JP7413355B2 - 接続構造及び薬液投与器具 - Google Patents
接続構造及び薬液投与器具 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
- A61M5/24—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
- A61M5/2459—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 upon internal pressure increase, e.g. pierced or burst
-
- 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
- A61M5/3129—Syringe barrels
- A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/14—Tube connectors; Tube couplings for connecting tubes having sealed ends
-
- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
-
- 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
- A61M5/343—Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub
-
- 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
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3104—Caps for syringes without needle
-
- 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
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3106—Plugs for syringes without needle
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1066—Tube connectors; Tube couplings having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
-
- 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
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
-
- 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
- A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
- A61M5/345—Adaptors positioned between needle hub and syringe nozzle
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Pulmonology (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
本実施形態に係る薬液投与器具10は、図1に示すように、薬液を供給する医療用容器12と、医療用容器12に装着された接続構造14とを備えている。図示の医療用容器12は、例えばシリンジである。医療用容器12は、基端側に薬液を収容する薬液収容部16を備えている。薬液収容部16は円筒状に形成されており、その内部に収容室18(図2参照)が形成されている。薬液収容部16及び収容室18は軸方向に延びている。
実施例1及び比較例1では、図5に示す接続針28を弾性封止体26に穿刺して、弾性封止体26の圧縮率の好適な範囲について評価を行った。なお、本明細書において、弾性封止体26の圧縮率とは、接続針28の穿刺前の弾性封止体26の体積をAとし、接続針28の穿刺後の弾性封止体26の体積をBとした際に、体積Bを体積Aで除算(B/A)して求まる値である。なお、穿刺後の弾性封止体26の体積Bは、穿刺前の弾性封止体26の体積Aから、弾性封止体26を貫通する部分の接続針28の斜線部V1の体積を減算した値と概ね同じとなる。
図7に示すように、本実施形態の薬液投与器具10A及び接続構造14Aは、コネクタ40において、図1~図5を参照しつつ説明した薬液投与器具10及び接続構造14と異なる。なお、薬液投与器具10A及び接続構造14Aにおいて、薬液投与器具10及び接続構造14と同様の構成については、同一符号を付してその詳細な説明は省略する。
実施例2及び比較例2では、図9に示す薬液投与器具10A及び接続構造14Aを用意して、接続針38の穿刺性の評価及び、弾性封止体26の耐圧性の評価を行った。弾性封止体26の耐圧性は、実施例1と同様に収容室18の内圧を600KPaとした条件の下で、液漏れの有無により評価を行った。
Claims (7)
- 薬液を収容する薬液収容部と、前記薬液収容部の先端に設けられた前記薬液を排出する薬液排出部と、を有する医療用容器の接続構造であって、
前記薬液排出部の外方を覆うように装着される装着部と、前記装着部の先端部に形成された開口部と、前記開口部と前記薬液排出部との間の空間に配置されて前記薬液排出部を封止する弾性封止体と、を有する封止部材と、
前記弾性封止体を穿刺する接続針と、前記接続針を保持する針ハブと、を有し、前記封止部材に装着可能なコネクタと、を備え、
前記コネクタは、前記封止部材に前記コネクタを装着して前記接続針を前記弾性封止体に穿刺した際に、前記弾性封止体を圧縮する押込構造を有し、
前記接続針の穿刺前の前記弾性封止体の体積をAとし、前記接続針の穿刺後の前記弾性封止体の体積をBとして、前記押込構造は圧縮率B/Aが70~95%の範囲で前記弾性封止体を圧縮するとともに、
前記押込構造は、前記接続針より太い径に形成され前記針ハブから前記弾性封止体に向けて突出した突出部よりなり、
前記突出部は、前記弾性封止体の軸方向に前記圧縮率を増大させる、接続構造。 - 請求項1記載の接続構造であって、前記押込構造は、前記弾性封止体の径に対して所定の径を有する前記接続針よりなり、
前記接続針は、前記弾性封止体の径方向に前記圧縮率を増大させる、接続構造。 - 請求項1又は2記載の接続構造であって、前記針ハブは、前記装着部に係合可能な案内壁を備え、前記案内壁が前記装着部に係合することにより、前記突出部が前記弾性封止体に向けて前記軸方向に押し込まれる、接続構造。
- 請求項1~3のいずれか1項に記載の接続構造であって、前記弾性封止体の体積Aは、前記開口部と前記薬液排出部との隙間に配置される前の前記弾性封止体の体積よりも圧縮されている、接続構造。
- 請求項1~4のいずれか1項に記載の接続構造であって、前記装着部は、前記開口部と前記薬液排出部との間に円板状の空間を形成するとともに、前記弾性封止体は、前記開口部と前記薬液排出部との間の空間を占める本体部と、前記本体部から突出して前記開口部の内部に挿入された第1凸部と、前記本体部から突出して前記薬液排出部の薬液流路の内部に挿入された第2凸部とを備えている、接続構造。
- 薬液を収容する薬液収容部と、前記薬液を排出する薬液排出部と、を有する医療用容器と、前記薬液排出部に接続される接続構造とを備えた、薬液投与器具であって、前記接続構造は、
前記薬液排出部の外方を覆うように装着される装着部と、前記薬液排出部の延在方向の前記装着部に形成された開口部と、前記開口部と前記薬液排出部との間の空間に配置されて前記薬液排出部を封止する弾性封止体と、を有する封止部材と、
前記弾性封止体を穿刺する接続針と、前記接続針を保持する針ハブと、を有するコネクタと、を備え、
前記コネクタは、前記封止部材に前記コネクタを装着して前記接続針を前記弾性封止体に穿刺した際に、前記弾性封止体を圧縮する押込構造を有し、
前記接続針の穿刺前の前記弾性封止体の体積をAとし、前記接続針の穿刺後の前記弾性封止体の体積をBとして、前記押込構造は圧縮率B/Aが70~95%の範囲で前記弾性封止体を圧縮するとともに、
前記押込構造は、前記接続針より太い径に形成され前記針ハブから前記弾性封止体に向けて突出した突出部よりなり、
前記突出部は、前記弾性封止体の軸方向に前記圧縮率を増大させる、薬液投与器具。 - 請求項6記載の薬液投与器具であって、前記医療用容器はシリンジ又は可撓性を有するバッグである、薬液投与器具。
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PCT/JP2020/006454 WO2020195363A1 (ja) | 2019-03-26 | 2020-02-19 | 接続構造及び薬液投与器具 |
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EP4243895A1 (en) * | 2020-11-16 | 2023-09-20 | West Pharmaceutical Services, Inc. | Connection system for a drug delivery device |
CN115092527B (zh) * | 2022-07-01 | 2023-07-04 | 厦门斯坦瑞科技有限公司 | 一种加液结构 |
WO2024134964A1 (ja) * | 2022-12-22 | 2024-06-27 | テルモ株式会社 | 薬液投与器具 |
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US5624402A (en) * | 1994-12-12 | 1997-04-29 | Becton, Dickinson And Company | Syringe tip cap |
JP2010131064A (ja) | 2008-12-02 | 2010-06-17 | Arte Corp | 容器兼用注射器 |
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