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WO2015105162A1 - Hollow needle and production method for hollow needle - Google Patents

Hollow needle and production method for hollow needle Download PDF

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Publication number
WO2015105162A1
WO2015105162A1 PCT/JP2015/050414 JP2015050414W WO2015105162A1 WO 2015105162 A1 WO2015105162 A1 WO 2015105162A1 JP 2015050414 W JP2015050414 W JP 2015050414W WO 2015105162 A1 WO2015105162 A1 WO 2015105162A1
Authority
WO
WIPO (PCT)
Prior art keywords
grinding
needle tube
needle
hollow needle
sharpened
Prior art date
Application number
PCT/JP2015/050414
Other languages
French (fr)
Japanese (ja)
Inventor
芳雄 檜垣
吉信 石田
Original Assignee
ニプロ株式会社
株式会社トリムス
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.)
Filing date
Publication date
Application filed by ニプロ株式会社, 株式会社トリムス filed Critical ニプロ株式会社
Publication of WO2015105162A1 publication Critical patent/WO2015105162A1/en

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Classifications

    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • 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
    • 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
    • A61M5/3286—Needle tip design, e.g. for improved penetration
    • 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
    • A61M5/42—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 having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/422—Desensitising skin

Definitions

  • the present invention relates to a hollow needle and a method for manufacturing the hollow needle, and more particularly to a hollow needle having a fluid passage formed therein and a sharpened tip at the tip and a method for manufacturing the hollow needle.
  • a puncture hollow needle is provided at the tip of a syringe or the like, and a fluid passage is formed inside the needle tube constituting the hollow needle, and the tip is provided to the patient.
  • a sharp point for puncturing is formed.
  • the hollow needle has a tapered portion formed on the outer peripheral surface of the needle tube and having a diameter reduced from the rear end side toward the front end side.
  • one having a straight portion having a smaller diameter than the main body portion and a constant diameter from the rear end side toward the front end side is known (Patent Documents 1 to 3).
  • transforms a plate-shaped member into a cylinder shape and joins edge parts is also known (patent document 4).
  • Patent Document 4 is a method in which a plate-like member formed in a fan shape is deformed into a cylindrical shape, and ends of the plate-like member are joined to each other, and forging is mainly performed. Since it is completely different from a general hollow needle manufacturing method, there is a problem that a dedicated large-scale apparatus is required. Further, as another conventional manufacturing method, there is a forging process for extending a metal (see, for example, Japanese Patent Application Laid-Open No. 2003-200218, FIG. 12). In particular, when a needle having a small diameter is manufactured, the use of a conventional metal material such as stainless steel has a high defective product rate and cannot be implemented at present.
  • the hollow needle As a material for the hollow needle, it is conceivable to use an alloy whose main component is a material whose hardness is higher than that of iron (for example, cobalt or the like). However, in this case, since the hardness is high, processing is not easy. Furthermore, as a conventional manufacturing method, there is an electrolytic process in which a needle diameter is reduced by passing an electric current through an electrolytic solution. When the electrolytic process is used, a hollow needle having a constant diameter is manufactured with high accuracy and stability. There is difficulty in respect. The present invention provides a hollow needle having a novel structure that solves these problems and a method for producing the hollow needle.
  • the hollow needle according to claim 1 is a needle tube having a fluid passage formed therein, wherein a sharpened portion is formed at the tip, and the opening of the fluid passage is opened at the sharpened portion.
  • a sharpened portion is formed at the tip, and the opening of the fluid passage is opened at the sharpened portion.
  • the hollow needle according to claim 3 is a needle tube having a fluid passage formed therein, and a hollow needle having a sharpened tip formed at a tip thereof.
  • a grinding part formed by grinding the outer surface of the tip side of the needle tube is provided so that the outer diameter of the grinding part is smaller than the outer diameter of the unground body part, and the side surface of the grinding part Provided with a through hole communicating with the fluid passage, While sealing the fluid passage of the needle tube in which the grinding portion is formed, processing the sealed portion to form the sharpened portion,
  • the boundary between the grinding part and the main body part is located on the base end side with respect to the through hole and at the rear of 4 mm or more than the tip of the sharpened part.
  • the hollow needle according to claim 4 is a needle tube having a fluid passage formed therein, a tapered portion formed on the outer peripheral surface of the needle tube and having a diameter reduced from the rear end side toward the front end side, and a front side of the taper portion
  • a hollow needle having a sharp point formed in A through hole communicating with the fluid passage is provided on the side surface of the needle tube,
  • the method for producing a hollow needle according to claim 6 includes a needle tube preparation step of preparing a needle tube having a fluid passage formed therein, and a method of manufacturing a hollow needle having a sharpened portion forming step of forming a sharpened portion at the tip of the needle tube. Between the needle tube preparation step and the sharpened portion forming step, a grinding step of grinding the outer surface on the tip side of the needle tube to form a ground portion is performed, and the outer diameter of the ground portion is not ground. It is characterized by a smaller diameter than the outer diameter.
  • the problems occurring in Patent Document 4 and other conventional manufacturing methods can be solved.
  • the position of the boundary between the grinding part and the main body part at least 3 mm behind the proximal end of the opening, the patient can be punctured when the hollow needle is punctured subcutaneously. Pain can be reduced.
  • the position of the boundary between the grinding part and the body part is provided at least 4 mm behind the proximal end of the opening at the sharpened part, so that the patient can be punctured when the hollow needle is punctured subcutaneously. Pain can be reduced.
  • the tapered portion is formed by grinding, it is possible to eliminate the problems occurring in Patent Document 4 and other conventional manufacturing methods.
  • the tapered portion is formed by grinding, the influence on the inner diameter portion of the needle tube at the time of processing can be reduced as compared with the conventional one, and as a result, the diameter of the fluid passage located in the tapered portion is made constant.
  • the inner diameter of the fluid passage located in the main body portion other than the tapered portion can be made the same diameter, so that the flow path resistance at the time of drug solution administration can be reduced.
  • the grinding part by the grinding process, it is possible to eliminate the problems that occur in Patent Document 4 and other conventional manufacturing methods. Moreover, the puncture pain to the patient when the hollow needle is punctured subcutaneously can be reduced.
  • Sectional drawing of the hollow needle concerning a present Example Sectional drawing of the needle tube in the state before forming a sharpened part. It is a figure explaining a sharp point, Comprising: (a) is a top view, (b) shows a side view, respectively. The front view of a grinding part formation apparatus. The enlarged side view of a grinding part formation apparatus. Sectional drawing of the hollow needle which concerns on 2nd Example. Sectional drawing of the needle tube in the state before forming a sharpened part. Sectional drawing of the hollow needle which concerns on 3rd Example. Sectional drawing of the hollow needle which concerns on 4th Example. Sectional drawing of the hollow needle which concerns on 5th Example.
  • FIG. 1 shows a cross-sectional view of a hollow needle 1 according to the present invention.
  • the hollow needle 1 of this embodiment is used for, for example, a needle used for blood collection, infusion, subcutaneous injection, and gingival injection. Can do. Note that the dimensions of the drawings (particularly, FIGS. 1 to 3 and FIGS. 6 to 8) used in this embodiment are exaggerated for explanation.
  • the hollow needle 1 is constituted by a needle tube T in which a fluid passage 2 is formed, and a tapered portion 3 as a grinding portion that decreases in diameter from the rear end side toward the front end side on the outer peripheral surface of the needle tube T.
  • a sharpened portion 4 formed in front of the tapered portion 3, and a body portion 5 that is not ground behind the tapered portion 3 and has an outer diameter larger than that of the tapered portion 3 is formed.
  • Stainless steel such as SUS304 can be used for the needle tube T, and the outer diameter of the main body 5 is constant.
  • the outer diameter of the main body 5 is the same. Can be set to ⁇ 0.3 mm, and in the case of the hollow needle 1 used for blood collection, the outer diameter of the main body 5 can be set to ⁇ 0.9 mm.
  • the fluid passage 2 formed inside the needle tube T has a constant inner diameter from the front end side to the rear end side by using a grinding part forming device 11 described later, and is used for, for example, administration of insulin.
  • the inner diameter can be set to ⁇ 0.16 mm, and in the case of the hollow needle 1 used for blood collection, the inner diameter can be set to ⁇ 0.5 mm.
  • the constant inner diameter of the fluid passage 2 in this embodiment does not mean that the inner diameter is the same throughout the entire area from the front end side to the rear end side of the fluid passage 2. This includes a manufacturing error in manufacturing T and an error due to a very small deformation of the needle tube T generated when the outer surface of the needle tube is ground.
  • the tapered portion 3 is formed on the outer peripheral surface of the needle tube T, and has a shape whose outer diameter is reduced from the position adjacent to the front of the main body portion 5 toward the distal end side.
  • the outer diameter of the tapered portion 3 is formed to be smaller than the outer diameter of the main body portion 5 that is not ground.
  • the tapered portion 3 is formed in a grinding step before the sharpened portion forming step for forming the sharpened portion 4.
  • the main body portion 5 is formed.
  • the outer diameter of the taper portion 3 is set to ⁇ 0.35 mm
  • the outer diameter of the tip portion of the tapered portion 3 can be set to ⁇ 0.22 mm, for example.
  • the inclination angle of the taper portion 2 that expands toward the base end is preferably less than 1 °, and in the case of the hollow needle 1 used for blood collection, it is less than 2 °. Is desirable.
  • the length from the tip of the sharpened portion 4 to the rear end of the tapered portion 3 can be set as appropriate.
  • the hollow needle 1 is used for subcutaneous injection, it is set to 4.5 mm, for example. be able to. More specifically, the boundary between the taper portion 3 as the grinding portion and the main body portion 5 is 3 mm or more behind the end portion E on the proximal end side of the opening portion of the fluid passage 2 that opens to the sharpened portion 4.
  • the boundary between the tapered portion 3 and the main body portion 5 serving as the grinding portion is the base of the opening portion of the fluid passage 2 that opens to the sharpened portion 4. It is desirable to be located at least 4 mm behind the end E on the end side.
  • the inner diameter of the fluid passage 2 in the tapered portion 3 is constant from the rear end side to the front end side, and is the same as the inner diameter of the fluid passage 2 in the main body portion 5.
  • the sharpened portion 4 is formed on the first blade surface 4a formed obliquely with respect to the axial direction of the needle tube T, and on the first blade surface 4a. It is formed from a pair of second blade surfaces 4b formed symmetrically with respect to the central axis of T.
  • the sharpened portion 4 is formed with respect to the needle tube T in which the tapered portion 3 shown in FIG. 2 is formed, and is formed in a sharpened portion forming step using a conventionally known sharpened portion forming apparatus.
  • the first blade surface 4a is formed by first grinding with a sharp inclination angle with respect to the axial direction of the needle tube T by the sharp part forming device, and then the needle tube on which the first blade surface 4a is formed.
  • the sharpened portion 4 constituted by the first and second blade surfaces 4a and 4b is an example, and a pair of third blade surfaces further formed on the back side of the second blade surface 4b,
  • the structure considered to be suitable, such as the sharpened portion 4 in which the two-blade surface 4b is omitted, can be appropriately employed.
  • a conventionally known electropolishing process is performed on the formed sharpened portion 4, and the sharpened portion 4 is electrolytically polished. It is desirable to do. Note that electropolishing may be performed not only on the sharpened portion but also on the entire needle tube T.
  • FIG. 4 and 5 illustrate a grinding portion for performing the grinding step, in which the tip portion of the needle tube T is ground to obtain a needle tube T having a grinding portion such as the tapered portion 3 as shown in FIG.
  • a forming apparatus 11 is shown.
  • the grinding part forming apparatus 11 is supplied with a needle tube T having a constant outer diameter and a constant inner diameter of the fluid passage 2 manufactured by a conventionally known needle pipe preparation process.
  • the needle tube T used for the manufacture of the hollow needle that forms only can be used as it is.
  • the needle tube preparation step for example, the needle tube T is obtained by forging a large-diameter tube larger than the needle tube T, or the plate-like member described in Patent Document 4 is transformed into a circular tube.
  • the needle tube T can be obtained.
  • the present invention can be used.
  • the invention of the present application may be applied to a hollow needle manufactured by the manufacturing method of Patent Document 4, and the process of accurately deforming and joining a plate-like member formed in a fan shape into an intended shape is a thin diameter.
  • the needle tube may be manufactured using a rectangular plate-shaped member, and the present invention may be applied later.
  • a joint is formed from the front end to the base end of the inner surface of the needle tube T, and the joint becomes a resistance, and the patient is in puncture and drug administration. Therefore, it is desirable to obtain the needle tube T by forging.
  • the grinding part forming apparatus 11 includes a conveying roller 12 rotated by a motor (not shown), a guide part 13 having an arc shape provided along the outer peripheral surface of the conveying roller 12, and adjacent to the conveying roller 12 and the guide part 13. And a rotating grindstone 14 provided.
  • the outer periphery of the conveying roller 12 is made of a resin such as rubber, and a plurality of annular protrusions 12a are formed along the circumferential direction as shown in FIG. It is supposed to be.
  • the guide portion 13 is fixed to the lower portion of the conveying roller 12, and a resin-made pressing member 15 that sandwiches the needle tube T with the conveying roller 12 is provided on the inner peripheral surface thereof.
  • a plurality of annular protrusions 15a are also formed on the inner peripheral surface of the.
  • a gap is formed between the conveying roller 12 and the guide portion 13 so that the needle tube T can pass through, and the needle tube T is sandwiched between the conveying roller 12 and the annular protrusions 12a and 15a of
  • a supply means 16 for the needle tube T is provided at the left end portion of the guide portion 13, and the needle tube T is aligned with the transport roller 12 one by one in a direction parallel to the rotation axis of the transport roller 12. It is supplied between the guide part 13.
  • the needle tube T is configured such that a required portion on the rear end side is sandwiched between the conveying roller 12 and the guide portion 13, and the front end portion protrudes to the rotating grindstone 14 side. ing.
  • the needle tube T supplied between the conveying roller 12 and the guide portion 13 by the supply means 16 is rotated by these frictions because the guide portion 13 is fixed while the conveying roller 12 rotates.
  • the guide roller 13 revolves with respect to the conveying roller 12 and moves from the left side to the right side in the drawing.
  • a discharge slope 17 is provided at the right end of the guide portion 13 in the figure, and the needle tube T is collected via the discharge slope 17.
  • the rotating grindstone 14 is a disk-shaped grindstone that is rotated by a driving means (not shown), and the rotation axis of the rotating grindstone 14 is provided so as to be orthogonal to the rotation axis of the conveying roller 12. Further, the rotating grindstone 14 has a required width as shown in FIG. 4, and the tip of the needle tube T comes into contact with an inclined portion slightly closer to the conveying roller 12 than the upper end of the rotating grindstone 14 as shown in FIG. When the needle tube T that is moved by the transport roller 12 is positioned in the vicinity of the lower end portion of the guide portion 13, the tip end portion of the needle tube T comes into contact with the lower portion.
  • the needle tube T passes through the rotating grindstone 14 while being rotated by the conveying roller 12 and the guide portion 13, the outer peripheral surface of the tip portion of the needle tube T is ground while being rotated, and the tapered portion 3 as shown in FIG. Can be obtained.
  • the urging force for urging the tip of the needle tube T upward from the lower side by the rotating grindstone 14 and the diameter of the rotating grindstone 14 the dimension of the tapered portion 3 can be changed, or a diagram described later. 6. It is possible to form the straight part 6 which comprises a grinding part as shown in FIG.
  • only the outer diameter portion of the needle tube T can be reduced by grinding the outer peripheral surface of the needle tube T formed with a constant inner diameter of the fluid passage 2 to form the grinding portion.
  • the inner diameter of the fluid passage 2 can be kept constant. Since the grinding part formed in this way has a small outer diameter at the tip part of the grinding part, the puncture resistance when puncturing the patient's skin by the sharpened part 4 located in front of the grinding part is reduced, Further, by reducing the area of the needle inserted into the patient's skin, the probability of contact with a pain point in the skin tissue during insertion can be reduced. As a result, puncture pain can be suppressed.
  • the tapered portion 3 is ground so that the inclination angle of the diameter expanding toward the proximal end is less than 2 °, thereby reducing the puncture pain to the patient. That is, if the inclination angle is 2 ° or more, the outer diameter of the tapered portion 3 is rapidly expanded, and there is a risk that the patient may be painful when the tapered portion 3 is punctured subcutaneously.
  • the inclination angle is preferably less than 1 ° from the viewpoint of further reducing puncture pain.
  • the tapered portion is formed, but the inner diameter of the fluid passage is reduced, for example, the inner diameter of the fluid passage is reduced toward the tip.
  • the tapered portion is formed by so-called joining processing as in Patent Document 4
  • irregularities called joining portions by joining processing are formed on the inner surface of the fluid passage. Therefore, although the puncture pain can be suppressed by the tapered portion, there is a problem that the flow path resistance increases in a portion where the inner diameter of the fluid passage in the tapered portion is reduced or a portion where the joint portion is formed. was there.
  • FIG. 6 shows a cross-sectional view of the hollow needle 1 according to the second embodiment
  • FIG. 7 shows a cross-sectional view of the needle tube T in which the grinding portion is formed when the hollow needle 1 according to the second embodiment is manufactured.
  • the hollow needle 1 of the present embodiment has a straight portion 6 formed between the sharpened portion 4 and the tapered portion 3 as the grinding portion, and the straight portion 6 has an outer diameter from the rear end side to the front end. It is almost constant toward the side.
  • the fluid passage 2 in the straight portion 6 also has a constant inner diameter, that is, the fluid passage 2 has a constant inner diameter from the main body portion 5 to the tapered portion 3 and the straight portion 6.
  • the sharpened portion 4 of the hollow needle 1 of the present embodiment has first and second blade surfaces 4b similar to those of the first embodiment, and further on the back surface side of the first blade surface 4a, the tip of the needle tube T is provided.
  • An arcuate chamfered shape 4c is formed along the outer peripheral edge of the end face. Since the chamfered shape 4c is formed in an arc shape along the outer edge of the distal end portion of the needle tube T, higher puncture performance by the sharpened portion 4 can be obtained.
  • the second tapered portion is formed by grinding between the sharpened portion 4 and the tapered portion 3 with respect to the straight portion 6 in this embodiment, and the second tapered portion is The outer diameter is reduced from the rear end side toward the front end side, and has an inclination angle different from that of the first taper portion 3. Further, the inner diameter of the second tapered portion may be constant.
  • FIG. 7 shows the needle tube T in which the first and second blade surfaces 4a and 4b are not formed in the sharpened portion 4, and the needle tube T performs, for example, a grinding process by two processes. It has become.
  • the grinding tube forming apparatus 11 is used to grind the needle tube T having a constant outer diameter, thereby forming the tapered portion 3 and the straight portion 6 simultaneously.
  • the position of the tip portion of the needle tube T that contacts the rotating grindstone 14 is changed, or the lower position by the rotating grindstone 14 is lowered.
  • the straight portion 6 can be formed in front of the tapered portion 3 as described above by adjusting the urging force from.
  • the outer peripheral edge of the end surface of the distal end portion of the needle tube T obtained in the first step is ground to form the chamfered shape 4c in a ring shape along the outer peripheral edge at the distal end of the needle tube T.
  • it can be obtained by reducing the diameter of the rotating grindstone 14 in the grinding part forming apparatus 11.
  • the first blade surface 4a in the sharpened portion 4 is ground, if the part of the chamfered shape 4c is left in an arc shape, the sharpened portion 4 is moved to the first sharpened portion 4 as shown in FIG.
  • the second blade surfaces 4a and 4b and the chamfered shape 4c can be configured. If it is not necessary to provide the chamfered shape 4c, the sharpened portion 4 may be formed by omitting the chamfering step.
  • FIG. 8 shows a cross-sectional view of the hollow needle 1 according to the third embodiment.
  • the shape of the sharpened portion 4 is different from that of the hollow needle 1 according to the first embodiment, and has a so-called pencil-type sharpened portion 21. It has become.
  • the hollow needle 1 of the present embodiment is melted so that the tapered portion 3 remains on the needle tube T in which the tapered portion 3 as the grinding portion shown in FIG. The region in front of the broken line portion in the figure), the tip of the fluid passage 2 is sealed by the molten portion M.
  • the sharpened portion 21 is formed by grinding the outer surface of the melting portion M using a rotating grindstone.
  • the boundary between the tapered portion 3 and the main body portion 5 is located at least 4 mm behind the tip of the sharpened portion 21, for example, the length from the tip of the sharpened portion 21 to the rear end of the tapered portion 3.
  • the thickness can be about 4.5 mm.
  • the sharpened portion 21 forms a curved surface 21a bulging outward on the outer peripheral surface thereof, and the curved surface 21a can be formed at the same time as the sharpened portion 21 is formed. By forming the curved surface 21a, it is possible to suppress puncture pain by the curved surface 21a when the sharpened portion 21 is punctured into the patient's skin.
  • a through hole 22 communicating with the fluid passage 2 from the side surface is formed in the side surface of the needle tube T at a position close to the portion sealed by the melted portion M.
  • the diameter of the through hole 22 is Is slightly smaller than the diameter of the fluid passage 2.
  • the formation of the tapered portion 3 can reduce puncture pain when puncturing the patient's skin by the sharpened portion 4, and the inside of the needle tube T. Since the inner diameter of the fluid passage 2 formed in the fluid passage 2 is constant from the main body portion 5 to the taper portion 3, the flow resistance of the drug flowing through the fluid passage 2 and discharged from the through hole 22 is tapered. It does not become high at the position of the part 3.
  • the hollow needle 1 in the said 2nd Example has the structure by which the said straight part 6 was formed ahead of the said taper part 3, this can be abbreviate
  • FIG. is there. Specifically, in the grinding process, the outer peripheral surface of the needle tube T is directly ground without forming the taper portion 3 to form the straight portion 6, and further, the tip portion of the straight portion 6 is ground. It can be manufactured so as to form the sharpened portion 4. At that time, by using grinding for the processing of the straight portion 6, a needle having a small outer diameter without a joint portion, which could not be manufactured by conventional press processing, can be manufactured, and the manufacturing method is used. The inner diameter can also be made constant.
  • the position of the boundary between the straight portion 6 and the main body portion 5 is 3 mm from the end portion E on the proximal end side of the opening portion of the fluid passage 2 that opens to the sharpened portion 4. For example, if it is formed from the tip of the sharpened portion 4 to a position of about 4.5 mm, puncture pain to the patient can be reduced.
  • FIG. 9 shows a cross-sectional view of the hollow needle 1 according to the fourth embodiment, and particularly shows a cross-sectional view of a hollow needle 1 having a small diameter suitable for insulin injection.
  • the hollow needle 1 of the present embodiment has a grinding part composed of a straight part 6. Similar to the first embodiment, the position of the boundary between the grinding portion and the main body portion 5 is 3 mm or more behind the end portion E on the proximal end side of the opening portion of the fluid passage 2 opened to the sharpened portion 4.
  • the hollow needle 1 is positioned so as to protrude about 4 to 8 mm from the hub of the syringe, and the main body 5 is held by the hub.
  • the outer diameter of the straight portion 6 is set to be smaller than the outer diameter of the main body portion 5 by at least one gauge.
  • the straight portion 6 and the main body portion 5 are ground so that the outer diameters are different by 1 gauge or more.
  • the outer diameter of the needle tube T of the hollow needle 1 used for insulin administration is 27 gauge (Burningham Wire Gage), and the hollow needle 1 for insulin self-injection is 29 gauge. Subcutaneous injection of insulin or the like depends on the drug and purpose, but generally the most preferable insertion depth of the hollow needle 1 is about 4 mm.
  • the diameter of the main body portion 5 is 28 gauge
  • the straight portion 6 is 30 gauge
  • the position of the boundary between the grinding portion and the main body portion 5 is the sharpened portion 4.
  • the hollow needle 1 is located 3 mm behind the end E on the proximal end side of the opening of the fluid passage 2 that is open, and the hollow needle 1 is exposed from the hub of the syringe by about 4 mm.
  • the diameter of the entire needle tube including the main body is about 10 to 16 mm.
  • FIG. 10 shows a cross-sectional view of a hollow needle 1 according to a fifth embodiment, and particularly shows a cross-sectional view of a large-diameter hollow needle 1 that is attached to a syringe, an indwelling needle, or the like and suitable for blood collection.
  • the hollow needle 1 has a grinding part composed of a straight part 6 and a tapered part 3 located behind the straight part 6.
  • the needle tube T of the hollow needle 1 used for blood collection is about 21 gauge to 23 gauge. In this embodiment, the diameter of the main body portion 5 is 23 gauge, and the straight portion 6 is 22 gauge.
  • the straight part 6 is formed 3 mm or more from the base end of opening of the sharpened part 4, even if the said straight part 6 is made into the taper part 3 like 1st Example, it is. Good.
  • the straight portion 6 is formed over 3 mm from the base end of the opening of the sharpened portion 4 as in the above embodiment, the possibility that the hollow needle 1 is in contact with the pain point is minimized.
  • the tapered portion 3 is formed over 3 mm from the base end of the opening of the sharpened portion 4, the thickness of the needle tube T can be increased accordingly, and the strength of the needle tube T can be increased. Accordingly, the shape of the hollow needle 1 may be appropriately determined in consideration of these effects. For example, in the case of a hollow needle 1 having a relatively low strength of the needle tube T, such as an insulin needle shown in FIG. 9, in order to improve the strength of the needle tube T, it is also an option to form the tapered portion 3 actively. It is.
  • the diameter of the fluid passage 2 inside the needle tube T is constant, but this may be a tapered shape in which the diameter of the proximal end is increased.
  • a needle tube T with a constant plate thickness expanded toward the proximal end is prepared and the outer surface of the needle tube T is ground in the same manner as in the above embodiment, a needle tube having an expanded portion on the inner surface Can be manufactured.
  • a sharpened portion may be formed at the proximal end portion of each hollow needle 1.
  • a rubber seal such as a container containing a medicine can be penetrated using the puncture portion on the proximal end side.
  • the grinding process means a process of changing the shape of the outer surface of the needle by the grindstone particles.
  • a processing apparatus used in the grinding process it is preferable to use a rotating grindstone.
  • the present invention has the following configurations.
  • the first is a needle tube having a fluid passage formed therein, and is formed on the outer peripheral surface of the needle tube and has a diameter that decreases from the rear end side toward the front end side, and is formed in front of the taper portion.
  • a hollow needle having a sharp point By forming the tapered portion by grinding the outer peripheral surface of the needle tube, the inner diameter of the fluid passage in the needle tube at the tapered portion is constant.
  • Second, in the first configuration by grinding the outer peripheral surface of the needle tube to form a straight portion in front of the tapered portion, The straight portion is provided between the sharpened portion and the tapered portion, and the inner diameter of the fluid passage in the straight portion is constant.
  • the sharpened portion is configured by a blade surface obtained by grinding the tip end portion of the needle tube in which the tapered portion is formed obliquely with respect to the axial direction.
  • a ring-shaped chamfered shape is formed on the end surface of the tip of the needle tube along the outer peripheral edge, and when the blade surface is further ground.
  • the sharpened portion is composed of the blade surface and the chamfered shape.
  • a through-hole communicating with the fluid passage is provided on a side surface of the needle tube, The tip of the needle tube having the tapered portion was melted to seal the fluid passage with the melted portion, and the melted portion was processed to form the sharpened portion.
  • a curved surface bulging outward is provided at the sharpened portion.
  • Eighth is a needle tube having a fluid passage formed therein, a straight portion having a smaller diameter than the main body portion on the outer peripheral surface of the needle tube and having a constant diameter from the rear end side toward the front end side;
  • a hollow needle having a sharpened portion formed in front of the straight portion By forming the straight portion by grinding the outer peripheral surface of the needle tube, the inner diameter of the fluid passage in the needle tube in the straight portion is constant.
  • grinding the outer peripheral surface of the needle tube having a fluid passage formed therein to form a straight portion having a constant diameter from the rear end side toward the front end side; And a step of grinding the tip of the straight part to form a sharpened part.
  • the outer surface of the needle tube T is ground from the sharpened portion 3 over a predetermined length or more, and other changes can be appropriately designed by those skilled in the art.
  • the present technology may be used for a needle for collecting tissue or cells.
  • the grinding is realized by a grindstone, but any grinding method may be used as long as only the outer surface of the needle tube T can be ground.
  • a processing technique such as laser processing may be used.

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Abstract

Provided is a hollow needle (1) that is a needle tube (T) having a fluid flow path (2) formed in the interior thereof, that has a sharp section (4) formed on the tip thereof, and in which the opening of the fluid flow path (2) opens at the sharp section. A ground section (a tapered section (3) and a straight section (6)) that is formed by grinding is provided to the outer surface of the tip side of the needle tube (T). The outer diameter of the ground section is configured to be smaller than the outer diameter of a main body section (5) that is not ground. The boundary of the ground section and the main body section is positioned at least 3 mm farther to the rear than the base end-side edge section of the opening. The present invention is configured so that the pain caused by puncturing is reduced and the flow path resistance of the fluid flow path does not increase.

Description

中空針および中空針の製造方法Hollow needle and method for producing hollow needle
　本発明は中空針および中空針の製造方法に関し、詳しくは内部に流体通路が形成されるとともに先端に先鋭部が形成された中空針および中空針の製造方法に関する。 The present invention relates to a hollow needle and a method for manufacturing the hollow needle, and more particularly to a hollow needle having a fluid passage formed therein and a sharpened tip at the tip and a method for manufacturing the hollow needle.
　従来、患者に薬剤を投与するため、注射器等の先端には穿刺用の中空針が設けられており、当該中空針を構成する針管の内部には流体通路が形成され、その先端には患者に穿刺するための先鋭部が形成されている。
　そして、患者に上記中空針を穿刺する際の穿刺痛を軽減するため、当該中空針には、上記針管の外周面に形成されて後端側より先端側に向けて縮径するテーパ部や、本体部よりも小径で後端側より先端側に向けて一定の径に形成されたストレート部を有するものが知られている（特許文献１～３）。
　また上記中空針を製造する場合に、板状の部材を筒状に変形させて、端部同士を接合するいわゆる接合加工を用いた中空針も知られている（特許文献４）。 Conventionally, in order to administer a drug to a patient, a puncture hollow needle is provided at the tip of a syringe or the like, and a fluid passage is formed inside the needle tube constituting the hollow needle, and the tip is provided to the patient. A sharp point for puncturing is formed.
In order to reduce puncture pain when the patient is punctured with the hollow needle, the hollow needle has a tapered portion formed on the outer peripheral surface of the needle tube and having a diameter reduced from the rear end side toward the front end side. In addition, one having a straight portion having a smaller diameter than the main body portion and a constant diameter from the rear end side toward the front end side is known (Patent Documents 1 to 3).
Moreover, when manufacturing the said hollow needle, the hollow needle using what is called a joining process which deform | transforms a plate-shaped member into a cylinder shape and joins edge parts is also known (patent document 4).
特開２００２－１５９５７６号公報JP 2002-159576 A 特開２００２－２９１８８４号公報JP 2002-291844 A 特開２００４－２４８６９４号公報JP 2004-248694 A 特開２００３－１９０２８２号公報JP 2003-190282 A
　しかしながら、上記特許文献４の製造方法は、扇状に形成された板状の部材を筒状に変形させ、かつ板状の部材の端部同士を接合するという方法であり、鍛造加工を主とした一般的な中空針の製造方法と全く異なるため、専用の大規模装置が必要となるという問題がある。
　また、従来の他の製造方法として、金属を伸ばす鍛造加工（例えば特開２００３－２００２１８号公報、図１２参照）があるが、鍛造は内径への影響が大きいため、製造面での技術的課題が多く、特に、細い径の針を製造する場合に、ステンレスのような従来金属材質を用いたのでは不良品率が高く、現状、実施できうるものではない。中空針の材質として、鉄より硬度が高い材質（例えば、コバルト等）を主成分とした合金を用いることも考えられるが、その場合、硬度が高いが故に、加工が容易ではない。
　さらに、従来の製造方法として、電解液を介して電流を流すことにより針径を細くする電解加工があるが、当該電解加工を用いた場合、一定径の中空針を精度良く安定して製造する点に難がある。
　本発明はこれらの課題を解決した新規の構造を有する中空針および中空針の製造方法を提供するものである。 However, the manufacturing method of Patent Document 4 is a method in which a plate-like member formed in a fan shape is deformed into a cylindrical shape, and ends of the plate-like member are joined to each other, and forging is mainly performed. Since it is completely different from a general hollow needle manufacturing method, there is a problem that a dedicated large-scale apparatus is required.
Further, as another conventional manufacturing method, there is a forging process for extending a metal (see, for example, Japanese Patent Application Laid-Open No. 2003-200218, FIG. 12). In particular, when a needle having a small diameter is manufactured, the use of a conventional metal material such as stainless steel has a high defective product rate and cannot be implemented at present. As a material for the hollow needle, it is conceivable to use an alloy whose main component is a material whose hardness is higher than that of iron (for example, cobalt or the like). However, in this case, since the hardness is high, processing is not easy.
Furthermore, as a conventional manufacturing method, there is an electrolytic process in which a needle diameter is reduced by passing an electric current through an electrolytic solution. When the electrolytic process is used, a hollow needle having a constant diameter is manufactured with high accuracy and stability. There is difficulty in respect.
The present invention provides a hollow needle having a novel structure that solves these problems and a method for producing the hollow needle.
　すなわち請求項１における中空針は、内部に流体通路が形成された針管であって、先端に先鋭部が形成されるとともに、当該先鋭部に上記流体通路の開口部が開口した中空針において、
　上記針管の先端側の外面に、研削により形成した研削部を設けて、当該研削部の外径が研削されていない本体部の外径よりも小径となるようにし、
　かつ当該研削部と上記本体部との境界が、上記開口部の基端側の端部よりも３ｍｍ以上後方に位置することを特徴としている。 That is, the hollow needle according to claim 1 is a needle tube having a fluid passage formed therein, wherein a sharpened portion is formed at the tip, and the opening of the fluid passage is opened at the sharpened portion.
Provide the grinding part formed by grinding on the outer surface of the tip side of the needle tube, so that the outer diameter of the grinding part is smaller than the outer diameter of the unground body part,
And the boundary of the said grinding part and the said main-body part is located behind 3 mm or more rather than the edge part of the base end side of the said opening part, It is characterized by the above-mentioned.
　請求項３における中空針は、内部に流体通路が形成された針管であって、先端に先鋭部が形成された中空針において、
　上記針管の先端側の外面を研削して形成した研削部を設けて、当該研削部の外径が研削されていない本体部の外径よりも小径となるようにするとともに、当該研削部の側面に上記流体通路に連通する貫通孔を設け、
　上記研削部の形成された針管の上記流体通路を封止するとともに、当該封止した部分を加工して上記先鋭部を形成し、
　当該研削部と上記本体部との境界が、上記貫通孔よりも基端側であって、かつ先鋭部の先端よりも４ｍｍ以上後方に位置することを特徴としている。 The hollow needle according to claim 3 is a needle tube having a fluid passage formed therein, and a hollow needle having a sharpened tip formed at a tip thereof.
A grinding part formed by grinding the outer surface of the tip side of the needle tube is provided so that the outer diameter of the grinding part is smaller than the outer diameter of the unground body part, and the side surface of the grinding part Provided with a through hole communicating with the fluid passage,
While sealing the fluid passage of the needle tube in which the grinding portion is formed, processing the sealed portion to form the sharpened portion,
The boundary between the grinding part and the main body part is located on the base end side with respect to the through hole and at the rear of 4 mm or more than the tip of the sharpened part.
　請求項４における中空針は、内部に流体通路が形成された針管であり、当該針管の外周面に形成されて後端側より先端側に向けて縮径するテーパ部と、当該テーパ部の前方に形成された先鋭部とを有する中空針において、
　針管の側面に上記流体通路に連通する貫通孔を設け、
　上記テーパ部を上記針管の外周面を研削して形成することにより、上記テーパ部における上記針管内の流体通路の内径を一定とし、
　かつ上記テーパ部の形成された針管の先端部を溶融させて上記流体通路を当該溶融部分によって封止するとともに、当該溶融部分を加工して上記先鋭部を形成したことを特徴としている。 The hollow needle according to claim 4 is a needle tube having a fluid passage formed therein, a tapered portion formed on the outer peripheral surface of the needle tube and having a diameter reduced from the rear end side toward the front end side, and a front side of the taper portion In a hollow needle having a sharp point formed in
A through hole communicating with the fluid passage is provided on the side surface of the needle tube,
By forming the tapered portion by grinding the outer peripheral surface of the needle tube, the inside diameter of the fluid passage in the needle tube in the tapered portion is made constant,
In addition, the tip of the needle tube in which the tapered portion is formed is melted to seal the fluid passage with the melted portion, and the melted portion is processed to form the sharpened portion.
　請求項６における中空針の製造方法は、内部に流体通路が形成された針管を準備する針管準備工程と、針管の先端に先鋭部を形成する先鋭部形成工程を有する中空針の製造方法において、
　上記針管準備工程と上記先鋭部形成工程との間に、上記針管の先端側の外面を研削して研削部を形成する研削工程を行い、当該研削部の外径を研削されていない本体部の外径よりも小径とすることを特徴としている。 The method for producing a hollow needle according to claim 6 includes a needle tube preparation step of preparing a needle tube having a fluid passage formed therein, and a method of manufacturing a hollow needle having a sharpened portion forming step of forming a sharpened portion at the tip of the needle tube.
Between the needle tube preparation step and the sharpened portion forming step, a grinding step of grinding the outer surface on the tip side of the needle tube to form a ground portion is performed, and the outer diameter of the ground portion is not ground. It is characterized by a smaller diameter than the outer diameter.
　上記請求項１の発明によれば、研削により針管の外径を小径とするため、特許文献４やその他従来の製造方法において生じていた不具合を解消することができる。
　また、研削部と本体部との境界の位置を先鋭部の上記開口部の基端側の端部よりも３ｍｍ以上後方に設けることで、中空針を皮下に穿刺した場合における患者への穿刺痛を低減することができる。 According to the first aspect of the present invention, since the outer diameter of the needle tube is reduced by grinding, the problems occurring in Patent Document 4 and other conventional manufacturing methods can be solved.
In addition, by providing the position of the boundary between the grinding part and the main body part at least 3 mm behind the proximal end of the opening, the patient can be punctured when the hollow needle is punctured subcutaneously. Pain can be reduced.
　上記請求項３の発明によれば、研削により針管の外径を小径とするため、特許文献４やその他従来の製造方法において生じていた不具合を解消することができる。
　また、研削部と本体部との境界の位置を先鋭部の上記開口部の基端側の端部よりも４ｍｍ以上後方に設けることで、中空針を皮下に穿刺した場合における患者への穿刺痛を低減することができる。 According to the third aspect of the present invention, since the outer diameter of the needle tube is reduced by grinding, the problems occurring in Patent Document 4 and other conventional manufacturing methods can be solved.
In addition, the position of the boundary between the grinding part and the body part is provided at least 4 mm behind the proximal end of the opening at the sharpened part, so that the patient can be punctured when the hollow needle is punctured subcutaneously. Pain can be reduced.
　上記請求項４の発明によれば、上記テーパ部は研削加工により形成されているため、特許文献４やその他従来の製造方法において生じていた不具合を解消することができる。
　また、上記テーパ部が研削加工により形成されることで、加工時における針管の内径部への影響を従来より低減することができ、その結果、テーパ部に位置する流体通路の径を一定とすることができ、かつテーパ部以外の本体部に位置する流体通路の内径とも同径とすることができるため、薬液投与時の流路抵抗を少なくすることができる。 According to the fourth aspect of the present invention, since the tapered portion is formed by grinding, it is possible to eliminate the problems occurring in Patent Document 4 and other conventional manufacturing methods.
In addition, since the tapered portion is formed by grinding, the influence on the inner diameter portion of the needle tube at the time of processing can be reduced as compared with the conventional one, and as a result, the diameter of the fluid passage located in the tapered portion is made constant. In addition, the inner diameter of the fluid passage located in the main body portion other than the tapered portion can be made the same diameter, so that the flow path resistance at the time of drug solution administration can be reduced.
　上記請求項６の発明によれば、研削工程によって研削部を形成することで、特許文献４やその他従来の製造方法において生じていた不具合を解消することができる。また中空針を皮下に穿刺した場合における患者への穿刺痛を低減することができる。 According to the sixth aspect of the present invention, by forming the grinding part by the grinding process, it is possible to eliminate the problems that occur in Patent Document 4 and other conventional manufacturing methods. Moreover, the puncture pain to the patient when the hollow needle is punctured subcutaneously can be reduced.
本実施例にかかる中空針の断面図。Sectional drawing of the hollow needle concerning a present Example. 先鋭部を形成する前の状態の針管の断面図。Sectional drawing of the needle tube in the state before forming a sharpened part. 先鋭部を説明する図であって（ａ）は平面図、（ｂ）は側面図をそれぞれ示す。It is a figure explaining a sharp point, Comprising: (a) is a top view, (b) shows a side view, respectively. 研削部形成装置の正面図。The front view of a grinding part formation apparatus. 研削部形成装置の拡大側面図。The enlarged side view of a grinding part formation apparatus. 第２実施例に係る中空針の断面図。Sectional drawing of the hollow needle which concerns on 2nd Example. 先鋭部を形成する前の状態の針管の断面図。Sectional drawing of the needle tube in the state before forming a sharpened part. 第３実施例に係る中空針の断面図。Sectional drawing of the hollow needle which concerns on 3rd Example. 第４実施例に係る中空針の断面図。Sectional drawing of the hollow needle which concerns on 4th Example. 第５実施例に係る中空針の断面図。Sectional drawing of the hollow needle which concerns on 5th Example.
　以下、図示実施例について説明すると、図１は本発明に係る中空針１の断面図を示し、本実施例の中空針１は例えば採血、輸液、皮下注射、歯肉注射に用いる針等に用いることができる。なお、本実施例で使用する図面（特に、図１～３、図６～８）の各寸法は、説明のため誇張したものとなっている。
　上記中空針１は、内部に流体通路２が形成された針管Ｔによって構成されており、当該針管Ｔの外周面には後端側より先端側に向けて縮径する研削部としてのテーパ部３と、当該テーパ部３の前方に形成された先鋭部４とを有し、上記テーパ部３の後方には研削されておらず、テーパ部３より外径が大径である本体部５が形成されている。
　上記針管ＴにはＳＵＳ３０４等のステンレスを用いることが可能であり、上記本体部５の外径は一定となっており、例えばインシュリンの投与に用いる中空針１の場合、上記本体部５の外径をφ０．３ｍｍとすることができ、採血に用いる中空針１の場合、上記本体部５の外径をφ０．９ｍｍとすることができる。
　またこの針管Ｔの内部に形成された流体通路２は、後述する研削部形成装置１１を用いることで、その先端側から後端側にかけてその内径が一定となっており、例えばインシュリンの投与に用いる中空針１の場合、その内径をφ０．１６ｍｍとすることができ、採血に用いる中空針１の場合、その内径をφ０．５ｍｍとすることができる。
　なお、本実施例で言う流体通路２の内径が一定とは、流体通路２の先端側から後端側の全域で当該内径が完全に同一であることを意味するものではなく、実際には針管Ｔの製造時における製造誤差や、針管外面を研削する際に生じる針管Ｔの極微小な変形による誤差を含むものである。 The illustrated embodiment will be described below. FIG. 1 shows a cross-sectional view of a hollow needle 1 according to the present invention. The hollow needle 1 of this embodiment is used for, for example, a needle used for blood collection, infusion, subcutaneous injection, and gingival injection. Can do. Note that the dimensions of the drawings (particularly, FIGS. 1 to 3 and FIGS. 6 to 8) used in this embodiment are exaggerated for explanation.
The hollow needle 1 is constituted by a needle tube T in which a fluid passage 2 is formed, and a tapered portion 3 as a grinding portion that decreases in diameter from the rear end side toward the front end side on the outer peripheral surface of the needle tube T. And a sharpened portion 4 formed in front of the tapered portion 3, and a body portion 5 that is not ground behind the tapered portion 3 and has an outer diameter larger than that of the tapered portion 3 is formed. Has been.
Stainless steel such as SUS304 can be used for the needle tube T, and the outer diameter of the main body 5 is constant. For example, in the case of the hollow needle 1 used for insulin administration, the outer diameter of the main body 5 is the same. Can be set to φ0.3 mm, and in the case of the hollow needle 1 used for blood collection, the outer diameter of the main body 5 can be set to φ0.9 mm.
Further, the fluid passage 2 formed inside the needle tube T has a constant inner diameter from the front end side to the rear end side by using a grinding part forming device 11 described later, and is used for, for example, administration of insulin. In the case of the hollow needle 1, the inner diameter can be set to φ0.16 mm, and in the case of the hollow needle 1 used for blood collection, the inner diameter can be set to φ0.5 mm.
It should be noted that the constant inner diameter of the fluid passage 2 in this embodiment does not mean that the inner diameter is the same throughout the entire area from the front end side to the rear end side of the fluid passage 2. This includes a manufacturing error in manufacturing T and an error due to a very small deformation of the needle tube T generated when the outer surface of the needle tube is ground.
　上記テーパ部３は針管Ｔの外周面に形成されるとともに、上記本体部５の前方に隣接した位置から先端側に向けてその外径が縮径する形状を有しており、後述する研削部形成装置１１により研削されることにより、テーパ部３の外径が研削されていない本体部５の外径よりも小径となるように形成されたものとなっている。
　上記テーパ部３は、図２に示すように、先鋭部４を形成する先鋭部形成工程の前の研削工程において形成され、例えば、当該先鋭部４が形成される前の状態において、本体部５の外径をφ０．３５ｍｍとした場合、テーパ部３の先端部の外径を例えばφ０．２２ｍｍとすることができる。
　またテーパ部２における基端部に向かって拡径する傾斜角は、インシュリンの投与に用いる中空針１の場合、１°未満にすることが望ましく、採血に用いる中空針１の場合、２°未満とすることが望ましい。
　また図１において、先鋭部４の先端から上記テーパ部３の後端部までの長さは、適宜設定することができるが、中空針１を皮下注射に用いる場合、例えば４．５ｍｍに設定することができる。
　より具体的には、上記研削部としてのテーパ部３と本体部５との境界が、上記先鋭部４に開口する流体通路２の開口部の基端側の端部Ｅよりも３ｍｍ以上後方に位置することが望ましい。しかしながら、皮膚の厚さが厚い人もいることから、より好ましくは、上記研削部としてのテーパ部３と本体部５との境界が、上記先鋭部４に開口する流体通路２の開口部の基端側の端部Ｅよりも４ｍｍ以上後方に位置することが望ましい。
　そして上述したように、当該テーパ部３における流体通路２の内径は後端側から先端側にかけて内径が一定となっており、本体部５における流体通路２の内径と同径となっている。 The tapered portion 3 is formed on the outer peripheral surface of the needle tube T, and has a shape whose outer diameter is reduced from the position adjacent to the front of the main body portion 5 toward the distal end side. By being ground by the forming device 11, the outer diameter of the tapered portion 3 is formed to be smaller than the outer diameter of the main body portion 5 that is not ground.
As shown in FIG. 2, the tapered portion 3 is formed in a grinding step before the sharpened portion forming step for forming the sharpened portion 4. For example, in the state before the sharpened portion 4 is formed, the main body portion 5 is formed. When the outer diameter of the taper portion 3 is set to φ0.35 mm, the outer diameter of the tip portion of the tapered portion 3 can be set to φ0.22 mm, for example.
In addition, in the case of the hollow needle 1 used for insulin administration, the inclination angle of the taper portion 2 that expands toward the base end is preferably less than 1 °, and in the case of the hollow needle 1 used for blood collection, it is less than 2 °. Is desirable.
In FIG. 1, the length from the tip of the sharpened portion 4 to the rear end of the tapered portion 3 can be set as appropriate. However, when the hollow needle 1 is used for subcutaneous injection, it is set to 4.5 mm, for example. be able to.
More specifically, the boundary between the taper portion 3 as the grinding portion and the main body portion 5 is 3 mm or more behind the end portion E on the proximal end side of the opening portion of the fluid passage 2 that opens to the sharpened portion 4. It is desirable to be located. However, since some people have thick skin, more preferably, the boundary between the tapered portion 3 and the main body portion 5 serving as the grinding portion is the base of the opening portion of the fluid passage 2 that opens to the sharpened portion 4. It is desirable to be located at least 4 mm behind the end E on the end side.
As described above, the inner diameter of the fluid passage 2 in the tapered portion 3 is constant from the rear end side to the front end side, and is the same as the inner diameter of the fluid passage 2 in the main body portion 5.
　上記先鋭部４は、図３（ａ）（ｂ）に示すように、針管Ｔの軸方向に対して斜めに形成された第１刃面４ａと、当該第１刃面４ａに形成されて針管Ｔの中心軸を挟んで対称に形成された一対の第２刃面４ｂとから形成されている。
　この先鋭部４は、図２に示す上記テーパ部３が形成された針管Ｔに対して形成され、従来公知の先鋭部形成装置を用いた先鋭部形成工程にて形成するようになっている。
　具体的には、上記先鋭部形成装置によって最初に針管Ｔの軸方向に対して所要の傾斜角で研削して第１刃面４ａを形成し、続いて第１刃面４ａの形成された針管Ｔを回転させ、その状態で針管Ｔの軸方向に対して所要の傾斜角で研削して上記第２刃面４ｂを形成する。
　このような第１、第２刃面４ａ、４ｂによって構成された先鋭部４は一例であり、その他上記第２刃面４ｂの裏側にさらに一対の第３刃面を形成したものや、上記第２刃面４ｂを省略した先鋭部４など、適宜、好適と思われる構成を採用することができる。
　さらに、上記先鋭部形成工程によって上記先鋭部４を形成した後に、極微小なバリや凹凸を取り除くため、形成した先鋭部４に対して従来公知の電解研磨工程を行い、先鋭部４を電解研磨することが望ましい。なお、先鋭部だけでなく、針管Ｔの全体に電解研磨を行ってもよい。 3 (a) and 3 (b), the sharpened portion 4 is formed on the first blade surface 4a formed obliquely with respect to the axial direction of the needle tube T, and on the first blade surface 4a. It is formed from a pair of second blade surfaces 4b formed symmetrically with respect to the central axis of T.
The sharpened portion 4 is formed with respect to the needle tube T in which the tapered portion 3 shown in FIG. 2 is formed, and is formed in a sharpened portion forming step using a conventionally known sharpened portion forming apparatus.
Specifically, the first blade surface 4a is formed by first grinding with a sharp inclination angle with respect to the axial direction of the needle tube T by the sharp part forming device, and then the needle tube on which the first blade surface 4a is formed. T is rotated, and in this state, the second blade surface 4b is formed by grinding at a required inclination angle with respect to the axial direction of the needle tube T.
The sharpened portion 4 constituted by the first and second blade surfaces 4a and 4b is an example, and a pair of third blade surfaces further formed on the back side of the second blade surface 4b, The structure considered to be suitable, such as the sharpened portion 4 in which the two-blade surface 4b is omitted, can be appropriately employed.
Further, after the sharpened portion 4 is formed by the sharpened portion forming step, in order to remove extremely small burrs and irregularities, a conventionally known electropolishing process is performed on the formed sharpened portion 4, and the sharpened portion 4 is electrolytically polished. It is desirable to do. Note that electropolishing may be performed not only on the sharpened portion but also on the entire needle tube T.
　図４、図５は、上記針管Ｔの先端部を研削して、図３に示すような当該テーパ部３等の研削部の形成された針管Ｔを得る、上記研削工程を行うための研削部形成装置１１を示している。
　この研削部形成装置１１には、従来公知の針管準備工程によって製造された外径および上記流体通路２の内径が一定の針管Ｔが供給され、例えばテーパ部が形成されずに先端部に先鋭部のみを形成する中空針の製造に使用する針管Ｔをそのまま使用することができる。
　上記針管準備工程では、例えば上記針管Ｔよりも大径な大径管を鍛造することによって上記針管Ｔを得ることや、上記特許文献４に記載されるような板状の部材を円管状に変形させて上記針管Ｔを得ることができる。
　特に特許文献４の製造方法を用いる専用の大規模装置を既に保持している場合であっても、本願発明を利用することは可能である。例えば、特許文献４の製造方法によって製造された中空針に本願発明を適用しても良いし、扇状に形成された板状の部材を意図する形状に正確に変形させ接合する加工は、細い径の中空針になればなるほど難しいことから、長方形状の板状部材を用いて針管を製造し、後に本願発明を適用しても良い。
　しかしながら、上記特許文献４の製造方法を用いて針管Ｔを得た場合、針管Ｔの内面の先端から基端にかけて接合部ができてしまい、当該接合部が抵抗となって穿刺および薬液投与時に患者に痛みを生じさせる原因となりうるため、鍛造によって針管Ｔを得ることが望ましい。 4 and 5 illustrate a grinding portion for performing the grinding step, in which the tip portion of the needle tube T is ground to obtain a needle tube T having a grinding portion such as the tapered portion 3 as shown in FIG. A forming apparatus 11 is shown.
The grinding part forming apparatus 11 is supplied with a needle tube T having a constant outer diameter and a constant inner diameter of the fluid passage 2 manufactured by a conventionally known needle pipe preparation process. The needle tube T used for the manufacture of the hollow needle that forms only can be used as it is.
In the needle tube preparation step, for example, the needle tube T is obtained by forging a large-diameter tube larger than the needle tube T, or the plate-like member described in Patent Document 4 is transformed into a circular tube. Thus, the needle tube T can be obtained.
In particular, even when a dedicated large-scale apparatus using the manufacturing method of Patent Document 4 is already held, the present invention can be used. For example, the invention of the present application may be applied to a hollow needle manufactured by the manufacturing method of Patent Document 4, and the process of accurately deforming and joining a plate-like member formed in a fan shape into an intended shape is a thin diameter. As the hollow needle becomes more difficult, the needle tube may be manufactured using a rectangular plate-shaped member, and the present invention may be applied later.
However, when the needle tube T is obtained using the manufacturing method of Patent Document 4, a joint is formed from the front end to the base end of the inner surface of the needle tube T, and the joint becomes a resistance, and the patient is in puncture and drug administration. Therefore, it is desirable to obtain the needle tube T by forging.
　研削部形成装置１１は、図示しないモータによって回転する搬送ローラ１２と、上記搬送ローラ１２の外周面に沿って設けられた円弧状を有するガイド部１３と、これら搬送ローラ１２およびガイド部１３に隣接して設けられた回転砥石１４とから構成されている。
　上記搬送ローラ１２の外周はゴムなどの樹脂製となっており、図５に示すように円周方向に沿って複数の環状突起１２ａが形成され、上記ガイド部１３との間で針管Ｔを挟持するようになっている。
　上記ガイド部１３は上記搬送ローラ１２の下部に固定されており、その内周面には上記搬送ローラ１２との間で針管Ｔを挟持する樹脂製の押圧部材１５が設けられ、当該押圧部材１５の内周面にも複数の環状突起１５ａが形成されている。
　そして、上記搬送ローラ１２とガイド部１３との間には上記針管Ｔが通過可能な程度の隙間が形成され、上記搬送ローラ１２およびガイド部１３の環状突起１２ａ、１５ａにより針管Ｔを挟持するようになっている。 The grinding part forming apparatus 11 includes a conveying roller 12 rotated by a motor (not shown), a guide part 13 having an arc shape provided along the outer peripheral surface of the conveying roller 12, and adjacent to the conveying roller 12 and the guide part 13. And a rotating grindstone 14 provided.
The outer periphery of the conveying roller 12 is made of a resin such as rubber, and a plurality of annular protrusions 12a are formed along the circumferential direction as shown in FIG. It is supposed to be.
The guide portion 13 is fixed to the lower portion of the conveying roller 12, and a resin-made pressing member 15 that sandwiches the needle tube T with the conveying roller 12 is provided on the inner peripheral surface thereof. A plurality of annular protrusions 15a are also formed on the inner peripheral surface of the.
A gap is formed between the conveying roller 12 and the guide portion 13 so that the needle tube T can pass through, and the needle tube T is sandwiched between the conveying roller 12 and the annular protrusions 12a and 15a of the guide portion 13. It has become.
　図４に示すように、ガイド部１３の左端部には針管Ｔの供給手段１６が設けられており、上記針管Ｔは搬送ローラ１２の回転軸と平行な向きで、１本ずつ搬送ローラ１２とガイド部１３との間に供給される。
　図５に示すように、針管Ｔは搬送ローラ１２とガイド部１３とによって後端側の所要の部分が挟持されるようになっており、先端部が上記回転砥石１４側に突出するようになっている。
　そして、供給手段１６によって搬送ローラ１２とガイド部１３との間に供給された針管Ｔは、上記搬送ローラ１２が回転する一方で上記ガイド部１３が固定されていることから、これらの摩擦によって回転するとともに、上記搬送ローラ１２に対して公転し、ガイド部１３を図示左方から図示右方へと移動するようになっている。
　そしてガイド部１３の図示右方端には排出スロープ１７が設けられており、針管Ｔはこの排出スロープ１７を介して回収されるようになっている。 As shown in FIG. 4, a supply means 16 for the needle tube T is provided at the left end portion of the guide portion 13, and the needle tube T is aligned with the transport roller 12 one by one in a direction parallel to the rotation axis of the transport roller 12. It is supplied between the guide part 13.
As shown in FIG. 5, the needle tube T is configured such that a required portion on the rear end side is sandwiched between the conveying roller 12 and the guide portion 13, and the front end portion protrudes to the rotating grindstone 14 side. ing.
The needle tube T supplied between the conveying roller 12 and the guide portion 13 by the supply means 16 is rotated by these frictions because the guide portion 13 is fixed while the conveying roller 12 rotates. At the same time, the guide roller 13 revolves with respect to the conveying roller 12 and moves from the left side to the right side in the drawing.
A discharge slope 17 is provided at the right end of the guide portion 13 in the figure, and the needle tube T is collected via the discharge slope 17.
　上記回転砥石１４は、図示しない駆動手段によって回転する円盤形の砥石となっており、当該回転砥石１４の回転軸は上記搬送ローラ１２の回転軸に対して直交するように設けられている。
　また回転砥石１４は図４に示すように所要の幅を有するとともに、図５に示すように針管Ｔの先端部が回転砥石１４の上端部よりも若干搬送ローラ１２側の傾斜した部分に接触するようになっており、上記搬送ローラ１２によって移動する針管Ｔが上記ガイド部１３の下端部近傍に位置すると、当該針管Ｔの先端部に下方から接触するようになっている。
　上記針管Ｔは、上記搬送ローラ１２とガイド部１３とによって回転しながら回転砥石１４を通過するため、針管Ｔの先端部の外周面が回転しながら研削され、図３に示すようなテーパ部３を得ることができる。
　その際、針管Ｔの先端部を回転砥石１４によって下方から上方に付勢する付勢力や、回転砥石１４の直径を調整することにより、上記テーパ部３の寸法を変化させたり、また後述する図６、図７に示すように研削部を構成するストレート部６を形成することが可能となっている。 The rotating grindstone 14 is a disk-shaped grindstone that is rotated by a driving means (not shown), and the rotation axis of the rotating grindstone 14 is provided so as to be orthogonal to the rotation axis of the conveying roller 12.
Further, the rotating grindstone 14 has a required width as shown in FIG. 4, and the tip of the needle tube T comes into contact with an inclined portion slightly closer to the conveying roller 12 than the upper end of the rotating grindstone 14 as shown in FIG. When the needle tube T that is moved by the transport roller 12 is positioned in the vicinity of the lower end portion of the guide portion 13, the tip end portion of the needle tube T comes into contact with the lower portion.
Since the needle tube T passes through the rotating grindstone 14 while being rotated by the conveying roller 12 and the guide portion 13, the outer peripheral surface of the tip portion of the needle tube T is ground while being rotated, and the tapered portion 3 as shown in FIG. Can be obtained.
At that time, by adjusting the urging force for urging the tip of the needle tube T upward from the lower side by the rotating grindstone 14 and the diameter of the rotating grindstone 14, the dimension of the tapered portion 3 can be changed, or a diagram described later. 6. It is possible to form the straight part 6 which comprises a grinding part as shown in FIG.
　そして本実施例においては、流体通路２の内径が一定に形成された針管Ｔの外周面を研削して上記研削部を形成することで、当該針管Ｔの外径部分だけを縮径させることができ、上記流体通路２の内径を一定のままとすることができる。
　このようにして形成した研削部は、当該研削部の先端部の外径が小さいことから、当該研削部の前方に位置する先鋭部４よって患者の皮膚を穿刺する際の穿刺抵抗が少なくなり、また患者の皮膚に挿入される針面積を低減することで挿入時に皮膚組織内の痛点に接触する確率を低減することができる。その結果、穿刺痛を抑制することができる。
　一方、針管Ｔの内部の流体通路２は、上記研削部においてもその内径が一定であることから、流通する薬剤の流路抵抗が増大せず、投与される薬剤の流速が早くならないため、患者への苦痛を軽減することができる。
　また上記テーパ部３は基端側に向かって拡径する傾斜角が２°未満となるように研削され、患者への穿刺痛を低減させるようになっている。すなわち傾斜角を２°以上とすると、テーパ部３において外径が急激に拡径することから、当該テーパ部３が皮下まで穿刺される際に患者に苦痛を与える恐れがある。なお、穿刺痛をより低減させる意味合いから、傾斜角は１°未満であることが望ましい。
　これに対し、上記特許文献１～３に示すような、上記テーパ部が形成されているものの、流体通路の内径が先端部に向けて縮径するなど、流体通路の内径が減少している場合や、特許文献４のように上記テーパ部をいわゆる接合加工によって形成すると、流体通路の内面には接合加工による接合部と呼ばれる凹凸が形成されることとなる。
　それ故、上記テーパ部によって穿刺痛を抑制することができるものの、当該テーパ部における流体通路の内径が減少する部分や、上記接合部が形成された部分において、流路抵抗が増大するという問題があった。
　このように流路抵抗が増大すると、注射器からの薬剤の供給圧力を上げなければならず、中空針の先端より排出される薬剤の流速が増大してしまうことから、患者に苦痛を与えるという問題があった。
　なお特許文献４の製造方法を用いて中空針１を製造すると、先鋭部近傍にも上記接合部が残存するため当該接合部が患者に苦痛を与えてしまうおそれがあり、当該接合部を除去する加工が必要となり、製造コストが高くなるという問題があった。 In the present embodiment, only the outer diameter portion of the needle tube T can be reduced by grinding the outer peripheral surface of the needle tube T formed with a constant inner diameter of the fluid passage 2 to form the grinding portion. The inner diameter of the fluid passage 2 can be kept constant.
Since the grinding part formed in this way has a small outer diameter at the tip part of the grinding part, the puncture resistance when puncturing the patient's skin by the sharpened part 4 located in front of the grinding part is reduced, Further, by reducing the area of the needle inserted into the patient's skin, the probability of contact with a pain point in the skin tissue during insertion can be reduced. As a result, puncture pain can be suppressed.
On the other hand, since the fluid passage 2 inside the needle tube T has a constant inner diameter even in the grinding part, the flow resistance of the circulating drug does not increase, and the flow rate of the administered drug does not increase. Can alleviate pain.
Further, the tapered portion 3 is ground so that the inclination angle of the diameter expanding toward the proximal end is less than 2 °, thereby reducing the puncture pain to the patient. That is, if the inclination angle is 2 ° or more, the outer diameter of the tapered portion 3 is rapidly expanded, and there is a risk that the patient may be painful when the tapered portion 3 is punctured subcutaneously. Note that the inclination angle is preferably less than 1 ° from the viewpoint of further reducing puncture pain.
On the other hand, as shown in Patent Documents 1 to 3, the tapered portion is formed, but the inner diameter of the fluid passage is reduced, for example, the inner diameter of the fluid passage is reduced toward the tip. In addition, when the tapered portion is formed by so-called joining processing as in Patent Document 4, irregularities called joining portions by joining processing are formed on the inner surface of the fluid passage.
Therefore, although the puncture pain can be suppressed by the tapered portion, there is a problem that the flow path resistance increases in a portion where the inner diameter of the fluid passage in the tapered portion is reduced or a portion where the joint portion is formed. was there.
When the flow path resistance increases in this way, the supply pressure of the drug from the syringe must be increased, and the flow rate of the drug discharged from the tip of the hollow needle increases, which causes pain for the patient. was there.
In addition, when the hollow needle 1 is manufactured using the manufacturing method of Patent Document 4, since the above-described joint remains in the vicinity of the sharpened portion, the joint may cause pain to the patient, and the joint is removed. There was a problem that processing was required and the manufacturing cost was high.
　図６は第２実施例にかかる中空針１の断面図を示し、図７は当該第２実施例にかかる中空針１を製造する際における、上記研削部を形成した針管Ｔの断面図を示している。
　本実施例の中空針１は、上記研削部として、上記先鋭部４とテーパ部３との間にストレート部６を形成したものであり、このストレート部６はその外径が後端側から先端側にむけて略一定となっている。
　また当該ストレート部６における流体通路２もその内径が一定となっており、つまり上記本体部５からテーパ部３およびストレート部６にかけて流体通路２の内径は一定となっている。
　そして本実施例の中空針１の先鋭部４は、第１実施例と同様の第１、第２刃面４ｂを有するとともに、さらに第１刃面４ａの裏面側には、針管Ｔの先端の端面の外周縁に沿って円弧状の面取り形状４ｃが形成されている。
　上記面取り形状４ｃは、針管Ｔの先端部外縁に沿って円弧状に形成されていることから、先鋭部４によるより高い穿刺性能を得ることが可能となっている。
　なお、本実施例における上記ストレート部６に対し、上記先鋭部４とテーパ部３との間に、研削により第２のテーパ部を形成することも可能であり、この第２のテーパ部はその外径が後端側から先端側にむけて縮径し、第１のテーパ部３とは異なる傾斜角を有している。また当該第２のテーパ部の内径を一定としてもよい。 6 shows a cross-sectional view of the hollow needle 1 according to the second embodiment, and FIG. 7 shows a cross-sectional view of the needle tube T in which the grinding portion is formed when the hollow needle 1 according to the second embodiment is manufactured. ing.
The hollow needle 1 of the present embodiment has a straight portion 6 formed between the sharpened portion 4 and the tapered portion 3 as the grinding portion, and the straight portion 6 has an outer diameter from the rear end side to the front end. It is almost constant toward the side.
The fluid passage 2 in the straight portion 6 also has a constant inner diameter, that is, the fluid passage 2 has a constant inner diameter from the main body portion 5 to the tapered portion 3 and the straight portion 6.
The sharpened portion 4 of the hollow needle 1 of the present embodiment has first and second blade surfaces 4b similar to those of the first embodiment, and further on the back surface side of the first blade surface 4a, the tip of the needle tube T is provided. An arcuate chamfered shape 4c is formed along the outer peripheral edge of the end face.
Since the chamfered shape 4c is formed in an arc shape along the outer edge of the distal end portion of the needle tube T, higher puncture performance by the sharpened portion 4 can be obtained.
In addition, it is also possible to form a second tapered portion by grinding between the sharpened portion 4 and the tapered portion 3 with respect to the straight portion 6 in this embodiment, and the second tapered portion is The outer diameter is reduced from the rear end side toward the front end side, and has an inclination angle different from that of the first taper portion 3. Further, the inner diameter of the second tapered portion may be constant.
　図７は上記先鋭部４における上記第１、第２刃面４ａ、４ｂが形成されていない状態の針管Ｔを示したものであり、当該針管Ｔは例えば研削工程を２つの工程によって行うようになっている。
　第１の工程では、上記研削部形成装置１１を用いて、外径が一定の針管Ｔを研削し、これにより上記テーパ部３と上記ストレート部６とを同時に形成する。
　具体的には、図２の第１実施例にかかるテーパ部３を形成する場合に対し、上記回転砥石１４に接触する針管Ｔの先端部の位置を変更したり、また上記回転砥石１４による下方からの付勢力を調整することで、上述したようなテーパ部３の前方にストレート部６を形成することができる。
　第２の工程では、上記第１の工程で得た針管Ｔの先端部の端面の外周縁を研削して、当該針管Ｔの先端に外周縁に沿ってリング状に上記面取り形状４ｃを形成するのであり、例えば上記研削部形成装置１１における回転砥石１４の径を小さくして得ることができる。
　そして、上記先鋭部４における第１刃面４ａを研削する際に、上記面取り形状４ｃの一部を円弧状に残存させるようにすれば、図６に示すように上記先鋭部４を上記第１、第２刃面４ａ、４ｂおよび上記面取り形状４ｃとから構成することが可能となる。なお、面取り形状４ｃを設ける必要が無い場合、面取り工程を省略して上記先鋭部４を形成してもよい。 FIG. 7 shows the needle tube T in which the first and second blade surfaces 4a and 4b are not formed in the sharpened portion 4, and the needle tube T performs, for example, a grinding process by two processes. It has become.
In the first step, the grinding tube forming apparatus 11 is used to grind the needle tube T having a constant outer diameter, thereby forming the tapered portion 3 and the straight portion 6 simultaneously.
Specifically, in contrast to the case where the tapered portion 3 according to the first embodiment of FIG. 2 is formed, the position of the tip portion of the needle tube T that contacts the rotating grindstone 14 is changed, or the lower position by the rotating grindstone 14 is lowered. The straight portion 6 can be formed in front of the tapered portion 3 as described above by adjusting the urging force from.
In the second step, the outer peripheral edge of the end surface of the distal end portion of the needle tube T obtained in the first step is ground to form the chamfered shape 4c in a ring shape along the outer peripheral edge at the distal end of the needle tube T. For example, it can be obtained by reducing the diameter of the rotating grindstone 14 in the grinding part forming apparatus 11.
Then, when the first blade surface 4a in the sharpened portion 4 is ground, if the part of the chamfered shape 4c is left in an arc shape, the sharpened portion 4 is moved to the first sharpened portion 4 as shown in FIG. The second blade surfaces 4a and 4b and the chamfered shape 4c can be configured. If it is not necessary to provide the chamfered shape 4c, the sharpened portion 4 may be formed by omitting the chamfering step.
　図８は第３実施例にかかる中空針１の断面図を示しており、第１実施例にかかる中空針１に対して先鋭部４の形状が異なり、いわゆるペンシルタイプの先鋭部２１を有するものとなっている。
　本実施例の中空針１は、上述した研削工程により図２に示す研削部としてのテーパ部３を形成した針管Ｔに対し、その先端部を上記テーパ部３が残存するように溶融させて（図示破線部よりも前方の領域）、当該溶融部分Ｍにより上記流体通路２の先端部を封止した構成となっている。
　上記溶融部分Ｍを形成した後、当該溶融部分Ｍを針外面を回転砥石を用いて研削することで先鋭部２１を形成する。本実施例では上記テーパ部３と本体部５との境界が、上記先鋭部２１の先端よりも４ｍｍ以上後方に位置し、例えば上記先鋭部２１の先端から上記テーパ部３の後端までの長さを約４．５ｍｍとすることが可能である。
　上記先鋭部２１は、その外周面に外方に膨出した曲面２１ａを形成しており、当該曲面２１ａは上記先鋭部２１を形成する際に同時に形成することができる。この曲面２１ａを形成することより、当該先鋭部２１が患者の皮膚に穿刺される際に、上記曲面２１ａにより穿刺痛を抑制することが可能となっている。
　また、上記針管Ｔの側面には上記溶融部分Ｍによって封止された部分に近接した位置に、その側面から流体通路２に連通する貫通孔２２が穿設されており、当該貫通孔２２の径は上記流体通路２の径よりも若干小径となっている。 FIG. 8 shows a cross-sectional view of the hollow needle 1 according to the third embodiment. The shape of the sharpened portion 4 is different from that of the hollow needle 1 according to the first embodiment, and has a so-called pencil-type sharpened portion 21. It has become.
The hollow needle 1 of the present embodiment is melted so that the tapered portion 3 remains on the needle tube T in which the tapered portion 3 as the grinding portion shown in FIG. The region in front of the broken line portion in the figure), the tip of the fluid passage 2 is sealed by the molten portion M.
After forming the melting portion M, the sharpened portion 21 is formed by grinding the outer surface of the melting portion M using a rotating grindstone. In this embodiment, the boundary between the tapered portion 3 and the main body portion 5 is located at least 4 mm behind the tip of the sharpened portion 21, for example, the length from the tip of the sharpened portion 21 to the rear end of the tapered portion 3. The thickness can be about 4.5 mm.
The sharpened portion 21 forms a curved surface 21a bulging outward on the outer peripheral surface thereof, and the curved surface 21a can be formed at the same time as the sharpened portion 21 is formed. By forming the curved surface 21a, it is possible to suppress puncture pain by the curved surface 21a when the sharpened portion 21 is punctured into the patient's skin.
Further, a through hole 22 communicating with the fluid passage 2 from the side surface is formed in the side surface of the needle tube T at a position close to the portion sealed by the melted portion M. The diameter of the through hole 22 is Is slightly smaller than the diameter of the fluid passage 2.
　上記構成を有する中空針１であっても、上記テーパ部３を形成したことにより、上記先鋭部４によって患者の皮膚に穿刺する際の穿刺痛を低減することができ、また針管Ｔの内部に形成された流体通路２は本体部５からテーパ部３にかけてその内径が一定となっていることから、上記流体通路２を流通して上記貫通孔２２より排出される薬剤の流路抵抗がテーパ部３の位置で高くならないようになっている。 Even in the hollow needle 1 having the above-described configuration, the formation of the tapered portion 3 can reduce puncture pain when puncturing the patient's skin by the sharpened portion 4, and the inside of the needle tube T. Since the inner diameter of the fluid passage 2 formed in the fluid passage 2 is constant from the main body portion 5 to the taper portion 3, the flow resistance of the drug flowing through the fluid passage 2 and discharged from the through hole 22 is tapered. It does not become high at the position of the part 3.
　なお、上記第２実施例における中空針１は、上記テーパ部３の前方に上記ストレート部６が形成された構成を有しているが、上記テーパ部３についてはこれを省略することが可能である。
　具体的には、上記研削工程において上記テーパ部３の加工を行わずに直接上記針管Ｔの外周面を研削して上記ストレート部６を形成し、さらにこのストレート部６の先端部を研削して先鋭部４を形成するようにして製造することができる。
　その際、上記ストレート部６の加工に研削加工を用いることで、従来のプレス加工では製造できなかった、接合部のない外径が小さい針を製造することができ、かつ当該製造方法を用いることで内径を一定にすることもできる。
　さらに、このような中空針１においても、上記ストレート部６と本体部５との境界の位置を、上記先鋭部４に開口する流体通路２の開口部の基端側の端部Ｅよりも３ｍｍ以上後方に位置させることができ、例えば上記先鋭部４の先端から約４．５ｍｍの位置まで形成すれば、患者への穿刺痛を低減することができる。 In addition, although the hollow needle 1 in the said 2nd Example has the structure by which the said straight part 6 was formed ahead of the said taper part 3, this can be abbreviate | omitted about the said taper part 3. FIG. is there.
Specifically, in the grinding process, the outer peripheral surface of the needle tube T is directly ground without forming the taper portion 3 to form the straight portion 6, and further, the tip portion of the straight portion 6 is ground. It can be manufactured so as to form the sharpened portion 4.
At that time, by using grinding for the processing of the straight portion 6, a needle having a small outer diameter without a joint portion, which could not be manufactured by conventional press processing, can be manufactured, and the manufacturing method is used. The inner diameter can also be made constant.
Further, also in such a hollow needle 1, the position of the boundary between the straight portion 6 and the main body portion 5 is 3 mm from the end portion E on the proximal end side of the opening portion of the fluid passage 2 that opens to the sharpened portion 4. For example, if it is formed from the tip of the sharpened portion 4 to a position of about 4.5 mm, puncture pain to the patient can be reduced.
　図９は第４実施例にかかる中空針１の断面図を示し、特にインシュリンの注射に好適な細い径の中空針１の断面図を示している。本実施例の中空針１はストレート部６からなる研削部を有している。
　上記第１の実施例と同様、上記研削部と本体部５との境界の位置は、上記先鋭部４に開口した流体通路２の開口部の基端側の端部Ｅよりも３ｍｍ以上後方に位置し、かつ中空針１は上記注射器のハブから４～８ｍｍ程度突出し、上記本体部５が上記ハブに保持されるようになっている。また、ストレート部６の外径は本体部５の外径に対して少なくとも１ゲージ分以上小径とされている。このようにストレート部６と本体部５とで、外径が１ゲージ分以上異なるように研削されることが、強度の面から好ましい。
　インシュリンの投与に用いる中空針１の針管Ｔの外径は２７ゲージ（Ｂｕｒｎｉｎｇｈａｍ　Ｗｉｒｅ　Ｇａｇｅ）からとなっており、インシュリン自己注射用の中空針１は２９ゲージからとなっている。またインシュリン等の皮下注射は、薬剤や目的によるが、一般的に最も好ましい中空針１の挿入深さは４ｍｍ前後とされている。
　本実施例では、インシュリン自己注射用の中空針として、本体部５の径を２８ゲージとし、ストレート部６を３０ゲージとし、研削部と本体部５との境界の位置は、上記先鋭部４に開口した流体通路２の開口部の基端側の端部Ｅよりも３ｍｍ後方に位置し、かつ中空針１は上記注射器のハブから４ｍｍ程度露出している。本体部を含めた針管全体の直径は１０～１６ｍｍ程度としている。
　このような構成により、研削により小径となった研削部が患者の皮下に挿入されるため、中空針１と痛点が接する可能性を低減することができ、患者の穿刺痛を低減することができる。また流体通路２の径が一定となっていることから、内部を流通する液体の流路抵抗を抑えることが可能となっている。 FIG. 9 shows a cross-sectional view of the hollow needle 1 according to the fourth embodiment, and particularly shows a cross-sectional view of a hollow needle 1 having a small diameter suitable for insulin injection. The hollow needle 1 of the present embodiment has a grinding part composed of a straight part 6.
Similar to the first embodiment, the position of the boundary between the grinding portion and the main body portion 5 is 3 mm or more behind the end portion E on the proximal end side of the opening portion of the fluid passage 2 opened to the sharpened portion 4. The hollow needle 1 is positioned so as to protrude about 4 to 8 mm from the hub of the syringe, and the main body 5 is held by the hub. Further, the outer diameter of the straight portion 6 is set to be smaller than the outer diameter of the main body portion 5 by at least one gauge. Thus, it is preferable from the viewpoint of strength that the straight portion 6 and the main body portion 5 are ground so that the outer diameters are different by 1 gauge or more.
The outer diameter of the needle tube T of the hollow needle 1 used for insulin administration is 27 gauge (Burningham Wire Gage), and the hollow needle 1 for insulin self-injection is 29 gauge. Subcutaneous injection of insulin or the like depends on the drug and purpose, but generally the most preferable insertion depth of the hollow needle 1 is about 4 mm.
In this embodiment, as a hollow needle for insulin self-injection, the diameter of the main body portion 5 is 28 gauge, the straight portion 6 is 30 gauge, and the position of the boundary between the grinding portion and the main body portion 5 is the sharpened portion 4. The hollow needle 1 is located 3 mm behind the end E on the proximal end side of the opening of the fluid passage 2 that is open, and the hollow needle 1 is exposed from the hub of the syringe by about 4 mm. The diameter of the entire needle tube including the main body is about 10 to 16 mm.
With such a configuration, since the grinding part having a small diameter by grinding is inserted under the skin of the patient, the possibility that the hollow needle 1 is in contact with the pain point can be reduced, and the puncture pain of the patient can be reduced. it can. Moreover, since the diameter of the fluid passage 2 is constant, it is possible to suppress the flow path resistance of the liquid flowing through the inside.
　図１０は第５実施例にかかる中空針１の断面図を示し、特に注射器や留置針等に装着されて採血に好適な大きい径の中空針１の断面図を示している。中空針１はストレート部６およびその後方に位置するテーパ部３からなる研削部を有している。
　採血に用いられる中空針１の針管Ｔは２１ゲージ～２３ゲージ程度であり、本実施例では本体部５の径を２３ゲージとし、ストレート部６を２２ゲージとしている。 FIG. 10 shows a cross-sectional view of a hollow needle 1 according to a fifth embodiment, and particularly shows a cross-sectional view of a large-diameter hollow needle 1 that is attached to a syringe, an indwelling needle, or the like and suitable for blood collection. The hollow needle 1 has a grinding part composed of a straight part 6 and a tapered part 3 located behind the straight part 6.
The needle tube T of the hollow needle 1 used for blood collection is about 21 gauge to 23 gauge. In this embodiment, the diameter of the main body portion 5 is 23 gauge, and the straight portion 6 is 22 gauge.
　なお、第４実施例および第５実施例において、先鋭部４の開口の基端より３ｍｍ以上ストレート部６を形成しているが、第１実施例同様、当該ストレート部６をテーパー部３としてもよい。
　上記実施例のようにストレート部６が先鋭部４の開口の基端より３ｍｍ以上に亘って形成した場合、痛点に中空針１が接する可能性は最小となる。
　これに対して、先鋭部４の開口の基端より３ｍｍ以上に亘ってテーパー部３を形成した場合、それだけ針管Ｔの肉厚を厚くすることができ、針管Ｔの強度を高めることができる。
　従って、中空針１の形状については、これらの効果を勘案して適宜定めればよい。例えば、図９に示すインシュリン針のように、針管Ｔの強度が比較的低い中空針１であれば、針管Ｔの強度を向上させるため、テーパー部３を積極的に形成することも一つの選択である。 In addition, in 4th Example and 5th Example, although the straight part 6 is formed 3 mm or more from the base end of opening of the sharpened part 4, even if the said straight part 6 is made into the taper part 3 like 1st Example, it is. Good.
When the straight portion 6 is formed over 3 mm from the base end of the opening of the sharpened portion 4 as in the above embodiment, the possibility that the hollow needle 1 is in contact with the pain point is minimized.
On the other hand, when the tapered portion 3 is formed over 3 mm from the base end of the opening of the sharpened portion 4, the thickness of the needle tube T can be increased accordingly, and the strength of the needle tube T can be increased.
Accordingly, the shape of the hollow needle 1 may be appropriately determined in consideration of these effects. For example, in the case of a hollow needle 1 having a relatively low strength of the needle tube T, such as an insulin needle shown in FIG. 9, in order to improve the strength of the needle tube T, it is also an option to form the tapered portion 3 actively. It is.
　なお、上記各実施例では、上記針管Ｔ内部の流体通路２の径が一定となっているが、これを基端側が拡径するテーパ状としてもよい。例えば、基端側に向けてテーパ状に拡径させた板厚が一定の針管Ｔを準備し、当該針管Ｔの外面を上記実施例と同様に研削すれば、内面に拡径部を有する針管を製造することが可能である。ただし、上述したように流路抵抗を抑えるために流体通路２の径を一定とすることが望ましい。
　また上記各実施例に記載した中空針１において、各中空針１の基端部に先鋭部を形成してもよい。この基端側の穿刺部を用いて薬剤を収容した容器等のゴムシールを貫通させることができる。 In each of the above-described embodiments, the diameter of the fluid passage 2 inside the needle tube T is constant, but this may be a tapered shape in which the diameter of the proximal end is increased. For example, if a needle tube T with a constant plate thickness expanded toward the proximal end is prepared and the outer surface of the needle tube T is ground in the same manner as in the above embodiment, a needle tube having an expanded portion on the inner surface Can be manufactured. However, as described above, it is desirable to keep the diameter of the fluid passage 2 constant in order to suppress the flow path resistance.
Further, in the hollow needle 1 described in each of the above embodiments, a sharpened portion may be formed at the proximal end portion of each hollow needle 1. A rubber seal such as a container containing a medicine can be penetrated using the puncture portion on the proximal end side.
　上記各実施例において、研削加工とは、砥石の粒子により針の外面の形状を変える加工を意味する。研削加工で用いられる加工装置としては、回転砥石を用いることが好ましい。 In each of the above embodiments, the grinding process means a process of changing the shape of the outer surface of the needle by the grindstone particles. As a processing apparatus used in the grinding process, it is preferable to use a rotating grindstone.
　また上記各実施例に記載された構成を含め、本発明は以下の構成を有することを特徴としている。
　第１は、内部に流体通路が形成された針管であり、当該針管の外周面に形成されて後端側より先端側に向けて縮径するテーパ部と、当該テーパ部の前方に形成された先鋭とを有する中空針において、
　上記テーパ部を上記針管の外周面を研削して形成することにより、上記テーパ部における上記針管内の流体通路の内径が一定である。
　第２は、上記第１の構成において、上記針管の外周面を研削して上記テーパ部の前方にストレート部を形成することにより、
　上記先鋭部とテーパ部との間に上記ストレート部を設け、かつ当該ストレート部における上記流体通路の内径が一定である。
　第３は、上記第１の構成において、上記針管の外周面を研削して上記テーパ部の前方に第２のテーパ部を形成することにより、
　上記先鋭部とテーパ部との間に上記第２のテーパ部を設け、かつ当該第２のテーパ部における上記流体通路の内径が一定である。
　第４は、上記第１ないし第３のいずれかの構成において、上記先鋭部を、上記テーパ部の形成された針管の先端部をその軸方向に対して斜めに研削した刃面によって構成する。
　第５は、上記第４の構成において、上記テーパ部を形成する際に、上記針管の先端の端面に外周縁に沿ってリング状の面取り形状を形成し、さらに上記刃面を研削する際に上記面取り形状の一部を円弧状に残存させて、
　上記先鋭部を上記刃面および上記面取り形状とから構成する。
　第６は、上記第１ないし第３のいずれかの構成において、針管の側面に上記流体通路に連通する貫通孔を設け、
　上記テーパ部の形成された針管の先端部を溶融させて上記流体通路を当該溶融部分によって封止するとともに、当該溶融部分を加工して上記先鋭部を形成した。
　第７は、上記第６の構成において、上記先鋭部に、外方に膨出する曲面を設けた。
　第８は、内部に流体通路が形成された針管であり、当該針管の外周面に本体部よりも小径に形成されるとともに後端側より先端側に向けて径が一定であるストレート部と、当該ストレート部の前方に形成された先鋭部とを有する中空針において、
　上記ストレート部を上記針管の外周面を研削して形成することにより、上記ストレート部における上記針管内の流体通路の内径が一定である。
　第９は、内部に流体通路が形成された針管の外周面を研削して、後端側より先端側に向けて径が一定であるストレート部を形成する工程と、
　ストレート部の先端部を研削して先鋭部を形成する工程とを有することを特徴とする中空針の製造方法である。 In addition, including the configurations described in the above embodiments, the present invention has the following configurations.
The first is a needle tube having a fluid passage formed therein, and is formed on the outer peripheral surface of the needle tube and has a diameter that decreases from the rear end side toward the front end side, and is formed in front of the taper portion. In a hollow needle having a sharp point,
By forming the tapered portion by grinding the outer peripheral surface of the needle tube, the inner diameter of the fluid passage in the needle tube at the tapered portion is constant.
Second, in the first configuration, by grinding the outer peripheral surface of the needle tube to form a straight portion in front of the tapered portion,
The straight portion is provided between the sharpened portion and the tapered portion, and the inner diameter of the fluid passage in the straight portion is constant.
Third, in the first configuration, by grinding the outer peripheral surface of the needle tube to form a second tapered portion in front of the tapered portion,
The second tapered portion is provided between the sharpened portion and the tapered portion, and the inner diameter of the fluid passage in the second tapered portion is constant.
Fourth, in any one of the first to third configurations, the sharpened portion is configured by a blade surface obtained by grinding the tip end portion of the needle tube in which the tapered portion is formed obliquely with respect to the axial direction.
Fifth, in the fourth configuration, when the tapered portion is formed, a ring-shaped chamfered shape is formed on the end surface of the tip of the needle tube along the outer peripheral edge, and when the blade surface is further ground. Leave a part of the chamfered shape in an arc shape,
The sharpened portion is composed of the blade surface and the chamfered shape.
Sixth, in any one of the first to third configurations, a through-hole communicating with the fluid passage is provided on a side surface of the needle tube,
The tip of the needle tube having the tapered portion was melted to seal the fluid passage with the melted portion, and the melted portion was processed to form the sharpened portion.
Seventh, in the sixth configuration, a curved surface bulging outward is provided at the sharpened portion.
Eighth is a needle tube having a fluid passage formed therein, a straight portion having a smaller diameter than the main body portion on the outer peripheral surface of the needle tube and having a constant diameter from the rear end side toward the front end side; In a hollow needle having a sharpened portion formed in front of the straight portion,
By forming the straight portion by grinding the outer peripheral surface of the needle tube, the inner diameter of the fluid passage in the needle tube in the straight portion is constant.
Ninth, grinding the outer peripheral surface of the needle tube having a fluid passage formed therein to form a straight portion having a constant diameter from the rear end side toward the front end side;
And a step of grinding the tip of the straight part to form a sharpened part.
　なお、本願における最も重要な構成は、先鋭部３から所定以上の長さに亘って、針管Ｔの外面が研削されていることであり、その他変更は当業者により適宜設計変更可能である。
　例えば、組織や細胞を採取するための針に本技術を用いても良い。また、上述の実施例では、研削を砥石により実現しているが、針管Ｔの外面のみの研削ができさえすれば研削方法は問わない。例えば、今後の技術発展次第であるが、レーザー加工といった加工技術を用いてもよい。 The most important configuration in the present application is that the outer surface of the needle tube T is ground from the sharpened portion 3 over a predetermined length or more, and other changes can be appropriately designed by those skilled in the art.
For example, the present technology may be used for a needle for collecting tissue or cells. In the above-described embodiment, the grinding is realized by a grindstone, but any grinding method may be used as long as only the outer surface of the needle tube T can be ground. For example, depending on future technological development, a processing technique such as laser processing may be used.
　１　中空針　　　　　　　　　２　流体通路
　３　テーパ部（研削部）　　　４　先鋭部
　５　本体部　　　　　　　　　６　ストレート部（研削部）
　Ｔ　針管 DESCRIPTION OF SYMBOLS 1 Hollow needle 2 Fluid passage 3 Tapered part (grinding part) 4 Sharp part 5 Body part 6 Straight part (grinding part)
T needle tube

Claims (11)

  1. 　内部に流体通路が形成された針管であって、先端に先鋭部が形成されるとともに、当該先鋭部に上記流体通路の開口部が開口した中空針において、
    　上記針管の先端側の外面に、研削により形成した研削部を設けて、当該研削部の外径が研削されていない本体部の外径よりも小径となるようにし、
    　かつ当該研削部と上記本体部との境界が、上記開口部の基端側の端部よりも３ｍｍ以上後方に位置することを特徴とする中空針。     In a hollow needle in which a fluid passage is formed inside, a sharpened portion is formed at the tip, and an opening of the fluid passage is opened at the sharpened portion,
    Provide the grinding part formed by grinding on the outer surface of the tip side of the needle tube, so that the outer diameter of the grinding part is smaller than the outer diameter of the unground body part,
    And the hollow needle characterized by the boundary of the said grinding part and the said main-body part being located 3 mm or more back rather than the edge part of the base end side of the said opening part.
  2. 　上記研削部の外径と上記本体部の外径とが、少なくとも１ゲージ分以上異なることを特徴とする請求項１に記載の注射針。 2. The injection needle according to claim 1, wherein the outer diameter of the grinding part and the outer diameter of the main body part differ by at least one gauge or more.
  3. 　内部に流体通路が形成された針管であって、先端に先鋭部が形成された中空針において、
    　上記針管の先端側の外面を研削して形成した研削部を設けて、当該研削部の外径が研削されていない本体部の外径よりも小径となるようにするとともに、当該研削部の側面に上記流体通路に連通する貫通孔を設け、
    　上記研削部の形成された針管の上記流体通路を封止するとともに、当該封止した部分を加工して上記先鋭部を形成し、
    　当該研削部と上記本体部との境界が、上記貫通孔よりも基端側であって、かつ先鋭部の先端よりも４ｍｍ以上後方に位置することを特徴とする中空針。     In a hollow needle having a fluid passage formed therein and a sharpened tip formed at the tip,
    A grinding part formed by grinding the outer surface of the tip side of the needle tube is provided so that the outer diameter of the grinding part is smaller than the outer diameter of the unground body part, and the side surface of the grinding part Provided with a through hole communicating with the fluid passage,
    While sealing the fluid passage of the needle tube in which the grinding portion is formed, processing the sealed portion to form the sharpened portion,
    A hollow needle characterized in that the boundary between the grinding part and the main body part is located on the proximal end side with respect to the through-hole and at the rear of 4 mm or more with respect to the distal end of the sharpened part.
  4. 　内部に流体通路が形成された針管であり、当該針管の外周面に形成されて後端側より先端側に向けて縮径するテーパ部と、当該テーパ部の前方に形成された先鋭部とを有する中空針において、
    　針管の側面に上記流体通路に連通する貫通孔を設け、
    　上記テーパ部を上記針管の外周面を研削して形成することにより、上記テーパ部における上記針管内の流体通路の内径を一定とし、
    　かつ上記テーパ部の形成された針管の先端部を溶融させて上記流体通路を当該溶融部分によって封止するとともに、当該溶融部分を加工して上記先鋭部を形成したことを特徴とする中空針。     A needle tube having a fluid passage formed therein, and a tapered portion formed on the outer peripheral surface of the needle tube and having a diameter reduced from the rear end side toward the front end side, and a sharpened portion formed in front of the tapered portion. A hollow needle having
    A through hole communicating with the fluid passage is provided on the side surface of the needle tube,
    By forming the tapered portion by grinding the outer peripheral surface of the needle tube, the inside diameter of the fluid passage in the needle tube in the tapered portion is made constant,
    The hollow needle is characterized in that the tip of the needle tube in which the tapered portion is formed is melted to seal the fluid passage with the melted portion, and the melted portion is processed to form the sharpened portion.
  5. 　上記先鋭部に、外方に膨出する曲面を設けたことを特徴とする請求項４に記載の中空針。 The hollow needle according to claim 4, wherein a curved surface bulging outward is provided at the sharpened portion.
  6. 　内部に流体通路が形成された針管を準備する針管準備工程と、針管の先端に先鋭部を形成する先鋭部形成工程を有する中空針の製造方法において、
    　上記針管準備工程と上記先鋭部形成工程との間に、上記針管の先端側の外面を研削して研削部を形成する研削工程を行い、当該研削部の外径を研削されていない本体部の外径よりも小径とすることを特徴とする中空針の製造方法。     In a method for producing a hollow needle having a needle tube preparation step of preparing a needle tube having a fluid passage formed therein and a sharpened portion forming step of forming a sharpened portion at the tip of the needle tube,
    Between the needle tube preparation step and the sharpened portion forming step, a grinding step of grinding the outer surface on the tip side of the needle tube to form a ground portion is performed, and the outer diameter of the ground portion is not ground. A method for producing a hollow needle, wherein the diameter is smaller than the outer diameter.
  7. 　上記研削工程において、上記研削部を基端側に向かって拡径する傾斜角が２°未満のテーパ状に研削することを特徴とする請求項６に記載の中空針の製造方法。 The method for producing a hollow needle according to claim 6, wherein, in the grinding step, the grinding portion is ground into a taper shape having an inclination angle of less than 2 ° for expanding the diameter toward the base end side.
  8. 　上記研削工程において、上記研削部を外径が後端側から先端側にむけて一定なストレート部とすることを特徴とする請求項６に記載の中空針の製造方法。 The method for manufacturing a hollow needle according to claim 6, wherein, in the grinding step, the grinding part is a straight part having a constant outer diameter from the rear end side to the front end side.
  9. 　上記研削工程において、上記研削部における上記ストレート部よりも基端側に隣接する位置に、基端側に向かって拡径するテーパ部を形成することを特徴とする請求項８に記載の中空針の製造方法。 9. The hollow needle according to claim 8, wherein, in the grinding step, a tapered portion having a diameter increasing toward the base end side is formed at a position adjacent to the base end side of the straight portion in the grinding portion. Manufacturing method.
  10. 　上記先鋭部形成工程の後に、上記先鋭部を電解研磨する電解研磨工程を行うことを特徴とする請求項６ないし請求項９のいずれかに記載の中空針の製造方法。 The hollow needle manufacturing method according to any one of claims 6 to 9, wherein an electropolishing step of electropolishing the sharpened portion is performed after the sharpened portion forming step.
  11. 　上記針管準備工程において、上記針管よりも大径な大径管を鍛造する、もしくは板状の部材を円管状に変形させることにより上記針管を得ることを特徴とする請求項６ないし請求項１０のいずれかに記載の中空針の製造方法。 11. The needle tube according to claim 6, wherein, in the needle tube preparation step, the needle tube is obtained by forging a large-diameter tube larger than the needle tube or deforming a plate-like member into a circular tube shape. The manufacturing method of the hollow needle in any one.
PCT/JP2015/050414 2014-01-08 2015-01-08 Hollow needle and production method for hollow needle WO2015105162A1 (en)

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