Intradermal needle, packaged article, and injection device

Provided are an intradermal needle having a protector that is movable from an open position near a needle hub to a closed position where a needle tip is covered, a packaged article, and an injection device. The protector has an arm that is supported in a freely pivotable manner by an axle pin positioned on the base end side of the wide diameter part of the intradermal needle, and a lid supported by the arm. With the axle of pivoting of the protector positioned near the needle hub, the lid may be housed compactly near the needle hub when the protector is in the open position.

FIELD OF THE INVENTION

This invention generally relates to an intradermal needle used for injecting drug into living body, a packaged article, and an injection device.

BACKGROUND DISCUSSION

An intradermal needle has been proposed for injecting drug into an upper layer of skin. Since the intradermal needle is designed to keep a needle tip of a needle tube within the upper layer of skin, the needle tube has a length of protrusion of 3 mm or shorter. By virtue of such short length of protrusion of the needle tube, the intradermal needle is less likely to cause erroneous puncture, as compared with widely-used needles for hypodermic injection. Even in the case of the intradermal needle however, the needle tip remains exposed, so that there remains a risk that the needle tip of the needle tube may accidentally puncture the user after the drug administration or upon disposal of the injection device.

To address this problem, International Patent Application Publication No. 2016/158143 describes a technique of providing a pivotable protector to the intradermal needle. With the intradermal needle described in International Patent Application Publication No. 2016/158143, the needle tip can be prevented from accidentally puncturing the user, by pivoting the protector to cover the needle tip of the needle tube after use.

SUMMARY

No special attention has been paid, however, to the aforementioned intradermal needle in terms of convenience of housing in a packaged article, making the intradermal needle inconvenient to handle.

The intradermal needle disclosed here may be housed more conveniently into a packaged article, may be improved to be easier to handle, a packaged article, and an injection device.

According to one aspect of the disclosure, an intradermal needle comprises a tubular tube having a needle tip configured to puncture a living body, a needle hub supporting the tubular needle and possessing a central axis extending through the needle hub, with the needle hub including a front end side and a base end side on opposite axial sides of the needle hub, and a flange fixed to and extending outwardly from the needle hub so that the flange is an enlarged diameter part of the needle hub. The tubular needle projects away from the needle hub on the front end side of the flange, and a pivotable protector is pivotable about a pivot axis perpendicular to the central axis of the needle hub to pivot from an open position in which the needle tip is exposed and uncovered by the protector to a closed position in which the needle tip is covered by the protector. The protector is pivotably mounted on an axle part positioned on the base end side of the flange so that the protector pivots on the axle part about the pivot axis.

According to the aforementioned intradermal needle, the pivoting axle part of the protector may be positioned so as not to overlap the wide diameter part which is the widest part of the intradermal needle, so that the protector may be sized compactly. Hence, the intradermal needle with the protector may now be housed within a small packaged article having an inner diameter comparable to the diameter of the wide diameter part.

In the intradermal needle, the axle of pivoting of the pivoting axle part may be arranged near the axis of the needle hub. With such structure, the protector can pivot nearly centered round the needle hub, making it possible to compactly house the lid, in the open position, more closely to the axis of the needle hub.

In the intradermal needle, the protector may have an arm that extends from the pivoting axle part, and a lid supported by the arm, wherein each of the pivoting axle part and the arm may be provided as a pair while the needle hub is located between, and the lid may be supported by the pair of arms. With the lid thus supported by the pair of arms, the protector will have enhanced strength, and may be pivoted reliably around the axle of pivoting, even under force applied from directions other than the direction of pivoting, while preventing the arms and the lid from deforming.

In the intradermal needle, the wide diameter part may have formed therein a cutout side that extends in the direction of pivoting of the arms. With such structure, the wide diameter part is prevented from coming into contact with the arms in pivoting motion. Again in the intradermal needle, an interval or distance between the one arm and the other arm may be smaller than a diameter of the wide diameter part. This makes it possible to reduce the distance between the arms comparable to the width of the cutout side of the wide diameter part, to thereby downsize the protector, and to improve convenience for housing into the packaged article.

The intradermal needle may be provided with a restriction member that restricts pivoting of the protector in the open position and the closed position. This successfully prevents the lid of the protector from moving out of a predetermined range of pivoting, and from undesirably obstructing use of the intradermal needle.

In the intradermal needle, the pivoting axle part may have formed therein a resisting member that produces resistive force against pivoting of the protector. This successfully prevents the protector from unintentionally pivoting to obstruct use of the intradermal needle.

The intradermal needle may be provided with a lock mechanism that fixes the protector in the closed position. With this structure, the needle tip is prevented from being exposed, due to re-opening of the protector having been held in the closed position.

In the intradermal needle, the pivoting axle part may be arranged on a bracket mounted on the needle hub. This enables arrangement of the pivoting axle part near the needle hub, with a simple structure.

In the intradermal needle, a socket may be mounted so as to cover the wide diameter part from the base end side, and the pivoting axle part may be arranged on the socket. Further, the socket may have formed thereon a sliding face over which the protector slides, and the sliding face may be provided with a non-return mechanism that blocks reverse pivoting of the protector towards the open position. Further in the intradermal needle, the protector may be provided with a cutout formed by cutting out a part that falls, in the open position, within a predetermined range around the needle hub. With such socket mounted thereon, the strength will be enhanced since the arms of the protector are supported by the sliding face of the socket. In addition, the non-return mechanism can allow the protector to reliably pivot to the closed position.

According to another aspect of the disclosure, a packaged article of the intradermal needle includes the aforementioned intradermal needle, and a container that houses the intradermal needle, wherein the container has a bottom face configured so that the inner diameter of the container nearly equals the diameter of the wide diameter part of the intradermal needle, and the intradermal needle is housed in the container, with the protector in the open position. As described above, the intradermal needle has a protector that can be housed compactly, and the packaged article that houses them may use a container designed for intradermal needle having no protector.

According to still another aspect of the disclosure involves an injection device having the aforementioned intradermal needle, and a syringe attached to the intradermal needle in a detachable manner. Hence, after use of the injection device, the protector of the intradermal needle may be pivoted to the closed position to cover the needle tip, so that the intradermal needle may be disposed safely, without inducing erroneous puncture.

With the intradermal needle, the packaged article, and the injection device according to these aspects, convenience for housing in a small packaged article and convenience for handling will be improved.

DETAILED DESCRIPTION

Set forth below with reference to the accompanying drawings is a detailed description of embodiments of an intradermal needle, a packaged article that includes an intradermal needle, and an injection device representing examples of the inventive intradermal needle, packaged article and injection device disclosed here.

First Embodiment

An intradermal needle10of this embodiment is provided as a product as illustrated inFIG.1, while being housed in a packaged article12that individually packages the intradermal needle (medical needle)10. The intradermal needle10, sealed in the packaged article12, is kept aseptic until just before use.

The packaged article12includes a container70that houses the intradermal needle10, and a seal member72that closes the container70. When used, the seal member72is peeled off by the user from the container70, thus making the intradermal needle10in the container70accessible to the user.

The container70possesses a cylindrical shape, with an inner space formed therein, and a bottom face74having a circular shape whose diameter is slightly larger than the diameter (outer diameter) of the wide diameter part (enlarged diameter part)30of the needle hub16. The container70also includes an upstanding cylinder wall76that extends up from the bottom face74in the axial direction of the intradermal needle10, and this cylinder wall76is sized so that an inner diameter of the container is slightly larger than the diameter (outer diameter) of the wide diameter part30of the intradermal needle10. In the cylinder wall76, an engagement part (not illustrated) that engages with a claw36of the wide diameter part30is formed. The engagement part and the claw36contribute to prevent disengagement of the intradermal needle10from the container70, and to restrict pivoting of the intradermal needle10around the axis, making it easy to attach a syringe20(seeFIG.4). The top end of the cylinder wall76includes a flange78onto which the seal member72is bonded.

The intradermal needle10is housed in the packaged article12, with the protector80held in the open position near the needle hub16. Since the protector80, in the open position, can fall within a cylindrical region having a diameter nearly equal to the diameter of the wide diameter part30, the packaged article12sized according to the wide diameter part30can now house the intradermal needle10.

The intradermal needle10enclosed in the packaged article12, with the protector80held in the open position, is used as it is in an injection device18(seeFIG.4). The intradermal needle10is designed so that the needle tip14ais covered, after use, with the protector80by pivoting the protector80around the axle of pivoting (pivot axis or pivot axle) to the closed position as illustrated inFIG.6.

Next, a structure of the protector80constituting a part of the intradermal needle10will be explained. The protector80has, as illustrated inFIG.2, a pair of connection parts82, an arm84that extends from each of the connection parts82, a lid86supported by the pair of arms84, and a bracket88mounted on a second member24of the needle hub16. In the description below, the direction approaching the axis of the needle hub16is referred to as inner or inside, while the direction departing from or moving away from the axis is referred to as outer or outside. Also, a face closer to the axis of the needle hub16is referred to as an inner circumferential face, while a face on the side departing from the axis is referred to as an outer circumferential face.

The bracket88is a cylindrical component that holds the second member24between from the outer circumferential side. As illustrated inFIG.3, the bracket88is composed of halves, which are a split piece88aand a split piece88b.Each of the split piece88aand the split piece88bhas a connection part having a wedge87cthinned towards the end, and a receiving part87dthat receives the wedge87c.The wedge87cis provided with a stopper piece87afor preventing unintentional release, and a hole87bthat engages with the stopper piece87ais formed in the receiving part87d.The split pieces88a,88bare engaged with each other by inserting the wedges87cof the split pieces88a,88binto the receiving parts87d,and by engaging the stopper pieces87awith the holes87b,thereby the bracket88is mounted so as to hold the second member24in between.

Each of the split pieces88a,88bhas a ring-shaped protrusion87eformed on the inner circumferential face, and a plurality of ribs87farranged at intervals in the circumferential direction on the inner circumferential face. The protrusion87e,when fitted in a groove33formed in a side wall of the second member24, blocks the bracket88from moving towards the front end or the base end. With the bracket88mounted on the second member24, the ribs87fengage with pivoting stop protrusions39that extend from the outer circumference of the second member24in radial directions. Rotation of the bracket88around the axis of the needle hub16may thus be blocked by the engagement between the pivoting stop protrusions39and the ribs87f.

Each of the split pieces88a,88bhas, on the outer circumferential face and at the center thereof in the circumferential direction, an axle pin89(pivoting axle part) formed so as to extend outwards. The axle pin89on one split piece88ais arranged at an opposite position 180 degrees from the axle pin89on the other split piece88b,while the second member24is positioned between the two axle pins, and the center axis of these axle pins89extends perpendicularly to and passes through the axis of the second member24. The axle pins89are members that support the connection parts82, whose center axis serves as a pivot axis or rotation axis of the protector80. The center axis (axle of pivoting or axis of rotation) of the axle pins89need not always be perpendicular to and pass through the axis of the needle hub16, and instead may be in the vicinity of the axis of the needle hub16, meaning the axis of rotation can be slightly spaced from the needle hub16axis.

Each axle pin89possesses a polygonal (non-circular) shape, and is slidable against a hole82athat also possesses a polygonal shape. This produces resistive force that acts to obstruct pivoting motion of the protector80, and blocks free pivoting of the protector80. That is, the polygonal outer circumferential faces of the axle pins89and the polygonal holes82aconstitute the resisting member, by which the protector80is prevented from unintentionally pivoting.

The axle pin89has a restriction projection89athat extends from the outer side face of the axle pin89. The restriction projection89aengages with an open position restriction groove or recess82cand a closed position restriction groove or recess82dof each connection part82and can thereby stop or hold the protector80in the open position or in the closed position. That is, the restriction projection89a,the open position restriction groove82cand the closed position restriction groove82dconstitute the restriction member.

In the protector80, the connection part82, the arm84and the lid86are formed integrally in one piece. Each of the connection part82and the arm84is provided as a pair, and the lid86is supported from both sides by the pair of arms84. The connection part82is provided as a pair, corresponding to the axle pins89. Each connection part82possesses a cylindrical shape that extends in the direction of the pivot axis, and has at the center thereof a hole82athat engages with each axle pin89. The connection parts82are attached to the bracket88, by fitting the connection parts82having the holes82aon the axle pins89from outside. Each hole82ahas a polygonal inner circumferential face, so as to produce resistive force against the axle pin89in the direction of pivoting.

Each connection part82has the open position restriction groove82cand the closed position restriction groove82dformed at the inner end of the connection part82(the end face remote from the arms84). The open position restriction groove82cengages with the restriction projection89aof the axle pin89, when the protector80is in the open position. This makes the protector80stop in the open position (i.e., the protector80is held in the open position). That is, as a result of engagement of the restriction projection89awith the open position restriction groove82c,the protector80is restricted from pivoting away from the open position. Meanwhile, the closed position restriction groove82dengages with the restriction projection89aof the axle pin89, when the protector80is pivoted to the closed position where the lid86covers the needle tip14aof the tubular needle14(seeFIG.6). That is, as a result of engagement of the restriction projection89awith the closed position restriction groove82d,the protector80is restricted from pivoting away from the closed position.

The arm84extends from the end of the outer circumference of the connection part82, towards the outside of the pivot axis. The length of the arm84is determined to an extent that the lid86will not interfere with or contact the wide diameter part30, when the protector80is pivoted to the closed position. In addition, the interval (distance in the direction of the pivot axis) between the one arm84and the other arm84is determined smaller than the diameter of the wide diameter part30(but excluding the cutout side31). With such structure, the protector80may be downsized, and the intradermal needle10may be housed within a cylindrical range having a diameter nearly equal to the diameter of the protector80, with the protector80held in the open position.

The wide diameter part30has a pair of cutout sides31formed conforming to the interval or distance between the arms84. As shown inFIG.3, the periphery of the wide diameter part30may thus be defined by the straight cutout sides31connected by curved segments. These cutout sides31are formed inside the inner face of the arms84, and extend in the direction of pivoting of the arms84. The wide diameter part30is thus designed not to obstruct pivoting of the arms84. As shown inFIG.3, dimension of the wide or enlarged diameter part30(flange) is smaller in the direction parallel to the axle of pivoting (pivot axis) than in the direction perpendicular to the axle of pivoting (pivot axis).

The lid86is formed so as to lie across the pair of arms84. At the center of the lid86, a semicircular cutout86ais formed by performing semicircular cutting out operation. The cutout86ais formed so as to eliminate a part of the lid86which comes near the axis of the second member24when the protector80is held in the open position. With the cutout86athus provided, there is produced, as illustrated inFIG.2, a gap between the male screw40of the second member24and the lid86, into which the front end of the syringe20(seeFIG.5) can be inserted. The lid86may alternatively be formed to give a curved face as illustrated inFIG.3, without special limitation.

The aforementioned protector80may be attached according to the procedures below. First, there is provided the needle hub16whose wide diameter part30has preliminarily formed therein the cutout sides31and the groove33. The split pieces88a,88bare then positioned in predetermined directions relative to the second member24of the needle hub16, and mounted on the second member24so as to hold the second member24or be held on the second member24from the outer circumferential side, to build up or construct the bracket88. Next, the connection part82is brought, with the arms84stretched apart, close to the axle pins89of the bracket88, and the axle pins89are inserted into the holes82aof the connection part82, to build up or construct the protector80. The protector80is then suitably pivoted to engage the restriction projections89awith the open position restriction groove82cto thereby fix the protector80in the open position. Attachment of the protector80is thus finished. The thus manufactured intradermal needle10is enclosed or packaged in the packaged article12(seeFIG.1), and marketed as a product.

The injection device18having the intradermal needle10will be explained below, featuring an internal structure of the intradermal needle10. The intradermal needle10has, as illustrated inFIG.4, a tubular needle14and a needle hub16, and composes a component of an injection device18. When used, the intradermal needle10is assembled on a syringe20provided separately from the intradermal needle10. The user attaches the syringe20to the intradermal needle10to assemble the injection device18, and then punctures a living body with the needle tip14aof the intradermal needle10. Upon pressing a plunger56of the syringe20while maintaining the punctured state, a chemical solution contained in the syringe20is intradermally injected through the tubular needle14into the living body.

After injection, the intradermal needle10is disposed, with the used tubular needle14covered and unexposed by the protector80, thus making it possible to avoid accidental puncture with the tubular needle14. The individual components of the injection device18(intradermal needle10and syringe20) will be explained below.

As illustrated inFIG.5, the tubular needle14of the intradermal needle10is given in the form of rigid hollow tube, with a needle hole15arranged at the axial center. A needle tip14ahaving a sharp blade face or pointed end is at the frontmost part (distal-most end) of the tubular needle14. The tubular needle14may have a diameter not specifically limited, whose gauge number is typically 26 to 33 (0.2 to 0.45 mm), and more preferably 30 to 33. Examples of materials from which the tubular needle14may be fabricated include stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, other metals, and hard resins.

The needle hub16of the intradermal needle10has a first member22to which the tubular needle14is fixed, and a second member24on which the syringe20to be attached to the first member22is assembled. Examples of materials from which the first and second members22,24may be fabricated include resin materials such as polycarbonate, polypropylene, and polyethylene. The needle hub16also has an elastic member26inside the second member24.

The first member22has an axial part28that directly holds the tubular needle14, the wide diameter part30that extends radially outward from the outer circumferential face of the axial part28, and an axially extending annular or ring-shaped protrusion32that extends ahead of an end face30aof the wide diameter part30. The axial part28possesses a near cylindrical shape, and, at the axial center of the axial part28, is provided with a fixing hole29that houses and fixes the tubular needle14. With the tubular needle14positioned in the fixing hole29, an adhesive34is injected to fix the tubular needle14and the first member22.

The axial part28has a housing part28ahoused in the second member24, and a protruding part28bthat protrudes ahead of the wide diameter part30. The protruding part28bof the axial part28protrudes slightly ahead of the ring protrusion32, and has an end face28b1that comes into contact with a surface of a living body. The tubular needle14fixed to the fixing hole29protrudes an appropriate amount (length of protrusion) ahead of the end face28b1. For example, the length of protrusion of the tubular needle14is designed equivalent to the depth of dermis from the skin surface of the living body, which preferably falls in the range from approximately 0.5 to 3.0 mm.

The wide diameter part30is formed like a disk that extends from the outer circumferential face of the axial part28in the direction perpendicular to the center axis of the axial part28. The wide diameter part30extends further beyond the ring protrusion32in the radial direction. On the base end face or surface30b,which is a face or surface on the base end side of the wide diameter part30(a face opposite to the end face30aat which the annular protrusion32is arranged), the second member24is bonded. As illustrated inFIG.4, on the outer circumference of the wide diameter part30, a pair of claws36are formed so as to protrude outward. The pair of claws36are arranged on the opposite sides (180° degrees opposite position) on the outer circumference of the wide diameter part30.

The annular or ring-shaped protrusion32is a part that slightly protrudes like a wall from the wide diameter part30towards the front end, and is configured to define a cylindrical shape that surrounds the axial part28while maintaining a predetermined distance in between. When using the intradermal needle10, the entire range of an end face32aof the ring protrusion32comes into contact with the skin of the living body. The ring protrusion32can therefore guide the injection device18so as to maintain the puncture posture perpendicular to the skin, and can maintain a constant depth of penetration of the tubular needle14into the skin.

As illustrated inFIG.5, the second member24is configured as a near cylindrical shape with a through-hole25formed along the center axis. On the front end side of the through-hole25, the housing part28aof the first member22is positioned, meanwhile in the middle of the through-hole25, an elastic member26is housed. On the base end side of the through-hole25, a nozzle44of the syringe20is inserted during assemblage of the injection device18. The inner circumferential face, on the base end side, of the through-hole25is tapered so as to allow surface contact with the outer circumferential face of the nozzle44.

On the front end of the second member24, there is provided a connecting wide diameter part38that extends outwards in the radial direction. The outer circumferential edge of the connecting wide diameter part38is inside the outer circumferential edge of the wide diameter part30of the first member22. The connecting wide diameter part38is fixed at its end face38ato the base end face30bof the wide diameter part30, by an appropriate method of bonding such as vibration welding. On the outer circumferential face or surface on the base end side of the second member24, there is provided a male screw40on which a female screw47of the syringe20is screwed.

In other words, the syringe20has in its front end part42, a nozzle44having an ejection channel45communicated with a reservoir61of the drug, and a connector46arranged around the nozzle44, with the female screw47threaded on the inner face. With the male screw40and the female screw47engaged, the end face of the nozzle44comes into contact with, and pressurizes the base end face of the elastic member26.

The elastic member26of the intradermal needle10is a cylindrical connecting or joining member that keeps the base end of the tubular needle14liquid-tight, and holds the needle hole15opposing to the ejection channel45of the nozzle44. The elastic member26includes a tubular needle hole48, and in the tubular needle hole48, an inner projection50that holds the inserted tubular needle14in contact therewith is formed. The elastic member26is tightly fixed while fitting itself to the inner circumference of the through-hole25of the second member24, and while allowing an outward projection52, which projects at the front end side outwards in the radial direction, to be positioned or held between the base end face of the first member22and a step24aof the second member24.

The bracket88is mounted on the outer circumferential surface of the second member24. The bracket88is provided with the pair of axle pins89. The axle pins89are arranged at 180 degrees opposite positions on the outer circumference of the bracket88. The axle pins89are individually fitted with the connection parts82having the holes82a.Each connection part82protrudes outwards by a predetermined length. From each connection part82, each arm84extends. The lid86is formed or provided at the free ends of such pair of arms84. The lid86has the cutout86athat produces, between the lid86in the open position and the needle hub16, the gap into which the syringe20can be inserted. That is, provision of the cutout86aenables attachment of the syringe20to the needle hub16, without interference from the protector80even when the protector80is housed in the open position near the axis of the needle hub16.

Meanwhile, the syringe20of the injection device18illustrated inFIG.4is provided as a prefilled syringe having the drug preliminarily filled therein. The syringe20has a syringe body54, a plunger56that is positioned in the syringe body54in a relatively movable manner, and a holder58that covers the outside of the syringe body54.

The syringe body54has the front end part42(nozzle44and connector46), and a barrel60having a reservoir61that communicates with the front end part42and stores the drug. A gasket62is provided at the front end of the plunger56. The gasket62is positioned in a liquid-tight manner in the reservoir61, and has at the base end of the gasket62an operation part64pushed by the user of the injection device18. Alternatively, the syringe20may be of a type having the gasket62preliminarily housed in the reservoir61, allowing the plunger56to be attached to the gasket62when the syringe20is used.

The holder58is a cylindrical body that houses and fixes the syringe body54, and is used for increasing the outer diameter of the injection device18, making it more convenient for the user to grip. Hence the holder58has on the base end thereof a finger flange66on which fingers of the user who pushes the operation part64of the plunger56are hooked or engaged. The injection device18may alternatively have no holder58.

The inner wall of the holder58surrounding the inner space has a plurality of support pieces (not illustrated) that support the front end part of the barrel60of the syringe body54. The outer circumference of the holder58also has a lock window68that locks a flange (not illustrated) provided to the base end of the syringe body54, and the holder58also has at around the front end thereof a check window69through which the reservoir61of the syringe body54can be visually checked.

The intradermal needle10, the packaged article12, and the injection device18according to this embodiment are basically composed as described above. Operations of these items will be explained below.

The intradermal needle10is marketed as a product as illustrated inFIG.1, while being enclosed in the container70of the packaged article12. As described above, the intradermal needle10in this state has the protector80held in the open position near the axis of the needle hub16. The packaged article12keeps the intradermal needle10air-tight, by virtue of the seal member72bonded to the flange78of the container70.

When using the injection device18, the seal member72of the packaged article12is peeled off, and the front end of the syringe20is inserted into the packaged article12, so as to connect the base end of the intradermal needle10and the syringe20. That is, as illustrated inFIG.4, the nozzle44of the front end part42of the syringe20is inserted into the through-hole25of the second member24, and the female screw47of the connector46is screwed on the male screw40of the intradermal needle10. In this process, the protector80of the intradermal needle10is kept in the open position as illustrated inFIG.5. The connector46of the syringe20is inserted in the gap between the semicircular cutout86aformed in the lid86of the protector80and the second member24.

After the intradermal needle10and the syringe20are connected, the syringe20is pulled out from the packaged article12. In this way, the pair of claws36of the intradermal needle10are released from the packaged article12, and thereby the intradermal needle10and the syringe20are integrally taken out from the packaged article12.

The tubular needle14of the intradermal needle10is then punctured into the living body to inject the drug stored in the reservoir61of the syringe20. The protector80in this state is held in the open position, while keeping the open position restriction groove82cof the connection part82engaged with the restriction projection89a.After injecting the drug, the used intradermal needle10is removed from the living body and is disposed.

When disposing the intradermal needle10, the user pivots the protector80with fingers to the closed position. In this process, upon application of a predetermined level or larger force in the direction of pivoting of the protector80towards the closed position, the arms84will elastically deform outwards, and the restriction projections89aare released from the open position restriction grooves82cto thereby allow the arms84to freely pivotable. Upon further pivoting of the protector80towards the closed position, the restriction projections89aengage the closed position restriction grooves82d(seeFIG.3) of the connection part82, thus the protector80stops pivoting. The protector80thus moves to the closed position. In the closed position, the protector80is held so as not to escape the closed position, as a result of engagement of the restriction projections89awith the closed position restriction grooves82dof the fixed connection part82. With the needle tip14aof the tubular needle14thus covered by the lid86of the protector80, the user is protected from the sharp needle tip14a.Thus the intradermal needle10can be disposed safely.

As described above, the intradermal needle10of this embodiment has the pivoting axle part (axle pin89) of the protector80provided on the bracket88which is mounted on the base end side of the wide diameter part30. This makes the protector80movable by pivoting nearly centered round the needle hub16, and thereby the protector80may be housed compactly in the open position near the needle hub16. This makes it possible to house the intradermal needle10with the protector80within the packaged article12whose inner diameter is nearly equal to the diameter (outer diameter) of the wide diameter part30.

The protector80is designed to include the pair of connection parts82and the pair of arms84arranged while placing the second member24in between, and to make the pair of arms84support the lid86from both sides. This enhances strength of the protector80, makes it less likely to deform under force applied from directions other than direction of pivoting, and makes the protector80pivotable safely to the closed position.

In the wide diameter part30of the needle hub16, the cutout sides31that extend in the direction of pivoting of the arms84are formed. With such structure, the wide diameter part30may be prevented from coming into contact with the arms84during pivoting operation of the arms84. The interval between the pair of arms84may be made smaller than the outer diameter of the wide diameter part30, which is variable depending on position of the cutout sides31. This makes it possible to house the protector80with the arms84compactly in the open position, improving convenience for housing in a small packaged article12.

The protector80is provided with the open position restriction grooves82c,the closed position restriction grooves82d,and the restriction projections89athat engage the open position restriction grooves82cand the closed position restriction grooves82d,all of which constitute a restriction member for restricting pivoting at the open position and the closed position. This successfully restricts pivoting of the protector80enclosed in the packaged article12, and prevents accidental contact of the lid86in the open position with the syringe20. It also makes it possible to prevent the protector80in the closed position from pivoting, and allowing the needle tip14ato accidentally be exposed.

With the cutout86ain the lid86in a part closer to the pivot axis, formed so as to eliminate a part thereof near the axis of the second member24, a space is now available for insertion of the syringe20.

In the intradermal needle10, the annular bracket88is mounted on the second member24, and the axle pins89are arranged to the bracket88. Hence the axle of pivoting of the protector80approaches near the axis of the needle hub16, and the protector80in the open position can be housed near the needle hub16, thus improving convenience for housing of the intradermal needle10.

Second Embodiment

An intradermal needle10A of a second embodiment will be explained below. The inner structure of the needle hub16of the intradermal needle10A is the same as that of the intradermal needle10illustrated inFIG.5, and so a detailed description of such inner structure will not be repeated. In the description below, structure and features of the intradermal needle10A that are the same as those in the intradermal needle10described above and illustrated inFIGS.1-6are identified by the same reference numerals and a detailed description of such structure and features is not repeated.

The intradermal needle10A is marketed as a product enclosed in the packaged article12A, with a lid96of a protector90held in the open position near the axis of the needle hub16, as illustrated inFIG.7. The packaged article12A includes a container70with a housing space for housing the intradermal needle10A, and a seal member72that seals the container70. The container70has a bottom face74whose inner diameter is nearly equal to the diameter (outer diameter) of the wide diameter part30of the intradermal needle10A, and from the bottom face74, the cylindrical cylinder wall76extends in the axial direction of the intradermal needle10A. The cylinder wall76has an inner diameter nearly equal to the diameter (outer diameter) of the wide diameter part30. The cylinder wall76has the flange78at the top end of the cylinder wall76, and the seal member72is bonded to the flange78.

The intradermal needle10A of this embodiment is composed of, as illustrated inFIG.8, the needle hub16having the first member22and the second member24, and the protector90mounted thereon. The protector90has a socket91mounted so as to cover the wide diameter part30from the base end side, the pair of arms94attached to the socket91, and the lid96supported by the arms94.

The protector90of this embodiment has the axle of pivoting (pivot axis) positioned on the base end side of the wide diameter part30, and the axle of pivoting (pivot axis) extends in the direction perpendicular to the axis of the needle hub16. The axle of pivoting of the protector90preferably lies perpendicular to and passes through the axis of the needle hub16, but may be positioned slightly spaced from the needle hub16axis so as to lie near the axis of the needle hub16. This enables the protector90to pivot nearly centered round the needle hub16, and thereby the lid96in the open position may be housed compactly near the needle hub16.

The socket91of the intradermal needle10A is mounted on the wide diameter part30of the first member22. The wide diameter part30has the pair of cutout sides31formed so as to cut out, in a straight or linear manner, in the direction of pivoting of the protector90. These cutout sides31are formed on the pivoting face91bof the socket91in a co-plane manner, so as not to interfere with the pivoting of the arms94. As illustrated inFIG.9, on both ends of cutout side31, recesses31aon which legs95of the socket91are engaged are formed. The legs95of the socket91engage their hooks95awith the recesses31a,to thereby mount the socket91on the wide diameter part30.

The socket91is shaped like a box with an open end on the front end side, and has the legs95extended from four corners thereof on the front end side. Each leg95has the hook95athat engages with the wide diameter part30. By fitting the legs95with the recesses31aof the wide diameter part30to thereby engage the hooks95awith the wide diameter part30as described above, the socket91is fixed on the needle hub16. The upper face of the socket91, on the base end side, also has a circular opening91a.The opening91ais larger than the outer diameter of the second member24of the needle hub16. With the second member24allowed to pass through the opening91a,the socket91is mounted on the wide diameter part30without coming into contact with the sidewall of the second member24.

Among the four side faces of the socket91, a pair of pivoting faces91bthat are opposed to the arms94individually have the axle pins92that compose the pivoting axle part. Each axle pin92extends like a pillar in the direction perpendicular to the axis of the needle hub16, whose center axis serves as the axle of pivoting (pivot axis) of the protector90. Each axle pin92has a polygonal shape when viewed from the direction of the pivot axis, and is designed to produce a predetermined level of resistive force against pivoting of the arms94. Such axle pin92is also provided to the pivoting face91bon the far side of the sheet of drawing, and these axle pins92are arranged on a common pivot axis, meaning the pivot axes for the two axle pins92are coaxial.

The pivoting face91balso has an arcuate ratchet groove93centered round the axle of pivoting (i.e., the center of the radius of curvature of each arcuate ratchet groove93is the pivot axis of the axle pin92on the respective side of the socket), and a protrusion part99arranged on an extension ahead of one end of the ratchet groove93. The ratchet groove93is a part engaged with the claw97of the arm94, and the claw97is designed to move, as the arm94pivots, along the ratchet groove93while keeping contact with the ratchet groove93towards the protrusion part99. In the ratchet groove93, a plurality of teeth93aare formed. These teeth93aare formed to give a saw-shaped cross section with upright faces on the side closer to the protrusion part99.

The protrusion part99also functions as the open position restriction member and the closed position restriction member. That is, upon contact of the protrusion part99with a first side edge94bof the arm94, the arm94is restricted from further pivoting in the open direction (i.e., in the counter-clockwise direction inFIG.8). Meanwhile, upon contact of the protrusion part99with a second side edge94cof the arm94, the arm94is restricted from further pivoting in the closed direction (i.e., in the clockwise direction inFIG.9). The ratchet groove93and the protrusion part99may alternatively be arranged on both of the pivoting faces91b,but may be arranged only on one face as illustrated above.

The arms94and the lid96attached to the socket91are formed integrally with one another as a single piece. The arms94are provided as a pair corresponding to the axle pins92, while being spaced from each other in the direction of the axle of pivoting. The arms94are formed like a plate which is flat in the direction of the axle of pivoting, and can pivot with the inner faces thereof slid over the pivoting faces91bof the socket91. In each arm94, a hole94athat engages with the axle pin92is formed. Each hole94apossesses a polygonal shape conforming to the outer configuration of the axle pins92. In the illustrated embodiment, one of the arms94has a clawed opening97ain which the claw97is arranged. The claw97composes a non-return mechanism that engages with the teeth93aof the ratchet groove93to allow pivoting from the open position to the closed position, while prohibiting the reverse pivoting.

The lid96is a plate-shaped member formed so as to lie across the pair of arms94, with both side ends supported by the arms94. Although not specifically limited, the lid96may alternatively be formed into a curved face as illustrated here. The lid96has at the center thereof a U-shaped cutout96a.The cutout96ais formed by cutting out a part of the lid96, which comes near the axis of the needle hub16when the protector90is held in the open position as illustrated inFIG.8. Provision of such cutout96aproduces a gap necessary for attaching the syringe20, between the needle hub16and the lid96. With the cutout96athus having the U shape which is oblong in the direction pivoting, the lid96can be pivoted to the closed position without interfering with the syringe20, even when the syringe20is attached.

The socket91can be mounted on the protector90by aligning the legs95to the recesses31aof the wide diameter part30, and pressing them towards the wide diameter part30. This allows the hooks95aof the legs95to engage with the wide diameter part30, to thereby fix the socket91on the wide diameter part30. A molded article having the arms94and the lid96integrally molded therein is prepared, and the axle pins92are engaged with the holes94awhile keeping the arms94stretched apart, thus attaching the arms94and the lid96to the socket91. The protector90is thus assembled to the needle hub16.

The intradermal needle10A of this embodiment is basically built as described above. Operations of these items will be explained below.

The intradermal needle10A is marketed as a product while being enclosed in the packaged article12A. The intradermal needle10A is enclosed in the packaged article12A with the protector90held in the open position, and becomes accessible to the user after the seal member72is peeled off from the container70. The syringe20(seeFIG.4) is then assembled to the intradermal needle10A. The protector90in this process is kept in the open position, with the aid of the resistive force in the direction of pivoting produced by the polygonal axle pins92(pivoting axle part) and the holes94a.The protector90is kept in the open position also during use. After using the intradermal needle10A, the user pivots the protector90with fingers to move the protector90to the closed position, as illustrated inFIG.10.

The arms94of the protector90in this process pivot while keeping contact between the claw97of the arm94and the ratchet groove93. The teeth93aof the ratchet groove93have the upright faces on the side closer to the closed position, which allows pivoting towards the closed position only, while restricting pivoting towards the open position. The arms94stop pivoting upon contact with the protrusion part99in the closed position. Hence the arms94are restricted by the ratchet groove93and the claw97, and thereby the protector90is kept locked in the closed position. That is, the protector90in the intradermal needle10A is fixed in the closed position, since the ratchet groove93and the claw97act as a lock mechanism. The needle tip14ais thus kept covered with the lid96, making the intradermal needle10A safely disposable.

In the aforementioned intradermal needle10A, the axle pins92(pivoting axle part) are provided to the socket91mounted on the wide diameter part30. This makes it possible to arrange the axle of pivoting of the axle pins92(pivoting axle part) on the base end side of the wide diameter part30, so as to lie near the needle hub16, with minimum working on the needle hub16. In addition, since the protector90is designed to pivot centered round the axle of pivoting near the needle hub16, so that the lid96of the protector90in the open position may be housed near the axis of the needle hub16, thus improving convenience for housing of the intradermal needle10A.

In the intradermal needle10A, the pair of axle pins92are provided to a box-shaped socket91, and the pair of arms94are provided corresponding to the individual axle pins92. Since a part of the arm94near the axle of pivoting is supported by the box-shaped socket91, so that the protector90will have further improved strength. Hence the protector90may be moved reliably to the closed position while preventing the arms94and the lid96from deforming, even under force applied from directions other than the direction of pivoting.

In the intradermal needle10A, the wide diameter part30is provided with the cutout sides31that extend in the direction of pivoting of the arms94, so that when the arms94is pivoted, the arms94are prevented from coming into contact with the wide diameter part30. In addition, in the intradermal needle10A, with the interval or distance between the pair of arms94being smaller than the diameter of the wide diameter part30, the protector90may be downsized, thus improving convenience for housing in the packaged article12A.

In the intradermal needle10A, the polygonal shape of the axle pins92contributes to produce resistive force against pivoting of the protector90. This successfully prevents the protector90from unintentionally pivoting to obstruct use of the intradermal needle10A.

In the intradermal needle10A, the ratchet groove93is provided to the socket91, and the claw97that comes into contact with the ratchet groove93is provided to the arm94. This successfully blocks the protector90from pivoting in the reverse direction, and prevents the needle tip14afrom being exposed, due to re-opening of the protector90having been held in the closed position.

The detailed description above describes embodiments of an intradermal needle, a packaged article that includes an intradermal needle, and an injection device representing examples of the inventive intradermal needle, packaged article and injection device disclosed here. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.