Puncture needle, puncture equipment, and puncture equipment assembly

Abstract

To provide a resin puncture needle that allows a fluid route to be secured easily when puncturing an elastic body that serves as a lid of a container in which fluid such as a medicine is encapsulated.SOLUTION: A resin puncture needle includes a needle part and a groove part. The needle part includes, in an integrated manner, a trunk part having a route through which the fluid passes, a puncture part provided on a tip side of the trunk part, and having a needle tip at the foremost part, and an intermediate part provided between the trunk part and the puncture part. A pair of protrusions includes a bottom face provided in the intermediate part in an integrated manner and extending from the trunk part to the puncture part, and a pair of protrusions provided on the bottom face in an integrated manner, extending in a direction along an axial center of the needle part from the trunk part to the puncture part, and protruding in a direction crossing the axial center of the needle part from the bottom face. The groove part causes a channel formed between the bottom face and the pair of protrusions to be communicated with the route of the trunk part and causes the channel to be opened outside the intermediate part.SELECTED DRAWING: Figure 2

Description

[Technical field]

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

[0002] For example, many medical drugs are supplied filled in containers sealed with lids made of elastic materials such as rubber. The elastic materials used in such containers come in a variety of shapes and materials, and for example, a needle made of synthetic resin for medical use is inserted into the elastic material to collect, prepare, administer, etc., the drug.

[0003] For example, as described in Patent Document 1, a puncture needle made of synthetic resin has been conventionally used to puncture an elastic body of a medicine container filled with the medicine to collect the medicine. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2014-97102 A Summary of the Invention [Problem to be solved by the invention]

[0005] When the 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 to be 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 a thick elastic body or an elastic body with a film coating applied to the inner surface of the container.

[0006] The present invention has been made to solve such problems, and its object is to provide a puncture needle made of a resin material that makes it easy to secure a fluid path when punctured into 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. [Means for solving the problem]

[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 has a body portion having a path through which a fluid passes, a puncture portion provided at the tip side of the body and having a needle tip at the most distal end, and an intermediate portion provided between the body portion and the puncture portion. The pair of protrusions is integrally provided on the intermediate portion and has 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 has a channel formed between the bottom surface and the pair of protrusions communicating with the path of the body, and opens the channel to the outside of the intermediate portion. Effect of the Invention

[0008] According to the present invention, it is possible to provide a puncture needle made of a resin material that facilitates securing a fluid path when punctured into an elastic body that serves as the lid of a container in which a liquid such as a medicinal liquid is sealed, a puncture tool including the puncture needle, and a puncture tool assembly including the puncture tool. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a schematic perspective view of a puncture tool assembly according to a first embodiment. [Diagram 2] 2 is a schematic perspective view of the front side of a puncture needle of the puncture tool of the puncture tool assembly shown in FIG. 1. [Diagram 3] 3 is a schematic perspective view of the rear side of the puncture needle of the puncture device shown in FIG. 2. [Figure 4] FIG. 3 is a front view of a puncture needle of the puncture device of the puncture device assembly shown in FIGS. 1 and 2 . [Diagram 5]FIG. 5 is a rear view of the puncture needle of the puncture device shown in FIG. 4. [Figure 6] 5 is a right side view of the puncture needle of the puncture device shown in FIG. 4. [Figure 7] FIG. 7 is a bottom view of the puncture needle of the puncture device shown in FIG. 6. [Figure 8] 8 is a cross-sectional view taken along line VIII-VIII in FIGS. 4 and 5. FIG. [Figure 9] FIG. 5 is a schematic cross-sectional view taken along line IX-IX in FIG. 4 . [Figure 10] FIG. 13 is a schematic diagram showing a state in which a needle part of a puncture needle is punctured into an elastic body. [Figure 11A] 11 is a schematic diagram showing a state following FIG. 10 in which the needle part of the puncture needle is punctured into the elastic body. [Figure 11B] 11B is a schematic cross-sectional view showing the needle part of the puncture needle shown in FIG. 11A as the cross section shown in FIG. 8. [Figure 12A] 12 is a schematic diagram showing a state subsequent to FIG. 11 in which the needle part of the puncture needle is punctured into the elastic body. [Figure 12B] 12B is a schematic cross-sectional view showing the needle part of the puncture needle shown in FIG. 12A as the cross section shown in FIG. 8. [Figure 13] 13 is a schematic perspective view showing a state in which a needle portion of a puncture needle is punctured into an elastic body and liquid is collected in a channel of a first groove portion. FIG. [Figure 14A] FIG. 9 is a cross-sectional view taken along line IX-IX of FIG. 4, showing a first modified example. [Figure 14B] 9 is a second modified cross-sectional view taken along line IX-IX in FIG. [Figure 14C] 9 is a cross-sectional view taken along line IX-IX of FIG. 4 according to a third modified example. [Figure 14D] FIG. 9 is a cross-sectional view taken along line IX-IX of FIG. 4, according to a fourth modified example. [Figure 14E] FIG. 9 is a cross-sectional view taken along line IX-IX of FIG. 4, showing a fifth modified example. [Figure 15] 8 is a cross-sectional view of the needle portion of the puncture needle according to the second embodiment taken along line VIII-VIII in FIG. 4. [Figure 16A] 8 is a cross-sectional view taken along line VIII-VIII of the needle portion shown in FIG. 15 according to a first modified example. [Figure 16B] 8 is a cross-sectional view taken along line VIII-VIII of the needle portion shown in FIG. 15 according to a second modification. [Figure 16C] 8 is a cross-sectional view taken along line VIII-VIII of the needle portion shown in FIG. 15 according to a third modification. [Figure 17] 8 is a cross-sectional view of the needle portion of the puncture needle according to the third embodiment taken along line VIII-VIII in FIG. 4. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings.

[0011] (First embodiment) A puncture tool assembly 1 according to a first embodiment will be described with reference to FIGS.

[0012] Fig. 1 is a schematic perspective view of the puncture tool 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 tool 10 of the puncture tool 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 tool 10 of the puncture tool assembly 1. Fig. 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 Figs. 1 to 3. That is, the side of the puncture needle 14 where a first groove portion 24 described later is exposed to the outside of the puncture needle 14 is defined as the front side of the puncture needle 14. Fig. 5 is a rear view of the needle portion 22 of the puncture needle 14 of the puncture device 10 shown in Fig. 4. That is, the side of the puncture needle 14 where a second groove portion 26 described later 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 arranged 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 arranged 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 arranged 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] Fig. 6 is a right side view of the needle portion 22 of the puncture needle 14 of the puncture device 10 shown in Fig. 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 Fig. 6. Fig. 7 is a bottom view of the needle portion 22 of the puncture needle 14 of the puncture device 10 shown in Fig. 6 as viewed from the direction indicated by the arrow VII. Fig. 8 is a cross-sectional view taken along the line VIII-VIII in Figs. 4 and 5. Fig. 9 is a schematic cross-sectional view taken along the line IX-IX in Fig. 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 of the puncture needle 14 of the puncture device 10 shown in Figure 4 when viewed from the front side.

[0016] 10 to 13 are diagrams for explaining a series of actions when the needle portion 22 is used with the puncture device 10 to puncture the inner surface Ei of the elastic body E of a suitable container through the outer surface Eo.

[0017] For example, butyl rubber, silicone rubber, or ETFE (Ethylene Tetrafluoroethylene), a copolymer of tetrafluoroethylene and ethylene, is used as the elastic body E. The hardness of the elastic body E is, for example, between 20 degrees and 55 degrees in 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 are used. An example of the connector 8 is a syringe that supplies a dissolving solution or aspirates and discharges a medicinal liquid from a container. Another example of the connector 8 is a device called an adapter that is attached to a container such as a vial while the puncture needle 14 of the puncture tool 10 is inserted into the container. For example, a syringe is connected to a path 52 of the puncture needle 14, which will be described later, via the adapter.

[0020] The puncture needle 14 can puncture the elastic body E shown in Figures 10 to 13, and can also be used without puncturing. Therefore, the type of container is not limited, and the container may be an ampoule, in addition to a vial, as a container for which the puncture needle 14 is used. Another example of a container for which the puncture needle 14 can puncture is an elastic body of a connector of a bag that is used while suspended and contains a liquid such as a drug solution or blood.

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

[0022] The connecting part 12 is connected to various connectors 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 having an outer shape 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 the line VIII-VIII shown in FIG. 4 and the 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 .

[0025] Needle portion 22 has a body portion 32 , a puncture portion 34 provided on the tip side of body portion 32 , and an intermediate portion 36 provided between body portion 32 and 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 the sake of simplicity, 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 aligned with the central axis of the first columnar portion 42. 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.

[0028] 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 this embodiment, the back side of the outer circumferential surface of the second columnar portion 44 extends straight, for example, 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.

[0029] The body 32 has a passage 52 for passing a fluid. The passage 52 is formed as a channel having a shape such as a circular tube, an elliptical tube, or a polygonal tube 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 liquids. The passage 52 may also be used as a passage for gases such as air.

[0030] The puncture portion 34 is provided on the tip 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 base end side of the intermediate portion 36. The puncture portion 34 is formed of a resin material integrally with the intermediate portion 36 on the tip side of the intermediate portion 36.

[0031] The puncturing part 34 has a needle tip (pointed end) 34a that becomes thinner toward the tip side. As described later, since it is necessary to first puncture the elastic body E with the needle tip 34a of the puncturing part 34, it is preferable that the needle tip 34a at the most distal end of the puncturing part 34 does not include the first groove portion 24 and the second groove portion 26 and is appropriately sharp. It is sufficient that the needle tip 34a is capable of forming a hole from the needle tip 34a in the elastic body E of an appropriate thickness, such as a rubber stopper of a container such as a vial, and penetrating the elastic body E when the puncturing needle 14 is moved in a direction along the axis C of the needle part 22 of the puncturing needle 14.

[0032] The boundary between the puncture portion 34 and the intermediate portion 36 can be set appropriately. For example, the region from a tip 63 of a bottom surface 62 of the first groove portion 24 to the needle tip 34a, which will be described later, may be the puncture portion 34, or the region from a tip 65 of a pair of protrusions 64 of the first groove portion 24 to the needle tip 34a, which will be described later, may be the puncture 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 puncture portion 34.

[0033] The intermediate section 36 is formed as a frame between the body section 32 and the puncture section 34. The intermediate section 36 has a first intermediate body (third columnar section) 36a provided on the tip side of the second columnar section 44 of the body section 32, and a second intermediate body (fourth columnar section) 36b provided on the tip side of the first intermediate body 36a.

[0034] 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, cylindrical, 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 in parallel to the axis C of the needle portion 22.

[0035] The second intermediate body 36b of the middle 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, and is also integrally formed with the puncture portion 34.

[0036] For this reason, intermediate portion 36 is formed as a combination of a columnar body (first intermediate body 36a) on the body 32 side and a frustum body (second intermediate body 36b) on the puncture portion 34 side. The outer shape of intermediate portion 36 may be formed into a columnar shape having an N-sided (N is an integer of 3 or more) cross section, or may be formed into a columnar shape having an elliptical cross section.

[0037] The first intermediate body 36a of the intermediate portion 36 extends from the tip of the second columnar portion 44 toward the puncture portion 34 along the axis C of the needle portion 22 of the puncture needle 14. The first intermediate body 36a and the second intermediate body 36b of the intermediate portion 36 form the outer circumferential surface of the needle portion 22 extending from the tip of the second columnar portion 44 of the body portion 32 toward the puncture portion 34. The outer circumferential surface of the needle portion 22 formed by the first intermediate body 36a and the second intermediate body 36b of the intermediate portion 36 smoothly connects the tip of the second columnar portion 44 and the needle tip 34a of the puncture portion 34. The maximum diameter of the outer circumferential surface of the needle portion 22 formed by the first intermediate body 36a of the intermediate portion 36 is the same outer diameter as the tip of the second columnar portion 44, and there is no region where the outer diameter becomes larger than the tip of the second columnar portion 44 toward the puncture portion 34. For this reason, the outer diameter of intermediate portion 36 is constant or simply decreases from the tip of second columnar portion 44 toward needle tip 34a of puncturing portion 34. The outer diameter gradually decreases from tip 65 of intermediate portion 36 toward needle tip 34a at the tip of puncturing portion 34.

[0038] The boundary position between the intermediate portion 36 and the puncture portion 34 along the axis C of the needle portion 22 may be the same or different on the front side and the 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 puncture portion 34. For example, on the back side, the region beyond the tip 95 of the second groove portion 26 is the puncture portion 34. In this case, the right and left boundary positions between the front side and the back side along the axis C of the needle portion 22 between the intermediate portion 36 and the puncture portion 34 are positions that connect the tips 65 of the pair of protrusions 64 and the tip 95 of the second groove portion 26.

[0039] In this embodiment, the second columnar section 44 has a hole 52a that communicates with the outside of the puncture needle 14 as the end of the path 52 on the puncture section 34 side. The edge of the hole 52a may be formed in a substantially annular 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, for example, and is formed in a substantially annular shape when viewed from the bottom side of the needle section 22 as shown in FIG. The end of the path 52 opposite to the hole 52a is formed in the connection portion 12, for example.

[0040] 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.

[0041] A hole 54a that communicates with the outside of the puncture needle 14 is formed as an 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 the bottom of the needle section 22 as shown in FIG. The end of the path 54 opposite to the hole 54a is formed in the connection portion 12, for example.

[0042] In this embodiment, a first groove 24 is provided on the front side of the middle portion 36 of the needle 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 22 is formed to a length that penetrates the inner surface Ei of the plate-like elastic body E that is punctured from the outer surface Eo side of the elastic body E.

[0043] The first groove portion 24 has a bottom surface 62 that is continuous with the inner circumferential surface of the passage 52, a pair of protrusions 64 that protrude from the bottom surface 62, and a closed end 66 on the body portion 32 side.

[0044] The bottom surface 62 is provided integrally 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 this embodiment, the bottom surface 62 is formed by combining a flat surface and a curved surface. The body portion 32 side of the bottom surface 62 is formed as a surface (first bottom surface) 62a that continues to the inner peripheral surface of the path 52. The first bottom surface 62a is formed as, for example, a flat surface. The puncture portion 34 side of the bottom surface 62 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 as, for example, a flat surface. The second bottom surface 62b is formed as a flat surface at the side closest to the needle tip 34a of the puncture portion 34, which is the tip 63 of the bottom surface 62. Tip 63 of bottom surface 62 is also the tip of first groove portion 24. The portion of second bottom surface 62b between tips 65 of the pair of protrusions 64 and tip 63 of first groove portion 24 is formed as a surface of a substantially isosceles triangle with the outer peripheral surface of puncturing portion 34 as two equal sides and tip 63 as the apex. In practice, tip 63 of first groove portion 24 is preferably formed at an angle larger than needle tip 34a of puncturing portion 34.

[0045] 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.

[0046] When the width of the bottom surface 62 is set to the outer diameter formed by the intermediate portion 36, it is preferable that the bottom surface 62 is formed to be longer in the direction along the axis C of the needle portion 22 than the width of the bottom surface 62.

[0047] 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 .

[0048] In this embodiment, the axis C of the needle 22 of the puncture needle 14, i.e., the central axis of the first columnar portion 42 of the body 32, is along the surface of the second bottom surface 62b of the first groove portion 24. As shown in Figs. 6 and 7, the needle tip 34a is offset toward the back side of the needle 22 with respect to the axis C of the needle 22 of the puncture needle 14. Also, the axis of the second columnar portion 44 of the body 32 is offset toward the back side of the needle 22 with respect to the axis C of the first columnar portion 42. The needle tip 34a is offset toward the back side with respect to the axis of the second columnar portion 44. The needle tip 34a is formed as a substantially conical region that tapers away from the body 32 side.

[0049] For this reason, the bottom surface 62 of the first groove portion 24 in this embodiment is positioned at a position along the inner surface of the rear side of the needle portion 22 in the path 52, and is positioned closer to the rear 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 rear side of the needle portion 22 in the path 52.

[0050] 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.

[0051] 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.

[0052] The pair of protrusions 64 extend on the bottom surface 62 along the axis C (longitudinal direction) of the needle 22 from the body 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 a front-side rib that suppresses 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 in the same direction relative to the bottom surface 62 toward the front side of the needle 22 (see FIG. 4). Therefore, the pair of protrusions 64 communicate with the path 52 and the hole (opening edge) 52a together with the bottom surface 62, and form a channel (flow path) 68 that opens from the axis C of the needle 22 to the outer circumferential surface of the middle portion 36, and opens to the front side in this embodiment. Therefore, fluids such as liquids and gases can be introduced and discharged into the channel 68.

[0053] The pair of protrusions 64 are formed so that the protruding height of the pair of protrusions 64 from 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.

[0054] The pair of protruding portions 64 have wall surfaces 72 continuous with the bottom surface 62 and protruding ends (opening edges) 74 .

[0055] 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 appropriately. 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 is substantially U-shaped and intersects with the axis C of the needle portion 22 of the puncture needle 14, for example, perpendicular to the axis C of the needle portion 22 of the puncture needle 14.

[0056] Of the protruding ends 74 of the pair of protruding parts 64, it is preferable that a part of the region from the second columnar part 44 side toward the puncture part 34 side has a region parallel to the axis C of the needle part 22 of the puncture needle 14. In this embodiment, the protruding ends 74 of the pair of protruding parts 64 have a first edge (first parallel part) 82 and a second edge (second parallel part) 84 that are preferably parallel to the axis C of the needle part 22 of the puncture needle 14 from the second columnar part 44 side toward the puncture part 34 side. 2, 4 and 9, the first edge 82 is narrow in width in the left-right direction on the outer peripheral surface of the intermediate portion 36, and is formed as an approximately linear edge along the axis C. The second edge 84 is wider in width in the left-right direction than the first edge 82, and is formed as a plane parallel to the axis C and the second bottom surface 62b of the needle portion 22. It is also preferable that the second edge 84 is formed as a curved surface, such as a circular arc or elliptical arc, protruding toward the front side opposite the back side, rather than a flat surface. It is also preferable that the second edge 84 has a surface closest to the front side formed as an approximately linear edge, similar to the first edge 82.

[0057] The protruding end 74 has a first inclined portion 86 between the first edge 82 and the second edge 84, the first inclined portion 86 being 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, the second inclined portion 88 being inclined relative to the second edge 84. The first inclined portion 86 is formed so that the 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 the protruding height from the second bottom surface 62b gradually decreases from the body 32 side toward the puncture portion 34 side. The position indicated by reference numeral 65 on the most distal side of the second inclined portion 88 (the tip of the intermediate portion 36) is continuous with the second bottom surface 62b. The position indicated by reference numeral 65 on the most distal side of the second inclined portion 88 is located at the base end of the puncture portion 34.

[0058] 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 .

[0059] Of the bottom surface 62 of the first groove portion 24, the second bottom surface 62b is formed closer to the back side of the needle portion 22 than the back side 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 with the front side 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 a fluid such as a liquid by 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.

[0060] On the rear side of the left and right edges of the area beyond tips 65 of the pair of protrusions 64 on second bottom surface 62b of first groove portion 24, the outer peripheral surface of puncture portion 34 is provided.

[0061] The closed end 66 is formed near the boundary between the second columnar section 44 of the body 32 and the first intermediate body 36a of the middle section 36. A part of the closed end 66 is formed as part of the outer circumferential surface of the first intermediate body 36a of the middle section 36, and is also formed as part of the opening edge of the hole 52a of the path 52.

[0062] The tip of the channel 68 is defined by the tip ends 65 of the pair of protrusions 64, and the base end of the channel 68 is defined by the closed end 66. Therefore, the channel 68 is formed between the tip ends 65 and the closed end 66 of the pair of protrusions 64.

[0063] In this embodiment, the body 32 has a path 54 separate from the path 52, and a hole 54a formed as an end of the path 54 on the needle tip 34a side described later and communicating 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. It is preferable that the hole 54a of the path 54 is located closer to the needle tip 34a side 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 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.

[0064] If the distance from the base end of the body 32 (the tip of the connection part 12) to the closed end 66 of the first groove part 24 is short and the length of the first groove part 24 is appropriate, when the puncture needle 14 is punctured as shown in FIG. 12A and FIG. 12B, the channel 68 of the first groove part 24 is likely to be adjacent to the inner surface Ei of the elastic body E. For this reason, it is assumed that the residual liquid in the container can be reduced by the action of the puncture needle 14 described later. Depending on the puncture depth of the needle part 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 are communicated by the first groove part 24. The longer the distance from the tip of the connection part 12 to the distal end of the first groove part 24, the easier it is to ensure a flow path for the fluid even in a thick elastic body. If the entire length of the first groove part 24 is too long, there is a possibility that the outer surface Eo and the inner surface Ei of the elastic body E are communicated by the first groove part 24. Therefore, the length between the closed end 66 of the first groove portion 24 and the tip 63 of the first groove portion 24 is set appropriately.

[0065] 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.

[0066] 3 and 5, the second groove portion 26 of the puncture portion 34 is formed of a resin material integrally with the intermediate portion 36 and the puncture portion 34. The second groove portion 26 has a bottom surface 92 that is continuous with the inner circumferential surface of the path 54, and a pair of protruding portions 94 that protrude from the bottom surface 92.

[0067] 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 including the needle tip 34a that is parallel to the axis C.

[0068] The pair of projections 94 have a closed end 94a and a pair of edges 94b.

[0069] 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 a part of the outer circumferential surface of the second intermediate body 36b of the intermediate portion 36.

[0070] The pair of edges 94b are formed as part of the outer circumferential surface of the intermediate portion 36 and the puncture portion 34. The pair of edges 94b can function as a rib on the back side that suppresses buckling of the puncture 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 puncture portion 34, and approach each other toward the needle tip 34a of the puncture portion 34. For this reason, the pair of edges 94b are formed so that the width becomes narrower toward the needle tip 34a of the puncture portion 34. In addition, the pair of edges 94b approach the axis C of the needle portion 22 toward the needle tip 34a of the puncture portion 34 from the second intermediate body 36b of the intermediate portion 36. For this reason, it is preferable that the pair of edges 94b of the second groove portion 26 does not have a portion parallel to the axis C of the needle portion 22.

[0071] The pair of protruding parts 94, together with the bottom surface 92, communicate with the path 54 and the hole part (opening edge) 54a, and form a channel (flow path) 98 that opens from the axis C of the needle part 22 to the outside of the puncture part 34 and the intermediate part 36, and in this embodiment, opens to the back side. For this reason, the channel 98 can be used to introduce and discharge fluids such as liquids and gases.

[0072] It is preferable that the paths 52, 54 are formed not only in the puncture needle 14, but also in the connection part 12 that is integrally formed with the puncture needle 14. The paths 52, 54 are formed as through holes parallel to the axis C of the needle part 22 in the connection part 12 and the puncture needle 14. That is, it is preferable that the paths 52, 54 are formed as through holes parallel to the axis C of the needle part 22 of the puncture tool 10.

[0073] The following dimensions are for the needle portion 22 of the puncture needle 14. The following dimensions are merely examples and may 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 to be used, etc. 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. The outer diameter of the first columnar portion 42 of the body 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. 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. 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 body 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 body 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 body 32 side. The distance between wall surfaces 72 of the pair of protruding portions 64 is constant, for example, 1.4 mm, from the body portion 32 side to the puncture portion 34 side. That is, the width between the edges 82, between the edges 84, between the inclined portions 86, and between the inclined portions 88 of the pair of protruding portions 64 is 1.4 mm. The protruding height of the second edge 84 from the bottom surface 62 of the pair of protruding portions 64 is, for example, 0.8 mm, and the protruding height of the first edge 82 is, for example, 1.4 mm. The diameter of each of the paths 52 and 54 is, for example, 0.9 mm. The dimensional relationship between the intermediate portion 36 and the first groove portion 24 is preferably such that, 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.

[0074] The dimensions of the puncture needle 14 can be appropriately set depending on the hardness and ease of deformation of the elastic body E that closes the container. As described above, the hardness of the elastic body E is, for example, between 20 degrees and 55 degrees in Shore A (ISO 7619; ASTM D2240; JIS K 6253). When the hardness of the elastic body E is such a degree, the protruding height (depth) from the protruding end 74 of the pair of protruding parts 64 to the bottom surface 62 of the first groove part 24, i.e., the depth of the channel 68, is preferably, for example, greater than 0.5 mm, and more preferably 0.8 mm or more. When at least the puncture part 34 and the intermediate part 36 of such a puncture needle 14 are punctured into the elastic body E, the channel 68 of the first groove part 24 is prevented from being blocked by the elastic deformation of the elastic body E.

[0075] When the width between the protruding ends 74 of the pair of protruding parts 64 is 1.4 mm, the depth of the first groove part 24 is, for example, 0.5 mm or more. Therefore, the depth of the first groove part 24 is preferably 36% or more of the width of the first groove part 24 (the width between the wall surfaces 72 of the pair of protruding parts 64) of 1.4 mm. Since the depth of the first groove part 24 is more preferably 0.8 mm or more, it is more preferable that the depth of the first groove part 24 is 58% or more of the width of the first groove part 24. By having the above-mentioned hardness of the elastic body E and the relationship that the depth of the first groove part 24 is 36% or more of the width of the first groove part 24, the channel 68 is prevented from being blocked by the elastic body E when the puncture needle 14 is punctured into the elastic body E.

[0076] Furthermore, the axis C of needle portion 22 coincides with the central axis (axis) of first columnar portion 42 as described above. The axis of second columnar portion 44 is offset from the axis of first columnar portion 42 toward the rear surface side, for example, by 0.2 mm. Furthermore, the axis including needle tip 34a of puncturing portion 34 is offset from the axis of second columnar portion 44 toward the rear surface side, for example, by 0.1 mm. Therefore, axis C of needle portion 22 is offset from the axis including needle tip 34a.

[0077] The action of the puncture needle 14 according to this embodiment will be described with reference to FIGS.

[0078] For example, a syringe as a connector 8 for putting air (gas) into a container and sampling liquid, or the above-mentioned adapter, etc., is connected in advance to the connection part 12 of the puncture tool 10. Alternatively, a connector 8 for transferring liquid to another container is connected in advance to the connection part 12 of the puncture tool 10.

[0079] 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).

[0080] Fig. 10, Fig. 11A and Fig. 12A show a series of diagrams in which the puncture needle 14 punctures the elastic body E of the container with the outer surface Eo facing up and the inner surface Ei facing down. Fig. 11B is a schematic cross-sectional view of the needle part 22 in the diagram shown in Fig. 11A, and Fig. 12B is a schematic cross-sectional view of the needle part 22 in the diagram shown in Fig. 12A. Fig. 13 is a diagram in which the outer surface Eo of the elastic body E is facing down and the inner surface Ei is facing up in a state in which the needle part 22 has punctured the elastic body E.

[0081] 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 a 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 perpendicularly 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.

[0082] 11A and 11B, the user of the puncture tool 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 tip 63 side of the second bottom surface 62b of the first groove portion 24, 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. As a result, the elastic body E is pushed aside by 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 protruding portions 64, and the pair of protruding portions 94 of the second groove portion 26, forming a puncture hole H that penetrates the elastic body E.

[0083] The body 32 also pushes aside the elastic body E in the puncture hole H. In this embodiment, the outer peripheral surface of the middle portion 36, the protruding ends 74 of the pair of protruding portions 64 of the first groove portion 24, and the outer peripheral surface of the body 32 maintain the state in which the elastic body E in the puncture hole H is pushed aside from the outer surface Eo to the inner surface Ei of the elastic body E. Therefore, in the puncture needle 10 that has punctured the elastic body E, the channel 68 of the first groove portion 24 is not blocked by the elastic body E, and the channel 68 and the path 52 ensure a flow path for leading the liquid in the container to the outside of the container.

[0084] The second bottom surface 62b of the first groove portion 24 is formed closer to the back side of the needle portion 22 than the back side surface of the path 52. For this reason, the distance between the bottom surface 62 and the protruding portion 64 is made larger 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 a fluid such as a liquid is more reliably secured.

[0085] When the axis C of the needle portion 22 is inserted perpendicularly to the outer surface Eo and the inner surface Ei of the elastic body E at an appropriate speed and the elastic body E in the puncture hole H is gradually pushed aside, there is no part of the elastic body E in the puncture hole H that scrapes away, thereby preventing the occurrence of coring.

[0086] The needle portion 22 of the puncture needle 14 gradually punctures the elastic body E while minimizing elastic deformation thereof due to the protruding ends 74 of a pair of protruding portions 64, which have an appropriate length in the direction along the axis C and have a gradual change in protruding length in the direction along the axis C toward the outside of the intermediate portion 36 relative to the bottom surface 62.

[0087] As shown in FIG. 12A and FIG. 12B, the user of the puncture tool 10 further punctures the needle portion 22 into the puncture hole H of the elastic body E, and brings the tip surface of the connection portion 12 (the base 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 in the container. Alternatively, the closed end 66 of the first groove portion 24 may not pass 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, and a liquid flow path is secured, so that liquid or gas can be put into the container through the channel 68 of the first groove portion 24 that 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.

[0088] The tips 95 of the pair of protrusions 94 of the second groove 26 that communicate with another path 54 are located further toward the needle tip 34a than the tips of the protruding ends 74 of the pair of protrusions 64 of the first groove 24.

[0089] The user of the puncture device 10 can then, for example, inject air into the container or expel air from the container through another passage 54 .

[0090] An example of a method for putting a liquid medicine into a container using a syringe will be briefly described below. As the connector 8 shown in Fig. 1, a syringe is connected to the liquid path 52, and an air bag (pressure adjustment unit) is connected to the gas path 54. When a medicine or the like is moved 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 the air inside the container moves to the air bag through the channel 98 of the second groove portion 26 and the path 54. Therefore, the pressure inside the container is kept constant.

[0091] An example of a method for collecting a medicinal liquid from a container using a syringe will be briefly described. As the connector 8 shown in FIG. 1, a syringe is connected to the liquid path 52, and an air bag is connected to the gas path 54. The barrel of the syringe is filled with an amount of air equal to the amount of medicinal liquid to be collected, and the piston of the syringe is pushed in, injecting the air in the barrel into the container via the liquid path 52. At this time, the pressure in the container rises, and the air in the container moves to the air bag via the gas flow path 54, so that the pressure in the container is kept in equilibrium. Next, the container is placed above, and the syringe is placed below.

[0092] For example, when the user turns the container upside down with the puncture needle 14 punctured into the puncture hole H as shown in FIG. 12, the inner surface Ei of the elastic body E of the container is disposed on the upper side, and the outer surface Eo is disposed 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. Also, 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 in some cases. 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. Then, the liquid in the container gathers on the inner surface Ei of the elastic body E.

[0093] When the piston 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 in the container decreases, and the air in the air bag moves to the container via the gas flow path 54, and the pressure in the container is kept in equilibrium.

[0094] 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 elastic body E with respect to the inner surface Ei of the elastic body E, as shown in Fig. 13. At this time, liquid is collected in the hole 52a through the channel 68 of the first groove 26.

[0095] 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 places the outer surface Eo of the elastic body E of the container on the upper side and the inner surface Ei on the lower side. 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 placed on the outer surface Eo side of the inner surface Ei of the elastic body E, the puncture hole H of 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 with the operation of removing the puncture needle 14 from the elastic body E. Therefore, when the puncture needle 14 according to this embodiment is removed from the elastic body E, foreign matter is prevented from entering the container from the outside of the container.

[0096] The following can be said about the puncture needle 14 according to this embodiment.

[0097] A first groove 24 is provided in the middle portion 36 of the needle portion 22 of the puncture needle 14 made of synthetic resin, forming a channel 68 communicating with the passage 52 of 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 protruding portions 64 protruding from the bottom surface 62 in a direction intersecting the axis C of the needle portion 22. The pair of protruding portions 64 can function as ribs on the front side of the needle portion 22. This prevents the needle portion 22 from unintentionally bending with respect to the axis C when the needle portion 22 of the puncture needle 14 is punctured into, for example, an elastic body E. Furthermore, when the puncture needle 14 of the puncture tool 10 is punctured into the elastic body E, if 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 part of the channel 68 can be communicated with the inside of the container. If the pair of protrusions 64 of the first groove 24 are kept in contact with the perforation of the elastic body E, the space between the pair of protrusions 64 can be used as a channel 68 for the drug solution. For this reason, for example, by turning a container such as a vial upside down and using the elastic body E with the inner surface Ei on top and the outer surface Eo on the bottom, the liquid in the container can be guided to the channel 68, and the liquid can be prevented from remaining in the container. For this reason, there are provided a puncture needle 14 made of a resin material that facilitates securing a fluid path 52 when puncturing an elastic body E that serves as the lid of a container in which a liquid such as a medicinal liquid is sealed, a puncture tool 10 including the puncture needle 14, and a puncture tool assembly 1 including the puncture tool 10. 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 also to prevent liquid from leaking from within the container. Furthermore, even when puncturing elastic bodies E having various thicknesses, a pair of protrusions 64 extending in a direction along the axis C of the needle portion 22 from the body portion 32 toward the puncture portion 34 makes it possible to secure a fluid channel 68 and provide a puncture needle 14 with improved stability of the puncture state.

[0098] A part of the protruding end 74 of the pair of protruding parts 64 is formed as end edges (parallel parts) 82, 84 parallel to the axis C (longitudinal direction) of the needle part 22. When the end edge (parallel part) 82 of the protruding end (opening edge) 74 of the needle part 22 passes through the inner surface Ei of the puncture hole H of the elastic body E, the size of the puncture hole H does not change due to the end edge (parallel part) 82, or even if it does change, the amount of change is small. Therefore, the end edge (parallel part) 82 can reduce the amount of change in the elastic deformation of the elastic body E around the puncture hole H. Therefore, when the puncture hole H is formed with the puncture needle 14, the puncture amount of the puncture needle 14 can be increased while suppressing an increase in the puncture resistance. 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 amount of change in elastic deformation of the elastic body E around the puncture hole H can be reduced by the edge (parallel portion) 84. Therefore, when the puncture hole H is formed with the puncture needle 14, the puncture depth of the puncture needle 14 can be increased while suppressing an increase in puncture resistance. In this way, the puncture depth of the needle portion 22 of the puncture needle 14 into the elastic body E can be increased while maintaining a constant puncture resistance when the synthetic resin puncture needle 14 punctures the elastic body E of the container. 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.

[0099] The amount by which the edges 82, 84 of the pair of protruding parts 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 part 34. The amount by which the first edge 82 of the pair of protruding parts 64 provided adjacent to the body 32 is greater than the amount by which the second edge 84 provided on the side closer to the puncturing part 34 than the first edge 82 is protruding. For this reason, when the puncture needle 14 is punctured into the puncture hole H of the elastic body E to deepen the puncture depth, in the case where two different edges 82, 84 are present in the elastic body E by puncturing, such that the height relative to the bottom surface 62 is lower on the tip side and higher on the base side along the axis C of the needle part 22, the load (resistance) applied to the user's finger or the like can be made smaller than the case where one edge 82 is present in the elastic body E by puncturing along the axis C of the needle part 22. Furthermore, by forming the pair of protruding parts 64 in this manner, when the puncture needle 14 punctures the elastic body E, a gap is less likely to occur between the puncture hole H and the elastic body E. Furthermore, by forming an inclined portion 86 between the two edges 82, 84, which is inclined with respect to the axis C of the needle portion 22 and which 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.

[0100] 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 from the first edge 82 toward 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 protruding portions 64 in this manner, when the puncture needle 14 punctures the elastic body E, a gap is less likely to occur between the puncture hole H and the elastic body E.

[0101] The bottom surface 62 of the first groove portion 24 is formed at a position closer to the back side of the puncture needle 14 than the inner peripheral surface on the back 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 middle 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. In addition, by making the outer diameter (cross-sectional area) of the middle portion 36 of the puncture needle 14 relatively small, it is possible to reduce the puncture resistance when the puncture needle 14 made of synthetic resin punctures the elastic body E of the container.

[0102] The puncture needle 14 has a first columnar portion 42 and a second columnar portion 44 in the body portion 32, the second columnar portion 44 is formed to have a smaller outer diameter than the first columnar portion 42, and the protruding end (opening edge) 74 of the first groove portion 24 is formed on the tip side of 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 container of a drug, and improves the sealing property 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, thereby preventing leakage of the drug solution from the gap between the puncture needle 14 and the elastic body E due to a change in the internal pressure in the container when the drug is injected or collected, or preventing substances outside the container from unintentionally mixing into the liquid in the container.

[0103] In addition, since the puncture portion 34 has a generally conical shape, when the needle tip 34a of the puncture needle 14 punctures the elastic body E, the puncture portion 34 is unlikely to be crushed by the resistance of the elastic body E. Therefore, it is possible to reduce an increase in puncture resistance due to the crushing of the puncture portion 34.

[0104] 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 puncture portion 34 are offset from each other. 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. Also, the needle tip 34a can be formed as a pointed tip without arranging the channel 68 of the first groove portion 24 at the needle tip 34a. Therefore, when the puncture needle 14 punctures the elastic body E, it can be punctured more reliably.

[0105] 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 more fluid to be collected in the channel 68, for example, in a container.

[0106] The distance between the edges 82, 84 of the pair of protruding portions 64 protruding from the bottom surface 62 is the same as the width of the bottom surface 62 of the first groove portion 24. For this reason, by forming the opening on the front side, which serves as an inlet for liquid or the like to the channel 68, to an appropriate size, it is possible to collect a larger amount of fluid in the channel 68, for example, in a container.

[0107] 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 penetrating the inner surface Ei of the plate-shaped elastic body E 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 the inner surface Ei of the elastic body E in that order, and the closed end 66 of the base end of the first groove 24 passes through the outer surface Eo of the elastic body E, and the tip of the first groove 24 can be placed in the container. Therefore, the fluid can be collected in the channel 68 in the container.

[0108] 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 having a different thickness or hardness, for example, an elastic body E having a low hardness, being easily deformed, and being 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 having a different thickness, the presence of the first groove portion 24 of the path 52 of the puncture needle 14 allows the liquid medicine in the container to be collected to the last.

[0109] The pair of protrusions 94 of the second groove 26 function as ribs on the rear surface side, and together with the pair of protrusions 64 of the first groove 24, can more reliably prevent the needle 22 from buckling. In addition, the tip 95 of the protrusion 94 of the second groove 26 communicating with the path 54 is located 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 located above the tips 65 of the pair of protrusions 64 of the first groove 24. In this state, for example, when air is introduced into the container through the path 54, the medicinal liquid in the container can be efficiently taken out through the path 52.

[0110] (Modification) Here, a modified example 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.

[0111] 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 illustration.

[0112] In the above-described first embodiment, an example has been 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 FIG.

[0113] 14A, the bottom surface 62 may be formed in a concave shape such as a roughly half-pipe shape, with the bottom surface 62 projecting toward the rear side along the left-right direction. 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 on the front side or rear side of the axis C of the needle portion 22.

[0114] As shown in Fig. 14B, the wall surfaces 72 of the pair of protrusions 64 of the first groove 24 do not have to be parallel to each other. In the example shown in Fig. 14B, the wall surfaces 72 and the 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, such as a substantially U-shaped or substantially D-shaped cross section. Depending on the mold used, the first groove 24 is easily manufactured if the width between the wall surfaces 72 is equal to or smaller than the width between the end edges (opening surfaces) 74. The puncture needle 14 is preferably manufactured by, for example, injection molding, but may also be manufactured using, for example, a 3D printer.

[0115] 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 having a cross section perpendicular to the axis C of the needle portion 22 of the puncture needle 14, such as a substantially trapezoidal shape. The distance between the protruding ends (opening edges) 74 of the pair of protrusions 64 that protrude relative to the bottom surface 62 is greater than the width of the bottom surface 62 of the first groove portion 24.

[0116] 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 surface 72 and the bottom surface 62 of a 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, the cross section being substantially triangular or the like.

[0117] As shown in FIG. 14E, the width of the bottom surface 62 in the left-right direction may be larger than the width of the protruding end (opening edge) 74 in the left-right direction. In the channel 68 shown in FIG. 14C, the shorter side of the trapezoid base is on the bottom surface 62, and in the channel 68 shown in FIG. 14E, the longer side of the trapezoid base is on the bottom surface 62. In the example shown in FIG. 14E, the width of the protruding end (opening edge) 74 in the left-right direction (the shorter side of the trapezoid 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 surface 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, such as a substantially trapezoidal shape. The distance between the protruding ends 74 of the pair of protruding portions 64 that protrude toward 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.

[0118] In this way, the shape of 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 shape as a whole.

[0119] 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 in a direction approaching each other or may be recessed in a direction separating each other, as long as the channel 68 can be secured. In other words, the wall surfaces 72 of the pair of protrusions 64 may be flat or may be appropriately curved.

[0120] Second embodiment The needle portion 22 of the puncture needle 14 of the puncture device 10 according to the second embodiment will be described with reference to Fig. 15. This embodiment is a modification of the first embodiment including various modifications, and the same members as those described in the first embodiment or members having the same functions are denoted by the same reference numerals as much as possible, and detailed descriptions thereof will be omitted.

[0121] 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.

[0122] The connection part 12 and the puncture needle 14 of the puncture tool 10 according to the first embodiment have been described as having two fluid paths 52, 54. The connection part 12 and the puncture needle 14 of the puncture tool 10 according to this 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 24 on the back side. In this embodiment, the first groove 24 is provided on the front side, but the second groove 26 is not provided on the back side. In this embodiment, the path 52 and the channel 68 are used as paths for both liquid and gas. As the connection tool 8 of the puncture tool 10 having the puncture needle 14 according to this embodiment, for example, a syringe is connected.

[0123] 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 different from the two edges 82, 84 (see Figures 6 and 8) along the axis C of the needle portion 22, and one inclined portion 87 different from the two inclined portions 86, 88 (see Figures 6 and 8) along the axis C of the needle portion 22.

[0124] 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 on the back side opposite the opening side (front side) of the first groove portion 24 from the inner peripheral surface on the flat side of the path 52.

[0125] 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 punctures the puncture hole H can be stably maintained.

[0126] Therefore, the bottom surface 62 can be positioned along the inner circumferential surface of the rear side of the path 52 and / or on the rear side opposite the opening side of the first groove portion 24 from the inner circumferential surface of the rear side of the path 52.

[0127] (First Modification) A first modified example 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 modified example of the needle portion taken along line VIII-VIII shown in Figs. 4 and 5.

[0128] 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 one surface. The bottom surface 62 is connected straight to the inner circumferential surface on the back side of the path 52. Therefore, the path 52 and the channel 68 of the first groove portion 24 are connected straight. The bottom surface 62 may be a flat surface or a curved surface.

[0129] 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.

[0130] The puncture needle 14 may be formed in this manner.

[0131] (Second Modification) A second modified example of the puncture needle 14 of the puncture device 10 according to the second embodiment will be described with reference to Fig. 16B. The puncture needle 14 according to this modified example is a further modified example of the first modified example. Fig. 16B is a cross-sectional view of the needle portion of the second modified example taken along line VIII-VIII shown in Figs. 4 and 5.

[0132] 16B, the closed end 66 of the first groove 24 is provided in the second columnar section 44 of the body section 32, not in the first intermediate body 36a of the intermediate section 36. That is, the first groove 24 is preferably provided not only in the intermediate section 36 and the puncture section 34, but also in the body section 32.

[0133] The puncture needle 14 may be formed in this manner.

[0134] (Third Modification) A third modified example of the puncture needle 14 of the puncture device 10 according to the second embodiment will be described with reference to Fig. 16C. The puncture needle 14 according to this modified example is a further modified example of the first or second modified example. Fig. 16C is a cross-sectional view of the needle part of the third modified example taken along line VIII-VIII shown in Figs. 4 and 5.

[0135] 16C, the protruding ends 74 of the pair of protruding portions 64 of the first groove portion 24 are formed as one 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.

[0136] The puncture needle 14 may be formed in this manner.

[0137] Third embodiment The puncture needle 14 of the puncture device 10 according to the third embodiment will be described with reference to FIG.

[0138] 17, the protruding ends 74 of the pair of protruding portions 64 of the first groove portion 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 portion 24 are formed as one edge (parallel portion) 83 along the axis C of the needle portion 22.

[0139] For example, the central axis (axis center) of the second columnar section 44 of the body 32 coincides with the axis center of the needle tip 34a of the puncture section 34. Furthermore, when the outer diameters of the body 32 and the first intermediate body 36a of the intermediate section 36 are the same shape up to the base end of the second intermediate body 36b, the axis C of the needle section 22 of the puncture needle 14 according to this embodiment can pass through the needle tip 34a of the puncture section 34.

[0140] The puncture needle 14 may be formed in this manner.

[0141] The present invention is not limited to the above-mentioned embodiment, and can be modified in various ways without departing from the gist of the present invention. The embodiments may be combined as appropriate, and in that case, the combined effect can be obtained. Furthermore, the above-mentioned embodiment includes various inventions, and various inventions can be extracted by combinations selected from the multiple components disclosed. For example, if the problem can be solved and the effect can be obtained even if some components are deleted from all the components shown in the embodiment, the configuration from which the components are deleted can be extracted as an invention. [Explanation of symbols]

[0142] 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...Middle 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 body having a passageway for passing a fluid; A puncture section provided at the tip side of the body and having a needle tip at the tip end; An intermediate portion provided between the body portion and the puncture portion A needle part integrally having the above-mentioned A bottom surface that is integrally provided in the middle portion and extends from the body portion toward the puncture portion; and a pair of protrusions that are integrally provided on the bottom surface, extend from the body portion toward the puncture portion in a direction along the axis of the needle portion, and protrude 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 communicates with the passage of the body portion, and a groove portion that opens the channel to the outside of the intermediate portion; A puncture needle made of a resin material.

2. At least a part of the edges of the pair of protrusions protruding from the bottom surface is parallel to a direction along the axis of the needle portion. The puncture needle according to claim 1.

3. The edges of the pair of protrusions are A first edge provided adjacent to the body portion and projecting relative to the bottom surface; a second edge that is provided closer to the puncture portion than the first edge and protrudes toward the bottom surface; having a protruding amount of the first edge from the bottom surface is greater than a protruding amount of the second edge; The puncture needle according to claim 2.

4. The pair of protruding portions are provided between the first edge and the second edge, are inclined with respect to an axis of the needle portion, and have an inclined portion in which an amount of protrusion from the bottom surface decreases from the first edge toward the second edge. The puncture needle according to claim 3.

5. The bottom surface is disposed at a position along an inner circumferential surface of the path on a side opposite to an opening side of the groove portion, or on a side opposite to the opening side of the groove portion with respect to the inner circumferential surface of the path. The puncture needle according to claim 1 or 2.

6. The body portion is a first column having the pathway; a second columnar portion provided between the first columnar portion and the puncture portion and having an opening edge of the path; having an outer diameter of the second columnar portion is equal to or smaller than an outer diameter of the first columnar portion; The outer circumferential surface of the second columnar portion is continuous with the outer circumferential surface of the puncture portion. The puncture needle according to claim 1 or 2.

7. 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 each other; The puncture needle according to claim 6.

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

9. a distance between edges of the pair of protruding portions protruding from the bottom surface is equal to or greater than a width of the bottom surface of the groove portion; The puncture needle according to claim 1 or 2.

10. The length of the pair of protrusions of the groove along the axis of the needle is formed to be equal to or longer than the length penetrating the inner surface of the plate-like elastic body punctured from the outer surface side. The puncture needle according to claim 1 or 2.

11. The puncture needle according to claim 1 or 2, a base portion provided on the body portion of the puncture needle; A puncture tool having the above integrally formed therewith.

12. The puncture device according to claim 11 , A connector connected to the base of the puncture tool; A puncture assembly having:

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