JP2015505513A - 低い引き込み起動力を有するプランジャサブアセンブリおよび自動注入器 - Google Patents
低い引き込み起動力を有するプランジャサブアセンブリおよび自動注入器 Download PDFInfo
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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
-
- 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
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
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- 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
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- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
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- A—HUMAN NECESSITIES
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- A61M5/3232—Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
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- 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
- A61M2005/208—Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
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- A61M2005/3235—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user triggered by radial deflection of the anchoring parts between needle mount and syringe barrel or needle housing, e.g. spreading of needle mount retaining hooks having slanted surfaces by engagement with correspondingly shaped surfaces on the piston at the end of an injection stroke
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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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- 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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- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
- A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
- A61M2005/3235—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user triggered by radial deflection of the anchoring parts between needle mount and syringe barrel or needle housing, e.g. spreading of needle mount retaining hooks having slanted surfaces by engagement with correspondingly shaped surfaces on the piston at the end of an injection stroke
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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
- 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
- A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
- A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
- A61M2005/3239—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user triggered by dislodgement of outer part anchoring the needle portion to the inside of the syringe barrel wall, e.g. a ring-shaped portion
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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
- 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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- A61M5/321—Means for protection against accidental injuries by used needles
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- A61M2005/3241—Needle retraction energy is accumulated inside of a hollow plunger rod
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- A61M2207/00—Methods of manufacture, assembly or production
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
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Abstract
Description
Claims (30)
- 1つ以上の係合突起(220A)を有するプランジャアウター(220)と、肩部(210A)を有するプランジャインナー(210)と、前記プランジャアウター(220)の前記係合突起(220A)が前記プランジャインナー(210)の前記肩部(210A)と解放可能に係合されるときに、前記プランジャアウター(220)と前記プランジャインナー(210)との間に第1のエネルギー蓄積状態で保持されるプランジャ付勢部材(270)とを備える自動注入器(100)のための低引き込み起動力プランジャサブアセンブリ(200)。
- 前記プランジャ付勢部材(270)が圧縮スプリングである、請求項1に記載のプランジャサブアセンブリ(200)。
- 前記プランジャ付勢部材(270)は、前記プランジャインナー(210)の張出部(212)と前記プランジャアウター(220)のベース(225)との間に前記第1のエネルギー蓄積状態で保持される、請求項1または2に記載のプランジャサブアセンブリ(200)。
- 前記1つ以上の係合突起(220A)は、前記プランジャ付勢部材(270)が前記第1のエネルギー蓄積状態から第2の拡張状態へ拡張できるようにするために、前記プランジャインナー(210)の肩部(210A)との係合から解放するように略径方向に屈曲できる、請求項1〜3のいずれか一項に記載のプランジャサブアセンブリ(200)。
- 前記プランジャインナーは、プランジャシール(800)の相補的な係合凹部(820)と係合するためのシール係合部材(216)を有する、請求項1〜4のいずれか一項に記載のプランジャサブアセンブリ(200)。
- 前記プランジャアウター(220)は、前記プランジャインナー(210)の前記肩部(210A)との解放可能な係合のための2つの係合突起(220A)を有する、請求項1〜5のいずれか一項に記載のプランジャサブアセンブリ(200)。
- ハウジング(14,16)と、起動機構(12)と、作動機構(10)と、プランジャサブアセンブリ(200)および針アセンブリ(40)を有するシリンジカートリッジ(20)とを備え、前記作動機構(10)は、作動ピル(104)のほぼ上部分内に初期エネルギー蓄積状態で存在する作動付勢部材(102)を備え、前記プランジャサブアセンブリ(200)は、1つ以上の係合突起(220A)を有するプランジャアウター(220)と、肩部(210A)を有するプランジャインナー(210)と、前記プランジャアウター(220)の前記係合突起(220A)が前記プランジャインナー(210)の前記肩部(210A)と解放可能に係合されるときに、前記プランジャアウター(220)と前記プランジャインナー(210)との間に第1のエネルギー蓄積状態で保持されるプランジャ付勢部材(270)とを備える、自動注入器(100)。
- 前記作動付勢部材(102)および前記プランジャ付勢部材(270)がそれぞれ圧縮スプリングである、請求項7に記載の自動注入器(100)。
- 前記プランジャ付勢部材(270)は、前記プランジャインナー(210)の張出部(212)と前記プランジャアウター(220)のベース(225)との間に前記第1のエネルギー蓄積状態で保持される、請求項7または8に記載の自動注入器(100)。
- 前記1つ以上の係合突起(220A)は、前記プランジャ付勢部材(270)が前記第1のエネルギー蓄積状態から第2の拡張状態へ拡張できるようにするために、前記プランジャインナー(210)の肩部(210A)との係合から解放するように略径方向に屈曲できる、請求項7〜9のいずれか一項に記載の自動注入器(100)。
- 前記プランジャインナーは、プランジャシール(800)の相補的な係合凹部(820)と係合するためのシール係合部材(216)を有する、請求項7〜10のいずれか一項に記載の自動注入器(100)。
- 前記プランジャアウター(220)は、前記プランジャインナー(210)の前記肩部(210A)との解放可能な係合のための2つの係合突起(220A)を有する、請求項7〜11のいずれか一項に記載の自動注入器(100)。
- 前記作動ピル(104)は、前記ハウジング(14,16)の内側基端にあるロッキングプラトー(14B)と最初に係合する1つ以上のロッキングフック(104A)を前記第1の作動ピル(104)の基端に有する、請求項7〜12のいずれか一項に記載の自動注入器(100)。
- 前記起動機構(12)は、前記ロッキングフック(104A)を前記ハウジング(14,16)の前記ロッキングプラトー(14B)から離脱させるために、前記作動ピル(104)の前記1つ以上のロッキングフック(104A)と係合できる、請求項13に記載の自動注入器(100)。
- 前記ハウジング(14,16)の内面に1つ以上の凹部(16D)を更に備え、前記1つ以上の係合突起(220A)が前記凹部(16D)と相互作用すると、前記係合突起(220A)の前記凹部(16D)内への略径方向の屈曲により、前記係合突起(220A)が前記プランジャインナー(210)の前記肩部(210A)から離脱でき、それにより、前記プランジャ付勢部材(270)が前記第1のエネルギー蓄積状態から第2の拡張状態へ拡張できる、請求項7〜14のいずれか一項に記載の自動注入器(100)。
- 前記シリンジカートリッジ(20)は、引き込み可能な針アセンブリ(40)を有する引き込み可能なシリンジである、請求項7〜15のいずれか一項に記載の自動注入器(100)。
- 前記針アセンブリ(40)がカニューレ(410)と針シール(430)とを備える、請求項16に記載の自動注入器(100)。
- 前記プランジャサブアセンブリ(200)は、前記カニューレ(410)の引き込みを容易にするために前記針アセンブリ(40)と係合できる、請求項17に記載の自動注入器(100)。
- 引き込みがプランジャ付勢部材(270)によって促される、請求項18に記載の自動注入器(100)。
- 前記プランジャサブアセンブリ(200)、前記作動ピル(104)、および、作動付勢部材(102)は、前記プランジャインナー(210)の前記肩部(210A)からの前記プランジャアウター(220)の前記係合突起(220A)の離脱時に、前記作動ピル(104)および前記作動付勢部材(102)を介して前記プランジャインナー(210)が基端方向で軸方向に並進できるようにするべく構成される、請求項7〜19のいずれか一項に記載の自動注入器(100)。
- 前記プランジャサブアセンブリ(200)は、前記針アセンブリ(40)の引き込みを容易にするために、前記プランジャインナー(210)の前記肩部(210A)からの前記プランジャアウター(220)の前記係合突起(220A)の離脱前に、または離脱とほぼ同時にプランジャシール(800)と針シール(430)との間の接触を可能にするように構成される、請求項7〜20のいずれか一項に記載の自動注入器(100)。
- 最初はキャップ(18)によってハウジング(14,16)の内面の対応する切り欠き(16A)内の係合位置に保持される1つ以上の突出部(150A)を有するスリーブ(150)を更に備え、前記キャップ(18)の取り外し時に、突出部(150A)は、前記切り欠き(16A)から離脱するように径方向内側に屈曲することが許容される、請求項7〜21のいずれか一項に記載の自動注入器(100)。
- 前記スリーブ(150)は、スリーブ(150)のブリッジ部(150B)が前記ハウジング(14,16)の内面の対応する深さ制限部(16B)と接触するまで先端方向に軸方向並進できるように構成される、請求項22に記載の自動注入器(100)。
- 前記ハウジング(14,16)内に1つ以上の窓(50)を更に備え、前記窓が透明、不透明、または、半透明である、請求項7〜23のいずれか一項に記載の自動注入器(100)。
- 前記起動機構(12)と前記ハウジング(14,16)の基端との間に触覚付勢部材(120)を更に備える、請求項7〜24のいずれか一項に記載の自動注入器(100)。
- 請求項7〜25のいずれか一項に記載の自動注入器(100)を組み立てる方法であって、
(i)作動付勢部材(102)をハウジング(14,16)内に挿入するとともに、前記作動ピル(104)の1つ以上のロッキングフック(104A)と前記ハウジング(14,16)のロッキングプラトー(14B)とを着脱可能に係合させることによって、前記作動付勢部材(102)を前記ハウジング(14,16)と前記作動ピル(104)との間で圧縮するステップであって、前記作動付勢部材(102)が最初は前記作動ピル(104)のほぼ上部分内でエネルギー蓄積状態に維持されるステップと、
(ii)1つ以上の係合突起(220A)を有するプランジャアウター(220)と、肩部(210A)を有するプランジャインナー(210)と、前記プランジャアウター(220)の前記係合突起(220A)が前記プランジャインナー(210)の前記肩部(210A)と解放可能に係合されるときに、前記プランジャアウター(220)と前記プランジャインナー(210)との間に第1のエネルギー蓄積状態で保持されるプランジャ付勢部材(270)とを備えるプランジャサブアセンブリ(200)を組み付けるステップと、
(iii)前記プランジャサブアセンブリ(200)の基端が前記作動ピル(104)と接触するように前記プランジャサブアセンブリ(200)を前記ハウジング(14,16)内に挿入するステップと
を備える方法。 - 起動機構(12)を前記ハウジング(14,16)に取り付けるステップを更に備え、前記起動機構(12)は、起動時に前記第1の作動ピル(104)の1つ以上のロッキングフック(104A)と接触するように構成される、請求項26に記載の方法。
- 前記プランジャアウター(220)の前記係合突起(220A)は、前記ハウジング(14,16)の第1の内径によって前記プランジャインナー(210)の前記肩部(210A)との解放可能な係合形態に維持される、請求項26または請求項27に記載の方法。
- (iv)シリンジカートリッジ(20)の薬剤チャンバ(222)に薬剤流体を充填するステップと、
(v)前記プランジャサブアセンブリ(200)の先端を前記シリンジカートリッジ(20)の基端に挿入するステップと
を更に備える、請求項26〜28のいずれか一項に記載の方法。 - ステップ(iv)およびステップ(v)がステップ(iii)の前または後に起こり得る、請求項29に記載の方法。
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