WO2017141548A1 - Syringe needle and medical apparatus - Google Patents

Syringe needle and medical apparatus Download PDF

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Publication number
WO2017141548A1
WO2017141548A1 PCT/JP2016/088742 JP2016088742W WO2017141548A1 WO 2017141548 A1 WO2017141548 A1 WO 2017141548A1 JP 2016088742 W JP2016088742 W JP 2016088742W WO 2017141548 A1 WO2017141548 A1 WO 2017141548A1
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WO
WIPO (PCT)
Prior art keywords
diameter portion
injection needle
side hole
small
needle according
Prior art date
Application number
PCT/JP2016/088742
Other languages
French (fr)
Japanese (ja)
Inventor
英之 朝倉
秀徳 藤原
大谷内　哲也
西川　尚穂
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2017141548A1 publication Critical patent/WO2017141548A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles

Definitions

  • the present invention relates to an injection needle and a medical instrument provided with such an injection needle.
  • an injection needle for injecting a fluid such as a chemical into a living body such as a human body is known.
  • medical instruments such as a needle-implanted syringe in which such an injection needle is directly fixed to the port of the syringe body, and a syringe needle with a hub fixed to a needle base (hub) connectable to the port of the syringe body. ing.
  • a through hole (side hole) is provided on the side surface of the injection needle, and in addition to the distal end opening surrounded by the blade surface of the distal end portion of the injection needle, fluid also flows out from this side hole. It is possible to make it possible.
  • a technique for providing a side hole in an injection needle for example, a technique described in Patent Document 1 is known.
  • tip part of an injection needle is provided.
  • the present invention has been made in view of such problems, and it is intended to provide an injection needle and a medical instrument that can effectively reduce injection resistance and diffuse fluid when injecting fluid into a living body. Objective.
  • the injection needle of the present invention is a syringe needle for injecting a fluid into a living body having a distal end opening surrounded by a blade surface at a distal end portion, and having a tubular shape and extending from a proximal end portion to a predetermined range.
  • the inner diameter of the reduced diameter portion gradually decreases from the large diameter portion side toward the small diameter portion side.
  • the injection needle of the present invention has a certain thickness from the base end portion to the tip end portion.
  • the large-diameter portion, the small-diameter portion, and the reduced-diameter portion are configured by a plate-like body that is curved in a tubular shape and whose butt end faces are joined to each other.
  • an outer peripheral end surface forming an outer peripheral edge of the at least one side hole extends along a radial direction of the small diameter portion.
  • the fluid preferably has a viscosity at room temperature of 1 to 100 cps.
  • the fluid preferably has a viscosity at room temperature of 10 to 20 cps.
  • the at least one side hole is at least one long hole extending in the longitudinal axis direction of the small diameter portion.
  • the at least one side hole is a plurality of holes arranged at intervals in the longitudinal axis direction of the small diameter portion.
  • the plurality of holes are arranged in the longitudinal axis direction of the injection needle.
  • the at least one side hole is preferably a square hole.
  • the at least one side hole is preferably a round hole.
  • the at least one side hole is provided on a side surface of the small diameter portion viewed from the blade surface side.
  • the injection needle of the present invention preferably includes a rough surface portion on the outer peripheral surface of the large diameter portion.
  • a medical instrument of the present invention includes any one of the injection needles of the present invention described above and a cylindrical cylinder, and includes an outer peripheral surface of the large-diameter portion of the injection needle, A junction is provided between the peripheral surface and the peripheral surface.
  • a joint is provided between the outer peripheral surface of the reduced diameter portion and the large diameter portion of the injection needle and the inner peripheral surface of the cylindrical body.
  • the injection needle according to the present invention is provided over a predetermined range from the base end portion, and is provided with a large diameter portion having a constant inner diameter dimension and a predetermined range from the distal end portion, and is constant smaller than the large diameter portion.
  • a small-diameter portion having an inner-diameter dimension, and a reduced-diameter portion having an inner-diameter dimension that is provided over a range between the large-diameter portion and the small-diameter portion and decreases from the large-diameter portion side toward the small-diameter portion side, And at least one side hole penetrating the side surface of the small diameter portion.
  • the injection needle according to the present invention it is possible to effectively reduce the fluid injection resistance generated in the entire inside of the injection needle. Moreover, according to the injection needle according to the present invention, the fluid can be dispersed and discharged through the tip opening and at least one side hole, so that the fluid can be effectively diffused in the living body.
  • the medical instrument according to the present invention since such an injection needle is joined to the cylindrical body at the large diameter portion, it is possible to effectively reduce the fluid injection resistance generated in the entire interior of the medical instrument.
  • the fluid can be effectively diffused in the living body through the tip opening of the injection needle and at least one side hole.
  • an injection needle and a medical instrument that can effectively reduce the injection resistance and diffuse the fluid when injecting the fluid into the living body.
  • FIG. 3A is a sectional view taken along line BB in FIG. 3C, and FIG.
  • 3B is a sectional view taken along line CC in FIG. It is a fragmentary perspective view which shows the manufacture point of the injection needle shown in FIG. 2, (a) is the state immediately after a punching process, (b) is the state of the initial stage of a press process, (c) is the state of the final stage of a press process. , (D) shows the state when the pressing process is completed. It is a figure which shows a part of injection needle which concerns on other embodiment of this invention, (a) is a perspective view, (b) is the side view seen from the blade surface side, (c) is the side of a blade surface It is the side view seen from. It is a fragmentary perspective view which shows the manufacture point of the injection needle shown in FIG.
  • the “tip” means the side (left side in FIG. 2 (a)) where the blade surface of the injection needle is located in the longitudinal axis direction of the injection needle
  • the “base end” means It means the opposite side (the right side in FIG. 2 (a)).
  • a medical device 100 includes an injection needle 1 for injecting a fluid such as a chemical into a living body such as a human body.
  • the injection needle 1 has a configuration that is particularly suitable for applications in which fluid is injected into the skin or skin of a living body.
  • the injection needle 1 has a configuration that is particularly suitable when a relatively high-viscosity fluid such as a biopharmaceutical centering on a protein preparation is targeted. Specifically, it is particularly suitable when the viscosity of the fluid at normal temperature (that is, 25 ° C.) is 1 to 100 cps, and more preferably 10 to 20 cps.
  • the medical instrument 100 is a syringe including an injection needle 1, a syringe body 102, and a plunger (not shown).
  • a cylindrical body 101 having a diameter smaller than that of the syringe main body 102 is integrally provided at the distal end portion of the cylindrical syringe main body 102, and an inner peripheral surface of the cylindrical body 101 and an injection needle 1 to be described later.
  • a joining portion is provided between the outer peripheral surface of the cylindrical large-diameter portion 11 (see FIG. 2).
  • the medical instrument 100 of the present embodiment is configured as a needle-implantable syringe in which the injection needle 1 is directly fixed to the port of the syringe body 102, and thus is supplied to the medical site in a state of being prefilled with fluid. It is particularly suitable for a prefilled syringe.
  • the fluid in the syringe body 102 is pushed from the injection needle 1 by pushing the gasket attached to the distal end side of the plunger toward the distal end side while the syringe body 102 is filled with fluid. Can be drained.
  • the syringe body 102 can be formed of a resin material such as cyclic polyolefin, cyclic polyolefin copolymer, or polypropylene.
  • the injection needle 1 can be formed with metal materials, such as stainless steel and a titanium alloy, for example.
  • the joint between the cylinder 101 and the large-diameter portion 11 of the injection needle 1 is, for example, an adhesive portion using an adhesive or the like, for example, a fusion portion using heating of the injection needle 1 by laser irradiation or the like. be able to.
  • the outer peripheral surface of the large diameter part 11 may be directly fused to the inner peripheral surface of the cylindrical body 101, or the inner peripheral surface of the cylindrical body 101 and the large diameter
  • the large-diameter portion 11 and the cylindrical body 101 may be fused by pressing the resin inner cylindrical body while melting it between the outer peripheral surface of the portion 11.
  • the injection needle 1 when the injection needle 1 is joined, not only the large diameter portion 11 but also the outer peripheral surface of the reduced diameter portion 13 (see FIG. 2) described later of the injection needle 1 is joined to the inner peripheral surface of the cylinder 101. It is preferable to configure. That is, it is preferable to provide a joint between the outer peripheral surface of the reduced diameter portion 13 and the large diameter portion 11 of the injection needle 1 and the inner peripheral surface of the cylindrical body 101. Since the reduced diameter portion 13 has a conical shape that decreases in diameter from the proximal end side toward the distal end side, the medical instrument 100 is configured by such joining so that the injection needle 1 can be pulled out to the distal end side. The joint strength with respect to can be increased efficiently.
  • the rough surface portion is constituted by a knurling 11 a (see FIG. 2) composed of a plurality of tubular grooves extending in the circumferential direction of the large diameter portion 11.
  • the medical instrument 100 is configured as a needle-implantable syringe in which the injection needle 1 is directly fixed to the cylindrical body 101 that is a port of the syringe body 102, but instead of such a configuration, for example, a syringe body You may comprise as a syringe needle with a hub fixed to the needle base (hub) connectable to this port. Further, the medical instrument 100 can employ other configurations as long as the outer peripheral surface of the large-diameter portion 11 of the injection needle 1 is joined to the inner peripheral surface of the cylindrical body 101.
  • the injection needle 1 has a tubular shape having a distal end opening 12b surrounded by a blade surface 12a at the distal end, and has a constant thickness from the distal end to the proximal end. t. Further, the injection needle 1 is provided over a predetermined range from the base end portion, and is provided with a large diameter portion 11 having a constant inner diameter dimension d11 and a predetermined range from the distal end portion. Are provided over a range between the small diameter portion 12 having a small constant inner diameter dimension d12 and the large diameter portion 11 and the small diameter portion 12, and decreases from the large diameter portion 11 side toward the small diameter portion 12 side. And a reduced diameter portion 13 having an inner diameter. In the present embodiment, each of the large diameter portion 11 and the small diameter portion 12 has a cylindrical shape, and the reduced diameter portion 13 has a conical shape whose diameter decreases from the proximal end side toward the distal end side.
  • the reduced diameter portion 13 has a configuration having an inner diameter that gradually decreases from the large diameter portion 11 side toward the small diameter portion 12 side as in the present embodiment, from the viewpoint of reducing fluid injection resistance.
  • an inner diameter dimension gradually decreases in this way
  • a configuration in which the inner diameter size decreases in a stepped shape is also possible.
  • the injection needle 1 is provided with at least one side hole 12c that penetrates the side surface of the small diameter portion 12.
  • at least one side hole 12 c is provided on a side surface of the small diameter portion 12 as viewed from the blade surface 12 a side, and a direction (longitudinal direction) along the longitudinal axis O of the small diameter portion 12. It is configured as one long hole extending in the axial direction.
  • the said long hole has comprised the shape of a square hole.
  • the outer peripheral end surface 12c1 forming the outer peripheral edge of the side hole 12c extends along the radial direction of the small diameter portion 12.
  • the injection needle 1 is composed of a plate-like body 14 that is curved in a tubular shape and whose butt end surfaces 14a are joined to each other.
  • the injection needle 1 of the present embodiment having such a configuration can be efficiently manufactured in the following manner.
  • deployment shape of the injection needle 1 is obtained by punching out a metal thin plate.
  • a notch 14b constituting the side hole 12c can be formed on the butted end surface 14a of the plate-like body 14 when the plate-like body 14 is curved in a tubular shape and the butted end surfaces 14a are joined to each other.
  • the knurl 11a (see FIG. 2) of the large-diameter portion 11 described above can be simultaneously formed in this punching process.
  • FIGS. 5 (b) and 5 (c) a pressing process for sandwiching the plate-like body 14 between the upper mold and the lower mold having a predetermined shape is performed a plurality of times, so that FIG. A tubular body having side holes 12c as shown in d) can be obtained.
  • the butt end surfaces 14a can be joined to each other with high accuracy by welding using laser irradiation.
  • the joining of the butt end surface 14a is not necessarily limited to welding, and for example, an adhesive can be used.
  • the blade surface 12a of a predetermined shape can be formed by cutting the front-end
  • the total length L1 of the injection needle 1 shown in FIG. 2 is 21.9 mm
  • the length L12 of the small diameter portion 12 is 8.7 mm
  • the length L13 of the reduced diameter portion 13 is 5.5 mm
  • the effective length is 12.7 mm ( Including a reduced diameter portion of 4.0 mm).
  • the small-diameter portion 12 is 29G (gauge) (outer diameter D12 is 0.338 mm)
  • the inner diameter d12 is 0.238 mm
  • the large-diameter portion 11 is 24G (outer diameter D11 is 0.565 mm)
  • the inner diameter d11 is
  • the thickness is 0.465 mm and the wall thickness t is 0.050 mm.
  • the blade surface length L12a is 1.8 mm
  • the total length L11a of the rough surface portion made of the knurl 11a is 4.8 mm
  • the gap G11a between the rough surface portion (knurl 11a) and the tip of the large diameter portion 11 is 0.4 mm.
  • the total length L1 of the injection needle 1 is preferably 10 to 90 mm, more preferably 13 to 38 mm.
  • the length L12 of the small diameter portion 12 is preferably 1 to 70 mm, more preferably 2 to 25 mm.
  • the length L13 of the reduced diameter portion 13 is preferably 1 to 50 mm, more preferably 2 to 20 mm.
  • the small diameter part 12 is preferably 34 to 23G, more preferably 31 to 25G.
  • the large diameter portion 11 is preferably 30 to 18G, more preferably 29 to 24G.
  • the wall thickness t is preferably 0.040 to 0.220 mm, more preferably 0.043 to 0.100 mm.
  • the blade surface length L12a is preferably 0.8 to 6.37 mm, and more preferably 1.10 to 2.60 mm.
  • the total length L11a of the rough surface portion is preferably 2 to 30 mm, more preferably 4 to 10 mm.
  • the distance G11a between the rough surface portion (knurl 11a) and the tip of the large diameter portion 11 is preferably 0.05 to 5.0 mm, more preferably 0.1 to 1.0 mm.
  • the side hole 12c shown in FIG. 3 has an overall length L12c of 1.5 mm, a width W12c of 0.094 mm, and a distance G12c from the base end of the blade surface 12a of 0.5 mm.
  • the total length L12c of the side hole 12c is preferably 0.2 to 5.0 mm, more preferably 1.0 to 2.5 mm.
  • the width W12c of the side hole 12c is preferably 0.03 to 1.0 mm, more preferably 0.05 to 0.3 mm.
  • the gap G12c between the side hole 12c and the base end of the blade surface 12a is preferably 0.3 to 3.0 mm, more preferably 0.5 to 2.0 mm.
  • the injection needle 1 is a syringe needle 1 for injecting a fluid into a living body, having a tubular shape and having a distal end opening 12b surrounded by a blade surface 12a at a distal end portion.
  • the large-diameter portion 11 provided over a predetermined range from the base end portion and having a constant inner diameter dimension d11, and the constant inner-diameter dimension provided over a predetermined range from the distal end portion and smaller than the large diameter portion 11
  • Small diameter portion 12 having d12 and a reduced diameter having an inner diameter dimension which is provided over a range between large diameter portion 11 and small diameter portion 12 and decreases from the large diameter portion 11 side toward the small diameter portion 12 side.
  • the configuration includes a portion 13 and at least one side hole 12c penetrating the side surface of the small diameter portion 12.
  • the injection needle 1 it is possible to effectively reduce the injection resistance of the fluid generated in the entire inside of the injection needle 1. Further, according to the injection needle 1 according to the present embodiment, the fluid can be dispersed and discharged through the tip opening 12b and at least one side hole 12c, so that the fluid can be effectively diffused in the living body. it can.
  • the injection needle 1 according to the present embodiment is configured such that the inner diameter of the reduced diameter portion 13 is gradually reduced from the large diameter portion 11 side toward the small diameter portion 12 side. Therefore, according to the injection needle 1 according to the present embodiment, the fluid injection resistance can be more effectively reduced.
  • the injection needle 1 according to the present embodiment is configured to have a constant thickness t from the proximal end portion to the distal end portion. Therefore, according to the injection needle 1 according to the present embodiment, the outer diameter of the small diameter portion 12 and the reduced diameter portion 13 is made smaller than that of the large diameter portion 11, and the puncture resistance at the time of puncture can be effectively reduced. it can.
  • the injection needle 1 according to the present embodiment is configured by a plate-like body 14 in which the large diameter portion 11, the small diameter portion 12, and the reduced diameter portion 13 are curved in a tubular shape and the butt end surfaces 14a are joined to each other. Therefore, according to the injection needle 1 according to the present embodiment, it is possible to efficiently manufacture by punching the plate-like body 14 from a thin plate, pressing the plate-like body 14 into a tube shape, and joining the butt end face 14a. .
  • the injection needle 1 is configured such that the outer peripheral end surface 12c1 that forms the outer peripheral edge of at least one side hole 12c extends along the radial direction of the small diameter portion 12. Therefore, according to the injection needle 1 which concerns on this embodiment, the side hole 12c (or the notch 14b which comprises the side hole 12c at the time of a press work) can also be formed in the punching process of the plate-shaped body 14 from a thin plate. Therefore, efficient production is possible, and moreover, the fluid can be diffused effectively because the fluid can be discharged radially from the side hole 12c at the time of injection.
  • the injection needle 1 according to the present embodiment is for injecting a fluid having a viscosity at normal temperature of 1 to 100 cps, more preferably 10 to 20 cps into a living body. Therefore, according to the injection needle 1 according to the present embodiment, a relatively high-viscosity fluid such as a biopharmaceutical centering on a protein preparation can be smoothly injected into the living body, and the effects in the living body can be obtained. Fluid diffusion can be realized.
  • the injection needle 1 according to the present embodiment is configured such that at least one side hole 12c is at least one long hole extending in the longitudinal axis direction of the small diameter portion 12. Therefore, according to the injection needle 1 according to the present embodiment, reduction and diffusion of fluid injection resistance can be effectively realized with a simple configuration.
  • the injection needle 1 according to the present embodiment is configured such that at least one side hole 12c is a square hole. Therefore, according to the injection needle 1 according to the present embodiment, reduction and diffusion of fluid injection resistance can be effectively realized with a simple configuration.
  • At least one side hole 12c is provided on a side surface of the small diameter portion 12 as viewed from the blade surface 12a side (that is, a side surface located on the opposite side of the blade edge). It is the composition. Therefore, according to the injection needle 1 according to the present embodiment, an increase in puncture resistance at the time of puncture due to the provision of at least one side hole 12c can be suppressed.
  • the injection needle 1 according to the present embodiment is configured to include a rough surface portion (for example, a knurling 11a) on the outer peripheral surface of the large diameter portion 11. Therefore, according to the injection needle 1 according to the present embodiment, the bonding strength when the large-diameter portion 11 of the injection needle 1 is bonded to the cylindrical body 101 of the medical device 100 can be increased.
  • a rough surface portion for example, a knurling 11a
  • the medical instrument 100 includes the above-described injection needle 1 and a cylindrical cylinder 101, and includes an outer peripheral surface of the large-diameter portion 11 of the injection needle 1 and an inner periphery of the cylindrical body 101. It is the structure that the junction part is provided between the surfaces. Therefore, according to the medical instrument 100 according to the present embodiment, it is possible to effectively reduce the injection resistance of the fluid generated in the entire interior of the medical instrument 100, and at the same time, the tip opening 12b of the injection needle 1 and at least one side hole 12c. Thus, the fluid can be effectively diffused in the living body.
  • the medical instrument 100 has a configuration in which a joint portion is provided between the outer peripheral surface of the reduced diameter portion 13 and the large diameter portion 11 of the injection needle 1 and the inner peripheral surface of the cylindrical body 101. Therefore, it is possible to efficiently increase the bonding strength against the withdrawal of the injection needle 1 toward the distal end side.
  • the injection needle and medical instrument according to the present embodiment have the same configuration as the embodiment described with reference to FIGS. 1 to 5 except that the shape of the side hole 22c of the injection needle 2 is different. .
  • one side hole 12c formed as a rectangular hole is provided.
  • four side holes 22c formed as square holes arranged at equal intervals and arranged in the longitudinal axis direction are provided.
  • each side hole 22c is provided on the side surface of the small diameter portion 22 as viewed from the blade surface 22a side, and the outer peripheral end surface 22c1 that forms the outer periphery of each side hole 22c is:
  • the small diameter portion 22 extends along the radial direction.
  • the injection needle 2 can be manufactured in the same manner as in the embodiment described with reference to FIGS. That is, first, as shown in FIG. 7A, in the punching process for obtaining the plate-like body 24 having the developed shape of the injection needle 2, the plate-like body 24 is tubular on the butt end surface 24 a of the plate-like body 24. It is possible to form a notch 24b that constitutes the side hole 22c when the butted end surfaces 24a are joined to each other. Then, as shown in FIGS. 7B and 7C, a tubular body having a side hole 22c as shown in FIG. 7D is obtained by bending the plate-like body 24 by performing a plurality of pressing steps. Can be obtained. Thereafter, the butt end surface 24a is joined, and the injection needle 2 can be obtained by forming the blade surface 22a having a predetermined shape at the tip of the tubular body.
  • each side hole 22c of the injection needle 2 shown in FIG. 6 is 0.2 mm
  • the width W22c of each side hole 22c is 0.094 mm
  • the gap g22c between the side holes 22c is 0.3 mm.
  • a gap G22c between the side hole 22c located on the most distal side and the base end of the blade surface 22a is 0.3 mm.
  • Various dimensions of the portions other than the side holes 22c are the same as those in the embodiment described with reference to FIGS.
  • the length L22c of each side hole 22c is preferably 0.1 to 1.0 mm, and more preferably 0.15 to 0.5 mm.
  • the width W22c of each side hole 22c is preferably 0.03 to 1.0 mm, more preferably 0.05 to 0.3 mm.
  • the gap g22c between the side holes 22c is preferably 0.1 to 1.0 mm, more preferably 0.2 to 0.5 mm.
  • the distance G22c between the side hole 22c located on the most distal side and the base end of the blade surface 22a is preferably 0.3 to 2.0 mm, more preferably 0.3 to 1.5 mm.
  • the injection needle 2 according to the present embodiment is configured such that at least one side hole 22c is a plurality of holes arranged at intervals in the longitudinal axis direction of the small diameter portion 22. Therefore, according to the injection needle 2 according to the present embodiment, it is possible to reliably diffuse the fluid.
  • the injection needle 2 according to the present embodiment is configured such that the plurality of holes (side holes 22c) are arranged in the longitudinal axis direction of the injection needle 2. Therefore, according to the injection needle 2 according to the present embodiment, the fluid can be reliably diffused with a simple configuration.
  • the injection needle and the medical instrument according to this embodiment have the same configuration as that of the embodiment described with reference to FIGS. 1 to 5 except that the shape of the side hole 32c of the injection needle is different.
  • one side hole 12c formed as a rectangular hole is provided.
  • Three side holes 32c formed as round holes arranged at equal intervals and shifted in the circumferential direction are provided. These three side holes 32c are constituted by a notch 34b and a through hole 34d.
  • the injection needle according to the present embodiment can be manufactured in the same manner as in the embodiment described with reference to FIGS. That is, first, as shown in FIG. 8A, in the punching process for obtaining the plate-like body 34 having the developed shape of the injection needle, a side hole 32c is formed in the butt end surface 34a of the plate-like body 34. The notch 34b and the through hole 34d can be formed. Then, as shown in FIGS. 8B and 8C, a tubular body having a side hole 32c as shown in FIG. 8D is obtained by bending the plate-like body 34 by performing a plurality of pressing steps. Can be obtained. Thereafter, the butt end surface 34a is joined, and a blade surface having a predetermined shape is formed at the distal end portion of the tubular body, whereby an injection needle can be obtained.
  • the injection needle according to the present embodiment is configured such that at least one side hole 32c is a round hole. Therefore, according to the injection needle according to the present embodiment, reduction and diffusion of fluid injection resistance can be effectively realized with a simple configuration.
  • the circumferential position and the longitudinal axis position where the side holes 12c are provided may be changed, and a plurality of side holes 12c may be arranged.
  • the number and shape of the side holes 22c, the interval between the side holes 22c may be changed, and a plurality of side holes arranged in the longitudinal axis direction may be used.
  • You may change the circumferential direction position and longitudinal-axis direction position which provide 22c.
  • the number, shape, and arrangement of the plurality of round holes constituting the side hole 32 c may be changed.
  • Injection needle 11 Large diameter part 11a Knurled (rough surface part) 12 Small-diameter portion 12a Blade surface 12b Tip opening 12c Side hole 12c1 Outer peripheral end surface of side hole 13 Reduced-diameter portion 14 Plate-like body 14a Butt end surface 14b Notch 2 Injection needle 22 Small-diameter portion 22a Blade surface 22c Side hole 22c1 Outer end surface of side hole 24 Plate-like body 24a Butt end face 24b Notch 32c Side hole 34a Butt end face 34b Notch 34d Through hole 100 Medical instrument 101 Tubular body 102 Syringe body O Longitudinal axis L1 Length of syringe needle L11a Length of rough surface part L12 Length of small diameter part Length L12a Blade length L12c Length of side hole L13 Length of reduced diameter portion W12c Width of side hole D11 Outer diameter size of large diameter portion D12 Outer diameter size of small diameter portion d11 Inner diameter size of large diameter

Abstract

This syringe needle (2) is characterized by being provided with: a large-diameter section (11) that is provided over a predetermined range from a proximal end section and has a certain inner diameter dimension; a small-diameter section (12) that is provided over a predetermined range from a distal end section and has a certain inner diameter dimension that is smaller than that of the large-diameter section (11); a decreasing-diameter section (13) that is provided over a range between the large-diameter section (11) and the small-diameter section (12) and has an inner diameter dimension that decreases from the side of the large-diameter section (11) toward the side of the small-diameter section (12); and at least one side hole (12c) penetrating through a side surface of the small-diameter section (12). In addition, this medical apparatus (100) is characterized by the following: being provided with the syringe needle (2) and a barrel (101) having a cylindrical shape; and having a joining section provided between an outer peripheral surface of the large-diameter section (11) of the syringe needle (2) and an inner peripheral surface of the barrel (101).

Description

注射針及び医療用器具Injection needle and medical device
　本発明は、注射針及びそのような注射針を備える医療用器具に関する。 The present invention relates to an injection needle and a medical instrument provided with such an injection needle.
　従来、人体などの生体内に薬液などの流体を注入するための注射針が知られている。また、そのような注射針をシリンジ本体のポートに直接固定した針植込み式シリンジや、シリンジ本体のポートに接続可能な針基（ハブ）に固定したハブ付き注射針などの医療用器具が知られている。 Conventionally, an injection needle for injecting a fluid such as a chemical into a living body such as a human body is known. Also known are medical instruments such as a needle-implanted syringe in which such an injection needle is directly fixed to the port of the syringe body, and a syringe needle with a hub fixed to a needle base (hub) connectable to the port of the syringe body. ing.
　このような医療用器具を、生体の皮下や皮内への注射に用いるものとする場合には、生体内で流体を効果的に拡散できるものとすることが望ましい。また、タンパク質製剤を中心とするバイオ薬などの比較的高粘度の流体を対象とする場合には、流体の注入抵抗を低減したものとすることも要求される。 When such a medical instrument is used for injection into the skin or skin of a living body, it is desirable that the fluid can be effectively diffused in the living body. In addition, when a relatively high viscosity fluid such as a biopharmaceutical centering on a protein preparation is targeted, it is also required to reduce the fluid injection resistance.
　このような要求に応えるためには、注射針の側面に貫通孔（側孔）を設け、注射針の先端部の刃面に囲まれた先端開口に加えて、この側孔からも流体を流出させられるようにすることが考えられる。ここで、注射針に側孔を設ける技術としては、例えば特許文献１に記載されるようなものが知られている。特許文献１では、注射針の先端部の刃面の裏側部分を貫通する側孔を設けている。 In order to meet such demands, a through hole (side hole) is provided on the side surface of the injection needle, and in addition to the distal end opening surrounded by the blade surface of the distal end portion of the injection needle, fluid also flows out from this side hole. It is possible to make it possible. Here, as a technique for providing a side hole in an injection needle, for example, a technique described in Patent Document 1 is known. In patent document 1, the side hole which penetrates the back side part of the blade surface of the front-end | tip part of an injection needle is provided.
特開２００３－１９０２８２号公報JP 2003-190282 A
　しかしながら、前述したような従来の医療用器具において、特許文献１に記載されるような側孔を設けるだけでは、生体の皮下や皮内などへの注射に用いる場合の前記したような要求に十分に応えることはできなかった。 However, in the conventional medical device as described above, the provision of the side hole as described in Patent Document 1 is sufficient for the above-described requirements when used for injection into the skin of the living body or the skin. It was not possible to meet.
　本発明は、このような課題に鑑みてなされたもので、生体内への流体の注入に際し、注入抵抗の低減と流体の拡散を効果的に実現できる注射針及び医療用器具を提供することを目的とする。 The present invention has been made in view of such problems, and it is intended to provide an injection needle and a medical instrument that can effectively reduce injection resistance and diffuse fluid when injecting fluid into a living body. Objective.
　本発明の注射針は、管状をなすと共に先端部に刃面に囲まれた先端開口を有する、生体内に流体を注入するための注射針であって、基端部から所定の範囲に亘って設けられ、一定の内径寸法を有する大径部と、前記先端部から所定の範囲に亘って設けられ、前記大径部よりも小さい一定の内径寸法を有する小径部と、前記大径部と前記小径部との間の範囲に亘って設けられ、前記大径部の側から前記小径部の側に向かって減少する内径寸法を有する縮径部と、前記小径部の側面を貫通する少なくとも１つの側孔とを備えることを特徴とする。 The injection needle of the present invention is a syringe needle for injecting a fluid into a living body having a distal end opening surrounded by a blade surface at a distal end portion, and having a tubular shape and extending from a proximal end portion to a predetermined range. A large-diameter portion having a constant inner diameter, a small-diameter portion having a constant inner-diameter smaller than the large-diameter portion, the small-diameter portion being smaller than the large-diameter portion, the large-diameter portion, and the A reduced diameter portion having an inner diameter that decreases from the large diameter portion side toward the small diameter portion side, and at least one penetrating a side surface of the small diameter portion. And a side hole.
　ここで、本発明の注射針は、前記縮径部の内径寸法が、前記大径部の側から前記小径部の側に向かって漸減していることが好ましい。 Here, in the injection needle of the present invention, it is preferable that the inner diameter of the reduced diameter portion gradually decreases from the large diameter portion side toward the small diameter portion side.
　また、本発明の注射針は、前記基端部から前記先端部まで一定の肉厚を有することが好ましい。 Moreover, it is preferable that the injection needle of the present invention has a certain thickness from the base end portion to the tip end portion.
　また、本発明の注射針では、前記大径部、前記小径部及び前記縮径部は、管状に湾曲すると共に突合せ端面が互いに接合された板状体によって構成されていることが好ましい。 In the injection needle of the present invention, it is preferable that the large-diameter portion, the small-diameter portion, and the reduced-diameter portion are configured by a plate-like body that is curved in a tubular shape and whose butt end faces are joined to each other.
　また、本発明の注射針は、前記少なくとも１つの側孔の外周縁を形成する外周端面が、前記小径部の径方向に沿って延在していることが好ましい。 In the injection needle of the present invention, it is preferable that an outer peripheral end surface forming an outer peripheral edge of the at least one side hole extends along a radial direction of the small diameter portion.
　また、本発明の注射針では、前記流体は、常温での粘度が１～１００ｃｐｓであることが好ましい。 In the injection needle of the present invention, the fluid preferably has a viscosity at room temperature of 1 to 100 cps.
　また、本発明の注射針では、前記流体は、常温での粘度が１０～２０ｃｐｓであることが好ましい。 In the injection needle of the present invention, the fluid preferably has a viscosity at room temperature of 10 to 20 cps.
　また、本発明の注射針は、前記少なくとも１つの側孔が、前記小径部の長手軸方向に延在する少なくとも１つの長孔であることが好ましい。 In the injection needle of the present invention, it is preferable that the at least one side hole is at least one long hole extending in the longitudinal axis direction of the small diameter portion.
　また、本発明の注射針は、前記少なくとも１つの側孔が、前記小径部の長手軸方向に間隔を空けて配置された複数の孔であることが好ましい。 In the injection needle of the present invention, it is preferable that the at least one side hole is a plurality of holes arranged at intervals in the longitudinal axis direction of the small diameter portion.
　また、本発明の注射針は、前記複数の孔が、前記注射針の長手軸方向に並んでいることが好ましい。 In the injection needle of the present invention, it is preferable that the plurality of holes are arranged in the longitudinal axis direction of the injection needle.
　また、本発明の注射針は、前記少なくとも１つの側孔が角孔であることが好ましい。 In the injection needle of the present invention, the at least one side hole is preferably a square hole.
　また、本発明の注射針は、前記少なくとも１つの側孔が丸孔であることが好ましい。 In the injection needle of the present invention, the at least one side hole is preferably a round hole.
　また、本発明の注射針は、前記少なくとも１つの側孔が、前記小径部における前記刃面の側から見た側面に設けられていることが好ましい。 In the injection needle of the present invention, it is preferable that the at least one side hole is provided on a side surface of the small diameter portion viewed from the blade surface side.
　さらに、本発明の注射針は、前記大径部の外周面に粗面部を備えることが好ましい。 Furthermore, the injection needle of the present invention preferably includes a rough surface portion on the outer peripheral surface of the large diameter portion.
　また、本発明の医療用器具は、前述した本発明のいずれかの注射針と、筒状をなす筒体とを備え、前記注射針の前記大径部の外周面と、前記筒体の内周面との間に接合部が設けられていることを特徴とする。 In addition, a medical instrument of the present invention includes any one of the injection needles of the present invention described above and a cylindrical cylinder, and includes an outer peripheral surface of the large-diameter portion of the injection needle, A junction is provided between the peripheral surface and the peripheral surface.
　さらに、本発明の医療用器具は、前記注射針の前記縮径部及び前記大径部の外周面と、前記筒体の内周面との間に接合部が設けられていることが好ましい。 Furthermore, in the medical instrument of the present invention, it is preferable that a joint is provided between the outer peripheral surface of the reduced diameter portion and the large diameter portion of the injection needle and the inner peripheral surface of the cylindrical body.
　本発明に従う注射針は、基端部から所定の範囲に亘って設けられ、一定の内径寸法を有する大径部と、先端部から所定の範囲に亘って設けられ、大径部よりも小さい一定の内径寸法を有する小径部と、大径部と小径部との間の範囲に亘って設けられ、大径部の側から小径部の側に向かって減少する内径寸法を有する縮径部と、小径部の側面を貫通する少なくとも１つの側孔とを備えている。したがって、本発明に従う注射針によれば、注射針の内部全体で生じる流体の注入抵抗を効果的に低減することができる。また、本発明に従う注射針によれば、先端開口と少なくとも１つの側孔とを通じて流体を分散して流出させることができるため、生体内で流体を効果的に拡散させることができる。 The injection needle according to the present invention is provided over a predetermined range from the base end portion, and is provided with a large diameter portion having a constant inner diameter dimension and a predetermined range from the distal end portion, and is constant smaller than the large diameter portion. A small-diameter portion having an inner-diameter dimension, and a reduced-diameter portion having an inner-diameter dimension that is provided over a range between the large-diameter portion and the small-diameter portion and decreases from the large-diameter portion side toward the small-diameter portion side, And at least one side hole penetrating the side surface of the small diameter portion. Therefore, according to the injection needle according to the present invention, it is possible to effectively reduce the fluid injection resistance generated in the entire inside of the injection needle. Moreover, according to the injection needle according to the present invention, the fluid can be dispersed and discharged through the tip opening and at least one side hole, so that the fluid can be effectively diffused in the living body.
　また、本発明に従う医療用器具によれば、そのような注射針を大径部にて筒体に接合しているので、医療用器具の内部全体で生じる流体の注入抵抗を効果的に低減できると共に、注射針の先端開口と少なくとも１つの側孔とを通じて生体内で流体を効果的に拡散させることができる。 Moreover, according to the medical instrument according to the present invention, since such an injection needle is joined to the cylindrical body at the large diameter portion, it is possible to effectively reduce the fluid injection resistance generated in the entire interior of the medical instrument. In addition, the fluid can be effectively diffused in the living body through the tip opening of the injection needle and at least one side hole.
　したがって、本発明によれば、生体内への流体の注入に際し、注入抵抗の低減と流体の拡散を効果的に実現できる注射針及び医療用器具を提供することができる。 Therefore, according to the present invention, it is possible to provide an injection needle and a medical instrument that can effectively reduce the injection resistance and diffuse the fluid when injecting the fluid into the living body.
本発明の一実施形態に係る医療用器具の一部を示す斜視図である。It is a perspective view which shows a part of medical instrument which concerns on one Embodiment of this invention. 本発明の一実施形態に係る注射針を示す図であり、（ａ）は刃面の側から見た側面、（ｂ）は刃面の側方から見た側面図、（ｃ）は（ａ）のＡ－Ａ断面図である。It is a figure which shows the injection needle which concerns on one Embodiment of this invention, (a) is the side surface seen from the blade surface side, (b) is the side view seen from the side of the blade surface, (c) is (a) FIG. 図２に示す注射針の一部を示す図であり、（ａ）は斜視図、（ｂ）は刃面の側から見た側面図、（ｃ）は刃面の側方から見た側面図である。It is a figure which shows a part of injection needle shown in FIG. 2, (a) is a perspective view, (b) is a side view seen from the side of a blade surface, (c) is a side view seen from the side of a blade surface. It is. （ａ）は、図３（ｃ）のＢ－Ｂ断面図、（ｂ）は、図３（ｃ）のＣ－Ｃ断面図である。FIG. 3A is a sectional view taken along line BB in FIG. 3C, and FIG. 3B is a sectional view taken along line CC in FIG. 図２に示す注射針の製造要領を示す部分斜視図であり、（ａ）は打ち抜き工程直後の状態、（ｂ）はプレス工程の初期段階の状態、（ｃ）はプレス工程の終期段階の状態、（ｄ）はプレス工程完了時の状態を示す。It is a fragmentary perspective view which shows the manufacture point of the injection needle shown in FIG. 2, (a) is the state immediately after a punching process, (b) is the state of the initial stage of a press process, (c) is the state of the final stage of a press process. , (D) shows the state when the pressing process is completed. 本発明の他の実施形態に係る注射針の一部を示す図であり、（ａ）は斜視図、（ｂ）は刃面の側から見た側面図、（ｃ）は刃面の側方から見た側面図である。It is a figure which shows a part of injection needle which concerns on other embodiment of this invention, (a) is a perspective view, (b) is the side view seen from the blade surface side, (c) is the side of a blade surface It is the side view seen from. 図６に示す注射針の製造要領を示す部分斜視図であり、（ａ）は打ち抜き工程直後の状態、（ｂ）はプレス工程の初期段階の状態、（ｃ）はプレス工程の終期段階の状態、（ｄ）はプレス工程完了時の状態を示す。It is a fragmentary perspective view which shows the manufacture point of the injection needle shown in FIG. 6, (a) is the state immediately after the punching process, (b) is the initial stage state of the pressing process, (c) is the final stage state of the pressing process. , (D) shows the state when the pressing process is completed. 本発明の更なる他の実施形態に係る注射針の製造要領を示す部分斜視図であり、（ａ）は打ち抜き工程直後の状態、（ｂ）はプレス工程の初期段階の状態、（ｃ）はプレス工程の終期段階の状態、（ｄ）はプレス工程完了時の状態を示す。It is a fragmentary perspective view which shows the manufacture point of the injection needle which concerns on further another embodiment of this invention, (a) is the state immediately after a punching process, (b) is the state of the initial stage of a press process, (c) is The final stage state of the pressing process, (d) shows the state when the pressing process is completed.
　以下、図１～図５を参照して、本発明の一実施形態に係る注射針及び医療用器具について詳細に例示説明する。なお、本明細書において、「先端」とは、注射針の長手軸方向において、注射針の刃面が位置する側（図２（ａ）における左側）を意味し、「基端」とはその反対側（図２（ａ）における右側）を意味する。 Hereinafter, with reference to FIG. 1 to FIG. 5, an injection needle and a medical instrument according to an embodiment of the present invention will be described in detail. In the present specification, the “tip” means the side (left side in FIG. 2 (a)) where the blade surface of the injection needle is located in the longitudinal axis direction of the injection needle, and the “base end” means It means the opposite side (the right side in FIG. 2 (a)).
　図１に示すように、本実施形態に係る医療用器具１００は、人体などの生体内に薬液などの流体を注入するための注射針１を備えている。本実施形態では、注射針１は、生体の皮下又は皮内に流体を注入する用途に特に適する構成になっている。また、本実施形態では、注射針１は、タンパク質製剤を中心とするバイオ薬などの比較的高粘度の流体を対象とする場合に特に適する構成になっている。具体的には、常温（すなわち、２５℃）での流体の粘度が１～１００ｃｐｓである場合に特に適しており、より好ましくは１０～２０ｃｐｓである。 As shown in FIG. 1, a medical device 100 according to this embodiment includes an injection needle 1 for injecting a fluid such as a chemical into a living body such as a human body. In the present embodiment, the injection needle 1 has a configuration that is particularly suitable for applications in which fluid is injected into the skin or skin of a living body. In the present embodiment, the injection needle 1 has a configuration that is particularly suitable when a relatively high-viscosity fluid such as a biopharmaceutical centering on a protein preparation is targeted. Specifically, it is particularly suitable when the viscosity of the fluid at normal temperature (that is, 25 ° C.) is 1 to 100 cps, and more preferably 10 to 20 cps.
　本実施形態に係る医療用器具１００は、注射針１と、シリンジ本体１０２と、プランジャ（図示省略）とで構成されるシリンジである。円筒状をなすシリンジ本体１０２の先端部には、シリンジ本体１０２よりも径の小さい円筒状をなす筒体１０１が一体に設けられており、筒体１０１の内周面と、注射針１の後述する円筒状の大径部１１（図２参照）の外周面との間には、接合部が設けられている。このように、本実施形態の医療用器具１００は、注射針１をシリンジ本体１０２のポートに直接固定した針植込み式シリンジとして構成されているため、予め流体を充填した状態で医療現場に供給されるプレフィルドシリンジとするのに特に適したものとなっている。医療用器具１００によれば、シリンジ本体１０２内に流体が充填された状態でプランジャの先端側に取り付けられたガスケットを先端側に向けて押し込むことで、シリンジ本体１０２内の流体を注射針１から流出させることができる。 The medical instrument 100 according to the present embodiment is a syringe including an injection needle 1, a syringe body 102, and a plunger (not shown). A cylindrical body 101 having a diameter smaller than that of the syringe main body 102 is integrally provided at the distal end portion of the cylindrical syringe main body 102, and an inner peripheral surface of the cylindrical body 101 and an injection needle 1 to be described later. A joining portion is provided between the outer peripheral surface of the cylindrical large-diameter portion 11 (see FIG. 2). As described above, the medical instrument 100 of the present embodiment is configured as a needle-implantable syringe in which the injection needle 1 is directly fixed to the port of the syringe body 102, and thus is supplied to the medical site in a state of being prefilled with fluid. It is particularly suitable for a prefilled syringe. According to the medical instrument 100, the fluid in the syringe body 102 is pushed from the injection needle 1 by pushing the gasket attached to the distal end side of the plunger toward the distal end side while the syringe body 102 is filled with fluid. Can be drained.
　シリンジ本体１０２は、例えば、環状ポリオレフィン、環状ポリオレフィンコポリマーやポリプロピレン等の樹脂材料によって形成することができる。また、注射針１は、例えば、ステンレス鋼やチタン合金等の金属材料によって形成することができる。筒体１０１と注射針１の大径部１１との間の接合部は、例えば接着剤などによる接着部としたり、例えば注射針１へのレーザー照射による加熱などを用いた融着部としたりすることができる。また、この接合部を融着部とする場合には、筒体１０１の内周面に大径部１１の外周面を直接融着してもよいし、筒体１０１の内周面と大径部１１の外周面との間に樹脂製の内筒体を溶融させながら押し込むことで、大径部１１と筒体１０１とを融着させてもよい。 The syringe body 102 can be formed of a resin material such as cyclic polyolefin, cyclic polyolefin copolymer, or polypropylene. Moreover, the injection needle 1 can be formed with metal materials, such as stainless steel and a titanium alloy, for example. The joint between the cylinder 101 and the large-diameter portion 11 of the injection needle 1 is, for example, an adhesive portion using an adhesive or the like, for example, a fusion portion using heating of the injection needle 1 by laser irradiation or the like. be able to. Moreover, when this joining part is used as a fusion part, the outer peripheral surface of the large diameter part 11 may be directly fused to the inner peripheral surface of the cylindrical body 101, or the inner peripheral surface of the cylindrical body 101 and the large diameter The large-diameter portion 11 and the cylindrical body 101 may be fused by pressing the resin inner cylindrical body while melting it between the outer peripheral surface of the portion 11.
　また、注射針１の接合に当たっては、大径部１１のみならず、注射針１の後述する縮径部１３（図２参照）の外周面も、筒体１０１の内周面に接合するように構成することが好ましい。すなわち、注射針１の縮径部１３及び大径部１１の外周面と、筒体１０１の内周面との間に接合部を設けることが好ましい。縮径部１３は基端側から先端側に向かって縮径する円錐状をなしているので、医療用器具１００をこのような接合によって構成することで、注射針１の先端側への引き抜けに対する接合強度を効率的に高めることができる。 Further, when the injection needle 1 is joined, not only the large diameter portion 11 but also the outer peripheral surface of the reduced diameter portion 13 (see FIG. 2) described later of the injection needle 1 is joined to the inner peripheral surface of the cylinder 101. It is preferable to configure. That is, it is preferable to provide a joint between the outer peripheral surface of the reduced diameter portion 13 and the large diameter portion 11 of the injection needle 1 and the inner peripheral surface of the cylindrical body 101. Since the reduced diameter portion 13 has a conical shape that decreases in diameter from the proximal end side toward the distal end side, the medical instrument 100 is configured by such joining so that the injection needle 1 can be pulled out to the distal end side. The joint strength with respect to can be increased efficiently.
　また、本実施形態では、注射針１の大径部１１の外周面に粗面部を設けることで、注射針１の筒体１０１との接合強度を高めている。粗面部は、本実施形態では、大径部１１の周方向に延在する複数の管状溝からなるローレット１１ａ（図２参照）で構成されている。 Further, in the present embodiment, by providing a rough surface portion on the outer peripheral surface of the large-diameter portion 11 of the injection needle 1, the bonding strength of the injection needle 1 with the cylinder 101 is increased. In the present embodiment, the rough surface portion is constituted by a knurling 11 a (see FIG. 2) composed of a plurality of tubular grooves extending in the circumferential direction of the large diameter portion 11.
　なお、本実施形態では医療用器具１００は、注射針１をシリンジ本体１０２のポートである筒体１０１に直接固定した針植込み式シリンジとして構成したが、このような構成に代え、例えば、シリンジ本体のポートに接続可能な針基（ハブ）に固定したハブ付き注射針として構成してもよい。また、医療用器具１００は、注射針１の大径部１１の外周面を筒体１０１の内周面に接合している限り、他の構成を採用することができる。 In the present embodiment, the medical instrument 100 is configured as a needle-implantable syringe in which the injection needle 1 is directly fixed to the cylindrical body 101 that is a port of the syringe body 102, but instead of such a configuration, for example, a syringe body You may comprise as a syringe needle with a hub fixed to the needle base (hub) connectable to this port. Further, the medical instrument 100 can employ other configurations as long as the outer peripheral surface of the large-diameter portion 11 of the injection needle 1 is joined to the inner peripheral surface of the cylindrical body 101.
　図２に示すように、本実施形態に係る注射針１は、先端部に刃面１２ａに囲まれた先端開口１２ｂを有する管状を成しており、先端部から基端部まで一定の肉厚ｔを有している。また、注射針１は、基端部から所定の範囲に亘って設けられ、一定の内径寸法ｄ１１を有する大径部１１と、先端部から所定の範囲に亘って設けられ、大径部１１よりも小さい一定の内径寸法ｄ１２を有する小径部１２と、大径部１１と小径部１２との間の範囲に亘って設けられ、大径部１１の側から小径部１２の側に向かって減少する内径寸法を有する縮径部１３とを備えている。本実施形態では、大径部１１及び小径部１２はそれぞれ円筒状をなしており、縮径部１３は基端側から先端側に向かって縮径する円錐状をなしている。 As shown in FIG. 2, the injection needle 1 according to the present embodiment has a tubular shape having a distal end opening 12b surrounded by a blade surface 12a at the distal end, and has a constant thickness from the distal end to the proximal end. t. Further, the injection needle 1 is provided over a predetermined range from the base end portion, and is provided with a large diameter portion 11 having a constant inner diameter dimension d11 and a predetermined range from the distal end portion. Are provided over a range between the small diameter portion 12 having a small constant inner diameter dimension d12 and the large diameter portion 11 and the small diameter portion 12, and decreases from the large diameter portion 11 side toward the small diameter portion 12 side. And a reduced diameter portion 13 having an inner diameter. In the present embodiment, each of the large diameter portion 11 and the small diameter portion 12 has a cylindrical shape, and the reduced diameter portion 13 has a conical shape whose diameter decreases from the proximal end side toward the distal end side.
　なお、縮径部１３は、本実施形態のように、大径部１１の側から小径部１２の側に向かって漸減する内径寸法を有する構成とすることが、流体の注入抵抗を低減する観点から好ましい。しかしながら、このように内径寸法が漸減する構成に代えて、例えば段差状に減少する構成とすることも可能である。 The reduced diameter portion 13 has a configuration having an inner diameter that gradually decreases from the large diameter portion 11 side toward the small diameter portion 12 side as in the present embodiment, from the viewpoint of reducing fluid injection resistance. To preferred. However, instead of the configuration in which the inner diameter dimension gradually decreases in this way, a configuration in which the inner diameter size decreases in a stepped shape, for example, is also possible.
　注射針１は、小径部１２の側面を貫通する少なくとも１つの側孔１２ｃを備えている。本実施形態では、少なくとも１つの側孔１２ｃは、図３に示すように、小径部１２における刃面１２ａの側から見た側面に設けられると共に、小径部１２の長手軸線Ｏに沿う方向（長手軸方向）に延在する１つの長孔として構成されている。また、当該長孔は角孔状を成している。 The injection needle 1 is provided with at least one side hole 12c that penetrates the side surface of the small diameter portion 12. In the present embodiment, as shown in FIG. 3, at least one side hole 12 c is provided on a side surface of the small diameter portion 12 as viewed from the blade surface 12 a side, and a direction (longitudinal direction) along the longitudinal axis O of the small diameter portion 12. It is configured as one long hole extending in the axial direction. Moreover, the said long hole has comprised the shape of a square hole.
　さらに、図４（ａ）に示すように、側孔１２ｃの外周縁を形成する外周端面１２ｃ１は、小径部１２の径方向に沿って延在している。また、図４（ｂ）に示すように、注射針１は、管状に湾曲すると共に突合せ端面１４ａが互いに接合された板状体１４からなっている。 Furthermore, as shown in FIG. 4A, the outer peripheral end surface 12c1 forming the outer peripheral edge of the side hole 12c extends along the radial direction of the small diameter portion 12. Further, as shown in FIG. 4B, the injection needle 1 is composed of a plate-like body 14 that is curved in a tubular shape and whose butt end surfaces 14a are joined to each other.
　このような構成になる本実施形態の注射針１は、以下の要領で効率的に製造することができる。まず、図５（ａ）に示すように、金属の薄板を打ち抜くことで、注射針１の展開形状をなす板状体１４を得る。この打ち抜き工程では、板状体１４の突合せ端面１４ａに、板状体１４を管状に湾曲させて突合せ端面１４ａを互いに接合したときに側孔１２ｃを構成する切欠き１４ｂを形成することができる。また、前述した大径部１１のローレット１１ａ（図２参照）も、この打ち抜き工程で同時に形成することができる。 The injection needle 1 of the present embodiment having such a configuration can be efficiently manufactured in the following manner. First, as shown to Fig.5 (a), the plate-shaped body 14 which makes | forms the expansion | deployment shape of the injection needle 1 is obtained by punching out a metal thin plate. In this punching step, a notch 14b constituting the side hole 12c can be formed on the butted end surface 14a of the plate-like body 14 when the plate-like body 14 is curved in a tubular shape and the butted end surfaces 14a are joined to each other. Further, the knurl 11a (see FIG. 2) of the large-diameter portion 11 described above can be simultaneously formed in this punching process.
　次に、図５（ｂ）、図５（ｃ）に示すように、所定の形状をなす上型と下型とで板状体１４を挟み込むプレス工程を複数回にわたって施すことで、図５（ｄ）に示すような側孔１２ｃを有する管状体を得ることができる。そして、突合せ端面１４ａを、レーザー照射を用いた溶接によって、精度良く互いに接合することができる。なお、突合せ端面１４ａの接合は必ずしも溶接に限られず、例えば接着剤を用いることも可能である。そして、このような接合工程の後、管状体の先端部を適宜斜めにカットすることで、所定形状の刃面１２ａを形成することができる。以上の工程を経ることで、本実施形態の注射針１を効率的に製造することができる。 Next, as shown in FIGS. 5 (b) and 5 (c), a pressing process for sandwiching the plate-like body 14 between the upper mold and the lower mold having a predetermined shape is performed a plurality of times, so that FIG. A tubular body having side holes 12c as shown in d) can be obtained. The butt end surfaces 14a can be joined to each other with high accuracy by welding using laser irradiation. The joining of the butt end surface 14a is not necessarily limited to welding, and for example, an adhesive can be used. And after such a joining process, the blade surface 12a of a predetermined shape can be formed by cutting the front-end | tip part of a tubular body diagonally suitably. By passing through the above process, the injection needle 1 of this embodiment can be manufactured efficiently.
　なお、図２に示した注射針１の全長Ｌ１は２１．９ｍｍ、小径部１２の長さＬ１２は８．７ｍｍ、縮径部１３の長さＬ１３は５．５ｍｍ、有効長は１２．７ｍｍ（縮径部４．０ｍｍを含む）である。また、小径部１２は２９Ｇ（ゲージ）（外径寸法Ｄ１２が０．３３８ｍｍ）、内径寸法ｄ１２が０．２３８ｍｍ、大径部１１は２４Ｇ（外径寸法Ｄ１１が０．５６５ｍｍ）、内径寸法ｄ１１が０．４６５ｍｍ、肉厚ｔは０．０５０ｍｍである。さらに、刃面長Ｌ１２ａは１．８ｍｍ、ローレット１１ａからなる粗面部の全長Ｌ１１ａは４．８ｍｍ、粗面部（ローレット１１ａ）と大径部１１の先端との間隔Ｇ１１ａは０．４ｍｍである。 The total length L1 of the injection needle 1 shown in FIG. 2 is 21.9 mm, the length L12 of the small diameter portion 12 is 8.7 mm, the length L13 of the reduced diameter portion 13 is 5.5 mm, and the effective length is 12.7 mm ( Including a reduced diameter portion of 4.0 mm). The small-diameter portion 12 is 29G (gauge) (outer diameter D12 is 0.338 mm), the inner diameter d12 is 0.238 mm, the large-diameter portion 11 is 24G (outer diameter D11 is 0.565 mm), and the inner diameter d11 is The thickness is 0.465 mm and the wall thickness t is 0.050 mm. Further, the blade surface length L12a is 1.8 mm, the total length L11a of the rough surface portion made of the knurl 11a is 4.8 mm, and the gap G11a between the rough surface portion (knurl 11a) and the tip of the large diameter portion 11 is 0.4 mm.
　注射針１の全長Ｌ１は、１０～９０ｍｍとすることが好ましく、より好ましくは１３～３８ｍｍである。小径部１２の長さＬ１２は、１～７０ｍｍとすることが好ましく、より好ましくは２～２５ｍｍである。縮径部１３の長さＬ１３は、１～５０ｍｍとすることが好ましく、より好ましくは２～２０ｍｍである。小径部１２は３４～２３Ｇとすることが好ましく、より好ましくは３１～２５Ｇである。大径部１１は３０～１８Ｇとすることが好ましく、より好ましくは２９～２４Ｇである。肉厚ｔは０．０４０～０．２２０ｍｍとすることが好ましく、より好ましくは０．０４３～０．１００ｍｍである。 The total length L1 of the injection needle 1 is preferably 10 to 90 mm, more preferably 13 to 38 mm. The length L12 of the small diameter portion 12 is preferably 1 to 70 mm, more preferably 2 to 25 mm. The length L13 of the reduced diameter portion 13 is preferably 1 to 50 mm, more preferably 2 to 20 mm. The small diameter part 12 is preferably 34 to 23G, more preferably 31 to 25G. The large diameter portion 11 is preferably 30 to 18G, more preferably 29 to 24G. The wall thickness t is preferably 0.040 to 0.220 mm, more preferably 0.043 to 0.100 mm.
　また、刃面長Ｌ１２ａは０．８～６．３７ｍｍとすることが好ましく、より好ましくは１．１０～２．６０ｍｍである。粗面部の全長Ｌ１１ａは２～３０ｍｍとすることが好ましく、より好ましくは４～１０ｍｍである。粗面部（ローレット１１ａ）と大径部１１の先端との間隔Ｇ１１ａは０．０５～５．０ｍｍとすることが好ましく、より好ましくは０．１～１．０ｍｍである。 Further, the blade surface length L12a is preferably 0.8 to 6.37 mm, and more preferably 1.10 to 2.60 mm. The total length L11a of the rough surface portion is preferably 2 to 30 mm, more preferably 4 to 10 mm. The distance G11a between the rough surface portion (knurl 11a) and the tip of the large diameter portion 11 is preferably 0.05 to 5.0 mm, more preferably 0.1 to 1.0 mm.
　また、図３に示した側孔１２ｃは、全長Ｌ１２ｃが１．５ｍｍ、幅Ｗ１２ｃが０．０９４ｍｍ、刃面１２ａの基端との間隔Ｇ１２ｃが０．５ｍｍである。ここで、側孔１２ｃの全長Ｌ１２ｃは０．２～５．０ｍｍとすることが好ましく、より好ましくは１．０～２．５ｍｍである。また、側孔１２ｃの幅Ｗ１２ｃは０．０３～１．０ｍｍとすることが好ましく、より好ましくは０．０５～０．３ｍｍである。さらに、側孔１２ｃと刃面１２ａの基端との間隔Ｇ１２ｃは０．３～３．０ｍｍとすることが好ましく、より好ましくは０．５～２．０ｍｍである。 Further, the side hole 12c shown in FIG. 3 has an overall length L12c of 1.5 mm, a width W12c of 0.094 mm, and a distance G12c from the base end of the blade surface 12a of 0.5 mm. Here, the total length L12c of the side hole 12c is preferably 0.2 to 5.0 mm, more preferably 1.0 to 2.5 mm. The width W12c of the side hole 12c is preferably 0.03 to 1.0 mm, more preferably 0.05 to 0.3 mm. Furthermore, the gap G12c between the side hole 12c and the base end of the blade surface 12a is preferably 0.3 to 3.0 mm, more preferably 0.5 to 2.0 mm.
　前述したように、本実施形態に係る注射針１は、管状をなすと共に先端部に刃面１２ａに囲まれた先端開口１２ｂを有する、生体内に流体を注入するための注射針１であって、基端部から所定の範囲に亘って設けられ、一定の内径寸法ｄ１１を有する大径部１１と、先端部から所定の範囲に亘って設けられ、大径部１１よりも小さい一定の内径寸法ｄ１２を有する小径部１２と、大径部１１と小径部１２との間の範囲に亘って設けられ、大径部１１の側から小径部１２の側に向かって減少する内径寸法を有する縮径部１３と、小径部１２の側面を貫通する少なくとも１つの側孔１２ｃとを備えるという構成になっている。 As described above, the injection needle 1 according to the present embodiment is a syringe needle 1 for injecting a fluid into a living body, having a tubular shape and having a distal end opening 12b surrounded by a blade surface 12a at a distal end portion. The large-diameter portion 11 provided over a predetermined range from the base end portion and having a constant inner diameter dimension d11, and the constant inner-diameter dimension provided over a predetermined range from the distal end portion and smaller than the large diameter portion 11 Small diameter portion 12 having d12 and a reduced diameter having an inner diameter dimension which is provided over a range between large diameter portion 11 and small diameter portion 12 and decreases from the large diameter portion 11 side toward the small diameter portion 12 side. The configuration includes a portion 13 and at least one side hole 12c penetrating the side surface of the small diameter portion 12.
　したがって、本実施形態に係る注射針１によれば、注射針１の内部全体で生じる流体の注入抵抗を効果的に低減することができる。また、本実施形態に係る注射針１によれば、先端開口１２ｂと少なくとも１つの側孔１２ｃとを通じて流体を分散して流出させることができるため、生体内で流体を効果的に拡散させることができる。 Therefore, according to the injection needle 1 according to the present embodiment, it is possible to effectively reduce the injection resistance of the fluid generated in the entire inside of the injection needle 1. Further, according to the injection needle 1 according to the present embodiment, the fluid can be dispersed and discharged through the tip opening 12b and at least one side hole 12c, so that the fluid can be effectively diffused in the living body. it can.
　また、本実施形態に係る注射針１は、縮径部１３の内径寸法は、大径部１１の側から小径部１２の側に向かって漸減しているという構成になっている。したがって、本実施形態に係る注射針１によれば、流体の注入抵抗をより効果的に低減することができる。 Further, the injection needle 1 according to the present embodiment is configured such that the inner diameter of the reduced diameter portion 13 is gradually reduced from the large diameter portion 11 side toward the small diameter portion 12 side. Therefore, according to the injection needle 1 according to the present embodiment, the fluid injection resistance can be more effectively reduced.
　また、本実施形態に係る注射針１は、基端部から先端部まで一定の肉厚ｔを有するという構成になっている。したがって、本実施形態に係る注射針１によれば、小径部１２及び縮径部１３の外径を大径部１１よりも小さいものとして、穿刺時の刺通抵抗を効果的に低減することができる。 Further, the injection needle 1 according to the present embodiment is configured to have a constant thickness t from the proximal end portion to the distal end portion. Therefore, according to the injection needle 1 according to the present embodiment, the outer diameter of the small diameter portion 12 and the reduced diameter portion 13 is made smaller than that of the large diameter portion 11, and the puncture resistance at the time of puncture can be effectively reduced. it can.
　また、本実施形態に係る注射針１は、大径部１１、小径部１２及び縮径部１３が、管状に湾曲すると共に突合せ端面１４ａが互いに接合された板状体１４によって構成されている。したがって、本実施形態に係る注射針１によれば、薄板からの板状体１４の打ち抜き、板状体１４の管形状へのプレス加工、突合せ端面１４ａの接合による効率的な製造が可能になる。 Further, the injection needle 1 according to the present embodiment is configured by a plate-like body 14 in which the large diameter portion 11, the small diameter portion 12, and the reduced diameter portion 13 are curved in a tubular shape and the butt end surfaces 14a are joined to each other. Therefore, according to the injection needle 1 according to the present embodiment, it is possible to efficiently manufacture by punching the plate-like body 14 from a thin plate, pressing the plate-like body 14 into a tube shape, and joining the butt end face 14a. .
　また、本実施形態に係る注射針１は、少なくとも１つの側孔１２ｃの外周縁を形成する外周端面１２ｃ１が、小径部１２の径方向に沿って延在しているという構成になっている。したがって、本実施形態に係る注射針１によれば、薄板からの板状体１４の打ち抜き工程で側孔１２ｃ（又はプレス加工時に側孔１２ｃを構成する切欠き１４ｂ）も形成しておくことができるため効率的な製造が可能となり、しかも、注射時には流体を側孔１２ｃから放射状に流出させることができるため流体を効果的に拡散させることができる。 Further, the injection needle 1 according to the present embodiment is configured such that the outer peripheral end surface 12c1 that forms the outer peripheral edge of at least one side hole 12c extends along the radial direction of the small diameter portion 12. Therefore, according to the injection needle 1 which concerns on this embodiment, the side hole 12c (or the notch 14b which comprises the side hole 12c at the time of a press work) can also be formed in the punching process of the plate-shaped body 14 from a thin plate. Therefore, efficient production is possible, and moreover, the fluid can be diffused effectively because the fluid can be discharged radially from the side hole 12c at the time of injection.
　また、本実施形態に係る注射針１は、常温での粘度が１～１００ｃｐｓ、より好ましくは１０～２０ｃｐｓである流体を生体内に注入するためのものである。したがって、本実施形態に係る注射針１によれば、タンパク質製剤を中心とするバイオ薬などの比較的高粘度の流体を、生体内にスムーズに注入することができ、また、生体内での効果的な流体の拡散を実現することができる。 Further, the injection needle 1 according to the present embodiment is for injecting a fluid having a viscosity at normal temperature of 1 to 100 cps, more preferably 10 to 20 cps into a living body. Therefore, according to the injection needle 1 according to the present embodiment, a relatively high-viscosity fluid such as a biopharmaceutical centering on a protein preparation can be smoothly injected into the living body, and the effects in the living body can be obtained. Fluid diffusion can be realized.
　また、本実施形態に係る注射針１は、少なくとも１つの側孔１２ｃが、小径部１２の長手軸方向に延在する少なくとも１つの長孔であるという構成になっている。したがって、本実施形態に係る注射針１によれば、簡単な構成により、流体の注入抵抗の低減と拡散を効果的に実現することができる。 Further, the injection needle 1 according to the present embodiment is configured such that at least one side hole 12c is at least one long hole extending in the longitudinal axis direction of the small diameter portion 12. Therefore, according to the injection needle 1 according to the present embodiment, reduction and diffusion of fluid injection resistance can be effectively realized with a simple configuration.
　また、本実施形態に係る注射針１は、少なくとも１つの側孔１２ｃが角孔であるという構成になっている。したがって、本実施形態に係る注射針１によれば、簡単な構成により、流体の注入抵抗の低減と拡散を効果的に実現することができる。 Further, the injection needle 1 according to the present embodiment is configured such that at least one side hole 12c is a square hole. Therefore, according to the injection needle 1 according to the present embodiment, reduction and diffusion of fluid injection resistance can be effectively realized with a simple configuration.
　また、本実施形態に係る注射針１は、少なくとも１つの側孔１２ｃが、小径部１２における刃面１２ａの側から見た側面（すなわち、刃先の反対側に位置する側面）に設けられているという構成になっている。したがって、本実施形態に係る注射針１によれば、少なくとも１つの側孔１２ｃを設けることによる穿刺時の刺通抵抗の増加を抑制することができる。 In addition, in the injection needle 1 according to the present embodiment, at least one side hole 12c is provided on a side surface of the small diameter portion 12 as viewed from the blade surface 12a side (that is, a side surface located on the opposite side of the blade edge). It is the composition. Therefore, according to the injection needle 1 according to the present embodiment, an increase in puncture resistance at the time of puncture due to the provision of at least one side hole 12c can be suppressed.
　さらに、本実施形態に係る注射針１は、大径部１１の外周面に粗面部（例えばローレット１１ａ）を備えるという構成になっている。したがって、本実施形態に係る注射針１によれば、注射針１の大径部１１を医療用器具１００の筒体１０１に接合する際の接合強度を高めることができる。 Furthermore, the injection needle 1 according to the present embodiment is configured to include a rough surface portion (for example, a knurling 11a) on the outer peripheral surface of the large diameter portion 11. Therefore, according to the injection needle 1 according to the present embodiment, the bonding strength when the large-diameter portion 11 of the injection needle 1 is bonded to the cylindrical body 101 of the medical device 100 can be increased.
　また、本実施形態に係る医療用器具１００は、前述した注射針１と、筒状をなす筒体１０１とを備え、注射針１の大径部１１の外周面と、筒体１０１の内周面との間に接合部が設けられているという構成になっている。したがって、本実施形態に係る医療用器具１００によれば、医療用器具１００の内部全体で生じる流体の注入抵抗を効果的に低減できると共に、注射針１の先端開口１２ｂと少なくとも１つの側孔１２ｃとを通じて生体内で流体を効果的に拡散させることができる。 The medical instrument 100 according to this embodiment includes the above-described injection needle 1 and a cylindrical cylinder 101, and includes an outer peripheral surface of the large-diameter portion 11 of the injection needle 1 and an inner periphery of the cylindrical body 101. It is the structure that the junction part is provided between the surfaces. Therefore, according to the medical instrument 100 according to the present embodiment, it is possible to effectively reduce the injection resistance of the fluid generated in the entire interior of the medical instrument 100, and at the same time, the tip opening 12b of the injection needle 1 and at least one side hole 12c. Thus, the fluid can be effectively diffused in the living body.
　また、本実施形態に係る医療用器具１００は、注射針１の縮径部１３及び大径部１１の外周面と、筒体１０１の内周面との間に接合部を設ける構成とした場合には、注射針１の先端側への引き抜けに対する接合強度を効率的に高めることができる。 Further, the medical instrument 100 according to the present embodiment has a configuration in which a joint portion is provided between the outer peripheral surface of the reduced diameter portion 13 and the large diameter portion 11 of the injection needle 1 and the inner peripheral surface of the cylindrical body 101. Therefore, it is possible to efficiently increase the bonding strength against the withdrawal of the injection needle 1 toward the distal end side.
　次に、図６～図７を参照して、本発明の他の実施形態に係る注射針及び医療用器具について詳細に例示説明する。 Next, with reference to FIGS. 6 to 7, an injection needle and a medical device according to another embodiment of the present invention will be described in detail.
　本実施形態に係る注射針及び医療用器具は、図１～５を用いて説明した実施形態の場合と比べると、注射針２の側孔２２ｃの形態が異なる他は同一の構成になっている。 The injection needle and medical instrument according to the present embodiment have the same configuration as the embodiment described with reference to FIGS. 1 to 5 except that the shape of the side hole 22c of the injection needle 2 is different. .
　図１～５を用いて説明した実施形態では、角孔状の長孔として形成された１つの側孔１２ｃを設けていたが、本実施形態では、図６に示すように、長手軸方向に等間隔を空けて配置されると共に長手軸方向に並ぶ角孔として形成された４つの側孔２２ｃを設けている。なお、本実施形態においても、各側孔２２ｃは、小径部２２における刃面２２ａの側から見た側面に設けられており、また、各側孔２２ｃの外周縁を形成する外周端面２２ｃ１は、小径部２２の径方向に沿って延在している。 In the embodiment described with reference to FIGS. 1 to 5, one side hole 12c formed as a rectangular hole is provided. However, in this embodiment, as shown in FIG. Four side holes 22c formed as square holes arranged at equal intervals and arranged in the longitudinal axis direction are provided. Also in the present embodiment, each side hole 22c is provided on the side surface of the small diameter portion 22 as viewed from the blade surface 22a side, and the outer peripheral end surface 22c1 that forms the outer periphery of each side hole 22c is: The small diameter portion 22 extends along the radial direction.
　また、注射針２は、図１～５を用いて説明した実施形態の場合と同様に製造することができる。すなわち、まず、図７（ａ）に示すように、注射針２の展開形状をなす板状体２４を得るための打ち抜き工程において、板状体２４の突合せ端面２４ａに、板状体２４を管状に湾曲させて突合せ端面２４ａを互いに接合したときに側孔２２ｃを構成する切欠き２４ｂを形成することができる。そして、図７（ｂ）、図７（ｃ）に示すように、複数回のプレス工程を施して板状体２４を湾曲させ、図７（ｄ）に示すような側孔２２ｃを有する管状体を得ることができる。その後、突合せ端面２４ａを接合し、管状体の先端部に所定形状の刃面２２ａを形成することで、注射針２を得ることができる。 Also, the injection needle 2 can be manufactured in the same manner as in the embodiment described with reference to FIGS. That is, first, as shown in FIG. 7A, in the punching process for obtaining the plate-like body 24 having the developed shape of the injection needle 2, the plate-like body 24 is tubular on the butt end surface 24 a of the plate-like body 24. It is possible to form a notch 24b that constitutes the side hole 22c when the butted end surfaces 24a are joined to each other. Then, as shown in FIGS. 7B and 7C, a tubular body having a side hole 22c as shown in FIG. 7D is obtained by bending the plate-like body 24 by performing a plurality of pressing steps. Can be obtained. Thereafter, the butt end surface 24a is joined, and the injection needle 2 can be obtained by forming the blade surface 22a having a predetermined shape at the tip of the tubular body.
　なお、図６に示した注射針２の各側孔２２ｃの長さＬ２２ｃが０．２ｍｍ、各側孔２２ｃの幅Ｗ２２ｃが０．０９４ｍｍ、側孔２２ｃ間の間隔ｇ２２ｃが０．３ｍｍであり、最も先端側に位置する側孔２２ｃと刃面２２ａの基端との間隔Ｇ２２ｃは０．３ｍｍである。なお、側孔２２ｃ以外の部分についての各種寸法は、図１～５を用いて説明した実施形態の場合と同一である。 The length L22c of each side hole 22c of the injection needle 2 shown in FIG. 6 is 0.2 mm, the width W22c of each side hole 22c is 0.094 mm, and the gap g22c between the side holes 22c is 0.3 mm. A gap G22c between the side hole 22c located on the most distal side and the base end of the blade surface 22a is 0.3 mm. Various dimensions of the portions other than the side holes 22c are the same as those in the embodiment described with reference to FIGS.
　ここで、各側孔２２ｃの長さＬ２２ｃは０．１～１．０ｍｍとすることが好ましく、より好ましくは０．１５～０．５ｍｍである。また、各側孔２２ｃの幅Ｗ２２ｃは０．０３～１．０ｍｍとすることが好ましく、より好ましくは０．０５～０．３ｍｍである。また、側孔２２ｃ間の間隔ｇ２２ｃは０．１～１．０ｍｍとすることが好ましく、より好ましくは０．２～０．５ｍｍである。さらに、最も先端側に位置する側孔２２ｃと刃面２２ａの基端との間隔Ｇ２２ｃは０．３～２．０ｍｍとすることが好ましく、より好ましくは０．３～１．５ｍｍである。 Here, the length L22c of each side hole 22c is preferably 0.1 to 1.0 mm, and more preferably 0.15 to 0.5 mm. Further, the width W22c of each side hole 22c is preferably 0.03 to 1.0 mm, more preferably 0.05 to 0.3 mm. Further, the gap g22c between the side holes 22c is preferably 0.1 to 1.0 mm, more preferably 0.2 to 0.5 mm. Furthermore, the distance G22c between the side hole 22c located on the most distal side and the base end of the blade surface 22a is preferably 0.3 to 2.0 mm, more preferably 0.3 to 1.5 mm.
　このように、本実施形態に係る注射針２は、少なくとも１つの側孔２２ｃは、小径部２２の長手軸方向に間隔を空けて配置された複数の孔であるという構成になっている。したがって、本実施形態に係る注射針２によれば、流体の確実な拡散を可能にすることができる。 Thus, the injection needle 2 according to the present embodiment is configured such that at least one side hole 22c is a plurality of holes arranged at intervals in the longitudinal axis direction of the small diameter portion 22. Therefore, according to the injection needle 2 according to the present embodiment, it is possible to reliably diffuse the fluid.
　また、本実施形態に係る注射針２は、前記複数の孔（側孔２２ｃ）が、注射針２の長手軸方向に並んでいるという構成になっている。したがって、本実施形態に係る注射針２によれば、簡単な構成により、流体の確実な拡散を可能にすることができる。 In addition, the injection needle 2 according to the present embodiment is configured such that the plurality of holes (side holes 22c) are arranged in the longitudinal axis direction of the injection needle 2. Therefore, according to the injection needle 2 according to the present embodiment, the fluid can be reliably diffused with a simple configuration.
　次に、図８を参照して、本発明の更なる他の実施形態に係る注射針及び医療用器具について詳細に例示説明する。 Next, an injection needle and a medical instrument according to still another embodiment of the present invention will be described in detail with reference to FIG.
　本実施形態に係る注射針及び医療用器具は、図１～５を用いて説明した実施形態の場合と比べると、注射針の側孔３２ｃの形態が異なる他は同一の構成になっている。 The injection needle and the medical instrument according to this embodiment have the same configuration as that of the embodiment described with reference to FIGS. 1 to 5 except that the shape of the side hole 32c of the injection needle is different.
　図１～５を用いて説明した実施形態では、角孔状の長孔として形成された１つの側孔１２ｃを設けていたが、本実施形態では、図８に示すように、長手軸方向に等間隔を空けると共に周方向に位置をずらして配置された丸孔として形成された３つの側孔３２ｃを設けている。これらの３つの側孔３２ｃは、切欠き３４ｂ、貫通孔３４ｄによって構成されている。 In the embodiment described with reference to FIGS. 1 to 5, one side hole 12c formed as a rectangular hole is provided. However, in this embodiment, as shown in FIG. Three side holes 32c formed as round holes arranged at equal intervals and shifted in the circumferential direction are provided. These three side holes 32c are constituted by a notch 34b and a through hole 34d.
　本実施形態に係る注射針は、図１～５を用いて説明した実施形態の場合と同様に製造することができる。すなわち、まず、図８（ａ）に示すように、注射針の展開形状をなす板状体３４を得るための打ち抜き工程において、板状体３４の突合せ端面３４ａに、側孔３２ｃを構成するための切欠き３４ｂ及び貫通孔３４ｄを形成することができる。そして、図８（ｂ）、図８（ｃ）に示すように、複数回のプレス工程を施して板状体３４を湾曲させ、図８（ｄ）に示すような側孔３２ｃを有する管状体を得ることができる。その後、突合せ端面３４ａを接合し、管状体の先端部に所定形状の刃面を形成することで、注射針を得ることができる。 The injection needle according to the present embodiment can be manufactured in the same manner as in the embodiment described with reference to FIGS. That is, first, as shown in FIG. 8A, in the punching process for obtaining the plate-like body 34 having the developed shape of the injection needle, a side hole 32c is formed in the butt end surface 34a of the plate-like body 34. The notch 34b and the through hole 34d can be formed. Then, as shown in FIGS. 8B and 8C, a tubular body having a side hole 32c as shown in FIG. 8D is obtained by bending the plate-like body 34 by performing a plurality of pressing steps. Can be obtained. Thereafter, the butt end surface 34a is joined, and a blade surface having a predetermined shape is formed at the distal end portion of the tubular body, whereby an injection needle can be obtained.
　このように、本実施形態に係る注射針は、少なくとも１つの側孔３２ｃは丸孔であるという構成になっている。したがって、本実施形態に係る注射針によれば、簡単な構成により、流体の注入抵抗の低減と拡散を効果的に実現することができる。 Thus, the injection needle according to the present embodiment is configured such that at least one side hole 32c is a round hole. Therefore, according to the injection needle according to the present embodiment, reduction and diffusion of fluid injection resistance can be effectively realized with a simple configuration.
　前述したところは、本発明の一実施形態を示したにすぎず、特許請求の範囲において種々の変更を加えることができる。例えば、図１～図５を用いて説明した実施形態の場合において、側孔１２ｃを設ける周方向位置や長手軸方向位置を変更してもよく、また、側孔１２ｃを複数配置してもよい。また、図６～図７を用いて説明した実施形態の場合において、側孔２２ｃの数や形状、側孔２２ｃ間の間隔を変更してもよく、また、長手軸方向に並ぶ複数の側孔２２ｃを設ける周方向位置や長手軸方向位置を変更してもよい。さらに、図８を用いて説明した実施形態の場合において、側孔３２ｃを構成する複数の丸孔の数や形状、配置を変更してもよい。 The above description only shows one embodiment of the present invention, and various modifications can be made within the scope of the claims. For example, in the case of the embodiment described with reference to FIGS. 1 to 5, the circumferential position and the longitudinal axis position where the side holes 12c are provided may be changed, and a plurality of side holes 12c may be arranged. . In the case of the embodiment described with reference to FIGS. 6 to 7, the number and shape of the side holes 22c, the interval between the side holes 22c may be changed, and a plurality of side holes arranged in the longitudinal axis direction may be used. You may change the circumferential direction position and longitudinal-axis direction position which provide 22c. Furthermore, in the case of the embodiment described with reference to FIG. 8, the number, shape, and arrangement of the plurality of round holes constituting the side hole 32 c may be changed.
　１　　　　注射針
　１１　　　大径部
　１１ａ　　ローレット（粗面部）
　１２　　　小径部
　１２ａ　　刃面
　１２ｂ　　先端開口
　１２ｃ　　側孔
　１２ｃ１　側孔の外周端面
　１３　　　縮径部
　１４　　　板状体
　１４ａ　　突合せ端面
　１４ｂ　　切欠き
　２　　　　注射針
　２２　　　小径部
　２２ａ　　刃面
　２２ｃ　　側孔
　２２ｃ１　側孔の外周端面
　２４　　　板状体
　２４ａ　　突合せ端面
　２４ｂ　　切欠き
　３２ｃ　　側孔
　３４ａ　　突合せ端面
　３４ｂ　　切欠き
　３４ｄ　　貫通孔
　１００　　医療用器具
　１０１　　筒体
　１０２　　シリンジ本体
　Ｏ　　　　長手軸線
　Ｌ１　　　注射針の全長
　Ｌ１１ａ　粗面部の全長
　Ｌ１２　　小径部の長さ
　Ｌ１２ａ　刃面長
　Ｌ１２ｃ　側孔の全長
　Ｌ１３　　縮径部の長さ
　Ｗ１２ｃ　側孔の幅
　Ｄ１１　　大径部の外径寸法
　Ｄ１２　　小径部の外径寸法
　ｄ１１　　大径部の内径寸法
　ｄ１２　　小径部の内径寸法
　Ｇ１１ａ　粗面部と大径部の先端との間隔
　Ｇ１２ｃ　側孔と刃面の基端との間隔
　ｔ　　　　肉厚
　Ｌ２２ｃ　各側孔の長さ
　Ｗ２２ｃ　各側孔の幅
　Ｇ２２ｃ　最も先端側に位置する側孔と刃面の基端との間隔
　ｇ２２ｃ　側孔間の間隔 1 Injection needle 11 Large diameter part 11a Knurled (rough surface part)
12 Small-diameter portion 12a Blade surface 12b Tip opening 12c Side hole 12c1 Outer peripheral end surface of side hole 13 Reduced-diameter portion 14 Plate-like body 14a Butt end surface 14b Notch 2 Injection needle 22 Small-diameter portion 22a Blade surface 22c Side hole 22c1 Outer end surface of side hole 24 Plate-like body 24a Butt end face 24b Notch 32c Side hole 34a Butt end face 34b Notch 34d Through hole 100 Medical instrument 101 Tubular body 102 Syringe body O Longitudinal axis L1 Length of syringe needle L11a Length of rough surface part L12 Length of small diameter part Length L12a Blade length L12c Length of side hole L13 Length of reduced diameter portion W12c Width of side hole D11 Outer diameter size of large diameter portion D12 Outer diameter size of small diameter portion d11 Inner diameter size of large diameter portion d12 Inner diameter size of small diameter portion G11a Distance between the rough surface portion and the tip of the large diameter portion G12c Between the side hole and the base end of the blade surface Interval t Thickness L22c Length of each side hole W22c Width of each side hole G22c Interval between the side hole located at the most distal end side and the base end of the blade surface g22c Interval between the side holes

Claims (16)

  1. 　管状をなすと共に先端部に刃面に囲まれた先端開口を有する、生体内に流体を注入するための注射針において、
    　基端部から所定の範囲に亘って設けられ、一定の内径寸法を有する大径部と、
    　前記先端部から所定の範囲に亘って設けられ、前記大径部よりも小さい一定の内径寸法を有する小径部と、
    　前記大径部と前記小径部との間の範囲に亘って設けられ、前記大径部の側から前記小径部の側に向かって減少する内径寸法を有する縮径部と、
    　前記小径部の側面を貫通する少なくとも１つの側孔とを備えることを特徴とする注射針。     In an injection needle for injecting a fluid into a living body having a tip opening that is tubular and has a tip opening surrounded by a blade surface at the tip,
    A large-diameter portion that is provided over a predetermined range from the base end portion and has a constant inner diameter;
    A small-diameter portion provided over a predetermined range from the tip portion, and having a constant inner diameter dimension smaller than the large-diameter portion;
    A reduced diameter portion having an inner diameter that is provided over a range between the large diameter portion and the small diameter portion and decreases from the large diameter portion side toward the small diameter portion;
    An injection needle comprising: at least one side hole penetrating the side surface of the small diameter portion.
  2. 　前記縮径部の内径寸法は、前記大径部の側から前記小径部の側に向かって漸減している、請求項１に記載の注射針。 2. The injection needle according to claim 1, wherein an inner diameter of the reduced diameter portion is gradually decreased from the large diameter portion side toward the small diameter portion side.
  3. 　前記基端部から前記先端部まで一定の肉厚を有する、請求項１又は２に記載の注射針。 The injection needle according to claim 1 or 2, wherein the injection needle has a constant thickness from the base end portion to the tip end portion.
  4. 　前記大径部、前記小径部及び前記縮径部は、管状に湾曲すると共に突合せ端面が互いに接合された板状体によって構成されている、請求項１～３のいずれか一項に記載の注射針。 The injection according to any one of claims 1 to 3, wherein the large-diameter portion, the small-diameter portion, and the reduced-diameter portion are configured by a plate-like body that is curved in a tubular shape and whose butt end faces are joined to each other. needle.
  5. 　前記少なくとも１つの側孔の外周縁を形成する外周端面が、前記小径部の径方向に沿って延在している、請求項４に記載の注射針。 The injection needle according to claim 4, wherein an outer peripheral end surface forming an outer peripheral edge of the at least one side hole extends along a radial direction of the small diameter portion.
  6. 　前記流体は、常温での粘度が１～１００ｃｐｓである、請求項１～５のいずれか一項に記載の注射針。 The injection needle according to any one of claims 1 to 5, wherein the fluid has a viscosity of 1 to 100 cps at room temperature.
  7. 　前記流体は、常温での粘度が１０～２０ｃｐｓである、請求項６に記載の注射針。 The injection needle according to claim 6, wherein the fluid has a viscosity at room temperature of 10 to 20 cps.
  8. 　前記少なくとも１つの側孔は、前記小径部の長手軸方向に延在する少なくとも１つの長孔である、請求項１～７のいずれか一項に記載の注射針。 The injection needle according to any one of claims 1 to 7, wherein the at least one side hole is at least one long hole extending in a longitudinal axis direction of the small diameter portion.
  9. 　前記少なくとも１つの側孔は、前記小径部の長手軸方向に間隔を空けて配置された複数の孔である、請求項１～７のいずれか一項に記載の注射針。 The injection needle according to any one of claims 1 to 7, wherein the at least one side hole is a plurality of holes arranged at intervals in a longitudinal axis direction of the small diameter portion.
  10. 　前記複数の孔は、前記注射針の長手軸方向に並んでいる、請求項９に記載の注射針。 The injection needle according to claim 9, wherein the plurality of holes are arranged in a longitudinal axis direction of the injection needle.
  11. 　前記少なくとも１つの側孔は角孔である、請求項８～１０のいずれか一項に記載の注射針。 The injection needle according to any one of claims 8 to 10, wherein the at least one side hole is a square hole.
  12. 　前記少なくとも１つの側孔は丸孔である、請求項９又は１０に記載の注射針。 The injection needle according to claim 9 or 10, wherein the at least one side hole is a round hole.
  13. 　前記少なくとも１つの側孔は、前記小径部における前記刃面の側から見た側面に設けられている、請求項８～１２のいずれか一項に記載の注射針。 The injection needle according to any one of claims 8 to 12, wherein the at least one side hole is provided on a side surface of the small diameter portion viewed from the blade surface side.
  14. 　前記大径部の外周面に粗面部を備える、請求項１～１３のいずれか一項に記載の注射針。 The injection needle according to any one of claims 1 to 13, wherein a rough surface portion is provided on an outer peripheral surface of the large diameter portion.
  15. 　請求項１～１４のいずれか一項に記載の注射針と、
    　筒状をなす筒体とを備え、
    　前記注射針の前記大径部の外周面と、前記筒体の内周面と間に接合部が設けられていることを特徴とする医療用器具。     An injection needle according to any one of claims 1 to 14;
    A cylindrical tube body,
    A medical instrument, wherein a joint is provided between an outer peripheral surface of the large-diameter portion of the injection needle and an inner peripheral surface of the cylindrical body.
  16. 　前記注射針の前記縮径部及び前記大径部の外周面と、前記筒体の内周面との間に接合部が設けられている、請求項１５に記載の医療用器具。 The medical instrument according to claim 15, wherein a joint portion is provided between an outer peripheral surface of the reduced diameter portion and the large diameter portion of the injection needle and an inner peripheral surface of the cylindrical body.
PCT/JP2016/088742 2016-02-18 2016-12-26 Syringe needle and medical apparatus WO2017141548A1 (en)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0265870A (en) * 1988-09-01 1990-03-06 Hakko Denki Seisakusho:Kk Preparation of stay needle
JP2000511809A (en) * 1996-06-10 2000-09-12 エラン コーポレーション ピーエルシー Needle for subcutaneous delivery of fluid
JP2003190282A (en) * 2001-12-27 2003-07-08 Terumo Corp Metal tubular body and its manufacturing method
JP2004248694A (en) * 2003-02-18 2004-09-09 Terumo Corp Medical needle
JP2005523082A (en) * 2002-04-16 2005-08-04 イムプリント ファーマスーティカルス リミテッド Side injection needle
JP2007000934A (en) * 2006-06-22 2007-01-11 Terumo Corp Metal tubular body and method for manufacturing the same
WO2007059005A2 (en) * 2005-11-15 2007-05-24 Amgen Inc. Lateral side ported needle
WO2015037233A1 (en) * 2013-09-11 2015-03-19 テルモ株式会社 Medical hollow needle assembly and method for manufacturing hollow needle

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0265870A (en) * 1988-09-01 1990-03-06 Hakko Denki Seisakusho:Kk Preparation of stay needle
JP2000511809A (en) * 1996-06-10 2000-09-12 エラン コーポレーション ピーエルシー Needle for subcutaneous delivery of fluid
JP2003190282A (en) * 2001-12-27 2003-07-08 Terumo Corp Metal tubular body and its manufacturing method
JP2005523082A (en) * 2002-04-16 2005-08-04 イムプリント ファーマスーティカルス リミテッド Side injection needle
JP2004248694A (en) * 2003-02-18 2004-09-09 Terumo Corp Medical needle
WO2007059005A2 (en) * 2005-11-15 2007-05-24 Amgen Inc. Lateral side ported needle
JP2007000934A (en) * 2006-06-22 2007-01-11 Terumo Corp Metal tubular body and method for manufacturing the same
WO2015037233A1 (en) * 2013-09-11 2015-03-19 テルモ株式会社 Medical hollow needle assembly and method for manufacturing hollow needle

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