JP6276993B2 - 少なくとも2つの薬剤の送達のためのニードル・アセンブリ - Google Patents
少なくとも2つの薬剤の送達のためのニードル・アセンブリ Download PDFInfo
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- JP6276993B2 JP6276993B2 JP2013537105A JP2013537105A JP6276993B2 JP 6276993 B2 JP6276993 B2 JP 6276993B2 JP 2013537105 A JP2013537105 A JP 2013537105A JP 2013537105 A JP2013537105 A JP 2013537105A JP 6276993 B2 JP6276993 B2 JP 6276993B2
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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
- A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
-
- 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
- A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
-
- 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
- A61M5/3294—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 comprising means for injection of two or more media, e.g. by mixing
-
- 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
- A61M2005/1787—Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid
-
- 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
- A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves
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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
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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
- A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing
-
- 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
- A61M5/31596—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
-
- 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
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
- A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
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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
- A61M5/50—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
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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
- A61M5/50—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
- A61M5/5086—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 for indicating if defective, used, tampered with or unsterile
Description
・ひとたびニードル・アセンブリが使用され、取り外されたならば一次薬物送達デバイスへのニードル・アセンブリの再取り付けを物理的に防ぐこと。
・ひとたび使用されてしまったならばドラッグ計量分配インタフェースを介しての引き続く液体の流れを物理的/液圧的に防ぐこと。
・視覚による警告(たとえば、ひとたび挿入または流体の流れが生じたならばニードル・アセンブリ上の表示窓内のカラーおよび/または警告テキスト/マークを変えること)。
・触覚によるフィードバック(たとえば、使用後のニードル・アセンブリの外面上の触覚による機能の有無)。
概括的に言えば、ニードル・アセンブリは、ニードル、ニードル・ハブ、およびニードル・アセンブリを薬物送達デバイス(またはペン型注入デバイス)に連結する手段を備える外側スリーブを含んでなる。ひとたび連結されたならば、ニードルは、薬物送達デバイスの薬剤カートリッジ(またはリザーバ/チャンバ)のセプタムを刺し貫き、単独の薬剤の送達が可能になる。しかしながら、或る種の環境下では、2つまたはそれ以上の薬剤の送達のためのデバイスおよび方法を提供することが望ましいかも知れない。
Claims (15)
- 2つまたはそれ以上の薬剤を送達するための薬物送達デバイスに取り付け可能なニードル・アセンブリ(1)であって、
ニードル・アセンブリ(1)は、
第1の薬剤(28)の単独の投与量を予め充填したリザーバを含んでなり、第2の薬剤(29)を収容する薬物送達デバイスに取り付けるように構成される、近位ハウジング部材(11)であって、ここで該リザーバは、ニードル・アセンブリ(1)を薬物送達デバイスに取り付ける前に、第1の薬剤(28)の単独の投与量で予め充填している第1の薬剤チャンバ(5)である、該近位ハウジング部材(11);
近位ハウジング部材(11)と可動状態で係合される遠位ハウジング部材(12)であって、近位および遠位ハウジング部材間の相対的な軸方向運動が、リザーバの体積を減少させ、そして第1の薬剤(28)の単独の投与量を遠位ハウジング部材に配置された注射針(2)に入らせ、送達させるようになっている、該遠位ハウジング部材(12);および
近位ハウジング部材(11)内に位置していて、ニードル・アセンブリ(1)が薬物送達デバイスに取り付けられたときに、第2の薬剤(29)の投与量を薬物送達デバイスからニードル・アセンブリ(1)の注射針(2)へ移送するための薬剤移送機能;
を含んでおり、
該薬剤移送機能が、さらに、薬物送達デバイス内の薬剤とニードル・アセンブリ(1)間の流体連通を確立する移送針(7)を含んでなり、第1および第2の状態の間で切り替え可能であり、該薬剤移送機能は、第1の状態において第1の薬剤(28)および第2の薬剤(29)の流体連通を阻止し、そして第2の状態において、ニードル・アセンブリ(1)の注射針(2)へ薬物送達デバイスから第2の薬剤(29)を移送し得るように構成される、
上記ニードル・アセンブリ(1)。 - 第1、第2の薬剤の流体連通は、薬物送達デバイスの作動時に確立される、請求項1に記載のニードル・アセンブリ(1)。
- さらに、遠位ハウジング部材(12)に取り付けられる注射針・ハブ(3)を含んでなり、ここで、注射針(2)は、注射針・ハブ(3)内に同軸に固定される、請求項1又は2に記載のニードル・アセンブリ(1)。
- 薬剤移送機能は、さらに、第1の薬剤チャンバ(5)と第2の薬剤チャンバ(14)の流体連通を阻止するように構成される移送シーリング部材(6)を含んでなる、請求項1〜3のいずれか1項に記載のニードル・アセンブリ(1)。
- 移送シーリング部材(6)は、一方向弁(32)を含んでなり、そして薬物送達デバイスの作動中に誘起される圧力が、一方向弁(32)を開かせる、請求項4に記載のニードル・アセンブリ(1)。
- 移送シーリング部材(6)は、注射針(2)の近位端(37)によって、突き通し可能なシーリング面(50)を含んでなる、請求項4又は5に記載のニードル・アセンブリ(1)。
- さらに、近位および遠位のハウジング部材(11、12)間の偶発的な相対的軸方向運動を阻止するための少なくとも1つの固定部材(25)を含んでなる、請求項1〜6のいずれか1項に記載のニードル・アセンブリ(1)。
- 少なくとも1つの固定部材(25)は、少なくとも1つのカム・ロックを含んでなる、請求項7に記載のニードル・アセンブリ(1)。
- 近位ハウジング部材(11)と可動状態で係合される遠位ハウジング部材(12)は、近位ハウジング部材(11)と摺動可能に係合される遠位ハウジング部材(12)を含んでなる、請求項1〜8のいずれか1項に記載のニードル・アセンブリ(1)。
- 近位ハウジング部材(11)は、第1の薬剤(28)を収容する第1の薬剤チャンバ(5)を含む、請求項1〜9のいずれか1項に記載のニードル・アセンブリ(1)。
- さらに、第1の薬剤チャンバ(5)内に少なくとも部分的に配置される軸方向へ可動の栓(4)を含んでなり、第1の薬剤チャンバ(5)の遠位端は、可動栓(4)によって密封される、請求項1に記載のニードル・アセンブリ(1)。
- 可動栓(4)は、
(i)注射針(2)の近位端(37)によって、突き通し可能な突き通し可能部分(39)、および
(ii)シーリング部分(38)
を含んでなる、請求項11に記載のニードル・アセンブリ(1)。 - 近位および遠位のハウジング部材(11、12)間の第1の相対的な軸方向運動が、注射針(2)の近位端(37)に可動栓(4)の突き通し可能部分(39)を突き通させ、近位および遠位のハウジング部材(11、12)間の第2の相対的な軸方向運動が、第1の薬剤(28)が送達されるように可動栓(4)を近位方向へ動かす、請求項12に記載のニードル・アセンブリ(1)。
- さらに、注射針(2)の遠位端(42)とユーザの間の偶発的な接触を防ぐための注射針・シールド(16)を含んでなる、請求項1〜13のいずれか1項に記載のニードル・アセンブリ(1)。
- 薬物送達デバイスおよび請求項1〜14のいずれか1項に記載のニードル・アセンブリ(1)を含んでなる、2つまたはそれ以上の薬剤を送達するための薬物送達システムであって、該薬物送達デバイスは、投与量設定機構、および第2の薬剤(29)を含む薬剤カートリッジ(13)を含んでなる、上記薬物送達システム。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP10189807.0 | 2010-11-03 | ||
EP10189807 | 2010-11-03 | ||
US201161432719P | 2011-01-14 | 2011-01-14 | |
US61/432,719 | 2011-01-14 | ||
PCT/EP2011/069109 WO2012059460A1 (en) | 2010-11-03 | 2011-10-31 | Needle assembly for the delivery of at least two medicaments |
Publications (2)
Publication Number | Publication Date |
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JP2013542797A JP2013542797A (ja) | 2013-11-28 |
JP6276993B2 true JP6276993B2 (ja) | 2018-02-07 |
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Application Number | Title | Priority Date | Filing Date |
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JP2013537105A Expired - Fee Related JP6276993B2 (ja) | 2010-11-03 | 2011-10-31 | 少なくとも2つの薬剤の送達のためのニードル・アセンブリ |
Country Status (4)
Country | Link |
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US (1) | US9950113B2 (ja) |
EP (1) | EP2635328A1 (ja) |
JP (1) | JP6276993B2 (ja) |
WO (1) | WO2012059460A1 (ja) |
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-
2011
- 2011-10-31 JP JP2013537105A patent/JP6276993B2/ja not_active Expired - Fee Related
- 2011-10-31 WO PCT/EP2011/069109 patent/WO2012059460A1/en active Application Filing
- 2011-10-31 US US13/881,977 patent/US9950113B2/en not_active Expired - Fee Related
- 2011-10-31 EP EP11776204.7A patent/EP2635328A1/en not_active Withdrawn
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US9950113B2 (en) | 2018-04-24 |
WO2012059460A1 (en) | 2012-05-10 |
US20130267932A1 (en) | 2013-10-10 |
EP2635328A1 (en) | 2013-09-11 |
JP2013542797A (ja) | 2013-11-28 |
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