Patent Description:
Intradermal needle has been proposed for injecting drug into un 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 <NUM> 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 the intradermal needle however remains to expose the needle tip, so that there remains a risk that the needle tip of the needle tube may accidentally puncture the user after the drag administration or upon disposal of the injection device.

Aiming at solving this problem, <CIT> describes a technique of providing a pivotable protector to the intradermal needle. With such intradermal needle, 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.

<CIT> discloses an injection device according to the preamble of claim <NUM>.

<CIT> discloses a safety shield assembly for a cannula. The safety shield assembly comprises a sheath that rotatable via a pin. The part of the sheath that is connected to the pin acts as an arm.

<CIT> discloses another safety shield assembly having a sheath that rotatable via a pin. The proximal end of the sheath that is connected to the pin acts as an arm.

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

It is therefore an object of the present invention to provide an intradermal needle which may be housed more conveniently into a packaging article, may be improved to be easier to handle, a packaging article thereof, and an injection device.

This object is solved by an intradermal needle having the features of claim <NUM>. A packaging article comprising the intradermal needle is stated in claim <NUM>. An injection device comprising the intradermal needle and a syringe is stated in claim <NUM>. Further developments are stated in the dependent claims.

According to the aforementioned intradermal needle, the pivoting axle part is provided near the axis of the needle hub, the lid is formed to give a width smaller than the diameter of the wide diameter part, and when the protector is placed in the open position, the lid is arranged near the axis of the needle hub. Hence, when the protector is placed in the open position, the lid is housed compactly near the axis of the needle hub. This consequently makes it possible to house the intradermal needle in a small packaging article having an inner diameter comparable to the diameter of the wide diameter part.

The intradermal needle may have, provided thereto, an open position restriction member that keeps, in the open position, a free end of the lid away from the needle hub. With such structure, when attaching a syringe to the needle hub, the free end of the lid is prevented from being brought into contact with the syringe to interfere the attachment of the syringe.

In the intradermal needle, the lid may have a closed position restriction member that restricts a stop position of the lid at the closed position of the protector, and the closed position restriction member may keep an inner face of the lid, facing to the needle tip, closer to the front end side than the ring protrusion. With this structure, the needle tube that protrudes out of the ring protrusion may be covered with the lid.

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

The intradermal needle has a cutout that houses in the open position a part of the needle hub, formed at a part closer to the pivoting axle part of the lid. With this structure, the lid in the open position may be housed at the position near the axis of the needle hub, and thereby the protector may be housed compactly.

In the intradermal needle, a pair of the arms may be arranged away from each other in an axial direction of the pivoting axle part. Further in this case, the pivoting axle part may have a pair of axle pins arranged as spaced from each other in the axial direction, and the arms are engaged with the axle pins in a freely pivotable manner. With this structure, the arms will have enhanced rigidity at around the pivoting axle part, and even under force applied from directions other than the direction around the axle of pivoting, the protector will be suppressed from pivoting in wrong directions, and will therefore be prevented from unfortunately disengaging to expose the needle tip.

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

Preferred embodiments of this invention will be detailed below, referring to the attached drawings.

An intradermal needle <NUM> of this embodiment is provided as a product as illustrated in <FIG>, while being housed in a packaging article <NUM> that individually packages the intradermal needle (medical needle) <NUM>. The intradermal needle <NUM>, sealed in the packaging article <NUM>, is kept aseptic until just before use.

The packaging article <NUM> has a container <NUM> that houses the intradermal needle <NUM>, and a seal member <NUM> that closes the container <NUM>. When used, the seal member <NUM> is peeled off by the user from the container <NUM>, thus making the user accessible to the intradermal needle <NUM> in the container <NUM>.

The container <NUM> is formed into a cylindrical shape, with an inner space formed therein. A bottom face <NUM> of the container <NUM> has a circular shape whose diameter is slightly larger than that of a wide diameter part <NUM> of a needle hub <NUM> described later. From the bottom face <NUM> of the container <NUM>, a cylindrical wall <NUM> extends in the axial direction of the intradermal needle <NUM>. The cylindrical wall <NUM> is formed to give an inner diameter slightly larger than the diameter of the wide diameter part <NUM> of the needle hub <NUM>. The container <NUM> also has a flange <NUM> formed at the top end. The seal member <NUM> is attached to the flange <NUM>.

The intradermal needle <NUM> is housed in such packaging article <NUM>, with the lid member <NUM> of the protector <NUM> kept in the open position. The protector <NUM> is formed so as to be enclosed, in the open position, within a cylindrical region having the diameter equal to that of the wide diameter part <NUM>, and is thus housed without interfering with the packaging article <NUM>.

The intradermal needle <NUM> has, as illustrated in <FIG>, a needle tube <NUM> and a needle hub <NUM>, and composes a component of an injection device <NUM>. When used, the intradermal needle <NUM> is assembled on a syringe <NUM> provided separately from the intradermal needle <NUM>. The user attaches the syringe <NUM> to the intradermal needle <NUM> to assemble the injection device <NUM>, and then punctures a living body with the needle tip 14a of the intradermal needle <NUM>. Upon pressing a plunger <NUM> of the syringe <NUM> while keeping a state of puncture, a chemical solution contained in the syringe <NUM> is intradermally injected through the needle tube <NUM> into the living body. After injection, the intradermal needle <NUM> is disposed, with the used needle tube <NUM> covered and unexposed with the protector <NUM>, thus making it possible to avoid accidental puncture with the needle tube <NUM>.

The individual constituents of the intradermal needle <NUM> will be explained below. As illustrated in <FIG>, the needle tube <NUM> of the intradermal needle <NUM> is given in the form of rigid hollow tube, with a needle hole <NUM> arranged at the axial center. The needle tube <NUM> has formed at the frontmost part the needle tip 14a composed of a sharp blade face. The needle tube <NUM> may have a thickness not specifically limited, whose gauge number is typically <NUM> to <NUM> (<NUM> to <NUM>), and more preferably <NUM> to <NUM>. Materials for composing the needle tube <NUM> are exemplified by stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, other metals, and hard resins.

The needle hub <NUM> of the intradermal needle <NUM> has a first member <NUM> that fixes the needle tube <NUM>, and a second member <NUM> on which the syringe <NUM> to be attached to the first member <NUM> is assembled. Materials for composing the first and second members <NUM>, <NUM> are exemplified by resin materials such as polycarbonate, polypropylene, and polyethylene. The needle hub <NUM> also has an elastic member <NUM> inside the second member <NUM>.

The first member <NUM> has an axial part <NUM> that directly holds the needle tube <NUM>, the wide diameter part <NUM> that extends like a flange radially from the outer circumferential face of the axial part <NUM>, and a ring protrusion <NUM> that extends ahead of an end face 30a of the wide diameter part <NUM>. The axial part <NUM> is formed into a near cylindrical shape, and has formed at the axial center a fixing hole <NUM> that houses and fixes the needle tube <NUM>. With the needle tube <NUM> inserted into the fixing hole <NUM>, an adhesive <NUM> is injected to fix the needle tube <NUM> and the first member <NUM>.

The axial part <NUM> has a housing part 28a housed in the second member <NUM>, and a protruding part 28b that protrudes ahead of the wide diameter part <NUM>. The protruding part 28b of the axial part <NUM> protrudes slightly ahead of the ring protrusion <NUM>, and has an end face 28b1 that comes into contact with a surface of a living body. The needle tube <NUM> fixed to the fixing hole <NUM> protrudes an appropriate dimension (length of protrusion) ahead of the end face 28b1. For example, the length of protrusion of the needle tube <NUM> is designed equivalent to the depth of dermis from the skin surface of the living body, which preferably falls in the range from approximately <NUM> to <NUM>.

The wide diameter part <NUM> is formed like a disk that extends from the outer circumferential face of the axial part <NUM> in the direction perpendicular to the center axis of the axial part <NUM>. The wide diameter part <NUM> extends further beyond the ring protrusion <NUM> in the radial direction. On the base end face 30b, which is a face on the base end side of the wide diameter part <NUM> (a face opposite to the end face 30a having the ring protrusion <NUM> arranged thereon), the second member <NUM> is bonded. The wide diameter part <NUM> has, formed on the outer circumference thereof, a pair of claws <NUM> (see <FIG>) that protrudes outward. The pair of claws <NUM> are arranged on the opposite sides (<NUM>° degrees opposite position) on the outer circumference of the wide diameter part <NUM>.

The ring protrusion <NUM> is a part that shortly protrudes like a wall from the wide diameter part <NUM> towards the front end, and is formed to give a cylindrical shape that surrounds the axial part <NUM> while keeping a predetermined distance in between. When using the intradermal needle <NUM>, the entire range of an end face 32a of the ring protrusion <NUM> comes into contact with the skin of the living body. The ring protrusion <NUM> can therefore guide the injection device <NUM> so as to keep a posture of puncture perpendicularly to the skin, and can keep a constant depth of puncture of the needle tube <NUM> into the skin.

The second member <NUM> is formed to give a near cylindrical shape with a through-hole <NUM> formed along the center axis. On the front end side of the through-hole <NUM>, the housing part 28a of the first member <NUM> is inserted, meanwhile in the middle of the through-hole <NUM>, an elastic member <NUM> is housed. On the base end side of the through-hole <NUM>, a nozzle <NUM> (see <FIG>) of the syringe <NUM> is inserted during assemblage of the injection device <NUM>. The inner circumferential face, on the base end side, of the through-hole <NUM> is tapered so as to allow surface contact with the outer circumferential face of the nozzle <NUM>.

On the front end of the second member <NUM>, there is provided a connecting wide diameter part <NUM> that extends outwards in the radial direction. The outer circumferential edge of the connecting wide diameter part <NUM> falls inside the outer circumferential edge of the wide diameter part <NUM> of the first member <NUM>. The connecting wide diameter part <NUM> is fixed at its end face 38a to the base end face 30b of the wide diameter part <NUM>, by an appropriate method of bonding such as vibration welding. On the outer circumferential face on the base end side of the second member <NUM>, there is provided a male screw <NUM> on which a female screw <NUM> (see <FIG>) of the syringe <NUM> is screwed.

Next, a structure of the protector <NUM> provided to the intradermal needle <NUM> will be explained. The protector <NUM> is housed in the packaging article <NUM> while being kept in the open position as illustrated in <FIG> and <FIG>, and is pivoted, after use of the intradermal needle <NUM>, around the axle of pivoting perpendicular to the axial direction of the axial part <NUM>, to reach the closed position as illustrated in <FIG> and <FIG>, to thereby cover the needle tip 14a. The protector <NUM> has, as illustrated in <FIG>, the lid member <NUM>, and a protector mounting part <NUM> that holds the lid member <NUM> in a freely pivotable manner.

Now in the description below, the direction approaching the axis of the needle hub <NUM> is referred to as inward, inner or inside, meanwhile the direction departing from the axis of the needle hub <NUM> is referred to as outward, outer or outside. The lid member <NUM> has a lid 82b and arms <NUM>.

The lid 82b is a plate-like member that covers the needle tip 14a of the needle tube <NUM>, when moved to the closed position (see <FIG>). Now the face of the lid 82b opposed, in the closed position, to the needle tube <NUM> is referred to as an inner face 82b1, and the face on the opposite side is referred to as an outer face 82b2.

The lid 82b is, as illustrated in <FIG>, formed to give a shape similar to the ring protrusion <NUM>, so as to cover the entire range of the ring protrusion <NUM>. The lid 82b has a width W (see <FIG>) equivalent to the diameter of the ring protrusion <NUM>.

If the lid 82b should have the width W larger than a diameter D of the wide diameter part <NUM>, the packaging article <NUM> manufactured while being sized to fit the diameter of the wide diameter part <NUM> would not be able to house the intradermal needle <NUM>. The width W of the lid 82b is therefore preferably made smaller than the diameter D of the wide diameter part <NUM>.

As illustrated in <FIG>, the lid 82b has, formed on the outer face 82b2 thereof and in a part closer to the pivoting axle part, a cutout <NUM> having a shape obliquely and curvedly cut off the outer face 82b2. The cutout <NUM> is, as illustrated in <FIG>, a part that receives the second member <NUM> in the open position of the lid 82b and contacts therewith, and is formed to give a curved face conforming to the cylindrical side face of the second member <NUM>. Although <FIG> illustrates the cutout <NUM> that partially extends through the lid 82b to reach the inner face 82b1, such through part is positioned away from the needle tip 14a of the needle tube <NUM>, without particular inconvenience for the protection of the needle tip 14a. With the cutout <NUM> provided in this way, the lid 82b in the open position may be arranged near the axis of the needle hub <NUM> and housed compactly, making housing in the packaging article <NUM> easier.

Meanwhile, the lid 82b has, formed on the free end side thereof (the side opposite to the axle mounting part 84c), an end face 82c that is obliquely cut. The end face 82c is provided to prevent the lid 82b from coming into contact with the syringe <NUM>, when the syringe <NUM> is attached to the intradermal needle <NUM> housed in the packaging article <NUM>. That is, the end face 82c of the lid 82b is formed so as to be positioned in the open position ahead of the syringe <NUM> to be attached, so that the lid 82b will not overlap the area of attachment of the syringe <NUM>.

As illustrated in <FIG>, the lid 82b has a wall 82d formed so as to protrude like a wall from the circumference of the inner face 82b1. The wall 82d has an end face 82d1 (first face) which serves as a face brought into contact in the closed position (see <FIG>) with the end face 32a of the ring protrusion <NUM>. That is, the end face 82d1 of the wall 82d comes into contact with the end face 32a of the ring protrusion <NUM> to stop pivoting of the protector <NUM> at the closed position of the lid 82b. Such wall 82d with the end face 82d1 constitutes the closed position restriction member.

The wall 82d has a height of protrusion measured from the inner face 82b1, equivalent to or larger than the length of protrusion of the needle tip 14a of the needle tube <NUM> from the ring protrusion <NUM>. Hence, the lid 82b in the closed position can keep the inner face 82b1 spaced ahead of the ring protrusion <NUM> in the front end direction, and can cover the needle tip 14a that protrudes ahead of the ring protrusion <NUM>.

The wall 82d has, formed on a part thereof, a wall-like guide piece <NUM> that further protrudes beyond the wall 82d. The guide piece <NUM> is formed to give a shape that falls within the inner circumference of the ring protrusion <NUM>. With the guide piece <NUM> inserted in the closed position within the ring protrusion <NUM>, the lid 82b may be prevented from rattling.

The wall 82d also has a cutoff partially on the free end side, in which a lock piece <NUM> with a claw 89a is formed so as to protrude from the inner face 82b1. The lock piece <NUM> constitutes a lock mechanism that fixes the lid 82b in the closed position, by engaging itself in the closed position with the opening 32b (see <FIG>) of the ring protrusion <NUM> from inside.

The lid 82b has, as illustrated in <FIG>, a pair of arms <NUM> that extend from both ends thereof in the direction of axle of pivoting. The arms <NUM> are formed integrally with the lid 82b. Each arm <NUM> has a first arm 84a that extends perpendicularly towards the inner face 82b1 of the lid 82b, a second arm 84b that extends after kinked at nearly right angles from the first arm 84a, and an axle mounting part 84c provided at the end of the second arm 84b.

The axle mounting part 84c is formed to give a cylindrical shape centered round the axle of pivoting, and has at the center thereof a round hole <NUM> that receives the axle pin 31a. The axle mounting part 84c has a cutoff face 84c1 that has been cut off obliquely as illustrated in <FIG>. The cutoff face 84c1, when viewed with the lid 82b kept in the open position, is formed inside a circular region having the same diameter as that of the wide diameter part <NUM>.

The second arm 84b is a part that extends from the axle mounting part 84c, and is integrally formed with the axle mounting part 84c. The second arm 84b is provided in order to position the first arm 84a in contact with the end face 38b of the connecting wide diameter part <NUM> of the second member <NUM>, when the lid 82b moves to the open position. That is, with such second member <NUM> provided in this way, the lid member <NUM> in the open position may be arranged inside the connecting wide diameter part <NUM>, enabling compact housing of the lid member <NUM> while being kept near the axis of the needle hub <NUM>. The length of the second arm 84b may suitably be determined depending on the thickness of the wide diameter part <NUM> and of the connecting wide diameter part <NUM>.

The first arm 84a extends after kinked at nearly right angles from the second arm 84b. The first arm 84a keeps the lid 82b a predetermined distance away from the pivoting axle part (axle pin 31a), and can thereby allow the lid 82b to be housed in the open position near the needle hub <NUM>.

The first arm 84a has an inclined face 84e that comes, in the open position, into contact with the connecting wide diameter part <NUM>. With the inclined face 84e kept in contact with the connecting wide diameter part <NUM>, the lid member <NUM> is banned to pivot towards the open position, and is restricted so that it can no longer approach the axis of the needle hub <NUM>. That is, the inclined face 84e constitutes the open position restriction member that restricts the position of the lid member <NUM> in the open position, so as to stop at a predetermined angle. The angle of the inclined face 84e is determined so that the lid member <NUM> in the open position will have, as illustrated in <FIG>, its free end spaced by a predetermined distance from the second member <NUM> of the needle hub <NUM>. In this way, the lid member <NUM> is prevented from interfering with the syringe <NUM> when attached to the intradermal needle <NUM>, thus successfully preventing the assemblage work from being interrupted.

As illustrated in <FIG>, the wide diameter part <NUM> has on one end thereof a cutoff side 30c at which the wide diameter part <NUM> is straightly cut off, and a protector mounting part <NUM> that extends from the center of the cutoff side 30c outwards in the radial direction. The protector mounting part <NUM> has a T-shape when viewed from the front end, and has the axle pins 31a that extend from both sides thereof. Each axle pin 31a is a member formed so as to extend in a cylindrical shape in the direction perpendicular to the axis of the needle hub <NUM>, with the center axis thereof allowed to serve as the pivoting axle part (axis of rotation) of the lid member <NUM>. As illustrated in <FIG>, the pivoting axle part of the protector <NUM> is formed inside a circular region E having the diameter equal to that of the wide diameter part <NUM> (near the axis of the needle hub <NUM>). With such structure, the entire part of the protector <NUM> including the protector mounting part <NUM> may be housed within the circular region E when the protector <NUM> is in the open position, thus enabling the housing in the small packaging article <NUM>.

The protector <NUM> is manufactured by attaching the lid member <NUM> to the protector mounting part <NUM>. That is, while expanding the arms <NUM> of the lid member <NUM> in the axial direction, the protector mounting part <NUM> is fitted in between the pair of axle mounting parts 84c. By fitting the axle pins 31a into the holes <NUM> of the axle mounting part 84c, the protector <NUM> is built up.

The intradermal needle <NUM> having the protector <NUM> is used with the syringe <NUM> attached thereto as illustrated in <FIG>. The syringe <NUM> has in its front end part <NUM>, a nozzle <NUM> having an ejection channel <NUM> communicated with a reservoir <NUM> of the chemical liquid, and a connector <NUM> arranged around the nozzle <NUM>, with the female screw <NUM> threaded on the inner face. With the male screw <NUM> and the female screw <NUM> engaged, the end face of the nozzle <NUM> comes into contact with, and pressurizes the base end face of the elastic member <NUM>.

The elastic member <NUM> of the intradermal needle <NUM> is a cylindrical relay member that keeps the base end of the needle tube <NUM> liquid-tight, and holds the needle hole <NUM> opposing to the ejection channel <NUM> of the nozzle <NUM>. The elastic member <NUM> has inside thereof a needle tube hole <NUM>, and the needle tube hole <NUM> has formed therein an inner projection <NUM> that holds the inserted needle tube <NUM> in contact therewith. The elastic member <NUM> is tightly fixed while fitting itself to the inner circumference of the through-hole <NUM> of the second member <NUM>, and while allowing an outward projection <NUM>, which projects at the front end side outwards in the radial direction, to be caught between the base end face of the first member <NUM> and a step 24a of the second member <NUM>.

Meanwhile, the syringe <NUM> of the injection device <NUM> is given as a prefilled syringe having the chemical liquid preliminarily filled therein, as illustrated in <FIG>. The syringe <NUM> has, as illustrated in <FIG>, a syringe body <NUM>, a plunger <NUM> that is inserted into the syringe body <NUM> in a relatively movable manner, and a holder <NUM> that covers the outside of the syringe body <NUM>.

The syringe body <NUM> has the front end part <NUM> (nozzle <NUM> and connector <NUM>), and a barrel <NUM> having a reservoir <NUM> that communicates with the front end part <NUM> and stores the chemical liquid. Meanwhile, the plunger <NUM> has at the front end thereof a gasket <NUM> that is inserted liquid-tight into the reservoir <NUM>, and has at the base end thereof an operation part <NUM> pushed by the user of the injection device <NUM>. Alternatively, the syringe <NUM> may be of a type having the gasket <NUM> preliminarily housed in the reservoir <NUM>, allowing the plunger <NUM> to be attached to the gasket <NUM> when the syringe <NUM> is used.

The holder <NUM> is a cylindrical body that houses and fixes the syringe body <NUM>, and is used for thickening the injection device <NUM>, making it more convenient for the user to grip. Hence the holder <NUM> has on the base end thereof a finger flange <NUM> on which fingers of the user who pushes the operation part <NUM> of the plunger <NUM> are hooked. The injection device <NUM> may alternatively have no holder <NUM>.

The holder <NUM> has, arranged on the inner wall thereof surrounding the inner space, a plurality of support pieces (not illustrated) that support the front end part of the barrel <NUM> of the syringe body <NUM>. The holder <NUM> also has, on the outer circumference thereof, a lock window <NUM> for locking a flange (not illustrated) provided to the base end of the syringe body <NUM>, and the holder <NUM> also has at around the front end thereof a check window <NUM> through which the reservoir <NUM> of the syringe body <NUM> can be visually checked.

The intradermal needle <NUM>, the packaging article <NUM> that houses the intradermal needle <NUM>, and the injection device <NUM> according to this embodiment are basically composed as described above. Operations of these items will be explained below.

The intradermal needle <NUM> is provided while being housed in a container <NUM> of the packaging article <NUM> as illustrated in <FIG>. As has been described above, the intradermal needle <NUM> in this state is prevented from dropping from the packaging article <NUM>, with the pair of claws <NUM> of the intradermal needle <NUM> kept hooked on an engagement part of the container <NUM>. The packaging article <NUM> encloses the intradermal needle <NUM> airtight, as a result of placement of the seal member <NUM> onto the flange <NUM> of the container <NUM>.

When using the injection device <NUM>, the seal member <NUM> of the packaging article <NUM> is peeled off, the front end of the syringe <NUM> is inserted into the packaging article <NUM>, so as to connect the base end of the intradermal needle <NUM> and the front end part <NUM> of the syringe <NUM>. That is, as illustrated in <FIG>, the nozzle <NUM> of the front end part <NUM> is inserted into the through-hole <NUM> of the second member <NUM>, and the female screw <NUM> of the connector <NUM> is screwed on the male screw <NUM> of the intradermal needle <NUM>. In this process, the protector <NUM> of the intradermal needle <NUM> is kept in the open position, and the free end of the lid member <NUM> is spaced by a predetermined distance from the axis of the intradermal needle <NUM>, so as not to interfere with the connector <NUM> of the syringe <NUM>. Hence, the protector <NUM> will no longer interfere attachment of the syringe <NUM>.

After the intradermal needle <NUM> and the syringe <NUM> are connected, the syringe <NUM> is pulled out from the packaging article <NUM>. In this way, the pair of claws <NUM> of the intradermal needle <NUM> are released from the packaging article <NUM>, and thereby the intradermal needle <NUM> and the syringe <NUM> are integrally taken out from the packaging article <NUM>.

The needle tube <NUM> of the intradermal needle <NUM> is then punctured into the living body to inject the chemical liquid having been stored in the reservoir <NUM> of the syringe <NUM>. After injecting the chemical liquid, the used intradermal needle <NUM> is disposed.

The user in this process pivots the protector <NUM> with fingers to move the protector <NUM> (lid member <NUM>) to the closed position. As illustrated in <FIG> and <FIG>, as the protector <NUM> pivots, the guide piece <NUM> of the lid member <NUM> is inserted inside the ring protrusion <NUM> while contacting therewith, and the lid member <NUM> covers the ring protrusion <NUM>. As the lid member <NUM> is further pushed into the base end side of the ring protrusion <NUM>, the claw 89a of the lock piece <NUM> hooks on the opening 32b of the ring protrusion <NUM>, to thereby lock the lid 82b in the closed position. That is, the lid member <NUM> is fixed on the ring protrusion <NUM> so as not to disengage. With the protector <NUM> thus fixed so as to cover the needle tip 14a of the intradermal needle <NUM>, the intradermal needle <NUM> can now be disposed safely.

As has been described above, with the protector <NUM> attached pivotably around the axle of pivoting provided to the wide diameter part <NUM>, and with the lid member <NUM> whose width W being made smaller than the diameter D of the wide diameter part <NUM>, the intradermal needle <NUM> of this embodiment can now be housed in a small packaging article <NUM> whose inner diameter is comparable to the diameter of the wide diameter part <NUM>.

Also provision of the arms <NUM> enables compact housing of the lid 82b near the axis of the needle hub <NUM>, when the protector <NUM> is in the closed position, thus improving the convenience for housing in the packaging article <NUM>.

In addition, the inclined face 84e is provided on each arm <NUM>, as the open position restriction member that keeps the free end of the lid 82b, in the open position, away from the male screw <NUM> of the intradermal needle <NUM>. With such structure, when attaching the syringe <NUM> to the needle hub <NUM>, the free end of the lid 82b may be prevented from accidentally coming into contact with the syringe <NUM>, and from interfering attachment of the syringe <NUM>.

The lid 82b also has the wall 82d (end face 82d1) as the closed position restriction member that restricts the stop position of the lid 82b in the closed position. With such wall 82d, the lid 82b in the closed position is kept with the inner face 82b1 thereof closer to the front end side than the ring protrusion <NUM>. This allows the lid 82b to cover the needle tip 14a from the front end side.

Also in the closed position, the lock piece <NUM> provided to the lid 82b engages with the opening 32b provided to the ring protrusion <NUM>, and thereby the lid member <NUM> is fixed to the closed position. Hence, the needle tube <NUM> is prevented from being accidentally exposed, due to re-opening of the lid member <NUM> after moved to the closed position.

In addition, the lid 82b has, provided to a part thereof close to the pivoting axle part, the cutout <NUM> that houses a part of the side wall of the needle hub <NUM> in the open position. This consequently makes it possible to arrange the lid 82b in the open position near the axis of the needle hub <NUM>, and to compactly house the protector <NUM> near the axis of the needle hub <NUM>.

Furthermore, with the pair of arms <NUM> arranged away from each other in the direction of pivoting axle part of the lid 82b, the arms <NUM> will have enhanced rigidity at around the axle of pivoting, and may be prevented from deforming even under force applied from directions other than the direction around the axle of pivoting, so that the lid 82b may be prevented from pivoting in wrong directions. Hence, the lid 82b will no longer pivot in wrong directions departing from the needle tube <NUM> so as to allow the user's fingers to accidentally come into contact with the needle tube <NUM>. With the pair of arms <NUM> in this case pivotably engaged using the axle pins 31a, the strength may further be enhanced than in a case where the pivoting axle part were composed of a thin hinge.

An intradermal needle 10A of this embodiment will be explained below, referring to <FIG>. The inner structure of the intradermal needle 10A is same as that of the intradermal needle <NUM> illustrated in <FIG>, and will therefore be not explained redundantly. In the intradermal needle 10A, the same structures as those in the intradermal needle <NUM> having been described referring to <FIG>, will be given the same reference signs, and will not be detailed redundantly.

The intradermal needle 10A of this embodiment is different from the intradermal needle <NUM> in terms of a protector <NUM>. The protector <NUM> will now be explained below. The protector <NUM> is formed pivotable about the wide diameter part <NUM> with the aid of a hinge <NUM> provided to the wide diameter part <NUM>. The hinge <NUM> is arranged inside the wide diameter part <NUM> when viewed in the radial direction. That is, distance R<NUM> measured from the axis M of the intradermal needle 10A to the hinge <NUM> is smaller than the radius R<NUM> of the wide diameter part <NUM>. The hinge <NUM>, although illustrated as being thinner than the other part, is not restricted thereto. For example, the hinge <NUM> may have the axle pins 31a and the axle mounting parts 84c as illustrated in <FIG> and <FIG>. The protector <NUM> is made pivotable while being centered round the hinge <NUM>, around an axis perpendicular to the axis M of the intradermal needle 10A (in a direction perpendicular to a sheet of this drawing).

From the hinge <NUM>, an arm <NUM> extends. From the arm <NUM>, the lid <NUM> extends after kinked near-vertically, and the lid <NUM> has on its free end a lock piece <NUM> which locks to the opening 32b of the ring protrusion <NUM>. The lid <NUM> has at the center thereof a projection <NUM> that opposes, in the closed position, to the needle tube <NUM>.

The arm <NUM> is a member that keeps the hinge <NUM> and an inner face 94a of the lid <NUM> apart, where length L<NUM> given by the arm <NUM> between the pivoting axle part of the hinge <NUM> and the lid <NUM> is set nearly equal to distance L<NUM>, in the axial direction of the intradermal needle 10A, between the hinge <NUM> and the end face of the ring protrusion <NUM>. The inner face 94a of the lid <NUM> comes into contact with the end face 32a of the ring protrusion <NUM>, when the protector <NUM> is pivoted to the closed position.

The lid <NUM> may have any shape so long as the center projection <NUM> can face an inner face 96a thereof to the needle tube <NUM>, when the protector <NUM> is pivoted to the closed position. The lid <NUM> is sized so as to fall, in the illustrated open position, inside a region with radius R<NUM> centered round the axis M of the intradermal needle 10A. This enables housing in the small packaging article <NUM> (see <FIG>).

Distance T<NUM> between the inner face 96a of the projection <NUM> and the inner face 94a of the lid <NUM> is larger than length of protrusion T<NUM>, measured from the end face of the ring protrusion <NUM>, of the needle tube <NUM>, and thereby the projection <NUM> can cover the needle tube <NUM>.

In the protector <NUM> of this embodiment, there is provided a restriction piece <NUM> that extends from the side wall of the intradermal needle 10A, as an open position restriction member that stops the protector <NUM> in the open position so as to keep the free end thereof away from the axis of the intradermal needle 10A. With the restriction piece <NUM> brought into contact with the lid <NUM>, the protector <NUM> may be kept a predetermined distance d<NUM> away from the axis of the intradermal needle 10A. The distance d<NUM> is preferably set larger than thickness d<NUM> of the connector <NUM> of the syringe <NUM>.

Also with the aforementioned intradermal needle 10A of this embodiment, convenience for housing in the small packaging article <NUM> is improved.

An intradermal needle 10B of the third embodiment will be explained below, referring to <FIG>. The inner structure of the intradermal needle 10B (see <FIG>) is same as that of the intradermal needle <NUM> illustrated in <FIG>, and will therefore be not explained redundantly. In the intradermal needle 10B, the same structures as those in the intradermal needle <NUM> having been described referring to <FIG>, will be given the same reference signs, and will not be detailed redundantly.

The protector 80A of this embodiment (see <FIG>) is built up by mounting the lid member 82A illustrated in <FIG> to the protector mounting part <NUM> illustrated in <FIG>. The lid member 82A of this embodiment is different from the lid member <NUM> illustrated in <FIG>, in that the axle mounting parts 84c have provided thereto intermediate lock pieces <NUM> and open position lock pieces <NUM>, aiming at producing resistive force during pivoting to enhance safety.

As illustrated in <FIG>, each axle mounting part 84c has the hole <NUM> into which each axle pin 31a of the protector mounting part <NUM> is inserted. Each axle mounting part 84c is built up so as to slide against the protector mounting part <NUM> (see <FIG>), on a sliding face 87a which resides in the outer circumference of the hole <NUM> and faces to the opposing arm <NUM>. In this embodiment, the intermediate lock piece <NUM> is formed on a circumferential part of the sliding face 87a, so as to protrude towards the opposing arm <NUM>.

Each intermediate lock piece <NUM> has a first projection 101a and a second projection 101b that protrude towards the axial center of each hole <NUM>, and an engagement recess <NUM> formed in between. The first projection 101a and the second projection 101b are formed away from each other in the circumferential direction of the hole <NUM>. The first projection 101a and the second projection 101b are parts that reside more closely to the axial center of the hole <NUM> than the engagement recess <NUM>. The first projection 101a and the second projection 101b have their ends on the center side, which are approximately a length equivalent to radius R3 away from the axis of the hole <NUM>, so as not to interfere with axle supports 31b (see <FIG>) formed at the bases of the axle pins 31a, when the lid member 82A pivots.

Each intermediate lock piece <NUM> may reside at any position not specifically limited in the circumferential direction of the hole <NUM>, but may preferably reside at a position where the lid member 82A can produce resistive force against pivoting, when the lid member 82A is pivoted ahead of the wide diameter part <NUM> (see <FIG>).

The open position lock piece <NUM> is formed so as to protrude outward in the radial direction from the outer circumference of the axle mounting part 84c that is formed cylindrically around the hole <NUM>. The open position lock piece <NUM> extends in the direction the second arm 84b extends, and is built so as to restrict pivoting of the lid member 82A when the lid member 82A is kept in the open position, while allowing itself to contact with the cutoff side 30c of the wide diameter part <NUM> (see <FIG>).

The lid member 82A of this embodiment does not have the guide piece <NUM> (see <FIG>) that protrudes from the wall 82d, and is built to cover the ring protrusion <NUM> solely with the wall 82d. Note however that the lid member 82A is not limited thereto, instead allowing provision of the guide piece <NUM>.

As illustrated in <FIG>, the needle hub 16A of this embodiment has a cutoff side 30c formed so as to straightly cut off the wide diameter part <NUM> at one end thereof, and a protector mounting part <NUM> that extends from the center of the cutoff side 30c outwards in the radial direction. The protector mounting part <NUM> has a T-shape when viewed from the front end, and has the axle pins 31a that extend from both sides thereof. Each axle pin 31a is a member formed so as to extend in a cylindrical shape in the direction perpendicular to the axis of the needle hub 16A, with the center axis thereof allowed to serve as the pivoting axle part (axis of rotation) of the lid member 82A.

On the base end side of the axle pins 31a of the protector mounting part <NUM>, there are provided the axle supports 31b that support the axle pins 31a, which are formed so as to extend in the axial direction of the axle pins 31a. The axle supports 31b are formed so as to expand in the radial direction of the axle pins 31a, and have steps 31b2 that are composed of end faces perpendicular to the axis of the axle pins 31a, between themselves and the axle pins 31a. The steps 31b2 constitute faces against which the sliding face 87a of the lid member 82A can slide. Between the axle supports 31b and the cutoff side 30c, there are formed recesses 31c that allow insertion of the axle mounting part 84c.

As illustrated in a partially enlarged view in <FIG>, the axle support 31b has a side face which is composed of an arcuate curved face 31b1 formed so as to extend along the range given by a length equivalent to radius R3 from the axis of the axle pin 31a. Hence the curved face 31b1 will no longer interfere with the intermediate lock piece <NUM> of the axle mounting part 84c. Meanwhile, the axle support 31b has, formed at the corner on the side closer to the base end face 30b, a pivoting restriction projection 31d that protrudes beyond the range given by a length equivalent to radius R3 from the axis of the axle pin 31a. The pivoting restriction projection 31d is built to come into contact with the intermediate lock piece <NUM> to thereby produce resistive force against pivoting of the lid member 82A.

Operations of the intradermal needle 10B of this embodiment will be explained below.

As illustrated in <FIG>, the protector 80A of the intradermal needle 10B of this embodiment is built by engaging the pair of holes <NUM> of the lid member 82A with the axle pins 31a of the protector mounting part <NUM>.

As illustrated in <FIG>, with the lid member 82A held in the open position, the open position lock piece <NUM> comes into contact with the cutoff side 30c that protrudes from the outer circumference of the axle mounting part 84c. Hence, the force of pivoting the lid member 82A clockwise from the illustrated position towards the closure, will be resisted by contact of the open position lock piece <NUM> with the cutoff side 30c. The lid member 82A may therefore be prevented from rattling during carriage or usage of the intradermal needle 10B, and from unintentional closure.

Note that if the user applies a predetermined level or larger force through its finger to pivot the lid member 82A towards the closure, the lid member 82A may be closed despite the resistive force produced by the open position lock piece <NUM> and the cutoff side 30c. Upon disengagement of the open position lock piece <NUM> from the cutoff side 30c, the lid member 82A becomes to pivot smoothly.

During pivoting of the lid member 82A towards the closure, the lid member 82A is temporarily restricted from pivoting in the middle way as illustrated in <FIG>. Pivoting of the lid member 82A in this process is restricted by resistive force, as a result of interference between the first projection 101a or the second projection 101b of the intermediate lock piece <NUM>, with the pivoting restriction projection 31d of the axle support 31b as illustrated in <FIG>. Upon fitting of the pivoting restriction projection 31d into the engagement recess <NUM> of the intermediate lock piece <NUM>, the lid member 82A stops pivoting. Upon such temporary stopping of pivoting of the lid member 82A at an intermediate position near the closed position, the lid member 82A is prevented from being slammed close, and thereby the user is prevented from erroneous handling and erroneous puncture. That is, by virtue of the temporary resistance against pivoting of the lid member 82A, the user will become cautious to move the lid member 82A towards the closed position, and can prevent erroneous puncture.

Upon further pivoting of the lid member 82A from the intermediate position towards the closure, the intermediate lock piece <NUM> is disengaged from the pivoting restriction projection 31d as illustrated in <FIG>. Then the lid member 82A moves to the closed position as illustrated in <FIG>, to thereby stop pivoting. With the needle tip 14a thus covered with the lid member 82A, the intradermal needle 10B now can be disposed safely.

The intradermal needle 10B of this embodiment can exhibit effects below.

The intradermal needle 10B of this embodiment has the open position lock piece <NUM> and the intermediate lock piece <NUM> that restrict pivoting of the lid member 82A. The open position lock piece <NUM> is formed so as to protrude outwards in the radial direction from the outer circumference of the axle mounting part 84c, and is designed to restrict pivoting of the lid member 82A, when the lid member 82A is heled in the open position near the axis of the needle hub 16A, and comes into contact with the cutoff side 30c. This successfully prevents accidental closure of the lid member 82A, during carriage or usage of the intradermal needle 10B.

In the intradermal needle 10B, the intermediate lock piece <NUM> is formed so as to protrude from the sliding face 87a of the axle mounting part 84c, and is designed to produce resistive force before the lid member 82A reaches the closed position, as a result of interference with the pivoting restriction projection 31d of the protector mounting part <NUM>. This temporarily slows down pivoting of the lid member 82A, giving the user a chance to be careful, and to avoid erroneous puncture.

Claim 1:
An intradermal needle (<NUM>) comprising:
a needle tube (<NUM>) having a needle tip (14a) that can be punctured into a living body;
a needle hub (<NUM>) that is adapted to support the needle tube (<NUM>);
a wide diameter part (<NUM>) that extends like a flange from the needle hub (<NUM>);
a ring protrusion (<NUM>) that extends to a front end side of the wide diameter part (<NUM>), and is formed into a cylindrical shape that surrounds a periphery of the needle tube (<NUM>); and
a protector (<NUM>) pivotably attached to the wide diameter part (<NUM>), so as to be movable from an open position near the needle hub (<NUM>) to a closed position where the needle tip (14a) is covered;
the protector (<NUM>) including:
an pivoting axle part (31a) arranged within a circular region (E) having the same diameter as a diameter of the wide diameter part (<NUM>);
a lid (82b) formed to give a width smaller than a diameter of the wide diameter part (<NUM>); and
an arm (<NUM>) that is pivotably supported by the pivoting axle part (31a),
characterized in that
the arm (<NUM>) is adapted to keep the lid (82b) in the open position away from the pivoting axle part (31a) and near an axis of the needle hub (<NUM>), and
the protector (<NUM>) further comprises a cutout (<NUM>) that is adapted to house a part of the needle hub (<NUM>) in the open position, formed at a part closer to the pivoting axle part (31a) of the lid (82b).