JP6047485B2 - 薬剤充填済みシリンジのための安全デバイスおよび注射デバイス - Google Patents
薬剤充填済みシリンジのための安全デバイスおよび注射デバイス Download PDFInfo
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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
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
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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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- 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
- A61M5/31—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
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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
- 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
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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
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
- A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
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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
- 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
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
-
- 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
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31566—Means improving security or handling thereof
- A61M5/31568—Means keeping track of the total dose administered, e.g. since the cartridge was inserted
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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
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31566—Means improving security or handling thereof
- A61M5/3157—Means providing feedback signals when administration is completed
-
- 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
- A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
-
- 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
- A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
- A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (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
1 安全デバイス
1.1 ニードル・シールド
1.1.1 遠位端面
1.1.2 横方向表面
1.1.3 中央アパーチャ
1.2 支持体
1.2.1 長手方向タング
1.2.2 ガイド・トラック
1.2.2.1 傾斜セクション
1.2.2.2 軸方向セクション
1.2.3 傾斜内面
1.2.4 撓曲ゲート要素
1.2.5 遠位端面
1.2.6 案内突起
1.3 外側体
1.3.1 握持手段
1.3.2 長手方向溝
1.3.3 ガイド・レール
1.3.3.1 第1のセクション
1.3.3.2 第2のセクション
1.3.4 内側軸方向くぼみ
1.3.5 錠止カットアウト部
1.3.6 錠止凹部
1.4 回転カラー
1.4.1 ガイド・ピン
1.4.2 支え面
1.4.3 近位リム
1.5 保持カラー
1.5.1 外側アーム
1.5.1.1 内向き突起
1.5.2 内側アーム
1.5.2.1 外向きの突起
1.5.2.2 傾斜外面
1.5.2.3 近位表面
1.5.3 ラチェット・アーム
1.6 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
D 注射デバイス
A 中心軸
I 第1位置
II 第2位置
PPS 開始位置
PPI 中間位置
PPE 終了位置
PI 初期位置
PD 遠位位置
PP 近位位置
PA 前進位置
PR 後退位置
D1 第1直径
D2 第2直径
Claims (14)
- 薬剤充填済みシリンジ(2)のための安全デバイス(1)であって、
−薬剤充填済みシリンジ(2)を中に保持する中空支持体(1.2)、
−支持体(1.2)に解放自在に取り付けられ、薬剤充填済みシリンジ(2)に取り付けられた保持カラー(1.5)、
−薬剤充填済みシリンジ(2)を中に受け入れるための中央開口部、および支持体(1.2)に形成されたガイド・トラック(1.2.2)を通って突出する少なくとも1つの外方へ突出するガイド・ピン(1.4.1)とを含んでなる回転カラー(1.4)、および
−外側体(1.3)の内面に形成されるガイド・レール(1.3.3)、
を含んでなるが、
ここで、ガイド・トラック(1.2.2)は、傾斜セクション(1.2.2.1)と、これに連結される軸方向セクション(1.2.2.2)とを含み、
回転カラー(1.4)は、支持体(1.2)内に配置され、支持体(1.2)の軸方向長さに沿って摺動可能であり、安全デバイス(1)の中心軸(A)まわりに回転可能であり、
一方保持カラー(1.5)はそれが回転カラー(1.4)によって支持体(1.2)に取り付けられた状態から解放されたとき、支持体(1.2)に対して近位方向へ可動である、上記安全デバイス(1)。 - 支持体(1.2)に対して摺動可能に配置された外側体(1.3)が外方突出ガイド・ピン(1.4.1)に当接して、回転カラー(1.4)が外側体(1.3)と共同で支持体(1.2)のほぼ軸方向全長に沿って一緒に動くことを特徴とする、請求項1に記載の安全デバイス(1)。
- ガイド・トラック(1.2.2)の傾斜セクション(1.2.2.1)が、ガイド・トラック(1.2.2)の軸方向セクション(1.2.2.2)に対して鋭角に向いており、傾斜セクション(1.2.2.1)は弾力的に偏向可能である撓曲ゲート要素(1.2.4)により制限される幅狭セクションによって軸方向セクション(1.2.2.2)に
連結されることを特徴とする、請求項1または2に記載の安全デバイス(1)。 - 安全デバイス(1)は、ガイド・ピン(1.4.1)が撓曲ゲート要素(1.2.4)により制限された幅狭セクションを通過するときに可聴フィードバックを発生することを特徴とする、請求項3に記載の安全デバイス(1)。
- 回転カラー(1.4)が、支持体内に配置されたスプリング(1.6)によって近位方向へ付勢されることを特徴とする、請求項1〜4のいずれか1項に記載の安全デバイス(1)。
- ニードル・シールド(1.1)が支持体(1.2)に対して摺動可能に配置され、一方ニードル・シールド(1.1)がスプリング(1.6)によって遠位方向に付勢されることを特徴とする、請求項5に記載の安全デバイス(1)。
- ニードル・シールド(1.1)が、可変直径(D1、D2)の中央アパーチャ(1.1.3)を有することを特徴とする、請求項6に記載の安全デバイス(1)。
- ニードル・シールド(1.1)が、可撓性が異なる2つの異なったプラスチック材料からなることを特徴とする、請求項6または7に記載の安全デバイス(1)。
- 保持カラー(1.5)が、外側体(1.3)に対してそれを錠止するように外側体(1.3)に形成された錠止カットアウト部(1.3.5)に掛止する少なくとも1つのラチェット・アーム(1.5.3)を含んでなることを特徴とする、請求項1〜8のいずれか1項に記載の安全デバイス(1)。
- 外側体(1.3)が、軸方向に互いから変位し、中心軸(A)に対して平行に整合する複数の錠止カットアウト部(1.3.5)を含んでなることを特徴とする、請求項9に記載の安全デバイス(1)。
- ガイド・レール(1.3.3)が、中心軸(A)に対して90度未満の角度に向いた第1のセクション(1.3.3.1)と、中心軸(A)に対してほぼ平行に延びる第2のセクション(1.3.3.2)とを含んでなることを特徴とする、請求項1〜10のいずれか1項に記載の安全デバイス(1)。
- 請求項1〜11のいずれか1項に記載の安全デバイス(1)および薬剤充填済みシリンジ(2)を含んでなる注射デバイス(D)であって、安全デバイス(1)が、
−内部に薬剤充填済みシリンジ(2)を保持する中空支持体(1.2)、
−支持体(1.2)に解放自在に取り付けられ、薬剤充填済みシリンジ(2)に取り付けられた保持カラー(1.5)、
−その内部に薬剤充填済みシリンジ(2)を収容するための中央開口部と、支持体(1.2)に形成されたガイド・トラック(1.2.2)を通って突出する少なくとも1つの外方へ突出するガイド・ピン(1.4.1)とを含んでなる回転カラー(1.4)、および
−外側体(1.3)の内面に形成されるガイド・レール(1.3.3)、
を含んでなり、
ここで、ガイド・トラック(1.2.2)は、傾斜セクション(1.2.2.1)と、これに連結される軸方向セクション(1.2.2.2)とを含み、
回転カラー(1.4)が、支持体(1.2)の軸方向長さに沿って摺動可能であり、安全デバイス(1)の中心軸(A)まわりに回転可能であり、
保持カラー(1.5)は、それが回転カラー(1.4)によって支持体(1.2)に取
り付けられた状態から解放されたとき、保持カラー(1.5)が支持体(1.2)に対して近位方向へ可動であり、
薬剤充填済みシリンジ(2)が、前進位置(PA)から後退位置(PR)へ支持体(1.2)内に後退可能であり、後退位置において、皮下注射針(2.1)が支持体(1.2)によって取り囲まれる、上記注射デバイス(D)。 - ラチェット・アーム(1.5.3)および複数の錠止カットアウト部が、内部キャビティ(2.3.1)に収容されている薬剤の量を視覚的に示すことを特徴とする、請求項12に記載の注射デバイス(D)。
- ニードル・シールド(1.1)を、2−ショット射出成形プロセスによって作ることを特徴とする、請求項8に記載の安全デバイス(1)の製造方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP10168322 | 2010-07-02 | ||
EP10168322.5 | 2010-07-02 | ||
PCT/EP2011/060322 WO2012000838A2 (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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JP2013529990A JP2013529990A (ja) | 2013-07-25 |
JP6047485B2 true JP6047485B2 (ja) | 2016-12-21 |
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Application Number | Title | Priority Date | Filing Date |
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JP2013517175A Expired - Fee Related JP6047485B2 (ja) | 2010-07-02 | 2011-06-21 | 薬剤充填済みシリンジのための安全デバイスおよび注射デバイス |
Country Status (15)
Country | Link |
---|---|
US (2) | US9067024B2 (ja) |
EP (1) | EP2588162B1 (ja) |
JP (1) | JP6047485B2 (ja) |
KR (1) | KR20130089243A (ja) |
CN (1) | CN103025371B (ja) |
AU (1) | AU2011273727B2 (ja) |
BR (1) | BR112012033616A2 (ja) |
CA (1) | CA2803486A1 (ja) |
DK (1) | DK2588162T3 (ja) |
MX (1) | MX2012015052A (ja) |
NZ (1) | NZ604075A (ja) |
RU (1) | RU2567795C2 (ja) |
SG (1) | SG186320A1 (ja) |
WO (1) | WO2012000838A2 (ja) |
ZA (1) | ZA201208887B (ja) |
Families Citing this family (55)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2314182T3 (es) | 2002-02-11 | 2009-03-16 | Antares Pharma, Inc. | Inyector intradermico. |
BRPI0614025A2 (pt) | 2005-01-24 | 2012-12-25 | Antares Pharma Inc | injetores de jato |
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- 2011-06-21 CA CA2803486A patent/CA2803486A1/en not_active Abandoned
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KR20130089243A (ko) | 2013-08-09 |
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CN103025371B (zh) | 2015-04-08 |
ZA201208887B (en) | 2013-09-25 |
EP2588162A2 (en) | 2013-05-08 |
DK2588162T3 (da) | 2020-04-06 |
SG186320A1 (en) | 2013-02-28 |
AU2011273727B2 (en) | 2015-12-24 |
NZ604075A (en) | 2014-03-28 |
US9440032B2 (en) | 2016-09-13 |
US20150290400A1 (en) | 2015-10-15 |
WO2012000838A3 (en) | 2012-03-29 |
JP2013529990A (ja) | 2013-07-25 |
BR112012033616A2 (pt) | 2016-11-22 |
WO2012000838A2 (en) | 2012-01-05 |
MX2012015052A (es) | 2013-04-03 |
CA2803486A1 (en) | 2012-01-05 |
EP2588162B1 (en) | 2020-01-01 |
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