JP2012024600A - 皮内注射器 - Google Patents
皮内注射器 Download PDFInfo
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- JP2012024600A JP2012024600A JP2011209427A JP2011209427A JP2012024600A JP 2012024600 A JP2012024600 A JP 2012024600A JP 2011209427 A JP2011209427 A JP 2011209427A JP 2011209427 A JP2011209427 A JP 2011209427A JP 2012024600 A JP2012024600 A JP 2012024600A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
- A61M5/3204—Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
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- 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
- A61M5/178—Syringes
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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
- A61M5/178—Syringes
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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
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
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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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
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- 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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- 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
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- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
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- A—HUMAN NECESSITIES
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- 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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
- A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
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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
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- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M5/2046—Media being expelled from injector by gas generation, e.g. explosive charge
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- A—HUMAN NECESSITIES
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- 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
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- A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum
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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
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
- A61M5/2459—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
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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
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- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
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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
- A61M5/178—Syringes
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- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
Abstract
【課題】注射時に皮膚の泡膨れや膨れを最小限にする皮内注射器を提供する。
【解決手段】注入される物質を入れるように構成されたチャンバ58と、チャンバ58と作動的に関係付けられ、皮内注入部位に物質を送出できるだけの長さを有している針48を備えている注射装置。カラーが針48を取囲み、カラー空洞を画定している。カラーは、針48と注入部位を囲み、且つ針48と注入部位から半径方向に、患者の皮膚がカラー空洞内に入り込んで物質を注入部位に皮内送出するために針48を正しく位置決めできるようにし、そして皮膚内の背圧が前記物質を注入部位を通して押し出すのを阻止又は防止しながら、注入された物質が皮下で広がるようにする面積だけ、離れて配置されている周辺前方皮膚接触面も有している。
【選択図】図7
【解決手段】注入される物質を入れるように構成されたチャンバ58と、チャンバ58と作動的に関係付けられ、皮内注入部位に物質を送出できるだけの長さを有している針48を備えている注射装置。カラーが針48を取囲み、カラー空洞を画定している。カラーは、針48と注入部位を囲み、且つ針48と注入部位から半径方向に、患者の皮膚がカラー空洞内に入り込んで物質を注入部位に皮内送出するために針48を正しく位置決めできるようにし、そして皮膚内の背圧が前記物質を注入部位を通して押し出すのを阻止又は防止しながら、注入された物質が皮下で広がるようにする面積だけ、離れて配置されている周辺前方皮膚接触面も有している。
【選択図】図7
Description
本発明は、注入器に関する。より厳密には、本発明は、注射時に皮膚の泡膨れや膨れを最小限にする皮内注射器に関する。
ある種の物質及びワクチンは、皮内に送出する方が、筋肉内に送出する場合よりも効果的であることが分かっている。従来から物質を皮内注射するものとして皮下噴射器がよく知られているが、皮下噴射器では皮内注射を正しく行なうことができない。
皮下噴射器は、注入物質の流れを利用して皮膚の透通抵抗に打ち勝つ。この高速の物質の流れは、注入すべき物質でもある。従来の皮下噴射器では、抵抗力の大部分を与える皮膚の最上層を透通させるのに高いエネルギーを必要とする。このような透通に十分な出力を提供し、次いで表皮層の真下に当該物質を沈着させること、即ち皮内注射に求められることは、やりがいのある課題である。注入力が物質を皮内に投与するには弱すぎれば、噴射で表皮を完全には透通できないため、物質全部は送出できないことになる。注入力が物質全部を送出できるほど十分であれば、強すぎて、注入物質の殆どが皮膚の表皮層よりも遙か深いところに送出されることになる。
物質を内皮に送出することを目的とした従来の注射針による注入法は、大きな欠陥に悩まされている。この方法は、注入処置の一環として注射針を慎重に配置することが求められるので、注射をする人に多大な技量が求められる。注射器のプランジャを押し込んで従来型の装置から急速に物質を注入すると、注入部位に背圧が発生し、針を抜くと注入された物質が押し戻されて注射孔から出てしまう結果となる。物質が注入部位から戻って出るのを防ぐため注入物質をゆっくりと送出することが必要なせいで、長時間注射のような状態に置かれるのは、患者にとって快適ではない。この様に、皮内注射器の改良が必要とされている。
米国特許出願第09/779,603号
本発明は、注射器に、それも好適に皮内注射装置に関している。この注射器の或る好適な実施形態は、注入される物質を入れるように作られたチャンバを有している。このチャンバには針が作動的に関係付けられており、物質を皮内注入部位に送出できるだけの長さを有している。カラーが針を取囲み、カラー空洞を画定している。カラーは、針及び注入部位を取り囲み、且つ針及び注入部位から半径方向に、患者の皮膚がカラー空洞内に入り込んで物質を注入部位に皮内送出するために針を正しく位置決めできるようにし、そして注入された物質が注入部位に広がって注射後に針によって皮膚にできた孔から注入された物質が流れ出るような事態を引き起こす背圧を阻止又は防止できるようにする面積だけ、離れて配置されている周辺前方皮膚接触面を有している。エネルギー源は、物質を注入部位に送出する際に役立つように針に関係付けられているのが望ましい。好適なエネルギー源は、約50から300psiの注入支援圧力を物質に供給するように構成されている。
この実施形態では、カラーは円形の周辺面を有し、内径が約4mmから7mmで、カラーの皮膚接触面は不連続となっている。皮膚接触面は、不連続ギャップを画定し、皮膚接触面とギャップは一緒になって閉形状を画定している。皮膚接触面は、閉形状の少なくとも約50%を占めているのが望ましい。更に、閉形状は丸くなっているのが望ましいが、適していれば他の形状であってもよい。好適な形状は円形で、不連続ギャップは、その形状に沿って実質的に等間隔に離して配置されているのが望ましく、少なくとも2つの実質的に大きさが等しい連続部分がこの不連続ギャップによって分離されているのがより望ましい。好適な針は、その遠位送出端が、皮膚接触面の前方端の約0.5mm範囲内に設けられている。
本発明は、物質の皮内投与の方法にも関する。好適な方法では、針と注入部位を取り囲んでいる面積分だけ針から離間した表面に皮膚を接触させている間に、物質は針を通して皮内注入部位に送出される。この面積は、患者の皮膚の注入部位に、相当量の注入された物質を針孔から押し出すような背圧を発生させること無く、物質を皮内注入できるようにするのに十分な大きさである。物質の送出は、物質に圧力をかけることにより支援するのが望ましく、この圧力は約50から300psiの間であるのが望ましい。針は後退位置から伸展位置に動かされ、伸展位置では、針は、患者の体内に物質を注入するため加圧ガス源を駆動的に関係付けることにより露出され、物質が注入されるとガスは抜かれ、ガスが抜かれると、針は、弾性的に変形された弾性部材で針を後退させるように付勢される。
或る注射器の実施形態の針は、後退位置を有しており、この後退位置は注射器本体内に在ってもよく、また伸展位置も有しており、この伸展位置では、針は、患者を透通して物質を注入するように配置されている。弾性針キャップが鋭利な針先端部を覆っており、このカバーは、針が伸展位置にある状態では弾性的に変形して、針を伸展位置から後退位置に向けて付勢するように配置、構成されている。
針は、後退位置から伸展位置に移動するときにはキャップを穿通するように配置されている。更に、或る実施形態は、圧縮ガスが入っているガスチャンバと、物質を注入するために針のような送出導管を通して物質を押し出すため、送出対象の物質に対して圧縮ガスで付勢されるプランジャと、を有している。プランジャとガスチャンバは、一旦プランジャが所定位置へ動かされ所定量の物質を注入すると、圧縮ガスがガスチャンバから放出され、キャップ又は使用されている他の弾性部材が針を後退させるように関係付けられている。
図1に示すように、外側ハウジング10は、近位端と遠位端14、16を有する望ましくは細長い円筒形の本体12を備えている。本出願の実施形態に関して使用する場合は、「遠位」という用語は注射器の前方に向う端又は方向を指し、「近位」という用語は注射器の後方に向かう端又は方向を指す。針穴18は、ハウジング10の前方即ち遠位端に配置され、ハウジングの内部から伸展する注射針を受け入れるように構成され、その大きさが決められている。
トリガアッセンブリ24は、近位端14に配置されるのが望ましいが、他の実施形態では、遠位端を含め注射器の他の部分に配置されている。トリガアッセンブリ24は、ボタン26を含んでおり、このボタンを、望ましくは軸方向にハウジング10内に押し込むと注射器を発射できるようになっている。トリガアッセンブリ24は、注射器を発射するのを選択的に防止するための安全ロックを含んでいる。図示の実施形態では、安全ロック28は、ボタン26の一部として構成され、注射器の発射を防止又は許容するロック位置とロック解除位置の間で軸方向に回転させることができるようになっている。
ボタン26には、装填位置に発射部材を保持する発射ラッチが設けられている。発射部材は、発射シリンダ30を備えているのが望ましく、図1では装填位置にある状態を示している。好適な発射部材30は、実質的に円筒形で、内部内腔32とその外側の両方に大径部と小径部を有しているが、他の実施形態では単一の内径と外径を有し、或いは別の形状を有する。
発射シリンダ内腔32にはピストン34が入っており、ピストン34は、外側ハウジング10に固定されているのが望ましい。ピストン34は、内腔32とピストン34の間に画定されたガスチャンバ36内に、注射器を発射させることができるだけの圧縮ガスの量と圧力を保持するために、望ましくは漏れの無いような関係で、シリンダ内腔32に挿入されている。圧縮ガスは、圧縮状態で提供してもよいし、注射器の発射の際に起動する様な、内部に入っているガス発生器の反応による生成物であってもよい。ガスチャンバ36内のガスをシールするために、Oリングのようなシール38を、ピストン上の溝40に配置するのが望ましい。好適なガスは二酸化炭素であるが、適していれば他のガスを使用してもよい。別の実施形態では、注射器を発射するのに、コイルばねの様な別のエネルギー源を採用している。
プランジャ42は、発射シリンダ30の前方に配置され、注射器が発射されると、発射シリンダ30がプランジャ42を遠位方向に押し出すように、発射シリンダ30と作動的に関係付けられている。プランジャ42は、薬剤カートリッジ44の中に入っており、このカートリッジには薬剤が入っているのが望ましいが、他の適切な流体が入っていてもよい。図1に示すように、プランジャ42は、薬剤カートリッジ44の大径部46内に配置されている。
中空の注射針48は、薬剤カートリッジ44の内部に開口しており、薬剤カートリッジ44に固定され、近位の鋭利な端部50がカートリッジの内部に突き出し、遠位の鋭利な端部52は、針開口部18と整列して薬剤カートリッジ44から突き出ているのが望ましい。この好適な実施形態では、針48の近位の鋭利な端部50は、大径部46と小径部56を分離し、接触するとプランジャ42の遠位方向への動作を止めるように構成されている肩部54の遠位方向に配置されている。
ストッパ60は、薬剤カートリッジ44内に、望ましくは狭くなった部分56内に配置されている。ストッパ60は薬剤チャンバ58をシールし、薬剤チャンバ58は、図示の装填位置では、薬剤カートリッジ44の大径部58内のプランジャ42とストッパ60の間に画定されている。また、装填位置では、ストッパ60は、薬剤チャンバ58と針48を分離している。
針キャップ62は、針48の周りに、望ましくは針48と針開口部18の間に、遠位の鋭利な端部52の前方を取り囲むように配置されている。図示の実施形態では、針キャップ62は、薬剤カートリッジ44の針ホルダ延長部64に嵌め込まれている。針キャップ62は、近位端14に向って近位方向にカートリッジ44と針48を付勢し後退させるだけの弾性があるのが望ましい。或る別の実施形態は、外側ハウジングの外側に取り付けられた針キャップを有している。この別の実施形態は、カートリッジと針を近位方向に付勢する弾性要素を有しているのが望ましい。
図1から図4に示すように、カラー20は、外側ハウジング10の外側で針開口部18を取囲んでいるのが望ましい。カラー空洞22は、カラー20内に画定され、カラー20及び針開口部18と実質的に同軸であるのが望ましい。カラー20は、針48と針開口部18を取囲み両者から半径方向に間隔を空けて設けられた周辺皮膚接触面66を有している。この間隔、並びにカラー空洞の軸方向の深さは、患者の皮膚がカラー空洞22内に入り込んで、望ましくは患者の皮膚の中又はその下に膨れや泡膨れを発生させること無く、物質を注入部位に皮内送出するために針を正しく位置決めすることができ、且つ皮膚内の背圧により物質が注入部位から押し出されるのを阻止又は防ぎつつ皮下で注入された物質が広がることができるようにする面積分だけ、皮膚接触面66を注入部位から間隔を空けて配置できるように選択されている。
注射器カラー20の形状は、注入される物質または薬剤の皮内配置に影響を及ぼす。カラー20とカラー空洞22の直径が小さすぎると、物質は膨れ又は泡膨れ状に注入されることになり、皮膚の外側の層を風船のように引き伸ばしてしまう。注射器を外すと、物質は針穴を通って直ちに泡膨れから出て行くので、注入した物質の一部又は全部が失われることになる。好適な皮膚接触面66は、この膨れ又は泡膨れ作用を低減又は無くすように構成されている。
好適なカラー20と皮膚接触面66は、閉形状で丸みを帯び、円形又は概ね楕円形の周辺部が患者の皮膚と接触するような形状である。図1−4の実施形態では、この周辺部は円形である。人の腕又は脚に実施する殆どのワクチン注射の場合、少なくとも約4mmの直径が望ましい。約2mmから10mmの直径が好適であり、注入される物質にもよるが、一般的には約4mmから7mmの直径が最も有用である。
この好適な実施形態では、カラー20と皮膚接触面66は、不連続で、皮膚接触面66を分割する不連続ギャップ68を画定している。皮膚接触面66は、針開口部18を取り囲むように配置され、角度的には、皮膚接触面16とギャップ68との組み合わせで画定される、針開口部18を取り囲むの仮想線による閉連続形状の、望ましくは少なくとも約50%、より望ましくは少なくとも約65%、最適には約90%を占めるように配置されているのがよい。好適なカラー20は、不快感を生じさせること無く患者の皮膚に注射器を正しく位置決めできるだけの皮膚接触面66の表面積を残しつつ、且つ正確な位置に注入できるように皮膚を引き伸ばせるだけの接触を作り出しながら、カラー20の2つ、3つ、又はそれ以上のギャップ68、即ち切り取り部を画定している。カラー20又は皮膚接触面66が円形の場合、カラー20の周辺回りに等間隔に間隔を空けた位置に、実質的に等量の除去領域即ちギャップ68を設けるのが好ましい。別の実施形態は、ギャップのない実質的に連続したカラーを有している。好適なカラー20は、丸みの付いた断面を有する外壁67と、実質的に平坦で軸方向の内壁69とを有し、それは軸から約20°未満の角度に配置されているのが望ましい。他の実施形態では、使用目的次第で、全壁を丸くしてもよいし、全壁を平らにしてもよいし、或いは内壁に丸みを付け外壁を平坦にしてもよい。
別の実施形態では、皮膚接触面が不連続な小直径の円又は楕円形のカラーを採用している。これは、間隔を空けて表面部分を設けるか、又は表面の一部を除去することで作り出せる。これにより皮膚に作用するカラーの力が小さくなり、皮膚の層と層の間の正しい位置に注入できるようになる。1つの望ましい例として、外径が約7mmで内部開口部が約4mmの大きさが等しい2つの半殻を有する等分割円形カラーがある。別の実施形態は、長軸又は短軸に沿って、或いはその両方に沿って分割された楕円形カラーを有している。図5及び図6の実施形態は、カラーの外側は実質的に円形であるが、短軸に沿って分割された楕円形カラー空洞72を画定しているカラー70を有している。従って、カラー70の肉厚はその外周に沿って変化する。
皮膚接触面は、その名が示唆するように皮膚に接触するように構成されている。ギャップは、皮膚上の特定の箇所の圧力を逃がし、望ましくは注入のために注射器が皮膚に押し付けられた際には皮膚と接触し続けるようになっている。図示の実施形態では、皮膚接触面66は実質的に平坦であるが、他の適した形状を使用することもできる。
図1と図7に示すように、注射器を使用する場合、カラー20は、ユーザーの皮膚78に押し付けられ、皮膚がカラー空洞22に入り込む。ボタン26を押すと、ラッチが外れて発射シリンダ30が放たれる。ガスチャンバ36内の圧縮ガスが、ピストン34と発射シリンダ30を押すように作用して、発射シリンダ30を、図7に示すように遠位方向に付勢し移動させる。すると発射シリンダ30はプランジャ42を遠位方向に押し、これにより薬剤チャンバ58内の流体と薬剤カートリッジ44が付勢され、針キャップ62が外側ハウジング10の遠位壁74に押し付けられることになる。針48は、こうして図示の後退位置から伸展位置へと、針開口部18を通ってカラー空洞72へ、そしてユーザーの皮膚78内へ所定の距離、移動する。ピストン42は、遠位方向に進むにつれ、薬剤チャンバ58内の流体を移動させ、ストッパ60も遠位方向に動かす。すると、針48の近位端50がストッパ60を貫き、針48の内部と薬剤チャンバ58が流体連通状態になる。プランジャ60が継続して遠位方向に移動することにより、流体は針48を通ってユーザーの皮膚内に注入される。
発射シリンダ30とピストン34は、ガスチャンバ36から圧縮ガスを放出できるように構成されているのが望ましい。図示の実施形態では、発射シリンダ30とピストンの長さは、発射シリンダ30の近位側の面取り部分76がピストン34の遠位側のシールを通り越してシールを解除し圧縮ガスを逃がすよう配置されるように選択される。ガスが逃げてガスチャンバ36内の圧力が低下すると、弾性針キャップ62又は代わりに採用されたばねは、薬剤カートリッジ44と針48を近位方向に後退させハウジング10内に引き戻す。この装置は、ガス圧力を注射器内のエネルギー源から発射及び逃がす場合にも使用できる。
伸展位置では、針48は、使用目的次第で、皮膚接触面66の前方端の近位側又は遠位側に、又は実質的にそれと面一に配置することができる。或る好適な実施形態では、針48は、皮膚接触面66の前方端から後方に即ち近位方向に、最長で約1mmの位置に、より好適には最長で約0.5mmの位置に、そして最短ではこれと略面一に、より好適にはそこから近位方向に少なくとも約0.2mmの位置に配置される。別の好適な実施形態では、針48は、皮膚接触面66の前方端の前方に即ち遠位方向に、最長で約1mmの位置に、より好適には最長で約0.5mmの位置に、そして最短ではこれと略面一に、より好適にはそこから遠位方向に少なくとも約0.2mm又は0.3mmの位置に配置される。或る面一の実施形態では、針48は、伸展位置で、皮膚接触面66の前方端のどちらかの側に、約0.2mmの間に、より望ましくは0.1mm以内に、最適には約0.05mm以内又はそれ以上近くに配置される。或る実施形態では、皮膚接触面66に対する針48の遠位端の位置と、カラー20及び皮膚接触面66の形状と大きさは、患者の注入部位における注入深度が約0.2インチになるように選択される。
送出される流体物質は、溶液であるのが望ましく、液体状のワクチンであるのが更に望ましい。上記の様に、ワクチンの皮内送出は、筋肉注射で送出するよりも更に効果的であることが分かっている。比較的少量、通常は約50マイクロリットル程度を投与するが、装置は約25から100マイクロリットルの間で投与できるように設計されている。
本発明の好適な実施形態では、ジェットスプレイは不要であるが、別の実施形態では使用することもできる。物質の好適な皮内注入は低い圧力で支援される。この圧力は、注射装置から針が突き出る長さによって変わるが、一般的には約50から300psiの圧力範囲であれば、物質を所望の位置及び箇所に投与するのに十分である。流体を真皮より深く注入させない実施形態では、従来の針なし注射装置で得られるような、皮膚の層と層の間ではなくて真皮より下方に物質を注入するような高圧は回避すべきであり、さもないと、物質はあまりに深いところに入ってしまい、皮内注入の目的を無にしてしまう。圧力支援注入は、圧力範囲65から250psiで行うのが望ましく、75から150psiであれば更に望ましい。
この圧力は、コイルばね、ガス推進剤、又は上記ガススプリングの様なエネルギー源を有している装置で容易に実現できる。カラーには、注射器に、所望量の物質の送出に対応する所定の距離だけプランジャを押す際のユーザーの親指の力により与えられる圧力も加わる。カラーは、針が、所望の箇所に物質が正しく送出されるように適切に位置決めされることを保証する。
或る実施形態では、注射装置は、注射器の遠位端に皮膚接触面を備えたハウジングと、注射器の遠位端の後退可能な注入支援針と、針の少なくとも一部を滑動可能に受け入れる開口部を有する流体チャンバと、流体チャンバ内を動けるプランジャと、トリガアッセンブリと、トリガアッセンブリを動かすとエネルギー源が起動してプランジャを第1の方向に動かし流体を流体チャンバから追い出すように、トリガアッセンブリと作動的に関係付けられているエネルギー源と、を含んでいる。後退可能な注入支援助針は、針の遠位端に位置する針の先端部と、流体が追い出されるオリフィスで終端している針先端部内の排出流路と、を有している。針は、エネルギー源が起動する前は、ハウジング内の後退位置にある。エネルギー源が起動するとプランジャは第1方向に移動し、その結果、針の少なくとも一部が、皮膚接触カラー内へと針挿入点まで前方に移動して、流体を、針の先端部を経由し針挿入点を通過させ針注入部位まで追い出す。針挿入点は針先端部にあり、針注入部位は針先端部に対して遠位方向にある。後退要素は、エネルギー源の作動後に針先端部をハウジング内部の後退位置に戻す。
2001年2月9日出願の米国特許出願第09/779,603号には、皮膚接触面を設けたカラーを含むように変更できる他の適した注射装置が記載されており、その内容を本願に参考文献として援用する。
ここでは、本発明の例示的実施形態を開示しているが、理解頂けるように、当業者であれば多くの変更並びに他の実施形態を考案できるであろう。例えば、カラーの不連続ギャップは、カラーから剪断切除するものに限らない。カラーは、突出部分と隣接する窪み部分を有しており、それらがギャップであり、周囲を取り囲む突起を備えた連続面とカラーが追従する形状を有している。従って、特許請求の範囲に述べる内容は、本発明の精神と範囲に含まれるそのような変更と実施形態の全てを包含することを意図しているものと理解頂きたい。
Claims (11)
- 皮内注射装置において、
薬剤チャンバと流体連通している通路を含む針と、
注入される物質を入れるように構成されたチャンバと、
前記針を取り囲み薬剤チャンバに収容されている薬剤を注入部位に皮内送出するように前記針と関連付けられた送出位置を形成し、かつ薬剤が注入部位を通して押し戻されるのを阻止すべく注入部位での背圧を阻止するように寸法付けられたカラーと、を備えた
皮内注射装置。 - 前記送出位置で前記針の送出端が前記カラーの前面の後方に配置される、請求項1に記載の注射装置。
- 前記薬剤の皮内送出を容易にする注入力を付与するように形状づけられたエネルギー源を更に備えている、請求項1又は2に記載の注射装置。
- 前記注入力は、前記物質に対して約50から300psiである、請求項3に記載の注射装置。
- 前記カラーは、円形周辺面と、約4mmから7mmの内径を有している、請求項1ないし4の何れかに記載の注射装置。
- 前記カラーの前面は不連続である、請求項1ないし5の何れかに記載の注射装置。
- 前記皮膚接触面は不連続なギャップを画定し、前記皮膚接触面と前記ギャップは一緒になって前記針の周りに閉形状を画定しており、前記皮膚接触面は前記閉形状の少なくとも約50%を占めている、請求項6に記載の注射装置。
- 前記閉形状は丸くなっている、請求項7に記載の注射装置。
- 前記不連続なギャップは、前記形状に沿って実質的に等間隔に配置されている、請求項6から8の何れかに記載の注射装置。
- 前記皮膚接触面は、前記不連続なギャップにより分離された少なくとも2つの実質的に大きさの等しい連続部分を有している、請求項6から9の何れかに記載の注射装置。
- 前記針は或る位置を有する送出端を有しており、それは前方皮膚接触面の約0.5mm以内に配置されている、請求項1ないし10の何れかに記載の注射装置。
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- 2003-02-11 WO PCT/US2003/003917 patent/WO2003068290A2/en active Application Filing
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Also Published As
Publication number | Publication date |
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JP2007222661A (ja) | 2007-09-06 |
US20140303558A1 (en) | 2014-10-09 |
US8758299B2 (en) | 2014-06-24 |
EP1476210B1 (en) | 2008-09-24 |
US20120179100A1 (en) | 2012-07-12 |
EP1476210A2 (en) | 2004-11-17 |
JP2005516737A (ja) | 2005-06-09 |
JP2014168691A (ja) | 2014-09-18 |
AU2003209095A1 (en) | 2003-09-04 |
CA2475573A1 (en) | 2003-08-21 |
BR0307589A (pt) | 2005-02-01 |
US20050033234A1 (en) | 2005-02-10 |
WO2003068290A3 (en) | 2004-01-29 |
US20130231612A1 (en) | 2013-09-05 |
EP1476210A4 (en) | 2005-05-25 |
US8162886B2 (en) | 2012-04-24 |
ES2314182T3 (es) | 2009-03-16 |
JP5721598B2 (ja) | 2015-05-20 |
US20160213859A1 (en) | 2016-07-28 |
KR20040103930A (ko) | 2004-12-09 |
CA2475573C (en) | 2013-03-26 |
US10646662B2 (en) | 2020-05-12 |
JP5060155B2 (ja) | 2012-10-31 |
US9737670B2 (en) | 2017-08-22 |
US20170340838A1 (en) | 2017-11-30 |
AU2003209095A8 (en) | 2003-09-04 |
JP3993169B2 (ja) | 2007-10-17 |
US9333309B2 (en) | 2016-05-10 |
WO2003068290A2 (en) | 2003-08-21 |
ATE409057T1 (de) | 2008-10-15 |
DE60323729D1 (de) | 2008-11-06 |
US8419686B2 (en) | 2013-04-16 |
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