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WO2012160852A1 - Injection needle assembly and drug injection device - Google Patents

Injection needle assembly and drug injection device Download PDF

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Publication number
WO2012160852A1
WO2012160852A1 PCT/JP2012/055359 JP2012055359W WO2012160852A1 WO 2012160852 A1 WO2012160852 A1 WO 2012160852A1 JP 2012055359 W JP2012055359 W JP 2012055359W WO 2012160852 A1 WO2012160852 A1 WO 2012160852A1
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
needle
discharge
injection
needle tube
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/JP2012/055359
Other languages
French (fr)
Japanese (ja)
Inventor
小川 淳一
陽一郎 岩瀬
立川 浩一
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 WO2012160852A1 publication Critical patent/WO2012160852A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46Devices 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/20Surgical instruments, devices or methods for vaccinating or cleaning the skin previous to the vaccination
    • A61B17/205Vaccinating by means of needles or other puncturing devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3287Accessories for bringing the needle into the body; Automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/344Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets

Definitions

  • the present invention relates to an injection needle assembly and a medicine injection device that are used by attaching a syringe to a needle hub.
  • Patent Documents 1 and 2 in an injection device configured such that a needle hub and a syringe are separable, the diameter of the needle hub and the syringe increases as the opening formed at the tube tip of the syringe moves toward the distal end side.
  • the injection needle can be easily inserted into the tube tip when the hub portion is fitted to the syringe, and the needle hub and the syringe are more liquid tightly fitted.
  • an injection apparatus has been proposed in which a needle hub to which an injection needle is attached and a syringe are screwed together.
  • the ability to acquire immunity equivalent to subcutaneous administration or intramuscular administration can be obtained by administering influenza vaccine using the upper skin layer where many immunocompetent cells are present as the target site, even if the dose is reduced.
  • the upper skin layer refers to the epidermis and dermis of the skin.
  • the present invention has been made in view of such a situation, and an object thereof is to facilitate assembly and fixing of a syringe and a needle hub in an injection device in which the syringe and the needle hub can be separated.
  • An injection needle assembly according to the present invention is provided on a needle tube having a needle tip to be punctured into the skin, a needle hub that holds the needle tube and into which a discharge portion of a syringe is inserted, and an inner peripheral surface of the insertion portion. And a holding portion made of an elastic member. And a holding
  • the drug injection device of the present invention includes a syringe having a discharge portion, a needle tube having a needle tip to be punctured into the skin, a needle hub that holds the needle tube and has a fitting portion into which the discharge portion of the syringe is fitted, and a fitting portion
  • the holding part which consists of an elastic member provided in the inner peripheral surface of this or the outer peripheral surface of the discharge part of a syringe is provided. And a holding
  • the holding portion made of an elastic member is provided on the inner peripheral surface of the insertion portion, so that the syringe is attached to the needle hub simply by pushing the discharge portion of the syringe into the insertion portion.
  • the portion is liquid-tightly held in the fitting portion.
  • the holding portion made of an elastic member is provided on the inner peripheral surface of the insertion portion or the outer peripheral surface of the discharge portion of the syringe, it is only necessary to push the discharge portion of the syringe into the insertion portion.
  • a syringe can be attached to the needle hub. And thereby, the discharge part of a syringe is liquid-tightly hold
  • the assembly of the syringe and the needle hub can be facilitated, and the syringe can be held liquid-tight on the needle hub.
  • 1 is a cross-sectional view of a drug injection device according to a first embodiment of the present invention. It is sectional drawing of the principal part of the chemical injection apparatus which concerns on the 1st Embodiment of this invention. It is sectional drawing which decomposes
  • FIG. 1 is an exploded view of a drug injection device 1 according to this embodiment
  • FIG. 2 is a cross-sectional view.
  • the drug injection device 1 is used when the needle tip is punctured from the skin surface and the drug is injected into the upper layer of the skin.
  • the drug injection device 1 includes an injection needle assembly 2 and a syringe 3 to which the injection needle assembly 2 is detachably connected.
  • the injection needle assembly 2 includes a hollow needle tube 5 having a needle hole, a needle hub 6 to which the needle tube 5 is fixed, a connection member 61 disposed in the needle hub 6, a needle And a cap 8 detachably attached to the hub 6.
  • the needle hub 6 includes a first member 11 that holds the needle tube 5 and a second member 12 into which a later-described discharge portion 52 of the syringe 3 is inserted.
  • FIG. 3 is a cross-sectional view of a main part of the medicine injection device 1.
  • FIG. 4 is an exploded cross-sectional view of the medicine injection device 1.
  • the needle tube 5 of the injection needle assembly 2 has a size of 26 to 33 gauge (outer diameter 0.2 to 0.45 mm) based on the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)). Those of 30 to 33 gauge are preferably used.
  • a needle tip 5A having a blade surface 5a is provided at one end of the needle tube 5.
  • the other end of the needle tube 5 opposite to the needle tip 5A is referred to as a “base end 5B”.
  • the axial length of the needle tube 5 on the blade surface 5a (hereinafter referred to as “bevel length B”) may be 1.4 mm (adult) or less, which is the thinnest thickness of the upper skin layer described later.
  • the bevel length may be about 0.5 mm or more when a short bevel is formed on a 33 gauge needle tube. That is, the bevel length B is preferably set in the range of 0.5 to 1.4 mm.
  • the bevel length B is more preferable if the thinnest thickness of the upper skin portion is 0.9 mm (child) or less, that is, the bevel length B is in the range of 0.5 to 0.9 mm.
  • the short bevel refers to a blade surface that is generally used for injection needles and forms an angle of 18 to 25 ° with respect to the longitudinal direction of the needle.
  • the material of the needle tube 5 examples include stainless steel, but are not limited thereto, and aluminum, aluminum alloy, titanium, titanium alloy, and other metals can be used.
  • the needle tube 5 can be not only a straight needle but also a tapered needle at least partially tapered.
  • the proximal end portion has a larger diameter than the needle distal end portion, and the intermediate portion may have a tapered structure.
  • the cross-sectional shape of the needle tube 5 may be not only a circle but also a polygon such as a triangle.
  • the first member 11 and the second member 12 of the needle hub 6 are formed as separate members, but may be formed integrally.
  • Examples of the material of the first member 11 and the second member 12 include synthetic resins such as polycarbonate, polypropylene, and polyethylene.
  • the first member 11 includes a base portion 15, an adjustment portion 16, a stabilization portion 17, and a guide portion 18.
  • the base portion 15 is formed in a substantially columnar shape, and has end faces 15a and 15b perpendicular to the axial direction.
  • the adjustment portion 16 is provided at the center of the end surface 15 a of the base portion 15, and includes a columnar convex portion that protrudes in the axial direction of the base portion 15.
  • the axis of the adjustment portion 16 is coincident with the axis of the base portion 15.
  • a through-hole 21 through which the needle tube 5 passes is provided in the axial center of the base portion 15 and the adjustment portion 16.
  • the base portion 15 is provided with an injection hole 22 (see FIGS. 2 and 4) for injecting the adhesive 20 (see FIG. 3) into the through hole 21.
  • the injection hole 22 is opened on the outer peripheral surface of the base portion 15 and communicates with the through hole 21. That is, the needle tube 5 is fixed to the base portion 15 by the adhesive 20 injected from the injection hole 22 into the through hole 21.
  • the proximal end 5B side of the needle tube 5 protrudes from the end face 15b of the base portion 15.
  • the base portion 15 is inserted into the second member 12 from the end face 15b side, and the proximal end 5B side of the needle tube 5 is inserted into an insertion hole 45 described later of the connection member 61.
  • the end surface 15b of the base part 15 is contact
  • a connecting piece 24 is provided on the outer peripheral surface of the base portion 15.
  • the connection piece 24 is formed as a ring-shaped flange protruding in the radial direction of the base portion 15, and has flat surfaces 24 a and 24 b that face the axial direction of the base portion 15.
  • the second member 12 is connected to the flat surface 24 b of the connection piece 24.
  • the distal end portion of the connection piece 24 is a guide portion 18. The guide portion 18 will be described in detail later.
  • the end surface of the adjusting portion 16 is a needle projecting surface 16a from which the needle tip 5A side of the needle tube 5 projects.
  • the needle projecting surface 16 a is formed as a plane orthogonal to the axial direction of the needle tube 5.
  • This needle protrusion surface 16a defines the depth at which the needle tube 5 is punctured by contacting the surface of the skin when the needle tube 5 is punctured into the upper layer portion of the skin. That is, the depth at which the needle tube 5 is punctured into the upper skin layer is determined by the length of the needle tube 5 protruding from the needle protruding surface 16a (hereinafter referred to as “projection length L”).
  • the thickness of the upper skin portion corresponds to the depth from the skin surface to the dermis layer, and is generally in the range of 0.5 to 3.0 mm. Therefore, the protruding length L of the needle tube 5 can be set in the range of 0.5 to 3.0 mm.
  • the vaccine is generally administered to the upper arm, but in the case of administration to the upper skin part, the shoulder peripheral part where the skin is thick, particularly the deltoid part is preferable. Therefore, the thickness of the upper layer of the deltoid muscle was measured for 19 children and 31 adults. This measurement was performed by imaging the upper layer of the skin with high ultrasonic reflectivity using an ultrasonic measurement device (NP60R-UBM, high-resolution echo for small animals, Nepagene). In addition, since the measured value was logarithmic normal distribution, the range of MEAN ⁇ 2SD was obtained by geometric mean.
  • the thickness of the upper skin layer of the deltoid muscle of the child was 0.9 to 1.6 mm.
  • the thickness of the upper skin layer of the deltoid muscle of adults was 1.4 to 2.6 mm at the distal part, 1.4 to 2.5 mm at the central part, and 1.5 to 2.5 mm at the proximal part. It was. From the above, it was confirmed that the thickness of the upper skin layer in the deltoid muscle was 0.9 mm or more in the case of children and 1.4 mm or more in the case of adults. Therefore, in the injection in the upper layer part of the deltoid muscle, the protruding length L of the needle tube 5 is preferably set in the range of 0.9 to 1.4 mm.
  • the blade surface 5a of the needle tip 5A can be reliably positioned on the upper skin layer.
  • the needle hole (chemical solution discharge port) that opens in the blade surface 5a can be located in the upper skin layer portion at any position in the blade surface 5a. Even if the drug solution outlet is located in the upper skin layer, if the needle tip 5A is stabbed deeper than the upper skin layer, the drug solution flows subcutaneously between the side surface of the end of the needle tip 5A and the cut skin. Therefore, it is important that the blade surface 5a is surely in the upper skin portion.
  • the needle projecting surface 16a is formed so that the distance S from the peripheral edge to the outer peripheral surface of the needle tube 5 is 1.4 mm or less, preferably in the range of 0.3 to 1.4 mm.
  • the distance S from the peripheral edge of the needle protruding surface 16a to the peripheral surface of the needle tube 5 is set in consideration of the pressure applied to the blisters formed by administering the drug to the upper skin layer. That is, the needle projecting surface 16a is set to a size that is sufficiently smaller than the blisters formed on the upper layer portion of the skin and does not hinder the formation of blisters. As a result, even if the needle protruding surface 16a presses the skin around the needle tube 5, it is possible to prevent the administered medicine from leaking.
  • the stabilizing portion 17 is formed in a cylindrical shape protruding from the flat surface 24 a of the connecting piece 24 provided on the base portion 15.
  • the needle tube 5 and the adjustment unit 16 are disposed in the cylindrical hole of the stabilization unit 17. That is, the stabilizing portion 17 is formed in a cylindrical shape that covers the periphery of the adjusting portion 16 through which the needle tube 5 passes, and is provided away from the needle tip 5A of the needle tube 5 in the radial direction.
  • the cap 8 is detachably fitted to the stabilizing portion 17.
  • the cap 8 covers the needle tip 5 ⁇ / b> A of the needle tube 5.
  • needle tip 5A can be prevented from touching a user's fingertip.
  • the used medicine injection device 1 or the needle assembly 2 can be always kept in a safe state, and the user can safely dispose of the used medicine injection device 1 or the needle assembly 2. It can be carried out.
  • the end surface 17a of the stabilizing portion 17 is located closer to the proximal end 5B of the needle tube 5 than the needle protruding surface 16a of the adjusting portion 16.
  • the needle projecting surface 16a first contacts the surface of the skin, and then contacts the end surface 17a of the stabilizing portion 17.
  • the drug injection device 1 is stabilized by the end surface 17a of the stabilizing portion 17 coming into contact with the skin, and the needle tube 5 can be maintained in a posture substantially perpendicular to the skin.
  • the needle tube 5 is skinned. It is possible to keep the posture substantially perpendicular to the angle.
  • the axial distance between the end surface 17a of the stable portion 17 and the needle protruding surface 16a is preferably set to 1.3 mm or less.
  • the inner diameter d of the stable portion 17 is set to a value equal to or larger than the diameter of the blister formed on the skin.
  • the distance T from the inner wall surface of the stabilizing portion 17 to the peripheral edge of the needle protruding surface 16a is set to be in the range of 4 mm to 15 mm. Thereby, it can prevent that blister formation is inhibited by pressure being applied to a blister from the inner wall surface of stable part 17.
  • the distance T from the inner wall surface of the stabilizing portion 17 to the periphery of the needle protruding surface 16a is not particularly limited as long as it is 4 mm or more. However, when the distance T is increased, the outer diameter of the stable portion 17 increases, so that it becomes difficult to bring the entire end surface 17a of the stable portion 17 into contact with the skin when the needle tube 5 is punctured into a thin arm like a child. . For this reason, the distance T is preferably set to 15 mm as a maximum in consideration of the thinness of the child's arm.
  • the adjusting unit 16 does not enter the skin. Therefore, considering the distance T (4 mm or more) from the inner wall surface of the stable portion 17 to the periphery of the needle protruding surface 16a and the diameter (about 0.3 mm) of the needle protruding surface 16a, the inner diameter d of the stable portion 17 is 9 mm or more. Can be set.
  • the shape of the stable part 17 is not limited to a cylindrical shape, and may be formed in a rectangular tube shape such as a quadrangular column or a hexagonal column having a cylindrical hole at the center.
  • the guide portion 18 is a portion on the tip side of the connecting piece 24 with respect to the stabilizing portion 17.
  • the guide portion 18 has a contact surface 18a that comes into contact with the skin.
  • the contact surface 18 a is a part of the flat surface 24 a of the connection piece 24, and is a flat surface that is substantially parallel to the end surface 17 a of the stabilizing portion 17.
  • the distance Y from the contact surface 18a of the guide portion 18 to the end surface 17a of the stable portion 17 punctures the needle tube 5 and the stable portion 17 by pressing the skin with an appropriate pressing force. Its length is set so that it can.
  • the guide portion 18 guides the pressing force applied to the skin by the needle tube 5 and the stabilizing portion 17, and the needle tip 5A (blade surface 5a) of the needle tube 5 can be reliably positioned on the upper layer portion of the skin. Can give you a sense of security.
  • An appropriate pressing force of the needle tube 5 and the stabilizing portion 17 is, for example, 3 to 20N.
  • the guide portion height Y is the length from the distal end surface of the guide portion 18 to the outer peripheral surface of the stable portion 17 (hereinafter referred to as “guide portion length”). It is determined appropriately based on X. For example, when the inner diameter d of the stabilizing portion 17 is 12 mm and the guide portion length X is 3.0 mm, the guide portion height Y is set in the range of 2.3 to 6.6 mm.
  • the second member 12 is formed on the inner surface of the second member main body 19, the second member main body 19 formed in a substantially cylindrical shape, the stopper portion 4 formed at the end of the second member main body 19, and the second member main body 19.
  • the holding part 9 is comprised.
  • One end portion of the second member main body 19 in the axial direction is an insertion portion 31 into which the base portion 15 of the first member 11 is inserted, and the other end portion is in the insertion portion 32 into which the discharge portion 52 of the syringe 3 is inserted. It has become.
  • the cylindrical hole 31 a of the insertion portion 31 is set to a size corresponding to the base portion 15 of the first member 11.
  • the insertion part 31 is provided with a fixing piece 34 connected to the connection piece 24 of the first member 11.
  • the fixing piece 34 is formed as a ring-shaped flange that protrudes radially outward continuously from the distal end of the insertion portion 31.
  • a flat surface 24b of the connection piece 24 provided on the first member 11 is brought into contact with and fixed to the fixed piece 34.
  • Examples of the fixing method of the fixing piece 34 and the connection piece 24 include an adhesive, ultrasonic welding, laser welding, and a fixing screw.
  • the cylindrical hole 32 a of the insertion part 32 is set larger than the discharge part 52 of the syringe 3.
  • the shape has a constant inner diameter in the axial direction in accordance with the shape of the discharge portion 52 of the syringe 3, but when the discharge portion 52 of the syringe 3 is tapered, the shape is adjusted accordingly. Tapered.
  • the holding part 9 is composed of a cylindrical elastic member, and is fixed in close contact with the inner peripheral surface of the fitting part 32.
  • the holding portion 9 may be configured to be adhered to the inner peripheral surface of the insertion portion 32 with an adhesive, or may be inserted into the holding portion 9, and may be configured not to be displaced when the discharge portion 52 of the syringe 3 is inserted into the insertion portion 32.
  • the inner diameter of the holding portion 9 is formed slightly smaller than the outer diameter of the discharge portion 52 of the syringe 3, and the syringe is placed in the holding portion 9 in a state where the holding portion 9 is provided on the inner peripheral surface of the insertion portion 32.
  • the diameter of the three discharge portions 52 can be fitted against the elastic force of the holding portion 9. Further, the thickness of the holding portion 9, that is, the difference between the outer diameter and the inner diameter of the holding portion 9 may be a thickness that can maintain the liquid tightness between the discharge portion 52 and the insertion portion 32 of the syringe 3.
  • Examples of the elastic material constituting the holding unit 9 include various rubber materials such as natural rubber, silicone rubber, and isobutylene rubber, various thermoplastic elastomers such as polyurethane and styrene, or mixtures thereof. .
  • the stopper portion 4 is formed on the end surface of the second member main body 19 on the side where the fitting portion 32 is formed, and is provided at two opposing positions.
  • the stopper portion 4 is a rod-like protruding portion 4a that extends from the end surface of the second member main body 19 on the side where the fitting portion 32 is formed along the long axis direction of the second member main body 19 to the side opposite to the insertion portion 31.
  • locking part 4b which protruded in the inner side in which the discharge part 52 of the syringe 3 is inserted from the front-end
  • the stopper portion 4 is formed such that a lock portion 7 described later formed on the syringe 3 is locked to the locking portion 4b when the discharge portion 52 of the syringe 3 is inserted.
  • the engaging portion 37 is formed as a step portion protruding radially inward from the inner surface of the second member main body 19, and has engaging surfaces 37 a and 37 b that are substantially orthogonal to the axial direction of the second member main body 19. ing.
  • a flange portion 42 described later of the connection member 61 is engaged with the engagement surface 37a of the engagement portion 37, and a stopper protrusion 43 of the connection member 61 is engaged with the engagement surface 37b.
  • connection member 61 is disposed in the second member main body 19 of the needle hub 6 and connects the first member 11 and the second member 12 via a needle tube, and between the first member 11 and the syringe 3. Intervened in.
  • the connection member 61 is made of an elastic member, and includes a main body 41, a flange 42 provided at one end of the main body 41 in the axial direction, and a stopper protrusion 43 provided at the other end of the main body 41. Have.
  • the main body 41 is formed in a substantially cylindrical shape and has end faces 41a and 41b perpendicular to the axial direction.
  • the end surface 41a of the base member 15 of the first member 11 is in contact with the end surface 41a of the main body 41, and the tip of the discharge unit 52 provided in the syringe 3 is in liquid-tight contact with the end surface 41b. That is, the end surface 41b is an abutting surface with which the tip of the discharge portion 52 abuts in a liquid-tight manner.
  • the main body portion 41 is provided with an insertion hole 45 through which the proximal end 5B side of the needle tube 5 protruding from the end surface 15b of the base portion 15 is inserted.
  • the insertion hole 45 extends in the axial direction of the main body 41 and is opened in the end faces 41a and 41b.
  • the inner surface of the main body 41 is formed by an end surface side separation portion 46, a contact surface side separation portion 47, and a close contact portion 48.
  • the end surface side separation portion 46 forms an opening of the insertion hole 45 in the end surface 41a.
  • the end surface side separation portion 46 is separated from the outer peripheral surface of the needle tube 5 and is formed in a taper shape such that the diameter of the insertion hole 45 continuously increases toward the end surface 41a. Thereby, the base end 5B side of the needle tube 5 protruding from the end surface 15b of the base portion 15 can be easily inserted into the insertion hole 45.
  • the shape of the end face side separation portion 46 in the insertion hole 45 is not limited to a tapered shape as long as the needle tube 5 can be easily inserted into the insertion hole 45.
  • the contact surface side separation portion 47 forms an opening of the insertion hole 45 in the end surface (contact surface) 41b.
  • the contact surface side separation portion 47 is separated from the outer peripheral surface of the needle tube 5, and is formed in a taper shape such that the diameter of the insertion hole 45 continuously increases toward the end surface 41b.
  • a needle side valve body 63 is provided in the contact surface side separation portion 47.
  • the needle-side valve body 63 is formed as a cylindrical protrusion that covers the outer periphery of the needle tube 5.
  • the outer peripheral surface of the needle-side valve body 63 is formed in a taper shape such that the diameter continuously decreases toward the tip.
  • the contact portion 48 is formed between the end surface side separation portion 46 and the contact surface side separation portion 47.
  • the close contact portion 48 is in liquid tight contact with the outer peripheral surface of the needle tube 5. Thereby, it is possible to prevent the medicine in the syringe 3 from entering between the needle tube 5 and the connecting member 61 and leaking to the first member 11 side of the needle hub 6.
  • the flange portion 42 is formed in a ring shape that protrudes radially outward from the outer peripheral surface of the main body portion 41.
  • the outer diameter of the flange portion 42 is substantially equal to the outer diameter of the base portion 15 of the first member 11.
  • One flat surface 42 a of the flange portion 42 is the same flat surface as the end surface 41 a of the main body portion 41.
  • a ring protrusion 44 is provided on the flat surface 42a.
  • the ring protrusion 44 abuts against the end surface 15 b of the base portion 15 of the first member 11 and is crushed.
  • the other flat surface 42 b of the flange portion 42 abuts on the engaging surface 37 a of the engaging portion 37 provided on the second member main body 19.
  • the connecting member 61 is attached to the needle hub 6 by sandwiching the flange portion 42 between the engaging portion 37 of the second member main body 19 and the base portion 15 of the first member 11.
  • the stopper protrusion 43 is formed in a ring shape that protrudes radially outward from the outer peripheral surface of the main body 41, as with the flange portion 42.
  • the stopper projection 43 engages with an engagement surface 37 b of the engagement portion 37 provided on the second member main body 19.
  • the connecting member 61 is locked from moving in the axial direction when the flange portion 42 and the stopper projection 43 are engaged with the engaging portion 37 of the second member main body 19. Thereby, it can prevent that a chemical
  • As a material of the connection member 61 an elastic material similar to that of the holding portion 9 can be used.
  • the syringe 3 includes a syringe body 51, a discharge portion 52 that is continuous with the syringe body 51, and lock portions 7 that are provided at two opposing positions on the outer peripheral surface of the syringe body 51.
  • the syringe body 51 is a circular cylinder.
  • the discharge part 52 protrudes from one end of the syringe body 51 in the axial direction, and is formed of a circular cylinder having an outer diameter smaller than that of the syringe body 51.
  • the discharge portion 52 has a constant outer diameter in the axial direction, but may have a tapered shape that narrows toward the tip.
  • the end surface 52a that is the tip of the discharge portion 52 is a plane orthogonal to the axial direction, and comes into liquid-tight contact with the end surface (contact surface) 41b of the connection member 61 when it is inserted into the insertion portion.
  • the lock portion 7 is composed of a protruding member provided on the outer peripheral surface of the syringe main body 51, and is formed in the second member main body 19 when the discharge portion 52 of the syringe 3 is inserted into the insertion portion 32.
  • the stopper portion 4 is formed at a position to be locked to the locking portion 4b.
  • the lock portion 7 is formed so as to protrude from the outer peripheral surface of the syringe body 51 in a substantially triangular shape, and the surface on the side facing the discharge portion 52 is tapered, and the surface on the side locked by the locking portion 4b. However, the surface is substantially perpendicular to the outer peripheral surface.
  • the discharge portion 52 of the syringe 3 can be smoothly inserted into the insertion portion 32, and once the lock portion 7 is engaged with the locking portion 4b. When stopped, it becomes difficult to come off.
  • a gasket (not shown) is accommodated in the syringe body 51.
  • the space in the syringe main body 51 is liquid-tightly partitioned by a gasket, and one space communicating with the discharge portion 52 forms a liquid chamber 56 together with the space in the discharge portion 52.
  • a plunger (not shown) is arranged in the other space in the syringe body 51. The plunger is connected to the gasket and protrudes from the opening at the other end of the syringe body 51. By operating this plunger, the gasket is moved in the axial direction within the syringe main body 51, and the medicine is sucked into the liquid chamber 56 and the medicine filled in the liquid chamber 56 is discharged.
  • synthetic resin such as polycarbonate, polypropylene, polyethylene, etc. can be used, and glass or the like may be used.
  • Examples of the medicine M filled in the syringe 3 include various vaccines for preventing various infectious diseases such as influenza, but are not limited to vaccines.
  • vaccines for example, glucose 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, proteolytic enzyme inhibitors, fat Emulsions, anticancer agents, anesthetics, stimulants, narcotics, heparin calcium, antibody drugs and the like can be mentioned.
  • the insertion portion 32 of the injection needle assembly 2 is accommodated in the cap 8 as shown in FIG.
  • the discharge part 52 of the syringe 3 is inserted into.
  • the holding portion 9 made of an elastic member is provided on the inner peripheral surface of the fitting portion 32, and the inner diameter of the holding portion 9 is formed to be slightly smaller than the outer diameter of the discharge portion 52. Therefore, the discharge portion 52 is fitted into the holding portion 9 (inside the fitting portion 32) against the elastic force of the holding portion 9.
  • the insertion of the injection needle assembly 2 to the syringe 3 is completed by inserting the discharge portion 52 until it comes into contact with the end surface 41b of the connection member 61 vertically.
  • the end surface 52a which is the tip of the discharge portion 52 abuts perpendicularly to the end surface (contact surface) 41b of the connection member 61 provided in the injection needle assembly 2. Then, by pressing the end surface 41b, the end surface 52a of the discharge portion 52 and the end surface 41b of the connecting member 61 are in liquid-tight contact, and the needle hole of the needle tube 5 and the liquid chamber 56 of the syringe 3 communicate with each other. As a result, a space can be prevented from being formed between the distal end of the discharge portion 52 and the proximal end 5B of the needle tube 5, and the remaining amount of the medicine can be reduced.
  • the medicine filled in the liquid chamber 56 of the syringe 3 can be prevented from leaking into the needle hub 6 of the injection needle assembly 2, and a predetermined amount of medicine is discharged from the needle tip 5 ⁇ / b> A of the needle tube 5. Can do.
  • the position of the needle tube 5 with respect to the needle hub 6 of the injection needle assembly 2 is precisely adjusted in order to bring the end surface 52a of the discharge portion 52 into contact with the end surface 41b of the connecting member 61 in a perpendicular manner so There is no need. Therefore, the assembly work of the needle hub 6 and the needle tube 5 can be simplified, and the production efficiency can be improved.
  • the contact member side separation portion 47 is provided on the connection member 61. Therefore, there is no possibility that the end surface 41b of the connection member 61 pressed against the end surface 52a of the discharge portion 52 is elastically deformed so as to enter the discharge portion 52, and the connection member 61 forms a needle hole on the proximal end 5B side in the needle tube 5. Blocking can be prevented.
  • the user when the syringe 3 is attached to the injection needle assembly 2, the user inserts the syringe 3 into the insertion portion 32 of the injection needle assembly 2. You only have to push it in so that it fits. Thereby, since operations such as screw tightening are not required, the user can easily prepare the medicine injection device 1. Further, the discharge part 52 of the syringe 3 is tightly held by the holding part 9 made of an elastic member, and the discharge part 52 of the syringe 3 is liquid-tightly held on the inner peripheral surface of the fitting part 32. Thereby, a chemical
  • the end surface 17a of the stabilizing portion 17 is pressed until the contact surface 18a of the guide portion 18 contacts the skin.
  • the length of the guide portion height y (see FIG. 3) is set so that the needle tube 5 and the stabilizing portion 17 can puncture the skin with an appropriate pressing force. Therefore, the force that presses the skin by the stabilizing portion 17 becomes a predetermined value.
  • the user can recognize an appropriate pressing force of the stabilizing portion 17, and the needle tip 5A and the blade surface 5a of the needle tube 5 can be surely positioned on the upper skin portion.
  • the guide part 18 becomes a mark for recognizing an appropriate pressing force of the stable part 17, so that the user can use the medicine injection device 1 with peace of mind.
  • the stabilizing portion 17 contacts the skin, the posture of the medicine injection device 1 is stabilized, and the needle tube 5 can be punctured straight to the skin. Moreover, the blurring which arises in the needle tube 5 after puncture can be prevented, and the administration of the medicine can be performed stably.
  • the skin may not stick into the skin even if the needle tip is brought into contact with the skin.
  • the skin inside the stable portion 17 is pulled and tension is applied to the skin. Therefore, it is difficult for the skin to escape from the needle tip 5 ⁇ / b> A of the needle tube 5. Therefore, by providing the stabilizing portion 17, it is possible to obtain an effect that the needle tip 5A is more easily pierced into the skin.
  • the plunger (not shown) is pushed to move the gasket (not shown) to the discharge part 52 side.
  • the medicine filled in the liquid chamber 56 of the syringe 3 is pushed out from the discharge part 52, passes through the needle hole of the needle tube 5, and is injected into the upper skin part from the needle tip 5 ⁇ / b> A.
  • the discharge part 52 of the syringe 3 is fixed to the needle hub 6 by the elastic force of the holding part 9, and both are not detached by the lock mechanism. For this reason, it is possible to prevent the syringe 3 from being detached from the injection needle assembly 2 in the drug administration to the upper skin portion where an injection pressure higher than the subcutaneous administration is applied.
  • the syringe 3 can be easily attached to the injection needle assembly 2, so that the burden on the user can be reduced. Moreover, since the discharge part 52 of the syringe 3 can be liquid-tightly fixed and held in the insertion part 32 of the injection needle assembly 2, the syringe 3 and the syringe 3 can be separated by liquid leakage to the syringe 3 side or drug injection pressure. The removal of the injection needle assembly 2 can be reduced, and the safety during use can be improved. In particular, this embodiment is effective for preventing liquid leakage and detachment when the outer diameter of the discharge portion 52 of the syringe 3 and the inner diameter of the cylindrical hole 32a of the fitting portion 32 are constant in the axial direction as in this embodiment.
  • the remaining amount of the medicine can be reduced. Further, even when the chemical liquid discharged from the discharge part 52 of the syringe 3 leaks to the contact surface side separation part 47, the leaked chemical liquid presses the needle side valve body part 63, whereby the needle side valve The body part 63 is pressed against the outer peripheral surface of the needle tube 5. Thereby, the pressure resistance performance between the needle tube 5 and the connection member 61 can be improved. As a result, the drug solution is less likely to leak to the first member 11 side of the needle hub 6, and the amount of the drug to be administered to the upper skin portion can be stabilized.
  • FIG. 5 is a cross-sectional view of a drug injection device 81 according to the second embodiment of the present invention.
  • the present embodiment is an example in which the configuration of the holding unit and the lock mechanism are different from those of the first embodiment.
  • parts corresponding to those in FIG. 5 are different from those of the first embodiment.
  • the drug injection device 81 includes an injection needle assembly 86 and a syringe 83 to which the injection needle assembly 86 is detachably connected.
  • the second member 87 includes a second member main body 89 formed in a substantially cylindrical shape, a stopper portion 71 formed on the inner peripheral surface of the second member main body 89, and a second member 87.
  • the holding member 73 is formed on the inner peripheral surface of the two-member main body 89.
  • One end portion in the axial direction of the second member main body 89 is an insertion portion 31 into which the base portion 15 of the first member 11 is inserted, and the other end portion is in the insertion portion 82 into which the discharge portion 52 of the syringe 83 is inserted. It has become.
  • the structure of the insertion part 31 is the same as that of 1st Embodiment.
  • the cylindrical hole 82 a of the insertion portion 82 is set to be larger than the discharge portion 52 of the syringe 83, and a groove is formed in the middle of the inner peripheral surface of the insertion portion 82.
  • the groove portion serves as a stopper portion 71 that constitutes a lock mechanism described later, and is provided at two opposing locations on the inner peripheral surface of the fitting portion 32.
  • the stopper portion 71 is configured by a groove portion having a predetermined depth formed in, for example, a quadrangular shape on the inner peripheral surface of the insertion portion 32, and is a groove portion that can be locked with a lock portion 72 of a syringe 83 described later.
  • the holding portion 73 is formed of an O-ring-like member, and is fixed in a state of being in close contact with the inner peripheral surface on the end surface side of the fitting portion 82.
  • the holding portion 73 may be configured to be adhered to the inner peripheral surface of the insertion portion 82 with an adhesive, or may be inserted into the holding portion 73, and may be configured so as not to be displaced when the discharge portion 52 of the syringe 83 is inserted into the insertion portion 82.
  • Various configurations can be adopted.
  • the inner diameter of the holding portion 73 is formed slightly smaller than the outer diameter of the discharge portion 52 of the syringe 83, and the discharge portion 52 of the syringe 83 is inserted into the insertion portion 82 against the elastic force of the holding portion 73.
  • the diameter can be.
  • the thickness of the holding portion 73 that is, the difference between the outer diameter and the inner diameter of the holding portion 73 suffices as long as the liquid tightness between the discharge portion 52 and the insertion portion 82 of the syringe 83 can be maintained.
  • a lock portion 72 that is engaged with a stopper portion 71 formed on the inner peripheral surface of the fitting portion 82 is formed on the outer peripheral surface of the discharge portion 52 of the syringe 83.
  • the lock portion 72 is formed at a position that is locked to a stopper portion 71 formed on the inner peripheral surface of the insertion portion 82 when the discharge portion 52 of the syringe 83 is inserted into the insertion portion 82.
  • the lock portion 72 is formed so as to protrude in a substantially triangular shape from the outer peripheral surface of the syringe main body 51, the surface facing the discharge portion 52 is tapered, and the surface engaged with the stopper portion 71 is The direction is perpendicular to the outer peripheral surface.
  • the lock portion 72 is formed in such a triangular shape, the discharge portion 52 of the syringe 83 can be smoothly inserted into the insertion portion 32, and the lock portion 72 is once locked to the stopper portion 71. When it is done, it becomes difficult to come off.
  • the discharge portion 52 of the syringe 83 in a state filled with the medicine is inserted into the insertion portion in which the holding portion 73 of the injection needle assembly 86 is formed. Push into 82. Then, the insertion of the injection needle assembly 86 to the syringe 83 is completed by inserting the discharge portion 52 until it vertically contacts the end surface 41 b of the connection member 61. At this time, the discharge part 52 of the syringe 83 is inserted into the insertion part 82 against the elastic force of the holding part 73.
  • the syringe 83 is attached to the injection needle assembly 86 in a state where the discharge part 52 is closely held by the holding part 73. Thereby, the liquid tightness of the distal end side of the discharge part 52 of the syringe 83 is maintained, and the discharge part 52 of the syringe 83 is fixed to the injection needle assembly 86.
  • the lock portion 72 formed on the outer peripheral surface of the discharge portion 52 of the syringe 83 is engaged with the stopper portion 71 formed on the second member main body 89. .
  • the position of the syringe 83 with respect to the injection needle assembly 86 is fixed, and the syringe 83 does not come out.
  • the medicine injection device 81 of this embodiment can also be used similarly to the first embodiment.
  • FIG. 6 is an exploded view of the medicine injection device 91 according to this embodiment
  • FIG. 7 is a cross-sectional view
  • FIG. 8 is an exploded cross-sectional view of the medicine injection device 91 according to this embodiment.
  • This embodiment is an example in which the configuration of the holding portion and the needle tube is different from that of the first embodiment. 6 to 8, parts corresponding to those in FIGS. 1 to 4 are denoted by the same reference numerals, and redundant description is omitted.
  • the drug injection device 91 includes an injection needle assembly 97 and a syringe 93 to which the injection needle assembly 97 is detachably connected.
  • the injection needle assembly 97 of the present embodiment is different from the first embodiment in the configuration of the second member and the needle tube. Other configurations are the same as those of the injection needle assembly 2 according to the first embodiment.
  • the injection needle assembly 97 includes a needle tube 95 and a needle hub 96 that holds the needle tube 95.
  • One end of the needle tube 95 is provided with a first needle tip 95A for puncturing a living body, and the other end is provided with a second needle tip 95B for puncturing a lid portion 98 of a syringe 93 described later. That is, the needle tube 95 is a double-ended needle.
  • the first needle tip 95A has a blade surface 95a.
  • the bevel length of the blade surface 95a is the same as the configuration of the blade surface 5a of the needle tip 5A of the first embodiment.
  • the second needle tip 95B has a blade surface 95b.
  • the length of the blade surface 95b in the direction in which the needle tube 95 extends can be arbitrarily set, but can be set to the same length as the blade surface 95a of the first needle tip 95A.
  • the needle tube 95 is held at its intermediate portion by a needle hub 96, and the second needle tip 95 ⁇ / b> B protrudes from the end surface 41 b of the connection member 61.
  • the same material as that of the first embodiment can be used.
  • the outer diameter on the second needle tip 95B side may be made larger than the outer diameter on the first needle tip 95A side, and the intermediate portion may have a tapered structure.
  • the shapes of the first needle tip 95A and the second needle tip 95B are different.
  • the needle hub 96 includes a first member 11 and a second member 92, and the second member 92 is configured such that the holding member 9 is not provided on the second member 12 in the first embodiment. Yes.
  • the second member 92 is the same as the second member 12 in the first embodiment except that the holding portion is not configured.
  • the syringe 93 includes a holding portion 94 that is formed of an elastic member and is formed in a bottomed cylindrical shape at the discharge portion 52 of the syringe 3 according to the first embodiment.
  • the bottom portion of the holding portion 94 serves as a lid portion 98 that seals the opening at the distal end of the discharge portion 52 and allows the needle tip 95B of the needle tube 95 to be pierced.
  • the holding portion 94 formed on the outer peripheral surface of the discharge portion 52 is formed to be slightly larger than the inner diameter of the insertion portion 32 when attached to the discharge portion 52.
  • the medicine M is filled in the syringe 93 in advance.
  • the medicine M filled in advance the same medicine as that used in the medicine injection device 1 in the first embodiment can be used.
  • the medicine M prefilled in the syringe 93 is liquid-tightly held by a holding portion 94 provided on the distal end side of the discharge portion 52 and a gasket (not shown) provided in the syringe body 51. That is, the medicine injection device 91 of this embodiment constitutes a prefilled syringe.
  • the discharge portion 52 of the syringe 93 in a state filled with the medicine is inserted into the insertion portion in which the holding portion 94 of the injection needle assembly 97 is formed. Push into 32. Then, the second needle tip 95B of the needle tube 95 passes through the lid portion 98 of the holding portion 94 by inserting the discharge portion 52 until it comes into contact with the end surface 41b of the connection member 61 vertically, and the inside of the discharge portion 52 of the syringe 93 Insert into. As a result, the mounting of the injection needle assembly 97 to the syringe 93 is completed, and the liquid passing through the needle tube 95 is completed.
  • a holding portion 94 made of an elastic member is formed on the outer peripheral surface of the discharge portion 52 of the syringe 93, and the discharge portion 52 is inserted into the insertion portion 32 against the elastic force of the holding portion 94.
  • the syringe 93 is attached to the injection needle assembly 97 in a state where the discharge part 52 is closely held by the holding part 94. Thereby, the liquid tightness of the distal end side of the discharge part 52 of the syringe 93 is maintained, and the discharge part 52 of the syringe 93 is fixed to the injection needle assembly 97.
  • the lock portion 7 formed on the outer peripheral surface of the discharge portion 52 of the syringe 93 is engaged with the stopper portion 4 formed on the second member main body 19. .
  • the position with respect to the injection needle assembly 97 of the syringe 93 is fixed, and the syringe 93 does not come out.
  • the drug injection device 91 according to the present embodiment can also be used in the same manner as in the first embodiment.
  • the discharge portion of the syringe has a cylindrical shape whose side surface is perpendicular to the end surface, and the inner peripheral surface of the fitting portion has a surface perpendicular to the end surface.
  • the discharge part of the syringe may be formed in a tapered shape such that the diameter continuously decreases toward the tip, and the insertion part may have a tapered shape in which the diameter continuously decreases as it reaches the insertion part side. .
  • the stopper portion and the lock portion that constitute the lock mechanism are provided at two positions at opposite positions.
  • any configuration may be used as long as the syringe and the needle hub are fixed. It may be provided.
  • the first member of the needle hub is provided with the stabilizing portion and the guide portion.
  • the injection needle assembly and the drug injection device according to the present invention can be configured such that the second member or the syringe is provided with a stabilizing portion and a guide portion.
  • connection piece 31 ... insertion part, 32 ... insertion part, 34 ... fixed piece, 37 ... engagement part, 41 ... main body part, 42 ... flange part, 43 ... stopper projection, 44 ... Ring projection, 45 ... insertion hole, 46 ... end face side separation part, 47 ... contact surface side separation part, 48 ... contact part, 51 ... syringe body, 52 ... discharge part 56 ... Liquid chamber 61 ... Connection member 63 ... Needle side valve element 71 ... Stopper part 72 ... Lock part

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Abstract

The invention facilitates the assembly and locking of the syringe and the needle hub in injection devices in which the syringe and needle hub are separable. The injection needle assembly (2) is equipped with: a needle tube (5) having a needle point (5A) that pierces the skin; a needle hub (6) that holds the needle tube (5) and has an insertion part (32) into which the outlet (52) of a syringe (3) is inserted; and a holding part (9) obtained from an elastic member that is provided on the inner circumferential surface of the insertion part (32). The holding part (9) holds the outlet (52) of the syringe (3), which has been inserted into the insertion part (32), inside the insertion part (32) so as to be liquid-tight.

Description

注射針組立体及び薬剤注射装置Injection needle assembly and drug injection device

 本発明は、シリンジを針ハブに装着して使用する注射針組立体及び薬剤注射装置に関する。 The present invention relates to an injection needle assembly and a medicine injection device that are used by attaching a syringe to a needle hub.

 従来、針管が取り付けられた針ハブと、薬剤が封入されるシリンジとが分離可能に構成された注射装置が提案されている。 Conventionally, an injection device has been proposed in which a needle hub to which a needle tube is attached and a syringe in which a medicine is sealed are separable.

 特許文献1及び2では、針ハブとシリンジとが分離可能に構成された注射装置において、シリンジの筒先に形成された開口部が先端側にいくにしたがって径が大きくなっており、針ハブとシリンジがテーパ嵌合された構成が記載されている。このような、針ハブとシリンジとのテーパ嵌合では、ハブ部をシリンジに嵌合させるときに注射針を筒先内に容易に挿入することができ、針ハブとシリンジとがより液密に嵌合される。
 また、近年では、注射針が取り付けられた針ハブとシリンジとが互いに螺合接続された注射装置が提案されている。
In Patent Documents 1 and 2, in an injection device configured such that a needle hub and a syringe are separable, the diameter of the needle hub and the syringe increases as the opening formed at the tube tip of the syringe moves toward the distal end side. Is described as a taper-fitted configuration. In such a taper fitting between the needle hub and the syringe, the injection needle can be easily inserted into the tube tip when the hub portion is fitted to the syringe, and the needle hub and the syringe are more liquid tightly fitted. Combined.
In recent years, an injection apparatus has been proposed in which a needle hub to which an injection needle is attached and a syringe are screwed together.

特開2006-116217号公報JP 2006-116217 A 特開2008-73237号公報JP 2008-73237 A

 ところで、近年、免疫担当細胞が多く存在する皮膚上層部を標的部位として、インフルエンザワクチンを投与することにより、投与量を少なくしても、皮下投与や筋肉投与と同等の免疫獲得能が得られることが報告されている。したがって、インフルエンザワクチンを皮膚上層部に投与することにより投与量を減らすことができるので、より多くのヒトにインフルエンザワクチンを接種できる可能性がある。なお、皮膚上層部とは、皮膚のうちの表皮と真皮を指す。 By the way, in recent years, the ability to acquire immunity equivalent to subcutaneous administration or intramuscular administration can be obtained by administering influenza vaccine using the upper skin layer where many immunocompetent cells are present as the target site, even if the dose is reduced. Has been reported. Therefore, since the dose can be reduced by administering the influenza vaccine to the upper skin layer, there is a possibility that more humans can be vaccinated with the influenza vaccine. The upper skin layer refers to the epidermis and dermis of the skin.

 このような、皮膚上層部への薬剤投与では、皮下投与に比べて高い注入圧力が必要である。そのため、特許文献1又は2の注射装置では、薬剤投与時において、シリンジ側から針ハブ側に向けて高い液圧がかかり、テーパ嵌合が外れ、針ハブとシリンジとが薬剤投与時に分離してしまうおそれがある。また、テーパ部に成形時にヒケが発生し、それによりテーパ嵌合のすき間から薬剤が漏れるおそれもある。 Such drug administration to the upper skin layer requires a higher injection pressure than subcutaneous administration. Therefore, in the injection device of Patent Document 1 or 2, during drug administration, high fluid pressure is applied from the syringe side to the needle hub side, the taper fitting is released, and the needle hub and syringe are separated during drug administration. There is a risk that. In addition, sink marks may occur at the time of molding in the tapered portion, which may cause the medicine to leak from the taper fitting gap.

 一方、シリンジと針ハブとを固定するために針ハブに対してシリンジを回転させることによって螺合する注射装置では、使用時に、医療従事者などの使用者がネジ締めする必要があり、注射装置を使用するまでの準備が煩雑である。また、シリンジと針ハブとを螺合することによって固定する注射装置は、医療従事者が使い慣れていない場合、ネジ締めを忘れる危険性がある。 On the other hand, in an injection device that is screwed by rotating the syringe with respect to the needle hub in order to fix the syringe and the needle hub, a user such as a medical worker needs to tighten the screw at the time of use. Preparation until using is complicated. In addition, an injection device that is fixed by screwing a syringe and a needle hub has a risk of forgetting screw tightening when medical personnel are not familiar with it.

 本発明は、このような状況に鑑みてなされたものであり、シリンジと針ハブとが分離可能な注射装置において、シリンジと針ハブとの組み立てや固定を容易にすることを目的とする。 The present invention has been made in view of such a situation, and an object thereof is to facilitate assembly and fixing of a syringe and a needle hub in an injection device in which the syringe and the needle hub can be separated.

 本発明の注射針組立体は、皮膚に穿刺される針先を有する針管と、針管を保持し、シリンジの排出部が嵌入される嵌入部を有する針ハブと、嵌入部の内周面に設けられた弾性部材からなる保持部とを備える。そして、保持部は、嵌入部に嵌入されたシリンジの排出部を、嵌入部内に液密に保持する。 An injection needle assembly according to the present invention is provided on a needle tube having a needle tip to be punctured into the skin, a needle hub that holds the needle tube and into which a discharge portion of a syringe is inserted, and an inner peripheral surface of the insertion portion. And a holding portion made of an elastic member. And a holding | maintenance part hold | maintains the discharge part of the syringe inserted in the insertion part liquid-tightly in the insertion part.

 本発明の薬剤注射装置は、排出部を有するシリンジと、皮膚に穿刺される針先を有する針管と、針管を保持し、シリンジの排出部が嵌入される嵌入部を有する針ハブと、嵌入部の内周面又はシリンジの排出部の外周面に設けられた弾性部材からなる保持部とを備える。そして、保持部は、嵌入部に嵌入されたシリンジの排出部を、嵌入部内に液密に保持することを特徴とする。 The drug injection device of the present invention includes a syringe having a discharge portion, a needle tube having a needle tip to be punctured into the skin, a needle hub that holds the needle tube and has a fitting portion into which the discharge portion of the syringe is fitted, and a fitting portion The holding part which consists of an elastic member provided in the inner peripheral surface of this or the outer peripheral surface of the discharge part of a syringe is provided. And a holding | maintenance part hold | maintains the discharge part of the syringe inserted in the insertion part liquid-tightly in the insertion part.

 本発明の注射針組立体では、嵌入部の内周面に弾性部材からなる保持部が設けられることにより、シリンジの排出部を嵌入部内に押し込むだけでシリンジが針ハブに装着され、シリンジの排出部が嵌入部内に液密に保持される。
 また、本発明の薬剤注射装置では、嵌入部の内周面又はシリンジの排出部の外周面に弾性部材からなる保持部が設けられていることにより、シリンジの排出部を嵌入部に押し込むだけでシリンジを針ハブに装着できる。そして、これにより、シリンジの排出部が嵌入部内に液密に保持される。
In the injection needle assembly of the present invention, the holding portion made of an elastic member is provided on the inner peripheral surface of the insertion portion, so that the syringe is attached to the needle hub simply by pushing the discharge portion of the syringe into the insertion portion. The portion is liquid-tightly held in the fitting portion.
Moreover, in the medicine injection device of the present invention, since the holding portion made of an elastic member is provided on the inner peripheral surface of the insertion portion or the outer peripheral surface of the discharge portion of the syringe, it is only necessary to push the discharge portion of the syringe into the insertion portion. A syringe can be attached to the needle hub. And thereby, the discharge part of a syringe is liquid-tightly hold | maintained in an insertion part.

 本発明の注射針組立体及び薬剤注射装置によれば、シリンジと針ハブとの組み立てを容易にすることができ、かつ、シリンジを針ハブに液密に保持することができる。 According to the injection needle assembly and the drug injection device of the present invention, the assembly of the syringe and the needle hub can be facilitated, and the syringe can be held liquid-tight on the needle hub.

本発明の第1の実施形態に係る薬剤注射装置の分解図である。It is an exploded view of the medicine injection device concerning a 1st embodiment of the present invention. 本発明の第1の実施形態に係る薬剤注射装置の断面図である。1 is a cross-sectional view of a drug injection device according to a first embodiment of the present invention. 本発明の第1の実施形態に係る薬剤注射装置の要部の断面図である。It is sectional drawing of the principal part of the chemical injection apparatus which concerns on the 1st Embodiment of this invention. 本発明の第1の実施形態に係る薬剤注射装置を分解して示す断面図である。It is sectional drawing which decomposes | disassembles and shows the chemical injection device which concerns on the 1st Embodiment of this invention. 本発明の第2の実施形態に係る薬剤注射装置の断面図である。It is sectional drawing of the chemical injection apparatus which concerns on the 2nd Embodiment of this invention. 本発明の第3の実施形態に係る薬剤注射装置の分解図である。It is an exploded view of the medicine injection device concerning a 3rd embodiment of the present invention. 本発明の第3の実施形態に係る薬剤注射装置の断面図である。It is sectional drawing of the chemical injection apparatus which concerns on the 3rd Embodiment of this invention. 本発明の第3の実施形態に係る薬剤注射装置を分解して示す断面図である。It is sectional drawing which decomposes | disassembles and shows the chemical injection apparatus which concerns on the 3rd Embodiment of this invention.

 以下、本発明の注射針組立体および薬剤注射装置を実施するための形態について、図1~図8を参照して説明する。なお、各図において共通の部材には、同一の符号を付している。 Hereinafter, modes for carrying out the injection needle assembly and the drug injection device of the present invention will be described with reference to FIGS. 1 to 8. FIG. In addition, the same code | symbol is attached | subjected to the common member in each figure.

1. 第1の実施の形態
[薬剤注射装置]
 まず、本発明の第1の実施形態に係る薬剤注射装置及び注射針組立体について、図1及び図2を参照して説明する。
 図1は、本実施形態例の薬剤注射装置1の分解図であり、図2は、断面図である。
1. First embodiment [drug injection device]
First, a drug injection device and a needle assembly according to a first embodiment of the present invention will be described with reference to FIGS. 1 and 2.
FIG. 1 is an exploded view of a drug injection device 1 according to this embodiment, and FIG. 2 is a cross-sectional view.

 薬剤注射装置1は、針先を皮膚の表面より穿刺し、皮膚上層部に薬剤を注入する場合に用いる。この薬剤注射装置1は、注射針組立体2と、この注射針組立体2が着脱可能に接続されるシリンジ3とから構成されている。 The drug injection device 1 is used when the needle tip is punctured from the skin surface and the drug is injected into the upper layer of the skin. The drug injection device 1 includes an injection needle assembly 2 and a syringe 3 to which the injection needle assembly 2 is detachably connected.

 図2に示すように、注射針組立体2は、針孔を有する中空の針管5と、この針管5が固定される針ハブ6と、針ハブ6内に配置される接続部材61と、針ハブ6に着脱可能に取り付けられるキャップ8とを備えている。そして、針ハブ6は、針管5を保持する第1部材11と、シリンジ3の後述する排出部52が嵌入される第2部材12とからなっている。 As shown in FIG. 2, the injection needle assembly 2 includes a hollow needle tube 5 having a needle hole, a needle hub 6 to which the needle tube 5 is fixed, a connection member 61 disposed in the needle hub 6, a needle And a cap 8 detachably attached to the hub 6. The needle hub 6 includes a first member 11 that holds the needle tube 5 and a second member 12 into which a later-described discharge portion 52 of the syringe 3 is inserted.

 次に、注射針組立体2及びシリンジ3について、図3及び図4を参照して説明する。
 図3は、薬剤注射装置1の要部の断面図である。図4は、薬剤注射装置1を分解して示す断面図である。
Next, the injection needle assembly 2 and the syringe 3 will be described with reference to FIGS. 3 and 4.
FIG. 3 is a cross-sectional view of a main part of the medicine injection device 1. FIG. 4 is an exploded cross-sectional view of the medicine injection device 1.

[注射針組立体]
 注射針組立体2の針管5は、ISOの医療用針管の基準(ISO9626:1991/Amd.1:2001(E))で26~33ゲージのサイズ(外径0.2~0.45mm)のものを使用し、好ましくは30~33ゲージのものを使用する。
[Injection needle assembly]
The needle tube 5 of the injection needle assembly 2 has a size of 26 to 33 gauge (outer diameter 0.2 to 0.45 mm) based on the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)). Those of 30 to 33 gauge are preferably used.

 針管5の一端には、刃面5aを有する針先5Aが設けられている。以下、針先5Aとは反対側である針管5の他端を「基端5B」という。刃面5aにおける針管5の軸方向の長さ(以下、「ベベル長B」という)は、後述する皮膚上層部の最薄の厚さである1.4mm(成人)以下であればよく、また、33ゲージの針管に短ベベルを形成したときのベベル長である約0.5mm以上であればよい。つまり、ベベル長Bは、0.5~1.4mmの範囲に設定されるのが好ましい。 A needle tip 5A having a blade surface 5a is provided at one end of the needle tube 5. Hereinafter, the other end of the needle tube 5 opposite to the needle tip 5A is referred to as a “base end 5B”. The axial length of the needle tube 5 on the blade surface 5a (hereinafter referred to as “bevel length B”) may be 1.4 mm (adult) or less, which is the thinnest thickness of the upper skin layer described later. The bevel length may be about 0.5 mm or more when a short bevel is formed on a 33 gauge needle tube. That is, the bevel length B is preferably set in the range of 0.5 to 1.4 mm.

 さらに、ベベル長Bは、皮膚上層部の最薄の厚さが0.9mm(小児)以下、すなわち、ベベル長Bが0.5~0.9mmの範囲であればなおよい。なお、短ベベルとは、注射用針に一般的に用いられる、針の長手方向に対して18~25°をなす刃面を指す。 Further, the bevel length B is more preferable if the thinnest thickness of the upper skin portion is 0.9 mm (child) or less, that is, the bevel length B is in the range of 0.5 to 0.9 mm. The short bevel refers to a blade surface that is generally used for injection needles and forms an angle of 18 to 25 ° with respect to the longitudinal direction of the needle.

 針管5の材料としては、例えば、ステンレス鋼を挙げることができるが、これに限定されるものではなく、アルミニウム、アルミニウム合金、チタン、チタン合金その他の金属を用いることができる。また、針管5は、ストレート針だけでなく、少なくとも一部がテーパー状となっているテーパー針を用いることができる。テーパー針としては、針先端部に比べて基端部が大きい径を有しており、その中間部分をテーパー構造とすればよい。また、針管5の断面形状は、円形だけでなく、三角形等の多角形であってもよい。 Examples of the material of the needle tube 5 include stainless steel, but are not limited thereto, and aluminum, aluminum alloy, titanium, titanium alloy, and other metals can be used. Further, the needle tube 5 can be not only a straight needle but also a tapered needle at least partially tapered. As the tapered needle, the proximal end portion has a larger diameter than the needle distal end portion, and the intermediate portion may have a tapered structure. Further, the cross-sectional shape of the needle tube 5 may be not only a circle but also a polygon such as a triangle.

 次に、針ハブ6について説明する。
 針ハブ6の第1部材11と第2部材12は、別部材として形成されているが、一体に形成することもできる。これら第1部材11及び第2部材12の材質としては、ポリカーボネート、ポリプロピレン、ポリエチレン等の合成樹脂を挙げることができる。
Next, the needle hub 6 will be described.
The first member 11 and the second member 12 of the needle hub 6 are formed as separate members, but may be formed integrally. Examples of the material of the first member 11 and the second member 12 include synthetic resins such as polycarbonate, polypropylene, and polyethylene.

 第1部材11は、ベース部15と、調整部16と、安定部17と、ガイド部18とを備えている。ベース部15は、略円柱状に形成されており、軸方向に垂直な端面15a,15bを有している。調整部16は、ベース部15の端面15aの中央部に設けられており、ベース部15の軸方向に突出する円柱状の凸部からなっている。この調整部16の軸心は、ベース部15の軸心に一致している。 The first member 11 includes a base portion 15, an adjustment portion 16, a stabilization portion 17, and a guide portion 18. The base portion 15 is formed in a substantially columnar shape, and has end faces 15a and 15b perpendicular to the axial direction. The adjustment portion 16 is provided at the center of the end surface 15 a of the base portion 15, and includes a columnar convex portion that protrudes in the axial direction of the base portion 15. The axis of the adjustment portion 16 is coincident with the axis of the base portion 15.

 ベース部15及び調整部16の軸心には、針管5が貫通する貫通孔21が設けられている。そして、ベース部15には、貫通孔21に接着剤20(図3参照)を注入するための注入用孔22(図2及び図4参照)が設けられている。この注入用孔22は、ベース部15の外周面に開口されており、貫通孔21に連通している。すなわち、注入用孔22から貫通孔21へ注入された接着剤20により、針管5がベース部15に固着される。 A through-hole 21 through which the needle tube 5 passes is provided in the axial center of the base portion 15 and the adjustment portion 16. The base portion 15 is provided with an injection hole 22 (see FIGS. 2 and 4) for injecting the adhesive 20 (see FIG. 3) into the through hole 21. The injection hole 22 is opened on the outer peripheral surface of the base portion 15 and communicates with the through hole 21. That is, the needle tube 5 is fixed to the base portion 15 by the adhesive 20 injected from the injection hole 22 into the through hole 21.

 針管5の基端5B側は、ベース部15の端面15bから突出する。ベース部15は、端面15b側から第2部材12内に挿入され、針管5の基端5B側が接続部材61の後述する挿通孔45に挿通される。そして、ベース部15の端面15bが接続部材61の後述する端面41aに当接される。 The proximal end 5B side of the needle tube 5 protrudes from the end face 15b of the base portion 15. The base portion 15 is inserted into the second member 12 from the end face 15b side, and the proximal end 5B side of the needle tube 5 is inserted into an insertion hole 45 described later of the connection member 61. And the end surface 15b of the base part 15 is contact | abutted to the end surface 41a which the connection member 61 mentions later.

 ベース部15の外周面には、接続片24が設けられている。この接続片24は、ベース部15の半径方向に突出するリング状のフランジとして形成されており、ベース部15の軸方向に対向する平面24a,24bを有している。接続片24の平面24bには、第2部材12が接続される。また、接続片24の先端部は、ガイド部18になっている。このガイド部18については、後で詳しく説明する。 A connecting piece 24 is provided on the outer peripheral surface of the base portion 15. The connection piece 24 is formed as a ring-shaped flange protruding in the radial direction of the base portion 15, and has flat surfaces 24 a and 24 b that face the axial direction of the base portion 15. The second member 12 is connected to the flat surface 24 b of the connection piece 24. Further, the distal end portion of the connection piece 24 is a guide portion 18. The guide portion 18 will be described in detail later.

 調整部16の端面は、針管5の針先5A側が突出する針突出面16aになっている。針突出面16aは、針管5の軸方向に直交する平面として形成されている。この針突出面16aは、針管5を皮膚上層部に穿刺するときに、皮膚の表面に接触して針管5を穿刺する深さを規定する。つまり、針管5が皮膚上層部に穿刺される深さは、針突出面16aから突出する針管5の長さ(以下、「突出長L」という。)によって決定される。 The end surface of the adjusting portion 16 is a needle projecting surface 16a from which the needle tip 5A side of the needle tube 5 projects. The needle projecting surface 16 a is formed as a plane orthogonal to the axial direction of the needle tube 5. This needle protrusion surface 16a defines the depth at which the needle tube 5 is punctured by contacting the surface of the skin when the needle tube 5 is punctured into the upper layer portion of the skin. That is, the depth at which the needle tube 5 is punctured into the upper skin layer is determined by the length of the needle tube 5 protruding from the needle protruding surface 16a (hereinafter referred to as “projection length L”).

 皮膚上層部の厚みは、皮膚の表面から真皮層までの深さに相当し、概ね、0.5~3.0mmの範囲内にある。そのため、針管5の突出長Lは、0.5~3.0mmの範囲に設定することができる。 The thickness of the upper skin portion corresponds to the depth from the skin surface to the dermis layer, and is generally in the range of 0.5 to 3.0 mm. Therefore, the protruding length L of the needle tube 5 can be set in the range of 0.5 to 3.0 mm.

 ところで、ワクチンは一般的に上腕部に投与されるが、皮膚上層部への投与の場合には、皮膚が厚い肩周辺部、特に三角筋部が好ましい。そこで、小児19人と大人31人について、三角筋の皮膚上層部の厚みを測定した。この測定は、超音波測定装置(NP60R-UBM 小動物用高解像度用エコー、ネッパジーン(株))を用いて、超音波反射率の高い皮膚上層部を造影することで行った。なお、測定値が対数正規分布となっていたため、幾何平均によってMEAN±2SDの範囲を求めた。 By the way, the vaccine is generally administered to the upper arm, but in the case of administration to the upper skin part, the shoulder peripheral part where the skin is thick, particularly the deltoid part is preferable. Therefore, the thickness of the upper layer of the deltoid muscle was measured for 19 children and 31 adults. This measurement was performed by imaging the upper layer of the skin with high ultrasonic reflectivity using an ultrasonic measurement device (NP60R-UBM, high-resolution echo for small animals, Nepagene). In addition, since the measured value was logarithmic normal distribution, the range of MEAN ± 2SD was obtained by geometric mean.

 その結果、小児の三角筋における皮膚上層部の厚みは、0.9~1.6mmであった。また、成人の三角筋における皮膚上層部の厚みは、遠位部で1.4~2.6mm、中央部で1.4~2.5mm、近位部で1.5~2.5mmであった。以上のことから、三角筋における皮膚上層部の厚みは、小児の場合で0.9mm以上、成人の場合で1.4mm以上であることが確認された。したがって、三角筋の皮膚上層部における注射において、針管5の突出長Lは、0.9~1.4mmの範囲に設定することが好ましい。 As a result, the thickness of the upper skin layer of the deltoid muscle of the child was 0.9 to 1.6 mm. In addition, the thickness of the upper skin layer of the deltoid muscle of adults was 1.4 to 2.6 mm at the distal part, 1.4 to 2.5 mm at the central part, and 1.5 to 2.5 mm at the proximal part. It was. From the above, it was confirmed that the thickness of the upper skin layer in the deltoid muscle was 0.9 mm or more in the case of children and 1.4 mm or more in the case of adults. Therefore, in the injection in the upper layer part of the deltoid muscle, the protruding length L of the needle tube 5 is preferably set in the range of 0.9 to 1.4 mm.

 突出長Lをこのように設定することで、針先5Aの刃面5aを皮膚上層部に確実に位置させることが可能となる。その結果、刃面5aに開口する針孔(薬液排出口)は、刃面5a内のいかなる位置にあっても、皮膚上層部に位置することが可能である。なお、薬液排出口が皮膚上層部に位置しても、針先5Aが皮膚上層部よりも深く刺されば、針先5A端部の側面と切開された皮膚との間から薬液が皮下に流れてしまうため、刃面5aが確実に皮膚上層部にあることが重要である。 By setting the protruding length L in this way, the blade surface 5a of the needle tip 5A can be reliably positioned on the upper skin layer. As a result, the needle hole (chemical solution discharge port) that opens in the blade surface 5a can be located in the upper skin layer portion at any position in the blade surface 5a. Even if the drug solution outlet is located in the upper skin layer, if the needle tip 5A is stabbed deeper than the upper skin layer, the drug solution flows subcutaneously between the side surface of the end of the needle tip 5A and the cut skin. Therefore, it is important that the blade surface 5a is surely in the upper skin portion.

 なお、26ゲージよりも太い針管では、ベベル長Bを1.0mm以下にすることは難しい。したがって、針管5の突出長Lを好ましい範囲(0.9~1.4mm)に設定するには、26ゲージよりも細い針管を使用することが好ましい。 Note that it is difficult to make the bevel length B 1.0 mm or less with a needle tube thicker than 26 gauge. Therefore, in order to set the protruding length L of the needle tube 5 within a preferable range (0.9 to 1.4 mm), it is preferable to use a needle tube thinner than 26 gauge.

 針突出面16aは、周縁から針管5の外周面までの距離Sが1.4mm以下となるように形成し、好ましくは0.3~1.4mmの範囲で形成する。この針突出面16aの周縁から針管5の周面までの距離Sは、皮膚上層部へ薬剤を投与することで形成される水疱に圧力が加わることを考慮して設定している。つまり、針突出面16aは、皮膚上層部に形成される水疱よりも十分に小さく、水疱の形成を妨げない大きさに設定している。その結果、針突出面16aが針管5の周囲の皮膚を押圧しても、投与された薬剤が漏れることを防止することができる。 The needle projecting surface 16a is formed so that the distance S from the peripheral edge to the outer peripheral surface of the needle tube 5 is 1.4 mm or less, preferably in the range of 0.3 to 1.4 mm. The distance S from the peripheral edge of the needle protruding surface 16a to the peripheral surface of the needle tube 5 is set in consideration of the pressure applied to the blisters formed by administering the drug to the upper skin layer. That is, the needle projecting surface 16a is set to a size that is sufficiently smaller than the blisters formed on the upper layer portion of the skin and does not hinder the formation of blisters. As a result, even if the needle protruding surface 16a presses the skin around the needle tube 5, it is possible to prevent the administered medicine from leaking.

 安定部17は、ベース部15に設けた接続片24の平面24aから突出する筒状に形成されている。安定部17の筒孔には、針管5及び調整部16が配置されている。つまり、安定部17は、針管5が貫通する調整部16の周囲を覆う筒状に形成されており、針管5の針先5Aから半径方向に離間して設けられている。 The stabilizing portion 17 is formed in a cylindrical shape protruding from the flat surface 24 a of the connecting piece 24 provided on the base portion 15. The needle tube 5 and the adjustment unit 16 are disposed in the cylindrical hole of the stabilization unit 17. That is, the stabilizing portion 17 is formed in a cylindrical shape that covers the periphery of the adjusting portion 16 through which the needle tube 5 passes, and is provided away from the needle tip 5A of the needle tube 5 in the radial direction.

 安定部17には、キャップ8が着脱可能に嵌合される。このキャップ8は、針管5の針先5Aを覆う。これにより、針ハブ6をシリンジ3に装着する場合に、針先5Aが使用者の指先等に触れないようにすることができる。また、使用済みの薬剤注射装置1或いは注射針組立体2を常に安全な状態に保つことができ、使用者は、安心して使用済みの薬剤注射装置1或いは注射針組立体2の廃棄処理等を行うことができる。 The cap 8 is detachably fitted to the stabilizing portion 17. The cap 8 covers the needle tip 5 </ b> A of the needle tube 5. Thereby, when attaching needle hub 6 to syringe 3, needle tip 5A can be prevented from touching a user's fingertip. In addition, the used medicine injection device 1 or the needle assembly 2 can be always kept in a safe state, and the user can safely dispose of the used medicine injection device 1 or the needle assembly 2. It can be carried out.

 図3に示すように、安定部17の端面17aは、調整部16の針突出面16aよりも針管5の基端5B側に位置している。針管5の針先5Aを生体に穿刺すると、まず、針突出面16aが皮膚の表面に接触し、その後、安定部17の端面17aに接触する。このとき、安定部17の端面17aが皮膚に接触することで薬剤注射装置1が安定し、針管5を皮膚に対して略垂直な姿勢に保つことができる。 3, the end surface 17a of the stabilizing portion 17 is located closer to the proximal end 5B of the needle tube 5 than the needle protruding surface 16a of the adjusting portion 16. When the living body is punctured with the needle tip 5A of the needle tube 5, the needle projecting surface 16a first contacts the surface of the skin, and then contacts the end surface 17a of the stabilizing portion 17. At this time, the drug injection device 1 is stabilized by the end surface 17a of the stabilizing portion 17 coming into contact with the skin, and the needle tube 5 can be maintained in a posture substantially perpendicular to the skin.

 なお、安定部17の端面17aは、針突出面16aと同一平面上に位置させたり、また、針突出面16aよりも針管5の針先5A側に位置させたりしても、針管5を皮膚に対して略垂直な姿勢に保つことができる。なお、安定部17を皮膚に押し付けた際の皮膚の盛り上がりを考慮すると、安定部17の端面17aと針突出面16aにおける軸方向の距離は、1.3mm以下に設定することが好ましい。 Even if the end surface 17a of the stabilizing portion 17 is positioned on the same plane as the needle projecting surface 16a, or is positioned closer to the needle tip 5A side of the needle tube 5 than the needle projecting surface 16a, the needle tube 5 is skinned. It is possible to keep the posture substantially perpendicular to the angle. In consideration of the swelling of the skin when the stable portion 17 is pressed against the skin, the axial distance between the end surface 17a of the stable portion 17 and the needle protruding surface 16a is preferably set to 1.3 mm or less.

 また、安定部17の内径dは、皮膚に形成される水疱の直径と同等であるか、それよりも大きい値に設定されている。具体的には、安定部17の内壁面から針突出面16aの周縁までの距離Tが4mm~15mmの範囲となるように設定されている。これにより、安定部17の内壁面から水疱に圧力が印加されることによって水疱形成が阻害されることを防止することができる。 Further, the inner diameter d of the stable portion 17 is set to a value equal to or larger than the diameter of the blister formed on the skin. Specifically, the distance T from the inner wall surface of the stabilizing portion 17 to the peripheral edge of the needle protruding surface 16a is set to be in the range of 4 mm to 15 mm. Thereby, it can prevent that blister formation is inhibited by pressure being applied to a blister from the inner wall surface of stable part 17.

 安定部17の内壁面から針突出面16aの周縁までの距離Tは、4mm以上であれば、特に上限はない。しかしながら、距離Tを大きくすると、安定部17の外径が大きくなるため、小児のように細い腕に針管5を穿刺する場合に、安定部17の端面17a全体を皮膚に接触させることが難しくなる。そのため、距離Tは、小児の腕の細さを考慮して15mmを最大と規定することが好ましい。 The distance T from the inner wall surface of the stabilizing portion 17 to the periphery of the needle protruding surface 16a is not particularly limited as long as it is 4 mm or more. However, when the distance T is increased, the outer diameter of the stable portion 17 increases, so that it becomes difficult to bring the entire end surface 17a of the stable portion 17 into contact with the skin when the needle tube 5 is punctured into a thin arm like a child. . For this reason, the distance T is preferably set to 15 mm as a maximum in consideration of the thinness of the child's arm.

 針突出面16aの周縁から針管5の外周面までの距離Sが0.3mm以上であれば、調整部16が皮膚に進入することはない。したがって、安定部17の内壁面から針突出面16aの周縁までの距離T(4mm以上)及び針突出面16aの直径(約0.3mm)を考慮すると、安定部17の内径dは9mm以上に設定することができる。 If the distance S from the peripheral edge of the needle protruding surface 16a to the outer peripheral surface of the needle tube 5 is 0.3 mm or more, the adjusting unit 16 does not enter the skin. Therefore, considering the distance T (4 mm or more) from the inner wall surface of the stable portion 17 to the periphery of the needle protruding surface 16a and the diameter (about 0.3 mm) of the needle protruding surface 16a, the inner diameter d of the stable portion 17 is 9 mm or more. Can be set.

 なお、安定部17の形状は、円筒状に限定されるものではなく、例えば、中心に筒孔を有する四角柱や六角柱等の角筒状に形成してもよい。 In addition, the shape of the stable part 17 is not limited to a cylindrical shape, and may be formed in a rectangular tube shape such as a quadrangular column or a hexagonal column having a cylindrical hole at the center.

 ガイド部18は、接続片24における安定部17よりも先端側の部分である。このガイド部18は、皮膚と接触する接触面18aを有している。接触面18aは、接続片24における平面24aの一部であり、安定部17の端面17aと略平行をなす平面である。ガイド部18の接触面18aが皮膚に接触するまで安定部17を押し付けることにより、安定部17及び針管5が皮膚を押圧する力を常に所定値以上に確保することができる。これにより、針管5の針突出面16aから突出している部分(突出長Lに相当)が確実に皮膚内に穿刺される。 The guide portion 18 is a portion on the tip side of the connecting piece 24 with respect to the stabilizing portion 17. The guide portion 18 has a contact surface 18a that comes into contact with the skin. The contact surface 18 a is a part of the flat surface 24 a of the connection piece 24, and is a flat surface that is substantially parallel to the end surface 17 a of the stabilizing portion 17. By pressing the stable portion 17 until the contact surface 18a of the guide portion 18 comes into contact with the skin, the force with which the stable portion 17 and the needle tube 5 press the skin can always be secured above a predetermined value. Thereby, the part (equivalent to the protrusion length L) which protrudes from the needle | hook protrusion surface 16a of the needle tube 5 is punctured in skin reliably.

 ガイド部18の接触面18aから安定部17の端面17aまでの距離(以下、「ガイド部高さ」という。)Yは、針管5及び安定部17が適正な押圧力で皮膚を押圧し穿刺することができるようにその長さが設定されている。これにより、針管5及び安定部17による皮膚への押圧力をガイド部18が案内し、針管5の針先5A(刃面5a)を皮膚上層部に確実に位置させることができると共に、使用者に安心感を与えることができる。なお、針管5及び安定部17の適正な押圧力は、例えば、3~20Nである。 The distance Y from the contact surface 18a of the guide portion 18 to the end surface 17a of the stable portion 17 (hereinafter referred to as “guide portion height”) Y punctures the needle tube 5 and the stable portion 17 by pressing the skin with an appropriate pressing force. Its length is set so that it can. As a result, the guide portion 18 guides the pressing force applied to the skin by the needle tube 5 and the stabilizing portion 17, and the needle tip 5A (blade surface 5a) of the needle tube 5 can be reliably positioned on the upper layer portion of the skin. Can give you a sense of security. An appropriate pressing force of the needle tube 5 and the stabilizing portion 17 is, for example, 3 to 20N.

 ガイド部高さYは、安定部17の内径dの範囲が11~14mmの場合、ガイド部18の先端面から安定部17の外周面までの長さ(以下、「ガイド部長さ」という。)Xに基づいて適宜決定される。例えば、安定部17の内径dが12mmであり、ガイド部長さXが3.0mmのとき、ガイド部高さYは、2.3~6.6mmの範囲に設定される。 When the range of the inner diameter d of the stable portion 17 is 11 to 14 mm, the guide portion height Y is the length from the distal end surface of the guide portion 18 to the outer peripheral surface of the stable portion 17 (hereinafter referred to as “guide portion length”). It is determined appropriately based on X. For example, when the inner diameter d of the stabilizing portion 17 is 12 mm and the guide portion length X is 3.0 mm, the guide portion height Y is set in the range of 2.3 to 6.6 mm.

 次に、第2部材12について説明する。第2部材12は、略筒状に形成された第2部材本体19と、第2部材本体19の端部に形成されたストッパ部4と、第2部材本体19の内周面に形成された保持部9とで構成されている。
 第2部材本体19の軸方向の一端部は、第1部材11のベース部15を挿入する挿入部31になっており、他端部は、シリンジ3の排出部52が嵌入する嵌入部32になっている。挿入部31の筒孔31aは、第1部材11のベース部15に対応した大きさに設定されている。
Next, the second member 12 will be described. The second member 12 is formed on the inner surface of the second member main body 19, the second member main body 19 formed in a substantially cylindrical shape, the stopper portion 4 formed at the end of the second member main body 19, and the second member main body 19. The holding part 9 is comprised.
One end portion of the second member main body 19 in the axial direction is an insertion portion 31 into which the base portion 15 of the first member 11 is inserted, and the other end portion is in the insertion portion 32 into which the discharge portion 52 of the syringe 3 is inserted. It has become. The cylindrical hole 31 a of the insertion portion 31 is set to a size corresponding to the base portion 15 of the first member 11.

 挿入部31には、第1部材11の接続片24に接続される固定片34が設けられている。この固定片34は、挿入部31の先端に連続して半径外方向に突出するリング状のフランジとして形成されている。固定片34には、第1部材11に設けた接続片24の平面24bが当接し、固着される。固定片34と接続片24の固着方法としては、例えば、接着剤、超音波溶着、レーザ溶着、固定ねじ等を挙げることができる。嵌入部32の筒孔32aは、シリンジ3の排出部52よりも大きく設定されている。その形状は、本実施形態ではシリンジ3の排出部52の形状に合わせて、軸方向に内径が一定のものであるが、シリンジ3の排出部52がテーパ状である場合には、それに合わせてテーパ状になる。 The insertion part 31 is provided with a fixing piece 34 connected to the connection piece 24 of the first member 11. The fixing piece 34 is formed as a ring-shaped flange that protrudes radially outward continuously from the distal end of the insertion portion 31. A flat surface 24b of the connection piece 24 provided on the first member 11 is brought into contact with and fixed to the fixed piece 34. Examples of the fixing method of the fixing piece 34 and the connection piece 24 include an adhesive, ultrasonic welding, laser welding, and a fixing screw. The cylindrical hole 32 a of the insertion part 32 is set larger than the discharge part 52 of the syringe 3. In the present embodiment, the shape has a constant inner diameter in the axial direction in accordance with the shape of the discharge portion 52 of the syringe 3, but when the discharge portion 52 of the syringe 3 is tapered, the shape is adjusted accordingly. Tapered.

 保持部9は、円筒形状の弾性部材で構成されており、嵌入部32の内周面に密着した状態で固定されている。保持部9は、嵌入部32の内周面に対して接着剤により接着される構成でも、嵌め込まれる構成でもよく、嵌入部32にシリンジ3の排出部52を嵌入したときにずれない構成であれば種々の形態を採ることができる。また、保持部9の内径はシリンジ3の排出部52の外径よりもやや小さく形成されており、保持部9が嵌入部32の内周面に設けられた状態で、保持部9内にシリンジ3の排出部52を保持部9の弾性力に抗して嵌入することができる径とされている。
 また、保持部9の肉厚、すなわち保持部9の外径と内径との差は、シリンジ3の排出部52と嵌入部32との液密性を保持できる厚みであればよい。
The holding part 9 is composed of a cylindrical elastic member, and is fixed in close contact with the inner peripheral surface of the fitting part 32. The holding portion 9 may be configured to be adhered to the inner peripheral surface of the insertion portion 32 with an adhesive, or may be inserted into the holding portion 9, and may be configured not to be displaced when the discharge portion 52 of the syringe 3 is inserted into the insertion portion 32. Various forms can be taken. Further, the inner diameter of the holding portion 9 is formed slightly smaller than the outer diameter of the discharge portion 52 of the syringe 3, and the syringe is placed in the holding portion 9 in a state where the holding portion 9 is provided on the inner peripheral surface of the insertion portion 32. The diameter of the three discharge portions 52 can be fitted against the elastic force of the holding portion 9.
Further, the thickness of the holding portion 9, that is, the difference between the outer diameter and the inner diameter of the holding portion 9 may be a thickness that can maintain the liquid tightness between the discharge portion 52 and the insertion portion 32 of the syringe 3.

 保持部9を構成する弾性材料としては、天然ゴム、シリコーンゴム、イソブチレンゴムのような各種ゴム材料や、ポリウレタン系、スチレン系等の各種熱可塑性エラストマー、或いはそれらの混合物等の弾性材料が挙げられる。 Examples of the elastic material constituting the holding unit 9 include various rubber materials such as natural rubber, silicone rubber, and isobutylene rubber, various thermoplastic elastomers such as polyurethane and styrene, or mixtures thereof. .

 ストッパ部4は、第2部材本体19の嵌入部32が形成された側の端面に形成されており、対向する2カ所に設けられている。ストッパ部4は、第2部材本体19の嵌入部32が形成された側の端面から、第2部材本体19の長軸方向に沿って、挿入部31とは反対側に延びる棒状の突出部4aと、その突出部4a先端からシリンジ3の排出部52が挿入される内側方向に突出した係止部4bとで構成されている。ストッパ部4は、シリンジ3の排出部52が挿入されたときに、シリンジ3に形成された後述するロック部7がその係止部4bに係止するように形成されている。 The stopper portion 4 is formed on the end surface of the second member main body 19 on the side where the fitting portion 32 is formed, and is provided at two opposing positions. The stopper portion 4 is a rod-like protruding portion 4a that extends from the end surface of the second member main body 19 on the side where the fitting portion 32 is formed along the long axis direction of the second member main body 19 to the side opposite to the insertion portion 31. And the latching | locking part 4b which protruded in the inner side in which the discharge part 52 of the syringe 3 is inserted from the front-end | tip of the protrusion part 4a is comprised. The stopper portion 4 is formed such that a lock portion 7 described later formed on the syringe 3 is locked to the locking portion 4b when the discharge portion 52 of the syringe 3 is inserted.

 挿入部31と嵌入部32との間には、接続部材61が係合する係合部37が設けられている。この係合部37は、第2部材本体19の内面から半径内方向に突出する段部として形成されており、第2部材本体19の軸方向に略直交する係合面37a,37bを有している。係合部37の係合面37aには、接続部材61の後述するフランジ部42が係合され、係合面37bには、接続部材61のストッパ突部43が係合される。 Between the insertion part 31 and the insertion part 32, the engaging part 37 with which the connection member 61 engages is provided. The engaging portion 37 is formed as a step portion protruding radially inward from the inner surface of the second member main body 19, and has engaging surfaces 37 a and 37 b that are substantially orthogonal to the axial direction of the second member main body 19. ing. A flange portion 42 described later of the connection member 61 is engaged with the engagement surface 37a of the engagement portion 37, and a stopper protrusion 43 of the connection member 61 is engaged with the engagement surface 37b.

 次に、接続部材61について説明する。
 接続部材61は、針ハブ6の第2部材本体19内に配置され、第1部材11と第2部材12とを針管を介して接続するものであり、第1部材11とシリンジ3との間に介在される。この接続部材61は、弾性部材で構成され、本体部41と、この本体部41の軸方向の一端に設けられたフランジ部42と、本体部41の他端に設けられたストッパ突部43を有している。
Next, the connection member 61 will be described.
The connection member 61 is disposed in the second member main body 19 of the needle hub 6 and connects the first member 11 and the second member 12 via a needle tube, and between the first member 11 and the syringe 3. Intervened in. The connection member 61 is made of an elastic member, and includes a main body 41, a flange 42 provided at one end of the main body 41 in the axial direction, and a stopper protrusion 43 provided at the other end of the main body 41. Have.

 本体部41は、略円柱状に形成されており、軸方向に垂直な端面41a,41bを有している。本体部41の端面41aには、第1部材11におけるベース部15の端面15bが当接し、端面41bには、シリンジ3に設けられた排出部52の先端が液密に当接する。つまり、端面41bは、排出部52の先端が液密に当接する当接面になっている。 The main body 41 is formed in a substantially cylindrical shape and has end faces 41a and 41b perpendicular to the axial direction. The end surface 41a of the base member 15 of the first member 11 is in contact with the end surface 41a of the main body 41, and the tip of the discharge unit 52 provided in the syringe 3 is in liquid-tight contact with the end surface 41b. That is, the end surface 41b is an abutting surface with which the tip of the discharge portion 52 abuts in a liquid-tight manner.

 本体部41には、ベース部15の端面15bから突出した針管5の基端5B側が挿通される挿通孔45が設けられている。この挿通孔45は、本体部41の軸方向に延びており、端面41a,41bに開口されている。本体部41の内面は、端面側離間部46と、当接面側離間部47と、密着部48から形成されている。 The main body portion 41 is provided with an insertion hole 45 through which the proximal end 5B side of the needle tube 5 protruding from the end surface 15b of the base portion 15 is inserted. The insertion hole 45 extends in the axial direction of the main body 41 and is opened in the end faces 41a and 41b. The inner surface of the main body 41 is formed by an end surface side separation portion 46, a contact surface side separation portion 47, and a close contact portion 48.

 端面側離間部46は、端面41aにおける挿通孔45の開口を形成する。この端面側離間部46は、針管5の外周面から離間しており、端面41aに向かうにつれて挿通孔45の径が連続的に大きくなるようなテーパー状に形成されている。これにより、ベース部15の端面15bから突出した針管5の基端5B側を挿通孔45に容易に挿通することができる。なお、挿通孔45における端面側離間部46の形状は、針管5が挿通孔45に挿通し易い形状であれば、テーパー状に限定されるものではない。 The end surface side separation portion 46 forms an opening of the insertion hole 45 in the end surface 41a. The end surface side separation portion 46 is separated from the outer peripheral surface of the needle tube 5 and is formed in a taper shape such that the diameter of the insertion hole 45 continuously increases toward the end surface 41a. Thereby, the base end 5B side of the needle tube 5 protruding from the end surface 15b of the base portion 15 can be easily inserted into the insertion hole 45. Note that the shape of the end face side separation portion 46 in the insertion hole 45 is not limited to a tapered shape as long as the needle tube 5 can be easily inserted into the insertion hole 45.

 当接面側離間部47は、端面(当接面)41bにおける挿通孔45の開口を形成する。この当接面側離間部47は、針管5の外周面から離間しており、端面41bに向かうにつれて挿通孔45の径が連続的に大きくなるようなテーパー状に形成されている。接続部材61に当接面側離間部47を設けることにより、本体部41の端面41b側が弾性変形して針管5の基端5Bを覆うことを防止することができる。 The contact surface side separation portion 47 forms an opening of the insertion hole 45 in the end surface (contact surface) 41b. The contact surface side separation portion 47 is separated from the outer peripheral surface of the needle tube 5, and is formed in a taper shape such that the diameter of the insertion hole 45 continuously increases toward the end surface 41b. By providing the contact surface side separation portion 47 in the connection member 61, it is possible to prevent the end surface 41 b side of the main body portion 41 from being elastically deformed and covering the proximal end 5 </ b> B of the needle tube 5.

 当接面側離間部47には、針側弁体部63が設けられている。この針側弁体部63は、針管5の外周を覆う筒状の突部として形成されている。この針側弁体部63の外周面は、先端に向かうにつれて径が連続的に小さくなるようなテーパー状に形成されている。当接面側離間部47に薬液が流れると、その薬液によって針側弁体部63が押圧され、針管5に密着するように変形して耐圧性能を向上させることができる。 A needle side valve body 63 is provided in the contact surface side separation portion 47. The needle-side valve body 63 is formed as a cylindrical protrusion that covers the outer periphery of the needle tube 5. The outer peripheral surface of the needle-side valve body 63 is formed in a taper shape such that the diameter continuously decreases toward the tip. When the chemical solution flows into the contact surface side separation portion 47, the needle side valve body portion 63 is pressed by the chemical solution and deformed so as to be in close contact with the needle tube 5, thereby improving the pressure resistance performance.

 密着部48は、端面側離間部46と当接面側離間部47との間に形成されている。この密着部48は、針管5の外周面に液密に密着する。これにより、シリンジ3内の薬剤が針管5と接続部材61との間に浸入して、針ハブ6の第1部材11側へ漏れることを防止することができる。 The contact portion 48 is formed between the end surface side separation portion 46 and the contact surface side separation portion 47. The close contact portion 48 is in liquid tight contact with the outer peripheral surface of the needle tube 5. Thereby, it is possible to prevent the medicine in the syringe 3 from entering between the needle tube 5 and the connecting member 61 and leaking to the first member 11 side of the needle hub 6.

 フランジ部42は、本体部41の外周面から半径外方向に突出するリング状に形成されている。このフランジ部42の外径は、第1部材11のベース部15の外径と略等しくなっている。フランジ部42の一方の平面42aは、本体部41の端面41aと同一の平面になっている。この平面42aには、リング突部44が設けられている。リング突部44は、第1部材11のベース部15の端面15bに当接して潰れる。フランジ部42の他方の平面42bは、第2部材本体19に設けた係合部37の係合面37aに当接する。接続部材61は、第2部材本体19の係合部37と第1部材11のベース部15によってフランジ部42が挟持されることにより、針ハブ6に取り付けられている。 The flange portion 42 is formed in a ring shape that protrudes radially outward from the outer peripheral surface of the main body portion 41. The outer diameter of the flange portion 42 is substantially equal to the outer diameter of the base portion 15 of the first member 11. One flat surface 42 a of the flange portion 42 is the same flat surface as the end surface 41 a of the main body portion 41. A ring protrusion 44 is provided on the flat surface 42a. The ring protrusion 44 abuts against the end surface 15 b of the base portion 15 of the first member 11 and is crushed. The other flat surface 42 b of the flange portion 42 abuts on the engaging surface 37 a of the engaging portion 37 provided on the second member main body 19. The connecting member 61 is attached to the needle hub 6 by sandwiching the flange portion 42 between the engaging portion 37 of the second member main body 19 and the base portion 15 of the first member 11.

 ストッパ突部43は、フランジ部42と同様に、本体部41の外周面から半径外方向に突出するリング状に形成されている。このストッパ突部43は、第2部材本体19に設けた係合部37の係合面37bに係合する。接続部材61は、フランジ部42及びストッパ突部43が第2部材本体19の係合部37に係合することにより、軸方向への移動が係止されている。これにより、薬液が接続部材61と第2部材本体19との間に浸入して第1部材11側へ漏れることを防止することができ、耐圧性能を向上させることができる。
 接続部材61の材質としては、保持部9と同様の弾性材料を用いることができる。
The stopper protrusion 43 is formed in a ring shape that protrudes radially outward from the outer peripheral surface of the main body 41, as with the flange portion 42. The stopper projection 43 engages with an engagement surface 37 b of the engagement portion 37 provided on the second member main body 19. The connecting member 61 is locked from moving in the axial direction when the flange portion 42 and the stopper projection 43 are engaged with the engaging portion 37 of the second member main body 19. Thereby, it can prevent that a chemical | medical solution permeates between the connection member 61 and the 2nd member main body 19, and leaks to the 1st member 11 side, and can improve a pressure | voltage resistant performance.
As a material of the connection member 61, an elastic material similar to that of the holding portion 9 can be used.

[シリンジ]
 シリンジ3は、シリンジ本体51と、このシリンジ本体51に連続する排出部52と、シリンジ本体51の外周面の対向する2カ所に設けられたロック部7とを備えている。シリンジ本体51は、円形の筒体からなっている。排出部52は、シリンジ本体51の軸方向の一端から突出しており、シリンジ本体51よりも小さい外径の円形の筒体からなっている。排出部52は本実施形態では、軸方向に外径が一定のものであるが、先端に向って細くなるテーパ状のものであっても良い。排出部52の先端となる端面52aは、軸方向に直交する平面であり、嵌入部内に嵌入したとき、接続部材61の端面(当接面)41bに液密に当接する。
[Syringe]
The syringe 3 includes a syringe body 51, a discharge portion 52 that is continuous with the syringe body 51, and lock portions 7 that are provided at two opposing positions on the outer peripheral surface of the syringe body 51. The syringe body 51 is a circular cylinder. The discharge part 52 protrudes from one end of the syringe body 51 in the axial direction, and is formed of a circular cylinder having an outer diameter smaller than that of the syringe body 51. In the present embodiment, the discharge portion 52 has a constant outer diameter in the axial direction, but may have a tapered shape that narrows toward the tip. The end surface 52a that is the tip of the discharge portion 52 is a plane orthogonal to the axial direction, and comes into liquid-tight contact with the end surface (contact surface) 41b of the connection member 61 when it is inserted into the insertion portion.

 ロック部7は、シリンジ本体51の外周面に設けられた突起状の部材で構成されており、シリンジ3の排出部52が嵌入部32に嵌入したときに、第2部材本体19に形成されたストッパ部4の係止部4bに係止される位置に形成されている。ロック部7は、シリンジ本体51の外周面から略三角形状に突出して形成されており、排出部52に面する側の面がテーパ状をなし、係止部4bに係止される側の面が、外周面にほぼ垂直面となっている。ロック部7がこのような三角形状に形成されることにより、シリンジ3の排出部52を嵌入部32に嵌入する際には円滑に挿入でき、また、一度ロック部7が係止部4bに係止された場合には、外れにくくなる。 The lock portion 7 is composed of a protruding member provided on the outer peripheral surface of the syringe main body 51, and is formed in the second member main body 19 when the discharge portion 52 of the syringe 3 is inserted into the insertion portion 32. The stopper portion 4 is formed at a position to be locked to the locking portion 4b. The lock portion 7 is formed so as to protrude from the outer peripheral surface of the syringe body 51 in a substantially triangular shape, and the surface on the side facing the discharge portion 52 is tapered, and the surface on the side locked by the locking portion 4b. However, the surface is substantially perpendicular to the outer peripheral surface. By forming the lock portion 7 in such a triangular shape, the discharge portion 52 of the syringe 3 can be smoothly inserted into the insertion portion 32, and once the lock portion 7 is engaged with the locking portion 4b. When stopped, it becomes difficult to come off.

 シリンジ本体51内には、ガスケット(不図示)が収納されている。シリンジ本体51内の空間は、ガスケットにより液密に仕切られており、排出部52に連通する一方の空間は、排出部52内の空間と共に液室56を形成している。シリンジ本体51内の他方の空間には、プランジャ(不図示)が配置される。プランジャは、ガスケットに接続されており、シリンジ本体51の他端の開口から突出している。このプランジャを操作することにより、ガスケットがシリンジ本体51内で軸方向に移動され、液室56への薬剤の吸引と、液室56に充填された薬剤の排出が行われる。 In the syringe body 51, a gasket (not shown) is accommodated. The space in the syringe main body 51 is liquid-tightly partitioned by a gasket, and one space communicating with the discharge portion 52 forms a liquid chamber 56 together with the space in the discharge portion 52. A plunger (not shown) is arranged in the other space in the syringe body 51. The plunger is connected to the gasket and protrudes from the opening at the other end of the syringe body 51. By operating this plunger, the gasket is moved in the axial direction within the syringe main body 51, and the medicine is sucked into the liquid chamber 56 and the medicine filled in the liquid chamber 56 is discharged.

 シリンジ本体51及び排出部52の材質としては、ポリカーボネート、ポリプロピレン、ポリエチレン等の合成樹脂を用いることができ、また、ガラス等を用いてもよい。 As the material of the syringe body 51 and the discharge part 52, synthetic resin such as polycarbonate, polypropylene, polyethylene, etc. can be used, and glass or the like may be used.

[薬剤注射装置の組立方法]
 次に、薬剤注射装置1の組立方法について説明する。本実施形態例では、薬剤注射装置1を組み立てる前に、シリンジ3の内部には薬剤Mが封入された状態とされる(図2、図3)。薬剤Mは、シリンジ3を注射針組立体2に装着する前に、シリンジ3の排出部52に薬剤吸引用の針を取り付け、バイアルから薬剤を吸引することでシリンジ3内に充填し、薬剤Mの充填が終了したら、薬剤吸引用の針を取り外す。
[Assembly method of drug injection device]
Next, a method for assembling the medicine injection device 1 will be described. In this embodiment, before assembling the medicine injection device 1, the medicine M is enclosed in the syringe 3 (FIGS. 2 and 3). The medicine M is filled in the syringe 3 by attaching a medicine suction needle to the discharge portion 52 of the syringe 3 and attaching the medicine to the syringe 3 before attaching the syringe 3 to the injection needle assembly 2. When filling is completed, the drug suction needle is removed.

 シリンジ3内に充填される薬剤Mとしては、例えばインフルエンザ等の各種の感染症を予防する各種のワクチンが挙げられるが、ワクチンに限定されるものではない。なお、ワクチン以外では、例えば、ブドウ糖等の糖質注射液、塩化ナトリウムや乳酸カリウム等の電解質補正用注射液、ビタミン剤、抗生物質注射液、造影剤、ステロイド剤、蛋白質分解酵素阻害剤、脂肪乳剤、抗癌剤、麻酔薬、覚せい剤、麻薬、ヘパリンカルシウム、抗体医薬等が挙げられる。 Examples of the medicine M filled in the syringe 3 include various vaccines for preventing various infectious diseases such as influenza, but are not limited to vaccines. In addition to vaccines, for example, glucose 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, proteolytic enzyme inhibitors, fat Emulsions, anticancer agents, anesthetics, stimulants, narcotics, heparin calcium, antibody drugs and the like can be mentioned.

 次に、薬剤Mが充填されたシリンジ3に注射針組立体2を装着するには、まず、図2に示すようにキャップ8内に収容された状態で、注射針組立体2の嵌入部32にシリンジ3の排出部52を挿入する。このとき、嵌入部32の内周面には弾性部材からなる保持部9が設けられており、保持部9の内径は排出部52の外径よりもやや小さく形成されている。したがって、排出部52は保持部9の弾性力に抗して保持部9内(嵌入部32内)に嵌入する。そして、排出部52を接続部材61の端面41bに垂直に当接するまで嵌入することにより、シリンジ3に対する注射針組立体2の装着が完了する。 Next, in order to attach the injection needle assembly 2 to the syringe 3 filled with the medicine M, first, the insertion portion 32 of the injection needle assembly 2 is accommodated in the cap 8 as shown in FIG. The discharge part 52 of the syringe 3 is inserted into. At this time, the holding portion 9 made of an elastic member is provided on the inner peripheral surface of the fitting portion 32, and the inner diameter of the holding portion 9 is formed to be slightly smaller than the outer diameter of the discharge portion 52. Therefore, the discharge portion 52 is fitted into the holding portion 9 (inside the fitting portion 32) against the elastic force of the holding portion 9. Then, the insertion of the injection needle assembly 2 to the syringe 3 is completed by inserting the discharge portion 52 until it comes into contact with the end surface 41b of the connection member 61 vertically.

 シリンジ3に対する注射針組立体2の装着が完了したとき、第2部材本体19に形成されたストッパ部4の係止部4bにシリンジ本体51の外周面に形成されたロック部7が係止する。これにより、シリンジ3の注射針組立体2に対する位置が固定され、シリンジ3が抜けることがない。 When the mounting of the injection needle assembly 2 to the syringe 3 is completed, the lock portion 7 formed on the outer peripheral surface of the syringe main body 51 is locked to the locking portion 4b of the stopper portion 4 formed on the second member main body 19. . Thereby, the position with respect to the injection needle assembly 2 of the syringe 3 is fixed, and the syringe 3 does not come out.

 そして、薬剤注射装置1の組み立てが完了した状態において、排出部52の先端である端面52aは、注射針組立体2に設けた接続部材61の端面(当接面)41bに垂直に当接する。そして、その端面41bを押圧することにより、排出部52の端面52aと接続部材61の端面41bが液密に密着し、針管5の針孔とシリンジ3の液室56が連通する。その結果、排出部52の先端と針管5の基端5Bとの間に空間が形成されないようにすることができ、薬剤の残存量を少なくすることができる。しかも、シリンジ3の液室56に充填された薬剤が注射針組立体2の針ハブ6内に漏出しないようにすることができ、所定の量の薬剤を針管5の針先5Aから排出することができる。 And in the state where the assembly of the medicine injection device 1 is completed, the end surface 52a which is the tip of the discharge portion 52 abuts perpendicularly to the end surface (contact surface) 41b of the connection member 61 provided in the injection needle assembly 2. Then, by pressing the end surface 41b, the end surface 52a of the discharge portion 52 and the end surface 41b of the connecting member 61 are in liquid-tight contact, and the needle hole of the needle tube 5 and the liquid chamber 56 of the syringe 3 communicate with each other. As a result, a space can be prevented from being formed between the distal end of the discharge portion 52 and the proximal end 5B of the needle tube 5, and the remaining amount of the medicine can be reduced. In addition, the medicine filled in the liquid chamber 56 of the syringe 3 can be prevented from leaking into the needle hub 6 of the injection needle assembly 2, and a predetermined amount of medicine is discharged from the needle tip 5 </ b> A of the needle tube 5. Can do.

 また、排出部52の端面52aを接続部材61の端面41bに垂直に当接させて両者を液密に密着させるため、注射針組立体2の針ハブ6対する針管5の位置を精密に調整する必要がない。したがって、針ハブ6と針管5の組立作業を単純化することができ、生産効率を向上させることができる。 Further, the position of the needle tube 5 with respect to the needle hub 6 of the injection needle assembly 2 is precisely adjusted in order to bring the end surface 52a of the discharge portion 52 into contact with the end surface 41b of the connecting member 61 in a perpendicular manner so There is no need. Therefore, the assembly work of the needle hub 6 and the needle tube 5 can be simplified, and the production efficiency can be improved.

 また、本実施の形態の注射針組立体2及び薬剤注射装置1では、接続部材61に当接面側離間部47を設けた。そのため、排出部52の端面52aに押圧された接続部材61の端面41bが排出部52内に入り込むように弾性変形する可能性が無く、接続部材61が針管5における基端5B側の針孔を塞ぐことを防止することができる。 Further, in the injection needle assembly 2 and the drug injection device 1 of the present embodiment, the contact member side separation portion 47 is provided on the connection member 61. Therefore, there is no possibility that the end surface 41b of the connection member 61 pressed against the end surface 52a of the discharge portion 52 is elastically deformed so as to enter the discharge portion 52, and the connection member 61 forms a needle hole on the proximal end 5B side in the needle tube 5. Blocking can be prevented.

 そして、本実施形態例の注射針組立体2及び薬剤注射装置1では、シリンジ3を注射針組立体2に装着する際には、使用者がシリンジ3を注射針組立体2の嵌入部32に嵌入するように押し込むだけでよい。これにより、ネジ締めなどの作業が必要ないため、使用者は、容易に薬剤注射装置1を準備することができる。また、シリンジ3の排出部52は、弾性部材からなる保持部9で密着保持されており、シリンジ3の排出部52は嵌入部32の内周面に液密に保持されている。これにより、シリンジ本体51側に薬剤が漏れることもない。さらに、ロック部7がストッパ部4の係止部4bに係止されることにより、シリンジ3と針ハブ6とが固定されている。これにより、シリンジ3が注射針組立体2から外れてしまうのを防止することができる。 In the injection needle assembly 2 and the drug injection device 1 according to this embodiment, when the syringe 3 is attached to the injection needle assembly 2, the user inserts the syringe 3 into the insertion portion 32 of the injection needle assembly 2. You only have to push it in so that it fits. Thereby, since operations such as screw tightening are not required, the user can easily prepare the medicine injection device 1. Further, the discharge part 52 of the syringe 3 is tightly held by the holding part 9 made of an elastic member, and the discharge part 52 of the syringe 3 is liquid-tightly held on the inner peripheral surface of the fitting part 32. Thereby, a chemical | medical agent does not leak to the syringe main body 51 side. Furthermore, the syringe 3 and the needle hub 6 are fixed by the locking portion 7 being locked to the locking portion 4 b of the stopper portion 4. Thereby, it can prevent that the syringe 3 remove | deviates from the injection needle assembly 2. FIG.

[薬剤注射装置の使用方法]
 次に、薬剤注射装置1の使用方法について説明する。針管5の針先5Aを生体に穿刺するには、まず、安定部17の端面17aを皮膚に対向させる。これにより、針管5の針先5Aが、穿刺する皮膚に対向される。次に、薬剤注射装置1を皮膚に対して略垂直に移動させ、針先5Aを皮膚に穿刺すると共に安定部17の端面17aを皮膚に押し付ける。このとき、針突出面16aが皮膚に接触して皮膚を平らに変形させることができ、針管5の針先5A側を突出長Lだけ皮膚に穿刺することができる。
[How to use drug injection device]
Next, a method for using the drug injection device 1 will be described. In order to puncture the living body with the needle tip 5A of the needle tube 5, first, the end surface 17a of the stabilizing portion 17 is opposed to the skin. Thereby, the needle tip 5A of the needle tube 5 is opposed to the skin to be punctured. Next, the drug injection device 1 is moved substantially perpendicularly to the skin, and the needle tip 5A is punctured into the skin and the end surface 17a of the stabilizing portion 17 is pressed against the skin. At this time, the needle protruding surface 16a can come into contact with the skin to deform the skin flatly, and the needle tip 5A side of the needle tube 5 can be punctured into the skin by the protruding length L.

 次に、ガイド部18の接触面18aが皮膚に接触するまで安定部17の端面17aを押し付ける。ここで、ガイド部高さy(図3参照)は、針管5及び安定部17が適正な押圧力で皮膚に穿刺することができるようにその長さが設定されている。そのため、安定部17によって皮膚を押圧する力が所定の値になる。 Next, the end surface 17a of the stabilizing portion 17 is pressed until the contact surface 18a of the guide portion 18 contacts the skin. Here, the length of the guide portion height y (see FIG. 3) is set so that the needle tube 5 and the stabilizing portion 17 can puncture the skin with an appropriate pressing force. Therefore, the force that presses the skin by the stabilizing portion 17 becomes a predetermined value.

 その結果、安定部17の適正な押圧力を使用者に認識させることができ、針管5の針先5A及び刃面5aを確実に皮膚上層部に位置させることができる。このように、ガイド部18が安定部17の適正な押圧力を認識させる目印となることで、使用者が安心して薬剤注射装置1を使用することができる。 As a result, the user can recognize an appropriate pressing force of the stabilizing portion 17, and the needle tip 5A and the blade surface 5a of the needle tube 5 can be surely positioned on the upper skin portion. Thus, the guide part 18 becomes a mark for recognizing an appropriate pressing force of the stable part 17, so that the user can use the medicine injection device 1 with peace of mind.

 また、安定部17が皮膚に当接することで、薬剤注射装置1の姿勢が安定し、針管5を皮膚に対して真っ直ぐに穿刺することができる。また、穿刺後に針管5に生じるブレを防止することができ、薬剤の安定した投与を行うことができる。また、例えば0.5mm程度のごく短い突出長の針管では、針先を皮膚に当接させても皮膚に刺さらない場合がある。しかし、安定部17に押し付けられた皮膚が垂直方向に押し下げられることにより、安定部17の内側の皮膚が引っ張られて皮膚に張力が加わった状態となる。そのため、針管5の針先5Aに対して皮膚が逃げ難くなる。したがって、安定部17を設けることにより、皮膚に針先5Aをより刺さり易くするという効果を得ることもできる。 Also, since the stabilizing portion 17 contacts the skin, the posture of the medicine injection device 1 is stabilized, and the needle tube 5 can be punctured straight to the skin. Moreover, the blurring which arises in the needle tube 5 after puncture can be prevented, and the administration of the medicine can be performed stably. For example, with a very short protruding tube of about 0.5 mm, the skin may not stick into the skin even if the needle tip is brought into contact with the skin. However, when the skin pressed against the stable portion 17 is pushed down in the vertical direction, the skin inside the stable portion 17 is pulled and tension is applied to the skin. Therefore, it is difficult for the skin to escape from the needle tip 5 </ b> A of the needle tube 5. Therefore, by providing the stabilizing portion 17, it is possible to obtain an effect that the needle tip 5A is more easily pierced into the skin.

 針管5の針先5A側を皮膚に穿刺した後、プランジャ(不図示)を押してガスケット(不図示)を排出部52側に移動させる。これにより、シリンジ3の液室56に充填された薬剤は、排出部52から押し出され、針管5の針孔を通って針先5Aから皮膚上層部に注入される。 After puncturing the skin with the needle tip 5A side of the needle tube 5, the plunger (not shown) is pushed to move the gasket (not shown) to the discharge part 52 side. As a result, the medicine filled in the liquid chamber 56 of the syringe 3 is pushed out from the discharge part 52, passes through the needle hole of the needle tube 5, and is injected into the upper skin part from the needle tip 5 </ b> A.

 そして、本実施形態例の薬剤注射装置1では、保持部9の弾性力によりシリンジ3の排出部52が針ハブ6に固定されると共に、ロック機構により両者が外れない構成とされている。このため、皮下投与に比べて高い注入圧力がかかる皮膚上層部への薬剤投与において、シリンジ3が注射針組立体2から外れてしまうことを防ぐことができる。 And in the medicine injection device 1 of this embodiment, the discharge part 52 of the syringe 3 is fixed to the needle hub 6 by the elastic force of the holding part 9, and both are not detached by the lock mechanism. For this reason, it is possible to prevent the syringe 3 from being detached from the injection needle assembly 2 in the drug administration to the upper skin portion where an injection pressure higher than the subcutaneous administration is applied.

 このように、本実施形態例では、シリンジ3を注射針組立体2に容易に装着することができるので、使用者の負担を低減させることができる。また、注射針組立体2の嵌入部32に、シリンジ3の排出部52を液密に固定して保持することができるので、シリンジ3側への液漏れや、薬剤の注入圧力によってシリンジ3と注射針組立体2が外れるのを低減することができ、使用時の安全性を向上させることができる。特に、本実施形態のようにシリンジ3の排出部52の外径と嵌入部32の筒孔32aの内径とが軸方向に一定である場合の液漏れや外れ防止に有効である。 Thus, in the present embodiment, the syringe 3 can be easily attached to the injection needle assembly 2, so that the burden on the user can be reduced. Moreover, since the discharge part 52 of the syringe 3 can be liquid-tightly fixed and held in the insertion part 32 of the injection needle assembly 2, the syringe 3 and the syringe 3 can be separated by liquid leakage to the syringe 3 side or drug injection pressure. The removal of the injection needle assembly 2 can be reduced, and the safety during use can be improved. In particular, this embodiment is effective for preventing liquid leakage and detachment when the outer diameter of the discharge portion 52 of the syringe 3 and the inner diameter of the cylindrical hole 32a of the fitting portion 32 are constant in the axial direction as in this embodiment.

 また、排出部52の先端と針管5の基端5Bとの間に空間が形成されていないため、薬剤の残存量を少なくすることができる。さらに、シリンジ3の排出部52から排出された薬液が当接面側離間部47に漏れた場合であっても、その漏れた薬液が針側弁体部63を押圧することにより、針側弁体部63が針管5の外周面に押し付けられる。これにより、針管5と接続部材61との間の耐圧性能を向上させることができる。その結果、薬液が針ハブ6の第1部材11側へ漏れにくくなり、皮膚上層部へ投与する薬剤の量を安定させることができる。 Further, since no space is formed between the distal end of the discharge part 52 and the proximal end 5B of the needle tube 5, the remaining amount of the medicine can be reduced. Further, even when the chemical liquid discharged from the discharge part 52 of the syringe 3 leaks to the contact surface side separation part 47, the leaked chemical liquid presses the needle side valve body part 63, whereby the needle side valve The body part 63 is pressed against the outer peripheral surface of the needle tube 5. Thereby, the pressure resistance performance between the needle tube 5 and the connection member 61 can be improved. As a result, the drug solution is less likely to leak to the first member 11 side of the needle hub 6, and the amount of the drug to be administered to the upper skin portion can be stabilized.

2. 第2の実施形態
[薬剤注射装置]
 次に、本発明の第2の実施形態に係る注射針組立体について、図5を参照して説明する。図5は、本発明の第2の実施形態に係る薬剤注射装置81の断面図である。本実施形態例は、保持部の構成と、ロック機構とが第1の実施形態と異なる例である。図5において、図2に対応する部分には同一符号を付し重複説明を省略する。
2. Second Embodiment [Drug Injection Device]
Next, an injection needle assembly according to a second embodiment of the present invention will be described with reference to FIG. FIG. 5 is a cross-sectional view of a drug injection device 81 according to the second embodiment of the present invention. The present embodiment is an example in which the configuration of the holding unit and the lock mechanism are different from those of the first embodiment. In FIG. 5, parts corresponding to those in FIG.

 この薬剤注射装置81は、注射針組立体86と、この注射針組立体86が着脱可能に接続されるシリンジ83から構成されている。 The drug injection device 81 includes an injection needle assembly 86 and a syringe 83 to which the injection needle assembly 86 is detachably connected.

[注射針組立体]
 本実施形態例の注射針組立体86では、第2部材87は、略筒状に形成された第2部材本体89と、第2部材本体89内周面に形成されたストッパ部71と、第2部材本体89の内周面に形成された保持部73とで構成されている。第2部材本体89の軸方向の一端部は、第1部材11のベース部15を挿入する挿入部31となっており、他端部は、シリンジ83の排出部52を嵌入する嵌入部82になっている。挿入部31の構成は、第1の実施形態と同様である。
[Injection needle assembly]
In the injection needle assembly 86 of the present embodiment example, the second member 87 includes a second member main body 89 formed in a substantially cylindrical shape, a stopper portion 71 formed on the inner peripheral surface of the second member main body 89, and a second member 87. The holding member 73 is formed on the inner peripheral surface of the two-member main body 89. One end portion in the axial direction of the second member main body 89 is an insertion portion 31 into which the base portion 15 of the first member 11 is inserted, and the other end portion is in the insertion portion 82 into which the discharge portion 52 of the syringe 83 is inserted. It has become. The structure of the insertion part 31 is the same as that of 1st Embodiment.

 嵌入部82の筒孔82aは、シリンジ83の排出部52よりも大きく設定されており、嵌入部82の内周面の中腹に溝部が形成されている。この溝部は、後述するロック機構を構成するストッパ部71となるものであり、嵌入部32の内周面の対向する2カ所に設けられている。ストッパ部71は、嵌入部32の内周面に例えば四角形状に形成した所定の深さの溝部で構成されており、後述するシリンジ83のロック部72が係止可能な溝部とされている。 The cylindrical hole 82 a of the insertion portion 82 is set to be larger than the discharge portion 52 of the syringe 83, and a groove is formed in the middle of the inner peripheral surface of the insertion portion 82. The groove portion serves as a stopper portion 71 that constitutes a lock mechanism described later, and is provided at two opposing locations on the inner peripheral surface of the fitting portion 32. The stopper portion 71 is configured by a groove portion having a predetermined depth formed in, for example, a quadrangular shape on the inner peripheral surface of the insertion portion 32, and is a groove portion that can be locked with a lock portion 72 of a syringe 83 described later.

 保持部73は、Oリング状の部材で構成されており、嵌入部82の端面側の内周面に密着した状態で固定されている。保持部73は、嵌入部82の内周面に対して接着材により接着される構成でも、嵌め込まれる構成でもよく、嵌入部82にシリンジ83の排出部52を嵌入したときにずれない構成であれば種々の構成を採ることができる。また、保持部73の内径はシリンジ83の排出部52の外径よりもやや小さく形成されており、保持部73の弾性力に抗してシリンジ83の排出部52を嵌入部82内に嵌入することができる径とされている。 
 また、保持部73の肉厚、すなわち保持部73の外径と内径との差は、シリンジ83の排出部52と嵌入部82との液密性を保持できる厚みであればよい。
The holding portion 73 is formed of an O-ring-like member, and is fixed in a state of being in close contact with the inner peripheral surface on the end surface side of the fitting portion 82. The holding portion 73 may be configured to be adhered to the inner peripheral surface of the insertion portion 82 with an adhesive, or may be inserted into the holding portion 73, and may be configured so as not to be displaced when the discharge portion 52 of the syringe 83 is inserted into the insertion portion 82. Various configurations can be adopted. Further, the inner diameter of the holding portion 73 is formed slightly smaller than the outer diameter of the discharge portion 52 of the syringe 83, and the discharge portion 52 of the syringe 83 is inserted into the insertion portion 82 against the elastic force of the holding portion 73. The diameter can be.
Further, the thickness of the holding portion 73, that is, the difference between the outer diameter and the inner diameter of the holding portion 73 suffices as long as the liquid tightness between the discharge portion 52 and the insertion portion 82 of the syringe 83 can be maintained.

[シリンジ]
 本実施形態例では、シリンジ83の排出部52の外周面に、嵌入部82の内周面に形成されたストッパ部71に係止するロック部72が形成されている。ロック部72はシリンジ83の排出部52が嵌入部82に嵌入したときに、嵌入部82の内周面に形成されたストッパ部71に係止される位置に形成されている。ロック部72は、シリンジ本体51の外周面から略三角形状に突出して形成されており、排出部52に面する側の面がテーパ状をなし、ストッパ部71に係止される側の面が、外周面に垂直な方向とされている。ロック部72がこのような三角形状に形成されることにより、シリンジ83の排出部52を嵌入部32に嵌入する際には円滑に挿入でき、また、一度ロック部72がストッパ部71に
係止された場合には、外れにくくなる。
[Syringe]
In the present embodiment, a lock portion 72 that is engaged with a stopper portion 71 formed on the inner peripheral surface of the fitting portion 82 is formed on the outer peripheral surface of the discharge portion 52 of the syringe 83. The lock portion 72 is formed at a position that is locked to a stopper portion 71 formed on the inner peripheral surface of the insertion portion 82 when the discharge portion 52 of the syringe 83 is inserted into the insertion portion 82. The lock portion 72 is formed so as to protrude in a substantially triangular shape from the outer peripheral surface of the syringe main body 51, the surface facing the discharge portion 52 is tapered, and the surface engaged with the stopper portion 71 is The direction is perpendicular to the outer peripheral surface. Since the lock portion 72 is formed in such a triangular shape, the discharge portion 52 of the syringe 83 can be smoothly inserted into the insertion portion 32, and the lock portion 72 is once locked to the stopper portion 71. When it is done, it becomes difficult to come off.

[薬剤注射装置の組立方法]
 本実施形態例の薬剤注射装置81においても、第1の実施形態と同様、薬剤が充填された状態のシリンジ83の排出部52を注射針組立体86の、保持部73が形成された嵌入部82に押し込む。そして、排出部52を接続部材61の端面41bに垂直に当接するまで嵌入することにより、シリンジ83に対する注射針組立体86の装着が完了する。このとき、シリンジ83の排出部52は、保持部73の弾性力に抗して嵌入部82に嵌入される。そして、シリンジ83は、その排出部52が保持部73に密着保持された状態で注射針組立体86に装着される。これにより、シリンジ83の排出部52の先端側の液密性が保持され、シリンジ83の排出部52が注射針組立体86に固定される。
[Assembly method of drug injection device]
Also in the medicine injection device 81 of the present embodiment example, as in the first embodiment, the discharge portion 52 of the syringe 83 in a state filled with the medicine is inserted into the insertion portion in which the holding portion 73 of the injection needle assembly 86 is formed. Push into 82. Then, the insertion of the injection needle assembly 86 to the syringe 83 is completed by inserting the discharge portion 52 until it vertically contacts the end surface 41 b of the connection member 61. At this time, the discharge part 52 of the syringe 83 is inserted into the insertion part 82 against the elastic force of the holding part 73. The syringe 83 is attached to the injection needle assembly 86 in a state where the discharge part 52 is closely held by the holding part 73. Thereby, the liquid tightness of the distal end side of the discharge part 52 of the syringe 83 is maintained, and the discharge part 52 of the syringe 83 is fixed to the injection needle assembly 86.

 また、シリンジ83に対する注射針組立体86の装着が完了したとき、第2部材本体89に形成されたストッパ部71にシリンジ83の排出部52の外周面に形成されたロック部72が係止する。これにより、シリンジ83の注射針組立体86に対する位置が固定され、シリンジ83が抜けることがない。
 その他、第1の実施形態と同様の効果を得ることができる。そして、本実施形態例の薬剤注射装置81も、第1の実施形態と同様にして使用することができる。
Further, when the mounting of the injection needle assembly 86 on the syringe 83 is completed, the lock portion 72 formed on the outer peripheral surface of the discharge portion 52 of the syringe 83 is engaged with the stopper portion 71 formed on the second member main body 89. . Thereby, the position of the syringe 83 with respect to the injection needle assembly 86 is fixed, and the syringe 83 does not come out.
In addition, the same effects as those of the first embodiment can be obtained. And the medicine injection device 81 of this embodiment can also be used similarly to the first embodiment.

3. 第3の実施形態
[薬剤注射装置]
 次に、本発明の第3の実施形態に係る注射針組立体について、図6~図8を参照して説明する。図6は、本実施形態例に係る薬剤注射装置91の分解図であり、図7は、断面図である。また、図8は、本実施形態例に係る薬剤注射装置91を分解して示す断面図である。本実施形態例は、保持部と、針管の構成が第1の実施形態と異なる例である。図6~図8において、図1~図4に対応する部分には同一符号を付し重複説明を省略する。
3. Third Embodiment [Drug Injection Device]
Next, an injection needle assembly according to a third embodiment of the present invention will be described with reference to FIGS. FIG. 6 is an exploded view of the medicine injection device 91 according to this embodiment, and FIG. 7 is a cross-sectional view. FIG. 8 is an exploded cross-sectional view of the medicine injection device 91 according to this embodiment. This embodiment is an example in which the configuration of the holding portion and the needle tube is different from that of the first embodiment. 6 to 8, parts corresponding to those in FIGS. 1 to 4 are denoted by the same reference numerals, and redundant description is omitted.

 この薬剤注射装置91は、注射針組立体97と、この注射針組立体97が着脱可能に接続されるシリンジ93から構成されている。 The drug injection device 91 includes an injection needle assembly 97 and a syringe 93 to which the injection needle assembly 97 is detachably connected.

[注射針組立体]
 本実施形態例の注射針組立体97は、第1の実施形態とは第2部材及び針管の構成が第1の実施形態と異なる。その他の構成は、第1の実施形態に係る注射針組立体2と同様である。
[Injection needle assembly]
The injection needle assembly 97 of the present embodiment is different from the first embodiment in the configuration of the second member and the needle tube. Other configurations are the same as those of the injection needle assembly 2 according to the first embodiment.

 本実施形態例の注射針組立体97は、針管95と、針管95を保持する針ハブ96とを備える。
 針管95の一端には、生体に穿刺される第1の針先95Aが設けられ、他端には後述するシリンジ93の蓋部98を穿刺する第2の針先95Bが設けられている。すなわち、この針管95は、両頭針である。第1の針先95Aは、刃面95aを有している。この刃面95aのベベル長は、第1の実施形態例の針先5Aの刃面5aの構成と同様である。
The injection needle assembly 97 according to this embodiment includes a needle tube 95 and a needle hub 96 that holds the needle tube 95.
One end of the needle tube 95 is provided with a first needle tip 95A for puncturing a living body, and the other end is provided with a second needle tip 95B for puncturing a lid portion 98 of a syringe 93 described later. That is, the needle tube 95 is a double-ended needle. The first needle tip 95A has a blade surface 95a. The bevel length of the blade surface 95a is the same as the configuration of the blade surface 5a of the needle tip 5A of the first embodiment.

 第2の針先95Bは、刃面95bを有している。この刃面95bの針管95が延びる方向の長さは、任意に設定することができるが、第1の針先95Aの刃面95aと同じ長さに設定することができる。そして、この針管95は、針ハブ96によってその中間部を保持され、第2の針先95Bは、接続部材61の端面41bから突出している。 The second needle tip 95B has a blade surface 95b. The length of the blade surface 95b in the direction in which the needle tube 95 extends can be arbitrarily set, but can be set to the same length as the blade surface 95a of the first needle tip 95A. The needle tube 95 is held at its intermediate portion by a needle hub 96, and the second needle tip 95 </ b> B protrudes from the end surface 41 b of the connection member 61.

 針管95の材料としては、第1の実施形態と同様の材料を用いることができる。また、テーパー針とする場合は、第1の針先95A側の外径よりも第2の針先95B側の外径を大きくし、その中間部分をテーパー構造とすればよい。なお、この場合は、第1の針先95Aと第2の針先95Bの形状が異なる。 As the material of the needle tube 95, the same material as that of the first embodiment can be used. In the case of using a tapered needle, the outer diameter on the second needle tip 95B side may be made larger than the outer diameter on the first needle tip 95A side, and the intermediate portion may have a tapered structure. In this case, the shapes of the first needle tip 95A and the second needle tip 95B are different.

 また、針ハブ96は、第1部材11と第2部材92とから構成され、第2部材92は、第1の実施形態における第2部材12に保持部9が設けられていない構成とされている。第2部材92において、保持部が構成されない以外は、第1の実施形態における第2部材12と同様である。 The needle hub 96 includes a first member 11 and a second member 92, and the second member 92 is configured such that the holding member 9 is not provided on the second member 12 in the first embodiment. Yes. The second member 92 is the same as the second member 12 in the first embodiment except that the holding portion is not configured.

[シリンジ]
 本実施形態例のシリンジ93は、第1の実施形態に係るシリンジ3の排出部52に、弾性部材で構成され、有底筒状に形成された保持部94を有する。保持部94の底部は、排出部52先端の開口を封止し、針管95の針先95Bが刺通可能な蓋部98とされる。また、排出部52の外周面に形成された保持部94は、排出部52に取り付けられた状態において、嵌入部32の内径よりもやや大きく形成されている。これにより、シリンジ93の排出部52を嵌入部32に嵌入した際には、保持部94の弾性力により、排出部52が嵌入部32内に密着保持される。
[Syringe]
The syringe 93 according to the present embodiment includes a holding portion 94 that is formed of an elastic member and is formed in a bottomed cylindrical shape at the discharge portion 52 of the syringe 3 according to the first embodiment. The bottom portion of the holding portion 94 serves as a lid portion 98 that seals the opening at the distal end of the discharge portion 52 and allows the needle tip 95B of the needle tube 95 to be pierced. In addition, the holding portion 94 formed on the outer peripheral surface of the discharge portion 52 is formed to be slightly larger than the inner diameter of the insertion portion 32 when attached to the discharge portion 52. Thereby, when the discharge part 52 of the syringe 93 is inserted into the insertion part 32, the discharge part 52 is tightly held in the insertion part 32 by the elastic force of the holding part 94.

 また、シリンジ93の内部には、予め薬剤Mが充填されている。予め充填される薬剤Mとしては、第1の実施形態における薬剤注射装置1に用いられる薬剤と同様のものが挙げられる。シリンジ93内に予め充填された薬剤Mは排出部52先端側に設けられた保持部94と、シリンジ本体51内に設けられたガスケット(図示せず)とにより液密に保持されている。すなわち、本実施形態例の薬剤注射装置91は、プレフィルドシリンジを構成するものである。 Further, the medicine M is filled in the syringe 93 in advance. As the medicine M filled in advance, the same medicine as that used in the medicine injection device 1 in the first embodiment can be used. The medicine M prefilled in the syringe 93 is liquid-tightly held by a holding portion 94 provided on the distal end side of the discharge portion 52 and a gasket (not shown) provided in the syringe body 51. That is, the medicine injection device 91 of this embodiment constitutes a prefilled syringe.

[薬剤注射装置の組立方法]
 本実施形態例の薬剤注射装置91においても、第1の実施形態と同様、薬剤が充填された状態のシリンジ93の排出部52を注射針組立体97の、保持部94が形成された嵌入部32に押し込む。そして、排出部52を接続部材61の端面41bに垂直に当接するまで嵌入することにより、針管95の第2の針先95Bが保持部94の蓋部98を刺通し、シリンジ93の排出部52内部に刺入する。これにより、シリンジ93に対する注射針組立体97の装着が完了すると共に、針管95への薬剤の通液が完了する。
[Assembly method of drug injection device]
Also in the medicine injection device 91 of the present embodiment example, as in the first embodiment, the discharge portion 52 of the syringe 93 in a state filled with the medicine is inserted into the insertion portion in which the holding portion 94 of the injection needle assembly 97 is formed. Push into 32. Then, the second needle tip 95B of the needle tube 95 passes through the lid portion 98 of the holding portion 94 by inserting the discharge portion 52 until it comes into contact with the end surface 41b of the connection member 61 vertically, and the inside of the discharge portion 52 of the syringe 93 Insert into. As a result, the mounting of the injection needle assembly 97 to the syringe 93 is completed, and the liquid passing through the needle tube 95 is completed.

 本実施形態例では、シリンジ93の排出部52の外周面には弾性部材からなる保持部94が形成されており、排出部52は保持部94の弾性力に抗して嵌入部32に嵌入される。そして、シリンジ93は、その排出部52が保持部94に密着保持された状態で注射針組立体97に装着される。これにより、シリンジ93の排出部52の先端側の液密性が保持され、シリンジ93の排出部52が注射針組立体97に固定される。 In this embodiment, a holding portion 94 made of an elastic member is formed on the outer peripheral surface of the discharge portion 52 of the syringe 93, and the discharge portion 52 is inserted into the insertion portion 32 against the elastic force of the holding portion 94. The The syringe 93 is attached to the injection needle assembly 97 in a state where the discharge part 52 is closely held by the holding part 94. Thereby, the liquid tightness of the distal end side of the discharge part 52 of the syringe 93 is maintained, and the discharge part 52 of the syringe 93 is fixed to the injection needle assembly 97.

 また、シリンジ93に対する注射針組立体97の装着が完了したとき、第2部材本体19に形成されたストッパ部4にシリンジ93の排出部52の外周面に形成されたロック部7が係止する。これにより、シリンジ93の注射針組立体97に対する位置が固定され、シリンジ93が抜けることがない。
 その他、第1の実施形態と同様の効果を得ることができる。そして、本実施形態例の薬剤注射装置91も、第1の実施形態と同様にして使用することができる。
Further, when the mounting of the injection needle assembly 97 to the syringe 93 is completed, the lock portion 7 formed on the outer peripheral surface of the discharge portion 52 of the syringe 93 is engaged with the stopper portion 4 formed on the second member main body 19. . Thereby, the position with respect to the injection needle assembly 97 of the syringe 93 is fixed, and the syringe 93 does not come out.
In addition, the same effects as those of the first embodiment can be obtained. The drug injection device 91 according to the present embodiment can also be used in the same manner as in the first embodiment.

 以上、本発明の薬剤注射装置および注射針組立体の実施の形態について、その作用効果も含めて説明した。しかしながら、本発明の注射針組立体および薬剤注射装置1は、上述の実施形態に限定されるものではなく、特許請求の範囲に記載した発明の要旨を逸脱しない範囲内で種々の変形実施が可能である。 The embodiments of the drug injection device and the needle assembly of the present invention have been described above, including their effects. However, the injection needle assembly and the drug injection device 1 of the present invention are not limited to the above-described embodiments, and various modifications can be made without departing from the spirit of the invention described in the claims. It is.

 例えば、上述の実施形態では、シリンジの排出部は、側面が端面に対して垂直な円筒形状とし、嵌入部の内周面も、その端面に対して垂直な面を有するように構成した。しかしながら、シリンジの排出部を、先端に向かうにつれて径が連続的に小さくなるようなテーパー状に形成し、嵌入部を挿入部側に至るにつれて連続的に径が小さくなるようなテーパー形状としてもよい。これにより、シリンジの排出部と嵌入部は、テーパー嵌合されるため、より両者が液密に保持される。 For example, in the above-described embodiment, the discharge portion of the syringe has a cylindrical shape whose side surface is perpendicular to the end surface, and the inner peripheral surface of the fitting portion has a surface perpendicular to the end surface. However, the discharge part of the syringe may be formed in a tapered shape such that the diameter continuously decreases toward the tip, and the insertion part may have a tapered shape in which the diameter continuously decreases as it reaches the insertion part side. . Thereby, since the discharge part and insertion part of a syringe are taper-fitted, both are hold | maintained more liquid-tightly.

 また、上述の実施形態では、ロック機構を構成するストッパ部及びロック部は対向する位置に2カ所ずつ設ける例としたが、シリンジと針ハブとが固定される構成であればよく、2個以上設けてもよい。 In the above-described embodiment, the stopper portion and the lock portion that constitute the lock mechanism are provided at two positions at opposite positions. However, any configuration may be used as long as the syringe and the needle hub are fixed. It may be provided.

 また、上述の実施形態では、針ハブの第1部材に安定部及びガイド部を設ける構成にした。しかしながら、本発明に係る注射針組立体及び薬剤注射装置としては、第2部材又はシリンジに安定部及びガイド部を設ける構成にすることもできる。 In the above-described embodiment, the first member of the needle hub is provided with the stabilizing portion and the guide portion. However, the injection needle assembly and the drug injection device according to the present invention can be configured such that the second member or the syringe is provided with a stabilizing portion and a guide portion.

 1、81、91・・・薬剤注射装置、2、86、97・・・注射針組立体、3、83、93・・・シリンジ、4・・・ストッパ部、4a・・・突出部、4b・・・係止部、5、95・・・針管、6、96・・・針ハブ、7・・・ロック部、8・・・キャップ、9、73、94・・・保持部、11・・・第1部材、12、87、92・・・第2部材、15・・・ベース部、16・・・調整部、17・・・安定部、18・・・ガイド部、19、89・・・第2部材本体、20・・・接着剤、21・・・貫通孔、22・・・注入用孔、24・・・接続片、31・・・挿入部、32・・・嵌入部、34・・・固定片、37・・・係合部、41・・・本体部、42・・・フランジ部、43・・・ストッパ突部、44・・・
リング突部、45・・・挿通孔、46・・・端面側離間部、47・・・接面側離間部、48・・・密着部、51・・・シリンジ本体、52・・・排出部、56・・・液室、61・・接続部材、63・・・針側弁体部、71・・・ストッパ部、72・・・ロック部
DESCRIPTION OF SYMBOLS 1, 81, 91 ... Drug injection device 2, 86, 97 ... Injection needle assembly 3, 83, 93 ... Syringe, 4 ... Stopper part, 4a ... Projection part, 4b ... Locking part, 5, 95 ... Needle tube, 6,96 ... Needle hub, 7 ... Lock part, 8 ... Cap, 9, 73, 94 ... Holding part, 11. .. 1st member, 12, 87, 92 ... 2nd member, 15 ... Base part, 16 ... Adjustment part, 17 ... Stabilization part, 18 ... Guide part, 19, 89 .. 2nd member main body, 20 ... adhesive, 21 ... through-hole, 22 ... injection hole, 24 ... connection piece, 31 ... insertion part, 32 ... insertion part, 34 ... fixed piece, 37 ... engagement part, 41 ... main body part, 42 ... flange part, 43 ... stopper projection, 44 ...
Ring projection, 45 ... insertion hole, 46 ... end face side separation part, 47 ... contact surface side separation part, 48 ... contact part, 51 ... syringe body, 52 ... discharge part 56 ... Liquid chamber 61 ... Connection member 63 ... Needle side valve element 71 ... Stopper part 72 ... Lock part

Claims (8)

 皮膚に穿刺される針先を有する針管と、
 前記針管を保持し、シリンジの排出部が嵌入される嵌入部を有する針ハブと、
 前記嵌入部の内周面に設けられた弾性部材からなる保持部と、を備え、
 前記保持部は、前記嵌入部に嵌入されたシリンジの排出部を、前記嵌入部内に液密に保持することを特徴とする
 注射針組立体。
A needle tube having a needle tip pierced into the skin;
A needle hub that holds the needle tube and has a fitting portion into which a discharge portion of a syringe is fitted;
A holding portion made of an elastic member provided on the inner peripheral surface of the fitting portion,
The said holding | maintenance part hold | maintains the discharge part of the syringe inserted in the said insertion part liquid-tightly in the said insertion part, The injection needle assembly characterized by the above-mentioned.
 前記針ハブは、ストッパを備え、
 前記ストッパが前記シリンジに設けられたロック部に係止することで前記嵌入部に嵌入されたシリンジの位置を固定する
 請求項1に記載の注射針組立体。
The needle hub includes a stopper,
The injection needle assembly according to claim 1, wherein the stopper fixes the position of the syringe inserted into the insertion portion by engaging with a lock portion provided in the syringe.
 前記保持部は、円筒形の部材で構成されている
 請求項1に記載の注射針組立体。
The injection needle assembly according to claim 1, wherein the holding portion is configured by a cylindrical member.
 前記保持部は、Oリングで構成されている
 請求項1に記載の注射針組立体。
The injection needle assembly according to claim 1, wherein the holding portion is configured by an O-ring.
 排出部を有するシリンジと、
 皮膚に穿刺される針先を有する針管と、
 前記針管を保持し、シリンジの排出部が嵌入される嵌入部を有する針ハブと、
 前記嵌入部の内周面又は前記シリンジの排出部の外周面に設けられた弾性部材からなる保持部と、を備え、
 前記保持部は、前記嵌入部に嵌入されたシリンジの排出部を、前記嵌入部内に液密に保持することを特徴とする
 薬剤注射装置。
A syringe having a discharge part;
A needle tube having a needle tip pierced into the skin;
A needle hub that holds the needle tube and has a fitting portion into which a discharge portion of a syringe is fitted;
A holding portion made of an elastic member provided on the inner peripheral surface of the fitting portion or the outer peripheral surface of the discharge portion of the syringe,
The said holding | maintenance part hold | maintains the discharge part of the syringe inserted in the said insertion part liquid-tightly in the said insertion part, The chemical injection apparatus characterized by the above-mentioned.
 前記シリンジはロック部を備え、
 前記針ハブは前記ロック部に係止するストッパを備え、
 前記ストッパが前記シリンジに設けられたロック部に係止することで前記嵌入部に嵌入されたシリンジの位置が固定される
 請求項5に記載の薬剤注射装置。
The syringe includes a lock part,
The needle hub includes a stopper that is locked to the lock portion;
The medicine injection device according to claim 5, wherein the position of the syringe inserted into the insertion portion is fixed by locking the stopper with a lock portion provided in the syringe.
 前記ロック部は前記シリンジの排出部の外周面に設けられた突起部で構成され、
 前記ストッパは前記嵌入部の内周面に設けられた溝部で構成されている
 請求項6に記載の薬剤注射装置。
The lock part is composed of a protrusion provided on the outer peripheral surface of the discharge part of the syringe,
The drug injection device according to claim 6, wherein the stopper is configured by a groove provided on an inner peripheral surface of the fitting portion.
 シリンジ内には予め薬剤が充填されており、
 前記排出部の先端は前記シリンジの排出部の外周面に設けられた前記保持部と一体に形成された蓋部に封止されており、
 前記排出部が前記嵌入部に嵌入すると共に、前記針管の前記針先とは反対側の端部が前記蓋部を貫通して前記排出部内に刺入する
 請求項5に記載の薬剤注射装置。
The syringe is prefilled with drugs,
The tip of the discharge part is sealed by a lid part formed integrally with the holding part provided on the outer peripheral surface of the discharge part of the syringe,
The drug injection device according to claim 5, wherein the discharge portion is inserted into the insertion portion, and an end portion of the needle tube opposite to the needle tip penetrates the lid portion and is inserted into the discharge portion.
PCT/JP2012/055359 2011-05-20 2012-03-02 Injection needle assembly and drug injection device Ceased WO2012160852A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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JP2011-113422 2011-05-20

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2016052169A1 (en) * 2014-09-29 2017-08-24 テルモ株式会社 Injection needle assembly and drug injection device
EP4129370A4 (en) * 2020-03-31 2024-04-24 Asti Corporation NEEDLE BASE UNIT, MANUFACTURING METHOD FOR NEEDLE BASE UNIT AND SYRINGE DEVICE
EP4464347A4 (en) * 2022-01-14 2025-11-12 Terumo Corp NEEDLE ASSEMBLY AND ADMINISTRATION DEVICE

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JPS5016775U (en) * 1973-06-09 1975-02-22
JPH0574545U (en) * 1990-04-28 1993-10-12 株式会社大塚製薬工場 Syringe
JP2004536671A (en) * 2001-07-27 2004-12-09 ベクトン・ディキンソン・アンド・カンパニー Lure connector assembly

Patent Citations (3)

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JPS5016775U (en) * 1973-06-09 1975-02-22
JPH0574545U (en) * 1990-04-28 1993-10-12 株式会社大塚製薬工場 Syringe
JP2004536671A (en) * 2001-07-27 2004-12-09 ベクトン・ディキンソン・アンド・カンパニー Lure connector assembly

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2016052169A1 (en) * 2014-09-29 2017-08-24 テルモ株式会社 Injection needle assembly and drug injection device
EP3202439A4 (en) * 2014-09-29 2018-09-19 Terumo Kabushiki Kaisha Injection needle assembly and medicine injection device
US10335551B2 (en) 2014-09-29 2019-07-02 Terumo Kabushiki Kaisha Needle assembly and drug injection device
EP4129370A4 (en) * 2020-03-31 2024-04-24 Asti Corporation NEEDLE BASE UNIT, MANUFACTURING METHOD FOR NEEDLE BASE UNIT AND SYRINGE DEVICE
EP4464347A4 (en) * 2022-01-14 2025-11-12 Terumo Corp NEEDLE ASSEMBLY AND ADMINISTRATION DEVICE

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