JP7546040B2 - Outer cylinder for needle-equipped syringe, syringe and drug solution administration device - Google Patents

Description

The present invention relates to an outer cylinder for a needle-equipped syringe, a syringe equipped with the same, and a drug solution administration device.

2. Description of the Related Art Syringes have been used for dispensing a fixed amount of liquid medicine (medicinal solution). One example of this type of syringe is an insulin injector for injecting insulin, a liquid medicine for treating diabetes.
Some diabetic patients need to administer insulin repeatedly, several times a day, using a syringe themselves, and the pain caused by the needle when administering the drug (self-injection) is a major problem.

In response to this, various techniques have been disclosed to reduce the pain experienced by patients when the needle is inserted. For example, it is known to use needles that are thinner than the injection needles used by medical professionals, and Patent Document 1 (JP 2002-159576) and Patent Document 2 (JP 2002-291884) disclose needles whose outer diameter is thin at the tip and thickens from the tip to the base, with the inner diameter changing accordingly. Patent Document 3 (JP 2005-087519) also discloses a drug injection device equipped with multiple relatively thin needles to ensure the injection amount of drug while reducing pain.

JP 2002-159576 A (US 2002-052580 A1, US 2005-096603 A1) JP2002-291884A (US2004-078008A1) JP 2005-087519 A

It has been found that some patients who self-inject insert the needle shallowly into multiple locations (arm, abdomen, buttocks, etc.) beforehand, in order to reduce the pain caused by the needle puncture, even if only slightly, in order to find a location that will cause less pain. However, such "test pricks" can result in blood or tissue fluids adhering to the tip of the needle, which can cause hygiene problems.

Therefore, the present invention provides an outer cylinder for a needle-equipped syringe, a syringe, and a drug solution administration device that can search for a relatively painless puncture site (low-pain site) (so-called "test prick") without directly puncturing with the injection needle, and can reliably puncture the vicinity of that site with the injection needle.

The above objectives are achieved by the following:
An outer cylinder for a needle-equipped syringe, the outer cylinder having an outer cylinder body portion and a needle fixing portion provided at a tip portion of the outer cylinder body portion, and an injection needle having a puncture needle tip at a tip portion and a base end portion fixed to the needle fixing portion of the outer cylinder,
the outer cylinder for the needle syringe includes a needle tip portion covering member that covers the puncture tip of the injection needle, and the needle tip portion covering member includes a skin abutment projection at a tip thereof ,
The needle tip covering member comprises an inner cavity that houses the tip of the injection needle, and an elastic rib that is provided on the inner surface of the inner cavity and protrudes inward, the elastic rib being in close contact with the outer surface of the tip of the stored injection needle .

The above object is also achieved by the following:
A syringe comprising the above-mentioned outer cylinder for a needle-equipped syringe, a gasket housed within the outer cylinder and capable of sliding within the outer cylinder in a liquid-tight state, and a plunger for pressing the gasket.

The above object is also achieved by the following:
A medicinal liquid administration device comprising the above-mentioned outer cylinder for a needle-equipped syringe, a gasket housed within the outer cylinder and capable of sliding within the outer cylinder in a liquid-tight state, a plunger for pressing the gasket, and a medical liquid filled within the outer cylinder.

FIG. 1 is a front view showing an embodiment of a drug solution administration device of the present invention. FIG. 2 is a front cross-sectional view of the drug solution administration device shown in FIG. FIG. 3 is an enlarged cross-sectional view of a portion A in FIG. FIG. 4 is a cross-sectional view illustrating a needle tip covering member used in the drug solution administration device shown in FIG. FIG. 5 is an explanatory diagram for explaining a method of using the drug solution administration device shown in FIG. FIG. 6 is a cross-sectional explanatory view for explaining a method of using the drug solution administration device shown in FIG. FIG. 7 is a cross-sectional explanatory view for explaining a method of using the drug solution administration device shown in FIG. FIG. 8 is an explanatory cross-sectional view showing another embodiment of the outer cylinder for a needle-equipped syringe of the present invention. FIG. 9 is an explanatory cross-sectional view showing another embodiment of the needle tip covering member used in the outer cylinder for a needle syringe of the present invention. FIG. 10 is a partial cross-sectional front view showing another embodiment of the drug solution administration device of the present invention. FIG. 11 is a front sectional view showing another embodiment of the drug solution administration device of the present invention. FIG. 12 is a cross-sectional view illustrating a needle tip covering member used in the drug solution administration device shown in FIG. FIG. 13 is a cross-sectional explanatory view for explaining a method of using the drug solution administration device shown in FIG. FIG. 14 is a cross-sectional explanatory view for explaining a method of using the drug solution administration device shown in FIG. FIG. 15 is a cross-sectional explanatory view for explaining a method of using the drug solution administration device shown in FIG.

The outer cylinder for needle syringe of the present invention, the syringe equipped therewith, and the drug solution administering device will be described using the examples shown in the drawings. In this example, the upper side (upward direction) in Fig. 1 is the tip side (tip direction), the lower side (downward direction) in Fig. 1 is the base side (base direction), and the up-down direction in Fig. 1 is the axial direction.
The outer cylinder 3 for a needle syringe of the present invention comprises an outer cylinder 31 having an outer cylinder main body 33 and a needle fixing part 34 provided at the tip of the outer cylinder main body 33, and an injection needle 32 having a puncture needle tip 35 at its tip and a base end fixed to the needle fixing part 34 of the outer cylinder 31. The outer cylinder 3 for a needle syringe comprises a needle tip part covering member 40 (hereinafter also simply referred to as covering member 40) that covers the puncture needle tip 35 of the injection needle 32, and the covering member 40 has a skin abutment projection 41 at its tip.

The medicinal liquid administration device 1 of the present invention comprises the above-mentioned outer cylinder 3 for a needle-equipped syringe, a gasket 21 housed within the outer cylinder 31 and capable of sliding within the outer cylinder 31 in a liquid-tight state, a plunger 22 for pressing the gasket 21, and a medical liquid 11 filled within the outer cylinder 31.

The syringe 2 of the present invention further comprises the above-mentioned outer cylinder 3 for a needle-equipped syringe, a gasket 21 housed within the outer cylinder 31 and capable of sliding within the outer cylinder 31 in a liquid-tight state, and a plunger 22 for pressing the gasket 21.

As shown in Figures 1 and 2, the outer tube 31 of the outer tube 3 for a needle-equipped syringe comprises an outer tube main body portion 33, a needle fixing portion 34 provided at the tip end of the outer tube main body portion 33, and a flange 36 provided at the base end of the outer tube main body portion 33 and protruding outward (in a direction perpendicular to the axial direction).

The outer tube body 33 is a transparent or semi-transparent, generally cylindrical part. The needle fixing part 34 protrudes from the tip of the outer tube body 33 (in this embodiment, a shoulder part formed at the tip of the outer tube body 33, which tapers toward the tip) toward the tip, and is a hollow tube with a smaller diameter than the outer tube body 33. As shown in Figures 2 and 3, the needle fixing part 34 has an annular head 37 at the tip, a short tapered tapered part 38 at the base end of the annular head 37, which tapers toward the base end, and a connecting part 39 that connects the base end of the tapered tapered part 38 to the tip of the outer tube body 33. The tapered tapered part 38 forms an annular recess between the annular head 37 and the connecting part 39.

The annular head 37 has a recess recessed from the distal end surface toward the proximal end side, and a hollow conical portion located within the recess and having an apex on the distal end side. The annular head 37 may have a hollow columnar (cylindrical) shape without the recess and the conical portion.
The annular recess (reduced diameter portion) does not have to be tapered, but may simply be reduced in diameter so that a step is formed between the base end of the annular head 37 and the connecting portion 39 .
A plurality of grooves extending in the axial direction of the outer tube 31 are formed on the outer surface of the connecting part 39. The connecting part 39 also has the function of increasing the fixing strength of the injection needle 32, but if the fixing strength can be obtained even if the connecting part 39 is omitted, the base end of the annular recess (tapered reduced diameter part 38) and the tip end of the outer tube main body part 33 may be directly connected.

The outer tube 31 can be made of glass or plastic, but it is preferable to use plastic. Examples of plastic include various resins such as polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly-(4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyesters such as polyethylene terephthalate, cyclic olefin polymers, and cyclic olefin copolymers. Of these, resins such as polypropylene, cyclic olefin polymers, and cyclic olefin copolymers are preferred because they are easy to mold, have excellent transparency, have no effect on medication, and are heat resistant.

The injection needle 32 is hollow and has a puncture needle tip 35 at its tip. The base end of the injection needle 32 is inserted into and fixed in the hollow part of the needle fixing part 34, and the inside of the injection needle 32 communicates with the internal space of the outer tube 31 (outer tube main body part 33). The injection needle 32 is generally made of a metal. Stainless steel is a suitable metal.

In the needle-equipped syringe outer cylinder 3 of this embodiment, the injection needle 32 is fixed to the outer cylinder 31 so as not to be detached. As a method for fixing the injection needle 32 to the outer cylinder 31 so as not to be detached, for example, the injection needle 32 may be inserted into the hollow part of the needle fixing part 34 of the pre-molded outer cylinder 31 and fixed to the needle fixing part 34 by adhesive, heat welding, etc. Alternatively, the injection needle 32 may be fixed by directly insert molding into the outer cylinder 31. In the case of insert molding, by molding the outer cylinder 31, the needle fixing part 34 becomes a cylindrical (hollow) shape into which the injection needle 32 is inserted, and the base end of the injection needle 32 is inserted and fixed in the hollow part of the needle fixing part 34.

Furthermore, the injection needle 32 may be fixed to the outer cylinder 31 by fusing (for example, heat fusing, ultrasonic fusing, laser fusing, or induction heating fusing) a thermoplastic resin tubular member. In this case, the outer cylinder 31 has a hollow tip portion with an inner cavity capable of accommodating the thermoplastic resin tubular member. The thermoplastic resin tubular member has a through hole capable of accommodating the base end portion of the injection needle. The thermoplastic resin tubular member with the base end portion of the injection needle inserted therein is inserted into the hollow tip portion of the outer cylinder, and the thermoplastic resin tubular member is directly or indirectly heated and melted, whereby the injection needle is fixed to the outer cylinder via the thermoplastic resin tubular member.

The injection needle 32 in this embodiment is a thin straight injection needle that extends from the tip to the base end with approximately the same outer diameter and inner diameter. However, it is not limited to this. For example, in order to reduce the puncture resistance (to reduce the pain given to the patient when puncturing), a tapered injection needle may be used in which the outer diameter of the tip side part (the part inserted when puncturing) including the puncture needle tip 35 is smaller than the outer diameter of the base side part. In addition, in order to increase the rigidity of the injection needle and suppress bending during puncturing, a tapered injection needle may be used in which the outer diameter of the base side part is larger than the outer diameter of the tip side part including the puncture needle tip 35. Such a tapered injection needle may be one in which a part between the tip and base end of the injection needle is tapered, or one in which the entire length from the tip to the base end is tapered.

The puncture needle tip 35 of the injection needle 32 is encapsulated by an encapsulating member. Here, the encapsulating member 40 is attached to the tip of the injection needle 32, and the tip (puncture needle tip) of the injection needle 32, which is connected to the internal space of the outer tube 31 (outer tube main body portion 33), is sealed by the encapsulating member 40.

The encasing member 40 is made of a soft material. The soft material is preferably rubber or elastomer. The material for forming the encasing member 40 is preferably an elastic material such as synthetic rubber such as natural rubber, isoprene rubber, butyl rubber, butadiene rubber, fluororubber, silicone rubber, or thermoplastic elastomer such as olefin-based elastomer or styrene-based elastomer. In this embodiment, the tip of the injection needle 32 including the puncture needle tip 35 is encapsulated by being inserted into the encasing member 40, so the encasing member 40 must be made of an elastic material that can be inserted by the injection needle 32 (puncture needle tip 35). Furthermore, in this embodiment, the encasing member 40 is capable of passing through the puncture needle tip 35.

4 (the injection needle 32 is shown in dashed lines to clearly show the shape of the encasing member 40), the encasing member 40 specifically comprises, from the distal end, a skin contact projection 41, a distal large diameter portion 42 smoothly connected to the skin contact projection 41, an intermediate small diameter portion 43 having a smaller diameter than the distal large diameter portion 42, and a proximal large diameter portion 44 having a larger diameter than the intermediate small diameter portion 43. Furthermore, the encasing member 40 is formed with a guide recess 45 that opens on the proximal side surface.

The guide recess 45 is preferably formed approximately coaxially with the skin abutment projection 41. In other words, the skin abutment projection 41 is preferably located on an extension of the central axis of the guide recess 45. The injection needle 32 (puncture needle tip 35) is inserted into the encasing member 40 from the guide recess 45. The guide recess 45 does not penetrate the encasing member 40 in the axial direction, and therefore the encasing member 40 has a closed tip and can be pierced by the puncture needle tip 35.

The skin contact protrusion 41 is cone-shaped and protrudes toward the tip. The shape of the skin contact protrusion 41 is not limited to a cone, and may be, for example, a polygonal pyramid shape such as a triangular pyramid or a square pyramid, or a needle shape. Here, the skin contact protrusion 41 is formed so that its tip is approximately coaxial with the injection needle 32 (the puncture needle tip 35, in front of the puncture needle tip 35). It is desirable that the skin contact protrusion 41 is designed to cause a predetermined stimulation (pain) by contacting the patient's skin.

A cap 12 is attached to the tip of the outer cylinder 3 for a needle syringe. The cap 12 includes an inner cap 13 and an outer cover 14, which are integrally fixed to each other at the base end (see FIG. 3).
The inner cap 13 is formed of an elastic material, similar to the above-mentioned covering member 40. As the material for forming the inner cap 13, the material for forming the above-mentioned covering member 40 can be suitably used.

When the inner cap 13 is attached to the needle syringe outer cylinder 3, the encapsulating member 40 is stored inside the tip side of the inner cap 13. In addition, the inner surface of the base end opening of the inner cap 13 is in close contact with the outer surface of the needle fixing portion 34 (annular head portion 37, tapered diameter reduction portion 38, connecting portion 39), suppressing unintended axial movement of the cap 12 including the inner cap 13. This prevents the cap 12 from being unintentionally detached from the needle syringe outer cylinder 3, and prevents the encapsulating member 40 from shifting due to contact with the inner peripheral surface of the inner cap 13. The outer cover 14 is made of a hard resin material and covers the tip surface and side surface of the inner cap 13 to protect the contents.

The inner cap 13 is configured so that the covering member 40 is not removed from the injection needle when it is removed from the outer tube. Specifically, the inner cap 13 does not substantially hold the covering member 40; in other words, the inner cap 13 does not have an engagement portion with the covering member 40. The inner cap 13 is capable of abutting against the covering member 40, and prevents it from moving toward the tip side.

In the drug solution administration device 1 (syringe 2), the gasket 21 housed in the outer cylinder 3 for the needle syringe is made of elastic rubber or synthetic resin. As shown in Figure 2, the gasket 21 has a substantially cylindrical main body portion extending with approximately the same outer diameter, and a plurality of annular ribs provided on the outer surface of the main body portion, and the outer surface of the annular ribs is in liquid-tight contact with the inner surface of the outer cylinder 3 for the needle syringe (outer cylinder main body portion 33) and can slide in a liquid-tight state.

As a material for forming the gasket 21, it is preferable to use elastic rubber (e.g., butyl rubber, latex rubber, silicone rubber, etc.), synthetic resin (e.g., styrene-based elastomers such as SBS elastomer and SEBS elastomer, olefin-based elastomers such as ethylene-α-olefin copolymer elastomer, etc.), etc.

The plunger 22 for pressing the gasket 21 is made of a hard or semi-hard resin. In this embodiment, as shown in FIG. 2, the plunger 22 has a small disk-shaped gasket pressing portion provided at the tip, a disk-shaped pressing operation portion provided at the base end, and a shaft portion having a cross-shaped cross section and extending in the axial direction of the needle syringe outer cylinder 3 between the gasket pressing portion and the pressing operation portion. The shaft portion may be a columnar shaft. The columnar shaft may be rod-shaped, columnar, polygonal columnar, cylindrical, polygonal tube-shaped, etc. The plunger 22 is connected to the gasket 21 at the tip (gasket pressing portion).

It is preferable to use a hard or semi-hard resin such as high density polyethylene, polypropylene, polystyrene, or polyethylene terephthalate as the constituent material of the plunger 22.

In the medicinal liquid administration device 1, as shown in Figure 2, a medical liquid 11 is stored (filled) inside the outer tube 3 for a needle syringe (in the space formed between the covering member 40 and the gasket 21).

Various types of medical liquid 11 (liquid medicine) can be used to fill the needle syringe barrel 3, but suitable medical liquids are those that require self-injection in small amounts, such as protein preparations, antibody preparations, hyaluronic acid, and insulin. Examples of drug administration devices that contain such medical liquids include insulin pens for diabetics, epinephrine for sufferers of food and insect bite allergies, and antidotes for soldiers who may be exposed to chemical and/or biological toxins on the battlefield.

A method of using such a drug solution administration device 1 (a state during use) will be described with reference to Figs.
5, the cap 12 is removed from the drug solution administration device 1. With the cap 12 removed, the covering member 40 remains attached to the injection needle 32, and the tip portion including the puncture needle tip 35 is covered by the covering member 40 and is not exposed to the outside.

Next, the user determines the puncture site using the skin contact projection 41 formed at the tip of the encasement member 40, as shown in FIG. 6. In the drug solution administration device 1 (outer cylinder 3 for needle syringe) from which the cap 12 has been removed, the skin contact projection 41 formed at the tip of the encasement member 40 is located on the tip side of the puncture needle tip 35 of the injection needle 32 and protrudes toward the tip. Therefore, the user can search for a relatively less painful site (low pain site) by pressing the skin contact projection 41 against multiple points of the puncture site (arm, abdomen, buttocks, etc.) 100 (so-called "trial puncture"). Note that when performing a trial puncture, it is necessary to apply a force that does not allow the injection needle 32 (puncture needle tip 35) to pass through the tip portion (blocked portion) of the encasement member 40.

In this embodiment, the skin contact protrusion 41 is formed to be approximately coaxial with the injection needle 32 (puncture needle tip 35). This allows the desired low pain site to be accurately located. In addition, by providing a stimulus in advance by contacting the skin contact protrusion 41 with the puncture site or its vicinity, it is possible to reduce pain during the actual puncture (make the pain less noticeable).

7, the needle syringe outer cylinder 3 (injection needle 32) is moved in the distal direction (towards the puncture site), and the injection needle 32 (puncture needle tip 35) is punctured into the desired puncture site (the low pain site found). Specifically, by moving the needle syringe outer cylinder 3 in the distal direction while pressing the skin abutment protrusion 41 against the puncture site, the puncture needle tip 35 of the injection needle 32 passes through the distal occlusion part (skin abutment protrusion 41) of the encasement member 40 and reaches the puncture site (skin) 100. By further pushing the needle syringe outer cylinder 3 in the distal direction, the injection needle 32 protrudes from the encasement member 40 in the distal direction and punctures the puncture site. The plunger 22 is then operated to administer (inject) the medical liquid 11 into the body.

In the present embodiment, the outer cylinder 3 for a needle-equipped syringe, and the syringe 2 and drug solution administration device 1 each include an outer cylinder 31 having an outer cylinder body 33 and a needle fixing part 34 provided at the tip of the outer cylinder body 33, an injection needle 32 having a puncture needle tip 35 at its tip and a base end fixed to the needle fixing part 34 of the outer cylinder 31, and a needle tip covering member 40 that covers the puncture needle tip 35 of the injection needle 32, and the covering member 40 has a skin abutment protrusion 41 at its tip. Therefore, the skin abutment protrusion 41 allows the injection needle 32 to search for a relatively less painful area (so-called "test prick") without directly puncturing the injection needle, which is hygienic. In addition, since the skin abutment protrusion 41 is formed at the tip of the needle tip covering member 40 that covers the puncture needle tip 35 of the injection needle 32, the injection needle can be reliably punctured near the location identified by the test puncture.

Next, an outer cylinder 3a for a needle-equipped syringe according to an embodiment of the present invention shown in FIG. 8 will be described.
The outer cylinder 3a for a needle syringe shown in Fig. 8 is disposed between the tip end of the needle fixing part 34 and the base end of the needle tip covering member 40a, and is provided with a needle cover 46 through which the injection needle 32 passes and which is elastically deformable in the axial direction of the injection needle 32. In the outer cylinder 3a for a needle syringe, the needle cover 46 is fixed to the base end side large diameter part 44a of the covering member 40a. The needle cover 46 is made of a soft resin material and has a thin cylindrical shape.

The needle cover 46 is elastically deformable in the axial direction so as to be folded as the injection needle 32 protrudes from the covering member 40a during puncture, in other words, as the covering member 40a moves toward the base end along the injection needle 32. As the needle cover 46, it is preferable to use synthetic rubber such as natural rubber, isoprene rubber, butadiene rubber, fluororubber, silicone rubber, etc., styrene-based elastomers such as SBS elastomers and SEBS elastomers, polyolefin-based elastomers such as ethylene-α-olefin copolymers, etc.

The form of the covering member in the present invention is not limited to the above, and may be, for example, a covering member 40b shown in Fig. 9. The covering member 40b in this embodiment has an inner cavity 47 that houses the tip of the injection needle 32, and an elastic rib 48 that is provided on the inner surface of the inner cavity 47 and protrudes inward, and the elastic rib 48 is in close contact with the outer surface of the tip of the stored injection needle 32. The injection needle 32 (puncture needle tip 35) is not inserted into the covering member 40b, but is covered by the covering member 40b in the inner cavity 47.
The above-mentioned covering members 40a, 40b are preferably made of the soft material described for the above-mentioned covering member 40.

Also, as in the drug solution administration device 1c (syringe 2c) shown in Figure 10, a cylindrical protective member 50 may be attached to the tip of the needle syringe outer cylinder 3c. The protective member 50 encloses the tip side portion of the needle syringe outer cylinder 3c, including the puncture needle tip 35, so that it can protrude. The protective member 50 has a tip opening 51 formed therein through which the injection needle 32 can protrude (expose to the outside) when puncturing, and is fitted with a seal cap 52 made of an elastic material. The seal cap 52 can be removed when puncturing.

In this embodiment of the drug solution administration device 1c (syringe 2c), a collar member 53 is attached to the tip (needle fixing portion 34) of the needle syringe outer cylinder 3c so as not to move in the axial direction. A coil spring 54 is disposed between the collar member 53 and the protective member 50 as a biasing member that biases the protective member 50 toward the tip direction relative to the needle syringe outer cylinder 3c. Such a protective member 50 can move in the base end direction during puncture to expose the injection needle 32, and after puncture, it moves in the tip direction due to the biasing force of the coil spring 54 and again encapsulates the tip side portion including the puncture needle tip 35 of the needle syringe outer cylinder 3c, thereby further improving the safety of the drug solution administration device 1c.

Next, we will explain the outer cylinder for a needle-equipped syringe of another embodiment of the present invention shown in Figures 11 to 15. In addition, in the drug solution administration device 10 (syringe 20), unless otherwise specified, the detailed description will be omitted for the configurations that are approximately the same as those of the above-mentioned drug solution administration device 1 (syringe 2) by using the same names and/or symbols.

12 (the injection needle 32 is shown in dashed lines to clearly show the shape of the injection needle 60), the enveloping member 60 of this embodiment comprises, in order from the tip side, a skin contact projection 61, a tip side large diameter portion 62 smoothly connected to the skin contact projection 61, an intermediate small diameter portion 63 having a smaller diameter than the tip side large diameter portion 62, and a base side large diameter portion 64 having a larger diameter than the intermediate small diameter portion 63. Furthermore, the enveloping member 60 has a through passage 65 that houses the tip portion of the injection needle 32 including the puncture needle tip 35. The through passage 65 penetrates the enveloping member 60 in the axial direction.

An elastic rib 68 protruding inward is formed at the center of the inner surface of the through passage 65 of the enveloping member 60. The inner shape (inner diameter) of the elastic rib 68 is smaller than the outer shape (outer diameter) of the injection needle 32. As a result, the enveloping member 60 has an inner cavity (through passage 65) that houses the tip of the injection needle 32, and an elastic rib 68 that is provided on the inner surface of the inner cavity (through passage 65) and protrudes inward, and the elastic rib 68 is in close contact with the outer surface of the tip of the stored injection needle 32. In this embodiment, the elastic rib 68 is provided continuously around the entire inner surface of the through passage 65 (inner cavity) to form a substantially annular rib, but is not limited to this, and for example, multiple protrusions may be provided at intervals. The enveloping member 60 is preferably formed of the soft material described in the enveloping member 40 described above.

The skin contact protrusion 61 is shaped like a cylinder cut diagonally, protruding so as to be convex toward the tip. The shape of the skin contact protrusion 61 is not limited to this, and may be, for example, a cone shape, a polygonal pyramid shape such as a triangular pyramid or a square pyramid, or a needle shape. Here, the skin contact protrusion 61 is formed so that its tip is approximately coaxial with the injection needle 32 (puncture needle tip 35). It is desirable that the skin contact protrusion 61 is designed to cause a predetermined stimulation (pain) by contacting the patient's skin.

Furthermore, the needle syringe outer cylinder 30 (medicinal solution administration device 10, syringe 20) of this embodiment is provided with a biasing member 70 that is disposed between the tip of the needle fixing portion 34 and the base end of the covering member 60 and can bias the covering member 60 in the tip direction. More specifically, the covering member 60 has a through passage 65 that houses the tip of the injection needle 32 including the puncture needle tip 35, and the needle syringe outer cylinder 30 is provided with a biasing member 70 that is disposed between the tip of the needle fixing portion 34 and the base end of the covering member 60 and biases the covering member 60 in the tip direction, and the tip of the biasing member 70 is fixed to the base end of the covering member 60. In this embodiment, a coil spring is used as the biasing member 70.

The tip of the urging member 70 is fixed to the base end (base end large diameter portion 64) of the covering member 60. The base end of the urging member 70 is disposed on the tip of the needle fixing portion 34 (inside a recess formed in the tip of the needle fixing portion 34). The base end of the urging member 70 may also be fixed to the tip of the needle fixing portion 34 (for example, a hollow cone-shaped portion located in the recess and having an apex on the tip side).

11, in this embodiment, with the cap 12 attached to the tip of the needle syringe outer cylinder 30, the tip of the injection needle 32 is inserted into the inner cap 13. More specifically, when the cap 12 is attached to the needle syringe outer cylinder 30, the inner cap 13 moves the covering member 60 in the proximal direction along the injection needle 32, and the injection needle 32 (puncture needle tip 35) protruding from the covering member 60 (through passage 65) is inserted into the inner cap 13. In the drug solution administration device 10, with the cap 12 attached, the tip of the injection needle 32, which is connected to the internal space of the outer cylinder 31 (outer cylinder main body 33), is sealed by the inner cap 13.

The following describes how to use (the manner in which the liquid medicine administration device 10 is used). Note that the description of the same manner as the liquid medicine administration device 1 described above will be omitted.
First, as shown in Fig. 13, the cap 12 is removed from the drug solution administration device 10. Here, the covering member 60 moves in the distal direction by the biasing force of the biasing member 70, and stores the distal end of the injection needle 32, including the puncture needle tip 35, in the through passage 65. Therefore, in a state where the cap 12 is removed, the distal end of the injection needle 32, including the puncture needle tip 35, is covered by the covering member 60 and is not exposed to the outside. As a result, the skin abutment projection 61 formed at the distal end of the covering member 60 is located on the distal side of the puncture needle tip 35 of the injection needle 32 and protrudes toward the distal direction.

In this embodiment of the needle syringe outer cylinder 30, the initial biasing force of the biasing member 70 (biasing force when the cap is removed) is stronger than the adhesion force (frictional resistance) between the encasing member 60 and the injection needle 32 by the elastic rib 68, and when the encasing member 60 moves and stores the tip of the injection needle 32 including the puncture needle tip 35 in the through passage 65, the biasing force of the biasing member 70 and the adhesion force (frictional resistance) between the encasing member 60 and the injection needle 32 are set to be balanced. In addition, since the tip of the biasing member 70 is fixed to the base end (base end side large diameter portion 64) of the encasing member 60, the encasing member 60 is prevented from being removed from the injection needle 32.

Next, the user determines the puncture site (low pain site) using the skin contact protrusion 61 formed on the tip of the encasement member 60 as shown in Fig. 14 (so-called "trial prick"). Note that when performing the trial prick, it is necessary to apply a force that does not cause the injection needle 32 (puncture needle tip 35) to be exposed from the tip of the encasement member 60 (a force smaller than the combined force of the adhesion force between the encasement member 60 and the injection needle 32 and the biasing force of the biasing member 70).

In this embodiment, the skin contact protrusion 61 is formed to be approximately coaxial with the injection needle 32 (puncture needle tip 35). This allows the desired low pain site to be accurately located. In addition, by providing a stimulus in advance by contacting the skin contact protrusion 61 with the puncture site or its vicinity, it is possible to reduce pain during the actual puncture (make the pain less noticeable).

15, the needle syringe outer cylinder 30 (injection needle 32) is moved in the distal direction (towards the puncture site), and the injection needle 32 (puncture needle tip 35) is punctured into the desired puncture site (the found low-pain site). Specifically, by moving the needle syringe outer cylinder 30 in the distal direction while pressing the skin abutment protrusion 61 against the puncture site, the puncture needle tip 35 of the injection needle 32 protrudes from the through passage 65 of the encasement member 60 and reaches the puncture site (skin) 100. By further pushing the needle syringe outer cylinder 30 in the distal direction, the injection needle 32 protrudes from the encasement member 60 in the distal direction and punctures the puncture site.

In the needle syringe outer cylinder 30 of this embodiment, as well as the syringe 20 and drug solution administration device 10 including the outer cylinder 30, the outer cylinder 31 includes an outer cylinder body 33 and a needle fixing part 34 provided at the tip of the outer cylinder body 33, an injection needle 32 having a puncture needle tip 35 at its tip and a base end fixed to the needle fixing part 34 of the outer cylinder 31, and a needle tip covering member 60 that covers the puncture needle tip 35 of the injection needle 32, and the covering member 60 includes a skin abutment projection 61 at its tip. Therefore, the skin abutment projection 61 allows the injection needle 32 to search for a relatively less painful area (so-called "test prick") without directly puncturing the injection needle, which is hygienic. In addition, since the skin abutment protrusion 61 is formed at the tip of the needle tip covering member 60 that covers the puncture needle tip 35 of the injection needle 32, the injection needle can be reliably punctured near the location identified by the test puncture.

In addition, in the outer tube 30 for a needle-equipped syringe, a needle cover 46 may be provided which is arranged between the tip end of the needle fixing portion 34 and the base end of the covering member 60 as described above, through which the injection needle 32 passes and which is elastically deformable in the axial direction of the injection needle 32.
In addition, in the outer cylinder for a needle syringe of the present invention, and the syringe and drug solution administering device including the same, the various aspects exemplified in the multiple embodiments can be used in appropriate combination. For example, in the outer cylinder for a needle syringe 3 described above, a biasing member 70 that is disposed between the tip end of the needle fixing portion 34 and the base end of the covering member 40 and is capable of biasing the covering member 40 in the tip direction may be provided.

The outer cylinder for a needle-equipped syringe of the present invention is as follows.
(1) An outer cylinder for a needle-equipped syringe, the outer cylinder including an outer cylinder body portion and a needle fixing portion provided at a tip portion of the outer cylinder body portion, and an injection needle having a puncture needle tip at a tip portion and a base end portion fixed to the needle fixing portion of the outer cylinder,
The outer cylinder for a needle syringe is provided with a needle tip covering member that covers the puncture tip of the injection needle, and the needle tip covering member is provided with a protrusion for contacting the skin at its tip.

The outer tube for a needle-equipped syringe of the present invention comprises an outer tube having an outer tube main body and a needle fixing portion provided at the tip of the outer tube main body, and an injection needle having a puncture tip at its tip and having a base end fixed to the needle fixing portion of the outer tube, and is provided with a needle tip covering member that covers the puncture tip of the injection needle, and the needle tip covering member has a protrusion at its tip for contacting the skin.
Therefore, the skin contact projection makes it possible to search for a relatively painless puncture site (low pain site) (so-called "trial prick") without directly puncturing the skin with the injection needle, which is hygienic.
In addition, since the skin contact projection is formed at the tip of the needle tip covering member that covers the puncture tip of the injection needle, the injection needle can be reliably punctured into the location specified by the test puncture or in the vicinity thereof.

The above embodiment may also be as follows.
(2) The outer cylinder for a needle syringe according to (1) above, wherein the needle tip covering member is made of a soft material.
(3) The outer cylinder for a needle syringe according to (1) or (2) above, wherein the needle tip covering member is capable of passing through the tip of the puncture needle.
(4) The outer cylinder for a needle syringe according to (1) or (2) above, wherein the needle tip covering member has a closed tip and is pierceable by the puncture needle tip.
(5) The outer cylinder for a needle-equipped syringe according to any one of (1) to (3) above, wherein the needle tip covering member has a through passage that houses the tip of the injection needle including the puncture needle tip.
(6) The outer cylinder for a needle-equipped syringe according to any one of (1) to (5) above, wherein the needle tip covering member is attached to the tip of the injection needle.
(7) An outer barrel for a needle-equipped syringe as described in any one of (1) to (6) above, wherein the needle tip covering member has an inner cavity for storing the tip of the injection needle, and an elastic rib provided on the inner surface of the inner cavity and protruding inward, the elastic rib being in close contact with the outer surface of the tip of the stored injection needle.
(8) The outer cylinder for a needle syringe described in any one of (1) to (7) above is provided with a biasing member disposed between the tip end of the needle fixing portion and the base end of the needle tip covering member, and capable of biasing the needle tip covering member in the tip direction.
(9) An outer cylinder for a needle syringe as described in any of (1) to (3) above, wherein the needle tip covering member has a through passage that houses the tip of the injection needle including the puncture needle tip, and the outer cylinder for a needle syringe is provided with a biasing member that is disposed between the tip of the needle fixing part and the base end of the needle tip covering member and biases the needle tip covering member in the tip direction, and the tip of the biasing member is fixed to the base end of the needle tip covering member.
(10) The outer cylinder for a needle syringe according to any one of (1) to (7) above, which is provided with a needle cover disposed between the tip end of the needle fixing part and the base end of the needle tip covering member, through which the injection needle passes and which is elastically deformable in the axial direction of the injection needle.

The syringe of the present invention is as follows.
(11) A syringe comprising an outer cylinder for a needle-equipped syringe as described in any one of (1) to (10) above, a gasket housed within the outer cylinder and capable of sliding within the outer cylinder in a liquid-tight state, and a plunger for pressing the gasket.

The syringe of the present invention comprises an outer tube having an outer tube main body and a needle fixing portion provided at the tip of the outer tube main body, and an injection needle having a puncture tip at its tip and having a base end fixed to the needle fixing portion of the outer tube, and is provided with a needle tip covering member that covers the puncture tip of the injection needle, and the needle tip covering member has a protrusion at its tip for contacting the skin.
Therefore, the skin contact projection makes it possible to search for a relatively painless puncture site (low pain site) (so-called "trial prick") without directly puncturing the skin with the injection needle, which is hygienic.
In addition, since the skin contact projection is formed at the tip of the needle tip covering member that covers the puncture tip of the injection needle, the injection needle can be reliably punctured into the location specified by the test puncture or in the vicinity thereof.

The drug solution administration device of the present invention is as follows.
(12) A medical liquid administration device comprising: an outer cylinder for a needle-equipped syringe as described in any one of (1) to (10) above; a gasket housed within the outer cylinder and capable of sliding within the outer cylinder in a liquid-tight state; a plunger for pressing the gasket; and a medical liquid filled within the outer cylinder.

The medicinal solution administration device of the present invention comprises an outer tube having an outer tube main body portion and a needle fixing portion provided at the tip of the outer tube main body portion, and an injection needle having a puncture needle tip at its tip and a base end fixed to the needle fixing portion of the outer tube, and is provided with a needle tip covering member that covers the puncture needle tip of the injection needle, and the needle tip covering member has a protrusion at its tip for contacting the skin.
Therefore, the skin contact projection makes it possible to search for a relatively painless puncture site (low pain site) (so-called "trial prick") without directly puncturing the skin with the injection needle, which is hygienic.
In addition, since the skin contact projection is formed at the tip of the needle tip covering member that covers the puncture tip of the injection needle, the injection needle can be reliably punctured into the location specified by the test puncture or in the vicinity thereof.

Claims (11)

An outer cylinder for a needle-equipped syringe, the outer cylinder having an outer cylinder body portion and a needle fixing portion provided at a tip portion of the outer cylinder body portion, and an injection needle having a puncture needle tip at a tip portion and a base end portion fixed to the needle fixing portion of the outer cylinder,
the outer cylinder for the needle syringe includes a needle tip portion covering member that covers the puncture tip of the injection needle, and the needle tip portion covering member includes a skin abutment projection at a tip thereof ,
The needle tip covering member has an inner cavity that houses the tip of the injection needle, and an elastic rib that is provided on the inner surface of the inner cavity and protrudes inward, and the elastic rib is in close contact with the outer surface of the tip of the stored injection needle . The outer barrel for a needle syringe according to claim 1, wherein the needle tip covering member is made of a soft material. The outer cylinder for a needle syringe according to claim 1 or 2, wherein the needle tip covering member is capable of passing through the puncture needle tip. The outer cylinder for a needle syringe according to claim 1 or 2, wherein the needle tip covering member has a closed tip and is pierceable by the puncture needle tip. The outer cylinder for a needle-equipped syringe according to any one of claims 1 to 3, wherein the needle tip covering member has a through passage that houses the tip of the injection needle, including the puncture needle tip. An outer cylinder for a needle-equipped syringe according to any one of claims 1 to 5, in which the needle tip covering member is attached to the tip of the injection needle. The outer cylinder for a needle syringe according to any one of claims 1 to 6, further comprising a biasing member arranged between the tip end of the needle fixing portion and the base end of the needle tip covering member, and capable of biasing the needle tip covering member in the tip direction. The needle tip covering member has a through passage that houses the tip of the injection needle including the puncture needle tip, and the needle syringe outer cylinder is provided with a biasing member that is disposed between the tip of the needle fixing part and the base end of the needle tip covering member and biases the needle tip covering member in the tip direction, and the tip of the biasing member is fixed to the base end of the needle tip covering member. An outer cylinder for a needle syringe according to any one of claims 1 to 3. 7. The outer cylinder for a needle-equipped syringe according to claim 1, further comprising a needle cover disposed between the tip end of the needle fixing portion and the base end of the needle tip covering member, through which the injection needle passes and which is elastically deformable in the axial direction of the injection needle. 10. A syringe comprising: an outer cylinder for a needle-equipped syringe according to claim 1 ; a gasket housed within said outer cylinder and capable of sliding within said outer cylinder in a liquid-tight state; and a plunger for pressing said gasket. 10. A medical liquid administration device comprising: an outer cylinder for a needle-equipped syringe as described in any one of claims 1 to 9 ; a gasket housed within the outer cylinder and capable of sliding within the outer cylinder in a liquid-tight state; a plunger for pressing the gasket; and a medical liquid filled within the outer cylinder.

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