JP2021526926A - 注射により薬液を投与するためのデバイス - Google Patents
注射により薬液を投与するためのデバイス Download PDFInfo
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- JP2021526926A JP2021526926A JP2020569195A JP2020569195A JP2021526926A JP 2021526926 A JP2021526926 A JP 2021526926A JP 2020569195 A JP2020569195 A JP 2020569195A JP 2020569195 A JP2020569195 A JP 2020569195A JP 2021526926 A JP2021526926 A JP 2021526926A
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- A61M5/2425—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
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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
- A61M5/2466—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 by piercing without internal pressure increase
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- A—HUMAN NECESSITIES
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- 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
- A61M5/281—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
- A61M5/282—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
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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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- A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
- A61M5/288—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened by piercing without internal pressure increase
-
- 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
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/3159—Dose expelling manners
- A61M5/31591—Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
-
- 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
- A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
- 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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- 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
- A61M5/2466—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 by piercing without internal pressure increase
- A61M2005/2474—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 by piercing without internal pressure increase with movable piercing means, e.g. ampoule remains fixed or steady
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Abstract
【選択図】図1A
Description
用量アセンブリであって、
投与予定の薬液を保持するように適用された潰れ可能なリザーバと、
少なくとも大部分が長手方向軸を画成し、注射前に該デバイスの内部に位置する、注射針と、
を含む用量アセンブリと、
該デバイスを作動させるためにユーザが力を加えることができる少なくとも1つのアクチュエータ要素であって、上記力は、長手方向軸に垂直な軸に沿った成分を有する、少なくとも1つのアクチュエータ要素と、
を含み、
ここで、少なくとも1つのアクチュエータ要素は、用量アセンブリの少なくとも一部分に作用するように構成および配置され、少なくとも1つのアクチュエータ要素および用量アセンブリは、作動力に応答して針が上記長手方向軸に沿って、および/または上記長手方向軸に平行な軸に沿って変位可能であるように構成および配置されて、針の一部分はハウジングおよび該デバイスの内部から外部に移動して、薬液の投薬を可能にする
デバイスが提供される。
2 用量アセンブリ
3 潰れ可能なリザーバ
31a 潰れ可能なポーチ
32 支持体
33 通路
4 注射針
41 ルーメン
5 コネクタ
6 ハウジング
7 セプタム
8 アクチュエータ要素
80 マウント
81 アクチュエータ要素の近位端部分
82 アクチュエータ要素の遠位端部分
83、84 アクチュエータ要素の横方向側部分
85 長いアーム
86 短いアーム
87 延出部
88 係合ピン
9、10 アクチュエータ要素の横方向外面
11、12 アクチュエータ要素の横方向内面
13 リング
14 薬液
15 静止面
20 キャリッジ
21 キャリッジの近位端部分
22 キャリッジの遠位端部分
23、24 キャリッジの2つの対向する横方向部分
25 キャリッジの延出部
26 キャリッジ構造
27、28 キャリッジ構造の外側移動面
29 キャリッジ構造のガイド通路
L 長手方向軸
A 力
Claims (13)
- 注射によって薬液(14)を投与するためのデバイス(1)であって、
用量アセンブリ(2)であって、
投与予定の薬液を保持するように適用された潰れ可能なリザーバ(3)と、
ルーメン(41)を有する注射針(4)であって、針の少なくとも大部分が長手方向軸(L)を画成し、注射前に針は該デバイスの内部に位置し、潰れ可能なリザーバに近い針の第1の端部はリザーバに直接または間接的に取り付けられ、作動前に針のルーメン(41)は潰れ可能なリザーバの内部チャンバと流体連通する、注射針と、
を含む用量アセンブリと、
該デバイスを作動させるためにユーザが力(A)を加えることができる少なくとも1つのアクチュエータ要素(8)であって、前記力は、長手方向軸に垂直な軸に沿った成分を有する、少なくとも1つのアクチュエータ要素と、
セプタム(7)を含むハウジング(6)であって、注射前、用量アセンブリ(2)はハウジング内に配設され、潰れ可能なリザーバ(3)および針(4)は、ハウジングの内部に位置し、セプタムは、潰れ可能なリザーバ(3)から離れた針の第2の端部で針のルーメンを遮る、ハウジングと、
を含み、
ここで、少なくとも1つのアクチュエータ要素は、用量アセンブリの少なくとも一部分に作用するように構成および配置され、少なくとも1つのアクチュエータ要素および用量アセンブリは、作動力に応答して針が前記長手方向軸に沿って、および/または前記長手方向軸に平行な軸に沿って変位可能であるように構成および配置されて、針の一部分はハウジングおよび該デバイスの内部から外部に移動して、薬液の投薬を可能にし、
セプタムは、ショアA硬度が65以下かつ30以上のエラストマーまたはゴム材料から形成され、前記ショアA硬度はDIN 53505に従って測定される、前記デバイス。 - 少なくとも1つのアクチュエータ要素(8)および用量アセンブリ(2)は、ユーザによる薬液(14)の投薬および/または前記少なくとも1つのアクチュエータ要素の解放後、針(4)の前記部分がデバイスの外部から内部に移動するように構成および配置される、請求項1に記載のデバイス(1)。
- 潰れ可能なリザーバ(3)は、投与予定の薬液(14)の単回用量、特に1000μl以下の体積を有する用量を含む、請求項1または2に記載のデバイス(1)。
- 潰れ可能なリザーバ(3)の壁の少なくとも大部分が可撓性材料から形成され、特に、潰れ可能なリザーバが投与予定の薬液(14)を含むとき、リザーバの壁の少なくとも大部分は伸長または膨張状態であり、薬液を投薬し終わっているとき、リザーバの壁の少なくとも大部分は潰れ状態である、請求項1〜3のいずれか1項に記載のデバイス(1)。
- 潰れ可能なリザーバ(3)は、可撓性ポーチ(31a)またはアンプルとして構成される、請求項1〜4のいずれか1項に記載のデバイス(1)。
- 前記ハウジングは、前記長手方向軸(L)に沿ってまたは平行に非伸長性および/または非圧縮性である、請求項1〜5のいずれか1項に記載のデバイス(1)。
- 少なくとも1つのアクチュエータ要素(8)は、ハウジング(6)に配設され、ハウジングの横方向かつ外部に位置決めされた外向きの表面を有し、外向きの表面に、ユーザが前記力(A)を加えることができる、請求項1〜6のいずれか1項に記載のデバイス(1)。
- 少なくとも1つのアクチュエータ要素(8)および用量アセンブリ(2)は、作動力(A)に応答して針(4)がセプタム(7)に向けて変位されるように構成および配置され、針はセプタムを穿孔するように付勢され、流体通過のために針のルーメン(41)を開き、潰れ可能なリザーバ(3)は潰れ状態に付勢され、それにより、リザーバに含まれる薬液(14)を針のルーメンを通して排出する、請求項1〜7のいずれか1項に記載のデバイス(1)。
- 少なくとも1つのアクチュエータ要素(8)および用量アセンブリ(2)は、リザーバ(3)からの薬液(14)の投薬後にさらなる力がユーザによって少なくとも1つのアクチュエータ要素に印加されるのに応答して、針(4)が内方向に変位されるように構成および配置され、針は、セプタム(7)を通ってまたは該セプタム内に引き戻され、それにより針がハウジング(6)内に収納される、請求項8に記載のデバイス(1)。
- 少なくとも1つのアクチュエータ要素(8)および用量アセンブリ(2)は、少なくとも1つのアクチュエータ要素へのユーザによる力の解放に応答して針が内方向に変位されるように構成および配置され、針は、セプタム(7)を通してまたは該セプタム内に引き戻され、それにより針がハウジング(6)内に収納される、請求項8に記載のデバイス(1)。
- 少なくとも1つのアクチュエータ要素(8)および用量アセンブリ(2)は、リザーバ(3)からの薬液(14)の投薬が完了した後に針(4)が内方向に変位されるように構成および配置され、針は、セプタム(7)を通ってまたは該セプタム内に引き戻され、それにより針がハウジング内に収納される、請求項8に記載のデバイス(1)。
- 潰れ可能なリザーバ(3)は、剛性支持体(32)に配置されている、または剛性支持体(32)を含む、請求項1〜11のいずれか1項に記載のデバイス(1)。
- 剛性支持体(32)は、概して、長手方向軸(L)に垂直な平面、または長手方向軸に平行な、もしくは長手方向軸を含む平面に沿って延び、少なくとも1つのアクチュエータ要素(8)および用量アセンブリ(2)は、潰れ可能なリザーバ(3)が潰れ状態に付勢されるとき、潰れ可能なリザーバが、支持体に向かう方向であって、支持体によって画成される平面に実質的に垂直な方向に圧縮されるように構成および配置される、請求項12に記載のデバイス(1)。
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PCT/EP2019/065507 WO2019238825A1 (en) | 2018-06-14 | 2019-06-13 | Device for administering a medicinal liquid by injection |
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US12023471B1 (en) * | 2020-01-07 | 2024-07-02 | Gholam A. Peyman | Plungerless aspiration and/or injection device and method using the same |
US20220088308A1 (en) * | 2019-02-12 | 2022-03-24 | Eli Lilly And Company | Fluidic subsystem for multi-use drug-delivery device |
EP4043049A1 (en) * | 2021-02-15 | 2022-08-17 | SHL Medical AG | An assembly for a medicament delivery device |
US20240238534A1 (en) * | 2023-01-18 | 2024-07-18 | Retractable Technologies, Inc. | Smallpox vaccination device |
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- 2019-06-13 CN CN201980039023.4A patent/CN112261961A/zh active Pending
- 2019-06-13 EP EP19729554.6A patent/EP3806935A1/en active Pending
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US20060200073A1 (en) * | 2003-07-08 | 2006-09-07 | Novo Nordisk A/S | Portable drug delivery device having an encapsulated needle |
JP2015091453A (ja) * | 2010-02-01 | 2015-05-14 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | 低用量で事前充填式の薬剤送達デバイス |
JP2014532524A (ja) * | 2011-11-07 | 2014-12-08 | イーライ リリー アンド カンパニー | 人間工学的改善を施した注射器具 |
JP2015533603A (ja) * | 2012-11-09 | 2015-11-26 | イインジェック テクノロジーズ インコーポレイテッド | 流体送達装置及び方法 |
JP2017520344A (ja) * | 2014-07-08 | 2017-07-27 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | 流体移送装置または引込み可能な針および隔壁を用いたセット |
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