WO2023106172A1 - Puncture needle - Google Patents

Puncture needle Download PDF

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Publication number
WO2023106172A1
WO2023106172A1 PCT/JP2022/044105 JP2022044105W WO2023106172A1 WO 2023106172 A1 WO2023106172 A1 WO 2023106172A1 JP 2022044105 W JP2022044105 W JP 2022044105W WO 2023106172 A1 WO2023106172 A1 WO 2023106172A1
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WO
WIPO (PCT)
Prior art keywords
groove
needle
puncture needle
needle body
puncture
Prior art date
Application number
PCT/JP2022/044105
Other languages
French (fr)
Japanese (ja)
Inventor
神原佳世
藤間大貴
杉木努
岡村遼
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023106172A1 publication Critical patent/WO2023106172A1/en

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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.
  • Japanese Patent No. 3171525 discloses a configuration in which, in a puncture needle for injecting a drug solution into a patient, 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. there is Such a puncture needle makes it easier to visually recognize the puncture needle in an ultrasound image.
  • the puncture needle described in Japanese Patent No. 3171525 mentioned above has a concave portion formed on the inner peripheral surface of the outer needle or the outer peripheral surface of the inner needle, so that ultrasonic waves and reflected waves are attenuated when passing through the outer needle. do. Therefore, it is not possible to efficiently improve the intensity of the reflected wave received by the ultrasonic probe.
  • An object of the present invention is to solve the above-mentioned problems.
  • One aspect of the present invention includes a hollow needle body that is pierced into tissue inside the skin of a human body, and a shaft portion that is inserted into the lumen of the needle body.
  • the puncture needle is formed with a concave portion for reflecting ultrasound waves below.
  • a concave portion is formed on the outer surface of the needle body of the puncture needle for reflecting ultrasonic waves under echo. Therefore, it is possible to efficiently improve the intensity of the reflected wave received by the ultrasonic probe as compared with the case where the concave portion is formed on the inner peripheral surface of the needle or the outer peripheral surface of the shaft portion. Therefore, the puncture needle can be easily visually recognized in the ultrasound image.
  • 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. 7A is a partially omitted side view of a needle body according to a first modified example.
  • FIG. 7B is a partially omitted side view of the needle body according to the second modification.
  • FIG. 8 is a partially enlarged vertical cross-sectional view of a puncture needle provided with a needle body according to a third modified example.
  • FIG. 9 is a partially enlarged vertical cross-sectional view of a puncture needle provided with a needle body according to a fourth modification.
  • FIG. 10 is a partially omitted side view of a needle body according to a fifth modification.
  • FIG. 11A is a partially omitted side view of a needle body according to a sixth modification.
  • FIG. 11B is a partially omitted side view of the needle body according to the seventh modification.
  • FIG. 12A is a side view of the first sample.
  • FIG. 12B is a side view of the second sample.
  • FIG. 13A is a side view of the third sample.
  • FIG. 13B is a side view of the fourth sample.
  • FIG. 14 is a table showing test results relating to groove width.
  • FIG. 15 is an explanatory diagram of the sliding test.
  • FIG. 16 is a table showing test results relating to groove depth.
  • FIG. 17 is a table showing test results relating to pitch.
  • FIG. 18 is a table showing test results relating to groove length.
  • 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.
  • 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.
  • 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 an obturator 12 and a needle member 14.
  • the obturator 12 has a unidirectionally extending shaft portion 16 and an obturator hub 18 .
  • Needle member 14 has a hollow needle body 20 and a needle hub 22 .
  • 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 tip surface 26 (see FIG. 3) extending in a direction perpendicular to the axial direction of the shaft portion 16 . Note that 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. Also, the distal end surface 26 may be a curved surface protruding in a hemispherical shape toward the distal direction (leftward in FIG. 3). Furthermore, 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 obturator hub 18 is attached to the proximal end of the shaft portion 16 .
  • the obturator hub 18 has a size and shape that facilitates manual manipulation.
  • the obturator hub 18 is made of hard resin material.
  • a needle hub 22 is detachable from the obturator hub 18 .
  • the obturator hub 18 has a female thread (not shown) for connecting the 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 punctured into 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 bending strength of POM is, for example, 89 MPa when tested according to ISO 178.
  • the light output from the light irradiation section 314 see FIG. 6) can be efficiently transmitted through the needle 20 .
  • 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 tip portion 32 .
  • the cross-sectional shape of the outer peripheral surface 34 of the needle body 30 is circular.
  • the cross-sectional shape of the inner peripheral surface 36 of the needle body 30 is circular.
  • the inner diameter 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 of needle body 30 is slightly larger than the outer diameter of shaft portion 16 . In other words, a gap is formed between the inner peripheral surface 36 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 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 thickness T of the needle body 30 is preferably set to 50 ⁇ m to 350 ⁇ m, more preferably 100 ⁇ m to 300 ⁇ m, and even more preferably 150 ⁇ m to 250 ⁇ m. Specifically, the thickness T of the needle body 30 is set to 200 ⁇ m.
  • An inner diameter Dc (diameter of the lumen) 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 .
  • the needle tip portion 32 is located at the tip (one end) of the needle body 30 .
  • Needle tip 32 has an inner surface 38 that closes the tip of lumen 24 of needle body 20 .
  • the inner surface 38 extends in a direction perpendicular to the axial direction of the needle body 30 . In the initial state, the inner surface 38 is close to or in contact with the distal end surface 26 of the shaft portion 16 .
  • the needle tip portion 32 has a tapered surface 40 whose diameter decreases toward the tip.
  • the inner surface 38 extends in the direction orthogonal to the axial direction of the needle body 30 so as to correspond to the flat distal end surface 26 extending in the direction orthogonal to the axial direction of the shaft portion 16 . , but not limited to these. It is preferable that the tip surface 26 has a shape corresponding to the inner surface 38 .
  • 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 .
  • Needle hub 22 has an unillustrated external thread that engages the internal thread of obturator hub 18 . That is, needle hub 22 is removably threaded to obturator hub 18 .
  • the outer surface 42 of the needle 20 is formed with a recess 44 for reflecting ultrasonic waves under echo.
  • the concave portion 44 is formed on the outer surface 42 of the needle body 20 by, for example, laser machining, cutting, rolling, press working, or the like.
  • the recessed portion 44 is formed, for example, only in a portion of the puncture portion 28 of the needle body 20 (see FIG. 1). Specifically, the recess 44 is formed at the tip of the needle body 30 . A recess 44 is formed in the outer peripheral surface 34 of the needle body 30 . However, the recessed portion 44 may be formed over the entire length of the puncture portion 28 of the needle body 20 . Alternatively, the recess 44 may be formed only on the tapered surface 40 .
  • the recess 44 has grooves 46 .
  • the groove portion 46 is formed narrower in the depth direction of the groove portion 46 .
  • the cross section of the groove portion 46 is V-shaped.
  • the groove portion 46 includes a spiral groove 48 with a single turn.
  • a groove width W of the spiral groove 48 is preferably set to 10 ⁇ m or more and 50 ⁇ m or less. Specifically, the groove width W is set to 25 ⁇ m, for example.
  • the groove width W of the spiral groove 48 refers to the width of the portion of the spiral groove 48 that opens to the outer surface 42 of the needle body 20 .
  • the groove depth Db of the spiral groove 48 is preferably set to 25 ⁇ m or more and 37.5% or less of the thickness T of the needle body 30, preferably 25% of the thickness T of the needle body 30. more preferred.
  • the pitch P of the spiral grooves 48 is preferably set to 100 ⁇ m or more, more preferably 300 ⁇ m.
  • the length of the spiral groove 48 (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. Set to 10 mm.
  • 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 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 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 grooves 46 formed on the outer surface 42 of the needle 20 .
  • a reflected wave of the ultrasonic waves reflected by the groove 46 of the needle body 20 is 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 outer diameter Da of the needle body 20 of the puncture needle 10 used for photoimmunotherapy is larger than the outer diameter of the needle body of the needle body of the puncture needle for drug administration, which is usually thought of as a puncture needle. That is, the puncture resistance of the puncture needle 10 is greater than that of the puncture needle for drug administration.
  • the recess 44 is formed in the outer surface 42 of the needle body 20 of the puncture needle 10 with relatively high puncture resistance
  • the configuration is such that the recess is formed in the outer surface of the needle body of the drug administration puncture needle with relatively low puncture resistance. As compared with , it is difficult to feel an increase in puncture resistance due to the concave portion 44 .
  • the puncture needle 10 used for photoimmunotherapy it is difficult to feel that the recess 44 greatly changes the puncture resistance. Furthermore, in the case of a puncture needle for drug administration, the pain felt by the patient 202 also increases due to the increased puncture resistance. However, since the photoimmunotherapy puncture procedure is performed under anesthesia, the patient 202 hardly feels pain even if the puncture resistance increases, which is another difference from the puncture needle for drug administration.
  • the user After puncturing the lesion 200 with the puncture needle 10, the user removes the obturator 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 outer surface 42 of the needle body 20 of the puncture needle 10 is formed with a recess 44 for reflecting ultrasonic waves under echo. Therefore, the intensity of the reflected wave received by the ultrasonic probe 302 can be efficiently improved compared to the case where the concave portion 44 is formed in the inner peripheral surface 36 of the needle 20 or the outer peripheral surface of the shaft portion 16 . Therefore, the puncture needle 10 can be easily visually recognized in the ultrasound image.
  • 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 puncture needle 10 can be used as a therapeutic device for irradiating cancer cells with light (including radiation) emitted from the light emitting unit 314 inserted into the lumen 24 of the needle body 20. can.
  • the inner diameter Dc of the needle body 20 is 0.5 mm or more.
  • the needle body 20 can be inserted into the lumen 24 of the needle body 20.
  • the degree of freedom of the outer diameter of the light irradiation section 314 is increased.
  • a lumen 24 of the needle body 20 is sealed at the tip of the needle body 20 .
  • the recessed portion 44 has a groove portion 46 .
  • the groove portion 46 is formed narrower in the depth direction.
  • the resistance (puncture resistance) when the needle body 20 is punctured into the patient 202 can be reduced compared to the case where the groove 46 is widened in the depth direction. Thereby, the patient 202 can be smoothly punctured with the needle body 20 . Moreover, the pain felt by the patient 202 when the needle body 20 is punctured can be suppressed.
  • the groove portion 46 has a spiral groove 48 with one turn.
  • ultrasonic waves can be efficiently reflected by the spiral grooves 48 .
  • the groove width W of the groove portion 46 is set to 10 ⁇ m or more and 50 ⁇ m or less.
  • the groove width W is 10 ⁇ m or more, the groove portion 46 can be detected by a general ultrasonic diagnostic imaging apparatus 300 . Moreover, since the groove width W is 50 ⁇ m or less, it is possible to prevent the puncture resistance of the needle body 20 from becoming excessively large.
  • the groove depth Db of the groove portion 46 is set to 25 ⁇ m or more and 37.5% or less of the thickness T of the needle body 30 .
  • the groove 46 can efficiently reflect the ultrasonic waves to the probe side. Further, since the groove depth Db is 37.5% or less of the thickness T of the needle body 30, it is possible to prevent the strength of the needle body 20 from being excessively lowered.
  • the pitch P of the grooves 46 is set to 100 ⁇ m or more.
  • the groove 46 can efficiently reflect ultrasonic waves to the probe side.
  • a groove length Lb of the groove portion 46 along the axial direction of the needle body 20 is set to 1 mm or more.
  • a needle body 50 according to a first modified example will be described.
  • the same reference numerals are given to the same configurations as those of the needle body 20 described above, and detailed description thereof will be omitted.
  • the same effects as those of the needle body 20 described above are obtained.
  • the recess 54 formed in the outer surface 52 of the needle body 50 includes grooves 56 .
  • the groove portion 56 has a spiral groove 58 with multiple windings.
  • the number of spiral grooves 58 is preferably 2 or more and 50 or less, and more preferably 11 or more and 44 or less.
  • the groove width, groove depth, pitch, and groove length of the groove portion 56 (spiral groove 58) are set in the same manner as the groove portion 46 (spiral groove 48) described above.
  • the outer diameter and effective length of the needle body 50 are set in the same manner as the outer diameter Da and effective length La of the needle body 20 described above. The same applies to needle bodies 60, 80, 90, 100, 110, and 130, which will be described later.
  • the groove portion 56 has a spiral groove 58 with multiple windings.
  • ultrasonic waves can be efficiently reflected by the spiral grooves 58.
  • recess 64 formed in outer surface 62 of needle 60 includes groove 66 .
  • the groove portion 66 has a plurality of groove rows 68 .
  • the plurality of groove rows 68 are arranged at intervals in the circumferential direction of the needle body 60 .
  • the groove portion 66 includes four groove rows 68 .
  • the plurality of groove rows 68 are positioned with a 90° phase shift in the circumferential direction of the needle body 60 .
  • the number of groove rows 68 may be one. Further, two, three, or five or more groove rows 68 may be arranged in the circumferential direction of the needle body 60 on the outer surface 62 of the needle body 60 .
  • Each groove row 68 includes a plurality of short grooves 70.
  • the plurality of short grooves 70 are arranged at intervals in the axial direction of the needle body 60 .
  • the length of each short groove 70 along the circumferential direction of the needle body 60 is set according to the balance between the number of groove rows 68 and the angle ⁇ to be formed, which will be described later. is.
  • Each short groove 70 includes a first slanted groove 72 and a second slanted groove 74 .
  • the first inclined groove 72 is inclined in the first circumferential direction along the circumferential direction of the needle body 60 toward the tip of the needle body 60 .
  • the second inclined groove 74 is inclined toward the tip of the needle body 60 in the second circumferential direction opposite to the first circumferential direction.
  • the tip of the first slanted groove 72 and the tip of the second slanted groove 74 are connected to each other to form a V-shape in this modified example, but they do not have to be connected.
  • the angle ⁇ between the first inclined groove 72 and the second inclined groove 74 is set to an acute angle. However, the formed angle ⁇ may be set to a right angle or an obtuse angle.
  • the total length of the first inclined groove 72 is the same as the total length of the second inclined groove 74 . However, the total length of the first inclined grooves 72 may be shorter or longer than the total length of the second inclined grooves 74 .
  • each short groove 70 is set in the same manner as the groove width W of the spiral groove 48 described above.
  • the groove depth of each short groove 70 is set similarly to the groove depth Db of the spiral groove 48 described above.
  • the interval (pitch) between adjacent short grooves 70 in each groove row 68 is set in the same manner as the pitch P of the spiral grooves 48 described above.
  • the groove length along the axial direction of the needle body 60 in the plurality of groove rows 68 is set similarly to the groove length Lb of the spiral groove 48 described above.
  • the groove portion 66 has a groove row 68 including a plurality of short grooves 70 spaced apart in the axial direction of the needle body 60 .
  • Each of the plurality of short grooves 70 has a length along the circumferential direction of the needle body 60 that is 1/4 or less of the circumferential length of the needle body 60 .
  • ultrasonic waves can be efficiently reflected by the plurality of short grooves 70 .
  • a plurality of groove rows 68 are provided at intervals in the circumferential direction of the needle body 60 .
  • Each of the plurality of short grooves 70 includes a first inclined groove 72 and a second inclined groove 74.
  • the first inclined groove 72 is inclined in the first circumferential direction along the circumferential direction of the needle body 60 toward the tip of the needle body 60 .
  • the second inclined groove 74 is inclined toward the tip of the needle body 60 in the second circumferential direction opposite to the first circumferential direction.
  • the tip of the first inclined groove 72 and the tip of the second inclined groove 74 are connected to each other.
  • the puncture resistance can be made relatively small, the lesion 200 can be smoothly punctured by the needle body 60 .
  • the needle distal end portion 82 of the needle body 80 has an inner surface 84 tapered toward the distal end. That is, at the needle distal end portion 82, the cross-sectional area of the lumen 24 of the needle body 80 decreases toward the distal end.
  • the outer surface 86 of the needle body 80 is formed with the recess 44 described above. However, the recesses 54 and 64 described above may be formed on the outer surface 86 of the needle body 80 .
  • a needle body 90 according to a fourth modification will be described. As shown in FIG. 9, a tip opening 94 is formed in the needle tip portion 92 of the needle body 90 . That is, the lumen 24 of the needle body 90 communicates with the tip opening 94 .
  • the outer surface 96 of the needle body 90 is formed with the recess 44 described above. However, the recesses 54 and 64 described above may be formed on the outer surface 96 of the needle body 90 .
  • recess 104 formed in outer surface 102 of needle 100 includes groove 106 .
  • the groove portion 106 has a plurality of annular grooves 108 extending around the circumference of the needle body 100 .
  • Each annular groove 108 extends circularly.
  • the plurality of annular grooves 108 are spaced apart in the axial direction of the needle body 100 .
  • the groove width of the annular groove 108 is set similarly to the groove width W of the spiral groove 48 described above.
  • the groove depth of the annular groove 108 is set similarly to the groove depth Db of the spiral groove 48 described above.
  • the interval (pitch) between the annular grooves 108 adjacent to each other is set in the same manner as the pitch P of the spiral grooves 48 described above.
  • the groove length of the groove portion 106 which is the length from the annular groove 108 located at the distal end to the annular groove 108 located at the proximal end, is set in the same manner as the groove length Lb of the spiral groove 48 described above.
  • the groove portion 106 has an annular groove 108 that extends around the needle body 100 in the circumferential direction.
  • a plurality of annular grooves 108 are provided at intervals in the axial direction of the needle body 100 .
  • ultrasonic waves can be more efficiently reflected by the plurality of annular grooves 108 .
  • grooves 118 include a plurality of grooves 66 and a plurality of grooves 46 . In the example of FIG. 11A, there are two grooves 66 and two grooves 46 .
  • the grooves 66 and the grooves 46 are alternately arranged at intervals in the axial direction of the needle body 110 .
  • the groove length of the groove portion 118 along the axial direction of the needle body 110 is set similarly to the groove length Lb of the spiral groove 48 described above.
  • the groove length of the groove portion 118 is, for example, 10 mm.
  • the groove 46 is provided, for example, at a position shifted by 5 mm in the proximal direction from the tip of the groove 118 and at a position shifted by 10 mm in the proximal direction from the tip of the groove 118 .
  • the number, positions and lengths of the grooves 66 and 46 can be set as appropriate.
  • the groove portion 118 has a plurality of patterns of groove portions (the groove portions 66 and the groove portions 46). According to such a configuration, since the reflection intensity of ultrasonic waves in the groove portion 66 and the reflection intensity of ultrasonic waves in the groove portion 46 are different from each other, compared to the case where a single pattern of groove portions is provided, the needle body can be detected by an ultrasonic image. The puncture position and puncture length of 110 can be easily grasped.
  • the groove portion 118 is not limited to the combination of the groove portion 66 and the groove portion 46 described above.
  • the groove 118 may be formed by combining a plurality of the grooves 46, 56, 66, 106 described above.
  • a needle body 130 according to a seventh modified example As shown in FIG. 11B, recess 136 formed in outer surface 132 of needle 130 has groove 138 .
  • Groove 138 includes groove 106 and groove 56 .
  • the groove portion 106 is located at the needle tip portion 32 of the needle body 130 .
  • the groove portion 56 is located in the needle body 30 of the needle body 130 .
  • the groove length of the groove portion 56 is, for example, 10 mm.
  • the needle distal end portion 32 of the needle body 130 is provided with the groove portion 106
  • the needle main body 30 of the needle body 130 is provided with the groove portion 56 having a shape different from that of the groove portion 106 .
  • the appearance of the needle tip portion 32 of the needle body 130 differs from the appearance of the needle main body 30 of the needle body 130 in the ultrasonic image, so the position of the needle tip portion 32 of the needle body 130 can be easily grasped. can.
  • the groove portion 138 is not limited to the combination of the groove portion 106 and the groove portion 56 described above. At least one of the grooves 46 , 56 , 66 may be provided in the needle tip portion 32 of the needle body 130 instead of the groove 106 . At least one of the grooves 46 , 66 , and 106 may be provided in the needle body 30 of the needle body 130 instead of the groove 56 . Further, the needle body 30 of the needle body 130 may be provided with the groove portion 118 instead of the groove portion 56 .
  • sample As shown in FIGS. 12A-13B, a first sample 140, a second sample 142, a third sample 144 and a fourth sample 146 were prepared in this test.
  • the first sample 140 is used for the sliding tests of Examples 1-5 and the strength tests of Examples 6-9, as will be described later.
  • the second sample 142 is used for the sliding test in Comparative Example 1.
  • the third sample 144 is used for capturing ultrasound images of Examples 1, 2, 6-8, and 10-18.
  • a fourth sample 146 is used for capturing an ultrasound image of Comparative Example 1.
  • the first sample 140 has a resin tube 148 and an inner needle 150 inserted through the lumen of the resin tube 148.
  • the distal end of the resin tube 148 is open.
  • the resin tube 148 is made of POM.
  • the dimensions of the resin tube 148 are the same as the dimensions of the needle body 30 described above.
  • the spiral groove 48 described above is formed on the outer peripheral surface of the resin tube 148 .
  • the inner needle 150 is a so-called bevel needle of 21G (gauge) and has a sharp tip.
  • the inner needle 150 protrudes from the tip opening of the resin tube 148 .
  • the second sample 142 is constructed identically to the first sample 140 except that it does not have the spiral grooves 48 .
  • the first sample 140 has a shape different from that of the puncture needle 10 described above.
  • first sample 140 is a substitute for puncture needle 10 .
  • the object of evaluation is the sliding resistance of the portion of the needle body 30 of the puncture needle 10 where the spiral groove 48 is located. Therefore, if the material and dimensions of the resin tube 148 are the same as the material and dimensions of the needle body 30 of the puncture needle 10, even if the other shapes and the like are different from each other, they do not affect the measurement result of the sliding resistance. Therefore, in the sliding test, even when the first sample 140 is used, the same result as when the puncture needle 10 is used is obtained.
  • the strength of the portion where the spiral groove 48 formed in the needle body 30 of the puncture needle 10 is located is evaluated. Therefore, if the material and dimensions of the resin tube 148 are the same as the material and dimensions of the needle body 30 of the puncture needle 10, even if the other shapes and the like are different from each other, the strength measurement results are not affected. Therefore, in the strength test, even if the first sample 140 is used, the same results as when the puncture needle 10 is used can be obtained.
  • the third sample 144 has a resin tube 148, the shaft portion 16 described above, and a sealing portion 152.
  • the shaft portion 16 is inserted into the lumen of the resin tube 148 .
  • the sealing portion 152 seals the tip opening of the resin tube 148 . This can prevent water from entering the lumen of the resin tube 148 . Therefore, the appearance of the ultrasonic image does not change due to moisture that has entered the resin tube 148 .
  • the sealing portion 152 is a photocurable adhesive.
  • the sealing portion 152 is made of a material different from the material of the resin tube 148 .
  • the fourth sample 146 is constructed identically to the third sample 144 except that it does not have the spiral grooves 48 .
  • the third sample 144 has a shape different from that of the puncture needle 10 described above.
  • third sample 144 is a substitute for puncture needle 10 .
  • the visibility (average luminance) of the ultrasonic image of the portion of the needle body 30 of the puncture needle 10 where the spiral groove 48 is located is evaluated. Therefore, if the material and dimensions of the resin tube 148 are the same as the material and dimensions of the needle body 30 of the puncture needle 10, the evaluation of the ultrasonic image will not be affected even if the other shapes and the like are different from each other. Therefore, in the evaluation of the ultrasonic image, even if the third sample 144 is used, the same result as when the puncture needle 10 is used can be obtained.
  • the groove width W of the first sample 140 and the third sample 144 according to Example 1 is 10 ⁇ m.
  • the groove width W of the first sample 140 and the third sample 144 according to Example 2 is 25 ⁇ m.
  • the groove width W of the first sample 140 and the third sample 144 according to Example 3 is 40 ⁇ m.
  • the groove width W of the first sample 140 and the third sample 144 according to Example 4 is 50 ⁇ m.
  • the groove width W of the first sample 140 and the third sample 144 according to Example 5 is 55 ⁇ m.
  • the groove depth Db was 50 ⁇ m
  • the pitch P was 300 ⁇ m
  • the groove length Lb was 10 mm.
  • the size of an object that can be detected by the ultrasonic diagnostic imaging apparatus 300 is about 1/10 of the wavelength of the ultrasonic waves emitted from the ultrasonic diagnostic imaging apparatus 300.
  • the lower limit of the wavelength of ultrasonic waves emitted from a general ultrasonic diagnostic imaging apparatus 300 is 100 ⁇ m (15 MHz). Therefore, the lower limit of the groove width W is set to 10 ⁇ m, which is 1/10 of 100 ⁇ m.
  • ultrasonic images were taken when the gel phantom was punctured with the third sample 144 according to Examples 1 and 2, which had a sliding evaluation of A, and the fourth sample 146 according to Comparative Example 1.
  • a linear probe was used as the type of ultrasonic probe 302 .
  • the center frequency of ultrasound was set to 11 MHz.
  • the average luminance ratio (average luminance ratio) of the portion of the spiral groove 48 where the slide evaluation was A based on the average luminance of the puncture needle in the ultrasonic image of Comparative Example 1 was calculated.
  • the groove width W is preferably set to 10 ⁇ m or more and 50 ⁇ m or less, and more preferably set to 10 ⁇ m or more and 25 ⁇ m or less.
  • the groove depth Db of the first sample 140 and the third sample 144 according to Example 6 is 25 ⁇ m (13% of the thickness T of the resin tube 148).
  • the groove depth Db of the first sample 140 and the third sample 144 according to Example 7 is 50 ⁇ m (25% of the thickness T of the resin tube 148).
  • the groove depth Db of the first sample 140 and the third sample 144 according to Example 8 is 75 ⁇ m (37.5% of the thickness T of the resin tube 148).
  • the groove depth Db of the first sample 140 and the third sample 144 according to Example 9 is 80 ⁇ m (40% of the thickness T of the resin tube 148).
  • the groove width W is 25 ⁇ m
  • the pitch P is 300 ⁇ m
  • the groove length Lb is 10 mm
  • the thickness T of the needle body 30 is 200 ⁇ m.
  • the lower limit of the groove depth Db is set to 25 ⁇ m, which is 1/4 of the lower limit (100 ⁇ m) of the wavelength of ultrasonic waves emitted from a general ultrasonic diagnostic imaging apparatus 300 .
  • the groove depth Db is 37.5% or less of the thickness T of the resin tube 148, the decrease in the strength of the resin tube 148 can be suppressed.
  • the groove depth Db is preferably set to 25 ⁇ m or more from the viewpoint of scattering of reflected waves. Further, it was found that the groove depth Db is preferably set to 37.5% or less of the thickness T of the resin tube 148 from the viewpoint of strength reduction. Further, it was found that the groove depth Db is more preferably set to 50 ⁇ m from the viewpoint of visibility of the third sample 144 in the ultrasonic image.
  • the pitch P of the spiral grooves 48 of the third sample 144 according to Example 10 is 100 ⁇ m.
  • the pitch P of the spiral grooves 48 of the third sample 144 according to Example 11 is 200 ⁇ m.
  • the pitch P of the spiral grooves 48 of the third sample 144 according to Example 12 is 300 ⁇ m.
  • the pitch P of the spiral grooves 48 of the third sample 144 according to Example 13 is 500 ⁇ m.
  • the pitch P of the spiral grooves 48 of the third sample 144 according to Example 14 is 1000 ⁇ m.
  • the groove width W is 25 ⁇ m
  • the groove depth Db is 50 ⁇ m
  • the groove length Lb is 10 mm.
  • the lower limit of the pitch P of the spiral grooves 48 is set at 100 ⁇ m, which is the lower limit of the wavelength of ultrasonic waves emitted from a general ultrasonic diagnostic imaging apparatus 300 .
  • the third sample 144 was easier to visually recognize than in Comparative Example 1 described above.
  • the average brightness ratio of the portion of the spiral groove 48 was 2.1.
  • the average brightness ratio of the portion of the spiral groove 48 was 2.4.
  • the average brightness ratio of the spiral grooves 48 was 2.6.
  • the average brightness ratio of the spiral grooves 48 was 1.7.
  • the average brightness ratio of the spiral grooves 48 was 1.6. That is, among Examples 10 to 14, Example 12 had the highest average luminance value.
  • the lower limit of the pitch of the spiral grooves 48 is preferably set to 100 ⁇ m, and more preferably set to 300 ⁇ m.
  • the groove length Lb of the third sample 144 of Example 15 is 1 mm.
  • the groove length Lb of the third sample 144 of Example 16 is 3 mm.
  • the groove length Lb of the third sample 144 of Example 17 is 5 mm.
  • the groove length Lb of the third sample 144 of Example 18 is 10 mm.
  • the groove width W is 25 ⁇ m
  • the groove depth Db is 50 ⁇ m
  • the pitch P is 300 ⁇ m.
  • the third sample 144 was easier to visually recognize than in Comparative Example 1 described above.
  • the maximum length of the puncture portion 28 of the needle body 20 is 100 mm. Therefore, the groove length Lb is preferably set to 1 mm or more and 100 mm or less.
  • the recess formed on the outer surface of the needle body may be formed by dimple processing or blast processing.
  • This embodiment discloses the following contents.
  • the above embodiment includes a hollow needle body (20, 50, 60, 80, 90, 100, 110, 130) that is pierced into the tissue inside the skin of the human body, and a needle body that is inserted into the lumen (24) of the needle body. and a shaft portion (16) which is formed on the outer surface (42, 52, 62, 86, 96, 102, 112, 132) of the needle (42, 52, 62, 86, 96, 102, 112, 132) for reflecting ultrasonic waves under echo (44 , 54, 64, 104, 116, 136).
  • a light irradiation section (314) that emits therapeutic light may be inserted into the lumen of the needle body with the shaft section removed from the needle body.
  • the inner diameter of the needle body may be 0.5 mm or more.
  • the puncture needle may be used for photoimmunotherapy.
  • the lumen of the needle body may be sealed at the distal end of the needle body.
  • the recess may have grooves (46, 56, 66, 106, 118, 138).
  • the groove may be formed narrower in the depth direction of the groove.
  • the groove portion may have a single-wound or multi-wound spiral groove (48, 58).
  • the groove portion has a groove row (68) including a plurality of short grooves (70) spaced apart in the axial direction of the needle body, each of the plurality of short grooves , the length along the circumferential direction of the needle body may be 1/4 or less of the circumferential length of the needle body.
  • a plurality of groove rows may be provided at intervals in the circumferential direction of the needle body.
  • each of the plurality of short grooves includes a first inclined groove (72) inclined in a first circumferential direction along the circumferential direction of the needle body toward the distal end of the needle body; a second slanted groove (74) slanted in a second circumferential direction opposite to the first circumferential direction toward the tip of the body, wherein the tip of the first slanted groove and the second slanted groove The tips may be connected to each other.
  • the groove portion may have an annular groove (108) 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 groove width (W) of the groove portion may be set to 10 ⁇ m or more and 50 ⁇ m or less.
  • the needle body has a needle body (30) that encircles the inner lumen of the needle body, and the groove depth (Db) of the groove is 25 ⁇ m or more and the thickness of the needle body ( T) may be set to 37.5% or less.
  • the pitch (P) of the grooves may be set to 100 ⁇ m or more.
  • the groove length (Lb) of the groove along the axial direction of the needle body may be set to 1 mm or more.

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Abstract

A puncture needle (10) according to the present invention comprises a hollow needle body (20) that is to puncture tissue on the inside of the skin of the human body, and a shaft part (16) inserted into a lumen (24) of the needle body (20). Recesses (44) that reflect ultrasonic waves during echo guidance are formed on the outer surface (42) of the needle body (20). The lumen of the needle body (20) is sealed at the tip of the needle body (20). The recesses (44) each have a groove part (46), the groove parts (46) being formed so as to narrow on progression along the depth direction of the groove parts (46).

Description

穿刺針puncture needle
　本発明は、穿刺針に関する。 The present invention relates to a puncture needle.
　特許第３１７１５２５号公報には、薬液を患者に注入する穿刺針において、外針の内周面又は内針の外周面にエコー下において超音波を反射させるための凹部を形成する構成が開示されている。このような穿刺針によれば、超音波画像において穿刺針を視認し易くなる。 Japanese Patent No. 3171525 discloses a configuration in which, in a puncture needle for injecting a drug solution into a patient, 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. there is Such a puncture needle makes it easier to visually recognize the puncture needle in an ultrasound image.
　上述した特許第３１７１５２５号公報に記載の穿刺針は、外針の内周面又は内針の外周面に凹部を形成しているため、超音波及び反射波は、外針を透過する際に減衰する。そのため、超音波プローブによって受信される反射波の強度を効率よく向上させることができない。 The puncture needle described in Japanese Patent No. 3171525 mentioned above has a concave portion formed on the inner peripheral surface of the outer needle or the outer peripheral surface of the inner needle, so that ultrasonic waves and reflected waves are attenuated when passing through the outer needle. do. Therefore, it is not possible to efficiently improve the intensity of the reflected wave received by the ultrasonic probe.
　本発明は、上述した課題を解決することを目的とする。 An object of the present invention is to solve the above-mentioned problems.
　本発明の一態様は、人体の皮膚の内側の組織に穿刺される中空の針体と、前記針体の内腔に挿入されるシャフト部と、を備え、前記針体の外面には、エコー下において超音波を反射させるための凹部が形成されている、穿刺針である。 One aspect of the present invention includes a hollow needle body that is pierced into tissue inside the skin of a human body, and a shaft portion that is inserted into the lumen of the needle body. The puncture needle is formed with a concave portion for reflecting ultrasound waves below.
　本発明によれば、穿刺針の針体の外面にエコー下において超音波を反射させるための凹部を形成している。そのため、針体の内周面又はシャフト部の外周面に凹部を形成する場合と比較して、超音波プローブによって受信される反射波の強度を効率よく向上させることができる。従って、超音波画像において穿刺針を視認し易くできる。 According to the present invention, a concave portion is formed on the outer surface of the needle body of the puncture needle for reflecting ultrasonic waves under echo. Therefore, it is possible to efficiently improve the intensity of the reflected wave received by the ultrasonic probe as compared with the case where the concave portion is formed on the inner peripheral surface of the needle or the outer peripheral surface of the shaft portion. Therefore, the puncture needle can be easily visually recognized in the ultrasound image.
図１は、本発明の一実施形態に係る穿刺針の側面図である。FIG. 1 is a side view of a puncture needle according to one embodiment of the present invention. 図２は、図１の穿刺針の分解側面図である。2 is an exploded side view of the puncture needle of FIG. 1; FIG. 図３は、図１の穿刺針の一部拡大縦断面図である。3 is a partially enlarged longitudinal sectional view of the puncture needle of FIG. 1. FIG. 図４は、光免疫療法の第１説明図である。FIG. 4 is a first explanatory diagram of photoimmunotherapy. 図５は、光免疫療法の第２説明図である。FIG. 5 is a second explanatory diagram of photoimmunotherapy. 図６は、光免疫療法の第３説明図である。FIG. 6 is a third explanatory diagram of photoimmunotherapy. 図７Ａは、第１変形例に係る針体の一部省略側面図である。図７Ｂは、第２変形例に係る針体の一部省略側面図である。FIG. 7A is a partially omitted side view of a needle body according to a first modified example. FIG. 7B is a partially omitted side view of the needle body according to the second modification. 図８は、第３変形例に係る針体を備えた穿刺針の一部拡大縦断面図である。FIG. 8 is a partially enlarged vertical cross-sectional view of a puncture needle provided with a needle body according to a third modified example. 図９は、第４変形例に係る針体を備えた穿刺針の一部拡大縦断面図である。FIG. 9 is a partially enlarged vertical cross-sectional view of a puncture needle provided with a needle body according to a fourth modification. 図１０は、第５変形例に係る針体の一部省略側面図である。FIG. 10 is a partially omitted side view of a needle body according to a fifth modification. 図１１Ａは、第６変形例に係る針体の一部省略側面図である。図１１Ｂは、第７変形例に係る針体の一部省略側面図である。FIG. 11A is a partially omitted side view of a needle body according to a sixth modification. FIG. 11B is a partially omitted side view of the needle body according to the seventh modification. 図１２Ａは、第１サンプルの側面図である。図１２Ｂは、第２サンプルの側面図である。FIG. 12A is a side view of the first sample. FIG. 12B is a side view of the second sample. 図１３Ａは、第３サンプルの側面図である。図１３Ｂは、第４サンプルの側面図である。FIG. 13A is a side view of the third sample. FIG. 13B is a side view of the fourth sample. 図１４は、溝幅に関する試験結果を示す表である。FIG. 14 is a table showing test results relating to groove width. 図１５は、摺動試験の説明図である。FIG. 15 is an explanatory diagram of the sliding test. 図１６は、溝深さに関する試験結果を示す表である。FIG. 16 is a table showing test results relating to groove depth. 図１７は、ピッチに関する試験結果を示す表である。FIG. 17 is a table showing test results relating to pitch. 図１８は、溝長さに関する試験結果を示す表である。FIG. 18 is a table showing test results relating to groove length.
　図１及び図２に示すように、本発明の一実施形態に係る穿刺針１０は、人体の皮膚の内側の組織内に位置するがん細胞等の病変部２００（図４参照）に穿刺可能である。穿刺針１０は、治療用の光を照射するための光照射部３１４（図６参照）を病変部２００内に挿入させるための医療機器である。穿刺針１０は、例えば、追って詳述する、がん細胞等の病変部に結合する物質と光感受性物質とを含む薬剤を患者２０２（図４参照）に投与した後で当該薬剤が結合した病変部２００に光を照射することにより病変部２００を治療する光免疫療法の治療用デバイスとして用いられる。また、穿刺針１０は、子宮頸がん又は前立腺がん等の病変部２００（腫瘍部）に穿刺して当該病変部２００に放射線を照射する組織内照射治療用デバイスとして用いることもできる。 As shown in FIGS. 1 and 2, the puncture needle 10 according to one embodiment of the present invention 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.
　穿刺針１０は、オブチュレーター１２と針部材１４とを備える。図２において、オブチュレーター１２は、一方向に延在したシャフト部１６と、オブチュレーターハブ１８とを有する。針部材１４は、中空の針体２０と、針ハブ２２とを有する。 The puncture needle 10 includes an obturator 12 and a needle member 14. In FIG. 2, the obturator 12 has a unidirectionally extending shaft portion 16 and an obturator hub 18 . Needle member 14 has a hollow needle body 20 and a needle hub 22 .
　使用前の状態（初期状態）において、シャフト部１６は、針体２０の内腔２４に取り外し可能に挿入されている（図３参照）。シャフト部１６は硬質であり、穿刺針１０を病変部２００に穿刺する際に針体２０を支持する。シャフト部１６は、棒状に延在している。換言すれば、シャフト部１６は、円柱状に形成されている。シャフト部１６は、全長に渡って略一定の外径を有する。シャフト部１６は、シャフト部１６の軸線方向と直交する方向に延在した平坦な先端面２６（図３参照）を有する。なお、先端面２６は、シャフト部１６の軸線方向と直交する方向に延在した平坦面であるこの例に限定されず、例えば、シャフト部１６の軸線方向と直交する面に対して緩やかに傾斜した平坦面であってもよい。また、先端面２６は、先端方向（図３の左方向）に向かって半球状に突出した湾曲面であってもよい。さらに、先端面２６は、先端方向に向かって円錐状に突出した湾曲面であってもよい。 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 tip surface 26 (see FIG. 3) extending in a direction perpendicular to the axial direction of the shaft portion 16 . Note that 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. For example, 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. Also, the distal end surface 26 may be a curved surface protruding in a hemispherical shape toward the distal direction (leftward in FIG. 3). Furthermore, the distal end surface 26 may be a curved surface projecting conically toward the distal direction.
　シャフト部１６は、例えば、金属材料によって構成されている。金属材料としては、例えば、ステンレス鋼が挙げられる。シャフト部１６は、ステンレス鋼以外の金属材料で構成されてもよい。また、シャフト部１６は、樹脂材料又はセラミックス材料等で構成されてもよい。シャフト部１６の横断面は、多角形状（三角形状又は四角形状等）であってもよい。シャフト部１６は、中空状（管状）に形成されてもよい。 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).
　オブチュレーターハブ１８は、シャフト部１６の基端部に取り付けられている。オブチュレーターハブ１８は、人手によって操作し易い大きさ及び形状を有する。オブチュレーターハブ１８は、硬質な樹脂材料によって構成されている。オブチュレーターハブ１８には、針ハブ２２が着脱可能である。オブチュレーターハブ１８は、針ハブ２２を接続するための図示しない雌ねじ部を有する。 The obturator hub 18 is attached to the proximal end of the shaft portion 16 . The obturator hub 18 has a size and shape that facilitates manual manipulation. The obturator hub 18 is made of hard resin material. A needle hub 22 is detachable from the obturator hub 18 . The obturator hub 18 has a female thread (not shown) for connecting the needle hub 22 .
　図２に示すように、針部材１４は、本実施形態では樹脂材料による一体成形品であるが、針部材１４は、針体２０と針ハブ２２とを別々に構成した後で、針体２０の基端部に針ハブ２２を接合することにより構成してもよい。針体２０は、人体の皮膚の内側の組織に穿刺される。針体２０は、硬質である。針体２０を構成する樹脂材料は、例えば、ポリアセタール（ＰＯＭ）が好ましい。具体的にＰＯＭの曲げ強さは、例えば、ＩＳＯ １７８に準じた試験をした場合、８９ＭＰａである。この場合、光照射部３１４（図６参照）から出力した光を針体２０に効率よく透過させることができる。ただし、針体２０を構成する樹脂材料は、例えば、ポリカーボネート、ポリプロピレン等であってもよい。針体２０と針ハブ２２とは、互いに異なる材料で構成されてもよい。 As shown in FIG. 2, 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 punctured into 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. Specifically, the bending strength of POM is, for example, 89 MPa when tested according to ISO 178. In this case, the light output from the light irradiation section 314 (see FIG. 6) can be efficiently transmitted through the needle 20 . However, 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.
　図１において、針体２０の穿刺部２８の長さ（有効長Ｌａ）は、１０ｍｍ以上３００ｍｍ以下に設定するのが好ましく、３０ｍｍ以上１００ｍｍ以下に設定するのがより好ましい。具体的に、針体２０の有効長Ｌａは、例えば、５０ｍｍ、７０ｍｍあるいは１００ｍｍに設定される。ユーザは、病変部２００の深さ及び大きさに応じて適切な有効長Ｌａの針体２０を有する穿刺針１０を選択する。 In FIG. 1, 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. Specifically, 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 .
　図３において、針体２０は、管状の針本体３０と、針先端部３２とを含む。針本体３０の外周面３４の横断面形状は、円形状である。針本体３０の内周面３６の横断面形状は、円形状である。針本体３０の内径は、シャフト部１６を針本体３０から抜去した後で、光照射部３１４（図６参照）が挿入可能な大きさに設定されている。針本体３０の内径は、シャフト部１６の外径よりも若干大きい。つまり、針本体３０の内周面３６とシャフト部１６の外周面との間には、シャフト部１６を針体２０の内腔２４に挿入する際の空気抜きとしての隙間が形成されている。 In FIG. 3 , the needle body 20 includes a tubular needle body 30 and a needle tip portion 32 . The cross-sectional shape of the outer peripheral surface 34 of the needle body 30 is circular. The cross-sectional shape of the inner peripheral surface 36 of the needle body 30 is circular. The inner diameter 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 of needle body 30 is slightly larger than the outer diameter of shaft portion 16 . In other words, a gap is formed between the inner peripheral surface 36 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 .
　針本体３０の外径Ｄａは、１．０ｍｍ以上２．０ｍｍ以下に設定されるのが好ましく、１．３ｍｍ以上１．７ｍｍ以下に設定されるのがより好ましい。具体的に、例えば１．５ｍｍに設定される。針本体３０の肉厚Ｔは、５０μｍ以上３５０μｍ以下に設定されるのが好ましく、１００μｍ以上３００μｍ以下に設定されるのがより好ましく、１５０μｍ以上２５０μｍ以下に設定されるのがより一層好ましい。具体的に、針本体３０の肉厚Ｔは２００μｍに設定される。針本体３０の内径Ｄｃ（内腔の直径）は、光照射部３１４を内腔２４に挿入するためのスペースを確保するために、０．５ｍｍ以上に設定される。 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 thickness T of the needle body 30 is preferably set to 50 μm to 350 μm, more preferably 100 μm to 300 μm, and even more preferably 150 μm to 250 μm. Specifically, the thickness T of the needle body 30 is set to 200 μm. An inner diameter Dc (diameter of the lumen) 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 .
　針先端部３２は、針本体３０の先端（一端）に位置する。針先端部３２は、針体２０の内腔２４の先端を閉塞する内面３８を有する。内面３８は、針本体３０の軸線方向と直交する方向に延在している。初期状態で、内面３８は、シャフト部１６の先端面２６に近接又は接触している。針先端部３２は、先端方向に向かって縮径したテーパ面４０を有している。なお、ここではシャフト部１６の軸線方向と直交する方向に延在した平坦な先端面２６に対応するよう、内面３８は針本体３０の軸線方向と直交する方向に延在しているとしたが、これに限られることはない。先端面２６は内面３８に対応した形状であることが好ましい。 The needle tip portion 32 is located at the tip (one end) of the needle body 30 . Needle tip 32 has an inner surface 38 that closes the tip of lumen 24 of needle body 20 . The inner surface 38 extends in a direction perpendicular to the axial direction of the needle body 30 . In the initial state, the inner surface 38 is close to or in contact with the distal end surface 26 of the shaft portion 16 . The needle tip portion 32 has a tapered surface 40 whose diameter decreases toward the tip. Here, the inner surface 38 extends in the direction orthogonal to the axial direction of the needle body 30 so as to correspond to the flat distal end surface 26 extending in the direction orthogonal to the axial direction of the shaft portion 16 . , but not limited to these. It is preferable that the tip surface 26 has a shape corresponding to the inner surface 38 .
　図１及び図２において、針ハブ２２は、針体２０の基端部に設けられている。針ハブ２２は、人手によって操作し易い大きさ及び形状を有する。針ハブ２２は、中空状に形成されている。つまり、針ハブ２２は、針体２０の内腔２４に連通する内腔を含む。針ハブ２２は、オブチュレーターハブ１８の雌ねじ部に螺合する図示しない雄ねじ部を有する。すなわち、針ハブ２２は、オブチュレーターハブ１８に取り外し可能にねじ接合する。 　In FIGS. 1 and 2, 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 . Needle hub 22 has an unillustrated external thread that engages the internal thread of obturator hub 18 . That is, needle hub 22 is removably threaded to obturator hub 18 .
　図２及び図３に示すように、針体２０の外面４２には、エコー下において超音波を反射させるための凹部４４が形成されている。凹部４４は、例えば、レーザ加工、切削加工、転造、プレス加工等によって針体２０の外面４２に形成される。 As shown in FIGS. 2 and 3, the outer surface 42 of the needle 20 is formed with a recess 44 for reflecting ultrasonic waves under echo. The concave portion 44 is formed on the outer surface 42 of the needle body 20 by, for example, laser machining, cutting, rolling, press working, or the like.
　凹部４４は、例えば、針体２０の穿刺部２８の一部分にのみ形成される（図１参照）。具体的に、凹部４４は、針本体３０の先端部に形成されている。凹部４４は、針本体３０の外周面３４に形成されている。ただし、凹部４４は、針体２０の穿刺部２８の全長に渡って形成されてもよい。また、凹部４４は、テーパ面４０にのみ形成されてもよい。 The recessed portion 44 is formed, for example, only in a portion of the puncture portion 28 of the needle body 20 (see FIG. 1). Specifically, the recess 44 is formed at the tip of the needle body 30 . A recess 44 is formed in the outer peripheral surface 34 of the needle body 30 . However, the recessed portion 44 may be formed over the entire length of the puncture portion 28 of the needle body 20 . Alternatively, the recess 44 may be formed only on the tapered surface 40 .
　図３において、凹部４４は、溝部４６を有する。溝部４６は、溝部４６の深さ方向に向かって幅狭に形成されている。換言すれば、溝部４６の横断面は、Ｖ字状に形成されている。溝部４６は、一条巻きの螺旋溝４８を含む。螺旋溝４８の溝幅Ｗは、１０μｍ以上５０μｍ以下に設定されるのが好ましい。具体的に、溝幅Ｗは、例えば２５μｍに設定される。ここで、螺旋溝４８の溝幅Ｗとは、螺旋溝４８のうち針体２０の外面４２に開口している部分の幅をいう。螺旋溝４８の溝深さＤｂは、２５μｍ以上且つ針本体３０の肉厚Ｔの３７．５％以下に設定されるのが好ましく、針本体３０の肉厚Ｔの２５％に設定されるのがより好ましい。 In FIG. 3, the recess 44 has grooves 46 . The groove portion 46 is formed narrower in the depth direction of the groove portion 46 . In other words, the cross section of the groove portion 46 is V-shaped. The groove portion 46 includes a spiral groove 48 with a single turn. A groove width W of the spiral groove 48 is preferably set to 10 μm or more and 50 μm or less. Specifically, the groove width W is set to 25 μm, for example. Here, the groove width W of the spiral groove 48 refers to the width of the portion of the spiral groove 48 that opens to the outer surface 42 of the needle body 20 . The groove depth Db of the spiral groove 48 is preferably set to 25 μm or more and 37.5% or less of the thickness T of the needle body 30, preferably 25% of the thickness T of the needle body 30. more preferred.
　螺旋溝４８のピッチＰは、１００μｍ以上に設定されるのが好ましく、３００μｍに設定されるのがより好ましい。図１において、針体２０の軸線方向に沿った螺旋溝４８の長さ（溝長さＬｂ）は、１ｍｍ以上１００ｍｍ以下に設定されるのが好ましく、具体的に、溝長さＬｂは、例えば１０ｍｍに設定される。 The pitch P of the spiral grooves 48 is preferably set to 100 μm or more, more preferably 300 μm. In FIG. 1, the length of the spiral groove 48 (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. Set to 10 mm.
　次に、穿刺針１０を用いた光免疫療法について説明する。本実施形態において、光免疫療法では、例えば、頭頸部の組織内（皮膚よりも内側）に位置するがん細胞を治療する。ただし、穿刺針１０は、頭頸部以外の部分のがん細胞を治療する際に用いてもよい。すなわち、穿刺針１０は、子宮頸がん又は前立腺がん等のがん細胞に穿刺した状態で放射線を当該がん細胞に照射する組織内照射治療用デバイスとして使用してもよい。また、穿刺針１０は、がん細胞以外の病変部の治療に用いてもよい。 Next, photoimmunotherapy using the puncture needle 10 will be described. In this embodiment, photoimmunotherapy treats, for example, cancer cells located in the tissue of the head and neck (inside the skin). However, 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 other than cancer cells.
　光免疫療法を行う場合、まず、がん細胞等の病変部２００に結合する物質と光感受性物質とを含む薬剤を患者２０２（図４参照）に点滴等によって投与する。薬剤としては、例えば、セツキシマブ サロタロカンナトリウムが用いられる。薬剤投与後、所定時間（例えば、２０時間）経過すると、薬剤は、頭頸部の病変部２００（がん細胞）に結合する。 When performing photoimmunotherapy, first, 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. As the drug, for example, cetuximab sarotarocan sodium is used. After a predetermined period of time (for example, 20 hours) has passed after administration of the drug, the drug binds to the lesion 200 (cancer cells) in the head and neck region.
　その後、図４に示すように、ユーザは、超音波画像診断装置３００に表示される超音波画像を見ながら病変部２００に穿刺針１０を穿刺する。すなわち、エコー下で穿刺針１０を病変部２００に穿刺する。この際、針体２０は、硬質であるため、ほとんど撓まない。つまり、針体２０は、略真直ぐな状態で人体の皮膚の内側の組織に穿刺される。 After that, as shown in FIG. 4 , 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. At this time, since 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.
　具体的に、皮膚に押し当てた超音波プローブ３０２から病変部２００に向けて超音波を発信させながら穿刺針１０を病変部２００に穿刺する。この際、超音波は、針体２０の外面４２に形成された溝部４６で反射する。超音波のうち針体２０の溝部４６で反射した反射波は、超音波プローブ３０２で受信される。超音波画像診断装置３００は、超音波プローブ３０２によって受信された反射波に基づいて超音波画像を作成して図示しない表示部に表示する。これにより、ユーザは、超音波画像を見ることにより、穿刺針１０が病変部２００の目標位置に穿刺されているか否かを容易に判断することができる。なお、針体２０の内腔２４の先端が針先端部３２によって閉塞されているため（図３参照）、針体２０の内腔２４に血液が流入することはない。 Specifically, 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 . At this time, the ultrasonic waves are reflected by grooves 46 formed on the outer surface 42 of the needle 20 . A reflected wave of the ultrasonic waves reflected by the groove 46 of the needle body 20 is 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 .
　ところで、光免疫療法に用いられる穿刺針１０の針体２０の外径Ｄａは、通常穿刺針として想起される薬剤投与用の穿刺針の針体の外径よりも太い。すなわち、穿刺針１０の穿刺抵抗は、薬剤投与用の穿刺針の穿刺抵抗よりも大きい。このように穿刺抵抗の比較的大きな穿刺針１０の針体２０の外面４２に凹部４４を形成する場合、穿刺抵抗の比較的小さな薬剤投与用の穿刺針の針体の外面に凹部を形成する構成と比較して、凹部４４による穿刺抵抗の増大を感じ難いと考えられる。つまり、光免疫療法に用いられる穿刺針１０の場合、凹部４４によって穿刺抵抗が大きく変化したとは感じ難いと考えられる。さらに、薬剤投与用の穿刺針の場合は、穿刺抵抗の増大により患者２０２が感じる痛みも増大する。しかしながら、光免疫療法の穿刺手技は麻酔下で行われるため、穿刺抵抗が増大しても患者２０２は痛みを感じ難いという点も、薬剤投与用の穿刺針との違いである。 By the way, the outer diameter Da of the needle body 20 of the puncture needle 10 used for photoimmunotherapy is larger than the outer diameter of the needle body of the needle body of the puncture needle for drug administration, which is usually thought of as a puncture needle. That is, the puncture resistance of the puncture needle 10 is greater than that of the puncture needle for drug administration. When the recess 44 is formed in the outer surface 42 of the needle body 20 of the puncture needle 10 with relatively high puncture resistance, the configuration is such that the recess is formed in the outer surface of the needle body of the drug administration puncture needle with relatively low puncture resistance. As compared with , it is difficult to feel an increase in puncture resistance due to the concave portion 44 . In other words, in the case of the puncture needle 10 used for photoimmunotherapy, it is difficult to feel that the recess 44 greatly changes the puncture resistance. Furthermore, in the case of a puncture needle for drug administration, the pain felt by the patient 202 also increases due to the increased puncture resistance. However, since the photoimmunotherapy puncture procedure is performed under anesthesia, the patient 202 hardly feels pain even if the puncture resistance increases, which is another difference from the puncture needle for drug administration.
　病変部２００に穿刺針１０を穿刺した後、図５に示すように、ユーザは、オブチュレーター１２を針部材１４から抜去する。 After puncturing the lesion 200 with the puncture needle 10, the user removes the obturator 12 from the needle member 14 as shown in FIG.
　続いて、図６において、レーザシステム３１０を準備する。レーザシステム３１０は、レーザ光を発振する図示しないレーザ本体部と、レーザ本体部に接続された光ファイバ３１２と、光ファイバ３１２の先端部に設けられた円柱状の光照射部３１４とを有する。レーザ本体部は、半導体レーザ素子を有する。光照射部３１４は、光ファイバ３１２から導かれたレーザ光を光照射部３１４の径方向外方に出射する。レーザ本体部から発振されるレーザ光のピーク波長は、例えば、６９０ｎｍである。ただし、レーザ光の波長（波長範囲及びピーク波長）は、病変部２００及び薬剤の種類等によって適宜設定可能である。 Subsequently, in FIG. 6, the laser system 310 is prepared. 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.
　レーザシステム３１０の準備後、レーザシステム３１０の光照射部３１４を針ハブ２２の基端方向から針体２０の内腔２４に挿入する。次いで、レーザ本体部からレーザ光を発振する。そうすると、レーザ光は、光ファイバ３１２を介して光照射部３１４に導かれ、光照射部３１４から光照射部３１４の径方向外方に向かって出射される。これにより、病変部２００にレーザ光が照射される。そうすると、病変部２００に結合した光感受性物質がレーザ光と反応するため、病変部２００（がん細胞）が破壊される。 After preparing the laser system 310 , 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 . Next, laser light is oscillated from the laser body. Then, 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 . As a result, the lesion 200 is irradiated with laser light. Then, the photosensitizer bound to the lesion 200 reacts with the laser beam, destroying the lesion 200 (cancer cells).
　本実施形態は、以下の効果を奏する。 The present embodiment has the following effects.
　本実施形態によれば、穿刺針１０の針体２０の外面４２にエコー下において超音波を反射させるための凹部４４を形成している。そのため、針体２０の内周面３６又はシャフト部１６の外周面に凹部４４を形成する場合と比較して、超音波プローブ３０２によって受信される反射波の強度を効率よく向上させることができる。従って、超音波画像において穿刺針１０を視認し易くできる。 According to this embodiment, the outer surface 42 of the needle body 20 of the puncture needle 10 is formed with a recess 44 for reflecting ultrasonic waves under echo. Therefore, the intensity of the reflected wave received by the ultrasonic probe 302 can be efficiently improved compared to the case where the concave portion 44 is formed in the inner peripheral surface 36 of the needle 20 or the outer peripheral surface of the shaft portion 16 . Therefore, the puncture needle 10 can be easily visually recognized in the ultrasound image.
　針体２０の内腔２４には、シャフト部１６を針体２０から抜去した状態で治療用の光を照射する光照射部３１４を挿入可能である。 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 .
　このような構成によれば、針体２０の内腔２４に挿入した光照射部３１４から照射される光（放射線を含む）をがん細胞に照射する治療用デバイスとして穿刺針１０を用いることができる。 According to such a configuration, the puncture needle 10 can be used as a therapeutic device for irradiating cancer cells with light (including radiation) emitted from the light emitting unit 314 inserted into the lumen 24 of the needle body 20. can.
　針体２０の内径Ｄｃは、０．５ｍｍ以上である。 The inner diameter Dc of the needle body 20 is 0.5 mm or more.
　このような構成によれば、一般的な薬剤投与用の穿刺針の外針の内径（０．４１ｍｍ）に比べて針体２０の内径Ｄｃが大きいため、針体２０の内腔２４に挿入される光照射部３１４の外径の自由度が高くなる。 According to such a configuration, since the inner diameter Dc of the needle body 20 is larger than the inner diameter (0.41 mm) of the outer needle of a general puncture needle for drug administration, the needle body 20 can be inserted into the lumen 24 of the needle body 20. The degree of freedom of the outer diameter of the light irradiation section 314 is increased.
　針体２０の内腔２４は、針体２０の先端部において封止されている。 A lumen 24 of the needle body 20 is sealed at the tip of the needle body 20 .
　このような構成によれば、穿刺針１０を患者２０２に穿刺した際に、針体２０の内腔２４に血液が流入することを阻止することができる。 According to such a configuration, it is possible to prevent blood from flowing into the lumen 24 of the needle body 20 when the puncture needle 10 is punctured into the patient 202 .
　凹部４４は、溝部４６を有する。溝部４６は、深さ方向に向かって幅狭に形成されている。 The recessed portion 44 has a groove portion 46 . The groove portion 46 is formed narrower in the depth direction.
　このような構成によれば、溝部４６を深さ方向に向かって幅広に形成した場合と比較して、針体２０を患者２０２に穿刺した際の抵抗（穿刺抵抗）を小さくすることができる。これにより、針体２０を患者２０２に円滑に穿刺することができる。また、針体２０の穿刺時に患者２０２が感じる痛みを抑えることができる。 According to such a configuration, the resistance (puncture resistance) when the needle body 20 is punctured into the patient 202 can be reduced compared to the case where the groove 46 is widened in the depth direction. Thereby, the patient 202 can be smoothly punctured with the needle body 20 . Moreover, the pain felt by the patient 202 when the needle body 20 is punctured can be suppressed.
　溝部４６は、１条巻きの螺旋溝４８を有する。 The groove portion 46 has a spiral groove 48 with one turn.
　このような構成によれば、超音波を螺旋溝４８によって効率的に反射させることができる。 According to such a configuration, ultrasonic waves can be efficiently reflected by the spiral grooves 48 .
　溝部４６の溝幅Ｗは、１０μｍ以上５０μｍ以下に設定されている。 The groove width W of the groove portion 46 is set to 10 μm or more and 50 μm or less.
　このような構成によれば、溝幅Ｗが１０μｍ以上であるため、一般的な超音波画像診断装置３００によって溝部４６を検出することができる。また、溝幅Ｗが５０μｍ以下であるため、針体２０の穿刺抵抗が過度に大きくなることを抑えることができる。 According to such a configuration, since the groove width W is 10 μm or more, the groove portion 46 can be detected by a general ultrasonic diagnostic imaging apparatus 300 . Moreover, since the groove width W is 50 μm or less, it is possible to prevent the puncture resistance of the needle body 20 from becoming excessively large.
　溝部４６の溝深さＤｂは、２５μｍ以上且つ針本体３０の肉厚Ｔの３７．５％以下に設定されている。 The groove depth Db of the groove portion 46 is set to 25 μm or more and 37.5% or less of the thickness T of the needle body 30 .
　このような構成によれば、溝深さＤｂが２５μｍ以上であるため、溝部４６で超音波を効率的にプローブ側まで反射させることができる。また、溝深さＤｂが針本体３０の肉厚Ｔの３７．５％以下であるため、針体２０の強度低下が過度に低下することを抑えることができる。 According to such a configuration, since the groove depth Db is 25 μm or more, the groove 46 can efficiently reflect the ultrasonic waves to the probe side. Further, since the groove depth Db is 37.5% or less of the thickness T of the needle body 30, it is possible to prevent the strength of the needle body 20 from being excessively lowered.
　溝部４６のピッチＰは、１００μｍ以上に設定されている。 The pitch P of the grooves 46 is set to 100 μm or more.
　このような構成によれば、溝部４６で超音波を効率的にプローブ側まで反射させることができる。 With such a configuration, the groove 46 can efficiently reflect ultrasonic waves to the probe side.
　溝部４６の針体２０の軸線方向に沿った溝長さＬｂは、１ｍｍ以上に設定されている。 A groove length Lb of the groove portion 46 along the axial direction of the needle body 20 is set to 1 mm or more.
　このような構成によれば、超音波画像において溝部４６を視認し易くすることができる。 According to such a configuration, it is possible to make it easier to visually recognize the groove portion 46 in the ultrasonic image.
（第１変形例）
　次に、第１変形例に係る針体５０について説明する。本変形例に係る針体５０において、上述した針体２０と同一の構成については同一の参照符号を付し、その詳細な説明は省略する。後述する第２～第７変形例に係る針体６０、８０、９０、１００、１１０、１３０についても同様である。また、第１～第７変形例において、上述した針体２０と同様の構成については同様の効果を奏する。 (First modification)
Next, a needle body 50 according to a first modified example will be described. In the needle body 50 according to this modified example, the same reference numerals are given to the same configurations as those of the needle body 20 described above, and detailed description thereof will be omitted. The same applies to needle bodies 60, 80, 90, 100, 110, and 130 according to second to seventh modifications described later. In addition, in the first to seventh modifications, the same effects as those of the needle body 20 described above are obtained.
　図７Ａに示すように、針体５０の外面５２に形成された凹部５４は、溝部５６を含む。溝部５６は、多条巻きの螺旋溝５８を有する。この場合、例えば、環状溝を針体５０の軸線方向に間隔を空けて複数設ける構成と比較して、針体５０の曲げ強さを向上させることができる。螺旋溝５８は、２条以上５０条以下に設定されるのが好ましく、１１条以上４４条以下に設定されるのがより好ましい。溝部５６（螺旋溝５８）の溝幅、溝深さ、ピッチ、溝長さは、上述した溝部４６（螺旋溝４８）と同様に設定される。なお、針体５０の外径及び有効長は、上述した針体２０の外径Ｄａ及び有効長Ｌａと同様に設定される。後述する針体６０、８０、９０、１００、１１０、１３０についても同様である。 As shown in FIG. 7A, the recess 54 formed in the outer surface 52 of the needle body 50 includes grooves 56 . The groove portion 56 has a spiral groove 58 with multiple windings. In this case, for example, the bending strength of the needle body 50 can be improved compared to a configuration in which a plurality of annular grooves are provided at intervals in the axial direction of the needle body 50 . The number of spiral grooves 58 is preferably 2 or more and 50 or less, and more preferably 11 or more and 44 or less. The groove width, groove depth, pitch, and groove length of the groove portion 56 (spiral groove 58) are set in the same manner as the groove portion 46 (spiral groove 48) described above. The outer diameter and effective length of the needle body 50 are set in the same manner as the outer diameter Da and effective length La of the needle body 20 described above. The same applies to needle bodies 60, 80, 90, 100, 110, and 130, which will be described later.
　本変形例によれば、溝部５６は、多条巻きの螺旋溝５８を有する。 According to this modified example, the groove portion 56 has a spiral groove 58 with multiple windings.
　このような構成によれば、超音波を螺旋溝５８によって効率的に反射させることができる。 According to such a configuration, ultrasonic waves can be efficiently reflected by the spiral grooves 58.
（第２変形例）
　次に、第２変形例に係る針体６０について説明する。図７Ｂに示すように、針体６０の外面６２に形成された凹部６４は、溝部６６を含む。溝部６６は、複数の溝列６８を有する。複数の溝列６８は、針体６０の周方向に間隔を空けて配置されている。本実施形態では、溝部６６は、４つの溝列６８を含む。複数の溝列６８は、針体６０の周方向に９０°位相をずらして位置している。溝列６８は、１つであってもよい。また、針体６０の外面６２には、針体６０の周方向に２つ、３つ、又は５つ以上の溝列６８が配置されてもよい。 (Second modification)
Next, a needle body 60 according to a second modified example will be described. As shown in FIG. 7B, recess 64 formed in outer surface 62 of needle 60 includes groove 66 . The groove portion 66 has a plurality of groove rows 68 . The plurality of groove rows 68 are arranged at intervals in the circumferential direction of the needle body 60 . In this embodiment, the groove portion 66 includes four groove rows 68 . The plurality of groove rows 68 are positioned with a 90° phase shift in the circumferential direction of the needle body 60 . The number of groove rows 68 may be one. Further, two, three, or five or more groove rows 68 may be arranged in the circumferential direction of the needle body 60 on the outer surface 62 of the needle body 60 .
　各溝列６８は、複数の短溝７０を含む。複数の短溝７０は、針体６０の軸線方向に間隔を空けて配置されている。各短溝７０における針体６０の周方向に沿った長さは、溝列６８の数と後述するなす角度θとの兼ね合いによる設定されるが、概ね針体６０の周長の１／４以下である。 Each groove row 68 includes a plurality of short grooves 70. The plurality of short grooves 70 are arranged at intervals in the axial direction of the needle body 60 . The length of each short groove 70 along the circumferential direction of the needle body 60 is set according to the balance between the number of groove rows 68 and the angle θ to be formed, which will be described later. is.
　各短溝７０は、第１傾斜溝７２と第２傾斜溝７４とを含む。第１傾斜溝７２は、針体６０の先端に向かって針体６０の周方向に沿った第１周方向に傾斜している。第２傾斜溝７４は、針体６０の先端に向かって第１周方向とは反対方向である第２周方向に傾斜している。 Each short groove 70 includes a first slanted groove 72 and a second slanted groove 74 . The first inclined groove 72 is inclined in the first circumferential direction along the circumferential direction of the needle body 60 toward the tip of the needle body 60 . The second inclined groove 74 is inclined toward the tip of the needle body 60 in the second circumferential direction opposite to the first circumferential direction.
　第１傾斜溝７２の先端と第２傾斜溝７４の先端とは本変形例においては互いに繋がっていてＶ字状をなしているが繋がっていなくても構わない。第１傾斜溝７２と第２傾斜溝７４とのなす角度θは、鋭角に設定されている。ただし、なす角度θは、直角又は鈍角に設定されてもよい。第１傾斜溝７２の全長は、第２傾斜溝７４の全長と同じである。ただし、第１傾斜溝７２の全長は、第２傾斜溝７４の全長よりも短くても長くてもよい。 The tip of the first slanted groove 72 and the tip of the second slanted groove 74 are connected to each other to form a V-shape in this modified example, but they do not have to be connected. The angle θ between the first inclined groove 72 and the second inclined groove 74 is set to an acute angle. However, the formed angle θ may be set to a right angle or an obtuse angle. The total length of the first inclined groove 72 is the same as the total length of the second inclined groove 74 . However, the total length of the first inclined grooves 72 may be shorter or longer than the total length of the second inclined grooves 74 .
　各短溝７０の溝幅は、上述した螺旋溝４８の溝幅Ｗと同様に設定される。各短溝７０の溝深さは、上述した螺旋溝４８の溝深さＤｂと同様に設定される。各溝列６８の互いに隣接する短溝７０の間隔（ピッチ）は、上述した螺旋溝４８のピッチＰと同様に設定される。複数の溝列６８における針体６０の軸線方向に沿った溝長さは、上述した螺旋溝４８の溝長さＬｂと同様に設定される。 The groove width of each short groove 70 is set in the same manner as the groove width W of the spiral groove 48 described above. The groove depth of each short groove 70 is set similarly to the groove depth Db of the spiral groove 48 described above. The interval (pitch) between adjacent short grooves 70 in each groove row 68 is set in the same manner as the pitch P of the spiral grooves 48 described above. The groove length along the axial direction of the needle body 60 in the plurality of groove rows 68 is set similarly to the groove length Lb of the spiral groove 48 described above.
　本変形例において、溝部６６は、針体６０の軸線方向に間隔を空けて配置された複数の短溝７０を含む溝列６８を有している。複数の短溝７０の各々は、針体６０の周方向に沿った長さが当該針体６０の周長の１／４以下である。 In this modified example, the groove portion 66 has a groove row 68 including a plurality of short grooves 70 spaced apart in the axial direction of the needle body 60 . Each of the plurality of short grooves 70 has a length along the circumferential direction of the needle body 60 that is 1/4 or less of the circumferential length of the needle body 60 .
　このような構成によれば、超音波を複数の短溝７０によって効率的に反射させることができる。 With such a configuration, ultrasonic waves can be efficiently reflected by the plurality of short grooves 70 .
　溝列６８は、針体６０の周方向に間隔を空けて複数設けられている。 A plurality of groove rows 68 are provided at intervals in the circumferential direction of the needle body 60 .
　このような構成によれば、針体６０の周方向の向きによって反射波の強度が変化することを抑えることができる。 According to such a configuration, it is possible to suppress the intensity of the reflected wave from changing depending on the orientation of the needle 60 in the circumferential direction.
　複数の短溝７０の各々は、第１傾斜溝７２と第２傾斜溝７４とを含む。第１傾斜溝７２は、針体６０の先端に向かって当該針体６０の周方向に沿った第１周方向に傾斜している。第２傾斜溝７４は、針体６０の先端に向かって第１周方向とは反対方向である第２周方向に傾斜している。第１傾斜溝７２の先端と第２傾斜溝７４の先端とは、互いに繋がっている。 Each of the plurality of short grooves 70 includes a first inclined groove 72 and a second inclined groove 74. The first inclined groove 72 is inclined in the first circumferential direction along the circumferential direction of the needle body 60 toward the tip of the needle body 60 . The second inclined groove 74 is inclined toward the tip of the needle body 60 in the second circumferential direction opposite to the first circumferential direction. The tip of the first inclined groove 72 and the tip of the second inclined groove 74 are connected to each other.
　このような構成によれば、穿刺抵抗を比較的小さくできるため、針体６０を病変部２００に円滑に穿刺することができる。 According to such a configuration, since the puncture resistance can be made relatively small, the lesion 200 can be smoothly punctured by the needle body 60 .
（第３変形例）
　次に、第３変形例に係る針体８０について説明する。図８に示すように、針体８０の針先端部８２は、先端方向に向かってテーパ状に縮径した内面８４を有している。すなわち、針先端部８２において、針体８０の内腔２４の横断面積は、先端方向に向かって小さくなっている。針体８０の外面８６には、上述した凹部４４が形成されている。ただし、針体８０の外面８６には、上述した凹部５４、６４が形成されてもよい。 (Third modification)
Next, a needle body 80 according to a third modification will be described. As shown in FIG. 8, the needle distal end portion 82 of the needle body 80 has an inner surface 84 tapered toward the distal end. That is, at the needle distal end portion 82, the cross-sectional area of the lumen 24 of the needle body 80 decreases toward the distal end. The outer surface 86 of the needle body 80 is formed with the recess 44 described above. However, the recesses 54 and 64 described above may be formed on the outer surface 86 of the needle body 80 .
（第４変形例）
　次に、第４変形例に係る針体９０について説明する。図９に示すように、針体９０の針先端部９２には、先端開口９４が形成されている。つまり、針体９０の内腔２４は、先端開口９４に連通している。針体９０の外面９６には、上述した凹部４４が形成されている。ただし、針体９０の外面９６には、上述した凹部５４、６４が形成されてもよい。 (Fourth modification)
Next, a needle body 90 according to a fourth modification will be described. As shown in FIG. 9, a tip opening 94 is formed in the needle tip portion 92 of the needle body 90 . That is, the lumen 24 of the needle body 90 communicates with the tip opening 94 . The outer surface 96 of the needle body 90 is formed with the recess 44 described above. However, the recesses 54 and 64 described above may be formed on the outer surface 96 of the needle body 90 .
（第５変形例）
　次に、第５変形例に係る針体１００について説明する。図１０に示すように、針体１００の外面１０２に形成された凹部１０４は、溝部１０６を含む。溝部１０６は、針体１００の周方向に一周延在した複数の環状溝１０８を有する。各環状溝１０８は、円形状に延在している。複数の環状溝１０８は、針体１００の軸線方向に間隔を空け設けられている。環状溝１０８の溝幅は、上述した螺旋溝４８の溝幅Ｗと同様に設定される。環状溝１０８の溝深さは、上述した螺旋溝４８の溝深さＤｂと同様に設定される。互いに隣接する環状溝１０８の間隔（ピッチ）は、上述した螺旋溝４８のピッチＰと同様に設定される。最先端に位置する環状溝１０８から最基端に位置する環状溝１０８までの長さである溝部１０６の溝長さは、上述した螺旋溝４８の溝長さＬｂと同様に設定される。 (Fifth modification)
Next, a needle body 100 according to a fifth modification will be described. As shown in FIG. 10 , recess 104 formed in outer surface 102 of needle 100 includes groove 106 . The groove portion 106 has a plurality of annular grooves 108 extending around the circumference of the needle body 100 . Each annular groove 108 extends circularly. The plurality of annular grooves 108 are spaced apart in the axial direction of the needle body 100 . The groove width of the annular groove 108 is set similarly to the groove width W of the spiral groove 48 described above. The groove depth of the annular groove 108 is set similarly to the groove depth Db of the spiral groove 48 described above. The interval (pitch) between the annular grooves 108 adjacent to each other is set in the same manner as the pitch P of the spiral grooves 48 described above. The groove length of the groove portion 106, which is the length from the annular groove 108 located at the distal end to the annular groove 108 located at the proximal end, is set in the same manner as the groove length Lb of the spiral groove 48 described above.
　本変形例によれば、溝部１０６は、針体１００の周方向に一周延在した環状溝１０８を有する。 According to this modification, the groove portion 106 has an annular groove 108 that extends around the needle body 100 in the circumferential direction.
　このような構成によれば、超音波を環状溝１０８によって効率的に反射させることができる。 With such a configuration, ultrasonic waves can be efficiently reflected by the annular groove 108 .
　環状溝１０８は、針体１００の軸線方向に間隔を空けて複数設けられている。 A plurality of annular grooves 108 are provided at intervals in the axial direction of the needle body 100 .
　このような構成によれば、複数の環状溝１０８によって超音波を一層効率的に反射させることができる。 According to such a configuration, ultrasonic waves can be more efficiently reflected by the plurality of annular grooves 108 .
（第６変形例）
　次に、第６変形例に係る針体１１０について説明する。図１１Ａに示すように、針体１１０の外面１１２に形成された凹部１１６は、溝部１１８を有する。溝部１１８は、複数の溝部６６と、複数の溝部４６とを含む。図１１Ａの例において、溝部６６は２つであり、溝部４６は２つである。 (Sixth modification)
Next, a needle body 110 according to a sixth modification will be described. As shown in FIG. 11A, recess 116 formed in outer surface 112 of needle 110 has groove 118 . Grooves 118 include a plurality of grooves 66 and a plurality of grooves 46 . In the example of FIG. 11A, there are two grooves 66 and two grooves 46 .
　溝部６６と溝部４６とは、針体１１０の軸線方向に間隔を空けて交互に配置されている。針体１１０の軸線方向に沿った溝部１１８の溝長さは、上述した螺旋溝４８の溝長さＬｂと同様に設定される。具体的に、溝部１１８の溝長さは、例えば、１０ｍｍである。この場合、溝部４６は、例えば、溝部１１８の先端から基端方向に５ｍｍずれた位置と、溝部１１８の先端から基端方向に１０ｍｍずれた位置とに設けられる。溝部６６及び溝部４６の数、位置及び長さは、適宜設定可能である。 The grooves 66 and the grooves 46 are alternately arranged at intervals in the axial direction of the needle body 110 . The groove length of the groove portion 118 along the axial direction of the needle body 110 is set similarly to the groove length Lb of the spiral groove 48 described above. Specifically, the groove length of the groove portion 118 is, for example, 10 mm. In this case, the groove 46 is provided, for example, at a position shifted by 5 mm in the proximal direction from the tip of the groove 118 and at a position shifted by 10 mm in the proximal direction from the tip of the groove 118 . The number, positions and lengths of the grooves 66 and 46 can be set as appropriate.
　本変形例によれば、溝部１１８は、複数パターンの溝部（溝部６６及び溝部４６）を有する。このような構成によれば、溝部６６における超音波の反射強度と溝部４６における超音波の反射強度とが互いに異なるため、単一パターンの溝部を設ける場合と比較して、超音波画像により針体１１０の穿刺位置及び穿刺長さが把握し易くなる。 According to this modified example, the groove portion 118 has a plurality of patterns of groove portions (the groove portions 66 and the groove portions 46). According to such a configuration, since the reflection intensity of ultrasonic waves in the groove portion 66 and the reflection intensity of ultrasonic waves in the groove portion 46 are different from each other, compared to the case where a single pattern of groove portions is provided, the needle body can be detected by an ultrasonic image. The puncture position and puncture length of 110 can be easily grasped.
　本変形例において、溝部１１８は、上述した溝部６６と溝部４６とを組み合わせた構成に限定されない。溝部１１８は、上述した溝部４６、５６、６６、１０６を複数組み合わせてよい。 In this modified example, the groove portion 118 is not limited to the combination of the groove portion 66 and the groove portion 46 described above. The groove 118 may be formed by combining a plurality of the grooves 46, 56, 66, 106 described above.
（第７変形例）
　次に、第７変形例に係る針体１３０について説明する。図１１Ｂに示すように、針体１３０の外面１３２に形成された凹部１３６は、溝部１３８を有する。溝部１３８は、溝部１０６と溝部５６とを含む。溝部１０６は、針体１３０の針先端部３２に位置する。溝部５６は、針体１３０の針本体３０に位置する。溝部５６の溝長さは、例えば、１０ｍｍである。 (Seventh modification)
Next, a needle body 130 according to a seventh modified example will be described. As shown in FIG. 11B, recess 136 formed in outer surface 132 of needle 130 has groove 138 . Groove 138 includes groove 106 and groove 56 . The groove portion 106 is located at the needle tip portion 32 of the needle body 130 . The groove portion 56 is located in the needle body 30 of the needle body 130 . The groove length of the groove portion 56 is, for example, 10 mm.
　このような構成によれば、針体１３０の針先端部３２に溝部１０６を設けるとともに針体１３０の針本体３０に溝部１０６とは形状の異なる溝部５６を設けている。この場合、超音波画像において針体１３０の針先端部３２の見え方が針体１３０の針本体３０の見え方と異なるため、針体１３０の針先端部３２の位置を容易に把握することができる。 According to such a configuration, the needle distal end portion 32 of the needle body 130 is provided with the groove portion 106 , and the needle main body 30 of the needle body 130 is provided with the groove portion 56 having a shape different from that of the groove portion 106 . In this case, the appearance of the needle tip portion 32 of the needle body 130 differs from the appearance of the needle main body 30 of the needle body 130 in the ultrasonic image, so the position of the needle tip portion 32 of the needle body 130 can be easily grasped. can.
　本変形例において、溝部１３８は、上述した溝部１０６と溝部５６とを組み合わせた構成に限定されない。針体１３０の針先端部３２には、溝部１０６に代えて溝部４６、５６、６６の少なくともいずれかが設けられてもよい。また、針体１３０の針本体３０には、溝部５６に代えて、溝部４６、６６、１０６の少なくともいずれかが設けられてもよい。さらに、針体１３０の針本体３０には、溝部５６に代えて、溝部１１８が設けられてもよい。 In this modified example, the groove portion 138 is not limited to the combination of the groove portion 106 and the groove portion 56 described above. At least one of the grooves 46 , 56 , 66 may be provided in the needle tip portion 32 of the needle body 130 instead of the groove 106 . At least one of the grooves 46 , 66 , and 106 may be provided in the needle body 30 of the needle body 130 instead of the groove 56 . Further, the needle body 30 of the needle body 130 may be provided with the groove portion 118 instead of the groove portion 56 .
　次に、本発明の効果を確認するために実施した試験について説明する。以下では、螺旋溝４８に関する試験を代表的に示すが、螺旋溝５８及び溝部６６についても螺旋溝４８と同様の試験結果を得ている。 Next, the test conducted to confirm the effect of the present invention will be explained. Although the test for the spiral groove 48 is representatively shown below, the same test results as for the spiral groove 48 are obtained for the spiral groove 58 and the groove portion 66 as well.
［サンプル］
　図１２Ａ～図１３Ｂに示すように、本試験では、第１サンプル１４０、第２サンプル１４２、第３サンプル１４４及び第４サンプル１４６を用意した。第１サンプル１４０は、後述するように、実施例１～５の摺動試験と、実施例６～９の強度試験とに用いられる。第２サンプル１４２は、比較例１における摺動試験に用いられる。第３サンプル１４４は、実施例１、２、６～８、１０～１８の超音波画像の撮影に用いられる。第４サンプル１４６は、比較例１の超音波画像の撮影に用いられる。 [sample]
As shown in FIGS. 12A-13B, a first sample 140, a second sample 142, a third sample 144 and a fourth sample 146 were prepared in this test. The first sample 140 is used for the sliding tests of Examples 1-5 and the strength tests of Examples 6-9, as will be described later. The second sample 142 is used for the sliding test in Comparative Example 1. The third sample 144 is used for capturing ultrasound images of Examples 1, 2, 6-8, and 10-18. A fourth sample 146 is used for capturing an ultrasound image of Comparative Example 1. FIG.
　図１２Ａに示すように、第１サンプル１４０は、樹脂チューブ１４８と、樹脂チューブ１４８の内腔に挿通された内針１５０とを有する。樹脂チューブ１４８の先端は、開口している。樹脂チューブ１４８は、ＰＯＭによって構成されている。樹脂チューブ１４８の寸法は、上述した針本体３０の寸法と同じである。樹脂チューブ１４８の外周面には、上述した螺旋溝４８が形成されている。内針１５０は、２１Ｇ（ゲージ）のいわゆるベベル針であって、鋭利な針先を有する。内針１５０は、樹脂チューブ１４８の先端開口から突出している。図１２Ｂに示すように、第２サンプル１４２は、螺旋溝４８を有していない点以外、第１サンプル１４０と同一に構成される。 As shown in FIG. 12A, the first sample 140 has a resin tube 148 and an inner needle 150 inserted through the lumen of the resin tube 148. The distal end of the resin tube 148 is open. The resin tube 148 is made of POM. The dimensions of the resin tube 148 are the same as the dimensions of the needle body 30 described above. The spiral groove 48 described above is formed on the outer peripheral surface of the resin tube 148 . The inner needle 150 is a so-called bevel needle of 21G (gauge) and has a sharp tip. The inner needle 150 protrudes from the tip opening of the resin tube 148 . As shown in FIG. 12B, the second sample 142 is constructed identically to the first sample 140 except that it does not have the spiral grooves 48 .
　このように、第１サンプル１４０は、上述した穿刺針１０とは異なる形状を有する。換言すれば、第１サンプル１４０は、穿刺針１０の代用品である。しかしながら、摺動試験では、穿刺針１０の針本体３０のうち螺旋溝４８が位置する部分の摺動抵抗を評価対象としている。そのため、樹脂チューブ１４８の材質及び寸法が穿刺針１０の針本体３０の材質及び寸法と同じであれば、それ以外の形状等が互いに異なっていても、摺動抵抗の測定結果に影響しない。よって、摺動試験では、第１サンプル１４０を用いても穿刺針１０を用いた場合と同じ結果が得られる。 Thus, the first sample 140 has a shape different from that of the puncture needle 10 described above. In other words, first sample 140 is a substitute for puncture needle 10 . However, in the sliding test, the object of evaluation is the sliding resistance of the portion of the needle body 30 of the puncture needle 10 where the spiral groove 48 is located. Therefore, if the material and dimensions of the resin tube 148 are the same as the material and dimensions of the needle body 30 of the puncture needle 10, even if the other shapes and the like are different from each other, they do not affect the measurement result of the sliding resistance. Therefore, in the sliding test, even when the first sample 140 is used, the same result as when the puncture needle 10 is used is obtained.
　また、後述する強度試験では、穿刺針１０の針本体３０に形成した螺旋溝４８が位置する部分の強度を評価対象としている。そのため、樹脂チューブ１４８の材質及び寸法が穿刺針１０の針本体３０の材質及び寸法と同じであれば、それ以外の形状等が互いに異なっていても、強度の測定結果に影響しない。よって、強度試験では、第１サンプル１４０を用いても穿刺針１０を用いた場合と同じ結果が得られる。 In addition, in the strength test described later, the strength of the portion where the spiral groove 48 formed in the needle body 30 of the puncture needle 10 is located is evaluated. Therefore, if the material and dimensions of the resin tube 148 are the same as the material and dimensions of the needle body 30 of the puncture needle 10, even if the other shapes and the like are different from each other, the strength measurement results are not affected. Therefore, in the strength test, even if the first sample 140 is used, the same results as when the puncture needle 10 is used can be obtained.
　図１３Ａに示すように、第３サンプル１４４は、樹脂チューブ１４８と、上述したシャフト部１６と、封止部１５２とを有する。シャフト部１６は、樹脂チューブ１４８の内腔に挿入されている。封止部１５２は、樹脂チューブ１４８の先端開口部を封止する。これにより、樹脂チューブ１４８の内腔への水分の浸入を防止できる。よって、樹脂チューブ１４８に浸入した水分によって超音波画像の見え方が変化することがない。封止部１５２は、光硬化型接着剤である。封止部１５２は、樹脂チューブ１４８の構成材料とは異なる材料によって構成されている。なお、本試験は、樹脂チューブ１４８（特に、螺旋溝４８）が形成されている部分の超音波画像の見え方を評価するものであるため、封止部１５２の構成材料と樹脂チューブ１４８の構成材料とが互いに異なっていても評価に影響を与えることはない。図１３Ｂに示すように、第４サンプル１４６は、螺旋溝４８を有していない点以外、第３サンプル１４４と同一に構成される。 As shown in FIG. 13A, the third sample 144 has a resin tube 148, the shaft portion 16 described above, and a sealing portion 152. The shaft portion 16 is inserted into the lumen of the resin tube 148 . The sealing portion 152 seals the tip opening of the resin tube 148 . This can prevent water from entering the lumen of the resin tube 148 . Therefore, the appearance of the ultrasonic image does not change due to moisture that has entered the resin tube 148 . The sealing portion 152 is a photocurable adhesive. The sealing portion 152 is made of a material different from the material of the resin tube 148 . In addition, since this test evaluates the appearance of the ultrasonic image of the portion where the resin tube 148 (especially the spiral groove 48) is formed, Even if the materials are different from each other, it does not affect the evaluation. As shown in FIG. 13B, the fourth sample 146 is constructed identically to the third sample 144 except that it does not have the spiral grooves 48 .
　このように、第３サンプル１４４は、上述した穿刺針１０とは異なる形状を有する。換言すれば、第３サンプル１４４は、穿刺針１０の代用品である。しかしながら、本試験では、穿刺針１０の針本体３０のうち螺旋溝４８が位置する部分の超音波画像の見え易さ（平均輝度）を評価対象としている。そのため、樹脂チューブ１４８の材質及び寸法が穿刺針１０の針本体３０の材質及び寸法と同じであれば、それ以外の形状等が互いに異なっていても、超音波画像の評価に影響しない。よって、超音波画像の評価では、第３サンプル１４４を用いても穿刺針１０を用いた場合と同じ結果が得られる。 Thus, the third sample 144 has a shape different from that of the puncture needle 10 described above. In other words, third sample 144 is a substitute for puncture needle 10 . However, in this test, the visibility (average luminance) of the ultrasonic image of the portion of the needle body 30 of the puncture needle 10 where the spiral groove 48 is located is evaluated. Therefore, if the material and dimensions of the resin tube 148 are the same as the material and dimensions of the needle body 30 of the puncture needle 10, the evaluation of the ultrasonic image will not be affected even if the other shapes and the like are different from each other. Therefore, in the evaluation of the ultrasonic image, even if the third sample 144 is used, the same result as when the puncture needle 10 is used can be obtained.
（溝幅Ｗの設定に関する試験）
　図１４に示すように、溝幅Ｗの設定に関する試験では、実施例１～５及び比較例１に対して摺動試験を行い、実施例１、２及び比較例１に対して超音波画像の撮影を行った。実施例１に係る第１サンプル１４０及び第３サンプル１４４の溝幅Ｗは、１０μｍである。実施例２に係る第１サンプル１４０及び第３サンプル１４４の溝幅Ｗは、２５μｍである。実施例３に係る第１サンプル１４０及び第３サンプル１４４の溝幅Ｗは、４０μｍである。実施例４に係る第１サンプル１４０及び第３サンプル１４４の溝幅Ｗは、５０μｍである。実施例５に係る第１サンプル１４０及び第３サンプル１４４の溝幅Ｗは、５５μｍである。なお、実施例１～５において、溝深さＤｂは５０μｍ、ピッチＰは３００μｍ、溝長さＬｂは１０ｍｍとした。 (Test for setting groove width W)
As shown in FIG. 14, in the test for setting the groove width W, a sliding test was performed on Examples 1 to 5 and Comparative Example 1, and ultrasonic images were obtained for Examples 1 and 2 and Comparative Example 1. I took a picture. The groove width W of the first sample 140 and the third sample 144 according to Example 1 is 10 μm. The groove width W of the first sample 140 and the third sample 144 according to Example 2 is 25 μm. The groove width W of the first sample 140 and the third sample 144 according to Example 3 is 40 μm. The groove width W of the first sample 140 and the third sample 144 according to Example 4 is 50 μm. The groove width W of the first sample 140 and the third sample 144 according to Example 5 is 55 μm. In Examples 1 to 5, the groove depth Db was 50 μm, the pitch P was 300 μm, and the groove length Lb was 10 mm.
　一般的に、超音波画像診断装置３００によって検出することができる物の寸法は、超音波画像診断装置３００から発信される超音波の波長の１／１０程度である。一般的な超音波画像診断装置３００から発信される超音波の波長の下限値は、１００μｍ（１５ＭＨｚ）である。そのため、１００μｍの１／１０である１０μｍを溝幅Ｗの下限値とした。 Generally, the size of an object that can be detected by the ultrasonic diagnostic imaging apparatus 300 is about 1/10 of the wavelength of the ultrasonic waves emitted from the ultrasonic diagnostic imaging apparatus 300. The lower limit of the wavelength of ultrasonic waves emitted from a general ultrasonic diagnostic imaging apparatus 300 is 100 μm (15 MHz). Therefore, the lower limit of the groove width W is set to 10 μm, which is 1/10 of 100 μm.
［試験方法］
　図１５に示すように、摺動試験では、実施例１～５に係る第１サンプル１４０と比較例１に係る第２サンプル１４２とを、円筒状の支持台１６２の一端面に配置された厚さ０．５ｍｍのシリコーンシート１６４に所定の穿刺速度で穿刺した。摺動試験では、この時の樹脂チューブ１４８における螺旋溝４８が設けられた部分の摺動抵抗を測定した。摺動評価については、Ａ～Ｄの４段階で評価した。具体的に、比較例１と同等の摺動抵抗である場合の摺動評価をＡとした。摺動抵抗が第１閾値よりも大きい場合の摺動評価をＢとした。摺動抵抗が第２閾値よりも大きい場合の摺動評価をＣとした。摺動抵抗が第３閾値よりも大きい場合の摺動評価をＤとした。第１閾値は、比較例１の摺動抵抗よりも大きい。第２閾値は、第１閾値よりも大きい。第３閾値は、第２閾値よりも大きい。 [Test method]
As shown in FIG. 15, in the sliding test, a first sample 140 according to Examples 1 to 5 and a second sample 142 according to Comparative Example 1 were placed on one end surface of a cylindrical support base 162 and placed on one end surface. A silicone sheet 164 with a thickness of 0.5 mm was punctured at a predetermined puncture speed. In the sliding test, the sliding resistance of the portion of the resin tube 148 provided with the spiral groove 48 at this time was measured. Sliding evaluation was evaluated on a four-grade scale from A to D. Specifically, A is the sliding evaluation when the sliding resistance is equivalent to that of Comparative Example 1. B was the sliding evaluation when the sliding resistance was greater than the first threshold. C is the sliding evaluation when the sliding resistance is greater than the second threshold. D was the sliding evaluation when the sliding resistance was greater than the third threshold. The first threshold is greater than the sliding resistance of Comparative Example 1. The second threshold is greater than the first threshold. The third threshold is greater than the second threshold.
　また、摺動評価がＡであった実施例１及び２に係る第３サンプル１４４と比較例１に係る第４サンプル１４６とをゲルファントムに穿刺した時の超音波画像を撮影した。超音波プローブ３０２の種類は、リニアプローブを使用した。超音波の中心周波数は、１１ＭＨｚに設定した。また、比較例１の超音波画像の穿刺針の平均輝度を基準にした摺動評価がＡであった螺旋溝４８の部分の平均輝度の比率（平均輝度比）を算出した。 In addition, ultrasonic images were taken when the gel phantom was punctured with the third sample 144 according to Examples 1 and 2, which had a sliding evaluation of A, and the fourth sample 146 according to Comparative Example 1. A linear probe was used as the type of ultrasonic probe 302 . The center frequency of ultrasound was set to 11 MHz. In addition, the average luminance ratio (average luminance ratio) of the portion of the spiral groove 48 where the slide evaluation was A based on the average luminance of the puncture needle in the ultrasonic image of Comparative Example 1 was calculated.
［結果］
　図１４に示すように、比較例１、実施例１及び実施例２の穿刺評価はＡ、実施例３の穿刺評価はＢ、実施例４の穿刺評価はＣ、実施例５の穿刺評価はＤであった。超音波画像では、実施例１及び実施例２において、比較例１に比べて視認し易くなった。実施例１の超音波画像において、螺旋溝４８の部分の平均輝度比は、２．６であった。実施例２の超音波画像において、螺旋溝４８の部分の平均輝度比は、実施例１と同じく２．６であった。 [result]
As shown in FIG. 14, the puncture evaluation of Comparative Example 1, Examples 1 and 2 is A, the puncture evaluation of Example 3 is B, the puncture evaluation of Example 4 is C, and the puncture evaluation of Example 5 is D. Met. In the ultrasonic image, in Examples 1 and 2, it became easier to visually recognize than in Comparative Example 1. In the ultrasonic image of Example 1, the average brightness ratio of the portion of the spiral groove 48 was 2.6. In the ultrasonic image of Example 2, the average brightness ratio of the portion of the spiral groove 48 was 2.6, the same as in Example 1.
　このように、摺動評価では、溝幅Ｗが広くなるほど摺動抵抗が高くなった。具体的に、溝幅Ｗが１０μｍ以上５０μｍ以下で摺動抵抗を抑えることができた。特に、溝幅Ｗが１０μｍ以上２５μｍ以下で摺動抵抗を一層抑えることができた。また、実施例１と実施例２とでは、平均輝度比が同じであった。以上より、溝幅Ｗは、１０μｍ以上５０μｍ以下に設定されるのが好ましく、１０μｍ以上２５μｍ以下に設定されるのがより好ましいという結果を得た。 Thus, in the sliding evaluation, the wider the groove width W, the higher the sliding resistance. Specifically, the sliding resistance could be suppressed when the groove width W was 10 μm or more and 50 μm or less. In particular, the sliding resistance could be further suppressed when the groove width W was 10 μm or more and 25 μm or less. Moreover, the average luminance ratio was the same between Example 1 and Example 2. FIG. From the above results, it was found that the groove width W is preferably set to 10 μm or more and 50 μm or less, and more preferably set to 10 μm or more and 25 μm or less.
（溝深さＤｂの設定に関する試験）
　図１６に示すように、溝深さＤｂの設定に関する試験では、実施例６～９に対して強度試験を行い、実施例６～８に対して超音波画像の撮影を行った。実施例６に係る第１サンプル１４０及び第３サンプル１４４の溝深さＤｂは、２５μｍ（樹脂チューブ１４８の肉厚Ｔの１３％）である。実施例７に係る第１サンプル１４０及び第３サンプル１４４の溝深さＤｂは、５０μｍ（樹脂チューブ１４８の肉厚Ｔの２５％）である。実施例８に係る第１サンプル１４０及び第３サンプル１４４の溝深さＤｂは、７５μｍ（樹脂チューブ１４８の肉厚Ｔの３７．５％）である。実施例９に係る第１サンプル１４０及び第３サンプル１４４の溝深さＤｂは、８０μｍ（樹脂チューブ１４８の肉厚Ｔの４０％）である。なお、実施例６～９において、溝幅Ｗは２５μｍ、ピッチＰは３００μｍ、溝長さＬｂは１０ｍｍ、針本体３０の肉厚Ｔは２００μｍである。 (Test for setting groove depth Db)
As shown in FIG. 16, in the test for setting the groove depth Db, strength tests were performed on Examples 6-9, and ultrasonic images were taken on Examples 6-8. The groove depth Db of the first sample 140 and the third sample 144 according to Example 6 is 25 μm (13% of the thickness T of the resin tube 148). The groove depth Db of the first sample 140 and the third sample 144 according to Example 7 is 50 μm (25% of the thickness T of the resin tube 148). The groove depth Db of the first sample 140 and the third sample 144 according to Example 8 is 75 μm (37.5% of the thickness T of the resin tube 148). The groove depth Db of the first sample 140 and the third sample 144 according to Example 9 is 80 μm (40% of the thickness T of the resin tube 148). In Examples 6 to 9, the groove width W is 25 μm, the pitch P is 300 μm, the groove length Lb is 10 mm, and the thickness T of the needle body 30 is 200 μm.
　一般的に、溝深さＤｂが超音波の波長よりも小さい場合に超音波は散乱し易くなる。また、溝深さＤｂが超音波の波長の１／４以上で後方散乱（超音波プローブ３０２に戻る反射波）が多くなる。そのため、一般的な超音波画像診断装置３００から発信される超音波の波長の下限値（１００μｍ）の１／４である２５μｍを溝深さＤｂの下限値とした。 Generally, when the groove depth Db is smaller than the wavelength of the ultrasonic waves, the ultrasonic waves tend to scatter. Also, when the groove depth Db is 1/4 or more of the wavelength of the ultrasonic wave, backscattering (reflected waves returning to the ultrasonic probe 302) increases. Therefore, the lower limit of the groove depth Db is set to 25 μm, which is 1/4 of the lower limit (100 μm) of the wavelength of ultrasonic waves emitted from a general ultrasonic diagnostic imaging apparatus 300 .
［試験方法］
　実施例６～９において、強度評価を行った。具体的に、実施例６～９に係る第１サンプル１４０を螺旋溝４８の溝長さ方向の中央位置まで豚肉に穿刺した状態で内針１５０を樹脂チューブ１４８から抜去し、穿刺状態の樹脂チューブ１４８を豚肉に向かって屈曲させる動作を行った。樹脂チューブ１４８が１回の屈曲動作で破断しなかった第１サンプル１４０の強度評価をＡとし、樹脂チューブ１４８が１回の屈曲動作で破断した第１サンプル１４０の強度評価をＢとした。また、強度評価がＡであった実施例６～８の第３サンプル１４４において、超音波画像の撮影を行った。この超音波画像は、上述した実施例１及び実施例２の超音波画像と同様の方法により撮影した。 [Test method]
In Examples 6 to 9, strength evaluation was performed. Specifically, the inner needle 150 is removed from the resin tube 148 in a state in which the first sample 140 according to Examples 6 to 9 is pierced into the pork to the center position in the groove length direction of the spiral groove 48, and the resin tube in the punctured state An operation was performed to bend 148 toward the pork. The strength evaluation of the first sample 140 in which the resin tube 148 did not break in one bending motion was given as A, and the strength evaluation of the first sample 140 in which the resin tube 148 broke in one bending motion was given as B. In addition, for the third sample 144 of Examples 6 to 8, whose strength evaluation was A, an ultrasonic image was taken. This ultrasonic image was captured by the same method as the ultrasonic images of the first and second embodiments described above.
［結果］
　実施例６～８の強度評価はＡ、実施例９の強度評価はＢであった。超音波画像では、実施例６～８において、上述した比較例１に比べて第３サンプル１４４を視認し易くなった。実施例６の超音波画像において、螺旋溝４８の部分の平均輝度比は、１．９であった。実施例７の超音波画像において、螺旋溝４８の部分の平均輝度比は、２．１であった。実施例８の超音波画像において、螺旋溝４８の平均輝度比は、２．１であった。つまり、実施例６よりも実施例７及び実施例８の平均輝度値が高かった。 [result]
The strength evaluation of Examples 6 to 8 was A, and the strength evaluation of Example 9 was B. In the ultrasonic images, in Examples 6 to 8, the third sample 144 was easier to visually recognize than in Comparative Example 1 described above. In the ultrasonic image of Example 6, the average brightness ratio of the portion of the spiral groove 48 was 1.9. In the ultrasonic image of Example 7, the average brightness ratio of the portion of the spiral groove 48 was 2.1. In the ultrasonic image of Example 8, the average brightness ratio of the spiral grooves 48 was 2.1. That is, the average luminance values of Examples 7 and 8 were higher than those of Example 6.
　このように、溝深さＤｂが樹脂チューブ１４８の肉厚Ｔの３７．５％以下で樹脂チューブ１４８の強度の低下を抑えることができた。以上より、溝深さＤｂは、反射波の散乱の観点より２５μｍ以上に設定されるのが好ましい。また、溝深さＤｂは、強度低下の観点から樹脂チューブ１４８の肉厚Ｔの３７．５％以下に設定されるのが好ましいという結果を得た。さらに、溝深さＤｂは、超音波画像における第３サンプル１４４の見え易さの観点から５０μｍに設定されるのがより好ましいという結果を得た。 As described above, when the groove depth Db is 37.5% or less of the thickness T of the resin tube 148, the decrease in the strength of the resin tube 148 can be suppressed. From the above, the groove depth Db is preferably set to 25 μm or more from the viewpoint of scattering of reflected waves. Further, it was found that the groove depth Db is preferably set to 37.5% or less of the thickness T of the resin tube 148 from the viewpoint of strength reduction. Further, it was found that the groove depth Db is more preferably set to 50 μm from the viewpoint of visibility of the third sample 144 in the ultrasonic image.
（ピッチＰの設定に関する試験）
　図１７に示すように、ピッチＰの設定に関する試験では、実施例１０～１４に対して超音波画像の撮影を行った。実施例１０に係る第３サンプル１４４の螺旋溝４８のピッチＰは、１００μｍである。実施例１１に係る第３サンプル１４４の螺旋溝４８のピッチＰは、２００μｍである。実施例１２に係る第３サンプル１４４の螺旋溝４８のピッチＰは、３００μｍである。実施例１３に係る第３サンプル１４４の螺旋溝４８のピッチＰは、５００μｍである。実施例１４に係る第３サンプル１４４の螺旋溝４８のピッチＰは、１０００μｍである。なお、実施例１０～１４において、溝幅Ｗは２５μｍ、溝深さＤｂは５０μｍ、溝長さＬｂは１０ｍｍである。 (Test for setting pitch P)
As shown in FIG. 17, in the test for setting the pitch P, ultrasonic images were taken for Examples 10-14. The pitch P of the spiral grooves 48 of the third sample 144 according to Example 10 is 100 μm. The pitch P of the spiral grooves 48 of the third sample 144 according to Example 11 is 200 μm. The pitch P of the spiral grooves 48 of the third sample 144 according to Example 12 is 300 μm. The pitch P of the spiral grooves 48 of the third sample 144 according to Example 13 is 500 μm. The pitch P of the spiral grooves 48 of the third sample 144 according to Example 14 is 1000 μm. In Examples 10 to 14, the groove width W is 25 μm, the groove depth Db is 50 μm, and the groove length Lb is 10 mm.
　一般的に、凹部の間隔が超音波の波長と同程度又はそれよりも大きい場合に超音波は散乱し易くなる。また、凹部が規則正しく存在する場合、超音波を比較的よく反射する。そのため、一般的な超音波画像診断装置３００から発信される超音波の波長の下限値である１００μｍを螺旋溝４８のピッチＰの下限値とした。 In general, when the distance between the recesses is about the same as or larger than the wavelength of the ultrasonic waves, the ultrasonic waves tend to scatter. In addition, when concave portions are regularly present, ultrasonic waves are reflected relatively well. Therefore, the lower limit of the pitch P of the spiral grooves 48 is set at 100 μm, which is the lower limit of the wavelength of ultrasonic waves emitted from a general ultrasonic diagnostic imaging apparatus 300 .
［試験方法］
　実施例１０～１４において、超音波画像の撮影を行った。この超音波画像は、上述した実施例１及び実施例２の超音波画像と同様の方法により撮影した。 [Test method]
In Examples 10 to 14, ultrasound images were taken. This ultrasonic image was captured by the same method as the ultrasonic images of the first and second embodiments described above.
［結果］
　超音波画像では、実施例１０～１４において、上述した比較例１に比べて第３サンプル１４４を視認し易くなった。実施例１０の超音波画像において、螺旋溝４８の部分の平均輝度比は、２．１であった。実施例１１の超音波画像において、螺旋溝４８の部分の平均輝度比は、２．４であった。実施例１２の超音波画像において、螺旋溝４８の平均輝度比は、２．６であった。実施例１３の超音波画像において、螺旋溝４８の平均輝度比は、１．７であった。実施例１４の超音波画像において、螺旋溝４８の平均輝度比は、１．６であった。つまり、実施例１０～１４のうち実施例１２の平均輝度値が最も高かった。 [result]
In the ultrasonic images, in Examples 10 to 14, the third sample 144 was easier to visually recognize than in Comparative Example 1 described above. In the ultrasonic image of Example 10, the average brightness ratio of the portion of the spiral groove 48 was 2.1. In the ultrasonic image of Example 11, the average brightness ratio of the portion of the spiral groove 48 was 2.4. In the ultrasonic image of Example 12, the average brightness ratio of the spiral grooves 48 was 2.6. In the ultrasonic image of Example 13, the average brightness ratio of the spiral grooves 48 was 1.7. In the ultrasonic image of Example 14, the average brightness ratio of the spiral grooves 48 was 1.6. That is, among Examples 10 to 14, Example 12 had the highest average luminance value.
　このように、螺旋溝４８のピッチの下限値は、１００μｍに設定されるのが好ましく、３００μｍに設定されるのがより好ましいという結果を得た。 Thus, it was found that the lower limit of the pitch of the spiral grooves 48 is preferably set to 100 μm, and more preferably set to 300 μm.
（溝長さＬｂの設定に関する試験）
　図１８に示すように、溝長さＬｂの設定に関する試験では、実施例１５～１８に対して超音波画像の撮影を行った。実施例１５の第３サンプル１４４の溝長さＬｂは、１ｍｍである。実施例１６の第３サンプル１４４の溝長さＬｂは、３ｍｍである。実施例１７の第３サンプル１４４の溝長さＬｂは５ｍｍである。実施例１８の第３サンプル１４４の溝長さＬｂは、１０ｍｍである。なお、実施例１５～１８において、溝幅Ｗは２５μｍ、溝深さＤｂは５０μｍ、ピッチＰは３００μｍである。 (Test for setting groove length Lb)
As shown in FIG. 18, in the test for setting the groove length Lb, ultrasonic images were taken for Examples 15-18. The groove length Lb of the third sample 144 of Example 15 is 1 mm. The groove length Lb of the third sample 144 of Example 16 is 3 mm. The groove length Lb of the third sample 144 of Example 17 is 5 mm. The groove length Lb of the third sample 144 of Example 18 is 10 mm. In Examples 15 to 18, the groove width W is 25 μm, the groove depth Db is 50 μm, and the pitch P is 300 μm.
［試験方法］
　実施例１５～１８において、超音波画像の撮影を行った。この超音波画像は、上述した実施例１及び実施例２の超音波画像と同様の方法により撮影した。 [Test method]
In Examples 15 to 18, ultrasound images were taken. This ultrasonic image was captured by the same method as the ultrasonic images of the first and second embodiments described above.
［結果］
　超音波画像では、実施例１５～１８において、上述した比較例１に比べて第３サンプル１４４を視認し易くなった。一般的に、光免疫療法に用いられる穿刺針１０において、針体２０の穿刺部２８の長さの最大値は１００ｍｍである。そのため、溝長さＬｂは、１ｍｍ以上１００ｍｍ以下に設定されるのが好ましい。 [result]
In the ultrasonic images, in Examples 15 to 18, the third sample 144 was easier to visually recognize than in Comparative Example 1 described above. Generally, in the puncture needle 10 used for photoimmunotherapy, the maximum length of the puncture portion 28 of the needle body 20 is 100 mm. Therefore, the groove length Lb is preferably set to 1 mm or more and 100 mm or less.
　本発明において、針体の外面に形成される凹部は、ディンプル加工又はブラスト加工によって形成してもよい。 In the present invention, the recess formed on the outer surface of the needle body may be formed by dimple processing or blast processing.
　なお、本発明は、上述した実施形態に限らず、本発明の要旨を逸脱することなく、種々の構成を取り得る。 It should be noted that the present invention is not limited to the above-described embodiments, and can take various configurations without departing from the gist of the present invention.
　本実施形態は、以下の内容を開示している。 This embodiment discloses the following contents.
　上記実施形態は、人体の皮膚の内側の組織に穿刺される中空の針体（２０、５０、６０、８０、９０、１００、１１０、１３０）と、前記針体の内腔（２４）に挿入されるシャフト部（１６）と、を備え、前記針体の外面（４２、５２、６２、８６、９６、１０２、１１２、１３２）には、エコー下において超音波を反射させるための凹部（４４、５４、６４、１０４、１１６、１３６）が形成されている、穿刺針を開示している。 The above embodiment includes a hollow needle body (20, 50, 60, 80, 90, 100, 110, 130) that is pierced into the tissue inside the skin of the human body, and a needle body that is inserted into the lumen (24) of the needle body. and a shaft portion (16) which is formed on the outer surface (42, 52, 62, 86, 96, 102, 112, 132) of the needle (42, 52, 62, 86, 96, 102, 112, 132) for reflecting ultrasonic waves under echo (44 , 54, 64, 104, 116, 136).
　上記の穿刺針において、前記針体の前記内腔には、前記シャフト部を前記針体から抜去した状態で治療用の光を照射する光照射部（３１４）を挿入可能であってもよい。 In the puncture needle described above, a light irradiation section (314) that emits therapeutic light may be inserted into the lumen of the needle body with the shaft section removed from the needle body.
　上記の穿刺針において、前記針体の内径は、０．５ｍｍ以上であってもよい。 In the above puncture needle, the inner diameter of the needle body may be 0.5 mm or more.
　上記の穿刺針において、前記穿刺針は、光免疫療法に用いられてもよい。 In the puncture needle described above, the puncture needle may be used for photoimmunotherapy.
　上記の穿刺針において、前記針体の前記内腔は、当該針体の先端部において封止されてもよい。 In the above puncture needle, the lumen of the needle body may be sealed at the distal end of the needle body.
　上記の穿刺針において、前記凹部は、溝部（４６、５６、６６、１０６、１１８、１３８）を有してもよい。 In the puncture needle described above, the recess may have grooves (46, 56, 66, 106, 118, 138).
　上記の穿刺針において、前記溝部は、当該溝部の深さ方向に向かって幅狭に形成されてもよい。 In the puncture needle described above, the groove may be formed narrower in the depth direction of the groove.
　上記の穿刺針において、前記溝部は、１条巻き又は多条巻きの螺旋溝（４８、５８）を有してもよい。 In the puncture needle described above, the groove portion may have a single-wound or multi-wound spiral groove (48, 58).
　上記の穿刺針において、前記溝部は、前記針体の軸線方向に間隔を空けて配置された複数の短溝（７０）を含む溝列（６８）を有し、前記複数の短溝の各々は、前記針体の周方向に沿った長さが当該針体の周長の１／４以下であってもよい。 In the puncture needle described above, the groove portion has a groove row (68) including a plurality of short grooves (70) spaced apart in the axial direction of the needle body, each of the plurality of short grooves , the length along the circumferential direction of the needle body may be 1/4 or less of the circumferential length of the needle body.
　上記の穿刺針において、前記溝列は、前記針体の周方向に間隔を空けて複数設けられてもよい。 In the puncture needle described above, a plurality of groove rows may be provided at intervals in the circumferential direction of the needle body.
　上記の穿刺針において、前記複数の短溝の各々は、前記針体の先端に向かって当該針体の周方向に沿った第１周方向に傾斜した第１傾斜溝（７２）と、前記針体の先端に向かって前記第１周方向とは反対方向である第２周方向に傾斜した第２傾斜溝（７４）と、を含み、前記第１傾斜溝の先端と前記第２傾斜溝の先端とは、互いに繋がってもよい。 In the puncture needle described above, each of the plurality of short grooves includes a first inclined groove (72) inclined in a first circumferential direction along the circumferential direction of the needle body toward the distal end of the needle body; a second slanted groove (74) slanted in a second circumferential direction opposite to the first circumferential direction toward the tip of the body, wherein the tip of the first slanted groove and the second slanted groove The tips may be connected to each other.
　上記の穿刺針において、前記溝部は、前記針体の周方向に一周延在した環状溝（１０８）を有してもよい。 In the above-described puncture needle, the groove portion may have an annular groove (108) extending around the circumference of the needle body.
　上記の穿刺針において、前記環状溝は、前記針体の軸線方向に間隔を空けて複数設けられてもよい。 In the puncture needle described above, a plurality of the annular grooves may be provided at intervals in the axial direction of the needle body.
　上記の穿刺針において、前記溝部の溝幅（Ｗ）は、１０μｍ以上５０μｍ以下に設定されてもよい。 In the puncture needle described above, the groove width (W) of the groove portion may be set to 10 μm or more and 50 μm or less.
　上記の穿刺針において、前記針体は、当該針体の内腔を周回する針本体（３０）を有し、前記溝部の溝深さ（Ｄｂ）は、２５μｍ以上且つ前記針本体の肉厚（Ｔ）の３７．５％以下に設定されてもよい。 In the puncture needle described above, the needle body has a needle body (30) that encircles the inner lumen of the needle body, and the groove depth (Db) of the groove is 25 μm or more and the thickness of the needle body ( T) may be set to 37.5% or less.
　上記の穿刺針において、前記溝部のピッチ（Ｐ）は、１００μｍ以上に設定されてもよい。 In the puncture needle described above, the pitch (P) of the grooves may be set to 100 μm or more.
　上記の穿刺針において、前記溝部の前記針体の軸線方向に沿った溝長さ（Ｌｂ）は、１ｍｍ以上に設定されてもよい。 In the puncture needle described above, the groove length (Lb) of the groove along the axial direction of the needle body may be set to 1 mm or more.
１０…穿刺針　　　　　　　　　　　　　　１６…シャフト部
２０、５０、６０、８０、９０、１００、１１０、１３０…針体
２４…内腔　　　　　　　　　　　　　　　３０…針本体
３２…針先端部
４４、５４、６４、１０４、１１６、１３６…凹部
４６、５６、６６、１０６、１１８、１３８…溝部
４８、５８…螺旋溝　　　　　　　　　　　６８…溝列
７０…短溝　　　　　　　　　　　　　　　７２…第１傾斜溝
７４…第２傾斜溝　　　　　　　　　　　　１０８…環状溝
３１４…光照射部　　　　　　　　　　　　Ｄｂ…溝深さ
Ｌｂ…溝長さ　　　　　　　　　　　　　　Ｐ…ピッチ
Ｗ…溝幅 DESCRIPTION OF SYMBOLS 10... Puncture needle 16... Shaft part 20, 50, 60, 80, 90, 100, 110, 130... Needle body 24... Bore 30... Needle body 32... Needle tip part 44, 54, 64, 104, 116, 136 ... concave portions 46, 56, 66, 106, 118, 138 ... grooves 48, 58 ... spiral grooves 68 ... groove row 70 ... short grooves 72 ... first inclined grooves 74 ... second inclined grooves 108 ... annular grooves 314 ... light irradiation portions Db... Groove depth Lb... Groove length P... Pitch W... Groove width

Claims (17)

  1. 　人体の皮膚の内側の組織に穿刺される中空の針体と、
    　前記針体の内腔に挿入されるシャフト部と、を備え、
    　前記針体の外面には、エコー下において超音波を反射させるための凹部が形成されている、穿刺針。     a hollow needle body to be pierced into the tissue inside the skin of the human body;
    a shaft portion inserted into the lumen of the needle body,
    The puncture needle, wherein the outer surface of the needle body is formed with a concave portion for reflecting ultrasonic waves under echo.
  2. 　請求項１記載の穿刺針であって、
    　前記針体の前記内腔には、前記シャフト部を前記針体から抜去した状態で治療用の光を照射する光照射部を挿入可能である、穿刺針。     The puncture needle according to claim 1,
    A puncture needle, wherein a light irradiation section that irradiates light for treatment can be inserted into the lumen of the needle body with the shaft section removed from the needle body.
  3. 　請求項２記載の穿刺針であって、
    　前記針体の内径は、０．５ｍｍ以上である、穿刺針。     The puncture needle according to claim 2,
    The puncture needle, wherein the inner diameter of the needle body is 0.5 mm or more.
  4. 　請求項１～３のいずれか１項に記載の穿刺針であって、
    　前記穿刺針は、光免疫療法に用いられる、穿刺針。     The puncture needle according to any one of claims 1 to 3,
    The puncture needle is a puncture needle used for photoimmunotherapy.
  5. 　請求項１～４のいずれか１項に記載の穿刺針であって、
    　前記針体の前記内腔は、当該針体の先端部において封止されている、穿刺針。     The puncture needle according to any one of claims 1 to 4,
    The puncture needle, wherein the inner lumen of the needle body is sealed at the distal end of the needle body.
  6. 　請求項１～５のいずれか１項に記載の穿刺針であって、
    　前記凹部は、溝部を有する、穿刺針。     The puncture needle according to any one of claims 1 to 5,
    The puncture needle, wherein the recess has a groove.
  7. 　請求項６記載の穿刺針であって、
    　前記溝部は、当該溝部の深さ方向に向かって幅狭に形成されている、穿刺針。     The puncture needle according to claim 6,
    The puncture needle, wherein the groove is narrow in the depth direction of the groove.
  8. 　請求項６又は７に記載の穿刺針であって、
    　前記溝部は、１条巻き又は多条巻きの螺旋溝を有する、穿刺針。     The puncture needle according to claim 6 or 7,
    The puncture needle, wherein the groove portion has a single-wound or multi-wound spiral groove.
  9. 　請求項６～８のいずれか１項に記載の穿刺針であって、
    　前記溝部は、前記針体の軸線方向に間隔を空けて配置された複数の短溝を含む溝列を有し、
    　前記複数の短溝の各々は、前記針体の周方向に沿った長さが当該針体の周長の１／４以下である、穿刺針。     The puncture needle according to any one of claims 6 to 8,
    the groove portion has a groove row including a plurality of short grooves spaced apart in the axial direction of the needle body;
    A puncture needle, wherein each of the plurality of short grooves has a length along the circumferential direction of the needle body that is 1/4 or less of the circumferential length of the needle body.
  10. 　請求項９記載の穿刺針であって、
    　前記溝列は、前記針体の周方向に間隔を空けて複数設けられている、穿刺針。     The puncture needle according to claim 9,
    The puncture needle, wherein a plurality of the groove rows are provided at intervals in the circumferential direction of the needle body.
  11. 　請求項９又は１０に記載の穿刺針であって、
    　前記複数の短溝の各々は、
    　前記針体の先端に向かって当該針体の周方向に沿った第１周方向に傾斜した第１傾斜溝と、
    　前記針体の先端に向かって前記第１周方向とは反対方向である第２周方向に傾斜した第２傾斜溝と、を含み、
    　前記第１傾斜溝の先端と前記第２傾斜溝の先端とは、互いに繋がっている、穿刺針。     The puncture needle according to claim 9 or 10,
    each of the plurality of short grooves,
    a first inclined groove inclined in a first circumferential direction along the circumferential direction of the needle body toward the tip of the needle body;
    a second inclined groove inclined in a second circumferential direction opposite to the first circumferential direction toward the tip of the needle,
    The puncture needle, wherein the tip of the first inclined groove and the tip of the second inclined groove are connected to each other.
  12. 　請求項６～１１のいずれか１項に記載の穿刺針であって、
    　前記溝部は、前記針体の周方向に一周延在した環状溝を有する、穿刺針。     The puncture needle according to any one of claims 6 to 11,
    The puncture needle, wherein the groove portion has an annular groove extending around in the circumferential direction of the needle body.
  13. 　請求項１２記載の穿刺針であって、
    　前記環状溝は、前記針体の軸線方向に間隔を空けて複数設けられている、穿刺針。     The puncture needle according to claim 12,
    The puncture needle, wherein a plurality of the annular grooves are provided at intervals in the axial direction of the needle body.
  14. 　請求項６～１３のいずれか１項に記載の穿刺針であって、
    　前記溝部の溝幅は、１０μｍ以上５０μｍ以下に設定されている、穿刺針。     The puncture needle according to any one of claims 6 to 13,
    The puncture needle, wherein the groove width of the groove is set to 10 μm or more and 50 μm or less.
  15. 　請求項６～１４のいずれか１項に記載の穿刺針であって、
    　前記針体は、当該針体の内腔を周回する針本体を有し、
    　前記溝部の溝深さは、２５μｍ以上且つ前記針本体の肉厚の３７．５％以下に設定されている、穿刺針。     The puncture needle according to any one of claims 6 to 14,
    The needle body has a needle body that surrounds the lumen of the needle body,
    The puncture needle, wherein the groove depth of the groove is set to 25 μm or more and 37.5% or less of the thickness of the needle body.
  16. 　請求項６～１５のいずれか１項に記載の穿刺針であって、
    　前記溝部のピッチは、１００μｍ以上に設定されている、穿刺針。     The puncture needle according to any one of claims 6 to 15,
    The puncture needle, wherein the pitch of the grooves is set to 100 μm or more.
  17. 　請求項６～１６のいずれか１項に記載の穿刺針であって、
    　前記溝部の前記針体の軸線方向に沿った溝長さは、１ｍｍ以上に設定されている、穿刺針。     The puncture needle according to any one of claims 6 to 16,
    The puncture needle, wherein the groove length of the groove portion along the axial direction of the needle body is set to 1 mm or more.
PCT/JP2022/044105 2021-12-06 2022-11-30 Puncture needle WO2023106172A1 (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09502904A (en) * 1993-09-29 1997-03-25 メディカル カレッジ オブ オハイオ Use of photodynamic therapy to treat prostate cells
JP2009165822A (en) * 2008-01-14 2009-07-30 Olympus Medical Systems Corp Endoscope treatment instrument
US20110054459A1 (en) * 2009-08-27 2011-03-03 Vivant Medical, Inc. Ecogenic Cooled Microwave Ablation Antenna
US20110160592A1 (en) * 2008-07-29 2011-06-30 Coco Research PTY Ltd. Echogenic medical needle
WO2011126109A1 (en) * 2010-04-08 2011-10-13 学校法人久留米大学 Puncture aspiration method and puncture aspiration device
WO2020049629A1 (en) * 2018-09-04 2020-03-12 オリンパス株式会社 Light irradiation device delivery apparatus and phototherapy method

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09502904A (en) * 1993-09-29 1997-03-25 メディカル カレッジ オブ オハイオ Use of photodynamic therapy to treat prostate cells
JP2009165822A (en) * 2008-01-14 2009-07-30 Olympus Medical Systems Corp Endoscope treatment instrument
US20110160592A1 (en) * 2008-07-29 2011-06-30 Coco Research PTY Ltd. Echogenic medical needle
US20110054459A1 (en) * 2009-08-27 2011-03-03 Vivant Medical, Inc. Ecogenic Cooled Microwave Ablation Antenna
WO2011126109A1 (en) * 2010-04-08 2011-10-13 学校法人久留米大学 Puncture aspiration method and puncture aspiration device
WO2020049629A1 (en) * 2018-09-04 2020-03-12 オリンパス株式会社 Light irradiation device delivery apparatus and phototherapy method

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