WO2017170635A1 - 薬液投与器具、薬液投与器具の使用方法及び薬液投与器具の製造方法 - Google Patents
薬液投与器具、薬液投与器具の使用方法及び薬液投与器具の製造方法 Download PDFInfo
- Publication number
- WO2017170635A1 WO2017170635A1 PCT/JP2017/012795 JP2017012795W WO2017170635A1 WO 2017170635 A1 WO2017170635 A1 WO 2017170635A1 JP 2017012795 W JP2017012795 W JP 2017012795W WO 2017170635 A1 WO2017170635 A1 WO 2017170635A1
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- WIPO (PCT)
- Prior art keywords
- pusher
- syringe
- gasket
- barrel
- pusher member
- Prior art date
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Classifications
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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
- A61M5/3129—Syringe barrels
- A61M5/3135—Syringe barrels characterised by constructional features of the proximal end
-
- 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
- A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
-
- 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
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
-
- 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
- A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
- A61M2005/3121—Means preventing contamination of the medicament compartment of a syringe via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
-
- 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
- A61M2005/3142—Modular constructions, e.g. supplied in separate pieces to be assembled by end-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
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
- A61M2005/31508—Means for blocking or restricting the movement of the rod or piston provided on the piston-rod
-
- 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
- A61M2207/00—Methods of manufacture, assembly or production
Definitions
- the present invention relates to a chemical solution administration device including a syringe that can be filled with a chemical solution and a gasket that is slidably inserted into the syringe, a method of using the chemical solution administration device, and a method of manufacturing the chemical solution administration device.
- a drug solution administration device includes a syringe that can be filled with a drug solution, a gasket that is slidably inserted into the syringe, and a pusher member that presses the gasket (for example, see Patent Document 1). ).
- the present invention provides a liquid medicine administration device that can be reliably sterilized using steam or gas in a state where a syringe and a gasket are assembled in advance as a liquid medicine administration equipment, a method of using the liquid medicine administration device, and It aims at providing the manufacturing method of a chemical
- the drug solution administration device of the present invention includes a syringe, a gasket, a pusher member, and a temporary holding part.
- the syringe has a cylindrical barrel portion that can be filled with a chemical solution, a discharge portion formed at a distal end portion of the barrel portion, and an opening portion formed at a proximal end portion of the barrel portion.
- the gasket is configured to be slidable in the cylindrical hole of the body portion.
- the pusher member has a pusher body to which a gasket is attached.
- the temporary holding portion holds the pusher member in a releasable manner in a state where the opening portion of the body portion and the front end surface of the gasket face each other with a space therebetween.
- medical solution administration device of this invention is a usage method of the chemical
- medical solution administration device of this invention is a manufacturing method of the chemical
- (1) A step of attaching the gasket to the pusher body of the pusher member.
- (2) A step of holding the pusher member by the temporary holding portion in a state where the opening formed at the proximal end portion of the barrel portion of the syringe and the distal end surface of the gasket face each other with a space therebetween.
- (3) A step of sterilizing the syringe, the gasket, the pusher member, and the temporary holding unit using a sterilization gas or high-pressure steam in a state where the pusher member is held by the temporary holding unit.
- the method of using the medicinal solution administration device and the method of manufacturing the medicinal solution administration device of the present invention when sterilization is performed using steam or gas, the syringe and the gasket are assembled in advance as the medicinal solution administration device. Can be sterilized reliably.
- FIG. 1 is a perspective view showing the drug solution administration device of the present embodiment.
- FIG. 2 is a cross-sectional view showing an administration component in the drug solution administration device of the present embodiment.
- FIG. 3 is an explanatory view showing a state of the pusher member, the gasket and the syringe of the present embodiment.
- the drug solution administration device 1 includes a syringe 11, a pusher member 12, a syringe holder 13 that holds the syringe 11, and a temporary holding unit 51 that temporarily holds the pusher member. .
- the syringe 11 is a syringe filled with a chemical solution M1 described later.
- the syringe 11 has a barrel portion 21 formed in a substantially cylindrical shape and a discharge portion 22 formed at the distal end portion of the barrel portion 21.
- a gasket 31 described later is slidably inserted into the cylindrical hole 21a of the barrel portion 21.
- the space closer to the discharge portion 22 than the gasket 31 in the body portion 21 and the space in the discharge portion 22 become a liquid chamber filled with the chemical solution M1.
- Examples of the chemical solution M1 include various vaccines that prevent various infectious diseases such as influenza, but are not limited to vaccines.
- Examples of the drug solution M1 other than the vaccine include, for example, saccharide injection solutions such as glucose, electrolyte correction injection solutions such as sodium chloride and potassium lactate, vitamin agents, antibiotic injection solutions, contrast agents, steroid agents, and proteolytic enzymes Inhibitors, fat emulsions, anticancer agents, anesthetics, heparin calcium, antibody drugs and the like.
- a flange portion 24 is provided at the base end portion of the body portion 21.
- the flange portion 24 protrudes outward in the radial direction from the outer peripheral surface of the base end portion of the body portion 21.
- the flange part 24 is latched by the through-hole 42 provided in the syringe holder 13 mentioned later. Thereby, the syringe 11 is held by the syringe holder 13.
- the flange portion 24 is formed with an opening portion 24a communicating with the cylindrical hole 21a of the body portion 21.
- the opening 24a opens in a circular shape.
- the gasket 31 mentioned later opposes the opening part 24a.
- a gasket 31 and a pusher body 34 which will be described later, are inserted into the opening 24a.
- the discharge part 22 is continuous with one end of the body part 21 and is formed in a substantially cylindrical shape coaxial with the body part 21.
- the discharge part 22 is formed in a tapered shape whose diameter continuously decreases toward the tip that is opposite to the body part 21.
- the cylindrical hole 22 a of the discharge part 22 communicates with the cylindrical hole 21 a of the trunk part 21.
- the luer lock part 26 which shows an example of a screwing part is joined to the discharge part 22.
- FIG. A needle hub 82 having a suction needle tube 81 for sucking a chemical solution and a needle hub having a needle tube that can puncture a living body are releasably attached to the luer lock portion 26.
- Examples of the material of the syringe 11 include polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. And various resins such as polyester such as butadiene-styrene copolymer, polyamide (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12). Among them, it is preferable to use a resin such as polypropylene, cyclic polyolefin, polyester, or poly- (4-methylpentene-1) in terms of easy molding. In addition, it is preferable that the material of the syringe 11 is substantially transparent in order to ensure internal visibility.
- FIG. 4 is a perspective view showing the pusher member 12.
- the pusher member 12 includes a gasket 31, a pusher main body 34 that presses the gasket 31, an operation part 35, a pusher-side engagement part 36, and a pusher-side retaining part 38. have.
- the gasket 31 is formed in a substantially cylindrical shape.
- One end of the gasket 31 is formed in a tapered shape whose diameter continuously decreases toward the tip. This taper shape corresponds to the shape of the inner surface of the front end portion of the body portion 21. Therefore, when the gasket 31 is moved to the front end portion side of the body portion 21, one end portion of the gasket 31 comes into contact with the inner surface at the front end portion of the body portion 21 so that no gap is generated.
- a connecting hole 31 a is formed in the other end portion of the gasket 31.
- the coupling portion 31a of the pusher body 34 is inserted into the coupling hole 31a, and the gasket 31 and the pusher body 34 are coupled.
- two peak portions 32 and 32 are provided on the outer peripheral surface of the gasket 31.
- the two peak portions 32 and 32 are convex portions that project from the outer peripheral surface of the gasket 31 in a ring shape.
- the two peak portions 32, 32 are provided with an interval in the axial direction of the gasket 31.
- the material of the gasket 31 is not particularly limited, but it is preferable that the gasket 31 is made of an elastic material in order to improve liquid tightness with the body portion 21.
- the elastic material include various rubber materials such as natural rubber, isobutylene rubber, butyl rubber and silicone rubber, various thermoplastic elastomers such as olefin and styrene, and mixtures thereof.
- the pusher body 34 is formed in a substantially rod shape, and the cross-sectional shape in a direction orthogonal to the axial direction of the pusher body 34 is formed in a substantially cross shape.
- the pusher body 34 is composed of four pusher pieces 34b protruding in a direction orthogonal to the axial direction.
- the four pusher pieces 34b are substantially perpendicular to each other.
- the pusher body 34 faces the opening 24 a of the syringe 11 in a state before being sterilized, while being held by a temporary holding portion 51 described later. And after performing a sterilization process, at the time of use, the pusher main body 34 is inserted in the trunk
- a connecting portion 34 a is provided at the tip of the pusher body 34.
- the connecting portion 34 a is inserted into the connecting hole 31 a of the gasket 31 and is connected to the gasket 31.
- the gasket 31 is attached to the tip of the pusher body 34.
- An operation unit 35 is provided at the proximal end of the pusher body 34.
- the operation unit 35 is formed in a substantially disc shape.
- the gasket 31 disposed at the tip of the pusher body 34 moves in the cylindrical hole 21 a of the body part 21 of the syringe 11.
- a pusher side engaging portion 36 and a pusher side retaining portion 38 are provided on the shaft portion of the pusher main body 34.
- the pusher side engaging portion 36 is provided on the distal end side in the axial direction of the pusher main body 34.
- the pusher side engaging portion 36 is provided between two pusher pieces 34b, 34b adjacent to each other among the four pusher pieces 34b of the pusher body 34 formed in a cross shape.
- the pusher side engaging portions 36 are provided at two locations that are symmetrical in the direction orthogonal to the axial direction of the pusher body 34 with the axis of the pusher body 34 interposed therebetween.
- the pusher side engaging portion 36 has a first engaging portion 36a and a second engaging portion 36b.
- the first engaging portion 36 a and the second engaging portion 36 b are arranged at a predetermined interval in the axial direction of the pusher body 34.
- the first engagement portion 36a is disposed closer to the distal end side in the axial direction of the pusher body 34 than the second engagement portion 36b.
- the pusher side retaining portion 38 is provided closer to the proximal end side in the axial direction of the pusher body 34 than the pusher side engaging portion 36.
- the pusher side retaining portion 38 includes two pusher pieces that are different from the two pusher pieces 34b, 34b provided with the pusher side engaging portion 36 among the four pusher pieces 34b of the pusher body 34. It is formed between 34b and 34b.
- the syringe holder 13 includes a cylinder main body portion 41, a through hole 42, a visual recognition window 46, a locking hole 47, and a holder collar portion 48.
- the cylinder main body 41 is formed in a substantially cylindrical shape and covers the outer peripheral surface of the barrel portion 21 and the flange portion 24 of the syringe 11 and the outer peripheral surface of the luer lock portion 26. And the cylinder main-body part 41 is comprised so that a user can hold
- a holder opening 41 a into which the syringe 11 and the pusher member 12 can be inserted is formed at the proximal end of the tube main body 41.
- the holder opening 41a is located on the distal end side with respect to the operation portion 35 which is a proximal end portion of the pusher body 34 inserted into the syringe holder 13.
- the cylinder main-body part 41 should just cover the outer peripheral surface of the flange part 24 at least.
- a viewing window 46 is opened at the tip of the cylinder body 41.
- the viewing window 46 is provided at a position where the liquid chamber formed in the body portion 21 of the syringe 11 is visible from the outside of the syringe holder 13 when the syringe 11 is mounted on the syringe holder 13. Thereby, even if the syringe holder 13 is attached to the syringe 11, the internal visibility can be secured.
- a holder collar 48 is provided at the base end of the tube main body 41.
- the holder collar 48 protrudes substantially perpendicularly from a part of the outer peripheral surface of the tube main body 41.
- the direction in which the syringe 11 and the pusher member 12 are inserted is determined in accordance with the short diameter portion of the holder collar 48. be able to.
- a through hole 42 and a locking hole 47 are opened in the cylinder main body 41.
- the through hole 42 and the locking hole 47 are formed on the proximal end side in the axial direction of the cylinder main body 41 with respect to the viewing window 46.
- the flange portion 24 of the syringe 11 is locked in the through hole 42. Thereby, the syringe 11 is held in the cylinder main body 41.
- the locking hole 47 is formed closer to the proximal end side in the axial direction of the cylinder body 41 than the through hole 42 in the vicinity of the through hole 42. Therefore, the locking hole 47 is formed closer to the proximal end side in the axial direction of the cylinder body 41 than the flange 24 of the syringe 11 held by the cylinder body 41. In this locking hole 47, the locking portion of the temporary holding portion 51 is locked.
- FIG. 5 is a perspective view showing the temporary holding portion 51.
- FIG. 6 is a perspective view showing the temporary holding portion 51 and the pusher member 12.
- the temporary holding portion 51 includes a cylindrical main body 52, two holding portion side engaging portions 53 and 53, two holding portion side retaining portions 54 and 54, a plurality of support ribs 55, And a stop 56.
- the cylinder body 52 is formed in a cylindrical shape. One end of the tube body 52 in the axial direction is open. Further, two holding portion side engaging portions 53 and 53 and two holding portion side retaining portions 54 and 54 are provided at the other end portion in the axial direction of the cylinder main body 52.
- the two holding portion side engaging portions 53 and 53 are arranged at positions facing each other at the edge portion of the opening formed at the other end portion of the cylinder main body 52.
- the two holding portion side engaging portions 53, 53 are bent substantially vertically from the edge of the tube main body 52 into the tube hole of the tube main body 52.
- the holding portion side engaging portion 53 is releasably engaged with the pusher side engaging portion 36 provided in the pusher main body 34. That is, the holding portion side engaging portion 53 is disposed between the first engaging portion 36 a and the second engaging portion 36 b of the pusher side engaging portion 36.
- the first engaging portion 36a is engaged with the holding portion side engaging portion 53 from the distal end side
- the second engaging portion 36b is engaged with the holding portion side engaging portion 53 from the proximal end side. Match. Accordingly, the pusher member 12 is temporarily held by the temporary holding portion 51 so as to be releasable.
- Two holding part side retaining parts 54, 54 which show an example of the retaining part, are arranged between the two retaining part side engaging parts 53, 53 at the edge of the opening formed at the other end of the cylinder body 52. Is provided. Further, the two holding portion side retaining portions 54, 54 are arranged at positions facing each other. The two holding portion side retaining portions 54, 54 are bent substantially vertically from the edge of the tube main body 52 into the tube hole of the tube main body 52. An insertion hole through which the pusher body 34 is inserted is formed by the two holding portion side engaging portions 53 and 53 and the two holding portion side retaining portions 54 and 54.
- the retaining portion and the temporary retaining portion 51 may be formed of different members.
- a plurality of support ribs 55 (four in this embodiment) showing an example of the support part are formed between the holding part side engaging part 53 and the holding part side retaining part 54.
- the plurality of support ribs 55 protrude from the inner wall of the cylinder main body 52 into the cylinder hole with a predetermined length.
- the plurality of support ribs 55 extend from the other end of the cylinder body 52 to a midway portion in the axial direction.
- the pusher body 34 when the pusher body 34 is inserted into the temporary holding portion 51, the plurality of support ribs 55 come into contact with the pusher piece 34 b of the pusher body 34. Therefore, the pusher body 34 is held by the plurality of support ribs 55. Accordingly, the pusher member 12 can be held by the temporary holding portion 51 without rattling. Further, in a state before the sterilization process, the gasket 31 is covered with the cylinder main body 52 of the temporary holding portion 51 as shown in FIGS. 3 and 6. Thereby, it can prevent that a user's finger contacts the gasket 31, and it can prevent that the gasket 31 which performed the sterilization process is contaminated.
- the locking portion 56 is provided at the tip of the outer peripheral surface of the cylinder main body 52.
- the locking portion 56 protrudes outward from the outer peripheral surface of the cylinder main body 52.
- FIGS. 1 and 3 when the tube main body 52 is inserted into the tube hole of the tube main body portion 41 of the syringe holder 13, the lock portion 56 is locked to the lock hole 47 of the syringe holder 13. .
- the temporary holding part 51 faces the flange part 24 of the syringe 11.
- the pusher member 12 is temporarily held by the temporary holding portion 51 in a state where the gasket 31 faces the opening 24 a of the syringe 11 with a space therebetween.
- FIG. 7 is a perspective view showing the drug administration device 1 when sucking the drug solution
- FIG. 8 is a cross-sectional view showing the drug administration device 1 after sterilization
- FIG. 9 is a cross-sectional view showing a state after sucking the chemical solution
- FIG. 10 is a cross-sectional view showing a state after administering the chemical solution.
- the syringe 11 is attached to the syringe holder 13.
- the pusher is inserted into the insertion holes formed at the distal ends of the two holding portion side engaging portions 53, 53 and the two holding portion side retaining portions 54, 54 of the temporary holding portion 51.
- the main body 34 is inserted.
- the pusher side engaging portion 36 is engaged with the holding portion side engaging portion 53 of the temporary holding portion 51.
- the gasket 31 is connected to the connecting portion 34a (see FIG. 2) of the pusher body 34.
- the gasket 31 is covered with the cylinder body 52 of the temporary holding portion 51 and the pusher member 12 is temporarily held by the temporary holding portion 51.
- the temporary holding portion 51 and the pusher member 12 are inserted into the tube hole of the tube main body portion 41 of the syringe holder 13. Then, as shown in FIGS. 1 and 3, the locking portion 56 of the temporary holding portion 51 is locked in the locking hole 47 of the syringe holder 13. Accordingly, the pusher member 12 is temporarily held by the temporary holding portion 51 in a state where the gasket 31 faces the opening 24 a of the syringe 11.
- the gasket 31 is not inserted into the cylindrical hole 21 a of the syringe 11, and is disposed outside the syringe 11. Therefore, the gap between the two peak portions 32 in the gasket 31 is open. Further, the cylindrical main body 52 of the temporary holding portion 51 has an axial tip portion, between the holding portion side engaging portion 53 and the supporting rib 55, between the supporting rib 55 and the holding portion side retaining portion 54, and the like. A plurality of gaps are formed.
- the manufacturing method of the chemical solution administration device 1 is completed by the above-described steps.
- the drug solution administration device 1 may be packaged with the gasket 31 facing the opening 24 a of the syringe 11, or the drug solution administration device 1 after the gasket 31 is inserted into the cylindrical hole 21 a of the syringe 11 as described later. May be packaged.
- an injection needle assembly 80 having a suction needle tube 81 for sucking a chemical solution from a vial container containing the chemical solution is attached to the syringe 11 in order to fill the liquid chamber of the syringe 11 with the chemical solution.
- the needle hub 82 of the injection needle assembly 80 is screwed into the luer lock portion 26 of the syringe 11. Thereby, the tube hole 21 a of the syringe 11 and the suction needle tube 81 of the injection needle assembly 80 are communicated with each other via the discharge part 22.
- the injection needle assembly 80 shown in FIG. 7 may be attached to the syringe 11 after the gasket 31 is inserted into the cylindrical hole 21 a of the syringe 11.
- the gasket 31 may be inserted into the cylindrical hole 21 a of the syringe 11 after the injection needle assembly 80 shown in FIG. 7 is attached to the syringe 11.
- the pusher-side retaining portion 38 gets over the retaining portion-side retaining portion 54 and is more than the retaining portion-side retaining portion 54. Move to the tip side. Then, the pusher side retaining portion 38 can come into contact with the retaining portion side retaining portion 54 from the tip end side. Thereby, it is possible to prevent the pusher member 12 from falling off from the temporary holding portion 51 attached to the syringe holder 13. At this time, the front end surface of the gasket 31 is separated from the front end surface of the cylindrical hole 22 a of the body portion 21.
- the needle tube 81 for suction of the injection needle assembly 80 is punctured into the vial, and the pusher member 12 is pulled toward the proximal end side of the syringe 11. Thereby, the chemical liquid M1 is sucked through the suction needle tube 81 of the injection needle assembly 80, and the liquid chamber of the syringe 11 is filled with the chemical liquid M1.
- the injection needle assembly 80 is removed from the luer lock portion 26.
- an injection needle assembly 90 having an administration needle tube 91 for puncturing a living body is attached to the syringe 11. That is, as shown in FIG. 9, the needle hub 92 of the injection needle assembly 90 is screwed into the luer lock portion 26 of the syringe 11. Thereby, the administration needle tube 91 of the injection needle assembly 90 and the cylindrical hole 21 a of the syringe 11 are communicated with each other via the discharge part 22.
- the administration needle tube 91 is punctured into the user's skin.
- the pusher member 12 is operated, and the gasket 31 is slid and moved toward the tip of the syringe 11.
- the medicinal solution M1 filled in the liquid chamber of the syringe 11 is pushed out from the administration needle tube 91 by the gasket 31.
- administration of the chemical solution to the living body using the chemical solution administration device 1 is completed.
- worn if it mounts
- Various other administration parts can be applied.
- the example which provided the luer lock part 26 as a screwing part was demonstrated in embodiment mentioned above, it is not limited to this,
- the male thread part is provided in the discharge part 22, and the female thread part is provided in the administration component And may be screwed together.
- the temporary holding part 51 and the syringe holder 13 may be molded integrally, or the syringe holder 13 may not be provided.
- the temporary holding portion may be releasably attached to the flange portion of the syringe or the temporary holding portion may be fixed to the syringe by adhesion or welding. Or you may shape
- the gasket 31 is covered with the cylinder body 52 of the temporary holding portion 51 until the gasket 31 is inserted into the syringe 11 after the sterilization process. Therefore, even when the syringe holder 13 is not provided, the user's fingers can be prevented from coming into contact with the gasket 31.
- the pusher member 12 is temporarily held by the temporary holding portion 51 by engaging the pusher side engaging portion 36 and the holding portion side engaging portion 53 has been described.
- the pusher member may be temporarily held in the temporary holding portion by fixing the pusher body of the pusher member and the cylinder main body of the temporary holding portion by ultrasonic welding or laser welding.
- the fixing strength between the pusher main body and the tube main body is set to a strength that breaks when the pusher member is pressed after sterilization.
- a thin portion that breaks when the pusher member is pressed may be provided, and the temporary holding portion and the pusher member may be molded integrally.
Abstract
Description
(1)押し子部材をシリンジの先端側に向かって押圧し、仮保持部による押し子部材の保持を解除する工程。
(2)押し子部材をシリンジの先端側に向かってさらに押圧して、ガスケットを胴部の筒孔内に挿入し、ガスケットの先端面を胴部における筒孔の先端面に当接させる工程。
(3)押し子部材をシリンジの基端側に向かって引くことで、胴部の筒孔内に薬液を充填させる工程。
(4)再び、押し子部材をシリンジの先端側に向かって押圧することにより、薬液を排出部から排出させる工程。
(1)ガスケットを押し子部材の押し子本体に取り付ける工程。
(2)シリンジの胴部の基端部に形成された開口部とガスケットの先端面とが間隔を空けて対向した状態で、押し子部材を仮保持部により保持する工程。
(3)押し子部材を仮保持部で保持させた状態で、シリンジ、ガスケット、押し子部材及び仮保持部に対して滅菌用ガスまたは高圧蒸気を用いて滅菌する工程。
[薬液投与器具の構成]
まず、本発明の薬液投与器具の実施の形態(以下、「本実施形態」という。)の構成について、図1~図6を参照して説明する。
図1は、本実施形態の薬液投与器具を示す斜視図である。図2は、本実施形態の薬液投与器具に投与部品を示す断面図である。図3は、本実施形態の押し子部材及びガスケットとシリンジの状態を示す説明図である。
シリンジ11は、後述する薬液M1が充填されるシリンジである。このシリンジ11は、略円筒状に形成された胴部21と、胴部21の先端部に形成された排出部22を有している。
図4は、押し子部材12を示す斜視図である。
図4に示すように、押し子部材12は、ガスケット31と、ガスケット31を押圧する押し子本体34と、操作部35と、押し子側係合部36と、押し子側抜け止め部38とを有している。
図1及び図2に示すように、シリンジホルダ13は、筒本体部41と、貫通孔42と、視認窓46と、係止孔47と、ホルダ鍔部48と、を有している。
次に、図5~図6を参照して仮保持部51について説明する。
図5は、仮保持部51を示す斜視図である。図6は、仮保持部51と押し子部材12を示す斜視図である。
次に、図1~図10を参照して上述した構成を有する薬液投与器具1の製造方法及び使用方法について説明する。
図7は、薬液を吸引する際の薬液投与器具1を示す斜視図、図8は、滅菌処理後の薬液投与器具1を示す断面図である。図9は、薬液を吸引した後の状態を示す断面図、図10は、薬液を投与した後の状態を示す断面図である。
Claims (10)
- 内部に薬液を充填可能な筒状の胴部と、前記胴部の先端部に形成された排出部と、前記胴部の基端部に形成された開口部とを有するシリンジと、
前記胴部の筒孔内を摺動可能なガスケットと、
前記ガスケットが取り付けられた押し子本体を有する押し子部材と、
前記胴部の前記開口部と前記ガスケットの先端面とが間隔を空けて対向した状態で、前記押し子部材を解除可能に保持する仮保持部と、
を備えた薬液投与器具。 - 前記押し子部材が前記シリンジの先端側に向かって押圧されることにより、前記仮保持部による前記押し子部材の保持が解除可能となる
請求項1に記載の薬液投与器具。 - 前記押し子本体は、押し子側係合部を有し、
前記仮保持部は、前記押し子側係合部と解除可能に係合する保持部側係合部を有し、
前記押し子側係合部と前記保持部側係合部との係合により、前記押し子部材が前記仮保持部に解除可能に保持される
請求項1又は2に記載の薬液投与器具。 - 前記押し子側係合部は、前記保持部側係合部に対して先端側から係合する第1係合部と、前記保持部側係合部に対して基端側から係合する第2係合部とを有し、
前記第1係合部と前記第2係合部との間に前記保持部側係合部が位置することにより、前記押し子部材が前記仮保持部に解除可能に保持される
請求項3に記載の薬液投与器具。 - 前記押し子側係合部は、前記押し子本体の軸心を間に挟んで対向する位置である2箇所に設けられ、
前記保持部側係合部は、前記胴部の軸心を間に挟んで対向する位置である2箇所に設けられている
請求項3又は4に記載の薬液投与器具。 - 前記押し子本体は、前記押し子側係合部よりも基端側で、かつ前記押し子本体の軸心周りにおいて前記押し子側係合部と異なる位置に設けられた押し子側抜け止め部を有し、
前記胴部の軸心周りにおいて前記保持部側係合部と異なる位置に設けられ、前記押し子側抜け止め部に対して基端側から当接可能な抜け止め部をさらに備え、
前記押し子側抜け止め部が前記抜け止め部を基端側から乗り越え、前記押し子側抜け止め部と前記抜け止め部が当接した際、前記押し子側抜け止め部及び前記抜け止め部は、前記押し子本体における基端側への移動を規制可能であり、
前記押し子側抜け止め部と前記抜け止め部が当接した際、前記ガスケットの先端面は、前記胴部における前記筒孔の先端面から離間している
請求項3から5のいずれか1項に記載の薬液投与器具。 - 前記仮保持部は、前記押し子本体を支持する支持部を有し、
前記押し子本体の軸の前記胴部の軸に対する傾きが、前記支持部により規制される
請求項1から6のいずれか1項に記載の薬液投与器具。 - 前記シリンジの前記排出部には、生体に穿刺可能な針先を有する針管を備えた注射針組立体及び前記薬液を吸引可能な針先を有する吸引用針管を備えた注射針組立体が着脱可能に装着され、
前記シリンジを保持するシリンジホルダをさらに備え、
前記仮保持部は、前記シリンジホルダに設けられている
請求項1から7のいずれか1項に記載の薬液投与器具。 - 内部に薬液を充填可能な筒状の胴部と、前記胴部の先端部に形成された排出部と、前記胴部の基端部に形成された開口部とを有するシリンジと、
前記胴部の筒孔内を摺動可能なガスケットと、
前記ガスケットが取り付けられた押し子本体を有する押し子部材と、
前記胴部の前記開口部と前記ガスケットの先端面とが間隔を空けて対向した状態で、前記押し子部材を解除可能に保持する仮保持部と、を備えた薬液投与器具の使用方法であって、
前記押し子部材を前記シリンジの先端側に向かって押圧し、前記仮保持部による前記押し子部材の保持を解除する工程と、
前記押し子部材を前記シリンジの先端側に向かってさらに押圧して、前記ガスケットを前記胴部の前記筒孔内に挿入し、前記ガスケットの先端面を前記胴部における前記筒孔の先端面に当接させる工程と、
前記押し子部材を前記シリンジの基端側に向かって引くことで、前記胴部の前記筒孔内に前記薬液を充填させる工程と、
再び、前記押し子部材を前記シリンジの先端側に向かって押圧することにより、前記薬液を前記排出部から排出させる工程と、
を含む薬液投与器具の使用方法。 - 内部に薬液を充填可能な筒状の胴部と、前記胴部の先端部に形成された排出部と、前記胴部の基端部に形成された開口部とを有するシリンジと、前記胴部の筒孔内を摺動可能なガスケットと、前記ガスケットが取り付けられた押し子本体を有する押し子部材と、前記胴部の前記開口部と前記ガスケットの先端面とが間隔を空けて対向した状態で、前記押し子部材を解除可能に保持する仮保持部と、を備えた薬液投与器具の製造方法であって、
前記ガスケットを前記押し子部材の前記押し子本体に取り付ける工程と、
前記シリンジの前記胴部の基端部に形成された開口部と前記ガスケットの先端面とが間隔を空けて対向した状態で、前記押し子部材を前記仮保持部により保持する工程と、
前記押し子部材を前記仮保持部で保持させた状態で、前記シリンジ、前記ガスケット、前記押し子部材及び前記仮保持部に対して滅菌用ガスまたは高圧蒸気を用いて滅菌する工程と、
を含む薬液投与器具の製造方法。
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WO2019077703A1 (ja) * | 2017-10-18 | 2019-04-25 | 前田産業株式会社 | 注射器のガスケット抜け防止機構 |
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JP2021522003A (ja) * | 2018-05-01 | 2021-08-30 | シーエスピー テクノロジーズ,インコーポレイティド | 薬剤送達デバイス、ならびに薬剤送達デバイスの使用および作製方法 |
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