WO2023120082A1 - Aiguille de ponction - Google Patents

Aiguille de ponction Download PDF

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Publication number
WO2023120082A1
WO2023120082A1 PCT/JP2022/044266 JP2022044266W WO2023120082A1 WO 2023120082 A1 WO2023120082 A1 WO 2023120082A1 JP 2022044266 W JP2022044266 W JP 2022044266W WO 2023120082 A1 WO2023120082 A1 WO 2023120082A1
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WIPO (PCT)
Prior art keywords
needle
tip
needle body
puncture needle
puncture
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PCT/JP2022/044266
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English (en)
Japanese (ja)
Inventor
神原佳世
藤間大貴
Original Assignee
テルモ株式会社
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Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023120082A1 publication Critical patent/WO2023120082A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light

Definitions

  • the present invention relates to a puncture needle.
  • a puncture needle used for photoimmunotherapy or the like includes a needle member and a support member.
  • the needle member has a hollow needle body that is pierced into tissue inside the skin of the human body. The tip of the lumen of the needle body is closed.
  • the support member is detachable from the needle member.
  • the support member has a shaft portion that is inserted into the lumen of the needle body in an attached state in which the support member is attached to the needle member.
  • Such a puncture needle is configured so that the tip of the shaft does not hit the inner surface of the tip of the needle body in the attached state so that the shaft part can be reliably inserted into the needle body lumen.
  • Japanese Patent No. 3171525 discloses a needle structure in which a concave portion is formed on the inner peripheral surface of the outer needle or the outer peripheral surface of the inner needle for reflecting ultrasonic waves under echo. According to such a configuration, it is possible to easily visually recognize the outer needle or the inner needle in the ultrasonic image.
  • the puncture needle if the outer surface of the needle body is provided with a concave portion for reflecting ultrasonic waves under echo, the puncture needle can be easily visually recognized in the ultrasonic image.
  • the puncture needle has a space between the inner surface of the distal end and the distal end of the shaft portion in the attached state. That is, the portion of the needle body surrounding the space (space adjacent portion) is not supported by the shaft portion, and thus has lower strength than the portion supported by the shaft portion. If a concave portion is provided in such a space-adjacent portion, there is a possibility that sufficient strength cannot be secured in the space-adjacent portion.
  • An object of the present invention is to solve the above-described problems.
  • One aspect of the present invention includes a needle member having a hollow needle body that is pierced into tissue inside the skin of a human body, and a support member having a shaft portion that is inserted into the lumen of the needle body,
  • the support member is attachable to and detachable from the needle member, the outer surface of the needle body is formed with a recess for reflecting ultrasonic waves under echo, and the tip of the lumen of the needle body is the needle body. is blocked by the inner surface of the distal end of the needle body, and in a mounting state in which the shaft portion is inserted into the lumen of the needle body and the support member is mounted on the needle member, there is a gap between the inner surface of the distal end and the distal end of the shaft portion.
  • a space is formed, the needle body has a space-adjacent portion surrounding the space, and the recess is provided only in a portion of the outer surface of the needle body other than the space-adjacent portion;
  • a puncture needle is
  • the puncture needle since the concave portion for reflecting ultrasonic waves under echo is formed on the outer surface of the needle body, the puncture needle can be easily visually recognized in the ultrasonic image.
  • the recess since the recess is not formed in the space-adjacent portion of the needle body, it is possible to prevent the strength of the space-adjacent portion from being excessively lowered by the recess.
  • FIG. 1 is a side view of a puncture needle according to one embodiment of the present invention.
  • 2 is an exploded side view of the puncture needle of FIG. 1;
  • FIG. 3 is a partially enlarged longitudinal sectional view of the puncture needle of FIG. 1.
  • FIG. 4 is a first explanatory diagram of photoimmunotherapy.
  • FIG. 5 is a second explanatory diagram of photoimmunotherapy.
  • FIG. 6 is a third explanatory diagram of photoimmunotherapy.
  • FIG. 7 is a partially enlarged vertical cross-sectional view of a puncture needle according to a first modified example.
  • FIG. 8 is a partially enlarged vertical cross-sectional view of a puncture needle according to a second modification.
  • FIG. 9A is a partially enlarged longitudinal sectional view of the first sample.
  • FIG. 9B is a partially enlarged longitudinal sectional view of the second sample.
  • FIG. 9C is a partially enlarged longitudinal sectional view of the third to fifth samples.
  • FIG. 10 is an explanatory diagram of the strength test.
  • FIG. 11 is a table showing strength test results and photographs of needle tips.
  • the puncture needle 10 can puncture a lesion 200 (see FIG. 4) such as cancer cells located in the tissue inside the skin of the human body. is.
  • the puncture needle 10 is a medical device for inserting a light irradiation section 314 (see FIG. 6) for irradiating light for treatment into the lesion 200 .
  • the puncture needle 10 is used, for example, after administering a drug containing a substance that binds to a lesion site such as cancer cells and a photosensitizer to the patient 202 (see FIG. 4), which will be described later in detail, and the lesion bound to the drug. It is used as a treatment device for photoimmunotherapy that treats a lesion 200 by irradiating the part 200 with light.
  • the puncture needle 10 can also be used as an interstitial irradiation treatment device that punctures a lesion 200 (tumor) such as cervical cancer or prostate cancer and irradiates the lesion 200 with radiation.
  • the puncture needle 10 includes a support member 12 and a needle member 14.
  • Support member 12 is an obturator that supports needle member 14 .
  • the support member 12 is detachable from the needle member 14 .
  • the support member 12 has a unidirectionally extending shaft portion 16 and a support hub 18 .
  • Needle member 14 has a hollow needle body 20 and a needle hub 22 .
  • the shaft portion 16 In the state before use (initial state), the shaft portion 16 is removably inserted into the lumen 24 of the needle body 20 (see FIG. 3).
  • the shaft portion 16 is rigid, and supports the needle body 20 when the puncture needle 10 punctures the lesion 200 .
  • the shaft portion 16 extends like a bar. In other words, the shaft portion 16 is formed in a cylindrical shape.
  • the shaft portion 16 has a substantially constant outer diameter over its entire length.
  • the shaft portion 16 has a flat distal end surface 26 (see FIG. 3) extending in a direction perpendicular to the axial direction of the shaft portion 16 .
  • the tip surface 26 is not limited to this example, which is a flat surface extending in a direction orthogonal to the axial direction of the shaft portion 16.
  • the tip surface 26 is gently inclined to a surface orthogonal to the axial direction of the shaft portion 16. It may be a flat surface.
  • the distal end surface 26 may be a curved surface protruding in a hemispherical shape toward the distal direction (leftward in FIG. 3).
  • the distal end surface 26 may be a curved surface projecting conically toward the distal direction.
  • the shaft portion 16 is made of, for example, a metal material. Examples of metal materials include stainless steel.
  • the shaft portion 16 may be made of a metal material other than stainless steel. Also, the shaft portion 16 may be made of a resin material, a ceramic material, or the like.
  • the cross section of the shaft portion 16 may be polygonal (triangular, quadrangular, or the like).
  • the shaft portion 16 may be formed hollow (tubular).
  • the support hub 18 is attached to the proximal end of the shaft portion 16 .
  • the support hub 18 has a size and shape that facilitates manual manipulation.
  • the support hub 18 is made of hard resin material.
  • Support hub 18 is detachable from needle hub 22 .
  • Support hub 18 has internal threads 23 for connecting needle hub 22 .
  • the needle member 14 is an integrally molded product made of a resin material in this embodiment.
  • the needle hub 22 may be joined to the proximal end of the needle hub 22 .
  • the needle body 20 is pierced into the tissue inside the skin of the human body.
  • the needle body 20 is rigid.
  • the resin material forming the needle body 20 is preferably polyacetal (POM), for example.
  • POM polyacetal
  • the resin material forming the needle body 20 may be, for example, polycarbonate, polypropylene, or the like. Needle body 20 and needle hub 22 may be constructed of different materials.
  • the length (effective length La) of the puncture portion 28 of the needle 20 is preferably set to 10 mm or more and 300 mm or less, more preferably 30 mm or more and 100 mm or less.
  • the effective length La of the needle 20 is set to 50 mm, 70 mm, or 100 mm, for example.
  • the user selects the puncture needle 10 having the needle body 20 with an appropriate effective length La according to the depth and size of the lesion 200 .
  • the needle body 20 includes a tubular needle body 30 and a needle distal end portion 32 protruding from the distal end portion of the needle body 30 in the distal direction.
  • the cross-sectional shape of the outer surface 30a of the needle body 30 is circular.
  • the cross-sectional shape of the inner peripheral surface 30b of the needle body 30 is circular.
  • the outer diameter Da of the needle body 30 is preferably set to 1.0 mm or more and 2.0 mm or less, and more preferably set to 1.3 mm or more and 1.7 mm or less. Specifically, it is set to 1.5 mm, for example.
  • the inner diameter Db of the needle body 30 is set to a size that allows the light irradiation section 314 (see FIG. 6) to be inserted after the shaft section 16 is removed from the needle body 30 .
  • the inner diameter Db (the diameter of the lumen 24 ) of the needle body 30 is set to 0.5 mm or more in order to secure a space for inserting the light irradiation section 314 into the lumen 24 .
  • An inner diameter Db of the needle body 30 is slightly larger than the outer diameter of the shaft portion 16 .
  • a gap is formed between the inner peripheral surface 30 b of the needle body 30 and the outer peripheral surface of the shaft portion 16 as an air vent when the shaft portion 16 is inserted into the lumen 24 of the needle body 20 .
  • the thickness T of the needle body 30 is preferably set to 50 ⁇ m or more and 350 ⁇ m or less, more preferably 100 ⁇ m or more and 300 ⁇ m or less, and even more preferably 150 ⁇ m or more and 250 ⁇ m or less. Specifically, the thickness T of the needle body 30 is set to 200 ⁇ m.
  • the needle body 20 has a tip inner surface 38 that closes the tip of the lumen 24 of the needle body 20 .
  • the tip inner surface 38 extends in a direction orthogonal to the axial direction of the needle body 20 .
  • the tip inner surface 38 extends in a direction orthogonal to the axial direction of the needle body 20 so as to correspond to the flat tip surface 26 extending in a direction orthogonal to the axial direction of the shaft portion 16.
  • the distal end surface 26 preferably has a shape corresponding to the distal end inner surface 38 .
  • the needle tip portion 32 is located at the tip (one end) of the needle body 30 .
  • An outer surface 32a of the needle tip portion 32 has a tapered surface 40 whose diameter is reduced toward the tip.
  • Tapered surface 40 has a so-called exponential tapered shape.
  • a taper angle ⁇ of the tapered surface 40 is set to 15° or more and 35° or less.
  • the taper angle ⁇ refers to the taper angle of the distal end of the needle tip 32 .
  • the tip inner surface 38 is positioned in the proximal direction of the needle body 20 from the proximal end of the tapered surface 40 .
  • the outer surface 32a of the needle tip portion 32 may have a so-called linear tapered tapered surface 40a (see the phantom line in FIG. 3) instead of the tapered surface 40 described above.
  • the needle hub 22 is provided at the proximal end of the needle body 20. As shown in FIG. Needle hub 22 has a size and shape that facilitates manual manipulation.
  • the needle hub 22 is hollow. That is, needle hub 22 includes a lumen that communicates with lumen 24 of needle body 20 .
  • the needle hub 22 has external threads 42 that screw onto the internal threads 23 of the support hub 18 . That is, needle hub 22 is removably threaded to support hub 18 .
  • the support member 12 is attached to the needle member 14 by screwing the support hub 18 onto the needle hub 22 while the shaft portion 16 is inserted into the lumen 24 of the needle body 20 .
  • the length of the lumen 24 along the axial direction of the needle body 20 is determined by the dimensional tolerance of the support member 12 and the needle member 14 when the shaft portion 16 is inserted into the lumen 24 of the needle body 20 . is set longer than the length along the axial direction of the portion of the shaft portion 16 that is inserted into the lumen 24 of the needle body 20 so that the tip inner surface 38 is not contacted. Therefore, as shown in FIG. 3, when the support member 12 is attached to the needle member 14, a space 44 exists between the distal end inner surface 38 and the distal end of the shaft portion 16 (distal surface 26).
  • the outer surface 20a of the needle 20 is formed with a recess 46 for reflecting ultrasonic waves under echo.
  • the concave portion 46 is formed on the outer surface 20a of the needle body 20 by, for example, laser processing, cutting, rolling, press processing, or the like.
  • the recessed portion 46 is formed, for example, only in a portion of the puncture portion 28 of the needle body 20 (see FIG. 1).
  • the recessed portion 46 is provided at a position that does not overlap with the space 44 when the support member 12 is attached to the needle member 14 and viewed from a direction orthogonal to the axial direction of the needle member 20 .
  • the concave portion 46 is not provided in the space adjacent portion 60 surrounding the space 44 of the needle body 20 . That is, the recessed portion 46 is provided at a position shifted in the axial direction of the needle body 20 with respect to the space adjacent portion 60 on the outer surface 20 a of the needle body 20 .
  • the concave portion 46 is provided only in a portion of the outer surface 20 a of the needle body 20 other than the space adjacent portion 60 .
  • the recess 46 has a body groove portion 48 and a tip groove portion 50 .
  • the body groove portion 48 is formed narrower in the depth direction of the body groove portion 48 .
  • the cross section of the body groove portion 48 is V-shaped.
  • the distal end of the body groove portion 48 in the axial direction of the needle 20 is positioned closer to the proximal end of the needle 20 than the space 44 (the distal end surface 26 of the shaft portion 16) when the support member 12 is mounted on the needle member 14. do.
  • the body groove portion 48 is provided in a portion of the needle body 30 surrounding the shaft portion 16 when the support member 12 is attached to the needle member 14 .
  • the body groove portion 48 includes a single spiral groove 52 .
  • the groove width, groove depth and pitch of the spiral groove 52 can be set as appropriate.
  • the shape and position of the body groove portion 48 can be set as appropriate.
  • the body groove portion 48 may have, for example, a spiral groove with multiple windings. Further, the body groove portion 48 may have, for example, a plurality of annular grooves extending around the needle body 30 in the circumferential direction.
  • the length of the spiral groove 52 (groove length Lb) along the axial direction of the needle body 20 is preferably set to 1 mm or more and 100 mm or less. Specifically, the groove length Lb is set to 10 mm, for example.
  • the tip groove portion 50 is positioned in the tip direction of the needle body 20 from the tip inner surface 38 . That is, the needle body 20 has an unprocessed region 53 between the body groove portion 48 and the tip groove portion 50 of the needle body 20 .
  • the tip groove portion 50 is provided on the tapered surface 40 .
  • the length (groove length Lc) of the tip groove portion 50 along the axial direction of the needle body 20 is preferably set to 1 mm or more and 3 mm or less, and is set to 1.8 mm, for example.
  • the tip groove portion 50 is formed narrower in the depth direction of the tip groove portion 50 . In other words, the cross section of the tip groove portion 50 is V-shaped.
  • the tip groove portion 50 has a plurality of annular grooves 54 extending around the needle body 20 in the circumferential direction.
  • the plurality of annular grooves 54 are provided at intervals in the axial direction of the needle body 20 .
  • Each annular groove 54 extends circularly.
  • Each annular groove 54 extends parallel to a plane orthogonal to the axial direction of the needle body 20 .
  • each annular groove 54 may extend so as to be inclined with respect to a plane perpendicular to the axial direction of the needle body 20 .
  • the cross-sectional shape and size of the plurality of annular grooves 54 are the same.
  • the groove width, groove depth and pitch of the annular groove 54 are set in the same manner as the groove width, groove depth and pitch of the spiral groove 52 described above.
  • the groove width, groove depth and pitch of the annular groove 54 may differ from the groove width, groove depth and pitch of the spiral groove 52 described above.
  • the tip groove portion 50 is not limited to the configuration having a plurality of annular grooves 54 .
  • the tip groove portion 50 may have, for example, a single-wound spiral groove or a multi-wound spiral groove.
  • a distance Ld along the axial direction of the needle body 20 between the distal end 56 (needle point) of the needle body 20 and the distal end 58 of the needle body 20 in the distal groove portion 50 in the axial direction (hereinafter referred to as the distal end separation distance Ld) is It is preferably set to 1.0 mm or more, and is set to 1.3 mm, for example.
  • the distance Le from the tip (tip inner surface 38) of the lumen 24 of the needle 20 to the tip in the axial direction of the needle 20 in the body groove 48 is longer than the length Lf of the space 44 along the axial direction of the needle 20. set to be long.
  • the distance Le is preferably set to 1.0 mm or more and 5.0 mm or less, and is set to 1.6 mm, for example.
  • photoimmunotherapy treats, for example, cancer cells located in the tissue of the head and neck (inside the skin).
  • the puncture needle 10 may be used when treating cancer cells in parts other than the head and neck region. That is, the puncture needle 10 may be used as an interstitial radiation therapy device that irradiates radiation to cancer cells such as cervical cancer or prostate cancer while being punctured.
  • the puncture needle 10 may also be used for treatment of lesions 200 other than cancer cells.
  • a drug containing a substance that binds to the lesion 200 such as cancer cells and a photosensitizer is administered to the patient 202 (see FIG. 4) by intravenous drip or the like.
  • the drug for example, cetuximab sarotarocan sodium is used.
  • a predetermined period of time for example, 20 hours
  • the drug binds to the lesion 200 (cancer cells) in the head and neck region.
  • the user inserts the shaft portion 16 into the lumen 24 of the needle body 20 and screws the female threaded portion 23 of the support hub 18 into the male threaded portion 42 of the needle hub 22 .
  • the support member 12 is fixed to the needle member 14 .
  • a space 44 is formed between the distal end inner surface 38 of the needle 20 and the distal end surface 26 of the shaft portion 16 .
  • the user punctures the lesion 200 with the puncture needle 10 while viewing the ultrasonic image displayed on the ultrasonic diagnostic imaging apparatus 300 . That is, the puncture needle 10 is punctured into the lesion 200 under echo.
  • the needle body 20 is rigid, it hardly bends. That is, the needle body 20 is pierced into the tissue inside the skin of the human body in a substantially straight state.
  • the puncture needle 10 is punctured into the lesion 200 while transmitting ultrasonic waves from the ultrasound probe 302 pressed against the skin toward the lesion 200 .
  • the ultrasonic waves are reflected by the concave portion 46 formed on the outer surface 20 a of the needle 20 .
  • reflected waves reflected by the concave portion 46 of the needle body 20 are received by the ultrasonic probe 302 .
  • the ultrasonic diagnostic imaging apparatus 300 creates an ultrasonic image based on the reflected waves received by the ultrasonic probe 302 and displays it on a display unit (not shown). Accordingly, the user can easily determine whether or not the puncture needle 10 is punctured at the target position of the lesion 200 by viewing the ultrasound image. Since the tip of the lumen 24 of the needle body 20 is closed by the needle distal end portion 32 (see FIG. 3), blood does not flow into the lumen 24 of the needle body 20 .
  • the user After puncturing the lesion 200 with the puncture needle 10, the user removes the support member 12 from the needle member 14 as shown in FIG.
  • the laser system 310 has a laser body (not shown) that oscillates laser light, an optical fiber 312 connected to the laser body, and a columnar light irradiation part 314 provided at the tip of the optical fiber 312 .
  • the laser body has a semiconductor laser element.
  • the light irradiation section 314 emits the laser light guided from the optical fiber 312 radially outward of the light irradiation section 314 .
  • the peak wavelength of laser light emitted from the laser body is, for example, 690 nm. However, the wavelength (wavelength range and peak wavelength) of the laser light can be appropriately set depending on the lesion 200, the type of drug, and the like.
  • the light irradiation section 314 of the laser system 310 is inserted into the lumen 24 of the needle body 20 from the proximal direction of the needle hub 22 .
  • laser light is oscillated from the laser body.
  • the laser light is guided to the light irradiation section 314 via the optical fiber 312 and emitted from the light irradiation section 314 outward in the radial direction of the light irradiation section 314 .
  • the lesion 200 is irradiated with laser light.
  • the photosensitizer bound to the lesion 200 reacts with the laser beam, destroying the lesion 200 (cancer cells).
  • the present embodiment has the following effects.
  • the puncture needle 10 can be easily recognized visually in the ultrasonic image. Moreover, since the recessed portion 46 is not formed in the space adjacent portion 60 of the needle body 20 , it is possible to prevent the strength of the space adjacent portion 60 from being excessively lowered by the recessed portion 46 .
  • the needle body 20 has a tubular needle body 30 and a needle distal end portion 32 provided at the distal end portion of the needle body 30 .
  • the outer surface 32a of the needle tip portion 32 includes a tapered surface 40 that decreases in diameter toward the tip.
  • the needle body 20 can be smoothly punctured into the tissue inside the skin of the human body.
  • the concave portion 46 has a tip groove portion 50 provided on the tapered surface 40 .
  • a tip separation distance Ld along the axial direction of the needle body 20 between the tip groove 50 in the axial direction of the needle body 20 and the tip end of the needle tip portion 32 is 1.0 mm or more.
  • the taper angle ⁇ of the needle tip portion 32 is 15° or more and 35° or less.
  • the tip groove portion 50 has an annular groove 54 extending one round in the circumferential direction of the needle body 20 .
  • the appearance of the needle tip portion 32 in the ultrasonic image does not change depending on the circumferential orientation of the needle body 20 .
  • the tip groove portion 50 can be formed relatively easily on the tapered surface 40 .
  • a plurality of annular grooves 54 are provided at intervals in the axial direction of the needle body 20 .
  • the recess 46 has a body groove 48 provided on the outer surface 30 a of the needle body 30 .
  • the body groove portion 48 is provided in a portion of the needle body 30 surrounding the shaft portion 16 when the support member 12 is attached to the needle member 14 .
  • the needle body 30 it is possible to make the needle body 30 easier to see in the ultrasonic image. Further, since the body groove portion 48 is provided in the portion of the needle body 30 supported by the shaft portion 16, breakage of the needle body 30 can be suppressed during the puncture procedure.
  • a light irradiation section 314 that irradiates therapeutic light can be inserted into the lumen 24 of the needle body 20 with the shaft section 16 removed from the needle body 20 .
  • the needle body 20 has an unprocessed region 53 in which the concave portion 46 is not formed between the tip groove portion 50 and the body groove portion 48 .
  • Tip inner surface 38 is located in unmachined region 53 .
  • the tip of the light irradiation section 314 comes close to the tip inner surface 38.
  • the tip of the light irradiation section 314 can be easily positioned in the unprocessed region 53 . Therefore, the tip position of the light irradiation unit 314 can be easily recognized in the ultrasonic image.
  • the puncture needle 10 is not limited to the configuration described above. As shown in FIG. 7 , the groove depth of tip groove portion 50 (plurality of annular grooves 54 ) may be shallower as it approaches tip end 56 of needle body 20 . Also, as shown in FIG. 8 , the recess 46 may have only the body groove 48 . That is, the concave portion 46 does not have to have the tip groove portion 50 . In this case, the lumen 24 of the needle body 20 may extend conically to the needle tip 32 . Further, recess 46 may have only tip groove 50 (not shown).
  • sample 100A In this test, as shown in FIGS. 9A to 9C, a first sample 100A, a second sample 100B, a third sample 100C, a fourth sample 100D and a fifth sample 100E were prepared.
  • first to fifth samples 100A to 100E the same reference numerals are given to the same configurations as the above-described puncture needle 10, and detailed description thereof will be omitted.
  • the first sample 100A is different from the puncture needle 10 described above in that it does not have the concave portion 46 .
  • the second sample 100B has a plurality of annular grooves 54 on the tapered surface 40 of the needle body 20 and the outer surface of the space adjacent portion 60 .
  • the tip separation distance Ld of the second sample 100B is 1.3 mm.
  • the third to fifth samples 100C to 100E have a plurality of annular grooves 54 only on the tapered surface 40 of the needle body 20.
  • the tip separation distance Ld of the third sample 100C is 0.7 mm.
  • the tip separation distance Ld of the fourth sample 100D is 1.0 mm.
  • the tip separation distance Ld of the fifth sample 100E is 1.3 mm.
  • the taper angle ⁇ is set to 31° for each of the first to fifth samples 100A to 100E.
  • a strength test was performed on the first to fifth samples 100A to 100E.
  • the third sample 100C will be described here, the same applies to the first sample 100A, the second sample 100B, the fourth sample 100D and the fifth sample 100E.
  • the leading edge 56 of the third sample 100C is placed on the surface 154a of the plate member 154.
  • the third sample 100C was pushed vertically toward it until it broke, and the breaking strength at this time was measured.
  • the pressing speed of the third sample 100C is 50 mm/min.
  • the strength evaluation was evaluated in two stages, A and B. Specifically, A was assigned to the strength evaluation of the first sample 100A that did not have the concave portion 46 . Further, A was also given to the strength evaluation when the breaking strength was approximately the same as the breaking strength of the first sample 100A. B was the strength evaluation when the breaking strength was significantly lower than the breaking strength of the first sample 100A.
  • the needle tip portion 32 was photographed from the direction perpendicular to the axis of the needle body 20 in each of the first to fifth samples 100A to 100E.
  • each of the first to fifth samples 100A to 100E was broken at the space adjacent portion 60 of the needle body 20 .
  • the strength evaluation was A for the first sample 100A, the third sample 100C, the fourth sample 100D and the fifth sample 100E, and the strength evaluation was B for the second sample 100B.
  • the annular groove 54 in the portion other than the space adjacent portion 60 of the outer surface 20a of the needle body 20, it is possible to suppress excessive decrease in the breaking strength of the space adjacent portion 60. rice field.
  • This embodiment discloses the following contents.
  • the above embodiment comprises a needle member (14) having a hollow needle body (20) that is pierced into tissue inside the skin of a human body, and a shaft portion (16) that is inserted into the lumen (24) of the needle body (24). and a support member (12), which is detachable from the needle member, the outer surface (20a) of the needle member having a recess (46) for reflecting ultrasound under echo. ) is formed, the distal end of the lumen of the needle body is closed by the distal end inner surface (38) of the needle body, the shaft portion is inserted into the lumen of the needle body, and the support member is inserted into the needle.
  • a space (44) is formed between the inner surface of the distal end and the distal end of the shaft portion when the needle body is attached to the member, and the needle body has a space adjacent portion (60) surrounding the space.
  • the puncture needle (10) is disclosed in which the concave portion is provided only in a portion other than the space adjacent portion of the outer surface of the needle body.
  • the needle body has a tubular needle body (30) and a needle tip (32) provided at the tip of the needle body, and the outer surface (32a) of the needle tip is ) may include a tapered surface (40) that tapers in the distal direction.
  • the recess may have a tip groove (50) provided on the tapered surface.
  • the distance (Ld) along the axial direction of the needle body between the distal end (56) of the needle body and the distal end (58) of the tip groove portion in the axial direction of the needle body is 1. 0 mm or more, and the taper angle ( ⁇ ) of the tip of the needle may be 15° or more and 35° or less.
  • the tip groove portion may have an annular groove (54) extending around the circumference of the needle body.
  • a plurality of the annular grooves may be provided at intervals in the axial direction of the needle body.
  • the recess has a body groove (48) provided on the outer surface (30a) of the needle body, and the body groove is configured to support the shaft portion of the needle body in the mounted state. It may be provided in the surrounding portion.
  • a light irradiation section (314) for irradiating treatment light can be inserted into the lumen of the needle body with the shaft section removed from the needle body.
  • the groove depth of the tip groove portion may be shallower toward the tip of the tip groove portion in the axial direction of the needle body.
  • the puncture needle may be used for photoimmunotherapy.

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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne une aiguille de ponction (10) comprenant une aiguille (20) avec une partie évidée (46) formée dans une surface externe (20a). Dans un état installé dans lequel une section d'arbre (16) est insérée dans une cavité interne (24) de l'aiguille (20) et un élément de support (12) installé sur un élément d'aiguille (14), un espace (44) est formé entre une surface interne de pointe (38) et une pointe (surface de pointe (26)) de la partie d'arbre (16). L'aiguille (20) comprend une partie adjacente à l'espace (60) entourant l'espace (44). La partie évidée (46) est disposée uniquement dans la surface externe (20a) de l'aiguille (20) à l'exception de la partie adjacente à l'espace (60).
PCT/JP2022/044266 2021-12-24 2022-11-30 Aiguille de ponction WO2023120082A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11508173A (ja) * 1996-04-04 1999-07-21 ゾーマテクス メディツィンテヒニッシェ インストルメンテ ゲゼルシャフト ミット ベシュレンクテル ハフツング レーザーアプリケーターセット
JP2009165822A (ja) * 2008-01-14 2009-07-30 Olympus Medical Systems Corp 内視鏡用処置具
WO2011126109A1 (fr) * 2010-04-08 2011-10-13 学校法人久留米大学 Procédé d'aspiration et d'introduction d'aiguille et dispositif d'aspiration et d'introduction d'aiguille
WO2020049629A1 (fr) * 2018-09-04 2020-03-12 オリンパス株式会社 Appareil de distribution de dispositif d'irradiation de lumière et procédé de photothérapie

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11508173A (ja) * 1996-04-04 1999-07-21 ゾーマテクス メディツィンテヒニッシェ インストルメンテ ゲゼルシャフト ミット ベシュレンクテル ハフツング レーザーアプリケーターセット
JP2009165822A (ja) * 2008-01-14 2009-07-30 Olympus Medical Systems Corp 内視鏡用処置具
WO2011126109A1 (fr) * 2010-04-08 2011-10-13 学校法人久留米大学 Procédé d'aspiration et d'introduction d'aiguille et dispositif d'aspiration et d'introduction d'aiguille
WO2020049629A1 (fr) * 2018-09-04 2020-03-12 オリンパス株式会社 Appareil de distribution de dispositif d'irradiation de lumière et procédé de photothérapie

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