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WO2024166623A1 - Aiguille d'injection - Google Patents

Aiguille d'injection Download PDF

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Publication number
WO2024166623A1
WO2024166623A1 PCT/JP2024/000995 JP2024000995W WO2024166623A1 WO 2024166623 A1 WO2024166623 A1 WO 2024166623A1 JP 2024000995 W JP2024000995 W JP 2024000995W WO 2024166623 A1 WO2024166623 A1 WO 2024166623A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube body
needle tube
needle
distal end
longitudinal direction
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2024/000995
Other languages
English (en)
Japanese (ja)
Inventor
まどか 堀江
毅 秋山
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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 Terumo Corp filed Critical Terumo Corp
Priority to JP2024576192A priority Critical patent/JPWO2024166623A1/ja
Publication of WO2024166623A1 publication Critical patent/WO2024166623A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M5/178—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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub

Definitions

  • the present invention relates to an injection needle.
  • Patent Document 1 discloses this type of injection needle.
  • the present invention aims to provide an injection needle that can prevent breakage due to excessive bending of the needle tube body.
  • the injection needle according to a first aspect of the present invention comprises: (1) a needle tube body having a distal end surface including a needle tip; a holder that holds the needle tube body in a state where the distal end surface is exposed to the outside, the holder includes a contact holder portion that holds the needle tube body by contacting an outer circumferential surface of the needle tube body,
  • the needle tube is an injection needle, and has a thick portion at the distal end of the contact holding portion in the longitudinal direction, the thick portion being thicker than the distal end surface.
  • the injection needle according to one embodiment of the present invention comprises: (2) The holder is a hub defining an insertion hole through which the needle tube is inserted; an adhesive body that adheres the needle tube body and the hub, The injection needle according to (1) above, wherein the distal end of the contact holding portion is constituted by the adhesive body surrounding the periphery of the needle tube body.
  • the injection needle according to one embodiment of the present invention comprises: (3) The injection needle according to (1) or (2) above, wherein the thick-walled portion of the needle tube body is an annular protrusion that is formed on the outer circumferential surface of the needle tube body and extends in a circumferential direction.
  • the injection needle according to one embodiment of the present invention comprises: (4) The injection needle according to (3) above, wherein the annular convex portion is arranged so as to straddle, in the longitudinal direction, a position of the distal end of the contact holding portion in the longitudinal direction.
  • the injection needle according to one embodiment of the present invention comprises: (5)
  • the needle tube body is a tubular body portion extending in the longitudinal direction; and
  • the annular protrusion is formed on an outer circumferential surface of the main body and extends in the circumferential direction,
  • the injection needle described in (4) above, in a cross-sectional view of the needle tube body passing through the central axis of the main body portion and parallel to the central axis, the distal side surface of the annular convex portion in the longitudinal direction is an inclined surface that inclines toward the outer peripheral surface of the main body portion as it moves toward the needle tip in the longitudinal direction.
  • the present invention provides an injection needle that can prevent breakage due to excessive bending of the needle tube body.
  • FIG. 1 is a cross-sectional view showing an injection needle according to an embodiment of the present invention.
  • FIG. 2 is an enlarged cross-sectional view of a portion of FIG. 1 .
  • 1A and 1B are diagrams showing an example of an excessively bent state of a needle tube of an injection needle.
  • FIG. 3 is a further enlarged cross-sectional view of a portion of FIG. 2 .
  • 1 is a flowchart showing an example of a method for manufacturing an injection needle.
  • FIG. 1 is a cross-sectional view showing an injection needle 1 as one embodiment of the injection needle according to the present invention.
  • the injection needle 1 includes a needle tube body 2 and a holder 3.
  • the central axis direction parallel to the central axis O of the needle tube body 2 in the injection needle 1 is referred to as the "longitudinal direction A of the needle tube body 2" or simply the “longitudinal direction A”.
  • the direction around the central axis O of the needle tube body 2 is referred to as the "circumferential direction B of the needle tube body 2" or simply the “circumferential direction B".
  • the radial direction of a virtual circle centered on the central axis O in any cross section perpendicular to the central axis O of the needle tube body 2 is referred to as the "radial direction C of the needle tube body 2" or simply the "radial direction C”.
  • the injection needle 1 may be, for example, an insulin injection needle used when administering insulin to a patient.
  • the injection needle according to the present invention is not limited to an insulin injection needle.
  • the injection needle according to the present invention may be an injection needle used for another purpose, such as a dental injection needle used when administering local anesthesia during dental treatment.
  • the needle tube body 2 has a distal end surface 41a including the needle tip 11.
  • a direction from the needle tip 11, which is the distal end of the needle tube body 2, toward the proximal end 12 opposite the needle tip 11 may be referred to as the "proximal side” or "removal direction A1" of the injection needle 1.
  • a direction opposite to the removal direction A1 from the proximal end 12 of the needle tube body 2 toward the needle tip 11, may be referred to as the "distal side” or "insertion direction A2" of the injection needle 1.
  • the holding body 3 holds the needle tube body 2 with the distal end surface 41a of the needle tube body 2 exposed to the outside. More specifically, the holding body 3 has a contact holding portion 21 that holds the needle tube body 2 by contacting the outer circumferential surface of the needle tube body 2.
  • the contact holding portion 21 covers the outside of the needle tube body 2 in the radial direction C.
  • the contact holding portion 21 comes into contact with the outer circumferential surface of the needle tube body 2, the needle tube body 2 and the holding body 3 do not move relatively in the longitudinal direction A and the circumferential direction B due to friction between the two, etc. Furthermore, the contact holding portion 21 is in contact with the outer circumferential surface of the needle tube body 2 over the entire area of the circumferential direction B of the needle tube body 2.
  • the needle tube body 2 and the holding body 3 do not move relatively in the radial direction C.
  • the needle tube body 2 is fixed to the holding body 3 by the contact holding portion 21 of the holding body 3 so as not to move relatively to the holding body 3 in the longitudinal direction A, the circumferential direction B, and the radial direction C.
  • the needle tube body 2 is held by the holder 3.
  • the contact retaining portion 21 in this embodiment is composed of an adhesive 32 that is formed by hardening the adhesive filled between the needle tube body 2 and the hub 31.
  • the adhesive 32 retains the needle tube body 2 by adhesive force in addition to the frictional force described above.
  • the needle tube body 2 is an enlarged cross-sectional view showing the vicinity of the portion of the needle tube body 2 shown in FIG. 1 that is held by the holding portion 3.
  • the needle tube body 2 has a thick portion 13 at the distal end 21a of the contact holding portion 21 in the longitudinal direction A, which is thicker than the distal end surface 41a.
  • the thickness of the needle tube body 2 refers to the thickness in the radial direction C of the needle tube body 2 in a cross section perpendicular to the central axis O.
  • the puncture portion 41 which is a portion of the needle tube body 2 further distal to the distal end 21a of the contact holding portion 21 in the longitudinal direction A, is not in contact with the holding body 3.
  • the position of the distal end 21a of the contact holding portion 21 in the longitudinal direction A of the needle tube body 2 is the base position of the puncture portion 41 of the needle tube body 2.
  • the needle tube body 2 has a thick portion 13 at this position. Therefore, the strength of the base of the puncture portion 41 of the needle tube body 2 is reinforced, and the needle tube body 2 can be prevented from bending excessively at this position. This prevents the needle tube body 2 from breaking. Even if the needle tube body 2 bends excessively at the base of the puncture portion 41, the needle tube body 2 can be prevented from breaking compared to a configuration in which the thick portion 13 is not provided. In this way, the needle tube body 2 having the thick portion 13 can prevent the needle tube body 2 from bending excessively and breaking.
  • FIG. 3 is a diagram showing a state in which the needle tube body 2 is bent 90° as an example of a state in which the needle tube body 2 is bent excessively at the base of the puncture portion 41 of the needle tube body 2. Bending at the base of the puncture portion 41 of the needle tube body 2 may occur unintentionally, for example, when the injection needle 1 is in use. Examples of when the injection needle 1 is in use include when the injection needle 1 is inserted into a living body such as a patient, and when the injection needle 1 is removed from the living body. When the injection needle 1 is in use, an excessive bending force may be applied unintentionally to the needle tube body 2 of the injection needle 1.
  • the needle tube body 2 of the injection needle 1 is provided with the above-mentioned thick portion 13, even if the above-mentioned bending force is applied to the needle tube body 2, excessive bending at the base of the puncture portion 41 of the needle tube body 2 (see FIG. 3) can be suppressed. As a result, breakage due to excessive bending of the needle tube body 2 can be suppressed. In addition, even if excessive bending (see FIG. 3) occurs at the base of the puncture portion 41 of the needle tube body 2, the breakage of the base of the puncture portion 41 of the needle tube body 2 can be suppressed compared to a configuration in which the thick portion 13 is not provided.
  • the bend at the base of the puncture portion 41 of the needle tube body 2 may be formed intentionally, for example.
  • the needle tube body 2 of the injection needle 1 may be used in a state in which it is intentionally bent, for example, at the discretion of a doctor, so that the bending angle at the base of the puncture portion 41 is a desired angle (for example, a bend of 45° or less).
  • the presence of the above-mentioned thick portion 13 can suppress the breakage of the base of the puncture portion 41 of the needle tube body 2 during the bending operation.
  • Figure 4 is an enlarged cross-sectional view showing the vicinity of the annular protrusion 81 as the thick-walled portion 13 in Figure 2 in a further enlarged manner.
  • the needle tube body 2 of this embodiment includes a held portion 42 and a connecting portion 43 in addition to the puncturing portion 41 described above.
  • the puncturing portion 41 includes the needle tip 11, which is the distal end of the needle tube body 2.
  • the distal end surface 41a of the puncturing portion 41 including the needle tip 11 is configured by a blade surface.
  • the blade surface includes one or more blade surface portions configured by a surface inclined with respect to the longitudinal direction A.
  • the held portion 42 is a portion that contacts the above-mentioned contact holding portion 21 of the holding body 3.
  • the held portion 42 is connected to the proximal side of the puncturing portion 41.
  • the connecting portion 43 is configured to be connectable to a syringe that defines a storage space that contains a medicinal liquid such as insulin.
  • the connecting portion 43 is connected to the syringe so as to communicate with the storage space of the syringe.
  • the connecting portion 43 is connected to the proximal side of the held portion 42.
  • the connecting portion 43 includes the proximal end 12 of the needle tube body 2.
  • the needle tube body 2 defines a hollow portion 2a that penetrates the puncturing portion 41, the held portion 42, and the connecting portion 43 in the longitudinal direction A.
  • a thick-walled portion 13 is provided at a position including the boundary between the puncturing portion 41 and the held portion 42. The configuration of the thick-walled portion 13 will be described in detail later.
  • the thickness of the needle tube body 2, excluding the position of the thickened portion 13, is, for example, a maximum outer diameter of 0.18 mm to 1.2 mm (corresponding to an outer diameter of 34 to 18 gauge), and the length of the puncture portion 41 is 1 mm to 10 mm, and in the case of an insulin injection needle, for example, it is preferably 3 mm to 6 mm.
  • the thickness of the needle tube body 2, excluding the position of the thickened portion 13, may be set in the range of, for example, 0.02 mm to 0.2 mm.
  • the puncture portion 41 of the needle tube body 2 of this embodiment includes a proximal side portion 51 in which the inner diameter of the inner circumferential surface and the outer diameter of the outer circumferential surface gradually decrease in the insertion direction A2, and a distal side portion 52 that is connected to the distal side of the proximal side portion 51 and in which the inner diameter of the inner circumferential surface and the outer diameter of the outer circumferential surface are uniform in the longitudinal direction A.
  • the puncture portion 41 may be configured such that the inner diameter of the inner circumferential surface and the outer diameter of the outer circumferential surface are uniform in the longitudinal direction A, except at the position of the thick portion 13.
  • the puncture portion 41 may also be configured such that the inner diameter of the inner circumferential surface and the outer diameter of the outer circumferential surface gradually decrease in the insertion direction A2 to the distal end face 41a, except at the position of the thick portion 13.
  • the puncture portion 41 of the needle tube body 2 in this embodiment has a uniform thickness regardless of the position in the longitudinal direction A, except for the position of the thick portion 13, but is not limited to this configuration.
  • the thickness of the puncture portion 41 may be configured to gradually decrease toward the distal end surface 41a in the insertion direction A2, for example, except for the position of the thick portion 13.
  • the thickness of the puncture portion 41 may be configured to gradually increase toward the distal end surface 41a in the insertion direction A2, for example, except for the position of the thick portion 13.
  • the material of the needle tube body 2 may be, for example, a metal material such as stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, or magnesium alloy.
  • a material that can be manufactured by plastic processing is selected as the material of the needle tube body 2. Examples of plastic processing include cutting a drawn tube having a specified inner diameter, and manufacturing a metal plate by pressing. Preferably, a material that can be used for pressing is selected as the material of the needle tube body 2.
  • the holding body 3 holds the needle tube body 2 in a state in which the extended end surface 41 a of the needle tube body 2 is exposed to the outside.
  • the holding body 3 includes a contact holding portion 21 that holds the needle tube body 2 by contacting the outer circumferential surface of the needle tube body 2.
  • the holding body 3 in this embodiment includes a hub 31 and an adhesive body 32.
  • the hub 31 defines an insertion hole 31a through which the needle tube body 2 is inserted.
  • the adhesive body 32 bonds the needle tube body 2 to the hub 31.
  • the contact holding portion 21 of the holding body 3 is formed by the adhesive body 32. Therefore, in this embodiment, the distal end 21a of the contact holding portion 21 is formed by the adhesive body 32 that surrounds the periphery of the needle tube body 2.
  • the hub 31 of this embodiment includes a connecting tube portion 61, a distal wall portion 62 that closes the distal end of the connecting tube portion 61, and a distal protrusion portion 63 that protrudes further distally from the distal wall portion 62.
  • the insertion hole 31a of the hub 31 described above is formed to penetrate the distal wall portion 62 and the distal protrusion portion 63.
  • the needle tube body 2 is inserted into the insertion hole 31a so that the puncture portion 41 protrudes distally from the insertion hole 31a and the connection portion 43 protrudes from the insertion hole 31a into the inside of the connecting tube portion 61 on the proximal side.
  • the proximal end of the connection portion 43 is located distal to the proximal end of the connecting tube portion 61 and does not protrude proximally from the connecting tube portion 61.
  • the connecting tube portion 61 is configured to be connectable to a syringe that defines a storage space for storing medicinal liquid such as insulin.
  • the connecting tube portion 61 has a female thread portion 61a on its inner circumferential surface.
  • the connecting tube portion 61 can be connected to a syringe by threading the female thread portion 61a into the male thread portion at the tip of the syringe.
  • the connection portion 43 of the needle tube body 2 described above communicates with the storage space of the syringe.
  • the distal protrusion 63 protrudes from the distal wall 62 so that the central axis is approximately aligned with that of the connecting tube 61.
  • a recess 71 is formed on the distal end surface 63a of the distal protrusion 63 in this embodiment.
  • the distal end surface 63a of the distal protrusion 63 is the distal end surface of the hub 31.
  • the recess 71 has a truncated cone shape, and the inner diameter gradually decreases from the edge 71a on the distal side to the bottom 71b on the proximal side.
  • the insertion hole 31a described above is composed of a recessed space 31a1 defined by the recess 71 and a through hole 31a2 that penetrates the distal protrusion 63 and the distal wall 62 from the bottom 71b of the recess 71 and opens into the inside of the connecting tube 61.
  • the diameter of the recessed space 31a1 in this embodiment is larger than the diameter of the through hole 31a2.
  • annular recess 72 is formed on the inner surface that defines the through hole 31a2 in this embodiment.
  • a plurality of annular recesses 72 are provided at different positions in the longitudinal direction A, but the number is not particularly limited.
  • the adhesive 32 enters the annular recess 72 in a fluid state before hardening. When the adhesive 32 hardens, the portion of the adhesive 32 that enters the annular recess 72 engages with the inner surface of the annular recess 72, thereby restricting the movement of the adhesive 32 and the needle tube body 2 adhered to the adhesive 32 in the longitudinal direction A relative to the hub 31.
  • the annular recess 72 by providing the annular recess 72 on the inner surface that defines the through hole 31a2 in this embodiment, the holding force of the needle tube body 2 by the holder 3 can be further increased.
  • the connecting tube portion 61, the distal wall portion 62, and the distal protrusion portion 63 are integrally formed, but this configuration is not limited to this.
  • the hub 31 may be formed, for example, by joining multiple members using various methods.
  • the hub 31 of this embodiment includes the connecting tube portion 61, the distal wall portion 62, and the distal protrusion portion 63, this configuration is not limited to this.
  • the hub 31 may have a configuration different from this embodiment as long as it is configured to define an insertion hole 31a through which the needle tube body 2 can be inserted.
  • the hub 31 may be formed from a thermoplastic such as polyethylene or polypropylene.
  • the adhesive 32 of this embodiment adheres the needle tube body 2 to the hub 31 while the needle tube body 2 is inserted through the insertion hole 31a of the hub 31. This adheres the needle tube body 2 to the hub 31.
  • the adhesive 32 of this embodiment is an adhesive that is filled in a fluid pre-cured state (hereinafter referred to as the "pre-cured state") so as to come into contact with the needle tube body 2 and the hub 31, and then hardens to adhere and fix the needle tube body 2 to the hub 31.
  • a UV-curable adhesive, a thermosetting adhesive, etc. can be used as the adhesive.
  • the adhesive 32 is filled into the insertion hole 31a in a pre-cured state. More specifically, the adhesive 32 in a pre-cured state is filled between the outer surface of the needle tube body 2 inserted into the insertion hole 31a and the inner surface of the insertion hole 31a. As a result, the space between the outer surface of the needle tube body 2 and the inner surface of the insertion hole 31a is filled with the adhesive 32 in a pre-cured state. In this state, the adhesive 32 hardens, and the needle tube body 2 is adhesively fixed to the hub 31.
  • the distal end 21a of the contact holding portion 21 of the holding body 3 is formed by the adhesive 32 that surrounds the periphery of the needle tube body 2.
  • the diameter of the recessed space 31a1 in this embodiment is larger than the diameter of the through hole 31a2.
  • the adhesive 32 in an uncured state is filled into the recessed space 31a1 in the recess 71 so as to protrude further distally than the distal end surface 63a of the distal protrusion 63 of the hub 31.
  • the cured adhesive 32 also protrudes further distally than the distal end surface 63a of the distal protrusion 63 of the hub 31.
  • the protrusion height L1 (see Figure 2) of the cured adhesive 32 from the distal end surface 63a may be 0 mm.
  • the adhesive 32 in this embodiment is configured so that its protrusion height L1 is 0 mm to 1 mm.
  • the holding body 3 in this embodiment includes the hub 31 and the adhesive 32, but is not limited to this configuration.
  • the holding body 3 may, for example, include a hub into which the needle tube body 2 is insert molded, and may not include an adhesive. In such a case, the contact holding portion 21 of the holding body 3 is formed by the hub.
  • the adhesive 32 is not limited to an adhesive.
  • the adhesive 32 may be configured to adhere and fix the needle tube body 2 to the hub 31 by welding, for example, by ultrasonic welding, laser welding, etc.
  • the thick portion 13 of the needle tube body 2 of this embodiment is an annular convex portion 81 that is formed on the outer circumferential surface of the needle tube body 2 and extends in the circumferential direction B.
  • the thick portion 13 By configuring the thick portion 13 with the annular convex portion 81 that protrudes radially outward on the outer circumferential surface of the needle tube body 2 in this way, it is possible to reduce the injection resistance of a medicinal solution such as insulin injected into a living body through the hollow portion 2a of the needle tube body 2, compared to the case where the thick portion 13 is configured with an annular convex portion that protrudes on the inner circumferential surface of the needle tube body 2, and it is possible to suppress a decrease in the operability of the injection needle 1.
  • the annular convex portion 81 as the thick portion 13 is arranged so as to straddle the position of the distal end 21a of the contact holder 21 in the longitudinal direction A. That is, the annular convex portion 81 of this embodiment is formed so as to straddle the position of the distal end 21a of the contact holder 21 from the proximal side of the position of the distal end 21a of the contact holder 21 to the distal side of the position of the distal end 21a of the contact holder 21 in the longitudinal direction A.
  • the bending force applied to the needle tube body 2 at the position of the distal end 21a of the contact holder 21, i.e., the bending force applied to the base position of the puncture portion 41 of the needle tube body 2 can be distributed and received over the entire area of the longitudinal direction A of the annular convex portion 81. Therefore, bending at the base position of the puncture portion 41 of the needle tube body 2 can be further suppressed.
  • the annular convex portion 81 as the thick portion 13 extends 1 mm or more distally from the position of the edge portion 71a of the recess 71 in the longitudinal direction A.
  • the adhesive body 32 of this embodiment is configured so that its protrusion height L1 (see FIG. 2) is 0 mm to 1 mm. Therefore, if the annular convex portion 81 as the thick portion 13 has a length of less than 1 mm distally from the position of the edge portion 71a of the recess 71 in the longitudinal direction A, and if the protrusion height L1 of the adhesive body 32 is 1 mm, the thick portion 13 is not located at the base of the puncture portion 41.
  • the reinforcing effect of the thick portion 13 cannot be obtained.
  • the protrusion height L1 may vary in the range of 0 mm to 1 mm. Therefore, by configuring the annular convex portion 81 as the thick portion 13 to extend 1 mm or more distally from the position of the edge portion 71a of the recessed portion 71 in the longitudinal direction A, the thick portion 13 can be reliably provided at the base of the puncture portion 41 even if there is variation in the above-mentioned protrusion height L1.
  • the length L2 (see FIG. 2) of the thick portion 13 from the edge portion 71a to the distal side may be, for example, 1.1 mm to 1.9 mm.
  • the length L3 (see FIG. 2) of the annular protrusion 81 as the thick portion 13 from the edge 71a to the proximal side is not particularly limited.
  • the annular protrusion 81 in this embodiment is formed so that its proximal end is located within the recess 71. From this perspective, the length L3 in this embodiment is set to be 0.1 mm to 1.2 mm.
  • the needle tube body 2 of this embodiment includes a tubular main body portion 82 extending in the longitudinal direction A, and an annular protrusion portion 81 extending in the circumferential direction B formed on the outer peripheral surface of the main body portion 82.
  • an annular protrusion portion 81 extending in the circumferential direction B formed on the outer peripheral surface of the main body portion 82.
  • the side surface 81a on the distal side in the longitudinal direction A of the annular protrusion portion 81 is an inclined surface that inclines so as to approach the outer peripheral surface of the main body portion 82 as it moves toward the needle tip 11 side (see FIG. 1, etc.) in the longitudinal direction A.
  • the side surface 81a on the distal side in the longitudinal direction A of the annular protrusion portion 81 is configured as a tapered surface that reduces in diameter toward the insertion direction A2.
  • the side surface 81a on the distal side of the annular convex portion 81 is configured by the above-mentioned inclined surface, so that the bending force applied to the needle tube body 2 at the position of the distal end 21a of the contact holder 21, i.e., the bending force applied to the base position of the puncture portion 41 of the needle tube body 2, can be received in a more distributed manner over the entire area in the longitudinal direction A of the annular convex portion 81.
  • the above cross-sectional view see Figs.
  • the side surface 81a on the distal side of the annular convex portion 81 is, for example, a surface perpendicular to the outer circumferential surface of the main body portion 82, stress is likely to concentrate at the position where the side surface 81a and the outer circumferential surface of the main body portion 82 intersect, and the puncture portion 41 may bend at this position.
  • the inclination angle ⁇ of the side surface 81a with respect to the central axis O is, for example, 0.1° to 1.0°.
  • the above-mentioned inclination angle ⁇ is defined by a tangent at an intersection position P1 where the side surface 81a intersects with the outer peripheral surface of the main body portion 82.
  • the main body portion 82 in this embodiment has a constant thickness regardless of the position in the longitudinal direction A.
  • the above-mentioned intersection position P1 in this embodiment is defined based on this premise.
  • the side surface 81b on the proximal side in the longitudinal direction A of the annular protrusion 81 is an inclined surface that inclines so as to approach the outer circumferential surface of the main body portion 82 as it approaches the proximal end 12 side in the longitudinal direction A, but is not limited to this configuration.
  • the proximal side surface 81b is located within the adhesive 32, so in the above cross-sectional view (see Figs.
  • the side surface 81b on the proximal side in the longitudinal direction A of the annular protrusion 81 may be, for example, a surface perpendicular to the outer circumferential surface of the main body portion 82.
  • the side surface 81b is also an inclined surface as in this embodiment.
  • the inclination angle ⁇ of the side surface 81b with respect to the central axis O is not particularly limited, but may be, for example, 0.1° to 11.0°.
  • the above-mentioned inclination angle ⁇ is defined by the tangent at the intersection position P2 where the side surface 81b intersects with the outer peripheral surface of the main body portion 82.
  • the main body portion 82 in this embodiment has a constant thickness regardless of the position in the longitudinal direction A. It is based on this premise that the above-mentioned intersection position P2 in this embodiment is defined.
  • annular protrusion 81 as the thick portion 13 in this embodiment has an arc-shaped outer surface in the above cross-sectional view (see Figures 2 and 4), but is not limited to this configuration.
  • the annular protrusion 81 may have, for example, a trapezoidal outer surface in the above cross-sectional view (see Figures 2 and 4).
  • the maximum thickness T1 (see Fig. 4) at the position of the thick portion 13 of the needle tube body 2 is the maximum thickness of the needle tube body 2.
  • the needle tube body 2 of this embodiment does not have a portion having a thickness greater than the maximum thickness T1 at any position other than the position of the thick portion 13 in the longitudinal direction A. Therefore, the maximum thickness T1 of the thick portion 13 of the needle tube body 2 is thicker than the thickness of any position proximal to the thick portion 13 of the needle tube body 2, and is thicker than the thickness of any position distal to the thick portion 13 of the needle tube body 2.
  • the annular convex portion 81 as the thick portion 13 in this embodiment is formed so as to have a maximum thickness T1 at the position of the edge portion 71a of the recess 71 in the longitudinal direction A.
  • the protruding height L1 (see FIG. 2) of the adhesive body 32 in this embodiment may be 0 mm.
  • the base of the puncture portion 41 is located at the position of the edge portion 71a of the recess 71 in the longitudinal direction A.
  • the annular convex portion 81 as the thick portion 13 is formed so as to have a maximum thickness T1 at the position of the edge portion 71a of the recess 71 in the longitudinal direction A so that the position of the base of the puncture portion 41 is reliably reinforced.
  • the outer diameter of the puncture portion 41 of the needle tube body 2 is small from the viewpoint of reducing puncture resistance.
  • the inner diameter of the puncture portion 41 of the needle tube body 2 is large from the viewpoint of reducing the injection resistance of medicinal liquids such as insulin. Taking these two points into consideration, it is preferable that the maximum outer diameter of the main body portion 82 of the needle tube body 2 at the position of the puncture portion 41 is set to 0.18 mm to 0.5 mm, and the wall thickness of the main body portion 82 of the needle tube body 2 at the position of the puncture portion 41 is set to 0.02 mm to 0.06 mm.
  • FIG. 5 is a flowchart showing an example of a method for manufacturing the injection needle 1.
  • the manufacturing method shown in FIG. 5 includes a needle tube body obtaining step S1 for obtaining the needle tube body 2 (see FIG. 1, etc.), and a fixing step S2 for adhesively fixing the needle tube body 2 to a hub 31 (see FIG. 1, etc.) formed separately from the needle tube body 2.
  • the needle tube body obtaining process S1 includes a tubular body obtaining process S1-1 for obtaining a tubular body in a state before the blade surface of the needle tube body 2 is formed, a blade surface forming process S1-2 for forming a blade surface on the end surface of one end side of the tubular body to form the needle tube body 2, and a polishing process S1-3 for polishing the formed needle tube body 2 using various polishing processes such as electrolytic polishing.
  • the tubular body obtaining step S1-1 can be performed by various known methods, and may include, for example, as shown in FIG. 5, a receiving step S1-1-1 in which a band-shaped metal plate material is received in a press molding machine, a press molding step S1-1-2 in which the plate material is continuously press molded by the press molding machine to obtain a plurality of tubular sections, some of which are connected to the plate material, a joining step S1-1-3 in which the seams of the tubular sections are welded or bonded with an adhesive to form a tubular body, and a separation step S1-1-4 in which the tubular body, in a state before the blade surface of the needle tube body 2 is formed, is separated from the plate material.
  • the thick portion 13 of the needle tube body 2 may be formed, for example, in the press molding step S1-1-2, by compressing the tubular portion from both sides in the axial direction, thereby causing a part of the outer circumferential surface to protrude radially outward.
  • the method of forming the thick portion 13 of the needle tube body 2 is not limited to this method.
  • the thick portion 13 may be formed, for example, by a convex rib that is formed in advance on the plate material before the press molding step S1-1-2.
  • a tubular portion may be formed by press processing, and a knurling process may be applied to the outer peripheral surface of the needle tube body 2 at a position that is held by the hub 31. In this way, the holding force of the needle tube body 2 by the hub 31 can be increased.
  • a blade surface is formed on one end surface of the tubular body obtained in the tubular body obtaining step S1-1, which will become the distal end surface 41a of the needle tube body 2.
  • the blade surface may be formed, for example, by grinding with a grindstone.
  • the method of forming the blade surface is not limited to this method.
  • the blade surface may be formed by wire cutting or the like instead of grinding with a grindstone.
  • the blade surface may be formed in the press molding step S1-1-2 in the above-mentioned tubular body obtaining step S1-1.
  • the needle tube body 2 (see FIG. 1, etc.) acquired in the needle tube body acquisition step S1 is adhesively fixed to the hub 31 (see FIG. 1, etc.).
  • the needle tube body 2 is inserted into the insertion hole 31a (see FIG. 1, etc.) of the hub 31 and positioned relative to the hub 31.
  • adhesive is injected into the insertion hole 31a from the recess 71 (see FIG. 1, etc.) to fill the gap between the inner circumferential surface defining the insertion hole 31a of the hub 31 and the outer circumferential surface of the needle tube body 2.
  • the adhesive is cured to form an adhesive body 32 (see FIG. 1, etc.), thereby adhesively fixing the needle tube body 2 to the hub 31.
  • the injection needle 1 can be manufactured.
  • the manufacturing method of the injection needle 1 is not limited to the manufacturing method shown in FIG. 5, and it may be manufactured by another manufacturing method.
  • the injection needle according to the present invention is not limited to the specific configuration shown in the above-mentioned embodiment, and various modifications, changes, and combinations are possible without departing from the scope of the claims.
  • the holder 3 is provided with a hub 31 that can be connected to the tip of a so-called pen-type syringe, but the shape of the hub 31 can be changed as appropriate depending on the configuration of the medical device to be connected.
  • the present invention relates to an injection needle.
  • Injection needle 2 Needle tube body 2a: Hollow portion 3: Holder 11: Needle tip 12 of needle tube body: Proximal end 13 of needle tube body: Thick portion 21: Contact holding portion 21a: Distal end 31 of contact holding portion: Hub 31a: Insertion hole 31a1: Recessed space 31a2: Through hole 32: Adhesive 41: Puncture portion 41a: Distal end surface 42 of needle tube body: Held portion 43: Connection portion 51: Proximal side portion 52 of puncture portion: Distal side portion 61 of puncture portion: Connection tube portion 61a: Female thread portion 62: Distal wall portion 63: Distal protruding portion 63a: Distal end surface 71 of distal protruding portion: Recess 71a: Edge portion 71b of recess: Bottom portion 72 of recess: Annular recess 81: Annular protruding portion (an example of a thick portion) 81a: Distal side of annular convexity 81b: Proxi

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Cette aiguille d'injection comprend un corps de tube d'aiguille ayant une surface d'extrémité distale qui comprend une pointe d'aiguille, et un corps de maintien qui maintient le corps de tube d'aiguille dans un état dans lequel la surface d'extrémité distale est exposée à l'extérieur. Le corps de maintien comprend une section de maintien de contact qui maintient le corps de tube d'aiguille en étant en contact avec la surface périphérique externe du corps de tube d'aiguille. Le corps de tube d'aiguille a une section de paroi épaisse à l'emplacement de l'extrémité distale, dans la direction longitudinale, de la section de maintien de contact, la section de paroi épaisse ayant une épaisseur de paroi qui est supérieure à l'épaisseur de paroi à l'emplacement de la surface d'extrémité distale.
PCT/JP2024/000995 2023-02-10 2024-01-16 Aiguille d'injection Ceased WO2024166623A1 (fr)

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JP2024576192A JPWO2024166623A1 (fr) 2023-02-10 2024-01-16

Applications Claiming Priority (2)

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JP2023019439 2023-02-10

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PCT/JP2024/000995 Ceased WO2024166623A1 (fr) 2023-02-10 2024-01-16 Aiguille d'injection

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JP (1) JPWO2024166623A1 (fr)
WO (1) WO2024166623A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747124A (ja) * 1993-08-04 1995-02-21 Hisao Kataoka 注射器
JP2004248694A (ja) * 2003-02-18 2004-09-09 Terumo Corp 医療用針
JP2011011000A (ja) * 2009-07-06 2011-01-20 Terumo Corp 針管、医療器具および医療器具の製造方法
JP2011015895A (ja) * 2009-07-10 2011-01-27 Olympus Corp 金属管と樹脂管との接合体およびその製造方法
WO2013115184A1 (fr) * 2012-01-31 2013-08-08 テルモ株式会社 Aiguille hypodermique et sa méthode de fabrication

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747124A (ja) * 1993-08-04 1995-02-21 Hisao Kataoka 注射器
JP2004248694A (ja) * 2003-02-18 2004-09-09 Terumo Corp 医療用針
JP2011011000A (ja) * 2009-07-06 2011-01-20 Terumo Corp 針管、医療器具および医療器具の製造方法
JP2011015895A (ja) * 2009-07-10 2011-01-27 Olympus Corp 金属管と樹脂管との接合体およびその製造方法
WO2013115184A1 (fr) * 2012-01-31 2013-08-08 テルモ株式会社 Aiguille hypodermique et sa méthode de fabrication

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