍｍ以上かつ０．２５ｍｍ以下であり、針２０の基端の外径Ｄ２は、先端の外径Ｄ１よりも大きく設定されている（かかる形状の針を「異径針」とも呼ぶ）。したがって、針の先端側を細くしたことにより穿刺痛が軽減されるだけでなく、基端側を太くしたことにより皮膚に穿刺するための針の強度を確保するとともに流路抵抗の上昇を防止することが可能である。また、針２０が保持体１２から先端側に脱落することを防止できる利点もある。 As shown in FIG. 2, the outer diameter D 1 of the tip of the needle 20 is 0.1mm or more and 0.25mm or less, the outer diameter D 2 of the proximal end of the needle 20, than the outer diameter D 1 of the tip It is set large (the needle having such a shape is also called “different diameter needle”). Therefore, not only is the puncture pain reduced by making the tip of the needle thinner, but also the strength of the needle for puncturing the skin is ensured and the increase in flow resistance is prevented by making the base end thicker. Is possible. Further, there is an advantage that the needle 20 can be prevented from falling off from the holding body 12 toward the distal end side.

針２０は、基端から凹状部１２１の内側底面１２３に対応する位置までの基部２１と、凹状部１２１の内側底面１２３から突出し、生体内に穿刺可能な部分である穿刺部２２とから構成される。なお、外径Ｄ２を有する太い部分の一部が凹状部１２１の内側底面１２３から外方に突出する構成であってもよい。 The needle 20 includes a base portion 21 from a base end to a position corresponding to the inner bottom surface 123 of the concave portion 121, and a puncture portion 22 that protrudes from the inner bottom surface 123 of the concave portion 121 and is a portion that can be punctured in a living body. The It may be configured such that part of the thick portion having an outer diameter D 2 is projected from the inner bottom surface 123 of the concave portion 121 outward.

ここで、皮膚の角質層の厚さは一般に、個人、性別、年齢、身体の部位、生活環境によって異なっていて一定ではないが、人の腕においては、通常１０〜３０μｍである。また、生きた表皮細胞層の厚さも種々の要因により一定ではないが、人の上腕部においては、通常３０〜１００μｍである。また、真皮層の厚さも一定ではないが、通常１〜３ｍｍである。   Here, the thickness of the stratum corneum of the skin generally varies depending on the individual, sex, age, body part, and living environment and is not constant, but is usually 10 to 30 μm in the human arm. Moreover, the thickness of the living epidermal cell layer is not constant due to various factors, but is usually 30 to 100 μm in the upper arm of a person. Also, the thickness of the dermis layer is not constant, but is usually 1 to 3 mm.

したがって、皮内投与を試みる場合、針２０の皮膚内に穿刺される部分の長さは、好ましくは０．０４〜２．５ｍｍ、より好ましくは０．５〜２．０ｍｍの範囲内である。結果的に、針２０のうち凹状部１２１の内側底面１２３から突出している部分、すなわち穿刺部２２の全長Ｌ（皮膚に入らない部分も含めての全長）は、皮膚の柔軟性により穿刺部２２の根元まで完全に押入されない場合があり得ることを考慮して、好ましくは０．１〜３ｍｍ、より好ましくは１〜２．５ｍｍの範囲内である。   Therefore, when attempting intradermal administration, the length of the portion of the needle 20 that is punctured into the skin is preferably in the range of 0.04 to 2.5 mm, more preferably 0.5 to 2.0 mm. As a result, the portion of the needle 20 that protrudes from the inner bottom surface 123 of the concave portion 121, that is, the total length L of the puncture portion 22 (the total length including the portion that does not enter the skin) is the puncture portion 22 due to the flexibility of the skin. In consideration of the fact that it may not be completely pushed down to the root of the diameter, it is preferably 0.1 to 3 mm, more preferably 1 to 2.5 mm.

また、針２０の穿刺部２２は、その先端側において、第１研削角で斜めにカットすることにより刃面が形成された主傾斜面２３と、第２研削角で斜めにカットすることにより刃面が形成された一対の先端傾斜面２４とを有している。これにより、針２０の先端は皮膚に穿刺し易い点形状を呈する。   Further, the puncture portion 22 of the needle 20 has a main inclined surface 23 in which a blade surface is formed by being obliquely cut at the first grinding angle and a blade by being obliquely cut at the second grinding angle. It has a pair of front-end | tip inclination surface 24 in which the surface was formed. Thereby, the tip of the needle 20 has a point shape that is easy to puncture the skin.

針２０は、その針先が内側底面１２３の凸形状と対応する凸形状の位置に配置されているので、内側底面１２３の中央部にある針と周辺部にある針とは同じ深さで穿刺される。   Since the needle tip of the needle 20 is disposed at a convex shape corresponding to the convex shape of the inner bottom surface 123, the needle at the center of the inner bottom surface 123 and the needle at the peripheral portion are punctured at the same depth. Is done.

図３に示すように、針は外径が先端から基端に向かって漸増していてもよい。図３に示す針２０ａは、図２に示す針２０よりも強度が大きく、流路抵抗の変化も滑らかとなる利点がある。一方、図２に示す針２０は、図３に示す針２０ａよりも製造が容易である。   As shown in FIG. 3, the outer diameter of the needle may gradually increase from the distal end toward the proximal end. The needle 20a shown in FIG. 3 has an advantage that the strength is higher than that of the needle 20 shown in FIG. 2 and the change in flow path resistance is smooth. On the other hand, the needle 20 shown in FIG. 2 is easier to manufacture than the needle 20a shown in FIG.

図３に示す針２０ａもまた、基部２１ａと穿刺部２２ａとから構成されており、先端の外径Ｄ１、および穿刺部２２の全長Ｌは、図２に示す針２０と同様である。なお、針の全長にわたってではなく、針の長手方向の一部において、外径が先端から基端に向かって漸増していてもよい。 The needle 20a shown in FIG. 3 also includes a base portion 21a and a puncture portion 22a. The outer diameter D 1 of the tip and the total length L of the puncture portion 22 are the same as those of the needle 20 shown in FIG. Note that the outer diameter may gradually increase from the distal end to the proximal end in a part of the longitudinal direction of the needle, not over the entire length of the needle.

針２０は、一般的には、ステンレス鋼を使用して、例えば、塑性加工によって製造される。但し、チタンなどの他の金属あるいはプラスチック等の材料から、針２０を製造することも可能である。針２０の本体１０への固着は、例えば、インサート成形あるいは接着によって達成される。   The needle 20 is generally manufactured using, for example, plastic processing using stainless steel. However, it is also possible to manufacture the needle 20 from other metals such as titanium or materials such as plastic. Adherence of the needle 20 to the main body 10 is achieved by, for example, insert molding or adhesion.

また、薬液注入装置１には、針２０の先端を保護するためのキャップ６０が備えられていることが好ましい。これにより、針２０の先端が誤って曲げられてしまうことを防止できるとともに、患者に恐怖感を与えないようにすることができる。キャップ６０は、保持体１２に対して、たとえば螺合もしくは嵌合等の方法により装着される。   Moreover, it is preferable that the chemical injection device 1 is provided with a cap 60 for protecting the tip of the needle 20. Thereby, it can prevent that the front-end | tip of the needle | hook 20 is bent accidentally, and it can be made not to give fear to a patient. The cap 60 is attached to the holding body 12 by a method such as screwing or fitting.

図１では、針２０の先端は、翼部１２２の粘着層３０が形成された端面１２４よりも突出しているが、端面１２４よりも基端側に位置されていてもよい。このようにすれば、針２０を誤って皮膚に穿刺したり先端が誤って曲げられたりする事態をより防止できる。この場合、吸引口１２５から空気を吸引することによって、凹状部１２１の内側底面１２３に皮膚を引き寄せることにより、針２０を皮膚に穿刺することが可能である。   In FIG. 1, the tip of the needle 20 protrudes from the end surface 124 on which the adhesive layer 30 of the wing portion 122 is formed, but may be located on the proximal side of the end surface 124. In this way, it is possible to further prevent situations where the needle 20 is accidentally punctured into the skin or the tip is bent erroneously. In this case, the needle 20 can be punctured into the skin by attracting the skin to the inner bottom surface 123 of the concave portion 121 by sucking air from the suction port 125.

このように構成された薬液注入装置１の使用方法について説明する。   The usage method of the chemical injection device 1 configured as described above will be described.

まず、キャップ６０を薬液注入装置１に装着した状態で、容器１１に接続されたバルブ４２を開け、バルブ４２に接続されたシリンジ等の薬液供給装置を使用して、容器１１内に薬液を充填する。薬液の充墳後、キャップ６０を外し、針２０の先端を上に向けた状態で、容器１１内にある空気を抜く。   First, with the cap 60 attached to the chemical solution injection device 1, the valve 42 connected to the container 11 is opened, and the chemical solution is filled into the container 11 using a chemical solution supply device such as a syringe connected to the valve 42. To do. After filling with the chemical solution, the cap 60 is removed, and the air in the container 11 is removed with the tip of the needle 20 facing upward.

そして、薬液注入装置１を皮膚の注射部位に、翼部１２２の端面１２４に形成された粘着層３０によって接着させる。保持体１２が皮膚にしっかりと接着されたことを確認した後、保持体１２の吸引口１２５に接続されたチューブ５１を介して凹状部１２１内の空気を吸引する。こうして凹状部１２１内に負圧が発生することにより、凹状部１２１の内側底面１２３に皮膚が引き寄せられ、針２０が穿刺部２２の根元近傍まで皮膚に刺さる。このとき、凹状部１２１の内側底面１２３に形成された粘着層３０に皮膚が接着される。したがって、針２０が皮膚から外れることを確実に防止できる。保持体１２の凹状部１２１の内側底面１２３に皮膚が接着されてから、押し子１３を押して容器１１内の薬液を皮内に注入する。皮内へ注入する抵抗で針２０が皮膚から離れようとするが、粘着層３０にて接着が維持される。   Then, the chemical liquid injector 1 is adhered to the injection site of the skin by the adhesive layer 30 formed on the end surface 124 of the wing part 122. After confirming that the holding body 12 is firmly adhered to the skin, the air in the concave portion 121 is sucked through the tube 51 connected to the suction port 125 of the holding body 12. When negative pressure is generated in the concave portion 121 in this way, the skin is attracted to the inner bottom surface 123 of the concave portion 121, and the needle 20 is stuck to the skin near the root of the puncture portion 22. At this time, the skin is adhered to the adhesive layer 30 formed on the inner bottom surface 123 of the concave portion 121. Therefore, it is possible to reliably prevent the needle 20 from coming off the skin. After the skin is adhered to the inner bottom surface 123 of the concave portion 121 of the holding body 12, the pusher 13 is pushed to inject the chemical solution in the container 11 into the skin. The needle 20 tends to leave the skin due to the resistance injected into the skin, but the adhesion is maintained in the adhesive layer 30.

薬液注入装置１で使用される薬液は、薬剤を含有する溶液、ゲルまたは懸濁液である。使用可能な薬剤は、経皮的な投与に適さない薬剤以外であるならば、実質的に制限されない。   The drug solution used in the drug solution injector 1 is a solution, gel, or suspension containing a drug. The drugs that can be used are not substantially limited as long as they are other than drugs that are not suitable for transdermal administration.

主な薬剤としては、たとえば、抗菌薬、抗ウイルス薬、ワクチン、抗腫瘍薬、免疫抑制薬、ステロイド薬、抗炎症薬、抗リウマチ薬、関節炎治療薬、抗ヒスタミン薬、抗アレルギー薬、糖尿病治療薬、ホルモン剤、骨・カルシウム代謝薬、ビタミン、血液製剤、造血薬、抗血栓薬、抗高脂血症薬、抗不整脈薬、血管拡張薬、プロスタグランジン、カルシウム拮抗薬、ＡＣＥ阻害薬、βブロッカー、降圧薬、利尿薬、キサンチン誘導体、βアゴニスト、抗喘息薬、鎮咳薬、去痰薬、抗コリン薬、止寫薬、健胃消化薬、抗潰瘍薬、下剤、睡眠薬、鎮静薬、解熱剤、かぜ薬、抗てんかん薬、抗精神病薬、抗うつ薬、抗不安薬、中枢神経刺激薬、副交感神経作用薬、交感神経作用薬、制吐剤、中枢興奮薬、抗パーキンソン病薬、筋弛緩薬、鎮痙薬、麻酔薬、鎮痒薬、抗片頭痛薬、診断薬、オリゴヌクレオチド、遺伝子薬などが挙げられる。ただし、薬剤は、好ましくは、経口投与で効果を表さないかあるいは減弱してしまうタンパク、ぺプチド、多糖類、オリゴヌクレオチド、ＤＮＡ等であり、具体的には、インスリン、成長ホルモン、インターフェロン、カルシトニン等の高分子量医薬品である。   Major drugs include, for example, antibacterial drugs, antiviral drugs, vaccines, antitumor drugs, immunosuppressive drugs, steroid drugs, anti-inflammatory drugs, antirheumatic drugs, arthritis drugs, antihistamine drugs, antiallergic drugs, diabetes treatment Drugs, hormones, bone / calcium metabolizers, vitamins, blood products, hematopoietics, antithrombotics, antihyperlipidemics, antiarrhythmics, vasodilators, prostaglandins, calcium antagonists, ACE inhibitors, β-blocker, antihypertensive, diuretic, xanthine derivative, β agonist, anti-asthma, antitussive, expectorant, anticholinergic, antidiarrheal, gastrointestinal, antiulcer, laxative, hypnotic, sedative, antipyretic , Cold medicine, antiepileptic drug, antipsychotic drug, antidepressant drug, anxiolytic drug, central nervous stimulant, parasympathomimetic drug, sympathomimetic drug, antiemetic, central stimulant drug, antiparkinsonian drug, muscle relaxant , Antispasmodics, anesthesia Drugs, antipruritics, anti-migraine drugs, diagnostic drugs, oligonucleotides, gene drugs and the like. However, the drug is preferably a protein, peptide, polysaccharide, oligonucleotide, DNA, or the like that does not show an effect or is attenuated by oral administration, specifically, insulin, growth hormone, interferon, It is a high molecular weight pharmaceutical such as calcitonin.

このように第１実施形態の薬液注入装置によれば、複数の針を使用することにより針を細くして痛みを軽減しつつ皮膚に穿刺できるとともに、針が皮膚から外れることを確実に防止することができる。したがって、十分な量のたとえば経口投与の難しい高分子医薬品などの薬液を、経皮的に皮内へ確実かつ容易に注入することができる。   Thus, according to the chemical injection device of the first embodiment, by using a plurality of needles, it is possible to puncture the skin while reducing the pain by reducing the needles, and to reliably prevent the needles from coming off the skin. be able to. Therefore, a sufficient amount of a drug solution such as a polymer drug that is difficult to administer orally, for example, can be reliably and easily injected into the skin percutaneously.

図４は、本発明の第２実施形態に係る薬液注入装置を示す図であって、（Ａ）は概略断面図、（Ｂ）はキャップを外した状態の底面図である。以下、第１実施形態と相違する点を中心に説明する。なお、第１実施形態と共通する機能を有する部材には同一の符号を用いる。   4A and 4B are diagrams showing a chemical liquid injector according to a second embodiment of the present invention, in which FIG. 4A is a schematic cross-sectional view, and FIG. 4B is a bottom view with a cap removed. Hereinafter, a description will be given focusing on differences from the first embodiment. In addition, the same code | symbol is used for the member which has a function which is common in 1st Embodiment.

第２実施形態に係る薬液注入装置１ａは、凹状部１２１の内側底面１２３と皮膚とを相互に近接移動させて接触させるための接触手段が、第１実施形態と相違している。   The medicinal-solution injection device 1a according to the second embodiment is different from the first embodiment in the contact means for bringing the inner bottom surface 123 of the concave portion 121 and the skin into close contact with each other.

具体的には、保持体１２は、凹状部１２１の開口端近傍の側方に設けられ皮膚に当接可能な翼部１２２ａを備え、当該翼部１２２ａは、皮膚面と平行に内側（半径方向内方）に移動可能な一対の翼片１２６を有している。ただし、３個以上の翼片１２６が放射状に配置されていてもよい。翼片１２６は、側壁１２７を介して保持体１２の基部に接続されており、これらは、たとえば樹脂により一体成形されることによって、各接続部分においてヒンジ結合される。したがって、翼片１２６、１２６が皮膚に当接された状態で当該翼片を内側にずらすことにより、皮膚を一対の翼片１２６、１２６で挟んで持ち上げ凹状部１２１の内側底面１２３に引き寄せて接触させることが可能となる。   Specifically, the holding body 12 includes a wing portion 122a provided on a side near the opening end of the concave portion 121 and capable of contacting the skin, and the wing portion 122a is formed inward (radial direction) in parallel with the skin surface. It has a pair of wing pieces 126 movable inwardly. However, three or more blade pieces 126 may be arranged radially. The wing piece 126 is connected to the base portion of the holding body 12 through the side wall 127, and these are hinge-coupled at each connection portion by being integrally formed with resin, for example. Therefore, when the wing pieces 126 and 126 are in contact with the skin, the wing pieces are displaced inward, so that the skin is sandwiched between the pair of wing pieces 126 and 126 and pulled up to the inner bottom surface 123 of the concave portion 121 to make contact. It becomes possible to make it.

このように構成された薬液注入装置１ａを使用する場合、まず、キャップ６０を薬液注入装置１に装着した状態で、容器１１に接続されたバルブ４２を開け、バルブ４２に接続されたシリンジ等の薬液供給装置を使用して、容器１１内に薬液を充填する。薬液の充墳後、キャップ６０を外し、針２０の先端を上に向けた状態で、容器１１内にある空気を抜く。   When using the chemical solution injection device 1a configured as described above, first, with the cap 60 attached to the chemical solution injection device 1, the valve 42 connected to the container 11 is opened, and a syringe connected to the valve 42, etc. The chemical solution is filled in the container 11 using the chemical solution supply device. After filling with the chemical solution, the cap 60 is removed, and the air in the container 11 is removed with the tip of the needle 20 facing upward.

そして、薬液注入装置１ａを皮膚の注射部位に、翼部１２２ａの端面１２４に形成された粘着層３０によって接着させる。保持体１２が皮膚にしっかりと接着されたことを確認した後、容器１１の側面を持ち、皮膚に向かって押し込む。これにより、一対の翼片１２６、１２６が内側に移動して、一対の翼片１２６、１２６に挟まれた皮膚が盛り上がり、針２０が穿刺部２２の根元近傍まで皮膚に刺さる。このとき、凹状部１２１の内側底面１２３に形成された粘着層３０に皮膚が接着される。したがって、針２０が皮膚から外れることを確実に防止できる。保持体１２の凹状部１２１の内側底面１２３に皮膚が接着されていたら、押し子１３を押して容器１１内の薬液を皮内に注入する。なお、第２実施形態では、翼片で皮膚を挟んで持ち上げ凹状部の内側底面に強制的に接触させるため、粘着層３０を省略することも可能である。   And the chemical | medical solution injection device 1a is adhere | attached on the injection site | part of skin with the adhesion layer 30 formed in the end surface 124 of the wing | wing part 122a. After confirming that the holding body 12 is firmly adhered to the skin, hold the side surface of the container 11 and push it toward the skin. As a result, the pair of wing pieces 126, 126 move inward, the skin sandwiched between the pair of wing pieces 126, 126 rises, and the needle 20 pierces the skin to the vicinity of the root of the puncture portion 22. At this time, the skin is adhered to the adhesive layer 30 formed on the inner bottom surface 123 of the concave portion 121. Therefore, it is possible to reliably prevent the needle 20 from coming off the skin. If the skin is adhered to the inner bottom surface 123 of the concave portion 121 of the holding body 12, the pusher 13 is pushed to inject the chemical solution in the container 11 into the skin. In the second embodiment, the pressure-sensitive adhesive layer 30 can be omitted because the skin is sandwiched between wing pieces and forcedly brought into contact with the inner bottom surface of the concave portion.

このように第２実施形態の薬液注入装置によっても、上記の第１実施形態と同様の効果を得ることが可能である。   Thus, also by the chemical | medical solution injection apparatus of 2nd Embodiment, it is possible to acquire the effect similar to said 1st Embodiment.

図５は、本発明の第３実施形態に係る薬液注入装置を示す図であって、（Ａ）は概略断面図、（Ｂ）はキャップを外した状態の底面図である。以下、第１実施形態と相違する点を中心に説明する。なお、第１実施形態と共通する機能を有する部材には同一の符号を用いる。   5A and 5B are diagrams showing a chemical liquid injector according to a third embodiment of the present invention, in which FIG. 5A is a schematic cross-sectional view, and FIG. 5B is a bottom view with a cap removed. Hereinafter, a description will be given focusing on differences from the first embodiment. In addition, the same code | symbol is used for the member which has a function which is common in 1st Embodiment.

第３実施形態に係る薬液注入装置１ｂは、凹状部１２１の内側底面１２３と皮膚とを相互に近接移動させて接触させるための接触手段が、第１実施形態と相違している。   The medicinal-solution injection device 1b according to the third embodiment is different from the first embodiment in the contact means for bringing the inner bottom surface 123 of the concave portion 121 and the skin into close contact with each other.

具体的には、保持体１２は、凹状部１２１の開口端近傍の側方に設けられ皮膚に当接可能な翼部１２２ｂを備え、当該翼部１２２ａは、皮膚面と平行に外側（半径方向外方）に移動可能な一対の翼片１２６ｂを有している。ただし、３個以上の翼片１２６ｂが放射状に配置されていてもよい。翼片１２６ｂは、側壁１２７ｂを介して保持体１２の基部に接続されており、これらは、たとえば樹脂により一体成形されることによって、各接続部分においてヒンジ結合される。したがって、翼片１２６ｂ、１２６ｂが皮膚に当接された状態で当該翼片を外側にずらすことにより、凹状部１２１の側壁１２７ｂがつぶれて略平坦になって凹状部１２１の内側底面１２３に皮膚を接触させることが可能となる。   Specifically, the holding body 12 includes a wing portion 122b that is provided on the side near the opening end of the concave portion 121 and can contact the skin, and the wing portion 122a is outside (radial direction) in parallel with the skin surface. It has a pair of wing pieces 126b movable outward. However, three or more blade pieces 126b may be arranged radially. The wing piece 126b is connected to the base portion of the holding body 12 via the side wall 127b, and these are hinge-coupled at each connection portion by being integrally formed of resin, for example. Accordingly, when the wing pieces 126b and 126b are in contact with the skin, the wing pieces are shifted outward, whereby the side wall 127b of the concave portion 121 is crushed and becomes substantially flat, and the skin is placed on the inner bottom surface 123 of the concave portion 121. It becomes possible to make it contact.

このように構成された薬液注入装置１ｂを使用する場合、まず、キャップ６０を薬液注入装置１に装着した状態で、容器１１に接続されたバルブ４２を開け、バルブ４２に接続されたシリンジ等の薬液供給装置を使用して、容器１１内に薬液を充填する。薬液の充墳後、キャップ６０を外し、針２０の先端を上に向けた状態で、容器１１内にある空気を抜く。   When using the chemical solution injection device 1b configured as described above, first, with the cap 60 attached to the chemical solution injection device 1, the valve 42 connected to the container 11 is opened and a syringe or the like connected to the valve 42 is used. The chemical solution is filled in the container 11 using the chemical solution supply device. After filling with the chemical solution, the cap 60 is removed, and the air in the container 11 is removed with the tip of the needle 20 facing upward.

そして、薬液注入装置１ｂを皮膚の注射部位に、翼部１２２ｂの端面１２４に形成された粘着層３０によって接着させる。保持体１２が皮膚にしっかりと接着されたことを確認した後、容器１１の側面を持ち、皮膚に向かって押し込む。これにより、一対の翼片１２６ｂ、１２６ｂが外側に移動して、一対の翼片１２６、１２６の間の皮膚が外側に引っ張られて針を刺し易くすると同時に、凹状部１２１の側壁１２７ｂがつぶれて略平坦になって針２０が穿刺部２２の根元近傍まで皮膚に刺さる。このとき、凹状部１２１の内側底面１２３に形成された粘着層３０に皮膚が接着される。したがって、針２０が皮膚から外れることを確実に防止できる。保持体１２の凹状部１２１の内側底面１２３に皮膚が接着されていたら、押し子１３を押して容器１１内の薬液を皮内に注入する。なお、第３実施形態では、翼片で皮膚が引っ張られるとともに凹状部の側壁がつぶれて皮膚を内側底面に強制的に接触させるため、粘着層３０を省略することも可能である。   And the chemical | medical solution injection device 1b is adhere | attached on the injection site | part of skin with the adhesion layer 30 formed in the end surface 124 of the wing | wing part 122b. After confirming that the holding body 12 is firmly adhered to the skin, hold the side surface of the container 11 and push it toward the skin. As a result, the pair of wing pieces 126b and 126b move outward, and the skin between the pair of wing pieces 126 and 126 is pulled outward to make it easy to pierce the needle, and at the same time, the side wall 127b of the concave portion 121 is crushed. It becomes substantially flat and the needle 20 pierces the skin to the vicinity of the root of the puncture portion 22. At this time, the skin is adhered to the adhesive layer 30 formed on the inner bottom surface 123 of the concave portion 121. Therefore, it is possible to reliably prevent the needle 20 from coming off the skin. If the skin is adhered to the inner bottom surface 123 of the concave portion 121 of the holding body 12, the pusher 13 is pushed to inject the chemical solution in the container 11 into the skin. In the third embodiment, the skin is pulled by the wing piece and the side wall of the concave portion is crushed so that the skin is forcibly brought into contact with the inner bottom surface. Therefore, the adhesive layer 30 can be omitted.

このように第３実施形態の薬液注入装置によっても、上記の第１実施形態と同様の効果を得ることが可能である。   As described above, the same effect as that of the first embodiment can be obtained by the chemical liquid injector according to the third embodiment.

次に、薬液の皮内投与に関する実験を行ったので、以下に説明する。   Next, an experiment related to intradermal administration of a chemical solution was performed, which will be described below.

〈実験１〉
インスリンを皮内に投与したときの血中動態が、従来実施されている皮下投与と同等であるか否かを確認する実験を実施した。 <Experiment 1>
An experiment was conducted to confirm whether the blood kinetics when insulin was administered intradermally was equivalent to the conventional subcutaneous administration.

（方法）
雄性ラット（Ｃｒｊ：Ｗｉｓｔｅｒ、１１週齢）を使用した。麻酔下で頚動脈にカテ一テルを留置し、薬液投与部位を毛刈りした。一夜絶食させた後、実験に供した。ラットを２群に分け、無麻酔拘束下でインスリンを、一方の群のラットに皮下、他方の群のラットに皮内投与した。注射には２９Ｇ針（外径０．３３ｍｍ）の付いたインスリンの用シリンジ（マイジェクター；テルモ株式会社製）を使用した。インスリン（ヒューマリンＲ注；塩野義製薬製）の投与量は、０．５Ｕ／ｋｇであり、投与容量が約２０μｌになるように生理食塩水で希釈して使用した。インスリンを投与した後、５分、１５分、３０分、１時問、２時問および４時間後に、頚動脈から血液を採取して、それぞれの血中インスリン量を酵素免疫測定法を用いたインスリン測定用のキット（グラザイムＩｎｓｕｌｉｎ−ＥＩＡ ＴＥＳＴ；和光純薬工業株式会社製）で測定した。 (Method)
Male rats (Crj: Wister, 11 weeks old) were used. Under anesthesia, a catheter was placed in the carotid artery and the drug solution administration site was shaved. After fasting overnight, it was used for the experiment. The rats were divided into two groups, and insulin was administered subcutaneously to one group of rats and intradermally to the other group of rats under unanesthetized restraint. A syringe for insulin (Myjector; manufactured by Terumo Corporation) with a 29G needle (outer diameter 0.33 mm) was used for injection. The dose of insulin (Humarin R injection; manufactured by Shionogi & Co., Ltd.) was 0.5 U / kg, and was used after diluting with physiological saline so that the dose volume was about 20 μl. After administration of insulin, blood was collected from the carotid artery 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours, and the amount of each insulin was measured using an enzyme immunoassay. It measured with the kit for a measurement (Gurazyme Insulin-EIA TEST; Wako Pure Chemical Industries Ltd. make).

（結果）
実験１の結果を図６に示す。図示のように、インスリン０．５Ｕ／ｋｇを皮内投与すると、５分〜１５分の間で血中インスリン濃度が最大になり、１時間持続する血中動態が得られた（図６中の破線）。これは、皮下注射したときの結果（図６中の実線）とほぼ同じであり、皮内投与しても皮下投与と同様の薬効を得ることができることがわかった。なお、図中の点は平均値、点から延びる縦線の長さは標準偏差を示す。 (result)
The result of Experiment 1 is shown in FIG. As shown in the figure, when 0.5 U / kg of insulin was administered intradermally, the blood insulin concentration was maximized between 5 minutes and 15 minutes, and blood dynamics lasting 1 hour were obtained (in FIG. 6). Dashed line). This is almost the same as the result of subcutaneous injection (solid line in FIG. 6), and it was found that the same medicinal effect as subcutaneous administration can be obtained even by intradermal administration. In addition, the point in a figure shows an average value, and the length of the vertical line extended from a point shows a standard deviation.

〈実験２〉
次に、１本あるいは３本の針で、どの程度の容量を皮内投与できるかを検討した。 <Experiment 2>
Next, it was examined how much volume could be administered intradermally with one or three needles.

（方法）
約１０ｋｇのブタを使用した。麻酔下で横腹を毛刈りし、チューブの先に取り付けた異径針を、ブタ横腹に垂直に深さ１．０ｍｍ〜１．２ｍｍになるように穿刺した。穿刺部位を固定した後、チューブの他端を生理食塩水を含む１０ｍｌのシリンジに接続し、シリンジポンプ（ＳＴＣ−５３１；テルモ株式会社製）を用いてブタの皮内に生理食塩水を持続注入した。単位時間当たりの投与量は、１時問当たり０．０５ｍｌ、０．１５ｍｌ、０．５ｍｌ、５ｍｌの４通りとした。チューブには側枝を設け、この側枝にコモカーディオ連続心拍出量モニター（ＣＯ−２０３；テルモ株式会社製）を接続して、注入圧を連続的に測定できるようにした。皮膚からの漏れは、生理食塩水に青インクを混合することにより肉眼で判断した。また、ポンプの注入圧が安定せずに異常に上昇した場合は、その時点で実験を終了した。観察時間は、１本の針を用いた場合は１時間、３本の針を用いた場合は３０分とした。本実験には、先端の外径が０．１８ｍｍ（内径０．０８ｍｍ）、チューブ側（基端）の外径が０．３５ｍｍ（内径０．２５ｍｍ）の全長１２ｍｍのステンレス製の異径針を用いた。また、針の先端には、第１研削角で斜めにカットすることにより刃面が形成された主傾斜面と、第２研削角で斜めにカットすることにより刃面が形成された一対の先端傾斜面とを設けた。 (Method)
About 10 kg pigs were used. Under anesthesia, the flank was shaved, and a different diameter needle attached to the tip of the tube was punctured to a depth of 1.0 mm to 1.2 mm perpendicular to the porcine flank. After fixing the puncture site, the other end of the tube is connected to a 10 ml syringe containing physiological saline, and physiological saline is continuously injected into the skin of the pig using a syringe pump (STC-531; manufactured by Terumo Corporation). did. There were four doses per unit time: 0.05 ml, 0.15 ml, 0.5 ml, and 5 ml per hour. The tube was provided with a side branch, and a comocardio continuous cardiac output monitor (CO-203; manufactured by Terumo Corporation) was connected to the side branch so that the injection pressure could be continuously measured. Leakage from the skin was judged with the naked eye by mixing blue ink into physiological saline. In addition, when the pump injection pressure was not stabilized and increased abnormally, the experiment was terminated at that time. The observation time was 1 hour when one needle was used and 30 minutes when three needles were used. In this experiment, a stainless steel different diameter needle having a total length of 12 mm and an outer diameter of the distal end of 0.18 mm (inner diameter 0.08 mm) and an outer diameter of the tube side (base end) of 0.35 mm (inner diameter 0.25 mm) was used. Using. In addition, at the tip of the needle, a main inclined surface having a blade surface formed by cutting obliquely at the first grinding angle and a pair of tips having a blade surface formed by cutting obliquely at the second grinding angle An inclined surface was provided.

（結果）
実験２の結果を図７に示す。図示のように、１本の針で投与量が１時間当たり０．１５ｍｌ以下である場合、比較的安定的に生理食塩水を投与することができた。しかし、０．５ｍｌ／ｈｒの投与量では、注入圧が上昇し、１時間後には皮膚も若干膨らんでいた。さらに５ｍｌ／ｈｒの投与量では、０．１〜０．２ｍｌ注入後、投与不能になった。５ｍｌ／ｈｒの実験結果が示すように、１本の単回投与ならば０．１〜０．２ｍｌ程度は皮内投与可能であることがわかった。さらに、３本の針による実験結果が示すように、針の本数を増やせば投与量も増やせる可能性のあることもわかった。 (result)
The result of Experiment 2 is shown in FIG. As shown in the figure, when the dosage was 0.15 ml or less per hour with one needle, physiological saline could be administered relatively stably. However, at a dose of 0.5 ml / hr, the injection pressure increased and the skin was slightly swollen after 1 hour. Furthermore, at a dose of 5 ml / hr, administration became impossible after injection of 0.1-0.2 ml. As shown by the experimental result of 5 ml / hr, it was found that about 0.1 to 0.2 ml can be administered intradermally in a single administration. Furthermore, as shown by the experimental results with three needles, it was found that increasing the number of needles could increase the dose.

上記実験１および２の結果から、本発明の薬液注入装置を使用して薬液を経皮的に皮内へ注入することにより、所望の薬効を得ることが可能となることがわかる。   From the results of the above experiments 1 and 2, it can be seen that a desired medicinal effect can be obtained by transdermally injecting a chemical solution into the skin using the chemical solution injection device of the present invention.

なお、本発明は、上述した実施形態に限定されるものではなく、特許請求の範囲内で種々改変することができる。   The present invention is not limited to the above-described embodiments, and various modifications can be made within the scope of the claims.

たとえば上述した実施形態では、容器内の薬液を針を介して経皮的に皮内へ注入するための駆動力を提供する薬液駆動手段として、押し子が使用される場合について説明したが、本発明の薬液駆動手段はかかる場合に限定されるものではない。たとえば、容器内の薬液を押圧するための板ばねが使用されてもよい。この場合、凸形状に反って配置された板ばねの凸面を押すことにより、板ばねが初期と反対方向に凸形状となるときの力が利用される。また、容器内のガスケットを押圧するためのコイルばねが使用されてもよい。また、弾性材料からなるバルーンを利用した機構が使用されてもよい。この場合、薬液が充填されて膨張したバルーンが縮むときの力が利用される。また、薬液を送出可能な電動ポンプが使用されてもよい。また、イオントフォレシス駆動を利用した機構が使用されてもよい。この場合、電気的反発または引力によってイオン性薬物が経皮的に生体に導入される。また、高吸水性物質の体積膨張を利用した機構が使用されてもよい。この場合、体積膨張という物理変化にともなう力によって薬液が送出される。   For example, in the above-described embodiment, the case where the pusher is used as the chemical solution driving means for providing the driving force for transdermally injecting the chemical solution in the container into the skin through the needle has been described. The chemical solution driving means of the invention is not limited to such a case. For example, a leaf spring for pressing the chemical solution in the container may be used. In this case, by pressing the convex surface of the leaf spring arranged in a convex shape, the force when the leaf spring becomes convex in the opposite direction to the initial is used. Further, a coil spring for pressing the gasket in the container may be used. Further, a mechanism using a balloon made of an elastic material may be used. In this case, the force when the balloon that has been inflated after being filled with the chemical solution is contracted is used. In addition, an electric pump capable of delivering a chemical solution may be used. Further, a mechanism using iontophoresis driving may be used. In this case, the ionic drug is transdermally introduced into the living body by electric repulsion or attractive force. Further, a mechanism using the volume expansion of the highly water-absorbing substance may be used. In this case, the chemical solution is delivered by a force accompanying a physical change called volume expansion.

本発明の第１実施形態に係る薬液注入装置を示す図であって、（Ａ）は概略断面図、（Ｂ）はキャップを外した状態の底面図である。It is a figure which shows the chemical | medical solution injection device which concerns on 1st Embodiment of this invention, Comprising: (A) is a schematic sectional drawing, (B) is a bottom view of the state which removed the cap. 図１に示される針の概略拡大図である。It is a schematic enlarged view of the needle | hook shown by FIG. 針の他の例を示す概略拡大図である。It is a schematic enlarged view which shows the other example of a needle | hook. 本発明の第２実施形態に係る薬液注入装置を示す図であって、（Ａ）は概略断面図、（Ｂ）はキャップを外した状態の底面図である。It is a figure which shows the chemical | medical solution injection device which concerns on 2nd Embodiment of this invention, Comprising: (A) is a schematic sectional drawing, (B) is a bottom view of the state which removed the cap. 本発明の第３実施形態に係る薬液注入装置を示す図であって、（Ａ）は概略断面図、（Ｂ）はキャップを外した状態の底面図である。It is a figure which shows the chemical | medical solution injection device which concerns on 3rd Embodiment of this invention, Comprising: (A) is a schematic sectional drawing, (B) is a bottom view of the state which removed the cap. 皮内投与および皮下投与の場合の血中インスリン濃度を示すグラフである。It is a graph which shows the blood insulin concentration in the case of intradermal administration and subcutaneous administration. １本あるいは３本の針で皮内投与できる容量を確認するための実験結果を示す図である。It is a figure which shows the experimental result for confirming the volume which can be intradermally administered with one or three needles.

符号の説明Explanation of symbols

１、１ａ、１ｂ 薬液注入装置、
１０ 本体、
１１ 容器、
１１１ 内部空間、
１１３ 充填口、
１２ 保持体、
１２１ 凹状部、
１２２、１２２ａ、１２２ｂ 翼部、
１２３ 内側底面、
１２５ 吸引口、
１２６、１２６ｂ 翼片、
１２７、１２７ｂ 側壁、
１３ 押し子、
１３１ ガスケット、
２０、２０ａ 針、
２１、２１ａ 基部、
２２、２２ａ 穿刺部、
３０ 粘着層、
６０ キャップ、
Ｄ１、Ｄ２ 針の外径、
Ｌ 穿刺部の全長。 1, 1a, 1b chemical solution injection device,
10 body,
11 containers,
111 internal space,
113 filling port,
12 holder,
121 concave part,
122, 122a, 122b wings,
123 Inside bottom,
125 suction port,
126, 126b wing pieces,
127, 127b sidewalls,
13 Pusher,
131 gasket,
20, 20a needle,
21, 21a base,
22, 22a Puncture part,
30 adhesive layer,
60 caps,
D1, D2 needle outer diameter,
L Total length of puncture site.

Claims (14)

薬液を収容可能な容器と、
先端側に開口する凹状部を備え、前記容器を保持するための保持体と、
前記容器内と連通され前記保持体を貫通して前記凹状部の内側底面から外方へ突出する複数の中空の針と、
前記容器内の薬液を前記針を介して経皮的に皮内へ注入するための駆動力を提供する薬液駆動手段と、
前記凹状部の内側底面と皮膚とを相互に近接移動させて接触させるための接触手段と、
前記保持体の皮膚に接触可能な端面に形成された粘着剤を含む粘着層と、
を有することを特徴とする薬液注入装置。 A container that can contain a chemical solution;
A holding body for holding the container, comprising a concave portion opening on the distal end side;
A plurality of hollow needles communicating with the inside of the container and penetrating the holding body and projecting outward from the inner bottom surface of the concave portion;
A drug solution driving means for providing a driving force for transdermally injecting the drug solution in the container into the skin through the needle;
Contact means for bringing the inner bottom surface of the concave portion and the skin into close contact with each other, and
An adhesive layer comprising an adhesive formed on an end surface of the holder that can contact the skin;
A chemical injection device characterized by comprising: 前記粘着層は、前記凹状部の内側底面に形成されていることを特徴とする請求項１に記載の薬液注入装置。   The chemical injection device according to claim 1, wherein the adhesive layer is formed on an inner bottom surface of the concave portion. 前記保持体は、前記凹状部内の空気を吸引するための吸引口を有し、
前記吸引口から空気を吸引することにより、前記凹状部の内側底面に皮膚を引き寄せて接触させる請求項１に記載の薬液注入装置。 The holding body has a suction port for sucking air in the concave portion,
The chemical | medical solution injection device of Claim 1 which attracts | sucks skin to the inner bottom face of the said concave-shaped part by attracting | sucking air from the said suction port. 前記保持体は、前記凹状部の開口端近傍の側方に設けられ皮膚に当接可能な翼部を備え、当該翼部は、皮膚面と平行に内側に移動可能な少なくとも一対の翼片を有し、
前記翼片が皮膚に当接された状態で当該翼片を内側にずらすことにより、皮膚を当該翼片で挟んで持ち上げ前記凹状部の内側底面に引き寄せて接触させる請求項１に記載の薬液注入装置。 The holding body includes a wing portion provided on a side near the opening end of the concave portion and capable of contacting the skin, and the wing portion includes at least a pair of wing pieces movable inward in parallel with the skin surface. Have
2. The medicinal solution injection according to claim 1, wherein the wing piece is moved inward while the wing piece is in contact with the skin, and the skin is lifted by being sandwiched by the wing piece and brought into contact with the inner bottom surface of the concave portion. apparatus. 前記保持体は、前記凹状部の開口端近傍の側方に設けられ皮膚に当接可能な翼部を備え、当該翼部は、皮膚面と平行に外側に移動可能な少なくとも一対の翼片を有し、
前記翼片が皮膚に当接された状態で当該翼片を外側にずらすことにより、前記凹状部の側壁がつぶれて略平坦になって前記凹状部の内側底面に皮膚を接触させる請求項１に記載の薬液注入装置。 The holding body includes a wing portion provided on a side near the opening end of the concave portion and capable of contacting the skin, and the wing portion includes at least a pair of wing pieces that can move outward in parallel with the skin surface. Have
The wing piece is shifted to the outside in a state where the wing piece is in contact with the skin, whereby the side wall of the concave portion is crushed and becomes substantially flat so that the skin is brought into contact with the inner bottom surface of the concave portion. The chemical injection device according to the description. 前記針の先端の外径は、０．１ｍｍ以上かつ０．２５ｍｍ以下であり、
前記針の基端の外径は、先端の外径よりも大きいことを特徴とする請求項１〜５のいずれか１つに記載の薬液注入装置。 The outer diameter of the tip of the needle is 0.1 mm or more and 0.25 mm or less,
The medical solution injector according to any one of claims 1 to 5, wherein an outer diameter of a proximal end of the needle is larger than an outer diameter of a distal end. 前記針は、外径が先端から基端に向かって漸増している部分を有することを特徴とする請求項６に記載の薬液注入装置。   The drug solution injection device according to claim 6, wherein the needle has a portion whose outer diameter gradually increases from the distal end toward the proximal end. 前記針は、基端から前記凹状部の内側底面に対応する位置までの基部と、前記凹状部の内側底面から突出し、生体内に穿刺可能な部分である穿刺部とからなり、
前記穿刺部の全長は、１ｍｍ以上かつ２．５ｍｍ以下であることを特徴とする請求項１〜７のいずれか１つに記載の薬液注入装置。 The needle comprises a base from a base end to a position corresponding to the inner bottom surface of the concave portion, and a puncture portion that protrudes from the inner bottom surface of the concave portion and is a portion that can be punctured in a living body,
The total length of the puncture part is 1 mm or more and 2.5 mm or less, The drug solution injection device according to any one of claims 1 to 7. 前記容器は、当該容器内に薬液を充填するための充填口を有することを特徴とする請求項１〜８のいずれか１つに記載の薬液注入装置。   The said liquid container has a filling port for filling the chemical | medical solution in the said container, The chemical | medical solution injection apparatus as described in any one of Claims 1-8 characterized by the above-mentioned. 前記薬液駆動手段は、前記容器内に挿入されるガスケットに連結され使用者により押され得る押し子、前記容器内の薬液を押圧するための板ばね、前記ガスケットを押圧するためのコイルばね、弾性材料からなるバルーンを利用した機構、電動ポンプ、イオントフォレシス駆動を利用した機構、および高吸水性物質の体積膨張を利用した機構のうちのいずれかを有することを特徴とする請求項１〜９のいずれか１つに記載の薬液注入装置。   The chemical liquid driving means is connected to a gasket inserted into the container and can be pushed by a user, a leaf spring for pressing the chemical liquid in the container, a coil spring for pressing the gasket, and an elasticity 10. A mechanism using a balloon made of a material, an electric pump, a mechanism using iontophoresis driving, and a mechanism using volume expansion of a superabsorbent substance. The chemical injection device according to any one of the above. 前記針の先端を保護するためのキャップを有することを特徴とする請求項１〜１０のいずれか１つに記載の薬液注入装置。   It has a cap for protecting the front-end | tip of the said needle | hook, The chemical | medical solution injection device as described in any one of Claims 1-10 characterized by the above-mentioned. 前記保持体は、前記凹状部の開口端近傍の側方に設けられ皮膚に当接可能な翼部を備え、
前記粘着層は、前記翼部の端面と前記凹状部の内側底面とに形成され、
前記針の先端は、前記翼部の前記粘着層が形成された端面よりも基端側に位置されることを特徴とする請求項１に記載の薬液注入装置。 The holding body includes a wing portion that is provided on a side near the opening end of the concave portion and can contact the skin,
The adhesive layer is formed on an end surface of the wing portion and an inner bottom surface of the concave portion,
The medical solution injection device according to claim 1, wherein a distal end of the needle is positioned closer to a proximal end side than an end surface of the wing portion where the adhesive layer is formed. 薬液を収容可能な容器と、
先端側に開口する凹状部、および当該凹状部の開口端近傍の側方に設けられ皮膚面と平行に内側に移動可能な少なくとも一対の翼片を有する皮膚に当接可能な翼部を備え、前記容器を保持するための保持体と、
前記容器内と連通され前記保持体を貫通して前記凹状部の内側底面から外方へ突出する複数の中空の針と、
前記容器内の薬液を前記針を介して経皮的に皮内へ注入するための駆動力を提供する薬液駆動手段と、
前記翼片が皮膚に当接された状態で当該翼片を内側にずらすことにより、皮膚を当該翼片で挟んで持ち上げ前記凹状部の内側底面に引き寄せて接触させるための接触手段と、
を有することを特徴とする薬液注入装置。 A container that can contain a chemical solution;
A concave portion that opens to the distal end side, and a wing portion that is provided on a side near the opening end of the concave portion and that has at least a pair of wing pieces that can move inward in parallel with the skin surface, and can be brought into contact with the skin, A holding body for holding the container;
A plurality of hollow needles communicating with the inside of the container and penetrating the holding body and projecting outward from the inner bottom surface of the concave portion;
A drug solution driving means for providing a driving force for transdermally injecting the drug solution in the container into the skin through the needle;
A contact means for lifting the skin by sandwiching the wing piece in the state where the wing piece is in contact with the skin and pulling it to the inner bottom surface of the concave portion to make contact;
A chemical injection device characterized by comprising: 薬液を収容可能な容器と、
先端側に開口する凹状部、および当該凹状部の開口端近傍の側方に設けられ皮膚面と平行に外側に移動可能な少なくとも一対の翼片を有する皮膚に当接可能な翼部を備え、前記容器を保持するための保持体と、
前記容器内と連通され前記保持体を貫通して前記凹状部の内側底面から外方へ突出する複数の中空の針と、
前記容器内の薬液を前記針を介して経皮的に皮内へ注入するための駆動力を提供する薬液駆動手段と、
前記翼片が皮膚に当接された状態で当該翼片を外側にずらすことにより、前記凹状部の側壁がつぶれて略平坦になって前記凹状部の内側底面に皮膚を接触させるための接触手段と、
を有することを特徴とする薬液注入装置。 A container that can contain a chemical solution;
A concave portion that opens to the distal end side, and a wing portion that is provided on a side near the opening end of the concave portion and that has at least a pair of wing pieces that can move outward in parallel with the skin surface, A holding body for holding the container;
A plurality of hollow needles communicating with the inside of the container and penetrating the holding body and projecting outward from the inner bottom surface of the concave portion;
A drug solution driving means for providing a driving force for transdermally injecting the drug solution in the container into the skin through the needle;
The contact means for contacting the skin with the inner bottom surface of the concave portion by squeezing the wing piece outward while the wing piece is in contact with the skin, and the side wall of the concave portion is crushed and becomes substantially flat. When,
A chemical injection device characterized by comprising:
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