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WO2011068130A1 - Seringue préremplie - Google Patents

Seringue préremplie Download PDF

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Publication number
WO2011068130A1
WO2011068130A1 PCT/JP2010/071509 JP2010071509W WO2011068130A1 WO 2011068130 A1 WO2011068130 A1 WO 2011068130A1 JP 2010071509 W JP2010071509 W JP 2010071509W WO 2011068130 A1 WO2011068130 A1 WO 2011068130A1
Authority
WO
WIPO (PCT)
Prior art keywords
puncture needle
prefilled syringe
space
needle
outer cylinder
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2010/071509
Other languages
English (en)
Japanese (ja)
Inventor
浩一 立川
信之介 大津
智紀 岡山
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Publication of WO2011068130A1 publication Critical patent/WO2011068130A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61M5/2422—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
    • 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
    • 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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M5/46—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 controlling depth of insertion
    • 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
    • A61M5/32—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
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • 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
    • A61M5/42—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 desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Definitions

  • the present invention relates to a prefilled syringe containing a chemical solution.
  • the upper skin layer refers to the epidermis and dermis (dermis layer) of the skin.
  • a type of syringe that is used by mounting a chemical cartridge containing a chemical (for example, see Patent Document 2).
  • this syringe is used with a chemical cartridge and a double-ended needle attached to the syringe body.
  • the syringe body is repeatedly used a plurality of times by performing sterilization treatment, and the drug solution cartridge and the double-ended needle are used only once and are disposable.
  • the conventional dental syringe is a type that is used with a chemical liquid cartridge attached, the chemical liquid can be prevented from being wasted and can be easily prepared during use.
  • a prefilled syringe containing a chemical solution in which a precipitate is generated it is necessary to agitate the chemical solution before administration of the chemical solution.
  • a gas such as air together with a chemical solution
  • the air inside moves, The chemical solution can be easily stirred.
  • the drug solution cannot be stirred even if it is filled with air.
  • the present invention comprises an outer cylinder, A chemical solution container provided with a container main body having a soft part that is installed in the outer cylinder and stores the chemical solution; A prefilled syringe comprising a pusher that is movably installed with respect to the outer cylinder and that presses and deforms the soft portion by the movement.
  • the prefilled syringe of the present invention it is preferable that the prefilled syringe has an operation unit that performs an operation of deforming the soft portion from the outside of the outer cylinder and stirring the chemical solution.
  • the operation portion has an opening formed in a side wall of the outer cylinder.
  • the operation portion has a pair of openings formed on a side wall of the outer cylinder and arranged to face each other with the soft portion interposed therebetween.
  • the soft part is a bag-like soft bag in which the chemical solution is stored.
  • one end has a needle tip capable of puncturing a living body and the other end is provided with a puncture needle capable of communicating with the inside of the soft bag.
  • the container main body removably adheres to the inner surfaces of the soft bag, and the inside of the container main body contains a first space in which the chemical solution is stored, and the first space. It has a weak seal part that partitions into a second space located on the tip side, The proximal end side of the puncture needle communicates with the second space, It is preferable that the base end side of the puncture needle communicates with the first space when the weak seal portion is peeled off.
  • the soft bag when the pusher is moved in the distal direction, the soft bag is pressed and deformed, the weak seal portion is peeled off, and the proximal end side of the puncture needle communicates with the first space. And it is preferable that the said chemical
  • a contact portion provided on the distal end side of the outer cylinder, spaced apart from the needle tip of the puncture needle in the radial direction of the puncture needle and capable of contacting the surface of the living body.
  • the prefilled syringe of the present invention it is preferable that the prefilled syringe has a protective member for sealing the space inside the abutting portion, and the aseptic state of the space inside the abutting portion is held in an unused state. .
  • the prefilled syringe of the present invention includes a needle support portion having a convex portion that supports the puncture needle and can come into contact with the surface of the living body.
  • FIG. 1 is a partial longitudinal sectional view showing a first embodiment (a state in which a protective member is removed) of a prefilled syringe of the present invention.
  • FIG. 2 is a partial longitudinal sectional view showing a state in which the protective member of the prefilled syringe shown in FIG. 1 is mounted.
  • FIG. 3 is a view for explaining the procedure for assembling the prefilled syringe shown in FIG. 1.
  • FIG. 4 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG.
  • FIG. 5 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG.
  • FIG. 6 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG.
  • FIG. 7 is a perspective view showing an outer cylinder in the second embodiment of the prefilled syringe of the present invention.
  • the present invention can be applied to a prefilled syringe that administers various chemicals to a living body, in the following embodiment, the present invention is typically applied to a prefilled syringe that administers a vaccine. Will be described.
  • FIG. 1 is a partial longitudinal sectional view showing a first embodiment of the prefilled syringe of the present invention (a state in which a protective member is removed), and FIG. 2 is a partial longitudinal section showing a state in which the protective member of the prefilled syringe shown in FIG.
  • FIG. 3 is a diagram for explaining a procedure for assembling the prefilled syringe shown in FIG. 1, and FIGS. 4 to 6 are partial longitudinal sectional views for explaining a method of using the prefilled syringe shown in FIG.
  • FIG. 3F is a cross-sectional view taken along line AA in FIG.
  • FIGS. 1 to 6 the upper side in FIGS. 1 to 6 is referred to as “base end”, the lower side as “tip”, the right side as “right”, and the left side as “left”. 5 and FIG. 6, illustration of the living body is omitted.
  • the prefilled syringe 1 includes an outer cylinder (syringe outer cylinder) 2, a chemical solution container 7 installed in the outer cylinder 2, and an axis of the outer cylinder 2 with respect to the outer cylinder 2.
  • the pusher 3 movably installed along the direction (longitudinal direction), the puncture needle 6, the needle support portion 4 that supports the puncture needle 6, and the distal end side of the puncture needle 6 on the distal end side of the outer cylinder 2
  • a contact portion 5 provided so as to surround the needle tip 61 and capable of contacting the surface of the living body, and a protective member (cap) 8 are provided.
  • the outer cylinder 2 is a cylindrical member, which is a cylindrical member in the illustrated configuration. And in this embodiment, the chemical
  • FIG. 1 is a cylindrical member, which is a cylindrical member in the illustrated configuration.
  • medical solution container 7 is accommodated in this outer cylinder 2, and is being fixed to the front end side of the outer cylinder 2.
  • the constituent material of the outer cylinder 2 is not particularly limited.
  • resins such as styrene copolymers, polyesters such as polyethylene terephthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12) can be mentioned.
  • Resin such as polypropylene, cyclic polyolefin, polyester, and poly- (4-methylpentene-1) is preferable because it is easy to mold.
  • the constituent material of the outer cylinder 2 is substantially transparent in order to ensure internal visibility.
  • the chemical liquid container 7 has a container main body (main body of the chemical liquid container) 71, and the chemical liquid is stored in advance in the container main body 71 in a liquid-tight (air-tight) manner.
  • the container main body 71 is constituted by a bag-like soft bag, and is formed by fixing the inner surfaces of the container main body 71 in a strip shape in the middle of the container main body 71 in the vertical direction in FIG.
  • a weak seal portion 74 is formed.
  • the inside of the container body 71 is partitioned by the weak seal portion 74 into a first space 76 on the proximal end side and a second space 77 on the distal end side.
  • the weak seal portion 74 can be formed, for example, by fusing the inner surfaces of the container body 71 (thermal fusion, high frequency fusion, ultrasonic fusion, etc.).
  • a portion of the container body 71 on the tip side of the weak seal portion 74, that is, a portion that defines the first space 76 of the container body 71 is a liquid retaining portion 72 that is a soft portion (soft bag).
  • the first space 76 is a hermetically sealed space that is kept sterile.
  • the external shape of the liquid retaining portion 72 is circular when viewed from a direction perpendicular to the paper surface in FIG. A polygon, an ellipse, etc. may be sufficient.
  • the central portion of the base end portion of the mounting portion 73 that is the base end side portion of the weak seal portion 74 of the container body 71 is fixed to the convex portion 43 of the needle support portion 4 to be described later.
  • the inner surfaces of the remaining portions of the base end portion are fixed to each other, whereby a strong seal portion 75 is formed at the base end portion of the mounting portion 73 (see FIG. 3F).
  • the strong seal portion 75 can be formed by, for example, fusing the inner surface of the container main body 71 and the outer surface of the convex portion 43, and fusing the inner surfaces of the container main body 71 together.
  • the second space 77 is defined, and the proximal end side of the puncture needle 6 communicates with the second space 77.
  • the second space 77 is a hermetically sealed space except for a proximal end opening 62 of the puncture needle 6 which will be described later, and the aseptic state is maintained in a state where the protective member 8 is attached to the contact portion. ing.
  • the dimension of the attachment part 73 is set smaller than the liquid retaining part 72.
  • the weak seal portion 74 is peeled off by, for example, pressing (pressing) the liquid retaining portion 72 of the container body 71 with the pusher 3 and increasing the internal pressure of the first space 76 to a predetermined threshold value or more. Is configured to do.
  • the threshold value is set to a value higher than the internal pressure of the first space 76 when the liquid retaining part 72 is deformed and the chemical liquid in the liquid retaining part 72 is stirred. Thereby, it is possible to prevent the weak seal portion 74 from being peeled when the liquid retaining portion 72 is deformed and the chemical liquid in the liquid retaining portion 72 is stirred.
  • the weak seal portion 74 is not limited to the case where the weak seal portion 74 is formed entirely from the right end portion to the left end portion in FIG. 1 of the container body 71, but the right end portion in FIG. To the left end portion.
  • the constituent material of the container main body 71 is not particularly limited.
  • polyolefin such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer, olefin elastomer, styrene elastomer, etc. And various combinations of these (e.g., blend resins, polymer alloys, laminates).
  • These resin materials are preferable in that they are rich in flexibility and transparency, and have heat resistance and water resistance that can withstand high-pressure steam sterilization (autoclave sterilization).
  • the constituent material of the container main body 71 is substantially transparent in order to ensure internal visibility.
  • the constituent material of the container body 71 are polyethylene, polypropylene, styrene elastomer such as styrene-butadiene copolymer and styrene-ethylene-butylene-styrene block copolymer, ethylene-butene copolymer, A soft resin obtained by blending an elastomer such as an olefin-based elastomer such as an ethylene-propylene copolymer and softening can be given.
  • This material is preferable in that it has high strength and flexibility, heat resistance (particularly heat resistance during sterilization) and water resistance, and is particularly excellent in workability and can reduce manufacturing costs.
  • the thickness of the sheet material constituting the container main body 71 is not particularly limited, and varies depending on other conditions such as the material, but is usually about 0.01 to 0.30 mm, preferably 0.05 to More preferably, it is about 0.15 mm.
  • the amount of the chemical solution stored in the first space 76 is not particularly limited, but is preferably about 0.02 to 2.0 mL, for example, 0.05 to 0.8 mL. The degree is more preferable. That is, the prefilled syringe 1 is particularly suitable when such a small amount of drug solution is administered.
  • the first space 76 may be filled with a gas such as air together with the chemical solution, or may not be filled.
  • a gas such as air together with the chemical solution, or may not be filled.
  • the filling and non-filling of air can be appropriately selected as necessary.
  • a pair of openings 21 are formed on the side wall of the outer cylinder 2 as an operation part that performs an operation of deforming the liquid retaining part 72 from the outside of the outer cylinder 2 and stirring the chemical liquid.
  • the pair of openings 21 is formed at a position corresponding to the liquid retaining part 72 on the side wall of the outer cylinder 2, that is, in the vicinity of the liquid retaining part 72. Further, the pair of openings 21 are disposed so as to face each other with the liquid retaining portion 72 interposed therebetween. A finger can be inserted into the outer cylinder 2 from the opening 21 and the liquid retaining portion 72 can be deformed by the finger or the like to stir the drug solution.
  • the shape of the opening 21 is circular in the illustrated configuration, but is not limited to this, and may be, for example, a polygon such as a quadrangle, an ellipse, or the like.
  • the dimensions of the opening 21 are not particularly limited, and are appropriately determined according to various conditions such as the dimensions of the outer cylinder 2 and the liquid retaining part 72.
  • the diameter of the opening 21 is preferably a minimum size that allows a finger to reach the chemical liquid container 7 and deform the liquid retaining portion 72. That is, the diameter of the opening 21 is preferably about 10 to 20 mm, and more preferably about 13 to 17 mm.
  • the opening 21 may be covered with a soft sheet (not shown). Further, as this sheet, for example, a filter for sterilization that allows air to pass but does not allow bacteria to pass may be used. Also in this case, the chemical solution can be stirred by deforming the liquid retaining portion 72 through the sheet.
  • the pusher 3 is an operation member that pushes and deforms the liquid retaining portion 72 of the chemical liquid container 7 by moving the pusher 3 in the distal direction along the axial direction with respect to the outer cylinder 2.
  • the pusher 3 has a bar-shaped main body 31 whose cross section is circular, for example.
  • the front end of the main body 31 is a part that comes into contact with the liquid retaining part 72 and is rounded. Thereby, the front-end
  • FIG. A disc-shaped flange 32 is formed at the base end of the main body 31.
  • the constituent material of the pusher 3 is not particularly limited, but for example, the same constituent material as that of the outer cylinder 2 can be used.
  • main body 31 of the pusher 3 and the outer cylinder 2 may be provided with a detachment prevention means (not shown) that prevents the pusher 3 from detaching from the outer cylinder 2.
  • the puncture needle 6 has a sharp needle tip 61 that can puncture a living body on the distal end side, and a base that can communicate with the inside of the liquid retaining portion 72 of the drug solution container 7, that is, the first space 76, on the proximal end side.
  • An end opening 62 is provided.
  • the proximal end opening 62 of the puncture needle 6 communicates with the first space 76 via the second space 77.
  • a needle having a size of 26 to 33 G (outer diameter: 0.2 to 0.45 mm) based on the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)) is used. It is preferable to use one having a size of 30 to 33G.
  • a cutting edge having a blade surface is formed on the distal end side of the puncture needle 6, and the axial length (hereinafter referred to as “bevel length”) B of the puncture needle 6 on the blade surface is the maximum of the upper layer portion of the skin.
  • the thickness is preferably 1.4 mm (adult) or less, which is a thin thickness, and is preferably about 0.5 mm or more which is the bevel length when a short bevel is formed on a 33G puncture needle. That is, the bevel length B is preferably set within a range of 0.5 to 1.4 mm.
  • the bevel length B is more preferably 0.9 mm (child) or less, which is the thinnest thickness of the upper skin layer. That is, the bevel length B is more preferably set within a range of 0.5 to 0.9 mm.
  • the depth (puncture depth) of the puncture needle 6 to be punctured on the upper skin portion is the length of the portion of the puncture needle 6 that protrudes from the distal end surface of the convex portion 42 described later (hereinafter referred to as “projection length”). Say) determined by L.
  • the thickness of the upper skin layer portion corresponds to the depth from the surface of the skin to the dermis layer, and is generally 0.5 to 3.0 mm. Therefore, the protruding length L of the puncture needle 6 is 0.5 to 3.0 mm. It is preferable to set within the range.
  • the administration site of influenza vaccine is generally the deltoid muscle.
  • the thickness of the upper skin layer in the pediatric deltoid muscle is 0.9 to 1.6 mm, and the upper skin thickness in the adult deltoid muscle is 1.4 to 2.6 mm in the distal portion.
  • the central portion is 1.4 to 2.5 mm, and the proximal portion is 1.5 to 2.5 mm.
  • the protruding length L of the puncture needle 6 can be set within a range of 0.9 to 1.4 mm.
  • the constituent material of the puncture needle 6 is not particularly limited.
  • various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, superelastic alloy such as Ni-Ti alloy, and various hard materials such as polyphenylene sulfide. Resin material etc. are mentioned.
  • the needle support portion 4 includes a base portion 40, a convex portion 42 fixed to the central portion of the distal end surface of the base portion 40, and a convex portion 43 fixed to the central portion of the base end surface of the base portion 40. It is fixed to the tip (tip part).
  • the base portion 40 has a disk shape, and the convex portions 42 and 43 each have a columnar shape.
  • the tip surface of the convex portion 42 is a part that comes into contact with the surface (skin) of a living body when a drug solution is administered (when the puncture needle 6 is punctured), and the shape of the tip surface is relative to the axis of the puncture needle 6.
  • the base 40 and any one or both of the convex part 42 and the convex part 43 may be formed integrally.
  • the needle support portion 4 may be formed integrally with the outer cylinder 2.
  • the puncture needle 6 is fixed to the center portion of the needle support portion 4 and supported by the base portion 40 and the convex portions 42 and 43, and the needle tip 61 on the distal end side is located on the distal end side with respect to the needle support portion 4. is doing. Further, in the configuration shown in the figure, the proximal end opening 62 of the puncture needle 6 is located on the proximal end side with respect to the convex portion 43, but if the proximal end opening 62 communicates with the second space 77, Not limited to this, the proximal end opening 62 may coincide with the proximal end surface of the convex portion 43, or may be located on the distal end side with respect to the proximal end surface of the convex portion 43.
  • the needle support part 4 has the convex part 42, when the puncture needle 6 is punctured into a predetermined part of the living body, the convex part 42 comes into contact with the epidermis, whereby the epidermis is brought into contact with the axis of the puncture needle 6.
  • the needle tip 61 of the puncture needle 6 can be punctured so as to be perpendicular to the epidermis.
  • the distance S from the outer peripheral edge (outer peripheral surface) of the convex portion 42 to the outer peripheral surface of the puncture needle 6 is preferably set to 1.4 mm or less, and is set within a range of 0.3 to 1.4 mm. Is more preferable.
  • This distance S is set in consideration of the pressure applied to the blisters formed by administering the drug solution to the upper skin layer. That is, the distance S is set so that the size of the tip surface of the convex portion 42 is sufficiently smaller than the blisters formed on the upper skin layer and does not hinder the formation of the blisters. Thereby, it can prevent that the chemical
  • the base 40 of the needle support portion 4 has a portion that comes into contact with the epidermis when the puncture needle 6 is punctured.
  • the abutment portion 5 and the puncture needle 6 press the epidermis by pressing the abutment portion 5 against the epidermis until the portion of the base 40 that abuts against the epidermis abuts the epidermis.
  • the distance Y from the distal end surface (lower end surface) of the base portion 40 to the distal end surface of the contact portion 5 is such that when the puncture needle 6 is punctured, the contact portion 5 and the puncture needle 6 press the epidermis with an appropriate pressing force.
  • the puncture needle 6 is set so as to be punctured reliably.
  • This distance Y is appropriately determined based on the inner diameter d of the contact portion 5 and the distance X from the outer wall surface (outer peripheral surface) of the base portion 40 to the outer wall surface (outer peripheral surface) of the contact portion 5.
  • the distance Y is preferably set within a range of 0.75 to 2.6 mm.
  • the pressing force with which the abutment portion 5 and the puncture needle 6 press the epidermis is reliably transmitted (guided) to the epidermis by the base portion 40, and the needle tip 61 of the puncture needle 6 is reliably positioned on the upper skin portion. be able to.
  • the thing similar to the constituent material of the said outer cylinder 2 can be used.
  • the abutting portion 5 has a cylindrical shape, a cylindrical shape in the illustrated configuration, and is fixed to the tip surface (tip portion) of the base portion 40 of the needle support portion 4. In this case, the contact portion 5 is provided away from the needle tip 61 on the distal end side of the puncture needle 6 in the radial direction of the puncture needle 6.
  • the distal end surface of the abutment portion 5 is located on the proximal end side with respect to the distal end side of the puncture needle 6 and on the proximal end side with respect to the distal end surface of the convex portion 42.
  • the tip surface of the contact portion 5 may be located at the same position as the tip surface of the convex portion 42 (on the same plane as the tip surface of the convex portion 42) in the axial direction of the puncture needle 6, You may be located in the front end side rather than the front end surface of the convex part 42. FIG. In these cases as well, the puncture needle 6 can be maintained in a posture perpendicular to the epidermis.
  • the distance r between the distal end surface of the abutment portion 5 and the distal end surface of the convex portion 42 in the axial direction of the puncture needle 6 is 1.3 mm. It is preferable to set as follows.
  • the distance T from the inner wall surface (inner circumferential surface) of the contact portion 5 to the outer peripheral edge of the convex portion 42 is preferably set to 4 mm or more, and there is no particular upper limit.
  • the distance T is preferably set to 15 mm or less in consideration of the thinness of the child's arm and the like. That is, the distance T is preferably set within a range of 4 to 15 mm.
  • the inner diameter d of the contact portion 5 is preferably set to a value equal to or larger than the diameter of the blister formed in the upper skin layer.
  • the distance S from the outer periphery of the convex part 42 to the outer peripheral surface of the puncture needle 6 is 0.3 mm or more, the convex part 42 does not enter the skin. Therefore, considering the preferable value (4 mm or more) of the distance T from the inner wall surface of the contact part 5 to the outer peripheral edge of the convex part 42 and the preferable value (0.3 mm or more) of the distance S, the contact part 5
  • the inner diameter d is preferably set to 9 mm or more.
  • the front end surface of the contact portion 5 and the front end surface of the convex portion 42 are brought into contact with the epidermis in the target region of the living body, Press with strength.
  • the epidermis of the part that is not in contact with the distal end surface of the contact part 5 on the inner side of the contact part 5 rises in a mountain shape, and the epidermis of the part that is in contact with the distal end surface of the convex part 42 is puncture needle 6.
  • the needle tip 61 on the distal end side of the puncture needle 6 is punctured into the living body.
  • the puncture depth of the puncture needle 6 is such that the positional relationship between the puncture needle 6 and the epidermis is regulated by the front end surface of the contact portion 5 and the front end surface of the convex portion 42 being in contact with the epidermis. Become deep.
  • the protection member 8 is a member that seals the space 52 inside the contact portion 5, and is detachably attached to the contact portion 5 in an unused state.
  • the protection member 8 has a bottomed cylindrical shape having a bottom portion on the front end side, or a bottomed cylindrical shape in the illustrated configuration.
  • the contact portion 5 is configured such that the inner space 52 is hermetically sealed.
  • the space 52 inside the contact portion 5 is hermetically sealed by the protective member 8, thereby sealing the space 52 and holding the sterile body of the space 52.
  • the protective member 8 is removed from the contact portion 5 as shown in FIG. Thereby, sealing of the space 52 inside the contact part 5 is cancelled
  • the protection member 8 Although it does not specifically limit as a constituent material of the protection member 8, For example, it is using elastic materials, such as various rubber materials, various thermoplastic elastomers, or those mixtures, and the same material as the constituent material of the said outer cylinder 2. FIG. it can.
  • the necessary members are sterilized, and then the protective member 8 is attached to the contact portion 5, whereby the space 52 inside the contact portion 5, the puncture needle 6, and the drug solution container 7.
  • the aseptic condition of the second space 77 is maintained.
  • FIG. 3 (a) a container main body 71, which is a bag-like soft bag molded into a predetermined shape, is prepared. As shown in FIG. Fill the amount of chemical solution. Thereby, the chemical
  • the inner surfaces of the boundary portion between the liquid retaining portion 72 and the mounting portion 73 of the container main body 71 are fused so as to be peelable by, for example, heat fusion, and the weak seal portion. 74 is formed.
  • a needle support portion 4 to which the contact portion 5 and the puncture needle 6 are fixed is prepared, and a protective member 8 is attached to the contact portion 5.
  • the chemical solution container 7 is installed so that the attachment portion 73 covers the convex portion 43 of the needle support portion 4, and the proximal end portion of the attachment portion 73 is installed.
  • the inner surface of the central portion, the convex portion 43, and the inner surfaces of the remaining portions of the base end portion of the attachment portion 73 are firmly fused together by, for example, heat fusion to form the strong seal portion 75.
  • the attachment portion 73 is fixed to the convex portion 43, and the second space 77 of the drug solution container 7, the lumen of the puncture needle 6, and the space 52 inside the contact portion 5 are integrally and airtight. Sealed.
  • the outer cylinder 2 is put on the chemical container 7, the chemical container 7 is accommodated in the outer cylinder 2, and the proximal end surface of the base 40 of the needle support portion 4 and the distal end of the outer cylinder 2 are attached.
  • fusion is performed by ultrasonic heat fusion or the like.
  • the pusher 3 is inserted into the outer cylinder 2. This completes the assembly of the prefilled syringe 1.
  • the pusher 3 may be inserted into the outer cylinder 2 when the prefilled syringe 1 is used.
  • the chemical solution is agitated as necessary.
  • a finger is inserted into the outer cylinder 2 from the pair of openings 21, and the liquid retaining portion 72 of the chemical solution container 7 is squeezed and deformed by the finger a predetermined number of times.
  • medical solution is stirred and a sediment dissolves.
  • the preparation for administering the drug solution is thus completed.
  • the liquid medicine 72 can be deformed as described above, whereby the chemical liquid can be stirred easily and reliably.
  • the liquid holding unit 72 is deformed to reliably stir the chemical solution. Can do.
  • the front end surface of the contact portion 5 and the front end surface of the convex portion 42 are applied to the epidermis at a site where a chemical solution such as an arm is administered. Touch and press with a predetermined strength.
  • the epidermis of the part that is not in contact with the distal end surface of the contact part 5 on the inner side of the contact part 5 rises in a mountain shape, and the epidermis of the part that is in contact with the distal end surface of the convex part 42 is puncture needle 6.
  • the needle tip 61 on the distal end side of the puncture needle 6 is punctured into the living body.
  • the needle tip 61 reaches the dermis by restricting the positional relationship between the puncture needle 6 and the epidermis by the contact portion 5 and the convex portion 42.
  • the needle tip 61 of the puncture needle 6 can be punctured into the dermis easily and reliably.
  • the liquid retaining portion 72 is further pressed and deformed by the distal end portion of the pusher 3 and is stored in the first space 76. Passes through the puncture needle 6, is discharged from the needle tip 61, and is administered to the target site.
  • the chemical liquid container 7 in which a necessary amount of the chemical liquid is stored is provided, so that waste of the chemical liquid can be prevented and it is economical.
  • the drug solution container 7 and the puncture needle 6 are installed in advance, and in a unused state, the space 52 inside the contact portion 5 in which the puncture needle 6 is disposed and the second space 77 of the drug solution container 7. Therefore, preparation for administration of the drug solution can be easily and quickly performed by simply removing the protective member 8.
  • the chemical solution when preparing to administer the chemical solution, can be easily and reliably agitated by deforming the liquid retaining portion 72 of the chemical solution container 7.
  • the puncture needle 6 when the drug solution is administered, the positional relationship between the puncture needle 6 and the epidermis is regulated by the front end surface of the abutment portion 5 and the front end surface of the convex portion 42 coming into contact with the epidermis. Furthermore, the puncture needle 6 can be punctured to a target puncture depth.
  • the pusher 3 can be easily moved and operated with a relatively weak force, and a drug solution can be administered.
  • the liquid retaining portion 72 is deformed to easily prevent air from entering. be able to.
  • the number of openings 21 is two. However, in the present invention, the number of openings 21 is not limited to this, and may be one, or may be three or more. .
  • a vent hole (venting means) penetrating the needle support portion 4 may be formed in the needle support portion 4.
  • the air holes are formed at positions where the convex portions 42 and 43 of the base portion 40 are absent.
  • a vent hole (not shown) penetrating the contact portion 5 may be formed in the contact portion 5.
  • the vent hole is formed as a side hole in the side wall of the contact portion 5. With this air hole, the space 52 inside the contact portion 5 communicates with the outside in a contact state in which the tip surface of the contact portion 5 is in contact with the surface of the living body.
  • the vent hole is closed.
  • the number of the air holes may be one or plural.
  • FIG. 7 is a perspective view showing an outer cylinder in the second embodiment of the prefilled syringe of the present invention.
  • the upper side in FIG. 7 is referred to as “base end”, the lower side is “tip”, the right side is “right”, and the left side is “left”.
  • the outer cylinder 2 is connected by a pair of support columns 22 at the distal end side of the outer cylinder 2, that is, at a position corresponding to the liquid retaining portion 72. Yes. Thereby, a pair of openings 21 is formed at a position corresponding to the liquid retaining portion 72 on the side wall of the outer cylinder 2.
  • the pair of support columns 22 are arranged so as to face each other via the liquid retaining part 72, and thereby the pair of openings 21 are formed to face each other via the liquid retaining part 72.
  • pillars 22 is two, However, In this invention, the number of support
  • the present invention may be a combination of any two or more configurations of the above embodiments.
  • medical solution container 7 is comprised with the soft bag
  • medical solution of the container main body 71 is accommodated is a soft part.
  • the liquid retaining part 72 may be configured by a soft bag or the like.
  • the soft part of the chemical liquid container 7 is deformed by a predetermined member such as the pusher 3 to stir the chemical liquid. May be.
  • a double-ended needle may be used as the puncture needle 6.
  • the cap was used as the protection member 8 which seals the space 52 inside the contact part 5, in this invention, it is not limited to this, For example, a film etc. may be used. .
  • prefilled syringe of the present invention is not limited to vaccine administration, and can be applied to prefilled syringes for administering various chemical solutions.
  • the container body of the chemical solution container has a soft portion
  • the chemical solution can be easily and reliably agitated by deforming the soft portion.
  • the container body is not filled with a gas such as air or when the amount of the stored chemical is small
  • the chemical can be reliably stirred.
  • the drug solution can be discharged from the needle tip of the puncture needle, and therefore it is not necessary to provide a sliding part such as a gasket on the pusher, so a relatively weak force
  • the pusher can be easily moved and the drug solution can be administered.
  • the container body has a soft part, so when storing the chemical in the container body, the soft part is deformed to prevent air from entering. be able to. Therefore, it has industrial applicability.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention a pour objet une seringue préremplie (1) pourvue : d'un tube extérieur (2) ; d'un réservoir de liquide médical (7) qui est disposé à l'intérieur du tube extérieur (2) ; d'un poussoir (3) qui est prévu dans le tube extérieur (2) de sorte à être mobile dans la direction axiale du tube extérieur (2) ; d'une aiguille d'introduction (6) ; d'une section (4) de support d'aiguille qui supporte l'aiguille d'introduction (6) ; d'une section de contact (5) qui est prévue à l'extrémité avant du tube extérieur (2) de sorte à entourer la pointe de l'aiguille (61) à l'extrémité avant de l'aiguille d'introduction (6), et qui peut faire contact avec la surface d'un corps vivant ; et d'un organe de protection (8). Le réservoir de liquide médical (7) est pourvu d'un corps de réservoir (71) qui est constitué d'un sac souple, et un liquide médical est tout d'abord contenu dans une section de rétention de liquide (72) du corps de réservoir (71). Une paire d'ouvertures (21) sont formées, de sorte à se faire mutuellement face, dans la paroi latérale du tube extérieur (2) en des positions correspondant à la section de rétention de liquide (72).
PCT/JP2010/071509 2009-12-02 2010-12-01 Seringue préremplie Ceased WO2011068130A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2009274838 2009-12-02
JP2009-274838 2009-12-02

Publications (1)

Publication Number Publication Date
WO2011068130A1 true WO2011068130A1 (fr) 2011-06-09

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WO (1) WO2011068130A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8882706B2 (en) 2009-12-04 2014-11-11 Becton, Dickinson And Company Pen needle removal device for a drug delivery device
ITUB20160615A1 (it) * 2016-02-10 2017-08-10 Orofino Pharmaceuticals Group Srl Cartuccia e siringa per l’iniezione di una soluzione farmaceutica e metodo per la produzione della cartuccia
US12324905B2 (en) 2019-04-26 2025-06-10 Becton Dickinson France Needle cover with undercut

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Publication number Priority date Publication date Assignee Title
JPS5731870A (en) * 1980-08-05 1982-02-20 Korupo Kk Injector
JPS5926452A (ja) * 1982-07-17 1984-02-10 リングナ−・プラス・フイツシヤ−・ゲ−・エム・ベ−・ハ−・エム・ドレ−ゲル 液状接着剤用デイスペンサ−
JP2001299912A (ja) * 2000-02-17 2001-10-30 Koriryo Yugenkoshi 注射用キット及び注射用器具
JP2004532677A (ja) * 2001-04-13 2004-10-28 ベクトン・ディキンソン・アンド・カンパニー 皮内針
JP2009516572A (ja) * 2005-11-21 2009-04-23 ベクトン・ディキンソン・アンド・カンパニー 皮内送出装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5731870A (en) * 1980-08-05 1982-02-20 Korupo Kk Injector
JPS5926452A (ja) * 1982-07-17 1984-02-10 リングナ−・プラス・フイツシヤ−・ゲ−・エム・ベ−・ハ−・エム・ドレ−ゲル 液状接着剤用デイスペンサ−
JP2001299912A (ja) * 2000-02-17 2001-10-30 Koriryo Yugenkoshi 注射用キット及び注射用器具
JP2004532677A (ja) * 2001-04-13 2004-10-28 ベクトン・ディキンソン・アンド・カンパニー 皮内針
JP2009516572A (ja) * 2005-11-21 2009-04-23 ベクトン・ディキンソン・アンド・カンパニー 皮内送出装置

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8882706B2 (en) 2009-12-04 2014-11-11 Becton, Dickinson And Company Pen needle removal device for a drug delivery device
US9861760B2 (en) 2009-12-04 2018-01-09 Becton, Dickinson And Company Pen needle removal device for a drug delivery device
US10744273B2 (en) 2009-12-04 2020-08-18 Becton, Dickinson And Company Pen needle removal device for a drug delivery device
US11786670B2 (en) 2009-12-04 2023-10-17 Becton, Dickinson And Company Pen needle removal device for a drug delivery device
ITUB20160615A1 (it) * 2016-02-10 2017-08-10 Orofino Pharmaceuticals Group Srl Cartuccia e siringa per l’iniezione di una soluzione farmaceutica e metodo per la produzione della cartuccia
WO2017137854A1 (fr) * 2016-02-10 2017-08-17 Orofino Pharmaceuticals Group Srl Cartouche à sac souple pour injecter une solution pharmaceutique et procédé de fabrication de cette cartouche
CN108601703A (zh) * 2016-02-10 2018-09-28 奥罗菲诺制药集团责任有限公司 用于注射药液的具有柔性袋的管筒和用于制造管筒的方法
JP2019504704A (ja) * 2016-02-10 2019-02-21 オロフィーノ ファーマシューティカルズ グループ エスアールエル 可撓性バッグを有する薬液注射用カートリッジ、及び該カートリッジを製造する方法
EA036241B1 (ru) * 2016-02-10 2020-10-16 Орофино Фармасьютикалз Груп Срл Картридж и шприц для инъекции фармацевтического раствора и способ изготовления указанного картриджа
US11097054B2 (en) 2016-02-10 2021-08-24 OROFINO PHARMACEUTICALS GROUP S.r.l. Cartridge with flexible bag for injecting a pharmaceutical solution and method for manufacturing the cartridge
US12324905B2 (en) 2019-04-26 2025-06-10 Becton Dickinson France Needle cover with undercut

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