Puncture needle, puncture tool, and puncture tool assembly

Abstract

A puncture needle (14) made of a resin material has a needle part (22) and a groove part (24). The needle part (22) integrally has a trunk part (32) having a path through which a fluid passes, a puncture part (34) provided on the distal end side of the trunk part (32) and having a needle tip at the most distal end, and an intermediate part (36) provided between the trunk part (32) and the puncture part (34). A pair of protruding parts (64) are provided integrally with the intermediate part (36) and are provided integrally with a bottom surface (62) extending from the trunk part (32) toward the puncture part (34), the pair of protruding parts extending from the trunk part (32) toward the puncture part (34) in a direction along an axis (C) of the needle part (22) and also protruding from the bottom surface (62) in a direction intersecting the axis (C) of the needle part (22). In the groove part (24), a channel formed between the bottom surface (62) and the pair of protruding parts (64) communicates with the path of the trunk part (32), and the channel is opened to the outside of the intermediate part (36).

Description

Lancing needle, puncture tool, and puncture tool assembly

[0001] The present invention relates to a puncture needle made of a resin material, a puncture device including the puncture needle, and a puncture device assembly including the puncture device.

[0002] For example, many medical drugs are supplied in containers sealed with elastic lids made of rubber or other materials. The elastic lids used in such containers come in a variety of shapes and materials, and the drug is collected, prepared, or administered by puncturing the elastic lid with a needle made of, for example, a medical synthetic resin.

[0003] For example, as described in Japanese Patent Application Laid-Open No. 2014-97102, a puncture needle made of synthetic resin has conventionally been used to puncture the elastic body of a medicine container filled with the medicine to collect the medicine.

[0004] JP 2014-97102 A

[0005] When a puncture needle is inserted into an elastic body, the fluid path of the puncture needle may be blocked by the elastic body depending on the amount of elastic deformation of the elastic body that serves as the lid of the container used, the elastic deformation of the puncture needle itself, etc. For example, it is expected that such blockage of the fluid path of the puncture needle is likely to occur in thick elastic bodies or elastic bodies that have a film coating applied to the inner surface of the container.

[0006] The present invention has been made to solve such problems, and its purpose is to provide a puncture needle made of a resin material that makes it easy to secure a fluid path when puncturing an elastic body that serves as the lid of a container filled with a liquid such as a medicinal solution, a puncture tool including the puncture needle, and a puncture tool assembly including the puncture tool.

[0007] According to one aspect of the present invention, a puncture needle made of a resin material has a needle portion and a groove portion. The needle portion integrally includes a body portion having a path through which a fluid passes, a puncture portion provided at the distal end of the body and having a needle tip at its most distal end, and an intermediate portion provided between the body portion and the puncture portion. The pair of protrusions are integrally provided on the intermediate portion and have a bottom surface extending from the body portion toward the puncture portion, and a pair of protrusions integrally provided on the bottom surface extending from the body portion toward the puncture portion in a direction along the axis of the needle portion and protruding from the bottom surface in a direction intersecting the axis of the needle portion. The groove portion forms a channel between the bottom surface and the pair of protrusions that communicates with the path in the body and opens the channel to the outside of the intermediate portion.

[0008] FIG. 1 is a schematic perspective view of a puncture device assembly according to a first embodiment. FIG. 2 is a schematic perspective view of the front side of a puncture needle of the puncture device of the puncture device assembly shown in FIG. 1. FIG. 3 is a schematic perspective view of the rear side of the puncture needle of the puncture device shown in FIG. 2. FIG. 4 is a front view of the puncture needle of the puncture device of the puncture device assembly shown in FIGS. 1 and 2. FIG. 5 is a rear view of the puncture needle of the puncture device shown in FIG. 4. FIG. 6 is a right side view of the puncture needle of the puncture device shown in FIG. 4. FIG. 7 is a bottom view of the puncture needle of the puncture device shown in FIG. 6. FIG. 8 is a cross-sectional view taken along line VIII-VIII in FIGS. 4 and 5. FIG. 9 is a schematic cross-sectional view taken along line IX-IX in FIG. 4. FIG. 10 is a schematic view showing a state in which the needle portion of the puncture needle is puncturing an elastic body. FIG. 11A is a schematic view showing a state subsequent to FIG. 10 in which the needle portion of the puncture needle is puncturing an elastic body. FIG. 11B is a schematic cross-sectional view showing the needle portion of the puncture needle shown in FIG. 11A as the cross-section shown in FIG. 8. FIG. 12A is a schematic view showing a state subsequent to FIG. 11B, in which the needle portion of the puncture needle is puncturing the elastic body. FIG. 12B is a schematic cross-sectional view showing the needle portion of the puncture needle shown in FIG. 12A as the cross-section shown in FIG. 8. FIG. 13 is a schematic perspective view showing a state in which liquid is collected in the channel of the first groove portion with the needle portion of the puncture needle puncturing the elastic body. FIG. 14A is a first modified example of the cross-sectional view taken along line IX-IX of FIG. 4. FIG. 14B is a second modified example of the cross-sectional view taken along line IX-IX of FIG. 4. FIG. 14C is a third modified example of the cross-sectional view taken along line IX-IX of FIG. 4. FIG. 14D is a fourth modified example of the cross-sectional view taken along line IX-IX of FIG. 4. FIG. 14E is a fifth modified example of the cross-sectional view taken along line IX-IX of FIG. 4. Fig. 15 is a cross-sectional view of the needle part of the puncture needle according to the second embodiment taken along line VIII-VIII shown in Fig. 4. Fig. 16A is a first modified example of the cross-sectional view of the needle part of Fig. 15 taken along line VIII-VIII. Fig. 16B is a second modified example of the cross-sectional view of the needle part of Fig. 15 taken along line VIII-VIII. Fig. 16C is a third modified example of the cross-sectional view of the needle part of Fig. 15 taken along line VIII-VIII. Fig. 17 is a cross-sectional view of the needle part of the puncture needle according to the third embodiment taken along line VIII-VIII shown in Fig. 4.

[0009] Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings.

[0010] First Embodiment A puncture device assembly 1 according to a first embodiment will be described with reference to FIGS. 1 to 13. FIG.

[0011] Fig. 1 is a schematic perspective view of the puncture device assembly 1. Fig. 2 is a schematic perspective view of the front side of the needle portion 22 of the puncture needle 14 of the puncture device 10 of the puncture device assembly 1. Fig. 3 is a schematic perspective view of the rear side of the needle portion 22 of the puncture needle 14 of the puncture device 10 of the puncture device assembly 1.

[0012] Figure 4 is a front view of the needle portion 22 of the puncture needle 14 of the puncture device 10 of the puncture device assembly 1 shown in Figures 1 to 3. That is, the side of the puncture needle 14 where a first groove portion 24 described below is exposed to the outside of the puncture needle 14 is defined as the front side of the puncture needle 14. Figure 5 is a rear view of the needle portion 22 of the puncture needle 14 of the puncture device 10 shown in Figure 4. That is, the side of the puncture needle 14 where a second groove portion 26 described below is exposed to the outside of the puncture needle 14 is defined as the rear side of the puncture needle 14.

[0013] When the needle portion 22 of the puncture needle 14 is positioned as shown in Figures 4 and 5, the puncture portion 34 side is referred to as the tip side, and the connection portion 12 side is referred to as the base side. Furthermore, when the needle portion 22 of the puncture needle 14 is positioned as shown in Figure 4, the right side of the needle portion 22 of the puncture needle 14 shown in Figure 4 is referred to as the right side of the puncture needle 14, and the left side of the needle portion 22 of the puncture needle 14 shown in Figure 4 is referred to as the left side of the puncture needle 14. Therefore, when the needle portion 22 of the puncture needle 14 is positioned as shown in Figure 5, the left side of the needle portion 22 of the puncture needle 14 shown in Figure 5 is referred to as the right side of the puncture needle 14, and the right side of the needle portion 22 of the puncture needle 14 shown in Figure 5 is referred to as the left side of the puncture needle 14.

[0014] Figure 6 is a right side view of the needle portion 22 of the puncture needle 14 of the puncture device 10 shown in Figure 4. The left side view of the needle portion 22 of the puncture needle 14 of the puncture device 10 is omitted here because it is simply the opposite of the right side view shown in Figure 6. Figure 7 is a bottom view of the needle portion 22 of the puncture needle 14 of the puncture device 10 shown in Figure 6, as seen from the direction indicated by arrow VII. Figure 8 is a cross-sectional view taken along line VIII-VIII in Figures 4 and 5. Figure 9 is a schematic cross-sectional view taken along line IX-IX in Figure 4.

[0015] The left-right direction (horizontal direction) of the puncture needle 14 of the puncture device 10 refers to the direction perpendicular to the axis C of the needle portion 22 when the needle portion 22 of the puncture needle 14 of the puncture device 10 shown in Figure 4 is viewed from the front.

[0016] 10 to 13 are diagrams illustrating a series of actions when the needle portion 22 is inserted into the inner surface Ei of the elastic body E of a suitable container through the outer surface Eo using the puncture device 10. FIG.

[0017] Examples of materials that can be used as the elastic body E include butyl rubber, silicone rubber, and ETFE (Ethylene Tetrafluoroethylene), a copolymer of tetrafluoroethylene and ethylene. The hardness of the elastic body E is, for example, between 20 and 55 degrees Shore A (ISO 7619; ASTM D2240; JIS K 6253). The thickness of the elastic body E is, for example, about 7 mm.

[0018] As shown in FIG. 1, the puncture tool assembly 1 has a connector 8 and a puncture tool 10 made of a resin material and connected to the connector 8 .

[0019] Various types of connectors 8 can be used. An example of the connector 8 is a syringe that supplies a dissolving solution or aspirates and dispenses a medicinal solution from a container. Another example of the connector 8 is an instrument called an adapter that attaches the puncture needle 14 of the puncture tool 10 to a container such as a vial while the puncture needle 14 is inserted into the container. For example, a syringe is connected to the passage 52 (described later) of the puncture needle 14 via an adapter.

[0020] The puncture needle 14 can puncture the elastic body E shown in Figures 10 to 13, or can be used without puncturing. Therefore, the type of container that can be punctured with the puncture needle 14 is not limited; in addition to vials, ampoules, for example, can also be used. Another example of a container that can be punctured with the puncture needle 14 is the elastic body of a connector of a hanging bag that contains a liquid such as a drug solution or blood.

[0021] The puncture device 10 has a connecting portion (base portion) 12 and a straight puncture needle 14. In the puncture device 10 according to this embodiment, the connecting portion 12 and the puncture needle 14 are integrally formed, for example, from a resin material. Examples of suitable resin materials include polyethylene, polypropylene, polyamide, polycarbonate, ABS, PEEK, and other suitable thermoplastic resin materials. Furthermore, the puncture needle 14 according to this embodiment is formed to a hardness such that when the needle tip 34a is inserted into an elastic body E of appropriate hardness, the needle tip 34a is not easily crushed and the shape of the puncture needle 14 can be maintained against elastic deformation of the elastic body E, as described below. Furthermore, the elastic body E is brought into close contact with the outer peripheral surface of the puncture needle 14 while inserted into the elastic body E.

[0022] The connecting part 12 is connected to various connecting tools 8. The connecting part 12 and the puncture needle 14 are preferably formed integrally, but may be formed as separate bodies and connected to each other. The connecting part 12 is formed, for example, in a block shape, with an outer shape that is equal to or larger than the diameter of the base end of the puncture needle 14.

[0023] The puncture needle 14 according to this embodiment is formed symmetrically with respect to a plane defined by line VIII-VIII shown in FIG. 4 and line VIII-VIII shown in FIG.

[0024] As shown in FIGS. 1 to 9 , the puncture needle 14 has a needle portion 22 , a first groove portion 24 , and a second groove portion 26 .

[0025] The needle portion 22 has a body portion 32 , a puncture portion 34 provided on the tip side of the body portion 32 , and an intermediate portion 36 provided between the body portion 32 and the puncture portion 34 .

[0026] The body portion 32 is formed integrally with the connection portion 12 shown in Fig. 1. The body portion 32 has a first columnar portion 42 on the connection portion 12 side and a second columnar portion 44 provided contiguous to the first columnar portion 42 on the tip side of the first columnar portion 42.

[0027] The first columnar portion 42 is formed, for example, in a columnar shape. In this embodiment, for simplicity of explanation, the first columnar portion 42 is formed in a cylindrical shape. The axis C of the needle portion 22 of the puncture needle 14 is assumed to coincide with the central axis of the first columnar portion 42.

[0028] In addition, the first columnar portion 42 is not limited to a cylindrical shape having a circular cross section, but may be formed into a columnar shape having an N-sided polygonal cross section (N is an integer of 3 or more), or may be formed into a columnar shape having an elliptical cross section.

[0029] The front side of the outer circumferential surface of the second columnar portion 44 is inclined with respect to the axis C of the needle portion 22 of the puncture needle 14. In the present embodiment, the back side of the outer circumferential surface of the second columnar portion 44 extends, for example, straight and parallel to the axis C of the needle portion 22 of the puncture needle 14, as shown in Fig. 6 . The second columnar portion 44 is inclined with respect to the axis C of the needle portion 22 of the puncture needle 14 on the front side of the puncture needle 14 shown in Fig. 1 . Therefore, the second columnar portion 44 has an inclined portion 44a in a region closer to the front side than the back side. The inclination direction of the inclined portion 44a is a direction in which the outer diameter of the body portion 32 becomes smaller toward the puncture portion 34 side.

[0030] The body 32 has a passage 52 for passing a fluid. The passage 52 is formed as a channel having a circular, elliptical, polygonal, or other shape that extends straight along the axis C (longitudinal direction) of the needle portion 22 of the puncture needle 14. The passage 52 is used as a passage for liquids such as medicinal solutions. The passage 52 may also be used as a passage for gases such as air.

[0031] The puncture portion 34 is provided on the distal side of the body portion 32 along the axis C of the needle portion 22. The intermediate portion 36 is provided between the body portion 32 and the puncture portion 34 along the axis C of the needle portion 22. The body portion 32 is formed of a resin material integrally with the intermediate portion 36 on the proximal side of the intermediate portion 36. The puncture portion 34 is formed of a resin material integrally with the intermediate portion 36 on the distal side of the intermediate portion 36.

[0032] The puncturing portion 34 has a needle tip (pointed end) 34a that tapers toward the tip. As will be described later, since it is necessary to first puncture the elastic body E with the needle tip 34a of the puncturing portion 34, it is preferable that the needle tip 34a at the most distal end of the puncturing portion 34 does not include the first groove portion 24 or the second groove portion 26 and is appropriately sharp. It is sufficient that the needle tip 34a is able to form a hole from the needle tip 34a in an elastic body E of an appropriate thickness, such as a rubber stopper of a container such as a vial, and penetrate the elastic body E when the puncturing needle 14 is moved in a direction along the axis C of the needle portion 22 of the puncturing needle 14.

[0033] The boundary between the puncturing portion 34 and the intermediate portion 36 can be set as appropriate. For example, the region from the tip 63 of the bottom surface 62 of the first groove portion 24 (described later) to the needle tip 34a may be the puncturing portion 34, or the region from the tip 65 of a pair of protrusions 64 of the first groove portion 24 (described later) to the needle tip 34a may be the puncturing portion 34. In this embodiment, the latter case is used. Therefore, the bottom surface 62 of the first groove portion 24 is provided in the intermediate portion 36 and also in the puncturing portion 34.

[0034] Intermediate section 36 is formed as a frame between body section 32 and puncture section 34. Intermediate section 36 has a first intermediate body (third columnar section) 36a provided on the tip side of second columnar section 44 of body section 32, and a second intermediate body (fourth columnar section) 36b provided on the tip side of first intermediate body 36a.

[0035] The first intermediate body 36a of the intermediate portion 36 is formed integrally with the second columnar portion 44 of the trunk portion 32 as a columnar body, for example, a cylindrical body, having the same constant outer diameter as the tip of the second columnar portion 44 of the trunk portion 32. It is preferable that the back side of the first intermediate body 36a of the intermediate portion 36 extends straight from the back side of the second columnar portion 44 of the trunk portion 32 and parallel to the axis C of the needle portion 22.

[0036] The second intermediate body 36b of the intermediate portion 36 is integrally formed with the first intermediate body 36a as a truncated cone body, for example a truncated cone shape, whose outer diameter decreases toward the puncture portion 34 side, and is also integrally formed with the puncture portion 34.

[0037] For this reason, the intermediate portion 36 is formed as a combination of a columnar body (first intermediate body 36a) on the body portion 32 side and a frustum body (second intermediate body 36b) on the puncture portion 34 side. The outer shape of the intermediate portion 36 may be formed as a columnar shape having an N-sided polygonal (N is an integer of 3 or more) cross section, or may be formed as a columnar shape having an elliptical cross section.

[0038] The first intermediate body 36a of the intermediate section 36 extends from the tip of the second columnar section 44 toward the puncture section 34 along the axis C of the needle section 22 of the puncture needle 14. The first intermediate body 36a and the second intermediate body 36b of the intermediate section 36 form the outer peripheral surface of the needle section 22 that extends from the tip of the second columnar section 44 of the body section 32 toward the puncture section 34. The outer peripheral surface of the needle section 22 formed by the first intermediate body 36a and the second intermediate body 36b of the intermediate section 36 smoothly connects the tip of the second columnar section 44 and the needle tip 34a of the puncture section 34. The maximum diameter of the outer peripheral surface of the needle section 22 formed by the first intermediate body 36a of the intermediate section 36 is the same outer diameter as the tip of the second columnar section 44, and there is no region where the outer diameter becomes larger than the tip of the second columnar section 44 as it approaches the puncture section 34. Therefore, the outer diameter of the intermediate portion 36 remains constant or only decreases from the tip of the second columnar portion 44 toward the needle tip 34a of the puncturing portion 34. The outer diameter then gradually decreases from the tip 65 of the intermediate portion 36 toward the needle tip 34a at the tip of the puncturing portion 34.

[0039] The boundary position between the intermediate portion 36 and the puncturing portion 34 along the axis C of the needle portion 22 may be the same or different on the front side and back side of the needle portion 22. As described above, on the front side, the region beyond the tips 65 of the pair of protrusions 64 is the puncturing portion 34. For example, on the back side, the region beyond the tip 95 of the second groove portion 26 is the puncturing portion 34. In this case, the boundary positions on the right and left sides between the front side and back side along the axis C of the needle portion 22, between the intermediate portion 36 and the puncturing portion 34, are the positions connecting the tips 65 of the pair of protrusions 64 and the tip 95 of the second groove portion 26.

[0040] In this embodiment, a hole 52a that communicates with the outside of the puncture needle 14 is formed in the second columnar section 44 as the terminal end of the path 52 on the puncture section 34 side. The edge of the hole 52a may be formed in a substantially circular ring shape, or may be formed in a substantially elliptical shape, for example. In this embodiment, the edge of the hole 52a is formed in a substantially elliptical shape when viewed from the front side of the needle section 22, as shown in FIG. 4, and is formed in a substantially circular ring shape when viewed from the bottom side of the needle section 22, as shown in FIG.

[0041] The end of the path 52 opposite to the hole 52 a is formed at the connection portion 12 , for example.

[0042] In this embodiment, the body portion 32 and the intermediate portion 36 have a path 54 separate from the path 52. The path 54 is formed as a channel having a circular, elliptical, polygonal, or other shape that extends straight along the axis C (longitudinal direction) of the needle portion 22 of the puncture needle 14. The path 54 is used as a passage for gas such as air. The path 54 may also be used as a passage for liquid such as a medicinal solution. The cross-sectional sizes (opening area per unit length) of the paths 52 and 54 may be the same or different.

[0043] A hole 54a that communicates with the outside of the puncture needle 14 is formed at the end of the path 54 on the puncture section 34 side. In this embodiment, the hole 54a is formed in the intermediate section 36. The edge of the hole 54a may be formed in a substantially circular ring shape, or may be formed in a substantially elliptical shape, for example. In this embodiment, the edge of the hole 54a is formed in a substantially circular ring shape, for example, when viewed from below the needle section 22 as shown in FIG. 7.

[0044] The end of the path 54 opposite to the hole 54 a is formed at the connection portion 12 , for example.

[0045] In this embodiment, a first groove 24 is provided on the front side of the intermediate portion 36 of the needle portion 22. Therefore, the first groove 24 is formed on the front side of the puncture needle 14. The length of the first groove 24 along the axis C of the needle portion 22 is formed to be a length that penetrates from the outer surface Eo side of the plate-shaped elastic body E through the inner surface Ei of the elastic body E that is punctured.

[0046] The first groove portion 24 has a bottom surface 62 that is continuous with the inner peripheral surface of the path 52, a pair of protrusions 64 that protrude from the bottom surface 62, and a closed end 66 on the body portion 32 side.

[0047] The bottom surface 62 is integrally formed with the intermediate portion 36 and extends from the body portion 32 toward the puncture portion 34 along the axis C (longitudinal direction) of the needle portion 22. The bottom surface 62 may be formed as a flat surface or a curved surface. In the present embodiment, the bottom surface 62 is formed by combining a flat surface and a curved surface. The portion of the bottom surface 62 facing the body portion 32 is formed as a surface (first bottom surface) 62a that is continuous with the inner circumferential surface of the path 52. The first bottom surface 62a is formed, for example, as a flat surface. The portion of the bottom surface 62 facing the puncture portion 34 is formed as a surface (second bottom surface) 62b that extends straight along the axis C of the needle portion 22 of the puncture needle 14. The second bottom surface 62b is formed, for example, as a flat surface. The portion of the second bottom surface 62b closest to the needle tip 34a of the puncture portion 34 is defined as the tip 63 of the bottom surface 62. The tip 63 of the bottom surface 62 is also the tip of the first groove portion 24. The portion of the second bottom surface 62b, from the tips 65 of the pair of protrusions 64 to the tip 63 of the first groove portion 24, is formed as a substantially isosceles triangular surface with the outer peripheral surface of the puncturing portion 34 as two equal sides and the tip 63 as the vertex. In practice, it is preferable that the tip 63 of the first groove portion 24 be formed at an angle larger than the needle tip 34a of the puncturing portion 34.

[0048] Between the first bottom surface 62a and the second bottom surface 62b, a third bottom surface 62c is formed as an inclined surface that is inclined with respect to the first bottom surface 62a and the second bottom surface 62b, and is continuous with the first bottom surface 62a and is also continuous with the second bottom surface 62b.

[0049] Furthermore, when the width of the bottom surface 62 is the outer diameter formed by the intermediate portion 36, it is preferable that the bottom surface 62 be formed longer in the direction along the axis C of the needle portion 22 than the width of the bottom surface 62.

[0050] When the bottom surface 62 is convex toward the front side, the height of the bottom surface 62 is formed lower than the height of the pair of protrusions 64 in order to secure the channel 68 of the first groove portion 24 .

[0051] In this embodiment, the axis C of the needle portion 22 of the puncture needle 14, i.e., the central axis of the first columnar portion 42 of the body portion 32, is aligned with the surface of the second bottom surface 62b of the first groove portion 24. As shown in Figures 6 and 7 , the needle tip 34a is offset toward the back surface of the needle portion 22 with respect to the axis C of the needle portion 22 of the puncture needle 14. Furthermore, the axis of the second columnar portion 44 of the body portion 32 is offset toward the back surface of the needle portion 22 with respect to the axis C of the first columnar portion 42. The needle tip 34a is offset toward the back surface with respect to the axis C of the second columnar portion 44. The needle tip 34a is formed as a generally conical region that tapers away from the body portion 32.

[0052] Therefore, the bottom surface 62 of the first groove portion 24 in this embodiment is positioned in a position along the inner surface of the back side of the needle portion 22 in the path 52, and is positioned closer to the back side of the needle portion 22 (opposite the opening side of the first groove portion 24 (the side of the pair of protrusions 64)) than the inner surface of the back side of the needle portion 22 in the path 52.

[0053] The protrusion 64 and closed end 66 of the first groove portion 24 are formed as the edge of an approximately U-shaped slit in the intermediate portion 36, extending parallel to the axis C on the front side of the needle portion 22, opening the puncture portion 34 side of the puncture needle 14 and closing the body portion 32 side.

[0054] In this embodiment, the width between the pair of protrusions 64 perpendicular to the axis C of the needle 22 is constant at any position along the axis C of the needle 22 .

[0055] The pair of protrusions 64 extend on the bottom surface 62 along the axis C (longitudinal direction) of the needle portion 22 from the body portion 32 toward the puncture portion 34, and protrude from the bottom surface 62 in a direction intersecting the axis C. The pair of protrusions 64 can function as front-side ribs that suppress buckling of the puncture needle 14. The pair of protrusions 64 protrude in the same direction relative to the bottom surface 62. In this embodiment, the pair of protrusions 64 protrude relative to the bottom surface 62 toward the front side of the needle portion 22 (see FIG. 4 ). Therefore, the pair of protrusions 64, together with the bottom surface 62, communicate with the path 52 and the hole portion (opening edge) 52a, and form a channel (flow path) 68 that opens from the axis C of the needle portion 22 to the outer peripheral surface of the middle portion 36 and, in this embodiment, opens to the front side. Therefore, fluids such as liquids and gases can be introduced and discharged through the channel 68.

[0056] The pair of protrusions 64 are formed so that the protruding height of the pair of protrusions 64 relative to the bottom surface 62 gradually decreases from the second columnar portion 44 side toward the puncture portion 34 side. Therefore, the pair of protrusions 64 are formed so as to gradually approach the axis C of the needle portion 22 from the closed end 66 toward the puncture portion 34.

[0057] The pair of protruding portions 64 have wall surfaces 72 that are continuous with the bottom surface 62 and protruding ends (opening edges) 74 .

[0058] 2, 4, and 9, the wall surfaces 72 of the pair of protrusions 64 are preferably formed as parallel planes facing each other. The distance between the protruding ends 74 of the pair of protrusions 64 that protrude from the bottom surface 62 is the same as the width of the bottom surface 62 of the first groove portion 24. The distance between the wall surfaces 72 of the pair of protrusions 64 can be set as appropriate. Therefore, the bottom surface 62 and the wall surfaces 72 of the pair of protrusions 64 form a channel (flow path) 68 whose cross section intersects with the axis C of the needle portion 22 of the puncture needle 14 is approximately U-shaped, for example, perpendicular to the axis C of the needle portion 22 of the puncture needle 14.

[0059] It is preferable that part of the region of the protruding ends 74 of the pair of protruding portions 64, which extends from the second columnar portion 44 side toward the puncture portion 34 side, has a region that is parallel to the axis C of the needle portion 22 of the puncture needle 14. In this embodiment, the protruding ends 74 of the pair of protruding portions 64 extend from the second columnar portion 44 side toward the puncture portion 34 side and have a first edge (first parallel portion) 82 and a second edge (second parallel portion) 84 that are preferably parallel to the axis C of the needle portion 22 of the puncture needle 14.

[0060] 2, 4, and 9, the first edge 82 is narrow in the left-right direction on the outer peripheral surface of the intermediate portion 36 and is formed as a generally linear edge along the axis C. The second edge 84 is wider in the left-right direction than the first edge 82 and is formed as a flat surface parallel to the axis C of the needle portion 22 and the second bottom surface 62b. It is also preferable that the second edge 84 is formed as a curved surface, such as a circular or elliptical arc, that protrudes toward the front side opposite the back side, rather than a flat surface. Similar to the first edge 82, it is also preferable that the surface of the second edge 84 closest to the front side is formed as a generally linear edge.

[0061] The protruding end 74 has a first inclined portion 86 between the first edge 82 and the second edge 84, which is inclined relative to the first edge 82 and the second edge 84. The protruding end 74 has a second inclined portion 88 between the second edge 84 and the bottom surface 62 on the needle tip 34a side, which is inclined relative to the second edge 84.

[0062] The first inclined portion 86 is formed so that its protruding height from the third bottom surface 62c gradually decreases from the body 32 side toward the puncture portion 34 side. The second inclined portion 88 is formed so that its protruding height from the second bottom surface 62b gradually decreases from the body 32 side toward the puncture portion 34 side. The most distal position of the second inclined portion 88, indicated by reference numeral 65 (the tip of the intermediate portion 36), is continuous with the second bottom surface 62b. Note that the most distal position of the second inclined portion 88, indicated by reference numeral 65, is located at the base end of the puncture portion 34.

[0063] The first edge 82 , the second edge 84 , the first inclined portion 86 , and the second inclined portion 88 form the opening edge of the channel 68 .

[0064] Of the bottom surfaces 62 of the first groove portion 24, the second bottom surface 62b is formed closer to the back surface of the needle portion 22 than the surface on the back surface of the path 52 in the body portion 32. Of the protruding ends 74 of the pair of protruding portions 64, the body portion 32 side is aligned along or approximately aligned along the front surface of the path 52. Therefore, even if the elastic body E enters the channel 68 between the pair of protruding portions 64 from the front side of the needle portion 22, the flow path (depth) of the fluid such as a liquid through the channel 68 is made larger than the diameter of the path 52, so that the flow paths of the channel 68 and the path 52 are more reliably secured.

[0065] The outer peripheral surface of the puncturing portion 34 is provided on the rear side of the left and right edges of the region beyond the tips 65 of the pair of protrusions 64 on the second bottom surface 62 b of the first groove portion 24 .

[0066] The closed end 66 is formed near the boundary between the second columnar section 44 of the body section 32 and the first intermediate body 36a of the intermediate section 36. A portion of the closed end 66 is formed as part of the outer peripheral surface of the first intermediate body 36a of the intermediate section 36, and is also formed as part of the opening edge of the hole 52a of the path 52.

[0067] The distal end of the channel 68 is defined by the distal ends 65 of the pair of protrusions 64, and the proximal end of the channel 68 is defined by the closed end 66. Therefore, the channel 68 is formed between the distal ends 65 and the closed end 66 of the pair of protrusions 64.

[0068] In this embodiment, the body 32 has a path 54 separate from the path 52, and a hole 54a formed at the end of the path 54 on the needle tip 34a side (described later) that communicates with the outside. The path 54 is formed as a channel extending straight along the axial direction of the puncture needle 14. The path 54 is used as a passage for gas, such as air. The hole 54a of the path 54 is preferably located closer to the needle tip 34a than the hole 52a of the path 52. The position of the hole 54a of the path 54 may be adjacent to the position of the hole 52a of the path 52 across the axis C of the needle portion 22 of the puncture needle 14. The edge of the hole 54a may be formed in a substantially circular ring shape, or may be formed in a substantially elliptical shape, for example.

[0069] If the distance from the base end of the body 32 (the tip of the connecting portion 12) to the closed end 66 of the first groove 24 is short and the length of the first groove 24 is appropriate, as shown in Figures 12A and 12B, when the puncture needle 14 is inserted, the channel 68 of the first groove 24 is likely to be adjacent to the inner surface Ei of the elastic body E. Therefore, it is expected that the action of the puncture needle 14, described below, can reduce residual liquid in the container. Depending on the puncture depth of the needle portion 22 into the elastic body E, there is a possibility that the outer surface Eo and the inner surface Ei of the elastic body E may be connected by the first groove 24. The longer the distance from the tip of the connecting portion 12 to the distal end of the first groove 24, the easier it is to ensure a fluid flow path even in a thick elastic body. If the overall length of the first groove 24 is too long, there is a possibility that the outer surface Eo and the inner surface Ei of the elastic body E may be connected by the first groove 24. Therefore, the length between the closed end 66 of the first groove 24 and the tip 63 of the first groove 24 is set appropriately.

[0070] In this embodiment, a second groove 26 is provided on the back side of the intermediate portion 36. Therefore, the second groove 26 is formed on the back side of the puncture needle 14. The second groove 26 extends parallel to the axis C and is formed as a substantially U-shaped slit that opens the needle tip 34a side of the puncture portion 34 of the puncture needle 14 and closes the body 32 side.

[0071] 3 and 5 , the second groove 26 of the puncturing portion 34 is formed of a resin material integrally with the intermediate portion 36 and the puncturing portion 34. The second groove 26 has a bottom surface 92 that is continuous with the inner circumferential surface of the path 54, and a pair of protrusions 94 that protrude from the bottom surface 92.

[0072] The bottom surface 92 may be formed as a flat surface or a curved surface. In this embodiment, the bottom surface 92 is long in a direction along the axis C of the needle portion 22 and extends convexly toward the front side. The tip of the bottom surface 92 is located on the rear side of the needle tip 34a. Therefore, the bottom surface 62 of the first groove portion 24 and the bottom surface 92 of the second groove portion 26 are adjacent to each other across an axis that includes the needle tip 34a and is parallel to the axis C.

[0073] The pair of protrusions 94 have a closed end 94a and a pair of end edges 94b.

[0074] The closed end 94a is formed, for example, near the boundary between the first intermediate body 36a and the second intermediate body 36b of the intermediate portion 36. The closed end 94a is formed as part of the outer circumferential surface of the second intermediate body 36b of the intermediate portion 36.

[0075] The pair of edges 94b are formed as part of the outer peripheral surfaces of the intermediate portion 36 and the puncturing portion 34. The pair of edges 94b can function as backside ribs that suppress buckling of the puncturing needle 14. The pair of edges 94b extend from the second intermediate body 36b of the intermediate portion 36 toward the needle tip 34a of the puncturing portion 34, and approach each other as they approach the needle tip 34a of the puncturing portion 34. For this reason, the pair of edges 94b are formed so that their width narrows as they approach the needle tip 34a of the puncturing portion 34. Furthermore, the pair of edges 94b approach the axis C of the needle portion 22 as they move from the second intermediate body 36b of the intermediate portion 36 toward the needle tip 34a of the puncturing portion 34. For this reason, it is preferable that no portion of the pair of edges 94b of the second groove portion 26 is parallel to the axis C of the needle portion 22.

[0076] The pair of protrusions 94, together with the bottom surface 92, communicate with the path 54 and the hole (opening edge) 54a, and form a channel (flow path) 98 that opens from the axis C of the needle 22 to the outside of the puncture section 34 and the intermediate section 36, and in this embodiment, opens to the back side. For this reason, fluids such as liquids and gases can be introduced into and discharged from the channel 98.

[0077] The paths 52, 54 are preferably formed not only in the puncture needle 14, but also in the connecting portion 12 that is integrally formed with the puncture needle 14. The paths 52, 54 are formed as through holes in the connecting portion 12 and the puncture needle 14 that are parallel to the axis C of the needle portion 22. In other words, the paths 52, 54 are preferably formed as through holes that are parallel to the axis C of the needle portion 22 of the puncture device 10.

[0078] The following shows the dimensions of the needle portion 22 of the puncture needle 14. The following dimensions are an example and can be changed as appropriate depending on the elastic body E to be punctured, the length and material of the needle portion 22 of the puncture needle 14 used, etc.

[0079] The length of the puncture needle 14 is, for example, 20.1 mm. Of these, the length of the body 32 of the needle part 22 is, for example, 7.6 mm, the length of the intermediate part 36 is, for example, 8.5 mm, and the length of the puncture part 34 is, for example, 4 mm.

[0080] The outer diameter of the first columnar portion 42 of the body portion 32 is, for example, 4 mm, and the outer diameter of the second columnar portion 44 and the outer diameter of the intermediate portion 36 are, for example, 3.6 mm.

[0081] The length of the first groove 24 along the axis C of the needle 22 depends on the thickness of the elastic body E, but is preferably 7.5 mm or more.

[0082] The length of the pair of protrusions 64 of the first groove 24 along the axis C of the needle 22 is, for example, 8.5 mm. Of these, the length of the first edge (first parallel portion) 82 on the body 32 side is, for example, 2.7 mm, and the length of the second edge (second parallel portion) 84 on the puncture portion 34 side is, for example, 2.2 mm. Therefore, the length of the first edge 82 on the body 32 side is longer than the length of the second edge 84 on the puncture portion 34 side. The length of the first inclined portion 86 along the axis C of the needle 22 between the edges 82, 84 is, for example, 1.3 mm, and the length of the second inclined portion 88 on the puncture portion 34 side along the axis C of the needle 22 is, for example, 2.2 mm. The inclination angle of the first inclined portion 86 on the trunk 32 side is, for example, 25° with respect to the edges 82, 84, and the inclination angle of the second inclined portion 88 on the puncturing portion 34 side is, for example, 20° with respect to the edges 82, 84. Therefore, the inclination angle of the first inclined portion 86 on the trunk 32 side is greater than the inclination angle of the second inclined portion 88 on the puncturing portion 34 side with respect to the edges 82, 84. Therefore, the inclined portion 88 on the puncturing portion 34 side is gentler than the inclined portion 86 on the trunk 32 side.

[0083] The distance between wall surfaces 72 of the pair of protrusions 64 is constant, for example, 1.4 mm, from the body 32 side to the puncture portion 34 side. That is, the width between the edges 82, 84, inclined portions 86, and inclined portions 88 of the pair of protrusions 64 is 1.4 mm. The protruding height of the second edge 84 from the bottom surface 62 of the pair of protrusions 64 is, for example, 0.8 mm, and the protruding height of the first edge 82 is, for example, 1.4 mm.

[0084] The diameter of each of the paths 52 and 54 is, for example, 0.9 mm.

[0085] The dimensional relationship between the intermediate portion 36 and the first groove portion 24 is preferably, for example, diameter of the path 52 ≦ width between the wall surfaces 72 of the first groove portion 24 ≦ width between the edges 82, 84 < diameter of the intermediate portion 36.

[0086] The dimensions of the puncture needle 14 can be appropriately set depending on the hardness and deformability of the elastic body E that closes the container. As described above, the hardness of the elastic body E is, for example, between 20 and 55 degrees Shore A (ISO 7619; ASTM D2240; JIS K 6253). When the hardness of the elastic body E is within this range, the protrusion height (depth) of the protruding ends 74 of the pair of protrusions 64 relative to the bottom surface 62 of the first groove portion 24, i.e., the depth of the channel 68, is preferably greater than 0.5 mm, and more preferably 0.8 mm or greater. When at least the puncture portion 34 and the intermediate portion 36 of such a puncture needle 14 are inserted into the elastic body E, the channel 68 of the first groove portion 24 is prevented from being closed by the elastic deformation of the elastic body E.

[0087] When the width between the protruding ends 74 of the pair of protrusions 64 is 1.4 mm, the depth of the first groove 24 is, for example, 0.5 mm or more. Therefore, the depth of the first groove 24 is preferably 36% or more of the width of the first groove 24 (the width between the wall surfaces 72 of the pair of protrusions 64), which is 1.4 mm. The depth of the first groove 24 is more preferably 0.8 mm or more, and therefore, the depth of the first groove 24 is more preferably 58% or more of the width of the first groove 24. By having the elastic body E have the above-mentioned hardness and the depth of the first groove 24 being 36% or more of the width of the first groove 24, the channel 68 is prevented from being blocked by the elastic body E when the puncture needle 14 is inserted into the elastic body E.

[0088] Furthermore, as described above, the axis C of the needle portion 22 coincides with the central axis (axis) of the first columnar portion 42. The axis of the second columnar portion 44 is offset from the axis of the first columnar portion 42 toward the rear surface, for example, by 0.2 mm. Furthermore, the axis including the needle tip 34a of the puncturing portion 34 is offset from the axis of the second columnar portion 44 toward the rear surface, for example, by 0.1 mm. Therefore, the axis C of the needle portion 22 is offset from the axis including the needle tip 34a.

[0089] The operation of the puncture needle 14 according to this embodiment will be described with reference to FIGS.

[0090] For example, a syringe or the adapter described above serving as a connector 8 for introducing air (gas) into a container and collecting a liquid is connected in advance to the connecting portion 12 of the puncture tool 10. Alternatively, a connector 8 for transferring a liquid to another container is connected in advance to the connecting portion 12 of the puncture tool 10.

[0091] An example of an object to be punctured by the puncture needle 14 of the puncture device 10 of this embodiment is an elastic body (rubber stopper) E of a container (not shown), such as a vial, which contains a medicinal solution and is sealed with a plate-shaped elastic body E made of rubber (see Figures 10 to 13).

[0092] Figures 10, 11A, and 12A show a series of diagrams illustrating puncturing the elastic body E of a container with the puncture needle 14 with the outer surface Eo facing up and the inner surface Ei facing down. Figure 11B is a schematic cross-sectional view of the needle portion 22 in the diagram shown in Figure 11A, and Figure 12B is a schematic cross-sectional view of the needle portion 22 in the diagram shown in Figure 12A. Figure 13 is a diagram illustrating the state in which the needle portion 22 has punctured the elastic body E with the outer surface Eo facing down and the inner surface Ei facing up.

[0093] 10 , a user of the puncture device 10, such as a doctor or nurse, punctures the outer surface Eo of the elastic body E of the container with the needle tip 34a of the needle portion 22 of the puncture device 10, puncturing the outer surface Eo of the elastic body E and forming a puncture hole H in the elastic body E. At this time, the user aligns the axis C of the needle portion 22 perpendicular to the outer surface Eo of the elastic body E, and punctures the elastic body E without rotating the needle portion 22 around the axis C of the needle portion 22.

[0094] 11A and 11B , the user of the puncture device 10 further punctures the needle portion 22 into the puncture hole H of the elastic body E, and causes the first groove portion 24 to reach the inner surface Ei of the elastic body E. The needle portion 22 of the puncture needle 14 punctures the inner surface Ei of the elastic body E with the needle tip 34a while the outer peripheral surface of the puncture portion 34, the outer peripheral surface of the intermediate portion 36, a part of the second bottom surface 62b of the first groove portion 24 on the tip 63 side, the protruding ends 74 of the pair of protruding portions 64, and the pair of protruding portions 94 of the second groove portion 26 are in close contact with the elastic body E. Therefore, the outer surface of the puncture portion 34, the outer surface of the intermediate portion 36, a portion of the tip 63 side of the second bottom surface 62b of the first groove portion 24, the protruding ends 74 of the pair of protrusions 64, and the pair of protrusions 94 of the second groove portion 26 push away the elastic body E, forming a puncture hole H that penetrates the elastic body E.

[0095] The body 32 also pushes away the elastic body E from the puncture hole H. In this embodiment, the outer peripheral surface of the intermediate portion 36, the protruding ends 74 of the pair of protrusions 64 of the first groove 24, and the outer peripheral surface of the body 32 maintain the state in which the elastic body E from the outer surface Eo to the inner surface Ei of the elastic body E is pushed away from the puncture hole H. Therefore, in the puncture needle 14 that has punctured the elastic body E, the channel 68 of the first groove 24 is not blocked by the elastic body E, and the channel 68 and the path 52 ensure a flow path for discharging the liquid in the container to the outside of the container.

[0096] The second bottom surface 62b of the first groove portion 24 is formed closer to the back surface of the needle portion 22 than the surface on the back surface of the path 52. Therefore, the distance between the bottom surface 62 and the protruding portion 64 is set to be greater than the diameter of the path 52. Therefore, even if the elastic body E around the puncture hole H enters between the pair of protruding portions 64, a flow path for fluids such as liquids is more reliably secured.

[0097] The axis C of the needle portion 22 is pierced perpendicularly to the outer surface Eo and inner surface Ei of the elastic body E at an appropriate speed, and when the elastic body E in the puncture hole H is gradually pushed away, there is no part of the elastic body E in the puncture hole H that is scraped off, thereby preventing the occurrence of coring.

[0098] The protruding ends 74 of the pair of protruding portions 64 have an appropriate length in the direction along the axis C and have a gradual change in the protruding length in the direction along the axis C toward the outside of the intermediate portion 36 relative to the bottom surface 62, so that the needle portion 22 of the puncture needle 14 gradually punctures while minimizing the elastic deformation of the elastic body E.

[0099] 12A and 12B , the user of the puncture device 10 further punctures the needle portion 22 through the puncture hole H in the elastic body E and brings the distal end surface of the connecting portion 12 (the proximal end of the needle portion 22) into contact with or close to the outer surface Eo of the elastic body E. At this time, for example, the closed end 66 of the first groove portion 24 passes the inner surface Ei of the elastic body E and is within the container. Alternatively, the closed end 66 of the first groove portion 24 may not have passed the inner surface Ei of the elastic body E. At this time, the protruding ends 74 of the pair of protruding portions 64 of the first groove portion 24 have already passed the inner surface Ei of the elastic body E. As described above, the channel 68 of the first groove portion 24 is not blocked by the elastic body E, ensuring a liquid flow path. Therefore, liquid or gas can be introduced into the container through the channel 68 of the first groove portion 24, which communicates with the path 52. Furthermore, the liquid in the container can be discharged out of the container through the first groove portion 24 and the path 52 .

[0100] The tips 95 of the pair of protrusions 94 of the second groove 26 that communicate with the other path 54 are located closer to the needle tip 34 a than the tips of the protruding ends 74 of the pair of protrusions 64 of the first groove 24 .

[0101] The user of the puncture device 10 can then inject or expel air into or from the container, for example, through another passage 54 .

[0102] An example of a method for introducing a liquid drug into a container using a syringe will now be briefly described. Assume that the connector 8 shown in Figure 1 has a syringe connected to the liquid path 52 and an air bag (pressure adjustment unit) connected to the gas path 54. When a drug or the like is transferred from the syringe to the container through the path 52 and the channel 68 of the first groove portion 24, the pressure inside the container increases, and air inside the container moves to the air bag through the channel 98 of the second groove portion 26 and the path 54. As a result, the pressure inside the container is maintained constant.

[0103] An example of a method for sampling a medicinal liquid from a container using a syringe will now be briefly described. Assume that the connector 8 shown in FIG. 1 has a syringe connected to the liquid path 52 and an air bag connected to the gas path 54. An amount of air equal to the amount of medicinal liquid to be sampled is previously placed in the barrel of the syringe, and the syringe piston is pushed in to inject the air in the barrel into the container via the liquid path 52. At this time, the pressure inside the container rises, and the air in the container moves to the air bag via the gas flow path 54, maintaining the pressure inside the container at equilibrium. Next, the container is placed above, and the syringe is placed below.

[0104] 12A and 12B , when the user turns the container upside down with the puncture needle 14 inserted into the puncture hole H, the inner surface Ei of the elastic body E of the container is positioned on the upper side and the outer surface Eo of the elastic body E is positioned on the lower side. At this time, the elastic body E on the outer periphery of the puncture hole H of the elastic body E is in close contact with the outer periphery of the body 32. Furthermore, in some cases, the elastic body E on the outer periphery of the puncture hole H of the elastic body E is in close contact with the outer periphery of the middle part 36. This prevents fluids such as liquids from leaking out of the gap between the outer periphery of the body 32 and the puncture hole H of the elastic body E, and the gap between the outer periphery of the middle part 36 and the puncture hole H of the elastic body E. The liquid in the container then collects on the inner surface Ei of the elastic body E.

[0105] When the plunger of the syringe is pulled back by the amount of medicinal liquid to be collected, the liquid is introduced into the path 52 through the channel 68 of the first groove portion 24. As a result, the medicinal liquid in the container moves to the barrel via the liquid path 52, and the medicinal liquid is collected. At this time, the pressure inside the container decreases, and the air in the air bag moves into the container via the gas flow path 54, maintaining the pressure inside the container at equilibrium.

[0106] If the user turns the container upside down and the closed end 66 of the first groove 24 is positioned above the inner surface Ei of the elastic body E, the closed end 66 of the first groove 24 will be positioned on the outer surface Eo side of the inner surface Ei of the elastic body E, as shown in Figure 13. At this time, liquid will pass through the channel 68 of the first groove 26 and be collected in the hole 52a.

[0107] After using the puncture needle 14 appropriately, before removing the puncture needle 14 from the puncture hole H of the elastic body E, the user positions the elastic body E of the container with the outer surface Eo facing up and the inner surface Ei facing down. In this state, the user removes the puncture needle 14 from the puncture hole H of the elastic body E. At this time, the elastic body E around the puncture hole H closes the puncture hole H while adhering to the outer peripheral surface of the puncture needle 14 due to its elastic force. Therefore, when the needle tip 34a is positioned closer to the outer surface Eo than the inner surface Ei of the elastic body E, the puncture hole H on the inner surface Ei of the elastic body E closes before the needle tip 34a is removed from the outer surface Eo of the elastic body E. In this way, the puncture hole H gradually closes as the puncture needle 14 is removed from the elastic body E. Therefore, the puncture needle 14 according to this embodiment prevents foreign matter from entering the container from outside the container when being removed from the elastic body E.

[0108] The puncture needle 14 according to this embodiment has the following advantages.

[0109] A first groove 24 is provided in the middle portion 36 of the needle portion 22 of the synthetic resin puncture needle 14, forming a channel 68 that communicates with the path 52 in the body portion 32. The first groove 24 extends from the body portion 32 toward the puncture portion 34 in a direction along the axis C of the needle portion 22, and has a pair of protrusions 64 that protrude from the bottom surface 62 in a direction intersecting the axis C of the needle portion 22. The pair of protrusions 64 can function as ribs on the front side of the needle portion 22. This prevents the needle portion 22 from unintentionally bending about the axis C when the needle portion 22 of the puncture needle 14 is inserted into, for example, an elastic body E.

[0110] Furthermore, when the puncture needle 14 of the puncture device 10 is inserted into the elastic body E, as long as the pair of protrusions 64 of the first groove 24 reach the inner surface Ei of the elastic body E, even if the pair of protrusion ends 74 of the first groove 24, including the closed end 66, are blocked by the elastic body E, a portion of the channel 68 can be connected to the inside of the container. As long as the pair of protrusions 64 of the first groove 24 remain in contact with the perforations in the elastic body E, the space between the pair of protrusions 64 can serve as a channel 68 for the medicinal solution. For this reason, for example, by turning a container such as a vial upside down and using it with the inner surface Ei of the elastic body E facing up and the outer surface Eo facing down, the liquid in the container can be guided to the channel 68, preventing any liquid from remaining in the container. For this reason, there are provided a puncture needle 14 made of a resin material that makes it easy to secure a fluid path 52 when puncturing an elastic body E that serves as the lid of a container filled with a liquid such as a medicinal solution, a puncture tool 10 including the puncture needle 14, and a puncture tool assembly 1 including the puncture tool 10.

[0111] Furthermore, by forming the length of the pair of protrusions 64 of the first groove portion 24 along the axis C of the needle portion 22 to an appropriate length, it is possible to prevent adjustment of the puncture depth of the puncture needle 14 for elastic bodies E of various thicknesses, and it is also possible to prevent liquid from leaking from inside the container.

[0112] Furthermore, even when puncturing elastic bodies E of various thicknesses, a pair of protrusions 64 extending from the body 32 toward the puncturing portion 34 in a direction along the axis C of the needle portion 22 makes it possible to secure a fluid channel 68 and provide a puncturing needle 14 with improved stability in the puncturing state.

[0113] A portion of the protruding ends 74 of the pair of protruding portions 64 is formed as edges (parallel portions) 82, 84 that are parallel to the axis C (longitudinal direction) of the needle portion 22. When the edge (parallel portion) 82 of the protruding end (opening edge) 74 of the needle portion 22 passes over the inner surface Ei of the puncture hole H in the elastic body E, the edge (parallel portion) 82 does not change the size of the puncture hole H, or if it does change, the amount of change is small. Therefore, the edge (parallel portion) 82 can reduce the amount of change in elastic deformation of the elastic body E around the puncture hole H. Therefore, when forming the puncture hole H with the puncture needle 14, the puncture depth of the puncture needle 14 can be increased while suppressing an increase in puncture resistance.

[0114] Similarly, when the edge (parallel portion) 84 of the protruding end (opening edge) 74 of the needle portion 22 passes over the inner surface Ei of the puncture hole H in the elastic body E, the size of the puncture hole H does not change, or if it does change, the amount of change is small, due to the edge (parallel portion) 84. Therefore, the edge (parallel portion) 84 can reduce the amount of change in elastic deformation of the elastic body E around the puncture hole H. Therefore, when forming the puncture hole H with the puncture needle 14, the puncture depth of the puncture needle 14 can be increased while suppressing an increase in puncture resistance.

[0115] In this way, the puncture resistance when the synthetic resin puncture needle 14 punctures the elastic body E of the container can be maintained constant, while the puncture depth of the needle portion 22 of the puncture needle 14 into the elastic body E can be increased. This makes it possible to maintain the state in which the puncture needle 14 punctures the elastic body E. For example, the elastic force of the elastic body E can prevent the puncture needle 14 from trying to slip out of the elastic body E. Therefore, by providing the end edges (parallel portions) 82, 84 of the protruding end (opening edge) 74 of the needle portion 22, the stability of the state in which the puncture needle 14 punctures the elastic body E can be improved.

[0116] The amount by which the edges 82, 84 of the pair of protruding portions 64 protrude from the bottom surface 62 is greater on the side closer to the body 32 than on the side closer to the puncturing portion 34. The amount by which the first edge 82 of the pair of protruding portions 64, which is provided adjacent to the body 32, protrudes is greater than the amount by which the second edge 84, which is provided closer to the puncturing portion 34 than the first edge 82. Therefore, when the puncture needle 14 is inserted into the puncture hole H of the elastic body E to deepen the puncture depth, if two different edges 82, 84 are inserted into the elastic body E by puncturing, such that their height relative to the bottom surface 62 is lower on the distal side and higher on the proximal side along the axis C of the needle portion 22, the load (resistance) applied to the user's finger or the like can be reduced compared to when only one edge 82 is inserted into the elastic body E along the axis C of the needle portion 22. Furthermore, by forming the pair of protrusions 64 in this manner, when the puncture needle 14 is inserted into the elastic body E, a gap is less likely to occur between the puncture hole H and the elastic body E.

[0117] Furthermore, by forming an inclined portion 86 between the two edges 82, 84 that is inclined with respect to the axis C of the needle portion 22 and that reduces the amount of protrusion from the bottom surface 62 as it moves from the more base-end edge 82 toward the more tip-end edge 84, the puncture needle 14 can be more smoothly punctured into the elastic body E.

[0118] In addition, between the first edge 82 and the second edge 84, there is an inclined portion 86 that reduces the amount of protrusion from the bottom surface 62 as it moves from the first edge 82 to the second edge 84. Therefore, when the puncture needle 14 is puncturing the elastic body E, the first edge 82 and the second edge 84 can be smoothly connected by the inclined portion 86. By forming the pair of protrusions 64 in this manner, it is less likely that a gap will occur between the puncture hole H and the puncture needle 14 when it is puncturing the elastic body E.

[0119] The bottom surface 62 of the first groove portion 24 is formed closer to the back surface of the puncture needle 14 than the inner circumferential surface on the back surface side of the path 52, or at a position coinciding with the axis C of the puncture needle 14. The necessary depth of the first groove portion 24 can be ensured while the outer diameter (cross-sectional area) of the intermediate portion 36 of the puncture needle 14 is relatively small. Therefore, when the puncture needle 14 punctures the elastic body E, it is possible to prevent the channel 68 as a fluid path from being blocked by the first groove portion 24. Furthermore, by making the outer diameter (cross-sectional area) of the intermediate portion 36 of the puncture needle 14 relatively small, it is possible to reduce puncture resistance when the synthetic resin puncture needle 14 punctures the elastic body E of the container.

[0120] The puncture needle 14 has a first columnar portion 42 and a second columnar portion 44 on the body portion 32, the second columnar portion 44 being formed with a smaller outer diameter than the first columnar portion 42, and the protruding end (opening edge) 74 of the first groove portion 24 being formed closer to the tip than the second columnar portion 44. Therefore, the second columnar portion 44, which is inserted into the elastic body E before the first columnar portion 42, is thinner, which minimizes the puncture resistance when the synthetic resin puncture needle 14 punctures a drug container, and improves the seal near the boundary between the second columnar portion 44 and the first columnar portion 42 or between the first columnar portion 42 and the elastic body E, preventing leakage of the drug solution from the gap between the puncture needle 14 and the elastic body E due to changes in the internal pressure within the container when the drug is injected or collected, or preventing substances from outside the container from unintentionally mixing into the liquid in the container.

[0121] Furthermore, since the puncturing portion 34 has a generally conical shape, the puncturing portion 34 is less likely to be crushed by the resistance of the elastic body E when the needle tip 34a of the puncturing needle 14 is inserted into the elastic body E. This makes it possible to reduce an increase in puncture resistance due to the crushing of the puncturing portion 34.

[0122] The axis C of the first columnar portion 42, the axis of the second columnar portion 44, and the axis including the needle tip 34a of the puncturing portion 34 are offset from one another. Therefore, the channel 68 of the first groove portion 24 and the path 52 can be secured even if they are positioned offset from the axis C of the needle portion 22. Furthermore, the needle tip 34a can be formed as a pointed tip without locating the channel 68 of the first groove portion 24 on the needle tip 34a. Therefore, when the puncturing needle 14 punctures the elastic body E, it can be more reliably punctured.

[0123] The cross-sectional area of ​​the channel 68 perpendicular to the axis C of the needle 22 is equal to or larger than the cross-sectional area of ​​the path 52 perpendicular to the axis C of the needle 22. This allows a larger amount of fluid to be collected in the channel 68, for example, in a container.

[0124] The distance between the edges 82, 84 of the pair of protrusions 64 that protrude from the bottom surface 62 is the same as the width of the bottom surface 62 of the first groove portion 24. Therefore, by forming the opening on the front side, which serves as an inlet for liquid or the like into the channel 68, to an appropriate size, it is possible to collect a larger amount of fluid in the channel 68, for example, inside a container.

[0125] The length of the pair of protrusions 64 of the first groove 24 along the axis C of the needle 22 is formed to be equal to or longer than the length of penetration through the inner surface Ei of the plate-shaped elastic body E that is punctured from the outer surface Eo side. Therefore, when the puncture needle 14 punctures the elastic body E, the needle tip 34a passes through the outer surface Eo and then the inner surface Ei of the elastic body E, and when the closed end 66 at the base end of the first groove 24 has passed through the outer surface Eo of the elastic body E, the tip of the first groove 24 can be positioned inside the container. Therefore, fluid can be collected in the channel 68 inside the container.

[0126] In this way, by appropriately setting the depth of the first groove portion 24, the width between the protruding ends (opening edges) 74 of the first groove portion 24, and the width between the wall surfaces 72 of the first groove portion 24, even when the puncture needle 14 is inserted into an elastic body E of a different thickness or hardness, for example, an elastic body E that has low hardness, is easily deformed, and is thick, the elastic body E does not block the channel 68 between the pair of protruding portions 64 of the first groove portion 24, and the fluid path 52 can be secured. Therefore, even when the puncture needle 14 is inserted into an elastic body E of a different thickness, the presence of the first groove portion 24 in the path 52 of the puncture needle 14 allows the medicinal liquid in the container to be collected to the last drop.

[0127] The pair of protrusions 94 of the second groove 26 function as ribs on the back side, and together with the pair of protrusions 64 of the first groove 24, can more reliably prevent the needle 22 from buckling.

[0128] Furthermore, the tip 95 of the protrusion 94 of the second groove 26 that communicates with the path 54 is closer to the needle tip 34a than the tips 65 of the pair of protrusions 64 of the first groove 24. Therefore, when the container is turned upside down with the puncture needle 14 puncturing the elastic body E, the tip 95 of the protrusion 94 of the second groove 26 is positioned above the tips 65 of the pair of protrusions 64 of the first groove 24. In this state, for example, if air is introduced into the container through the path 54, the medicinal liquid in the container can be efficiently extracted through the path 52.

[0129] (Modifications) Here, modifications of the shape of the channel 68 of the first groove portion 24 of the needle portion 22 described in the first embodiment will be described with reference to FIGS. 14A to 14E.

[0130] Figures 14A to 14E are schematic diagrams showing modified examples of the cross-sectional view taken along line IX-IX in Figure 4. In Figures 14A to 14E, the path 54 is omitted from the illustration.

[0131] In the first embodiment described above, an example was described in which the wall surfaces 72 of a pair of protrusions 64 of the first groove portion 24 are parallel to each other, and the height of the bottom surface 62 is constant along the left-right direction of the needle portion 22, as shown in Figure 9.

[0132] 14A , the bottom surface 62 may be formed in a concave shape such as a roughly half-pipe shape, with a convex shape extending in the left-right direction toward the rear side. Therefore, the wall surfaces 72 and the bottom surface 62 of the pair of protrusions 64 form a channel 68 having a roughly U-shaped cross section perpendicular to the axis C of the needle portion 22 of the puncture needle 14. The bottommost portion of the second bottom surface 62b may be located along the axis C of the needle portion 22, or may be located closer to the front or rear of the axis C of the needle portion 22.

[0133] As shown in Figure 14B, the wall surfaces 72 of a pair of protrusions 64 of the first groove 24 do not have to be parallel to each other. In the example shown in Figure 14B, the wall surfaces 72 and bottom surface 62 of the pair of protrusions 64 form a concave channel 68 having a cross section perpendicular to the axis C of the needle portion 22 of the puncture needle 14 that is generally U-shaped or D-shaped. Depending on the mold used, manufacturing is easier if the width between the wall surfaces 72 of the first groove 24 is equal to or less than the width between the edge (opening surface) 82. The puncture needle 14 is preferably manufactured by, for example, injection molding, but may also be manufactured using, for example, a 3D printer.

[0134] 14C , the height of the bottom surface 62 is constant in the left-right direction of the needle portion 22, but the wall surfaces 72 of the pair of protrusions 64 of the first groove portion 24 do not have to be parallel to each other. In the example shown in Fig. 14C , the wall surfaces 72 and the bottom surface 62 of the pair of protrusions 64 form a concave channel 68 whose cross section perpendicular to the axis C of the needle portion 22 of the puncture needle 14 is, for example, approximately trapezoidal. The distance between the protruding ends (opening edges) 74 of the pair of protrusions 64 that protrude from the bottom surface 62 is greater than the width of the bottom surface 62 of the first groove portion 24.

[0135] As shown in Fig. 14D, it is also preferable that the boundary between the wall surface 72 and the bottom surface 62 is not clearly defined. In this case, the bottommost portion of the bottom surface 62 is formed in a line along the axis C of the needle portion 22. In the example shown in Fig. 14D, the wall surfaces 72 and the bottom surface 62 of a pair of protrusions 64 form a concave channel 68 whose cross section perpendicular to the axis C of the needle portion 22 of the puncture needle 14 is substantially triangular or the like.

[0136] As shown in FIG. 14E , the left-right width of the bottom surface 62 may be greater than the left-right width of the protruding end (opening edge) 74. Note that the channel 68 shown in FIG. 14C has a trapezoidal base with a shorter side located on the bottom surface 62, while the channel 68 shown in FIG. 14E has a trapezoidal base with a longer side located on the bottom surface 62. In the example shown in FIG. 14E , the left-right width of the protruding end (opening edge) 74 (the shorter side of the trapezoidal base) may be large enough to allow liquid to flow toward the bottom surface 62 of the first groove portion 24. In the example shown in FIG. 14E , the wall surfaces 72 and the bottom surface 62 of the pair of protruding portions 64 form a concave channel 68 having a cross section perpendicular to the axis C of the needle portion 22 of the puncture needle 14, e.g., a substantially trapezoidal shape. The distance between the protruding ends 74 of the pair of protruding portions 64 that protrude from the bottom surface 62 is smaller than the width of the bottom surface 62 of the first groove portion 24. Such a puncture needle 14 may be manufactured using, for example, a 3D printer.

[0137] In this way, the channel 68 of the first groove portion 24 may be formed into various shapes. As described in the first embodiment above, the shape of the protruding ends 74 of the pair of protruding portions 64 may be formed as a substantially linear edge on the body portion 32 side and as an edge that is wider on the puncture portion 34 side than the edge 82 side. Alternatively, the shape of the protruding ends 74 of the pair of protruding portions 64 may be formed as a line overall.

[0138] Although not shown, the wall surfaces 72 of the pair of protrusions 64 are parallel to each other toward the opposing wall surface 72, and may protrude toward each other or may be recessed away from each other as long as the channel 68 is secured. In other words, the wall surfaces 72 of the pair of protrusions 64 may be flat or may be appropriately curved.

[0139] Second Embodiment The needle portion 22 of the puncture needle 14 of the puncture device 10 according to a second embodiment will be described using Figure 15. This embodiment is a modification of the first embodiment including various modifications, and components that are the same as or have the same functions as those described in the first embodiment are assigned the same reference numerals as much as possible, and detailed descriptions thereof will be omitted.

[0140] FIG. 15 is a schematic diagram showing a modified cross section of the puncture needle 14 of the puncture device 10 shown in FIGS. 4 and 5 taken along line VIII-VIII.

[0141] The connecting portion 12 and puncture needle 14 of the puncture device 10 according to the first embodiment have been described as having two fluid paths 52, 54. The connecting portion 12 and puncture needle 14 of the puncture device 10 according to the present embodiment have only one fluid path 52. The puncture needle 14 according to the first embodiment has been described as having a first groove 24 on the front side and a second groove 26 on the rear side. In the present embodiment, the first groove 24 is provided on the front side, but the second groove 26 is not provided on the rear side. In the present embodiment, the path 52 and the channel 68 are used as passages for both liquid and gas. A syringe, for example, is connected as the connecting device 8 of the puncture device 10 having the puncture needle 14 according to the present embodiment.

[0142] The protruding ends 74 of the pair of protruding portions 64 of the first groove portion 24 are formed as one edge (parallel portion) 83 that is different from the two edge portions 82, 84 (see Figures 6 and 8) along the axis C of the needle portion 22, and one inclined portion 87 that is different from the two inclined portions 86, 88 (see Figures 6 and 8) along the axis C of the needle portion 22.

[0143] The first bottom surface 62a is provided along the inner peripheral surface on the back side of the path 52. The second bottom surface 62b is not located along the inner peripheral surface on the back side of the path 52, but is located closer to the back side than the inner peripheral surface on the flat side of the path 52 and on the opposite side from the opening side (front side) of the first groove portion 24.

[0144] The puncture needle 14 may be formed in this manner. When the body 32, puncture portion 34, and intermediate portion 36 of the needle portion 22 of the puncture needle 14 according to this embodiment have the same dimensions as the needle portion 22 described in the first embodiment, the length of the edge 83 can be formed to be approximately the combined length of the edges 82, 84. Therefore, when the puncture needle 14 punctures the elastic body E, the channel 68 is secured, and the puncture state in which the needle portion 22 is inserted into the puncture hole H can be stably maintained.

[0145] Therefore, the bottom surface 62 can be positioned along the inner surface of the back side of the path 52, and / or on the back side opposite the opening side of the first groove portion 24 from the inner surface of the back side of the path 52.

[0146] (First Modification) A first modification of the puncture needle 14 of the puncture device 10 according to the second embodiment will be described with reference to Fig. 16A. Fig. 16A is a cross-sectional view of the first modification of the needle portion taken along line VIII-VIII shown in Figs. 4 and 5.

[0147] 16A , the bottom surface 62 is formed straight and parallel to the axis C of the needle portion 22. Therefore, the bottom surface 62 is formed, for example, as a single surface. The bottom surface 62 is then in communication with the inner circumferential surface on the back side of the path 52 in a straight line. Therefore, the path 52 and the channel 68 of the first groove portion 24 are in communication with each other in a straight line. The bottom surface 62 may be a flat surface or a curved surface.

[0148] The protruding ends 74 of the pair of protruding portions 64 of the first groove portion 24 are formed as one edge (parallel portion) 83 along the axis C of the needle portion 22 and one inclined portion 87 along the axis C of the needle portion 22.

[0149] The puncture needle 14 may be formed in this manner.

[0150] (Second Modification) A second modification of the puncture needle 14 of the puncture device 10 according to the second embodiment will be described using Fig. 16B. The puncture needle 14 according to this modification is a further modification of the first modification. Fig. 16B is a cross-sectional view of the second modification taken along line VIII-VIII of the needle portion shown in Figs. 4 and 5.

[0151] 16B , the closed end 66 of the first groove 24 is provided in the second columnar section 44 of the body 32, not in the first intermediate body 36a of the intermediate section 36. That is, the first groove 24 may be provided not only in the intermediate section 36 and the puncture section 34, but also preferably in the body 32.

[0152] The puncture needle 14 may be formed in this manner.

[0153] (Third Modification) A third modification of the puncture needle 14 of the puncture device 10 according to the second embodiment will be described using Fig. 16C. The puncture needle 14 according to this modification is a further modification of the first or second modification. Fig. 16C is a cross-sectional view of the third modification taken along line VIII-VIII of the needle portion shown in Figs. 4 and 5.

[0154] 16C , the protruding ends 74 of the pair of protruding portions 64 of the first groove portion 24 are formed as a single inclined portion 87 along the axis C of the needle portion 22. Even when the puncture needle 14 punctures the elastic body E, the channel 68 is secured.

[0155] The puncture needle 14 may be formed in this manner.

[0156] Third Embodiment A puncture needle 14 of a puncture device 10 according to a third embodiment will be described with reference to FIG.

[0157] 17 , the protruding ends 74 of the pair of protruding portions 64 of the first groove 24 may be formed along the outer circumferential surface of the intermediate portion 36 between the tip of the body portion 32 and the base end of the puncture portion 34. The protruding ends 74 of the pair of protruding portions 64 of the first groove 24 are formed as a single edge (parallel portion) 83 along the axis C of the needle portion 22.

[0158] For example, the central axis (axial center) of the second columnar portion 44 of the body 32 coincides with the axial center of the needle tip 34a of the puncture portion 34. Furthermore, if the outer diameters of the body 32 and the first intermediate body 36a of the intermediate portion 36 are the same shape up to the base end of the second intermediate body 36b, the puncture needle 14 according to this embodiment can have the axial center C of the needle portion 22 pass through the needle tip 34a of the puncture portion 34.

[0159] The puncture needle 14 may be formed in this manner.

[0160] Therefore, according to the first to third embodiments, it is possible to provide a puncture needle made of a resin material that makes it easy to secure a fluid path when puncturing an elastic body that serves as the lid of a container in which a liquid such as a medicinal solution is sealed, a puncture tool including the puncture needle, and a puncture tool assembly including the puncture tool.

[0161] The present invention is not limited to the above-described embodiments, and various modifications can be made in the implementation stage without departing from the spirit of the invention. Furthermore, the embodiments may be implemented in appropriate combinations, in which case the combined effects can be obtained. Furthermore, the above-described embodiments include various inventions, and various inventions can be extracted by combining selected elements from the disclosed elements. For example, if the problem can be solved and the desired effect can be obtained even if some elements are deleted from all elements shown in the embodiments, the configuration from which these elements are deleted can be extracted as an invention.

[0162] 1...Puncture tool assembly, 8...Connecting tool, 10...Puncture tool, 12...Connecting portion, 14...Puncture needle, 22...Needle portion, 24...First groove portion, 26...Second groove portion, 32...Body portion, 34...Puncture portion, 34a...Needle tip, 36...Intermediate portion, 36a...First intermediate body, 36b...Second intermediate body, 42...First columnar portion, 44...Second columnar portion, 44a...Inclined portion, 52...Path, 52a...Hole portion, 54...Path, 54a...Hole portion, 62...Bottom surface, 62a...First bottom surface (flat surface), 62b...Second bottom surface (flat surface) ), 62c...third bottom surface (inclined surface), 63...tip, 64...protruding portion, 65...tip, 66...closed end, 68...channel (flow path), 72...wall surface, 74...protruding end, 82...first edge (opening edge), 84...second edge (opening edge), 86...first inclined portion (opening edge), 88...second inclined portion (opening edge), 92...bottom surface, 94...protruding portion, 94a...closed end, 94b...edge, 95...tip, 98...channel, E...elastic body, Ei...inner surface, Eo...outer surface, H...puncture hole.

Claims

1. A puncture needle made of a resin material, comprising: a body having a path for passing a fluid; a puncture portion provided on the tip side of the body and having a needle tip at its most extreme end; and an intermediate portion provided between the body and the puncture portion; a bottom surface provided integrally with the intermediate portion and extending from the body toward the puncture portion; and a pair of protrusions provided integrally with the bottom surface, extending from the body toward the puncture portion in a direction along the axis of the needle portion and protruding from the bottom surface in a direction intersecting the axis of the needle portion, a channel formed between the bottom surface and the pair of protrusions communicating with the path in the body, and a groove portion opening the channel to the outside of the intermediate portion.

2. The puncture needle according to claim 1, wherein at least a portion of the edges of the pair of projections that project from the bottom surface are parallel to a direction along the axis of the needle portion.

3. The puncture needle according to claim 2, wherein the edges of the pair of protruding portions have a first edge that is provided adjacent to the body and protrudes toward the bottom surface, and a second edge that is provided closer to the puncture portion than the first edge and protrudes toward the bottom surface, and wherein the first edge protrudes toward the bottom surface by a greater amount than the second edge.

4. The puncture needle according to claim 3, wherein the pair of protrusions are provided between the first edge and the second edge, are inclined with respect to the axis of the needle portion, and have an inclined portion such that the amount of protrusion from the bottom surface decreases as the protrusion moves from the first edge to the second edge.

5. A puncture needle as described in claim 1 or claim 2, wherein the bottom surface is positioned along the inner circumferential surface of the path on the side opposite the opening side of the groove portion, or on the side opposite the opening side of the groove portion relative to the inner circumferential surface of the path.

6. A puncture needle as claimed in claim 1 or claim 2, wherein the body portion has: a first columnar portion having the path; and a second columnar portion provided between the first columnar portion and the puncture portion and having an opening edge of the path, the outer diameter of the second columnar portion being the same as or smaller than the outer diameter of the first columnar portion, and the outer peripheral surface of the second columnar portion being continuous with the outer peripheral surface of the puncture portion.

7. The puncture needle according to claim 6, wherein an axis of the first columnar portion, an axis of the second columnar portion, and an axis of the puncture portion including the needle tip are offset from one another.

8. The puncture needle according to claim 1 or 2, wherein a cross-sectional area of ​​the channel perpendicular to the axis of the needle portion is equal to or larger than a cross-sectional area of ​​the path perpendicular to the axis of the needle portion.

9. The puncture needle according to claim 1 or 2, wherein the distance between the edges of the pair of protruding parts protruding from the bottom surface is equal to or greater than the width of the bottom surface of the groove.

10. A puncture needle as described in claim 1 or claim 2, wherein the length of the pair of protrusions of the groove along the axis of the needle portion is formed to be the same as or longer than the length penetrating the inner surface of a plate-shaped elastic body that is punctured from the outer surface side.

11. A puncture tool comprising the puncture needle according to claim 1 or 2 and a base provided on the body of the puncture needle.

12. A puncture assembly comprising: the puncture according to claim 11; and a connector connected to the base of the puncture.

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