WO2012160855A1 - Ensemble aiguille d'injection et dispositif d'injection de médicament - Google Patents

Ensemble aiguille d'injection et dispositif d'injection de médicament Download PDF

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Publication number
WO2012160855A1
WO2012160855A1 PCT/JP2012/055940 JP2012055940W WO2012160855A1 WO 2012160855 A1 WO2012160855 A1 WO 2012160855A1 JP 2012055940 W JP2012055940 W JP 2012055940W WO 2012160855 A1 WO2012160855 A1 WO 2012160855A1
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WO
WIPO (PCT)
Prior art keywords
needle
syringe
tube
needle tube
medicine
Prior art date
Application number
PCT/JP2012/055940
Other languages
English (en)
Japanese (ja)
Inventor
倫子 鹿角
陽一郎 岩瀬
横田　崇之
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2012160855A1 publication Critical patent/WO2012160855A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw

Definitions

  • the present invention relates to an injection needle assembly and a drug injection device in which a syringe in which a drug is contained and an air vent is performed can be attached.
  • prefilled syringes in which a medicine is prefilled in a syringe are often used.
  • Such a prefilled syringe does not require an operation of sucking the drug from the vial into the syringe at the time of drug administration, and thus it is possible to reduce the time required for drug administration.
  • Patent Document 1 discloses a prefilled syringe including a syringe body filled with a medicine and a cap attached to the syringe body and sealing the medicine in the syringe body.
  • a needle hub to which the injection needle is fixed is attached to the medicine discharge portion which is the tip of the prefilled syringe, and the proximal end of the injection needle is communicated with the inside of the syringe body.
  • medical agent is discharged
  • a skin contact portion capable of adjusting the depth of puncture of the injection needle is provided in order to perform stable puncture.
  • the air is vented after the syringe is attached to the needle hub, the liquid droplet leaks from the tip of the injection needle, and the chemical adheres between the skin contact portion and the skin contact portion and the needle tube. There is a fear. For this reason, it is also conceivable to vent the syringe before attaching the syringe to the needle hub.
  • the present invention has been made in view of the above points, and an object of the present invention is to provide an injection needle assembly to which a syringe that has been evacuated can be attached, and a medicine injection device using the injection needle assembly.
  • an injection needle assembly includes a needle tip that is pierced into the skin and a needle tube having a proximal end opposite to the needle tip. Also, it has a medicine filled inside and a discharge part for discharging the medicine, a fitting part into which a discharge part of a syringe in a state where air is discharged from the inside is inserted, a needle tube holding the needle tube, A needle hub having a holding portion for positioning the proximal end at the fitting portion.
  • the cap which covers the needle tip of a needle tube is provided. The inner wall surface of the cap is provided with a collection unit that collects liquid droplets leaking from the needle tip.
  • the drug injection device is a device in which a syringe is attached to the above-described injection needle assembly.
  • This syringe has a medicine filled inside and a discharge part for discharging the medicine, and air is discharged from the inside.
  • the recovery unit that recovers the liquid droplet leaking from the needle tip is provided on the inner wall surface of the cap. For this reason, even if the syringe which filled the inside with the chemical
  • the injection needle assembly and the drug injection device of the present invention it is possible to suppress the formation of liquid droplets at the needle tip of the needle tube, so that a syringe filled with the drug and exhausted air is attached in advance. Is possible. For this reason, the operation
  • FIG. 1 is an exploded view of a medicine injection device 100 according to the present embodiment.
  • the drug injection device 100 is used when the needle tip is punctured from the surface of the skin and, for example, the drug is injected into the upper layer of the skin.
  • the drug injection device 100 includes an injection needle assembly 1 and a syringe 2 connected to the injection needle assembly 1 and filled with a drug (medicine solution).
  • the injection needle assembly 1 includes a hollow needle tube 3 having a needle hole, a needle hub 4 to which the needle tube 3 is fixed, an elastic member 7 disposed in the needle hub 4, and a detachable attachment to the needle hub 4. And a cap 5 for protecting the needle tube 3.
  • the needle hub 4 includes a first member 6 that holds the needle tube 3 and a second member 8 into which a later-described discharge portion 42 of the syringe 2 is inserted.
  • the needle tube 3 of the injection needle assembly 1 has a size of 26 to 33 gauge (outer diameter 0.2 to 0.45 mm) according to the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)). Those of 30 to 33 gauge are preferably used.
  • FIG. 2 is a cross-sectional view showing a state in which the syringe 2, the needle tube 3, and the needle hub 4 are assembled.
  • a needle tip 3 ⁇ / b> A having a blade surface 3 a is provided at one end of the needle tube 3.
  • the other end of the needle tube 3 opposite to the needle tip 3A is referred to as a “base end 3B”.
  • the axial length of the needle tube 3 on the blade surface 3a (hereinafter referred to as “bevel length”) may be 1.4 mm (adult) or less, which is the thinnest thickness of the upper skin portion described later, What is necessary is just about 0.5 mm or more which is the bevel length when a short bevel is formed in a 33 gauge needle tube. That is, the bevel length is preferably set in the range of 0.5 to 1.4 mm.
  • the bevel length is further preferably such that the thinnest thickness of the upper skin layer is 0.9 mm (child) or less, that is, the bevel length 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 3 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 3 can be not only a straight needle but also a tapered needle having at least a part tapered. As the tapered needle, the proximal end has a larger diameter than the needle distal end, and the intermediate portion may have a tapered structure. Further, the cross-sectional shape of the needle tube 3 may be not only a circle but also a polygon such as a triangle.
  • the first member 6 and the second member 8 of the needle hub 4 are formed as separate members, but may be formed integrally.
  • Examples of the material of the first member 6 and the second member 8 include synthetic resins such as polycarbonate, polypropylene, and polyethylene.
  • the first member 6 includes a base portion 9, an adjustment portion 10, a stabilization portion 11, and a guide portion 12.
  • the first member 6 is configured as a holding unit that holds the needle tube 3.
  • the base portion 9 is formed in a substantially cylindrical shape and has end faces 9a and 9b perpendicular to the axial direction.
  • the adjustment unit 10 is provided at the center of the end surface 9 a of the base unit 9, and includes a columnar projection that protrudes in the axial direction of the base unit 9.
  • the axis of the adjustment unit 10 is coincident with the axis of the base unit 9.
  • a through hole 13 through which the needle tube 3 passes is provided in the axial center of the base portion 9 and the adjustment portion 10.
  • the base portion 9 is provided with an injection hole 15 for injecting the adhesive 14 into the through hole 13.
  • the injection hole 15 is opened on the outer peripheral surface of the base portion 9 and communicates with the through hole 13. That is, the needle tube 3 is fixed to the base portion 9 by the adhesive 14 injected from the injection hole 15 to the through hole 13.
  • the proximal end 3B side of the needle tube 3 protrudes from the end surface 9b of the base portion 9.
  • the base portion 9 is inserted into the second member 8 from the end surface 9b side, and the proximal end 3B side of the needle tube 3 is inserted into an insertion hole 71 described later of the elastic member 7.
  • the end surface 9b of the base part 9 is contact
  • a connecting piece 16 is provided on the outer peripheral surface of the base portion 9.
  • the connection piece 16 is formed as a ring-shaped flange projecting in the radial direction of the base portion 9, and has flat surfaces 16 a and 16 b facing the axial direction of the base portion 9.
  • the second member 8 is connected to the flat surface 16 b of the connection piece 16. Further, the distal end portion of the connection piece 16 is a guide portion 12. The guide portion 12 will be described in detail later.
  • the end surface of the adjusting portion 10 is a needle protruding surface 10a from which the needle tip 3A side of the needle tube 3 protrudes.
  • the needle projecting surface 10 a is formed as a plane orthogonal to the axial direction of the needle tube 3.
  • the needle protruding surface 10a defines the depth of puncturing the needle tube 3 in contact with the skin surface when the needle tube 3 is punctured into the upper skin portion. That is, the depth at which the needle tube 3 is punctured into the upper skin layer is determined by the length of the needle tube 3 protruding from the needle protruding surface 10a (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 3 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.
  • the thickness of the upper layer of the deltoid muscle of 19 children and 31 adults 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.
  • the protruding length L of the needle tube 3 is preferably set in the range of 0.9 to 1.4 mm.
  • the blade surface 3a of the needle tip 3A can be reliably positioned on the upper skin portion.
  • the needle hole (medicine discharge port) that opens in the blade surface 3a can be located in the upper skin layer portion at any position within the blade surface 3a. Even if the medicine discharge port is located in the upper skin layer, if the needle tip 3A is stabbed deeper than the upper skin layer, the medicine flows subcutaneously between the side surface of the end of the needle tip 3A and the cut skin. Therefore, it is important that the blade surface 3a is surely in the upper skin portion.
  • the needle projecting surface 10a is formed such that the distance S from the peripheral edge to the outer peripheral surface of the needle tube 3 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 10a to the peripheral surface of the needle tube 3 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 protruding surface 10a is set to a size that is sufficiently smaller than the blisters formed in the upper skin layer and does not hinder the formation of blisters. As a result, even if the needle protruding surface 10a presses the skin around the needle tube 3, it is possible to prevent the administered medicine from leaking.
  • the stabilizing part 11 is formed in a cylindrical shape protruding from the flat surface 16 a of the connecting piece 16 provided on the base part 9.
  • the needle tube 3 and the adjustment unit 10 are disposed in the cylindrical hole of the stabilization unit 11. That is, the stabilizing portion 11 is formed in a cylindrical shape that covers the periphery of the adjusting portion 10 through which the needle tube 3 passes, and is provided away from the needle tip 3A of the needle tube 3 in the radial direction.
  • the end surface 11a of the stabilizing portion 11 is located closer to the proximal end 3B side of the needle tube 3 than the needle protruding surface 10a of the adjusting portion 10.
  • the needle protruding surface 10 a contacts the surface of the skin, and then contacts the end surface 11 a of the stabilizing portion 11.
  • the drug injection device 100 is stabilized by the end surface 11a of the stabilizing portion 11 coming into contact with the skin, and the needle tube 3 can be maintained in a posture substantially perpendicular to the skin.
  • the stabilizing portion 11 is formed with a first vent hole 17 penetrating from the outer peripheral surface to the inner peripheral surface.
  • the adjustment portion 10 is also provided with a second ventilation hole 18 that penetrates the side surface thereof and communicates with the through hole 13.
  • the first ventilation hole 17 and the second ventilation hole 18 constitute a space surrounded by the stabilizing portion 11 and the skin and a ventilation means for opening the through hole 13 to the outside.
  • the needle tube 3 is skinned. It is possible to keep the posture substantially perpendicular to the angle.
  • the axial distance between the end surface 11a of the stable portion 11 and the needle protruding surface 10a is preferably set to 1.3 mm or less.
  • the inner diameter d of the stable portion 11 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 stable portion 11 to the peripheral edge of the needle protruding surface 10a 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 the blister from the inner wall surface of the stable part 11.
  • the distance T from the inner wall surface of the stable portion 11 to the peripheral edge of the needle protruding surface 10a 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 11 is increased, so that it becomes difficult to bring the entire end surface 11a of the stable portion 11 into contact with the skin when the needle tube 3 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 10 does not enter the skin. Therefore, considering the distance T (4 mm or more) from the inner wall surface of the stable portion 11 to the periphery of the needle protruding surface 10a and the diameter (about 0.3 mm) of the needle protruding surface 10a, the inner diameter d of the stable portion 11 is 9 mm or more. Can be set.
  • the shape of the stable part 11 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 12 is a portion on the peripheral side with respect to the position of the stable portion 11 in the connection piece 16.
  • the guide portion 12 has a contact surface 12a that comes into contact with the skin.
  • the contact surface 12 a is a part of the flat surface 16 a of the connection piece 16 and is a flat surface that is substantially parallel to the end surface 11 a of the stabilizing portion 11.
  • the distance Y from the contact surface 12a of the guide portion 12 to the end surface 11a of the stable portion 11 punctures the needle tube 3 and the stable portion 11 by pressing the skin with an appropriate pressing force. Its length is set so that it can.
  • the guide portion 12 guides the pressing force applied to the skin by the needle tube 3 and the stabilizing portion 11, and the needle tip 3A (blade surface 3a) of the needle tube 3 can be reliably positioned on the upper skin portion of the skin. Can give you a sense of security.
  • An appropriate pressing force of the needle tube 3 and the stable portion 11 is, for example, 3 to 20N.
  • the guide portion height Y is the length from the tip surface of the guide portion 12 to the outer peripheral surface of the stable portion 11 (hereinafter referred to as “guide portion length”). It is determined appropriately based on X. For example, when the inner diameter d of the stable portion 11 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 cap 5 (see FIG. 1) is detachably fitted to the guide portion 12.
  • the cap 5 covers the needle tip 3 ⁇ / b> A of the needle tube 3.
  • needle tip 3A can be prevented from touching a user's fingertip.
  • the used medicine injection device 100 or the needle assembly 1 can be always kept in a safe state, and the user can safely dispose of the used medicine injection device 100 or the needle assembly 1 or the like. It can be carried out.
  • the second member 8 is formed in a substantially cylindrical shape.
  • One end portion of the second member 8 in the axial direction is an insertion portion 19 into which the base portion 9 of the first member 6 is inserted, and the other end portion is in the insertion portion 20 into which the discharge portion 42 of the syringe 2 is inserted. It has become.
  • the cylindrical hole 19 a of the insertion portion 19 is set to a size corresponding to the base portion 9 of the first member 6.
  • the insertion part 19 is provided with a fixing piece 21 connected to the connection piece 16 of the first member 6.
  • the fixed piece 21 is formed as a ring-shaped flange that protrudes radially outward continuously from the tip of the fitting portion 20.
  • a flat surface 16 b of the connection piece 16 provided on the first member 6 is brought into contact with and fixed to the fixed piece 21.
  • Examples of the fixing method of the fixing piece 21 and the connection piece 16 include an adhesive, ultrasonic welding, laser welding, and a fixing screw.
  • the cylinder hole 20a of the insertion part 20 is set to a size corresponding to the discharge part 42 of the syringe 2, and the diameter continuously decreases toward the insertion part 19 side.
  • a thread groove 22 for screwing the discharge part 42 of the syringe 2 is formed on the inner surface of the fitting part 20.
  • a stopper 23 that protrudes toward the axis of the cylindrical hole 20 a is provided closer to the insertion portion 19 than the screw groove 22.
  • the discharge portion 42 of the syringe 2 is locked by the stopper 23, thereby preventing further insertion of the syringe 2.
  • a gap is provided between the end face 42a of the discharge portion 42 and the base end 3B of the needle tube 3 in the axial direction of the tube hole 20a.
  • a hub side display unit 25 is provided on the outer peripheral surface of the insertion unit 20 as a recognition unit for recognizing that the insertion of the discharge unit 42 is completed.
  • the hub side display part 25 coincides with a syringe side display part 44 (described later) provided in the discharge part 42 in the circumferential direction of the second member 8.
  • the second member 8 of the needle hub 4 is formed of a transparent or translucent synthetic resin so that the syringe-side display portion 44 can be visually recognized through the fitting portion 20.
  • a convex part is provided in one base end of the thread part 43 of the syringe 2 or the thread groove 22 of the insertion part 20, and the recessed part engaged with the convex part is made into the other base end. You may form by providing. In this case, it is possible to recognize that the insertion of the discharge portion 42 into the insertion portion 20 is completed by the engagement between the convex portion and the concave portion.
  • the engaging portion 24 is formed as a step portion protruding radially inward from the inner surface of the second member 8, and has engaging surfaces 24 a and 24 b that are substantially orthogonal to the axial direction of the second member 8. .
  • a first flange portion 72 (to be described later) of the elastic member 7 is engaged with the engagement surface 24a of the engagement portion 24, and a second flange portion 73 of the elastic member 7 is engaged with the engagement surface 24b.
  • the elastic member 7 is disposed in the second member 8 of the needle hub 4 and is interposed between the first member 6 that holds the needle tube 3 and the syringe 2.
  • the elastic member 7 includes a main body portion 70, a first flange portion 72 provided at one end of the main body portion 70 in the axial direction, and a second flange portion 73 provided at the other end of the main body portion 70. is doing.
  • the main body 70 is formed in a substantially cylindrical shape and has end faces 70a and 70b perpendicular to the axial direction.
  • the end surface 9 b of the base portion 9 of the first member 6 is in contact with the end surface 70 a of the main body portion 70.
  • the end surface 70b of the main-body part 70 is spaced apart from the end surface 42a of the discharge
  • the main body portion 70 is provided with an insertion hole 71 through which the proximal end 3B side of the needle tube 3 protruding from the end surface 9b of the base portion 9 of the first member 6 is inserted.
  • the insertion hole 71 extends in the axial direction of the main body 70 and is opened to the end faces 70a and 70b.
  • the inner surface of the main body portion 70 is formed by a base side separation portion 74, a syringe side separation portion 75, and a close contact portion 76.
  • the base side separation portion 74 forms an opening of the insertion hole 71 in the end surface 70a.
  • the base-side separation portion 74 is separated from the outer peripheral surface of the needle tube 3 and is formed in a tapered shape such that the diameter of the insertion hole 71 continuously increases toward the end surface 70a. Thereby, the base end 3 ⁇ / b> B side of the needle tube 3 protruding from the end surface 9 b of the base portion 9 can be easily inserted into the insertion hole 71.
  • the shape of the base-side separation portion 74 in the insertion hole 71 is not limited to a tapered shape as long as the needle tube 3 can be easily inserted into the insertion hole 71.
  • the syringe side separation part 75 forms the opening of the insertion hole 71 in the end surface 70b.
  • the syringe-side separation portion 75 is separated from the outer peripheral surface of the needle tube 3, and is formed in a taper shape such that the diameter of the insertion hole 71 continuously increases toward the end surface 70b.
  • a needle-side valve element 77 is provided in the syringe-side separation part 75.
  • the needle side valve body 77 is formed as a cylindrical protrusion that covers the outer periphery of the needle tube 3.
  • the outer peripheral surface of the needle side valve body 77 is formed in a taper shape whose diameter continuously decreases toward the tip.
  • the contact portion 76 is formed between the base side separation portion 74 and the syringe side separation portion 75.
  • the contact portion 76 is in liquid-tight contact with the outer peripheral surface of the needle tube 3, and the medicine in the syringe 2 enters between the needle tube 3 and the elastic member 7 and leaks to the first member 6 side of the needle hub 4. To prevent.
  • the first flange portion 72 is formed in a ring shape that protrudes radially outward from the outer peripheral surface of the main body portion 70.
  • the outer diameter of the first flange portion 72 is substantially equal to the outer diameter of the base portion 9 of the first member 6.
  • the elastic member 7 is attached to the needle hub 4 by holding the first flange portion 72 between the engaging portion 24 of the second member 8 and the base portion 9 of the first member 6.
  • the second flange portion 73 is formed in a ring shape that protrudes radially outward from the outer peripheral surface of the main body portion 70, similarly to the first flange portion 72.
  • the second flange portion 73 engages with the engagement surface 24 b of the engagement portion 24 provided on the second member 8.
  • the elastic member 7 is locked to move in the axial direction by the first flange portion 72 and the second flange portion 73 engaging the engaging portion 24 of the second member 8. Thereby, it can prevent that a chemical
  • Examples of the material of the elastic member 7 include various rubber materials such as synthetic rubber, natural rubber, silicone rubber, and isobutylene rubber, various thermoplastic elastomers such as polyurethane and styrene, or mixtures thereof. .
  • the syringe 2 includes a syringe body 41 and a discharge portion 42 that is continuous with the syringe body 41.
  • the syringe body 41 is formed of a circular cylinder.
  • the discharge part 42 protrudes from one end of the syringe body 41 in the axial direction, and is composed of a circular cylinder having an outer diameter smaller than that of the syringe body 41.
  • the discharge portion 42 is formed in a tapered shape whose diameter continuously decreases toward the tip.
  • the end surface 42 a that is the tip of the discharge portion 42 abuts against a stopper 23 provided on the inner wall surface of the second member 8, thereby limiting the insertion depth of the syringe 2 with respect to the needle hub 4.
  • a gap is provided between the end face 42 a and the proximal end 3 ⁇ / b> B of the needle tube 3 in the axial direction of the needle tube 3.
  • the insertion depth of the syringe 2 may be limited by the end surface 41 a of the syringe main body 41 coming into contact with the distal end of the insertion portion 20 of the second member 8, and the end surface 42 a and the needle tube 3 may be limited.
  • Other configurations may be used as long as a predetermined gap is provided between the base ends 3B.
  • the outer peripheral surface of the discharge portion 42 is provided with a screw portion 43 for screwing onto the second member 8 of the needle hub 4 and a syringe-side display portion 44.
  • the syringe-side display unit 44 is recognized via the second member 8 of the needle hub 4 when the discharge unit 42 is inserted into the insertion unit 20 provided in the needle hub 4. And when the discharge part 42 contacts the engaging part 24 of the insertion part 20 and the insertion is completed, the syringe side display part 44 coincides with the hub side display part 25 of the needle hub 4 in the circumferential direction.
  • a gasket (not shown) is accommodated in the syringe body 41.
  • the space in the syringe body 41 is liquid-tightly partitioned by a gasket, and one space communicating with the discharge part 42 forms a liquid chamber 46 together with the space in the discharge part 42.
  • a plunger (not shown) is arranged in the other space in the syringe body 41. The plunger is connected to the gasket and protrudes from the opening at the other end of the syringe body 41. By operating this plunger, the gasket is moved in the axial direction in the syringe body 41, and the medicine filled in the syringe body 41 is discharged.
  • the syringe 2 is vented after the medicine (chemical solution) 80 is filled, and the internal air is discharged in advance.
  • an amount of medicine 80 slightly larger than the volume of the syringe 2 is injected into the syringe 2, and a droplet 81 is formed at the discharge port 42 b. It is desirable to keep it.
  • synthetic resins such as polycarbonate, polypropylene, and polyethylene can be used, and glass or the like may be used.
  • a gap is provided between the proximal end 3B of the needle tube 3 and the end surface 42a of the discharge portion 42 of the syringe 2.
  • a discharge port 42 b is opened in the discharge part 42 of the syringe 2, and the syringe 2 is inserted into the insertion part 20 in a state where the internal space communicates with the internal space of the insertion part 20.
  • FIG. 3 is a cross-sectional view of the drug injection device 100 of the present embodiment provided with the syringe 2, the needle hub 4, and the cap 5 assembled.
  • the cap 5 includes a first tube portion 51 provided with a tube hole 51a, a second tube portion 52 provided with a tube hole 52a that is continuous with the first tube portion 51 and communicates with the tube hole 51a, and a second tube. And a bottom portion 53 provided with a recess 53a that is continuous with the portion 52 and communicates with the cylindrical hole 52a.
  • the first tube portion 51 has, for example, a cylindrical shape, and an opening for inserting the needle hub 4 is formed in the cap 5.
  • the diameter of the cylinder hole 51a of the first cylinder part 51 is configured to be larger than the diameter of the guide part 12, and the needle hub 4 is inserted from the cylinder hole 51a.
  • the 2nd cylinder part 52 is formed following the 1st cylinder part 51, and the axis
  • the diameter of the cylindrical hole 52a is substantially equal to the diameter of the guide portion 12, and is smaller than the diameter of the cylindrical hole 51a.
  • the diameter of the cylindrical hole 52a is defined by the protruding portion 52c protruding from the inner surface 52b of the second cylindrical portion 52.
  • the guide portion 12 of the needle hub 4 is fitted to the second cylindrical portion 52, and the needle hub 4 is fixed to the cap 5.
  • the wall surface of the protrusion 52c that forms the cylindrical hole 52a may be formed in a tapered shape in which the diameter of the cylindrical hole 52a decreases toward the bottom 53 side.
  • the bottom portion 53 is formed continuously with the second cylinder portion 52.
  • the recess 53a of the bottom 53 is formed in a circular shape, and the axis of the recess 53a coincides with the axis of the cylinder hole 52a. Further, the diameter of the concave portion 53a is substantially equal to the diameter of the stable portion 11 and is smaller than the diameter of the cylindrical hole 52a.
  • the bottom 53 is formed with a protruding portion 53c that protrudes from an inner surface 53b continuous from the inner surface 52b of the second cylindrical portion 52 or the wall surface (cylinder hole 52a) of the protruding portion 52c.
  • the diameter of the recess 53a is defined by the protrusion 53c.
  • the stable portion 11 of the first member 6 is fitted into the recess 53 a, and the needle hub 4 is fixed to the cap 5.
  • the concave portion 53a may be formed in a tapered shape having a diameter that decreases toward the bulging portion 54 described later.
  • a bulging portion 54 that bulges inside the cap 5 is formed at the center of the recess 53a.
  • the bulging portion 54 is provided with a collecting portion 55 for collecting the medicine 80 leaking from the tip 3A of the needle tube 3.
  • the collection part 55 is constituted by a protrusion protruding from the bulging part 54 and is formed in a cylindrical shape having a cylindrical hole 55a. The medicine 80 leaked from the tip 3A of the needle tube 3 is collected by the collection unit 55.
  • the collection unit 55 will be described below.
  • the syringe 2 pre-filled with the medicine 80 is vented, and then the syringe 2 is housed in the cap 5 and the needle tip 3A is moved downward.
  • the needle hub 4 is attached to the needle hub 4 in the state of facing.
  • medical agent 80 is formed in the discharge port 42b of the syringe 2.
  • FIG. Even if the air is not vented, the droplet 81 may be formed due to the weight of the medicine 80.
  • FIG. 4 shows a drug injection device 110 configured to bring the discharge portion 42 of the syringe 2 into contact with the elastic member 7 with respect to the drug injection device 100 according to the present embodiment as a comparative example.
  • parts corresponding to those of the drug injection device 100 (FIG. 2) according to the present embodiment are denoted by the same reference numerals as those in FIG.
  • no stopper is provided on the wall surface of the cylindrical hole 20 a in the insertion portion 20 of the second member 8.
  • the discharge part 42 of the syringe 2 inserted into the insertion part 20 is in contact with the elastic member 7, and is in liquid-tight contact with the end surface 70 b of the elastic member 7 at the end surface 42 a of the discharge part 42.
  • the rest is the same as the drug injection device 100 shown in FIG.
  • the droplet 81 formed on the discharge part 42 of the syringe 2 has been in contact with the proximal end 3 ⁇ / b> B of the needle tube 3.
  • the medicine 80 in the syringe 2 enters the inside of the needle tube 3 by capillary action.
  • the medicine 80 may slightly leak from the needle tip 3A of the needle tube 3 and a droplet 82 may be formed.
  • the discharge portion 42 is made fluid-tight to the fitting portion 20 by bringing the outer wall surface of the discharge portion 42 into surface contact with the inner wall surface of the cylindrical hole 20 a. It is inserted. Therefore, when the discharge portion 42 is fitted, the internal space of the cylindrical hole 20a between the end surface 42a of the discharge portion 42 and the end surface 70a of the elastic member 7 is airtight to some extent.
  • a collecting portion 55 for collecting the medicine 80 leaking from the needle tube 3 is provided on the inner wall surface of the cap 5. For this reason, even if the droplet 81 comes into contact with the proximal end 3B of the needle tube 3, when the cap 5 is removed from the needle hub 4, a droplet of the medicine 80 is not formed on the distal end 3A of the needle tube 3. Accordingly, it is possible to prevent the medicine 80 from adhering to the surroundings or injecting the patient into the patient while the liquid droplet is attached to the needle tube 3.
  • the medicine 80 leaks from the needle tip 3A by using the syringe 2 filled with the medicine 80 and previously vented, a droplet is dropped on the needle tip 3A. Is not formed. For this reason, the syringe 2 filled with the medicine 80 and evacuated can be attached in advance to the injection needle assembly 1, and the work of discharging the air in the syringe after being attached to the needle hub is possible. unnecessary.
  • the medicine injection is performed so that the end surface 42a of the discharge portion 42 of the syringe 2 contacts the end surface 70b of the elastic member 7. It is also possible to configure the device 100.
  • the collection unit 55 is configured by a protrusion protruding from the inner wall surface of the cap 5. Further, this protrusion is arranged in the vicinity of the needle tip 3 ⁇ / b> A of the needle tube 3.
  • the droplet comes into contact with the recovery unit 55 disposed in the vicinity of the needle tip 3 ⁇ / b> A of the needle tube 3.
  • the liquid droplet that has contacted the collection unit 55 travels along the wall surface of the collection unit 55 due to its own weight or the like, or is transferred to the bottom of the cylindrical hole 55a of the collection unit 55 and moved to be accumulated in the cylindrical hole 55a.
  • the medicine 80 for example, a liquid having a smaller surface tension such as a vaccine, the liquid droplet can be easily moved from the needle tip 3A to the collection unit 55.
  • the distance between the collection portion 55 and the needle tip 3A is preferably 0.5 mm or more and 3 mm or less.
  • the liquid droplets are attached to the wall surface of the collection unit 55, at least a part of the needle tip 3A of the needle tube 3 is located in the cylindrical hole 55a of the collection unit 55. That is, it is desirable that the needle tube 3 and the collection unit 55 intersect in the axial direction of the needle tube 3.
  • the surface of the collection unit 55 is more than the needle tube 3 with respect to the medicine 80.
  • High wettability is preferred.
  • the recovery part 55 may be molded integrally with the bottom part 53.
  • the collection unit 55 may be formed by attaching another member made of a material having higher wettability than the needle tube 3 to the medicine 80. Further, the wettability of the collection unit 55 may be improved by surface treatment such as plasma discharge or ultraviolet irradiation.
  • the configuration is such that a liquid drop formed on the needle tip 3A is collected by providing a cylindrical projection on the bottom 53 of the cap 5, but the liquid drop may be attached to the cap 5 side.
  • other configurations may be used.
  • a protrusion close to the axial direction of the needle tube 3 may be provided, and the droplet may be attached to the protrusion by moving the droplet in the axial direction of the needle tube 3.
  • the protrusion You may make it make it make a droplet adhere to.
  • the collecting portion 55 is formed in a cylindrical shape and the needle tip 3A is disposed in the cylindrical hole 55a as in the present embodiment, the collected liquid droplets can be retained in the cylindrical hole 55a. it can.
  • the diameter of the cylinder hole 55a is small, it may be difficult to insert the needle tip 3A into the cylinder hole 55a without making contact with the inner surface of the collection part 55 that forms the cylinder hole 55a.
  • the shortest distance from the inner surface of the collection unit 55 to the inner surface of the collection unit 55 may be within the above-described distance. That is, the needle tip 3A does not have to be located on the central axis of the cylindrical hole 55a, and at least one point of the collecting portion 55 only needs to be within the above-mentioned distance from the needle tip 3A.
  • FIG. 5 is a cross-sectional view showing a configuration of the medicine injection device 200 according to the present embodiment. Parts that can have the same configuration as that of the medicine injection device 100 (see FIG. 3) according to the first embodiment are denoted by the same reference numerals as those in FIG.
  • the drug injection device 200 includes a needle tip 3A that is punctured into the skin, a needle tube 3 having a proximal end 3B opposite to the needle tip 3A, a needle hub 4 that holds the needle tube 3, and a needle hub 4 And a syringe 2 filled with a medicine 80 inside. Further, for example, a cap 5 a that is fitted to the needle hub 4 and covers the needle tip 3 A of the needle tube 3 is provided.
  • the injection needle assembly 1 ⁇ / b> A includes the needle tube 3, the needle hub 4, and the cap 5.
  • the same syringe 2, needle tube 3, and needle hub 4 as those in the first embodiment are used. Therefore, the syringe 2 is pre-bleeded after the medicine 80 is filled therein. For this reason, the droplet 81 by the chemical
  • the cap 5a includes a first tube portion 51 provided with a tube hole 51a, a second tube portion 52 provided with a tube hole 52a that is continuous with the first tube portion 51 and communicates with the tube hole 51a, and a second tube. And a bottom portion 53 provided with a recess 53a that is continuous with the portion 52 and communicates with the cylindrical hole 52a. These configurations are also the same as in the first embodiment, and the bulging portion 54 of the bottom portion 53 is provided with a collecting portion 55A for collecting the droplets formed on the needle tip 3A of the needle tube 3.
  • the recovery unit 55A includes, for example, a cylindrical protrusion 56 having a cylindrical hole 56a, and a soft material 57 that is disposed inside the cylindrical hole 56a and can puncture the needle tip 3A of the needle tube 3.
  • a soft material 57 for example, an absorbent body that absorbs the medicine 80 such as foamed polyurethane and polyacrylamide gel can be used.
  • the distance from the needle tube 3 to the projection 56 may be arbitrarily set in the surface direction perpendicular to the axis of the needle tube 3. If the distance from the needle tip 3A to the soft material 57 is 0.5 mm or more and 3 mm or less in the axial direction of the needle tube 3, the needle tip 3A is formed on the needle tip 3A without puncturing the soft material 57.
  • the liquid droplets can be brought into contact with the soft material 57 and absorbed by the soft material 57.

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

Abstract

L'invention porte sur un ensemble aiguille d'injection auquel une seringue de laquelle l'air a été évacué peut être fixée, et un dispositif d'injection de médicament utilisant l'ensemble aiguille d'injection. Cet ensemble aiguille d'injection (1) comporte : un tube d'aiguille (3) ayant une pointe d'aiguille (3A) qui perce la peau et une extrémité de base (3B) sur l'extrémité opposée à la pointe d'aiguille (3A) ; un raccord d'aiguille (4) ayant une partie d'introduction (20) dans laquelle une sortie (42) d'une seringue (2) est introduite, la seringue étant remplie d'un médicament (80), la sortie (42) pour évacuer le médicament (80) et l'air évacué à partir de l'intérieur de celle-ci, et une partie de maintien, qui maintient le tube d'aiguille (3) et positionne l'extrémité de base du tube d'aiguille (3) dans la partie d'introduction (20) ; et un capuchon (5), qui comporte, sur la surface de paroi interne, une partie de récupération (55) destinée à récupérer des gouttes de liquide (81) qui ont fui de la pointe d'aiguille (3A). Le dispositif d'injection de médicament (100) est configuré par fixation d'une seringue (2), qui est remplie du médicament (80) et à partir de laquelle l'air a été évacué, à l'ensemble aiguille d'injection (1).
PCT/JP2012/055940 2011-05-20 2012-03-08 Ensemble aiguille d'injection et dispositif d'injection de médicament WO2012160855A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2011-113421 2011-05-20
JP2011113421 2011-05-20

Publications (1)

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WO2012160855A1 true WO2012160855A1 (fr) 2012-11-29

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11511358A (ja) * 1995-08-22 1999-10-05 エム ディー シー インベストメント ホールディングス，インコーポレイテッド 注射針引っ込み自在の予充填医薬液注射アンプル
JP2002078799A (ja) * 2000-09-08 2002-03-19 Terumo Corp 液体注入器具
WO2011040263A1 (fr) * 2009-09-30 2011-04-07 テルモ株式会社 Ensemble aiguille d'injection et dispositif d'injection de médicament

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11511358A (ja) * 1995-08-22 1999-10-05 エム ディー シー インベストメント ホールディングス，インコーポレイテッド 注射針引っ込み自在の予充填医薬液注射アンプル
JP2002078799A (ja) * 2000-09-08 2002-03-19 Terumo Corp 液体注入器具
WO2011040263A1 (fr) * 2009-09-30 2011-04-07 テルモ株式会社 Ensemble aiguille d'injection et dispositif d'injection de médicament

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