WO2012157312A1

WO2012157312A1 - Injection needle unit

Info

Publication number: WO2012157312A1
Application number: PCT/JP2012/055096
Authority: WO
Inventors: 小川　淳一; 陽一郎岩瀬; 立川　浩一
Original assignee: テルモ株式会社
Priority date: 2011-05-13
Filing date: 2012-02-29
Publication date: 2012-11-22

Abstract

This injection needle unit (1) is provided with a needle tube (5), a needle hub (6), a housing case (8), and a lid member (9). The needle hub (6) is provided with a tip section (15, 16) from which the needle tip (5A) of the needle tube (5) protrudes, a connection unit (32) which, positioned on the side opposite of the tip section (15, 16), is connected to a cylinder (3), and a flange (13) which, disposed around the circumference of the tip section (15, 16), has a diameter greater than that of the connection unit (32). Further, the housing case (8) is provided with a case main body (61) which has an opening (61a) and houses the needle hub (6), and with a support unit (66) which, provided on a bottom surface (62) opposite of the opening (61a) of the case main body (61), is in contact with the flange (13). Further, the needle hub (6) is provided with a contact unit (36) in surface contact with the lateral surface (63) of the case main body (61).

Description

Injection needle unit

The present invention relates to an injection needle unit including a needle hub that holds a needle tube that punctures the needle tip from the surface of the skin, and a storage case that stores the needle hub.

Conventionally, a needle hub that holds a needle tube (hereinafter referred to as the “injection needle assembly” together with the needle tube and the needle hub) keeps the cutting edge of the needle tube protected and sterilized. It is housed in a housing case made of a hard material such as plastic, and the sterilized state of the needle tip of the needle tube is maintained. Then, the syringe is connected to the needle hub, and the needle assembly is removed from the storage case.

For example, Patent Literature 1 discloses an injection needle set including such an injection needle assembly and a storage case. In Patent Document 1, a convex portion is provided on the outer peripheral surface of the needle hub that holds the needle tube, and a concave portion that engages with the convex portion is provided on the inner peripheral surface of the storage case that stores the needle hub. A technique for preventing the needle hub from rotating with respect to the storage case by engaging the recess is disclosed.

In recent years, in order to reduce blurring when puncturing a needle tube, a technique has been proposed in which a flange-like member that faces and / or contacts the skin is provided on the tip side of the needle hub where the needle tip of the needle tube protrudes. ing.

In order to prevent the needle tip of the needle tube from being accidentally punctured by the user when taking out the injection needle assembly from the storage case, the needle hub has the needle tip of the needle tube facing the bottom surface of the storage case. Stored in a storage case.

Japanese Patent Laid-Open No. 2005-212336

However, if a flange-like member is provided on the distal end side of the needle hub, the diameter on the distal end side becomes larger than the connecting portion connected to the syringe. Therefore, it is necessary to increase the storage space for storing the injection needle assembly in the storage case. there were. When the storage space is increased, the side surface portion on the connection portion side of the needle hub does not contact the side surface portion of the storage case, and the contact area between the side surface portion of the storage case and the side surface portion of the needle hub is reduced. As a result, the needle hub moves and tilts easily in the case body of the storage case due to external force generated when the needle hub is transported or dropped, and the needle tip of the needle tube touches the case body and is damaged. Have the problem of

An object of the present invention is made in view of such a situation, and an injection needle unit that can prevent a needle hub stored in a storage case from moving in the storage case due to an impact force generated during transportation or dropping. Is to provide.

In order to solve the above-described problems and achieve the object of the present invention, an injection needle unit of the present invention includes a needle tube having a needle tip that is punctured into the skin, and a tip portion that holds the needle tube and from which the needle tip of the needle tube projects. And a needle hub having a connection portion that is located on the opposite side of the tip portion and to which the syringe is connected, and a flange portion that is provided around the tip portion and has a diameter larger than that of the connection portion. In addition, the storage device includes a case main body that houses the needle hub and has an opening, and a support case that is provided on a bottom surface facing the opening of the case main body and has a support portion that comes into contact with the flange portion. Further, the needle hub is provided with a contact portion that makes surface contact with the side surface portion of the case main body.

According to the injection needle unit of the present invention, the contact area between the side surface of the case body of the storage case is provided on the needle hub, thereby increasing the contact area between the needle hub that holds the needle tube and the storage case. Can do. As a result, it is possible to regulate the movement of the needle hub within the case body of the storage case by external force generated during transportation or dropping, the needle tip of the needle tube contacts the case body, and the needle tip is damaged. Can be prevented.

It is a disassembled side view which shows the 1st Embodiment of the injection needle unit of this invention. It is sectional drawing which shows the injection needle assembly concerning the 1st Example of the injection needle unit of this invention. It is sectional drawing which shows the state which carried out the cross section of the storage case and cover member concerning the 1st Example of the injection needle unit of this invention. It is sectional drawing which shows the modification of the storage case and cover member concerning the 1st Example of the injection needle unit of this invention. It is sectional drawing which shows the injection needle assembly concerning the 2nd Example of the injection needle unit of this invention.

Hereinafter, embodiments of the injection needle unit of the present invention will be described with reference to FIGS. In addition, the same code | symbol is attached | subjected to the common member in each figure. The present invention is not limited to the following form.
The description will be given in the following order.
1. 1. First Embodiment 1-1. Configuration example of injection needle unit 1-2. Assembling method of the injection needle unit 1-3. 1. Method for assembling drug injection device Second embodiment

<1. First Embodiment>
1-1. Configuration example of injection needle unit [injection needle unit]
First, a first embodiment of the injection needle unit of the present invention (hereinafter referred to as “this example”) will be described with reference to FIGS.
FIG. 1 is an exploded side view showing the injection needle unit of this example. FIG. 2 is a cross-sectional view showing an injection needle assembly according to the injection needle unit of this example.

As shown in FIG. 1, the injection needle unit 1 includes an injection needle assembly 2, a storage case 8 in which the injection needle assembly 2 is stored, and a lid member 9. As shown in FIG. 2, a syringe 3 is detachably connected to the injection needle assembly 2. The injection needle assembly 2 and the syringe 3 constitute a drug injection device 60. This medicine injection device 60 is used when the needle tip is punctured from the surface of the skin and the medicine is injected into the upper layer of the skin. The upper skin layer refers to the epidermis and dermis of the skin.

Here, the skin is composed of three parts: epidermis, dermis, and subcutaneous tissue. The epidermis is a layer of about 50 to 200 μm from the skin surface, and the dermis is a layer of about 1.5 to 3.5 mm continuing from the epidermis. Influenza vaccines are generally administered subcutaneously or intramuscularly, and are therefore administered in the lower layer of the skin or deeper.

On the other hand, it has been studied to reduce the dose of the vaccine by administering the influenza vaccine with the upper skin layer where many immunocompetent cells are present as the target site. The upper skin layer refers to the epidermis and dermis of the skin.

The syringe 3 may be one that is filled with a medicine when the medicine injection device is used, or may be a prefilled syringe that is filled with a medicine in advance. Moreover, as a medicine with which the syringe 3 is filled, a vaccine can be mentioned, but a medicine using a high-molecular substance such as a cytokine or a hormone may be used. The detailed configuration of the syringe 3 will be described later.

[Injection needle assembly]
Next, the injection needle assembly 2 will be described with reference to FIG.
As shown in FIG. 2, the injection needle assembly 2 includes a hollow needle tube 5 having a needle hole, a needle hub 6 to which the needle tube 5 is fixed, and an elastic member 7 disposed in the needle hub 6. Yes. The needle hub 6 includes a first member 11 that is a holding portion that holds the needle tube 5, and a second member 12 that is fixed to the first member 11.

The needle tube 5 of the injection needle assembly 2 has a size of 22 to 33 gauge (outer diameter 0.2 to 0.7 mm) based on the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)). Things can be used. In addition, when used for administration to the upper skin layer, those having a gauge of 26 to 33 gauge can be used, preferably those having a gauge of 30 to 33 gauge.

A needle tip 5A having a blade surface 5a is provided at one end of the needle tube 5. The other axial end of the needle tube 5 opposite to the needle tip 5A is hereinafter 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, Further, it may be about 0.5 mm or more which is a bevel length 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.

Further, the bevel length B is more preferable if the thinnest thickness of the upper skin portion is 0.9 mm (child) or less, that is, the bevel length B is in the range of 0.5 to 0.9 mm. The short bevel refers to a blade surface that is generally used for injection needles and forms an angle of 18 to 25 ° with respect to the longitudinal direction of the needle. Further, a coating agent made of, for example, a silicone resin or a fluorine resin is applied to the surface of the needle tip 5A of the needle tube 5. Thereby, when the needle tube 5 is punctured into a living body, friction between the skin and the needle tube can be reduced, and pain associated with puncture can be reduced.

Examples of the material of the needle tube 5 include stainless steel, but are not limited thereto, and aluminum, aluminum alloy, titanium, titanium alloy, and other metals can be used. Moreover, the needle tube 5 can be applied not only with a straight needle but also with a tapered needle at least partially having a tapered structure. As the tapered needle, the proximal end portion has a larger diameter than the needle distal end portion, and the intermediate portion may have a tapered structure. Further, the cross-sectional shape of the needle tube 5 may be not only a circle but also a polygon such as a triangle. The needle tube 5 is fixed to the needle hub 6.

[Needle hub]
Next, the needle hub 6 will be described. The first member 11 and the second member 12 of the needle hub 6 are formed as separate members, but may be formed integrally. Examples of the material of the first member 11 and the second member 12 include synthetic resins such as polycarbonate, polypropylene, and polyethylene.

The first member 11 includes a substantially columnar base portion 15, an adjustment portion 16, and a flange portion 13 that protrudes radially outward from an outer peripheral surface on one side in the axial direction of the base portion 15. Note that one side in the axial direction of the base portion 15 and the adjusting portion 16 constitute the tip portion of the present invention.

The flange portion 13 includes a stabilizing portion 17, a guide portion 18, and a connection piece 24. The outer diameter of the flange portion 13 is set larger than the outer diameter of the connection portion 32 of the second member 12 described later. In addition, although the example which comprised the flange part 13 by the stable part 17, the guide part 18, and the connection piece 24 was demonstrated, it is not limited to this. The flange portion 13 is not limited to the above-described configuration as long as it protrudes radially outward from the outer periphery of the base portion 15 or the adjustment portion 16.

The base portion 15 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 on the one end side in the axial direction of the base portion 15, and is composed of a columnar convex portion protruding in the axial direction of the base portion 15. The axis of the adjustment unit 16 is coincident with the axis of the base unit 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 for injecting the adhesive 20 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 so as to be substantially orthogonal to 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 to the through hole 21.

Further, the adjusting portion 16 is provided with a discharge hole 23 for discharging the coating agent that is transmitted through the needle tube 5 and infiltrates into the through hole 21. The discharge hole 23 is formed so as to communicate with the through hole 21 from the outer surface of the adjustment portion 16. Further, the axial center of the discharge hole 23 is provided so as to be substantially orthogonal to the axial center of the through hole 21. The discharge hole 23 has an outlet part 23 a and an inlet part 23 b communicating with the through hole 21 on the outer wall of the adjustment part 16.

The proximal end 5B side of the needle tube 5 protrudes from an end face 15b which is the other end of the base portion 15 in the axial direction. The base portion 15 is inserted into the second member 12 from the end surface 15b side, and the proximal end 5B side of the needle tube 5 is inserted into an insertion hole 45 described later of the elastic member 7. And the end surface 15b of the base part 15 is contact | abutted to the end surface 41a which the elastic member 7 mentions later.

Further, a connecting piece 24 constituting the flange portion 13 is provided on the outer peripheral surface of the base portion 15. The connection piece 24 is formed as a ring-shaped flange that protrudes outward in the radial direction of the base portion 15, and has

flat surfaces

24 a and 24 b that face the axial direction of the base portion 15. The second member 12 is connected to the flat surface 24 b of the connection piece 24. Further, the distal end portion of the connection piece 24 is a guide portion 18. The guide portion 18 will be described in detail later.

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.

By the way, the vaccine is generally administered to the upper arm, but when administration to the upper layer of the skin is considered, it is considered that the shoulder peripheral part where the skin is thick, particularly the deltoid part is suitable. 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.

As a result, the thickness of the upper skin layer of the deltoid muscle of the child was 0.9 to 1.6 mm. In addition, the thickness of the upper skin layer of the deltoid muscle of adults was 1.4 to 2.6 mm at the distal part, 1.4 to 2.5 mm at the central part, and 1.5 to 2.5 mm at the proximal part. It was. From the above, it was confirmed that the thickness of the upper skin layer in the deltoid muscle was 0.9 mm or more in the case of children and 1.4 mm or more in the case of adults. Therefore, in the injection in the upper layer part of the deltoid muscle, the protruding length L of the needle tube 5 is preferably set in the range of 0.9 to 1.4 mm.

By setting the protruding length L in this way, the blade surface 5a of the needle tip 5A can be reliably positioned on the upper skin layer. As a result, the needle hole (chemical solution discharge port) that opens in the blade surface 5a can be located in the upper skin layer portion at any position in the blade surface 5a. Even if the drug solution outlet is located in the upper skin layer, if the needle tip 5A is deeply stabbed into 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.

When used for administration to the upper layer of the skin, it is difficult to make the bevel length B 1.0 mm or less with a needle tube thicker than 26 gauge. Therefore, in order to set the protruding length L of the needle tube 5 within a preferable range (0.9 to 1.4 mm), it is preferable to use a needle tube thinner than 26 gauge.

The needle projecting surface 16a is formed so that the distance S from the peripheral edge to the 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, it is possible to prevent the needle protruding surface 16a from pressing the skin around the needle tube 5 and leaking the administered medicine.

The stabilizing portion 17 of the flange portion 13 is formed in a cylindrical shape protruding from the flat surface 24 a of the connection 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 end surface 17a of the stabilizing portion 17 is located on the proximal end 5B side of the needle tube 5 with respect to the needle protruding surface 16a of the adjusting portion 16. When the living body is punctured with the needle tip 5A of the needle tube 5, the needle projecting surface 16a first contacts the surface of the skin, and then contacts the end surface 17a of the stabilizing portion 17. At this time, the drug injection device 60 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.

Even if the end surface 17a of the stabilizing portion 17 is positioned on the same plane as the needle projecting surface 16a, or is positioned closer to the needle tip 5A side of the needle tube 5 than the needle projecting surface 16a, the needle tube 5 is skinned. It is possible to keep the posture substantially perpendicular to the angle. In consideration of the swelling of the skin when the stable portion 17 is pressed against the skin, the axial distance between the end surface 17a of the stable portion 17 and the needle protruding surface 16a is preferably set to 1.3 mm or less.

Further, the inner diameter d of the stable portion 17 is set to a value equal to or larger than the diameter of the blister formed on the skin. Specifically, the distance T from the inner wall surface of the stabilizing portion 17 to the peripheral edge of the needle protruding surface 16a is set to be in the range of 4 mm to 15 mm. Thereby, it can prevent that blister formation is inhibited by pressure being applied to a blister from the inner wall surface of stable part 17.

The shortest distance T from the inner wall surface of the stabilizing portion 17 to the outer peripheral surface of the adjusting portion 16 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.

If the distance S from the peripheral edge of the needle projecting surface 16a to the peripheral surface of the needle tube 5 is 0.3 mm or more, the adjusting unit 16 does not enter the skin. Therefore, considering the distance T (4 mm or more) from the inner wall surface of the stable portion 17 to the periphery of the needle protruding surface 16a and the diameter (about 0.3 mm) of the needle protruding surface 16a, the inner diameter d of the stable portion 17 is 9 mm or more. Can be set.

In addition, the shape of the stable part 17 is not limited to a cylindrical shape, and may be formed in a rectangular tube shape such as a quadrangular column or a hexagonal column having a cylindrical hole at the center.

The guide portion 18 of the flange portion 13 is a tip side portion located on the outer side in the radial direction of the first member 11 with respect to the stabilizing portion 17 of the connection piece 24. The guide portion 18 has a contact surface 18a that comes into contact with the skin. The contact surface 18 a is a part of the flat surface 24 a of the connection piece 24, and is a flat surface that is substantially parallel to the end surface 17 a of the stabilizing portion 17. By pressing the stable portion 17 until the contact surface 18a of the guide portion 18 comes into contact with the skin, the force with which the stable portion 17 and the needle tube 5 press the skin can always be secured above a predetermined value. Thereby, the part (equivalent to the protrusion length L) which protrudes from the needle | hook protrusion surface 16a of the needle tube 5 is punctured in skin reliably.

The distance Y from the contact surface 18a of the guide portion 18 to the end surface 17a of the stable portion 17 (hereinafter referred to as “guide portion height”) Y punctures the needle tube 5 and the stable portion 17 by pressing the skin with an appropriate pressing force. Its length is set so that it can. An appropriate pressing force for the needle tube 5 and the stabilizing portion 17 is, for example, 3 to 20 N (Newton). As a result, the guide portion 18 guides the user with the pressing force applied to the skin by the needle tube 5 and the stabilizing portion 17, and the needle tip 5 </ b> A (the blade surface 5 a) of the needle tube 5 can be reliably positioned at the upper skin portion. In addition to being able to give a sense of security to the user.

The guide portion height Y is appropriately determined based on the inner diameter d of the stable portion 17 and the length X 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”). The 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.

[Second member]
Next, the second member 12 will be described.
The second member 12 is formed in a substantially cylindrical shape. One end portion of the second member 12 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 connected by inserting a later-described discharge portion 52 of the syringe 3. It is the connection part 32 to do. 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 fixed piece 34 is formed as a disk-shaped flange that protrudes radially outward 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 diameter of the fixed piece 34 is set to be approximately equal to the diameter of the flange portion 13 of the first member 11. Further, a contact portion 36 is provided on the outer edge of the fixed piece 34. The contact portion 36 is a substantially cylindrical member that protrudes from the outer edge of the fixed piece 34 toward the connection portion 32. When the needle hub 6 that holds the needle tube 5 is stored in the storage case 8, the contact portion 36 comes into surface contact with a side surface portion 63 of the case body 61 described later.

In addition, although the example which formed the contact part 36 in the substantially cylindrical shape was demonstrated in this example, it is not limited to this, The shape of the contact part 36 respond | corresponds to the shape of the case main body 61 mentioned later, For example, it is appropriately set to a rectangular tube shape or the like.

Furthermore, the contact portion 36 is not limited to a cylindrical member, and may be a tongue-like member protruding from the outer edge of the fixed piece 34 toward the connecting portion 32 side.

The cylinder hole 32a of the connection part 32 is set to a size corresponding to the discharge part 52 of the syringe 3, and the diameter continuously decreases toward the insertion part 31 side. A thread groove 35 for screwing the discharge part 52 of the syringe 3 is formed on the inner surface of the connection part 32. The outer diameter of the connection portion 32 is set smaller than the outer diameters of the flange portion 13 and the fixed piece 34.

Between the insertion part 31 and the connection part 32, the engaging part 37 with which the elastic member 7 engages is provided. The engaging portion 37 is formed as a step portion protruding radially inward from the inner surface of the second member 12, and has engaging

surfaces

37 a and 37 b that are substantially orthogonal to the axial direction of the second member 12. . The engaging surface 37a of the engaging portion 37 is engaged with an elastic side flange portion 42, which will be described later, of the elastic member 7, and the engaging protrusion 37 of the elastic member 7 is engaged with the engaging surface 37b.

[Elastic member]
Next, the elastic member 7 will be described. The elastic member 7 is disposed in the second member 12 of the needle hub 6 and is interposed between the first member 11 and the syringe 3. The elastic member 7 includes a main body 41, an elastic side 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. .

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 15a of the base portion 15 of the first member 11 is in contact with the end surface 41a of the main body portion 41, and the tip of the discharge portion 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. Note that the shape of the end face side separation portion 46 in the insertion hole 45 is not limited to a tapered shape as long as the needle tube 5 can be easily inserted into the insertion hole 45.

The contact surface side separation portion 47 forms an opening of the insertion hole 45 in the end surface 41b. The contact surface side separation portion 47 is separated from the outer peripheral surface of the needle tube 5, and is formed in a taper shape such that the diameter of the insertion hole 45 continuously increases toward the end surface 41b. By providing the contact surface side separation portion 47 on the elastic member 7, it is possible to prevent the end surface 41b side of the main body portion 41 from elastically deforming and covering the proximal end 5B of the needle tube 5 and closing the needle hole.

Further, the contact surface side separation portion 47 in the insertion hole 45 is not limited to the one formed in a taper shape, and is, for example, a concave portion that is larger than the diameter of the contact portion 48 and is separated from the outer peripheral surface of the needle tube 5. There may be. That is, the shape of the contact surface side separation portion 47 in the insertion hole 45 may be any shape that can prevent the end surface 41b side of the main body portion 41 from elastically deforming and covering the proximal end 5B of the needle tube 5 and closing the needle hole. .

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, the medicine in the syringe 3 can be prevented from penetrating from between the needle tube 5 and the elastic member 7 to the first member 11 side of the needle hub 6.

The elastic side 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 elastic side flange portion 42 is substantially equal to the outer diameter of the base portion 15 of the first member 11. Therefore, one plane of the elastic side flange portion 42 abuts on an engagement surface 37 a of the engagement portion 37 provided on the second member 12, and the other plane is an end surface 15 b of the base portion 15 of the first member 11. Abut. The elastic member 7 is attached to the needle hub 6 by holding the elastic side flange portion 42 between the engaging portion 37 of the second member 12 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, similarly to the elastic flange portion 42. The stopper protrusion 43 engages with the engagement surface 37 b of the engagement portion 37 provided on the second member 12. The elastic member 7 is locked to move in the axial direction by the elastic side flange portion 42 and the stopper projection 43 engaging the engaging portion 37 of the second member 12.

Examples of the material of the elastic member 7 include various rubber materials such as natural rubber and silicone rubber, various thermoplastic elastomers such as polyurethane and styrene, or mixtures thereof.

[Syringe]
The syringe 3 includes a syringe body 51 and a discharge unit 52 that is continuous with 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 part 52 is formed in a taper shape whose diameter continuously decreases toward the tip. An end surface 52a that is the tip of the discharge portion 52 is a plane that is orthogonal to the axial direction, and is in liquid-tight contact with the end surface 41b of the elastic member 7. Further, on the outer peripheral surface of the discharge portion 52, a screw portion 53 for screwing with the second member 12 of the needle hub 6 is provided.

In the syringe body 51, a gasket (not shown) is accommodated. A space in the syringe body 51 is 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.

As the material of the syringe body 51 and the discharge part 52, synthetic resins such as polycarbonate, polypropylene, and polyethylene may be used, and metals such as stainless steel and aluminum may be used.

[Storage case and lid member]
Next, the storage case 8 and the lid member 9 will be described with reference to FIG.
FIG. 3 is an explanatory view showing a state in which the storage case 8 and the lid member 9 in the injection needle unit 1 of the present example are cross-sectioned.

As shown in FIG. 3, the storage case 8 has a case main body 61 formed in a hollow cylindrical shape. The case body 61 has an opening 61a at one end in the axial direction, and the other end in the axial direction is closed. The case main body 61 includes a substantially circular bottom surface portion 62 and a side surface portion 63 that extends substantially vertically from the outer edge of the bottom surface portion 62. Further, a case-side flange portion 64 is provided at one end portion of the case body 61 on the opening portion 61a side so as to protrude from the side surface portion 63 in the radially outward direction. Then, the injection needle assembly 2 is inserted into the case main body 61.

Further, a plurality of rib-shaped support portions 68 are erected at the corners of the bottom surface portion 62 and the side surface portion 63. The support part 68 is formed in a substantially flat plate shape. The plurality of support portions 68 are arranged at substantially equal intervals on one surface 62 a that faces the opening 61 a side of the bottom surface portion 62. The plurality of support portions 68 protrude from the one surface 62a of the bottom surface portion 62 toward the opening 61a side.

When the injection needle assembly 2 is housed in the case main body 61, the plurality of support portions 68 come into contact with the contact surface 18a of the guide portion 18 of the flange portion 13 in the needle hub 6, and the inner wall of the side surface portion 63 and the needle hub 6 is in surface contact. As a result, the contact area between the needle hub 6 of the injection needle assembly 2 and the case body 61 of the storage case 8 increases, and the movement and inclination of the needle hub 6 in the storage case 8 are restricted. As a result, it is possible to prevent the injection needle assembly 2 from moving in the case main body 61 due to an external force generated during transportation or dropping, and the needle tip 5A of the needle tube 5 contacts the case main body 61, and the needle tip 5A. Can be prevented from being damaged.

Here, the length of the support portion 68 from the bottom surface portion 62 is set longer than the combined length of the protruding length L of the needle tube 5 and the guide portion height Y (see FIG. 2) in the injection needle assembly 2. . As a result, the needle tip 5A of the needle tube 5 of the injection needle assembly 2 can be prevented from coming into contact with the bottom surface portion 62 of the case main body 61 and being deformed.

Furthermore, the opening 61 a of the case body 61 is hermetically sealed by the film-like lid member 9. The lid member 9 is attached to the storage case 8 by heat welding to the end of the opening 61a in the case body 61. Thereby, it is possible to prevent sterilization or the like from entering the case main body 61.

Further, by storing the injection needle assembly 2 in the storage case 8, the needle tip 5A of the needle tube 5 is covered with the case body 61. Thereby, when attaching needle hub 6 to syringe 3, needle tip 5A can be prevented from touching a user's fingertip.

As the material of the case body 61, a synthetic resin (plastic) such as polycarbonate, polypropylene, or polyethylene may be used.

In this example, the lid member 9 has been described as a film-like member. However, the present invention is not limited to this, and the lid member 9 is made of a synthetic resin (plastic) such as polycarbonate, polypropylene, or polyethylene, like the case body 61. ) May be used. In addition, when the lid member 9 is formed using a synthetic resin, the lid member 9 is attached by being fitted to the case main body 61.

Furthermore, in this example, when the lid member 9 is attached to the case main body 61, the example in which the connecting portion 32 of the lid member 9 and the needle hub 6 is separated is described, but the present invention is not limited to this. For example, as shown in FIG. 4, when the cover member 9 is attached to the storage case 8 with the axial length of the case main body 61 </ b> A in the storage case 8 </ b> A corresponding to the axial length of the needle hub 6, The lid member 9 may be in contact with the end portion of the connection portion 32 of the injection needle assembly 2 housed in the case main body 61A.

Thus, in the injection needle assembly 2, the contact surface 18a of the guide portion 18 on one side in the axial direction is supported by the support portion 68A of the case body 61A, and the connection portion 32 on the other side in the axial direction is the lid member 9. Supported by. Therefore, the injection needle assembly 2 is supported not only by the contact portion 36 and the side surface portion 63A of the case main body 61A but also at both ends in the axial direction by the support portion 68A and the lid member 9 of the storage case 8A. Thereby, needle hub 6 can be held firmly and the movement can be controlled more.

1-2. Next, a method for assembling the injection needle unit 1 will be described.
As shown in FIG. 3, the injection needle unit 1 is assembled by inserting the injection needle assembly 2 into the storage case 8. First, the needle tip 5 </ b> A of the needle tube 5 of the injection needle assembly 2 is directed toward the opening side of the case body 61. Next, the injection needle assembly 2 is inserted into the case main body 61. At this time, the contact portion 36 of the needle hub 6 comes into surface contact with the inner wall of the side surface portion 63 of the case body 61. As a result, the movement and inclination of the injection needle assembly 2 within the case main body 61 are restricted.

Then, the contact surface 18 a of the guide portion 18 that is the flange portion 13 comes into contact with the support portion 68. Then, the lid member 9 is attached to the end of the case body 61 on the opening 61 a side by, for example, heat welding, and the opening 61 a of the case body 61 is hermetically sealed by the lid member 9. Thereby, the assembly of the injection needle unit 1 is completed.

1-3. Next, a method for assembling the medicine injection device 60 will be described with reference to FIGS.

As shown in FIG. 2, the drug injection device 60 is assembled by attaching the injection needle assembly 2 to the syringe 3. In order to attach the injection needle assembly 2 to the syringe 3, first, the lid member 9 sealing the opening 61a of the case body 61 shown in FIG. 3 is removed. Here, since the contact portion 36 of the needle hub 6 and the inner wall of the side surface portion 63 of the case main body 61 are in surface contact with each other, the injection needle assembly 2 is difficult to drop off from the case main body 61. Therefore, it is possible to prevent the injection needle assembly 2 from falling out of the case body 61 against the user's intention.

Next, the discharge part 52 of the syringe 3 is inserted into the connection part 32 of the injection needle assembly 2 stored in the storage case 8. Then, the storage case 8 and the syringe 3 are gripped, and the screw portion 53 provided in the discharge portion 52 is screwed into the screw groove 35 of the connection portion 32 (see FIG. 2).

Next, the needle assembly 2 attached to the syringe 3 is pulled out from the case body 61 of the storage case 8. Thereby, the mounting of the injection needle assembly 2 to the syringe 3 is completed, and the assembly of the medicine injection device 60 is completed. As described above, the syringe 3 and the injection needle assembly 2 can be connected without the user's hand coming into contact with the injection needle assembly 2. Therefore, the needle tip 5A of the needle tube 5 can be kept clean until puncturing the living body.

<2. Second Embodiment>
Next, a second embodiment of the needle assembly constituting the needle unit of the present invention will be described with reference to FIG.
FIG. 5 is a view showing a second embodiment of the injection needle assembly 71.

The difference between the needle assembly 71 according to the second embodiment and the needle assembly 2 according to the first embodiment is a place where a contact portion is provided. Therefore, here, the contact portion 86 will be described, and portions common to the injection needle assembly 2 will be denoted by the same reference numerals and redundant description will be omitted.

As shown in FIG. 5, the needle hub 72 of the injection needle assembly 71 shown in the second embodiment is composed of a first member 73 and a second member 74. The guide portion 18 that is the flange portion 13 of the first member 73 is provided with a substantially cylindrical contact portion 86. The contact portion 86 protrudes from the outer edge of the guide portion 18 toward the connection portion 32 side. The contact portion 86 comes into surface contact with the side surface portion 63 of the case body 61 when the needle hub 72 that holds the needle tube 5 is stored in the storage case 8.

Other configurations are the same as those of the injection needle assembly 2 according to the above-described first embodiment, and thus description thereof is omitted. Also by the injection needle assembly 71 having such a needle hub 72, the same operation and effect as the injection needle assembly 2 according to the above-described first embodiment can be obtained.

The embodiment of the injection needle unit of the present invention has been described above, including its effects. However, the injection needle unit of the present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the gist of the invention described in the claims.

For example, in the embodiment described above, the example in which the elastic member is provided between the first member and the second member has been described. However, the injection needle assembly may be configured without providing the elastic member. The first member and the second member may be integrally formed.

In the above embodiment, the first member of the needle hub is provided with the stabilizing portion and the guide portion. However, the injection needle unit according to the present invention may be configured such that the second member or the syringe is provided with a stabilizing portion and a guide portion.

Furthermore, although described as an injection needle assembly for injecting a drug into the upper layer of the skin, the present invention is not limited to this and may be applied to an injection needle assembly used for subcutaneous administration or intramuscular administration.

DESCRIPTION OF SYMBOLS 1 ... Injection needle unit, 2,71 ... Injection needle assembly, 3 ... Syringe, 5 ... Needle tube, 5A ... Needle tip, 5B ... Base end, 5a ... Blade surface, 6, 72 ... Needle hub, 8, 8A ... Storage Case: 9 ... Lid member, 11, 73 ... 1st member, 12, 74 ... 2nd member, 13 ... Flange part, 15 ... Base part (tip part), 16 ... Adjustment part (tip part), 16a ... Needle protrusion Surface, 17 ... Stable part, 18 ... Guide part, 32 ... Connection part, 36,86 ... Contact part, 51 ... Syringe body, 52 ... Discharge part, 52a ... End face (tip), 56 ... Liquid chamber, 60 ... Drug injection Device, 61, 61A ... case body, 61a ... opening, 62,62A ... bottom part, 62a ... one side, 63,63A ... side part, 68 ... supporting part

Claims

A needle tube having a needle tip pierced into the skin;
A tip portion that holds the needle tube and from which the needle tip of the needle tube protrudes; a connection portion that is located on the opposite side of the tip portion and to which a syringe is connected; and is provided around the tip portion, and the connection A needle hub having a flange portion with a diameter larger than the portion;
A housing case that houses the needle hub and has an opening, and a housing case that includes a support portion that is provided on a bottom surface portion facing the opening of the case body and contacts the flange portion;
An injection needle unit in which the needle hub is provided with a contact portion that makes surface contact with a side surface portion of the case body.
The injection needle unit according to claim 1, wherein the contact portion is provided so as to protrude from an outer edge of the flange portion toward the connection portion side of the needle hub.
The injection needle unit according to claim 1, further comprising a lid member that closes the opening and abuts against the connection portion of the needle hub housed in the case body.
The stabilizer is provided on the flange portion so as to cover the periphery of the needle tube in a state where the needle tip of the needle tube protrudes and has an end surface that comes into contact with skin when the needle tube is punctured into a living body. The injection needle unit according to 1.