JP7443426B2 - 注入装置 - Google Patents
注入装置 Download PDFInfo
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- JP7443426B2 JP7443426B2 JP2022097166A JP2022097166A JP7443426B2 JP 7443426 B2 JP7443426 B2 JP 7443426B2 JP 2022097166 A JP2022097166 A JP 2022097166A JP 2022097166 A JP2022097166 A JP 2022097166A JP 7443426 B2 JP7443426 B2 JP 7443426B2
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- conduit
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- expandable element
- injection device
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- 238000002347 injection Methods 0.000 title claims description 47
- 239000007924 injection Substances 0.000 title claims description 47
- 238000013519 translation Methods 0.000 claims description 39
- 239000012530 fluid Substances 0.000 claims description 32
- 238000007789 sealing Methods 0.000 claims description 4
- 230000006835 compression Effects 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 230000001954 sterilising effect Effects 0.000 description 30
- 230000007246 mechanism Effects 0.000 description 24
- 238000004891 communication Methods 0.000 description 23
- 238000004659 sterilization and disinfection Methods 0.000 description 23
- 238000000034 method Methods 0.000 description 17
- 239000003814 drug Substances 0.000 description 14
- 229940079593 drug Drugs 0.000 description 14
- 239000003206 sterilizing agent Substances 0.000 description 11
- 238000001802 infusion Methods 0.000 description 7
- 230000005465 channeling Effects 0.000 description 6
- 230000036512 infertility Effects 0.000 description 6
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 5
- 230000008878 coupling Effects 0.000 description 5
- 238000010168 coupling process Methods 0.000 description 5
- 238000005859 coupling reaction Methods 0.000 description 5
- 230000036316 preload Effects 0.000 description 5
- 230000035939 shock Effects 0.000 description 5
- 239000000356 contaminant Substances 0.000 description 4
- OSVXSBDYLRYLIG-UHFFFAOYSA-N dioxidochlorine(.) Chemical compound O=Cl=O OSVXSBDYLRYLIG-UHFFFAOYSA-N 0.000 description 3
- JCXJVPUVTGWSNB-UHFFFAOYSA-N nitrogen dioxide Inorganic materials O=[N]=O JCXJVPUVTGWSNB-UHFFFAOYSA-N 0.000 description 3
- 244000052769 pathogen Species 0.000 description 3
- 238000010254 subcutaneous injection Methods 0.000 description 3
- 239000007929 subcutaneous injection Substances 0.000 description 3
- 230000000699 topical effect Effects 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 description 2
- 239000004775 Tyvek Substances 0.000 description 2
- 229920000690 Tyvek Polymers 0.000 description 2
- 230000004075 alteration Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 235000019398 chlorine dioxide Nutrition 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 239000011261 inert gas Substances 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000005192 partition Methods 0.000 description 2
- MGWGWNFMUOTEHG-UHFFFAOYSA-N 4-(3,5-dimethylphenyl)-1,3-thiazol-2-amine Chemical compound CC1=CC(C)=CC(C=2N=C(N)SC=2)=C1 MGWGWNFMUOTEHG-UHFFFAOYSA-N 0.000 description 1
- 239000004155 Chlorine dioxide Substances 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- QBWCMBCROVPCKQ-UHFFFAOYSA-N chlorous acid Chemical compound OCl=O QBWCMBCROVPCKQ-UHFFFAOYSA-N 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 210000002445 nipple Anatomy 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
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- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
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- A61J1/14—Details; Accessories therefor
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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- A61J1/1443—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
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- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
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- 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
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- A61J1/14—Details; Accessories therefor
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- A61J1/201—Piercing means having one piercing end
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- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
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- A61J1/2048—Connecting means
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- A—HUMAN NECESSITIES
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- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
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- A61J1/2068—Venting means
- A61J1/2072—Venting means for internal venting
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
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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
- A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
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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
- A61M5/50—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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- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
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- 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
- A61M5/24—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
- A61M2005/247—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 fixed or steady piercing means, e.g. piercing under movement of ampoule
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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
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- 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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- 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
- A61M5/31—Details
- A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
- A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
-
- 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
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
- A61M2005/31518—Piston or piston-rod constructions, e.g. connection of piston with piston-rod designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
- A61M39/18—Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
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- Public Health (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Heart & Thoracic Surgery (AREA)
- Fluid Mechanics (AREA)
- Physics & Mathematics (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Chemical & Material Sciences (AREA)
- Pulmonology (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- External Artificial Organs (AREA)
- Basic Packing Technique (AREA)
Description
一態様では、本開示は、無菌一次容器穿刺機構を形成する方法を提供する。本方法は、第1端部、第1空洞、第1空洞と連通する開口部を備えた第2端部、開口部を少なくとも部分的に封止する隔壁、および第1空洞内の製品を含む滅菌前一次容器を取得するステップを含む。本方法は、中空流路形成部材の第1端部分を含む注入アセンブリを取得するステップをさらに含む。本方法はまた、流路形成部材の第1端部分の周囲にかつ一次容器まで延在する第2空洞を形成するために、非滅菌環境で注入アセンブリを一次容器の第2端部に組み付けるステップも含む。さらに、本方法は、第2空洞とその中の流路形成部材の第1端部分とを最終的に滅菌するステップを含む。
本明細書に組み込まれかつその一部を構成する添付図面は、本開示の実施形態を例示し、本明細書の詳細な説明とともに、本開示の原理を説明する役割を果たす。図面は、単に好ましい実施形態を例示するためのものであり、本開示を限定するものとして解釈されるべきではない。業界の慣例に従って、さまざまな特徴が正確な尺度で描かれていないことが強調される。実際には、さまざまな特徴の寸法は、考察を明確にするために、任意に増大または低減している場合がある。本開示の上述したおよび他の目的、特徴および利点は、添付図面とともに以下の詳細な説明から明らかである。
Claims (20)
- 注入装置であって、
流体を充填するように構成されている容器であって、第1の端部、第2の端部、およびその中に配置された可動ピストンを有している容器と、
前記容器の第2の端部の開口部を囲んでいるシールと、
後退状態から展開状態へ移動可能な導管と、
前記可動ピストンを駆動するように構成されている駆動部材と、
圧縮状態および拡張状態を有するとともに、前記導管に結合されている拡張可能要素であって、前記導管が後退状態にあるときに、圧縮状態にある、拡張可能要素と、
ロックであって、第1の位置にある間、前記拡張可能要素を圧縮状態に維持するように構成されており、前記駆動部材から可動ピストンに対して力を加えることで、ロックが第1の位置から移動して、前記拡張可能要素を圧縮状態から拡張状態に移動させるとともに、前記シールを通して前記導管を後退状態から展開状態へ移動させて前記容器に充填された流体と連通させるように構成されている、ロックと、を備えている注入装置。 - 前記ロックが、前記第1の位置にある間、前記拡張可能要素の経路を妨害することによって前記拡張可能要素の拡張を防止し、前記駆動部材から力を加えることで、前記ロックが前記第1の位置からかつ前記経路から半径方向外向きに移動する、請求項1に記載の注入装置。
- 前記拡張可能要素が圧縮状態から拡張状態へ移動すると、前記導管が少なくとも10mm/秒の速度で前記容器の第1の端部に向かって移動する、請求項1に記載の注入装置。
- 前記シールが空洞を有するブート部分を含んでおり、
前記導管が後退状態にある間、該導管の穿刺端部が前記空洞内に封入されており、
前記導管が展開状態にある間、前記穿刺端部が前記容器の中へ延びる、請求項1に記載の注入装置。 - 前記シールが、前記ブート部分と一体または別体の隔壁をさらに備えており、前記隔壁が前記容器の第2の端部を少なくとも部分的に封止している、請求項4に記載の注入装置。
- 前記シールの開口部が、前記導管の周囲に摺動シールを形成している、請求項4に記載の注入装置。
- 前記ロックが、
前記容器の第2の端部に結合されているカラーであって、先端軸方向縁部を有しているカラーと、
前記カラーに対して摺動可能なリテーナ部材であって、半径方向または横方向内向きに延在するカム、ラッチまたは作動部分を有しており、前記カラーの先端軸方向縁部が、カム、ラッチまたは作動部分を係合するように構成されている、リテーナ部材と、
前記導管に結合されている保持部分と、を有しており、
前記拡張可能要素が、前記リテーナ部材と保持部分との間で圧縮状態に保持されており、前記拡張可能要素が圧縮状態にある間、前記保持部分が、前記カム、ラッチまたは作動部分に当接しており、
前記容器が前記導管に向かって並進した後で、前記カム、ラッチまたは作動部分を前記カラーによって半径方向外向きに移動させることで、前記拡張可能要素が圧縮状態から拡張状態に移動することができ、それによって前記導管を展開状態に移動させる、請求項1に記載の注入装置。 - 前記容器の第2の端部に結合されているカラーであって、先端軸方向縁部を有しており、カラーの先端軸方向縁部が、前記ロックと係合するように構成されている、カラーをさらに備えている、請求項1に記載の注入装置。
- 前記ロックおよびカラーが、互いに対して摺動可能である、請求項8に記載の注入装置。
- 前記導管が後退状態にあるとき、前記ロックが横方向内向きに延びている、請求項1記載の注入装置。
- 注入装置であって、
流体を充填するように構成されている容器であって、第1の端部および第2の端部を有している容器と、
前記容器の第2の端部の開口部を囲んでいるシールと、
後退状態から展開状態へ移動可能な導管と、
圧縮状態および拡張状態を有するとともに、前記導管に結合されている拡張可能要素であって、前記導管が後退状態にあるとき、拡張可能要素はロックによって圧縮状態に維持されており、ロックが拡張可能要素を解放して、拡張可能要素が圧縮状態から拡張状態へ移動することで、前記シールを通して前記導管を展開状態に駆動する、拡張可能要素と、
前記容器の第1の端部から第2の端部に向かって移動するように構成されているピストンと、
前記ピストンを前記容器の第1の端部から第2の端部に向かって駆動するように構成されている駆動部材と、を備えている注入装置。 - 前記ロックが、第1の位置にある間、前記拡張可能要素を圧縮状態に維持するように構成されており、前記駆動部材から前記ピストンに対して力を加えることで、前記ロックが第1の位置から移動して、前記拡張可能要素を圧縮状態から拡張状態に移動させるように構成されている、請求項11に記載の注入装置。
- 前記ロックが、前記第1の位置にある間、前記拡張可能要素の経路を妨害することによって前記拡張可能要素の拡張を防止し、前記駆動部材から力を加えることで、前記ロックが前記第1の位置からかつ前記経路から半径方向外向きに移動する、請求項12に記載の注入装置。
- 前記拡張可能要素がばねである、請求項11に記載の注入装置。
- 前記導管が後退状態にあるとき、前記シールが該導管の第1の端部を囲むチャンバを有している、請求項11に記載の注入装置。
- 前記駆動部材からピストンに力を加えることによって、前記容器が前記導管の方へ並進するように構成されており、
前記容器が前記導管の方へ並進することによって、前記ロックが前記拡張可能要素を解放する、請求項11に記載の注入装置。 - 前記容器が前記導管に向かって並進した後で該導管が展開状態に移動する、請求項16に記載の注入装置。
- 前記ロックが、
前記容器の第2の端部に結合されているカラーであって、先端軸方向縁部を有しているカラーと、
前記カラーに対して摺動可能なリテーナ部材であって、半径方向または横方向内向きに延在するカム、ラッチまたは作動部分を備えており、前記カラーの先端軸方向縁部が、カム、ラッチまたは作動部分を係合するように構成されている、リテーナ部材と、を備えている、請求項11に記載の注入装置。 - 前記導管に結合されている保持部分をさらに備えており、
前記保持部分が、前記カム、ラッチまたは作動部分に当接して、前記拡張可能要素を圧縮状態に維持するように構成されている、請求項18に記載の注入装置。 - 前記容器が前記導管の方へ並進することによって、前記カム、ラッチまたは作動部分が半径方向外向きに移動するため、前記拡張可能要素が圧縮状態から拡張状態に移動することが可能になり、それによって前記導管を展開状態に移動させる、請求項19に記載の注入装置。
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