WO2012160852A1 - Ensemble aiguille d'injection et dispositif d'injection de médicament - Google Patents
Ensemble aiguille d'injection et dispositif d'injection de médicament Download PDFInfo
- 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
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- WO
- WIPO (PCT)
- Prior art keywords
- syringe
- needle
- discharge
- injection
- needle tube
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/46—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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/20—Surgical instruments, devices or methods, e.g. tourniquets for vaccinating or cleaning the skin previous to the vaccination
- A61B17/205—Vaccinating by means of needles or other puncturing devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/002—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
- A61M5/178—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
- A61M5/344—Constructions 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
L'invention facilite l'assemblage et le verrouillage de la seringue et du raccord d'aiguille dans des dispositifs d'injection dans lesquels la seringue et le raccord d'aiguille peuvent être séparés. L'ensemble aiguille d'injection (2) comporte : un tube d'aiguille (5) ayant une pointe d'aiguille (5A) qui perce la peau ; un raccord d'aiguille (6) qui reçoit le tube d'aiguille (5) et comprend une partie d'introduction (32) dans laquelle la sortie (52) d'une seringue (3) est introduite ; et une partie de maintien (9) obtenue à partir d'un élément élastique qui est disposé sur la surface circonférentielle interne de la partie d'introduction (32). La partie de maintien (9) reçoit la sortie (52) de la seringue (3), qui a été introduite dans la partie d'introduction (32), à l'intérieur de la partie d'introduction (32) de façon à être étanche aux liquides.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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JP2011113422 | 2011-05-20 | ||
JP2011-113422 | 2011-05-20 |
Publications (1)
Publication Number | Publication Date |
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WO2012160852A1 true WO2012160852A1 (fr) | 2012-11-29 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/JP2012/055359 WO2012160852A1 (fr) | 2011-05-20 | 2012-03-02 | Ensemble aiguille d'injection et dispositif d'injection de médicament |
Country Status (1)
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WO (1) | WO2012160852A1 (fr) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2016052169A1 (ja) * | 2014-09-29 | 2017-08-24 | テルモ株式会社 | 注射針組立体及び薬剤注射装置 |
EP4129370A4 (fr) * | 2020-03-31 | 2024-04-24 | Asti Corporation | Unité de base d'aiguille, procédé de production d'unité de base d'aiguille et dispositif de seringue |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5016775U (fr) * | 1973-06-09 | 1975-02-22 | ||
JPH0574545U (ja) * | 1990-04-28 | 1993-10-12 | 株式会社大塚製薬工場 | 注射器 |
JP2004536671A (ja) * | 2001-07-27 | 2004-12-09 | ベクトン・ディキンソン・アンド・カンパニー | ルアーコネクタアセンブリ |
-
2012
- 2012-03-02 WO PCT/JP2012/055359 patent/WO2012160852A1/fr active Application Filing
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5016775U (fr) * | 1973-06-09 | 1975-02-22 | ||
JPH0574545U (ja) * | 1990-04-28 | 1993-10-12 | 株式会社大塚製薬工場 | 注射器 |
JP2004536671A (ja) * | 2001-07-27 | 2004-12-09 | ベクトン・ディキンソン・アンド・カンパニー | ルアーコネクタアセンブリ |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2016052169A1 (ja) * | 2014-09-29 | 2017-08-24 | テルモ株式会社 | 注射針組立体及び薬剤注射装置 |
EP3202439A4 (fr) * | 2014-09-29 | 2018-09-19 | Terumo Kabushiki Kaisha | Ensemble aiguille d'injection et dispositif d'injection de médicament |
US10335551B2 (en) | 2014-09-29 | 2019-07-02 | Terumo Kabushiki Kaisha | Needle assembly and drug injection device |
EP4129370A4 (fr) * | 2020-03-31 | 2024-04-24 | Asti Corporation | Unité de base d'aiguille, procédé de production d'unité de base d'aiguille et dispositif de seringue |
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