JP5938402B2 - 薬剤充填済みシリンジおよび注射デバイスのための安全デバイス - Google Patents
薬剤充填済みシリンジおよび注射デバイスのための安全デバイス Download PDFInfo
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- 239000007924 injection Substances 0.000 title claims description 91
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- 229940071643 prefilled syringe Drugs 0.000 claims description 19
- 238000000926 separation method Methods 0.000 claims description 17
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- 230000001154 acute effect Effects 0.000 description 4
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- 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
- A61M5/32—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
-
- 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
- A61M5/32—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
-
- 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
- A61M5/32—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
- 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
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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
- A61M5/32—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
-
- 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
- A61M5/32—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
-
- 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
- A61M5/32—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
- A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
- A61M5/3272—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position having projections following labyrinth paths
-
- 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
- A61M5/50—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 preventing re-use, or for indicating if defective, used, tampered with or unsterile
-
- 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
- A61M5/32—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
- A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
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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
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Environmental & Geological Engineering (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
ム1.1.4を横方向へ片寄せて負荷をかけ、それによって、ガイド・ピン1.1.3が横方向に付勢される。
1 安全デバイス
1.1 ニードル・シールド
1.1.1 皮膚接触面
1.1.2 第1長手方向タング
1.1.3 ガイド・ピン
1.1.4 可撓性アーム
1.1.5 台形カットアウト部
1.2 支持体
1.2.1 第1長手方向溝
1.2.2 第2長手方向タング
1.2.3 外向きの突起
1.2.4 錠止凹部
1.2.5 ガイド・トラック
1.2.5.1 傾斜セクション
1.2.5.2 拡幅セクション
1.2.6 分離壁
1.2.7 クリップ
1.2.8 平らな側部
1.3 外側体
1.3.1 ハンド・フランジ
1.3.2 長手方向凹部
1.3.2.1 第1部分
1.3.2.2 第2部分
1.3.3 ウェブ
1.3.4 クランプ・アーム
1.3.4.1 錠止キャッチ
1.3.5 平らな外側側部
1.4 圧縮スプリング
2 薬剤充填済みシリンジ
2.1 皮下注射針
2.2 ニードル・キャップ
2.3 バレル
2.3.1 内部キャビティ
2.3.2 バレル・カラー
2.4 ピストン
2.5 ピストンロッド
3 キャップ・リムーバ
3.1 クランプ手段
A 中心軸
D 注射デバイス
L 横方向
I 初期位置
II 後退位置
III 前進位置
PI 開始位置
PII 中間位置
PIII 終了位置
Claims (16)
- 薬剤充填済みシリンジ(2)のための安全デバイス(1)と、遠位端に取り付けられた皮下注射針(2.1)を備えた薬剤充填済みシリンジ(2)とを含んでなる注射デバイス(D)であって、
ここで安全デバイス(1)が、
−薬剤充填済みシリンジ(2)を中に取付けるための中空支持体(1.2)、
−支持体(1.2)に対して摺動可能である中空ニードル・シールド(1.1)、および
−支持体(1.2)に対するニードル・シールド(1.1)の動きを案内する案内手段、を含んでなり、
案内手段が、
−半径方向に延びるガイド・ピン(1.1.3)を備えた可撓性アーム(1.1.4)、
−ガイド・ピン(1.1.3)が突入するガイド・トラック(1.2.5)、および
−安全デバイス(1)の中心軸(A)に対して平行な方向でガイド・トラック(1.2.5)内に延びる分離壁(1.2.6)、を含んでなり、
ここで、ニードル・シールド(1.1)が支持体(1.2)に対して摺動したとき、ガイド・ピン(1.1.3)がガイド・トラック(1.2.5)に沿って動いて、可撓性アーム(1.1.4)を中心軸(A)に対して直角な横方向(L)へ偏向させ、ガイド・トラック(1.2.5)に沿ったガイド・ピン(1.1.3)の動きが、可撓性アーム(1.1.4)および分離壁(1.2.6)の相互作用によって案内され、
薬剤充填済みシリンジ(2)が安全デバイス(1)の支持体(1.2)内に保持されて、皮下注射針(2.1)が支持体(1.2)の遠位端から突出し、一方、皮下注射針(2.1)が、初期位置(I)および前進位置(III)において、ニードル・シールド(1.1)によって取り囲まれ、後退位置(II)において露出され、
安全デバイス(1)が、支持体(1.2)とニードル・シールド(1.1)間の相対回転を阻止するための手段(1.2.1.1.2.2)、及びニードル・シールド(1.1)が初期位置(I)にあるとき、エネルギを付与されない状態に配置される圧縮スプリング(1.4)
を含んでなる、上記注射デバイス(D)。 - 可撓性アーム(1.1.4)が、ニードル・シールド(1.1)または支持体(1.2)のうちの一方に連結され、ガイド・トラック(1.2.5)が、ニードル・シールド(1.1)または支持体(1.2)のうちの他方に形成されることを特徴とする、請求項1に記載の注射デバイス(D)。
- 分離壁(1.2.6)が、安全デバイス(1)の中心軸(A)に対して平行に延びるガイド・トラック(1.2.5)の拡幅セクション(1.2.5.2)内に延びることを特徴とする、請求項1または2に記載の注射デバイス(D)。
- 分離壁(1.2.6)が、安全デバイス(1)が再使用を阻止されるまでニードル・シールド(1.1)が支持体(1.2)に対して移動しなければならない最短の軸方向距離を実質的に定める、中心軸(A)に対して平行に延びる軸方向寸法を有することを特徴とする、請求項1〜3のいずれか1項に記載の注射デバイス(D)。
- ニードル・シールド(1.1)が支持体(1.2)に対して最短の軸方向距離に一致するか、またはそれを超える距離だけ後退したときに可聴フィードバックが発生することを特徴とする、請求項1〜4のいずれか1項に記載の注射デバイス(D)。
- 分離壁(1.2.6)が、ガイド・ピン(1.1.3)が遠位方向または近位方向の一方の方向からガイド・トラック(1.2.5)内の終了位置(PIII)にアクセスするのを阻止し、このとき、ガイド・ピン(1.1.3)が、遠位方向または近位方向のうち他方の方向から終了位置(PIII)に入ることを可能にすることを特徴とする、請求項1〜5のいずれか1項に記載の注射デバイス(D)。
- ガイド・トラック(1.2.5)が、支持体(1.2)の表面、またはニードル・シールド(1.1)の表面に凹部として形成されることを特徴とする、請求項1〜6のいずれか1項に記載の注射デバイス(D)。
- ガイド・トラック(1.2.5)が、ニードル・シールド(1.1)または支持体(1.2)の一方に開口部を形成することを特徴とする、請求項1〜7のいずれか1項に記載の注射デバイス(D)。
- 分離壁(1.2.6)が、可撓性であり、ガイド・ピン(1.1.3)が、ガイド・トラック(1.2.5)に沿って動いて分離壁(1.2.6)を偏向させ、それによって、可撓性の分離壁(1.2.6)の偏向が可撓性アーム(1.1.4)の偏向に依存することを特徴とする、請求項8に記載の注射デバイス(D)。
- 分離壁(1.2.6)の弾性が可撓性アーム(1.1.4)の弾性に合わせてあり、分離壁(1.2.6)が偏向した可撓性アーム(1.1.4)によって、偏向可能であることを特徴とする、請求項8又は9に記載の注射デバイス(D)。
- ガイド・ピン(1.1.3)が、偏向した可撓性アーム(1.1.4)によって、横方向(L)に付勢されることを特徴とする、請求項1〜10のいずれか1項に記載の注射デバイス(D)。
- 静止位置における可撓性アーム(1.1.4)が、中心軸(A)に対して本質的に平行に延びることを特徴とする、請求項1〜11のいずれか1項に記載の注射デバイス(D)。
- ガイド・トラック(1.2.5)が、中心軸(A)に対して斜めに向いた傾斜セクション(1.2.5.1)を含んでなることを特徴とする、請求項1〜12のいずれか1項に記載の注射デバイス(D)。
- ニードル・シールド(1.1)は、開始位置(PI)において、ガイド・トラック(1.2.5)の傾斜セクション(1.2.5.1)内に保持されるガイド・ピン(1.1.3)によって初期位置(I)に保持され、一方、初期位置(I)において、ニードル・シールド(1.1)は、支持体(1.2)から遠位方向へ突出することを特徴とする、請求項1〜13のいずれか1項に記載の注射デバイス(D)。
- ニードル・シールド(1.1)が、初期位置(I)から後退位置(II)へ、そしてさらに前進位置(III)へ可動であり、一方、初期位置(I)および前進位置(III)において、ニードル・シールド(1.1)が支持体(1.2)から突出することを特徴とする、請求項1〜14のいずれか1項に記載の注射デバイス(D)。
- 支持体(1.2)、ニードル・シールド(1.1)間の相対回転を阻止するための手段が、第1の長手方向溝(1.2.1)と第1の長手方向タング(1.1.2)を含んでなることを特徴とする、請求項1〜15のいずれか1項に記載の注射デバイス(D)。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP10168317.5 | 2010-07-02 | ||
EP10168317 | 2010-07-02 | ||
PCT/EP2011/060319 WO2012000835A1 (en) | 2010-07-02 | 2011-06-21 | Safety device for a pre-filled syringe and injection device |
Publications (2)
Publication Number | Publication Date |
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JP2013529988A JP2013529988A (ja) | 2013-07-25 |
JP5938402B2 true JP5938402B2 (ja) | 2016-06-22 |
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Application Number | Title | Priority Date | Filing Date |
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JP2013517172A Active JP5938402B2 (ja) | 2010-07-02 | 2011-06-21 | 薬剤充填済みシリンジおよび注射デバイスのための安全デバイス |
Country Status (21)
Country | Link |
---|---|
US (1) | US9352099B2 (ja) |
EP (1) | EP2588168B2 (ja) |
JP (1) | JP5938402B2 (ja) |
KR (1) | KR101840625B1 (ja) |
CN (1) | CN103079612B (ja) |
AR (1) | AR082053A1 (ja) |
AU (1) | AU2011273724B2 (ja) |
BR (1) | BR112013000038B1 (ja) |
CA (1) | CA2803628A1 (ja) |
DK (1) | DK2588168T4 (ja) |
ES (1) | ES2538371T3 (ja) |
HK (1) | HK1184731A1 (ja) |
HU (1) | HUE025529T2 (ja) |
MX (1) | MX2013000061A (ja) |
NZ (1) | NZ604077A (ja) |
PL (1) | PL2588168T3 (ja) |
RU (1) | RU2569702C2 (ja) |
SG (1) | SG186317A1 (ja) |
TW (1) | TWI598123B (ja) |
WO (1) | WO2012000835A1 (ja) |
ZA (1) | ZA201208884B (ja) |
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RU2013104397A (ru) | 2014-08-10 |
NZ604077A (en) | 2014-07-25 |
RU2569702C2 (ru) | 2015-11-27 |
KR101840625B1 (ko) | 2018-03-21 |
AU2011273724A1 (en) | 2013-01-10 |
HUE025529T2 (en) | 2016-04-28 |
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US9352099B2 (en) | 2016-05-31 |
JP2013529988A (ja) | 2013-07-25 |
CA2803628A1 (en) | 2012-01-05 |
DK2588168T4 (da) | 2022-09-26 |
TW201210649A (en) | 2012-03-16 |
WO2012000835A1 (en) | 2012-01-05 |
CN103079612A (zh) | 2013-05-01 |
CN103079612B (zh) | 2015-09-16 |
BR112013000038A2 (pt) | 2020-08-25 |
AR082053A1 (es) | 2012-11-07 |
AU2011273724B2 (en) | 2015-01-15 |
TWI598123B (zh) | 2017-09-11 |
ES2538371T3 (es) | 2015-06-19 |
DK2588168T3 (en) | 2015-06-08 |
BR112013000038B1 (pt) | 2021-01-19 |
HK1184731A1 (en) | 2014-01-30 |
EP2588168B1 (en) | 2015-03-04 |
EP2588168A1 (en) | 2013-05-08 |
MX2013000061A (es) | 2013-02-15 |
PL2588168T3 (pl) | 2015-08-31 |
KR20130041153A (ko) | 2013-04-24 |
ZA201208884B (en) | 2013-09-25 |
US20130324923A1 (en) | 2013-12-05 |
SG186317A1 (en) | 2013-01-30 |
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