JP5271422B2 - 自己注射器装置 - Google Patents
自己注射器装置 Download PDFInfo
- Publication number
- JP5271422B2 JP5271422B2 JP2011537700A JP2011537700A JP5271422B2 JP 5271422 B2 JP5271422 B2 JP 5271422B2 JP 2011537700 A JP2011537700 A JP 2011537700A JP 2011537700 A JP2011537700 A JP 2011537700A JP 5271422 B2 JP5271422 B2 JP 5271422B2
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- needle
- container
- housing
- roller
- drug
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- 239000007924 injection Substances 0.000 title description 37
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Images
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Landscapes
- Health & Medical Sciences (AREA)
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- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
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- Hematology (AREA)
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- Vascular Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Physics & Mathematics (AREA)
- Fluid Mechanics (AREA)
- Environmental & Geological Engineering (AREA)
- Diabetes (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
図1A〜1Dは、自己注射器装置の一つの実施態様を概略的に図示する。
図1Aは、自己注射器装置10の組立における工程を概略的に図示し、そのより完全な組立品が図1Bに示されている。
図1Aにおいて、ニードル部分組立品12は可撓性基体14の平らな部分の所定の位置に置かれる。
図2A〜2Gは、数100によって一般的に示されている、再使用自己注射器装置の使用方法を示す連続的な一連のイラストで構成される。装置100は、カートリッジ組立品106の除去及び交換を可能にするために、図2B及び2Cにおいて示されるように開けられ得る蓋104を有するハウジング102を含む。
カートリッジ組立品106の構成の詳細が図3〜9において見られる。図3はカートリッジ組立品106の近位端面図である。図4はカートリッジ組立品106の右側面図である。図5はカートリッジ組立品106の下面図である。図6はカートリッジ組立品106の平面図である。図7はカートリッジ組立品106の部材を示す分解透視図である。図8A及び8Bは二つの異なる操作位置におけるカートリッジ組立品を示す。
1.PPはポリプロプレンである。
2.PCTFEはポリクロロトリフルオロエチレンである。ポリクロロトリフルオロエチレンは、全ての提案ポリマー中で最良の水バリア性を有するフッ素ポリマーである。それはHoneywell社の製品であるALCAR(登録商標)の商標でも知られている。
3.EVOHはエチレンビニルアルコールである。エチレンビニルアルコールは卓越した酸素バリア性を有するが水蒸気は通す傾向があるポリマーであるため、外層によって全て保護されなければならない。
4.SIOxは酸化珪素である。それはPETフィルム上にコーティングされた非常に薄いガラス層である。
コーティングプロセスは多くの異なる方法で達成できる。
別のオプションは、シールされた内部金属箔の二次包装である透明で可撓性薬物封入フィルムを利用することである。このオプションは高い溶存酸素及び水分安定性の低い損失という要求事項を有する薬物にとって適している。それは製造時に、そして使用者による注射前の薬物の目視検査が可能であり、そして紫外線への感受性が少ないという利点を有する。この解決法はまた、非常に高い安定性の要求事項を有する薬物にとっても、つまり二次包装が窒素下でシールされるか又は酸素吸収材料を含有する場合の薬物にとって適する場合がある。そのような実施態様は、例えばカートリッジ106が箔包装700内の所定位置に置かれて示されている図35〜37において示されている。包装700は、それらの外周周りで一緒にシールされる下層702及び上層704からできている。上層704は、図36及び37において最もよく見られるように、カートリッジ106の貯蔵のための内部スペース710を作出するために隆起している。ノッチ706及び708は、カートリッジ106が使用のために除外できるように、包装の幅と交差してそれが引き離され得るように、包装700中に事前に形成される。包装700は、好ましくは水蒸気及び空気不透過性の金属箔材料で作られる。前述のように、包装の内部710は、窒素下でシールされるか又は酸素吸収剤を含有し得る。可撓性容器108は、それが製造されるとき、そして使用のために包装700からそれが取り除かれるとき、それが薬剤で満たされていること、そして薬剤が澄んでいて粒子を含有しないことを確認するために目視検査され得るように、透明な材料で作られるであろう。
可撓性容器108の形状及び寸法は、種々の配慮に基づいて選択され得る。幾つかの代替例が図26A〜26Hにおいて示され、そして可撓性容器108を構成するための可撓性フィルム成形の使用によって与えられる設計柔軟性の故に、任意の所望の形状を容易に形成でき、そして装置100と共に利用できることが当然のことと理解されるであろう。
カートリッジ組立品106以外の装置100の部分の構成の詳細が図10〜24において最もよく示されている。デバイスの主要な内部作用部材を図示しそして述べるために、図10〜24の再使用装置、及び図25の使い捨て装置が概略的な形で示されていることが当然のことと理解されるであろう。一連の図2A〜2Gにおいてよりよく示されている装置100の外部機構に関して、装置100の更なる詳細を以下に説明する。
以下の表IIでは装置100に対する一回の完全な注射サイクルを通して要求されるインターロックが記載されている。表IIにおいて可撓性容器108はサシェ(sachet)と称される。
図27
上述の図1〜24の実施態様において、薬剤が可撓性容器から排出される、ローラーと可撓性容器の間の相対的な動きの間、可撓性容器はハウジングに対して固定された位置に保持されており、そしてローラーは、ハウジングに対して長手方向に動いて、可撓性容器の上を転って、薬剤を排出する。ローラーをハウジングに対して固定された位置に保持し、一方で可撓性容器をハウジングに対して長手方向に動かすことによっても、ローラーと可撓性容器の間の同じ相対的な動きを達成するこができる。図27〜30において、幾つかのそのような配置が概略的に図示されている。
図28は、図28の実施態様において、患者の体内へ最初に部分的に針を挿入するために、第二カートリッジが供されることを除いて、図27のそれと幾分似ている実施態様を概略的に図示している。
図29は、一般的に符号500によって指定されている、固定ローラーの別の実施態様を概略的に図示する。
図30は、それが第二の運び台602を追加すること以外、図29の実施態様と同様の、数600によって指定されている、更なる実施態様を概略的に図示する。他の部材は図29におけるものと同じ番号が付けられている。
図25は、自己注射器装置の使い捨て実施態様の概略的な分解透視図である。図25は、図10と多くの態様において類似しており、そして図10の部材と同じ図25の部材は、図10において使用されたものと同じ数字で識別され、そして変更されたそれらの部材はダッシュ記号の接尾辞をつけて示される。このように図25の装置は装置100’と呼ばれる。ハウジングはハウジング本体102’及び蓋104’を含むが、蓋は繰り返し開閉のために設計されてはいない。その代わりに、蓋104’は、ハウジング102’、104’が、使用者によってハウジングへの損傷なしではアクセス不可能である内部202を有するクローズド使い捨てハウジングを含むように、ハウジング本体102’に恒久的に取り付けられるように設計されている。
図41及び42〜43は、使い捨て注射器デバイス100’を用いて使用することができる外部包装の二つの異なるタイプを示す。
ここで図9〜24及び図2A〜2Gの概略図に関して、装置の使用方法を述べる。
(a)患者の体101に対して自己注射器装置100又は100’の近位端272を置く―患者の体101は単に概略的に図示されており、そして例えば注射部位として一般的に使用されるような患者のアーム又は腿であり得る;
(b)例えば、図2Eにおける矢印103によって示されるのと同じものを押し下げることによって、第二のトリガー270を手動で解放することにより、主駆動ばね226を解放する;
(c)針144が装置100又は100’の近位端272から外に延び、それによって針144を患者の体101内に挿入するように、主駆動ばね226を用いて装置100又は100’内で針144を近位に駆動する;及び
(d)針144が患者の体101内に挿入された後又は挿入中に、主駆動ばね226を用いて装置100及び100’内の可撓性容器108に亘ってローラー210を転がすことによって、ローラー210と可撓性容器108の間の相対的な動きを生みだし、そしてそれによって薬剤を患者の体101内に針144を通して薬剤容器108から外に強制的に出す。薬剤を容器から強制的に出すための、ローラーと可撓性容器の間の相対的な動きの中で、薬剤が容器から針に流れることができるように、可撓性薬剤容器内の壊れやすいシールが破られる。
図31A〜31B
先に述べたように、ローラー210は、ハウジング中に配列されそして可撓性容器108に係合するために、そして針144を通して可撓性容器108から薬剤を排出するために置かれたローラー210として記載され得る。図31〜34は、ローラーポンプ210を代替し得るであろう代替ポンプの配置を概略的に図示する。
ここで図32A〜32Bを参照すると、磁気ポンプ620は一対の磁石622及び624を含む。一方の端部で磁石は626で旋回可能なように連結されている。他方の端部で、その内に可撓性容器108が置かれているそれらの間の隙間630を画成するように、628で概略的に示されている機械的ブロッキングデバイスが磁石を離して保持する。機械的ブロッカー(mechanical blocker)628を除く際に、磁石622は磁石624に向かって動き、そうすることで隙間630を閉じ、そして図32Bにおいて概略的に図示されているような位置に可撓性容器108を潰すために可撓性容器108に圧力をかけ、そうすることで薬剤を可撓性容器108から排出する。磁気ポンプ620は可撓性容器108の反対側に一対の磁石622及び624を含むものとして記載され得る。
図33A〜33Bは、可撓性容器108の反対側の電磁石642及び磁気的にひきつける塊(magnetically attractive mass)644を含む電磁石ポンプ640を概略的に図示する。電磁石642は、ワイヤ648を介して電池646から電力を受ける電気コイル型磁石であり得る。磁気的にひきつける塊644は鋼板であり得る。図33Aの作動されていない位置において、隙間650は電磁石642と鋼板644の間に画成され、そして可撓性容器108は隙間650中に置かれる。
図34A及び34Bは代替ポンプ装置660を概略的に図示し、ここでポンプは弾性材料でできた可撓性容器108の構造を含むため、容器は図34Aにおいて示されるような膨張された位置へと圧縮することができる。薬剤を可撓性容器108から排出することが望まれるとき、壊れやすいシール143は如何なる適切な手段によっても孔を開けられ、そうすることで可撓性容器108の引き伸ばされた壁が図34Bの位置に後退することが可能になり、そうすることで薬剤が可撓性容器108から、そして破られシール143を通ってニードルハブ140へと強制的に出される。
Claims (14)
- 自己注射器装置であって:
液体薬剤を含む可撓性容器;
容器と連通した針;
ハウジング、ここで容器がハウジング中に受けられる;
可撓性容器と係合するように、そしてポンプと容器の間の相対的な動きの際に、針を通して薬剤を容器から排出するように、ハウジング中に配列され、そして位置決めされるポンプ;及び
針がハウジング中に完全に受けられる第一の針位置から、針がハウジングから突出する第二の針位置へと針を延ばすように、針と操作可能に関連付けられる主駆動ばね;
を含み、主駆動ばねが、ポンプと可撓性容器の間で相対的な動きを作出するために、ポンプと操作可能に関連付けられる、
上記装置。 - 請求項1に記載の装置であって:
薬剤を容器から排出後、針をハウジング内に後退させて戻すように、針と操作可能に関連付けられる後退ばね
を更に含む、上記装置。 - 請求項2に記載の装置であって:
ハウジングが、ハウジング内部及び開口部を有するハウジング本体、及びハウジング本体に可動に取り付けられるハウジング蓋を更に含み、ここで、その蓋が、開口部を閉じる閉位置と、ハウジング内部が開口部を通してアクセス可能である開位置との間を可動である、
上記装置。 - 請求項3に記載の装置であって:
蓋の開口部が主駆動ばね及び後退ばねを延ばすように、蓋を主駆動ばね及び後退ばねに連結するコッキングリンケージ
を更に含む、上記装置。 - 請求項1に記載の装置であって:
ハウジング中を往復動可能に配列された容器運び台を更に含み、ここで容器が、第一と第二の針位置に対応する第一と第二の運び台位置の間でハウジング内を、運び台、容器及び針が一緒に可動であるように、運び台中に受ける、
上記装置。 - 請求項5に記載の装置であって:
ニードル戻しシャーシ;
ハウジング及びニードル戻しシャーシ間を連結した後退ばね;
ニードル戻しシャーシ及び容器運び台と操作可能に関連付けられるインターロック、ここでインターロックは、後退ばねが針戻しシャーシ、容器運び台、容器及び針を、針がハウジング中に完全に戻って受けられる安全な位置へと引くことができるように、ポンプが薬剤を容器から排出後、ニードル戻しシャーシを解放する;
を更に含む、上記装置。 - 請求項5に記載の装置であって:
ポンプがローラーを含み;
容器運び台がローラートラックを含み;そして
ローラーが、ローラーが可撓性容器の上を転がるにつれて、ローラーがローラートラックによって誘導されるように、ローラートラック中に受けられる;
上記装置。 - 請求項7に記載の装置であって、
主駆動ばねが針をその第二の針位置に移動した後まで、ローラーが可撓性容器の上を転がるのを防止するための、ローラーと容器運び台の間のローラーインターロック、
を更に含む、上記装置。 - 請求項1に記載の装置であって:
可撓性容器及び針が、ハウジング中に交換可能に受けられる交換可能なカートリッジ組立品の部分として一緒に連結され;そして
ポンプ及び主駆動ばねが、逐次交換可能なカートリッジ組立品を用いる再使用のためにハウジングに連結される;
上記装置。 - ポンプがローラーを含む、請求項1に記載の装置。
- ポンプが膨張可能なバルーンを含む、請求項1に記載の装置。
- ポンプが、可撓性容器の対向側に一対の磁石を含む、請求項1に記載の装置。
- ポンプが、可撓性容器の対向側に電磁石及び磁気的に引き付けられる塊を含む、請求項1に記載の装置。
- ポンプが可撓性容器の内部と連通した流体圧力源を含む、請求項1に記載の装置。
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2012
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- 2012-03-14 HK HK12102570.0A patent/HK1161991A1/xx not_active IP Right Cessation
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2013
- 2013-05-14 JP JP2013102324A patent/JP5907929B2/ja active Active
- 2013-06-25 JP JP2013132411A patent/JP5943879B2/ja active Active
- 2013-08-05 US US13/958,999 patent/US20130324933A1/en not_active Abandoned
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2014
- 2014-02-19 US US14/183,991 patent/US20140171871A1/en not_active Abandoned
- 2014-02-19 US US14/184,055 patent/US20140171872A1/en not_active Abandoned
- 2014-03-05 JP JP2014042360A patent/JP2014128706A/ja active Pending
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2015
- 2015-01-09 HK HK15100271.3A patent/HK1199848A1/xx not_active IP Right Cessation
- 2015-12-27 IL IL243299A patent/IL243299B/en active IP Right Grant
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2016
- 2016-10-19 US US15/297,305 patent/US20170035972A1/en not_active Abandoned
- 2016-10-19 CY CY20161101044T patent/CY1118234T1/el unknown
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2017
- 2017-01-26 US US15/416,267 patent/US20170128665A1/en not_active Abandoned
- 2017-06-19 US US15/626,297 patent/US20170281854A1/en not_active Abandoned
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2018
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2019
- 2019-05-01 US US16/400,492 patent/US20190255254A1/en not_active Abandoned
- 2019-10-18 US US16/657,942 patent/US20200254182A1/en not_active Abandoned
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2020
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