WO2014045677A1 - Biopsy needle and biopsy system - Google Patents

Biopsy needle and biopsy system Download PDF

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Publication number
WO2014045677A1
WO2014045677A1 PCT/JP2013/068498 JP2013068498W WO2014045677A1 WO 2014045677 A1 WO2014045677 A1 WO 2014045677A1 JP 2013068498 W JP2013068498 W JP 2013068498W WO 2014045677 A1 WO2014045677 A1 WO 2014045677A1
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WO
WIPO (PCT)
Prior art keywords
needle
ultrasonic
needle tube
biopsy
acoustic impedance
Prior art date
Application number
PCT/JP2013/068498
Other languages
French (fr)
Japanese (ja)
Inventor
鈴木　啓太
Original Assignee
オリンパスメディカルシステムズ株式会社
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Publication date
Application filed by オリンパスメディカルシステムズ株式会社 filed Critical オリンパスメディカルシステムズ株式会社
Publication of WO2014045677A1 publication Critical patent/WO2014045677A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A61B2010/045—Needles

Definitions

  • the present invention relates to a biopsy needle for collecting body tissue, and more particularly to a biopsy needle used under observation by an ultrasound image, and a biopsy system using the biopsy needle.
  • Patent Document 1 describes a biopsy needle used for such an application.
  • the biopsy needle is provided with a plurality of annular grooves on the outer peripheral surface so that the ultrasonic wave emitted from the ultrasonic probe of the ultrasonic endoscope can be preferably reflected toward the ultrasonic probe. The visibility of the biopsy needle is improved by returning more ultrasonic waves to the ultrasonic probe by the annular groove.
  • the present invention has been made in view of the above-described problems, and provides a biopsy needle that can stabilize an image in an image of an ultrasonic observation section by uniformizing the ultrasonic reflection mode. With the goal.
  • the biopsy needle according to the first aspect of the present invention is formed hollow using a first material, has a needle body having a reflection groove on the outer peripheral surface, and a first of the first material in the reflection groove.
  • a contact auxiliary layer formed using a second material having a second acoustic impedance different from the acoustic impedance.
  • the second acoustic impedance is substantially equal to a third acoustic impedance of a tissue into which the needle body is inserted. Good.
  • a biopsy system includes the biopsy needle of the first aspect and an endoscope having a probe that emits ultrasonic waves, and the second acoustic impedance is the third acoustic impedance.
  • the thickness of the auxiliary contact layer is an integral multiple of one half of the wavelength of the ultrasonic wave emitted from the probe.
  • the ultrasonic wave reflection mode at the portion where the concave portion is provided on the outer peripheral surface of the needle tube is made uniform, and the ultrasonic wave is more reliably reflected to the ultrasonic scanning mechanism, and the ultrasonic observation unit It is possible to provide a biopsy needle that can stabilize the image of the needle tube in the above image.
  • FIG. 3 is a cross-sectional view taken along line AA in FIG. 2.
  • FIG. 3 is a cross-sectional view taken along line BB in FIG. 2. It is a half sectional view showing the vicinity of the sheath adjuster in the operation part of the treatment instrument.
  • the biopsy needle of the present embodiment is used by being inserted into a channel of an ultrasonic endoscope so as to be able to advance and retreat, and attached to a treatment instrument for performing treatment in the body together with the ultrasonic endoscope.
  • FIG. 1 is a perspective view illustrating a schematic configuration of a biopsy system 150 including the treatment tool 1 and the ultrasonic endoscope 100 according to the present embodiment.
  • the ultrasonic endoscope 100 includes an insertion portion 101 inserted into the body from the distal end, an operation portion 109 attached to the proximal end of the insertion portion 101, and one end on the side of the operation portion 109.
  • Universal cord 112 to which (first end) is connected; light source device 113 connected to the other end (second end) of universal cord 112 via branch cable 112a; branch cable 112b to the other end of universal cord 112 And an ultrasonic observation unit 115 connected to the other end of the universal cord 112 via a branch cable 112c.
  • the insertion portion 101 includes a distal end hard portion 102, a bending portion 105, and a flexible tube portion 106, which are arranged in this order from the distal end side.
  • the distal end hard portion 102 includes an optical imaging mechanism 103 for performing optical observation and an ultrasonic scanning mechanism 104 for performing ultrasonic observation.
  • the optical imaging mechanism 103 is an imaging optical system whose field of view is directed diagonally forward of the hard tip portion 102, an image sensor such as a CCD or CMOS that detects an image of a subject incident through the imaging optical system, and the operation of the image sensor.
  • image sensor such as a CCD or CMOS that detects an image of a subject incident through the imaging optical system
  • Various components such as a CPU to be controlled are provided.
  • the ultrasonic scanning mechanism (probe) 104 includes an ultrasonic transducer (not shown) that emits and receives ultrasonic waves.
  • the ultrasonic scanning mechanism 104 receives the reflected wave reflected by the ultrasonic wave emitted from the ultrasonic vibrator when it hits the observation target, and observes the signal based on the ultrasonic wave received by the ultrasonic vibrator. Output to the unit 115.
  • the bending portion 105 is formed in a cylindrical shape. By pulling an angle wire (not shown) fixed to the distal end of the bending portion 105 and extending to the operation portion 109 in the operation portion 109, the bending portion 105 bends in a predetermined direction such as four directions of up, down, left, and right.
  • the flexible tube portion 106 is a cylindrical member that is formed flexibly so that the distal end hard portion 102 can be guided to a desired position in the digestive tract and the body cavity.
  • a cylindrical channel 107 for inserting the treatment instrument 1 and a conduit (not shown) for performing air supply / water supply and suction are provided inside each of the bending portion 105 and the flexible tube portion 106.
  • One end (first end) of the channel 107 is opened in the vicinity of the distal end portion of the distal end hard portion 102, and the other end (second end) of the channel 107 is opened on the side surface on the distal end side of the operation portion 109.
  • a base end cap 108 formed in a flange shape is fixed to the other end of the channel 107.
  • the treatment tool 1 used together with the ultrasonic endoscope 100 can be fixed to the proximal end cap 108.
  • the operation unit 109 has an outer surface formed so that a user who uses the ultrasonic endoscope 100 can hold in the hand, and a bending operation mechanism for bending the bending unit 105 by pulling the angle wire. 110 and a plurality of switches 111 for supplying air, supplying water, or sucking through a pipe line.
  • the light source device 113 is a device for emitting illumination light for imaging by the optical imaging mechanism 103.
  • the optical observation unit 114 is configured to display a video image captured by the image sensor of the optical imaging mechanism 103 on the monitor 116.
  • the ultrasonic observation unit 115 receives the signal output from the ultrasonic scanning mechanism 104, generates an image based on this signal, and displays the image on the monitor 116.
  • FIG. 2 is a side view showing the treatment instrument 1 in a partial sectional view.
  • FIG. 3 is a diagram showing the configuration of the distal end side of the insert 2 and is a cross-sectional view along the axial direction of the insert 2.
  • the treatment instrument 1 includes an insertion body 2, an operation unit 8, and a stylet 27.
  • the insert 2 includes a cylindrical needle tube (biopsy needle) 3 having a distal end and a proximal end, and a cylindrical sheath 7 into which the needle tube 3 is inserted.
  • the material of the needle tube 3 is preferably a material that has flexibility and elasticity that can be easily restored to a linear state even when bent by an external force.
  • a material (first material) of the needle tube 3 an alloy material such as a stainless alloy, a nickel titanium alloy, and a cobalt chromium alloy can be employed as a material (first material) of the needle tube 3.
  • FIG. 4 is an enlarged plan view of the distal end portion of the needle tube 3
  • FIG. 5 is an enlarged sectional view of the distal end portion.
  • the opening 31 provided at the distal end of the needle tube 3 is formed by cutting off the distal end of the tubular member forming the needle tube obliquely at one or more planes with respect to the axis of the tubular member so that it can be inserted into a living tissue. It is sharply formed.
  • the specific shape of the opening 31 may be appropriately selected from various known shapes in consideration of the target tissue and the like.
  • a plurality of minute recesses (reflection grooves) 32 are provided on the outer peripheral surface of the needle tube 3 in order to improve reflection characteristics with respect to ultrasonic waves.
  • the recesses 32 are formed on the outer peripheral surface of the needle tube 3 at substantially equal intervals in the circumferential direction, and are formed so that the phase in the circumferential direction is different from the recesses adjacent in the longitudinal direction of the needle tube 3. .
  • positioning aspect is an example and the arrangement
  • the recess 32 in the present embodiment is formed in an annular shape, and the recess 32 is disposed by being filled with a second material 33.
  • the acoustic impedance (second acoustic impedance) of the second material 33 is different from the acoustic impedance (first acoustic impedance) of the material (first material) of the needle tube 3.
  • the recess 32 is filled with the second material 33, and the contact auxiliary layer 35 made of the second material 33 is formed on the recess 32 on the outer peripheral surface of the needle tube 3.
  • the second material 33 preferably has an acoustic impedance lower than that of the needle tube 3 material (first material), and further has an acoustic impedance equivalent to the acoustic impedance of the tissue to be biopsied.
  • first material the needle tube 3 material
  • second material the second material because the hardness is lower than that of the metal used as the first material and the acoustic impedance is closer to the body tissue.
  • the sheath 7 has a flexible tubular member such as a metal coil or resin, and extends from the distal end of the operation unit 8.
  • the resin that can be used as the material of the sheath 7 include polyether ether ketone (PEEK), fluorine resin, olefin resin, urethane resin, and nylon (polyamide) resin.
  • PEEK polyether ether ketone
  • fluorine resin fluorine resin
  • olefin resin olefin resin
  • urethane resin urethane resin
  • nylon (polyamide) resin nylon (polyamide) resin.
  • the operation unit 8 includes an operation main body 9, a sheath adjuster 18 provided on the distal end side of the operation main body 9, and a needle slider 23 provided on the proximal end side of the operation main body 9.
  • the operation body 9 includes a sheath slider 10 for adjusting the protruding length of the sheath 7, a slide rail 13 extending from the sheath slider 10 toward the proximal end side of the operation portion 8, and a slider stopper 14 provided on the slide rail 13.
  • FIG. 6 is a cross-sectional view taken along line AA in FIG.
  • the sheath slider 10 is formed in a substantially cylindrical shape, and penetrates in the thickness direction of the sheath slider 10 to attach a screw 11 for fixing the sheath adjuster 18 to the outer surface thereof.
  • a screw hole 10a is formed.
  • a pair of protrusions 10b and 10c are formed inside the sheath slider 10 so as to fit into a groove of a slide rail 22 described later of the sheath adjuster 18.
  • the tip of the screw 11 can abut on the outer surface of a slide rail 22 to be described later, and a large-diameter portion 12 having a larger diameter than the shaft is provided on the head. Further, a plurality of grooves are formed on the outer periphery of the large diameter portion 12. Thereby, the screw 11 can be easily turned by hand.
  • FIG. 7 is a cross-sectional view taken along line BB in FIG.
  • the slide rail 13 is a substantially cylindrical member for moving the needle slider 23 back and forth in the direction of the central axis, and a groove 13a extending parallel to the central axis is formed on the outer surface.
  • a groove 13b is formed.
  • the groove 13a and the groove 13b are respectively disposed at positions facing the slide rail 13 in the radial direction.
  • thread 16 mentioned later among the outer peripheral surfaces of the slide rail 13 is formed flat.
  • the slider stopper 14 has a ring member 15 in which a screw hole 15 a penetrating in the thickness direction is formed and the slide rail 13 is inserted therein, and a screw 16 screwed into the screw hole 15 a of the ring member 15.
  • the ring member 15 has an inner diameter slightly larger than the diameter of the slide rail 13, and is attached to the slide rail 13 so as to be able to advance and retract in the direction of the central axis of the slide rail 13.
  • the ring member 15 is formed with protrusions 15 b and 15 c inserted into the groove 13 a and the groove 13 b, and the ring member 15 does not rotate in the circumferential direction of the slide rail 13.
  • the tip of the screw 16 can contact the outer peripheral surface of the slide rail 13, and the ring member 15 can be fixed to the slide rail 13 by screwing the screw 16 into the screw hole 15 a of the ring member 15.
  • a large diameter portion 17 having a large diameter is provided at the base end of the screw 16, and a plurality of grooves are formed on the outer periphery of the large diameter portion 17. Thereby, the screw 16 can be easily turned by hand.
  • FIG. 8 is a half sectional view showing the vicinity of the sheath adjuster 18 in the operation unit 8.
  • the sheath adjuster 18 is provided to adjust the amount of projection of the sheath 7 from the tip of the channel 107 of the ultrasonic endoscope 100 as shown in FIG.
  • the sheath adjuster 18 includes a fixed screw portion 19 fixed to the proximal end cap 108 of the ultrasonic endoscope 100 and a slide fixed to the fixed screw portion 19 and inserted into the sheath slider 10. Rail 22.
  • the fixing screw portion 19 is formed with a through hole 20 through which the sheath 7 is inserted and a screw groove 21 for attaching the fixing screw portion 19 to the base end cap 108. Further, on the outer peripheral surface of the fixing screw portion 19, an unevenness functioning as a slip stopper is formed when the fixing screw portion 19 is attached to the base end base 108 or the fixing screw portion 19 is removed from the base end base 108. .
  • the slide rail 22 is a cylindrical member in which a pair of grooves extending in parallel with the central axis is formed, and the sheath 7 and the needle tube 3 are inserted therein.
  • the front end of the slide rail 22 is fixed to the fixing screw portion 19, and the slide rail 22 is inserted into the sheath slider 10.
  • a protrusion 10b formed on the sheath slider 10 is fitted into the groove 22ab.
  • a protrusion 10c formed on the sheath slider 10 is fitted in the groove 22b.
  • the tip end of the screw 11 screwed into the screw hole 10 a of the sheath slider 10 can come into contact with the outer surface of the slide rail 22.
  • the slide rail 22 and the sheath slider 10 are fixed by pressing the tip of the screw 11 against the outer surface of the slide rail 22.
  • the slide rail 22 of the sheath adjuster 18 and the sheath slider 10 can move relative to each other along the longitudinal direction of the groove.
  • FIG. 9 is an enlarged half sectional view showing the needle slider 23 in the operation unit 8.
  • FIG. 10 is an enlarged view of the needle slider 23 in the operation unit 8, and is a view taken in the direction of arrow C in FIG.
  • the needle slider 23 is a cylindrical member into which the slide rail 13 of the operation main body 9 is inserted, and a pair of protrusions 23 a (two protrusions) that fit into the grooves 13 a and 13 b of the slide rail 13. One of the 23a is not shown).
  • the distal end of the needle slider 23 can come into contact with the proximal end of the slider stopper 14.
  • a screw thread 23c for screwing a knob 28 and a syringe 120, which will be described later, is formed at the proximal end of the needle slider 23.
  • the outer surface shape of the needle slider 23 is a cylindrical surface so that a user using the treatment instrument 1 can hold it. Further, as shown in FIG. 10, a gauge number display section 24 is formed on the outer surface of the needle slider 23, in which a gauge number indicating the diameter of the needle tube 3 is displayed by engraving or the like.
  • the proximal end of the needle tube 3 is fixed inside the needle slider 23.
  • a stylet 27 described later can be inserted from the proximal end of the needle tube 3 fixed to the needle slider 23.
  • the needle slider 23 By moving the needle slider 23 in the direction of the central axis along the grooves 13a and 13b (see FIG. 7) of the slide rail 13, the needle tube 3 can protrude and retract from the sheath 7.
  • the needle slider 23 and the slide rail 13 are coupled so that the needle slider 23 and the slide rail 13 are not detached when the needle slider 23 is moved to the proximal end side of the slide rail 13.
  • the distal end of the needle tube 3 fixed to the needle slider 23 is drawn into the distal end of the sheath 7 and is covered by the sheath 7. It is in.
  • FIG. 11A is a side view of the stylet 27. 12 is a cross-sectional view taken along the line DD of FIG. 11A.
  • the stylet 27 is a metal wire, and can be inserted into the needle tube 3 so as to advance and retract. That is, the outer diameter of the stylet 27 is smaller than the inner diameter of the needle tube 3.
  • the tip of the stylet 27 is sharply formed, and a knob 28 made of resin or the like is provided at the base end of the stylet 27.
  • the tip of the stylet 27A may be formed in a substantially hemispherical shape.
  • the knob 28 provided at the base end of the stylet 27 is formed with a gauge number display portion 29 in which the gauge number of the needle tube 3 into which the stylet 27 can be suitably inserted is displayed by engraving or the like. That is, if the stylet 27 has the same numerical value as the gauge number displayed on the gauge number display section 24 provided on the needle slider 23 displayed on the knob 28, the stylet 27 is preferably inserted into the needle tube 3. Can be used. Thereby, the mistake in the case of using the some treatment tool 1 from which the diameter of the needle tube 3 and the stylet 27 differs can be avoided by one procedure.
  • the knob 28 is formed with a thread groove 28 a that fits into a thread 23 c (see FIG. 9) formed at the proximal end of the needle slider 23.
  • the stylet 27 can be fixed to the needle slider 23 by screwing the screw groove 28 a of the knob 28 with the screw thread 23 c of the needle slider 23.
  • the tip of the stylet 27 is set so as to slightly protrude from the tip of the needle tube 3 (see FIG. 3).
  • FIG. 13 to FIG. 18 are operation explanatory views for explaining the operation at the time of using the treatment instrument 1.
  • a biopsy in which the needle tube 3 of the treatment instrument 1 is inserted into a tissue such as a lesion located in the deep part of the body tissue and the cells of the lesion are collected through the inside of the needle tube 3. This will be described as an example.
  • the user inserts the insertion portion 101 of the ultrasonic endoscope 100 into the body, and optically observes a site to be treated using the optical imaging mechanism 103. Further, the ultrasonic scanning mechanism 104 can be used to observe the deep part of the site to be treated.
  • a part to be biopsied is determined.
  • the user inserts the insertion body 2 of the treatment instrument 1 from the distal end side into the channel 107 from the proximal end cap 108 provided in the operation unit 109 of the ultrasonic endoscope 100. Further, the user fixes the fixing screw portion 19 provided in the operation unit 8 of the treatment instrument 1 to the base end cap 108. Thereby, the treatment tool 1 is fixed to the ultrasonic endoscope 100.
  • the user loosens the screw 11 provided on the sheath slider 10 and observes the sheath 7 and the body by the optical imaging mechanism 103 and the ultrasonic scanning mechanism 104 while using the sheath adjuster 18 to set the ultrasonic endoscope 100.
  • the amount of protrusion of the sheath 7 from the distal end of the insertion portion 101 is adjusted to an appropriate amount.
  • the slider stopper 14 is moved according to the position of the target tissue T to be biopsied and fixed to the slide rail 13. As a result, the maximum length by which the needle tube 3 can protrude from the sheath 7 is limited to the length until the needle slider 23 comes into contact with the slider stopper 14.
  • the user pushes the needle slider 23 toward the distal end side of the operation unit 8. Then, the needle tube 3 protrudes from the sheath 7 as shown in FIG. Further, as shown in FIG. 16, the distal end of the needle tube 3 is punctured into the tissue and pushed forward to the target tissue T to be biopsied. At this time, the needle tube 3 exposed to the outside from the surface of the tissue can be observed by the optical imaging mechanism 103, and the tip side portion of the needle tube 3 inserted into the tissue is observed by the ultrasonic scanning mechanism 104. Can do.
  • FIG. 17 is an enlarged view showing a cross section of the needle tube 3 in the tissue.
  • the outer peripheral surface of the needle tube 3 has an angle at which it is difficult to reflect the ultrasonic wave emitted from the ultrasonic scanning mechanism 104 toward the ultrasonic operation mechanism 104, but one of the inner surfaces of the recesses 32 formed on the outer peripheral surface.
  • the unit has an angle at which the ultrasonic wave emitted from the ultrasonic scanning mechanism 104 is easily reflected toward the ultrasonic operation mechanism 104. As a result, the number of ultrasonic waves received by the ultrasonic scanning mechanism 104 increases, and the tip of the needle tube 3 is clearly projected on the ultrasonic observation unit 115.
  • the contact assisting layer 35 is formed on the concave portion 32, air hardly remains in the concave portion 32 when the needle tube 3 is inserted into the tissue, and there is no gap between the needle tube 3 and the tissue.
  • the contact assisting layer 35 secures a suitable contact state.
  • the user can observe an ultrasonic image based on the ultrasonic wave received by the ultrasonic scanning mechanism 104 with the ultrasonic observation unit 115 shown in FIG.
  • the user causes the tip of the needle tube 3 to reach the target tissue T on which biopsy is performed. Note that when the tip of the needle tube 3 reaches the target tissue T to be biopsied, the stylet 27 is inserted into the needle tube 3, so that the tissue does not enter the needle tube 3.
  • the user turns the knob 28 of the stylet 27 shown in FIG. 2 to remove the knob 28 from the needle slider 23, and pulls out the stylet 27 from the insert 2 and the operation unit 8.
  • a through hole extending from the distal end of the needle tube 3 to the proximal end of the needle slider 23 is generated.
  • the user fixes an appropriate syringe 120 having a distal end fitted to a thread 23 c formed at the proximal end of the needle slider 23 to the thread 23 c.
  • the inside of the needle tube 3 is sucked by the syringe 120, and the cells of the target tissue T to be biopsied from the tip of the needle tube 3 are sucked into the syringe 120.
  • the needle slider 23 When a necessary amount of cells and the like are sucked into the syringe 120, the needle slider 23 is pulled to the base end side of the operation unit 8 to the full, and the distal end of the needle tube 3 is accommodated in the sheath 7. Thereby, the needle tube 3 comes out of the tissue.
  • the fixing screw portion 19 is removed from the base end cap 108 of the operation portion 109 of the ultrasonic endoscope 100, and the treatment tool 1 is removed from the channel 107. The series of treatments is thus completed.
  • the contact auxiliary layer 35 made of the second material 33 is provided on the plurality of recesses 32 and the recesses 32 are filled, air does not remain in the recesses 32.
  • the above-described variation in the state of the boundary between the recess and the tissue can be suppressed.
  • the reflection mode of the ultrasonic wave at the portion where the concave portion 32 is provided on the outer peripheral surface of the needle tube 3 is made uniform, and the ultrasonic wave is more reliably reflected to the ultrasonic scanning mechanism 104, so The image of the needle tube 3 can be stabilized.
  • the second material 33 forming the contact assisting layer 35 has an acoustic impedance different from that of the first material forming the needle tube 3, the recess 32 serving as an interface between the first material and the second material is formed. Ultrasonic reflection preferably occurs on the inner surface. Therefore, it is possible to reliably return ultrasonic waves to the ultrasonic scanning mechanism 104 according to the inner surface shape of the recess 32.
  • the second material has an acoustic impedance equivalent to that of the tissue into which the needle tube 3 is inserted, reflection of ultrasonic waves at the interface between the second material and the tissue can be suppressed.
  • the ultrasonic wave is reflected at the interface between the second material and the tissue, it is reflected in a direction substantially equivalent to that reflected by the outer peripheral surface of the needle tube, so that it is difficult to contribute to the improvement of the visibility in the ultrasonic image. Therefore, the second material preferably has an acoustic impedance as close as possible to the tissue into which the needle tube is inserted.
  • the shape of the reflection groove of the contact auxiliary layer is not limited to the above-described ring shape.
  • a groove 32a having a circular shape on the outer peripheral surface and having a predetermined depth may be used.
  • a groove 32b extending in the circumferential direction of the needle tube 3 is formed in the longitudinal direction of the needle tube 3.
  • a plurality may be formed at intervals in the direction.
  • 19A and 19B show enlarged cross-sectional shapes of the grooves 32a and 32b, respectively.
  • FIGS. 1 and 2 The difference between the biopsy needle of the present embodiment and the biopsy needle of the first embodiment is the arrangement of the second material in the contact auxiliary layer.
  • components that are the same as those already described are assigned the same reference numerals and redundant description is omitted.
  • FIG. 20 is an enlarged view showing a cross section of the distal end portion of the needle tube 50 of the present embodiment.
  • the concave portion 52 provided on the outer peripheral surface of the needle tube 50 has a spherical inner surface
  • the second material 53 forming the contact assisting layer 55 has a predetermined thickness t on the inner surface of the concave portion 52.
  • t a dimension in a direction orthogonal to a tangent line that contacts the inner surface at this position.
  • the predetermined thickness t is an integral multiple of one half of the wavelength of the ultrasonic wave emitted from the ultrasonic scanning mechanism 104. That is, when the wavelength of the emitted ultrasonic wave is 1, the thickness t can be expressed by n / 2 ⁇ l (where n is a natural number).
  • the acoustic impedance of the second material 53 is different from that of the first material, and is also different from the acoustic impedance of the tissue into which the needle tube 50 is inserted (third acoustic impedance).
  • the ultrasonic wave emitted from the ultrasonic scanning mechanism 104 is transmitted between the tissue and the contact auxiliary layer as shown in FIG. Reflected at the interface with 55 and the interface between the contact auxiliary layer and the recess 52. Then, when the ultrasonic wave enters perpendicularly to the inner surface of the concave portion 52, the path between the ultrasonic wave reflected at the interface between the tissue and the contact auxiliary layer 55 and the ultrasonic wave reflected at the interface between the contact auxiliary layer and the concave portion 52.
  • the shape of the inner surface of the concave portion is not limited to this, and may include a flat portion such as the concave portion 57 shown in FIG. Even in such a case, the same effect can be obtained by setting the thickness t of the contact auxiliary layer 55 to a value that is uniform and an integral multiple of one half of the wavelength of the ultrasonic wave.
  • the ultrasonic reflection mode at the site where the concave portion is provided on the outer peripheral surface of the needle tube is made uniform, and the ultrasonic wave is more reliably reflected to the ultrasonic scanning mechanism, so that the ultrasonic observation is performed. It is possible to provide a biopsy needle that can stabilize the image of the needle tube in the image of the part.

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Abstract

This biopsy needle is provided with a needle main body which is formed with a hollow center using a first material and which has a reflective groove on the outer circumference surface, and with a contact auxiliary layer which is formed in the reflective groove using a second material having a second acoustic impedance different from the first acoustic impedance of the first material.

Description

生検針および生検システムBiopsy needle and biopsy system
　本発明は、体組織を採取する生検針、より詳しくは、超音波画像による観察下において用いられる生検針、および生検針を用いた生検システムに関する。
本願は、２０１２年０９月２１日に、米国に仮出願された米国特許出願第６１／７０３，９５５号に基づき優先権を主張し、その内容をここに援用する。 The present invention relates to a biopsy needle for collecting body tissue, and more particularly to a biopsy needle used under observation by an ultrasound image, and a biopsy system using the biopsy needle.
This application claims priority based on US Patent Application No. 61 / 703,955 filed provisionally in the United States on September 21, 2012, the contents of which are incorporated herein by reference.
　従来、微量の体組織を採取し、顕微鏡で観察する、生検といわれる検査方法が知られている。臓器等の深部の組織を採取する場合は、光学内視鏡による観察が困難であるため、超音波内視鏡等による臓器の超音波断層像を取得し、超音波観察下で臓器に生検針を刺入して組織を採取することがある。特許文献１には、このような用途に用いる生検針が記載されている。この生検針には、超音波内視鏡の超音波プローブから出射される超音波を好適に超音波プローブに向かって反射できるように、外周面に複数の円環状の溝が設けられている。円環状の溝により、より多くの超音波が超音波プローブに戻ることで、生検針の視認性が向上する。 Conventionally, an inspection method called biopsy, in which a small amount of body tissue is collected and observed with a microscope, is known. When collecting deep tissue such as organs, it is difficult to observe with an optical endoscope, so an ultrasonic tomographic image of the organ is obtained with an ultrasonic endoscope, etc., and a biopsy needle is taken into the organ under ultrasonic observation. The tissue may be collected by inserting the. Patent Document 1 describes a biopsy needle used for such an application. The biopsy needle is provided with a plurality of annular grooves on the outer peripheral surface so that the ultrasonic wave emitted from the ultrasonic probe of the ultrasonic endoscope can be preferably reflected toward the ultrasonic probe. The visibility of the biopsy needle is improved by returning more ultrasonic waves to the ultrasonic probe by the annular groove.
日本国特許第３８９００１３号Japanese Patent No. 3890013
しかしながら、前述した 特許文献１に記載されているような従来の生検針を臓器等に刺入すると、円環状の溝内の環境は個々の円環状の溝において様々に変化し、一定とならない。すなわち、ある円環状の溝内には組織や組織からの浸出液等が進入して溝内を埋める一方、ある円環状の溝には組織が進入せず、空気が残存することもある。このような環境の違いにより、超音波の反射態様が円環状の溝ごとに異なる結果、超音波プローブに超音波が充分に戻らないことがあるという問題がある。 However, when a conventional biopsy needle as described in the above-mentioned patent document 1 is inserted into an organ or the like, the environment in the annular groove varies in each annular groove and is not constant. That is, tissue or exudate from the tissue enters a certain annular groove and fills the groove, while tissue does not enter a certain annular groove and air may remain. Due to such a difference in environment, there is a problem that the ultrasonic wave may not be sufficiently returned to the ultrasonic probe as a result of the ultrasonic reflection mode being different for each annular groove.
　本発明は、上記の様な問題に鑑みてなされたものであり、超音波の反射態様が均一化されることにより、超音波観察部の画像における像を安定化させることができる生検針の提供を目的とする。 The present invention has been made in view of the above-described problems, and provides a biopsy needle that can stabilize an image in an image of an ultrasonic observation section by uniformizing the ultrasonic reflection mode. With the goal.
　本発明の第１の態様に係る生検針は、第一の材料を用いて中空に形成され、外周面に反射溝を有する針本体と、前記反射溝内に前記第一の材料の第一の音響インピーダンスと異なる第二の音響インピーダンスを有する第二の材料を用いて形成された接触補助層と、を備える。 The biopsy needle according to the first aspect of the present invention is formed hollow using a first material, has a needle body having a reflection groove on the outer peripheral surface, and a first of the first material in the reflection groove. A contact auxiliary layer formed using a second material having a second acoustic impedance different from the acoustic impedance.
　本発明の第２の態様によれば、上記第１の態様において、前記第二の音響インピーダンスは、前記針本体が刺入される組織の第三の音響インピーダンスと実質的に同等であってもよい。 According to a second aspect of the present invention, in the first aspect, the second acoustic impedance is substantially equal to a third acoustic impedance of a tissue into which the needle body is inserted. Good.
　本発明の第３の態様に係る生検システムは、上記第１の態様の生検針と、超音波を出射するプローブを有する内視鏡とを備え、前記第二の音響インピーダンスは、前記第三の音響インピーダンスと異なり、前記接触補助層の厚さは前記プローブから出射される超音波の波長の２分の１の整数倍である。 A biopsy system according to a third aspect of the present invention includes the biopsy needle of the first aspect and an endoscope having a probe that emits ultrasonic waves, and the second acoustic impedance is the third acoustic impedance. Unlike the acoustic impedance, the thickness of the auxiliary contact layer is an integral multiple of one half of the wavelength of the ultrasonic wave emitted from the probe.
　上記本発明の各態様によれば、針管の外周面において凹部が設けられた部位における超音波の反射態様が均一化されてより確実に超音波が超音波走査機構に反射され、超音波観察部の画像における針管の像を安定化させることができる生検針を提供できる。 According to each aspect of the present invention, the ultrasonic wave reflection mode at the portion where the concave portion is provided on the outer peripheral surface of the needle tube is made uniform, and the ultrasonic wave is more reliably reflected to the ultrasonic scanning mechanism, and the ultrasonic observation unit It is possible to provide a biopsy needle that can stabilize the image of the needle tube in the above image.
本発明の第一実施形態の生検システムの概略構成を示す図である。It is a figure which shows schematic structure of the biopsy system of 1st embodiment of this invention. 本発明の生検針である針管を備えた、同生検システムの処置具を一部断面視で示す側面図である。It is a side view which shows the treatment tool of the biopsy system provided with the needle tube which is the biopsy needle of this invention in a partial cross section view. 同処置具における挿入体の先端側の構成を示す断面図である。It is sectional drawing which shows the structure of the front end side of the insertion body in the treatment tool. 同針管の先端部分の拡大平面図である。It is an enlarged plan view of the tip part of the needle tube. 同針管の先端部分の拡大断面図である。It is an expanded sectional view of the tip part of the needle tube. 図２のＡ－Ａ線における断面図である。FIG. 3 is a cross-sectional view taken along line AA in FIG. 2. 図２のＢ－Ｂ線における断面図である。FIG. 3 is a cross-sectional view taken along line BB in FIG. 2. 同処置具の操作部におけるシースアジャスター近傍を示す半断面図である。It is a half sectional view showing the vicinity of the sheath adjuster in the operation part of the treatment instrument. 同操作部における針スライダを拡大して示す半断面図である。It is a half sectional view which expands and shows the needle slider in the operation part. 同針スライダを拡大して示す図で、図２のＣ矢視図である。It is a figure which expands and shows the needle slider, and is a C arrow line view of FIG. 同処置具におけるスタイレットを示す側面図である。It is a side view which shows the stylet in the treatment tool. スタイレットの他の構成例を示す側面図である。It is a side view which shows the other structural example of a stylet. 図１１ＡのＤーＤ線における断面図である。It is sectional drawing in the DD line of FIG. 11A. 同処置具の使用時の動作を説明するための図である。It is a figure for demonstrating the operation | movement at the time of use of the treatment tool. 同処置具の使用時の動作を説明するための図である。It is a figure for demonstrating the operation | movement at the time of use of the treatment tool. 同処置具の使用時の動作を説明するための図である。It is a figure for demonstrating the operation | movement at the time of use of the treatment tool. 同処置具の使用時の動作を説明するための図である。It is a figure for demonstrating the operation | movement at the time of use of the treatment tool. 組織に刺入された針管の断面を拡大して示す図である。It is a figure which expands and shows the cross section of the needle tube pierced by the structure | tissue. 同処置具を用いた処置の一過程を示す模式図である。It is a mimetic diagram showing one course of treatment using the treatment implement. 同実施形態の変形例における針管の先端部を示す拡大図である。It is an enlarged view which shows the front-end | tip part of the needle tube in the modification of the embodiment. 同実施形態の変形例における針管の先端部を示す拡大図である。It is an enlarged view which shows the front-end | tip part of the needle tube in the modification of the embodiment. 本発明の第二実施形態の生検針である針管の拡大断面図である。It is an expanded sectional view of a needle tube which is a biopsy needle of a second embodiment of the present invention. 同針管における超音波の反射態様を示す図である。It is a figure which shows the reflection aspect of the ultrasonic wave in the needle tube. 同実施形態の変形例における針管の拡大断面図である。It is an expanded sectional view of the needle tube in the modification of the embodiment.
本発明の第一実施形態について、図１から図１９Ｂを参照して説明する。本実施形態の生検針は、例えば超音波内視鏡のチャンネルに進退自在に挿通されて超音波内視鏡とともに体内で処置をするための処置具に取り付けられて使用される。 A first embodiment of the present invention will be described with reference to FIGS. 1 to 19B. The biopsy needle of the present embodiment is used by being inserted into a channel of an ultrasonic endoscope so as to be able to advance and retreat, and attached to a treatment instrument for performing treatment in the body together with the ultrasonic endoscope.
まず、図１を参照し、本実施形態の生検針を取り付けた処置具１とともに使用される超音波内視鏡の一例について説明する。図１は、本実施形態の処置具１および超音波内視鏡１００を備えた生検システム１５０の概略構成を示す斜視図である。
図１に示すように、超音波内視鏡１００は、先端から体内に挿入される挿入部１０１と、挿入部１０１の基端に取り付けられた操作部１０９と、操作部１０９の側部に一端(第一端)が接続されたユニバーサルコード１１２と、ユニバーサルコード１１２の他端（第二端）に分岐ケーブル１１２ａを介して接続された光源装置１１３と、ユニバーサルコード１１２の他端に分岐ケーブル１１２ｂを介して接続された光学的観察部１１４と、ユニバーサルコード１１２の他端に分岐ケーブル１１２ｃを介して接続された超音波観察部１１５とを備える。 First, with reference to FIG. 1, an example of an ultrasonic endoscope used with the treatment tool 1 to which the biopsy needle of this embodiment is attached will be described. FIG. 1 is a perspective view illustrating a schematic configuration of a biopsy system 150 including the treatment tool 1 and the ultrasonic endoscope 100 according to the present embodiment.
As shown in FIG. 1, the ultrasonic endoscope 100 includes an insertion portion 101 inserted into the body from the distal end, an operation portion 109 attached to the proximal end of the insertion portion 101, and one end on the side of the operation portion 109. Universal cord 112 to which (first end) is connected; light source device 113 connected to the other end (second end) of universal cord 112 via branch cable 112a; branch cable 112b to the other end of universal cord 112 And an ultrasonic observation unit 115 connected to the other end of the universal cord 112 via a branch cable 112c.
挿入部１０１は、先端硬質部１０２と、湾曲部１０５と、および可撓管部１０６とを有し、先端側からこの順に並べられている。 The insertion portion 101 includes a distal end hard portion 102, a bending portion 105, and a flexible tube portion 106, which are arranged in this order from the distal end side.
先端硬質部１０２は、光学的観察を行うための光学撮像機構１０３と、超音波観察を行うための超音波走査機構１０４とを備える。 The distal end hard portion 102 includes an optical imaging mechanism 103 for performing optical observation and an ultrasonic scanning mechanism 104 for performing ultrasonic observation.
光学撮像機構１０３は、先端硬質部１０２の斜め前方に視野が向けられた撮像光学系と、撮像光学系を通じて入射した被写体の像を検出するＣＣＤやＣＭＯＳなどのイメージセンサと、イメージセンサの動作を制御するＣＰＵ等の不図示の各種構成を備える。 The optical imaging mechanism 103 is an imaging optical system whose field of view is directed diagonally forward of the hard tip portion 102, an image sensor such as a CCD or CMOS that detects an image of a subject incident through the imaging optical system, and the operation of the image sensor. Various components (not shown) such as a CPU to be controlled are provided.
超音波走査機構（プローブ）１０４は、超音波を出射し、受信する超音波振動子（図示略）を備える。超音波走査機構１０４は、超音波振動子が発した超音波が観察対象に当たって反射した反射波を超音波振動子によって受信し、超音波振動子が受信した超音波に基づいた信号を超音波観察部１１５へ出力する。 The ultrasonic scanning mechanism (probe) 104 includes an ultrasonic transducer (not shown) that emits and receives ultrasonic waves. The ultrasonic scanning mechanism 104 receives the reflected wave reflected by the ultrasonic wave emitted from the ultrasonic vibrator when it hits the observation target, and observes the signal based on the ultrasonic wave received by the ultrasonic vibrator. Output to the unit 115.
湾曲部１０５は、筒状に形成されている。湾曲部１０５の先端に固定されて操作部１０９まで延びる図示しないアングルワイヤを操作部１０９において牽引することによって、湾曲部１０５は、たとえば上下左右の４方向等の所定の方向へ湾曲する。 The bending portion 105 is formed in a cylindrical shape. By pulling an angle wire (not shown) fixed to the distal end of the bending portion 105 and extending to the operation portion 109 in the operation portion 109, the bending portion 105 bends in a predetermined direction such as four directions of up, down, left, and right.
可撓管部１０６は、消化管内や体腔内において先端硬質部１０２を所望の位置に案内できるように柔軟に形成された筒状部材である。 The flexible tube portion 106 is a cylindrical member that is formed flexibly so that the distal end hard portion 102 can be guided to a desired position in the digestive tract and the body cavity.
湾曲部１０５と可撓管部１０６とのそれぞれの内部には、処置具１を挿通するための筒状のチャンネル１０７と、送気送水や吸引などを行うための図示しない管路とが設けられている。 Inside each of the bending portion 105 and the flexible tube portion 106, a cylindrical channel 107 for inserting the treatment instrument 1 and a conduit (not shown) for performing air supply / water supply and suction are provided. ing.
チャンネル１０７の一端（第一端）は先端硬質部１０２の先端部近傍に開口され、チャンネル１０７の他端（第二端）は操作部１０９の先端側の側面に開口されている。チャンネル１０７の他端には、フランジ状に形成された基端口金１０８が固定されている。基端口金１０８には、超音波内視鏡１００とともに使用される処置具１を固定することができる。 One end (first end) of the channel 107 is opened in the vicinity of the distal end portion of the distal end hard portion 102, and the other end (second end) of the channel 107 is opened on the side surface on the distal end side of the operation portion 109. A base end cap 108 formed in a flange shape is fixed to the other end of the channel 107. The treatment tool 1 used together with the ultrasonic endoscope 100 can be fixed to the proximal end cap 108.
操作部１０９は、超音波内視鏡１００を使用するユーザが手に持つことができるように形成された外面を有し、アングルワイヤを牽引して湾曲部１０５を湾曲動作させるための湾曲操作機構１１０と、管路を通じて送気、送水、あるいは吸引をするための複数のスイッチ１１１とを備えている。 The operation unit 109 has an outer surface formed so that a user who uses the ultrasonic endoscope 100 can hold in the hand, and a bending operation mechanism for bending the bending unit 105 by pulling the angle wire. 110 and a plurality of switches 111 for supplying air, supplying water, or sucking through a pipe line.
光源装置１１３は、光学撮像機構１０３によって撮像するための照明光を発するための装置である。 The light source device 113 is a device for emitting illumination light for imaging by the optical imaging mechanism 103.
光学的観察部１１４は、光学撮像機構１０３のイメージセンサによって撮像された映像をモニター１１６に映し出すように構成されている。 The optical observation unit 114 is configured to display a video image captured by the image sensor of the optical imaging mechanism 103 on the monitor 116.
超音波観察部１１５は、超音波走査機構１０４から出力された信号を受信し、この信号に基づいて画像を生成してモニター１１６に映し出す。 The ultrasonic observation unit 115 receives the signal output from the ultrasonic scanning mechanism 104, generates an image based on this signal, and displays the image on the monitor 116.
次に、図２から図１２を参照し、超音波内視鏡１００とともに使用される本実施形態の処置具１の構成について説明する。
図２は、処置具１を一部断面視で示す側面図である。図３は、挿入体２の先端側の構成を示す図で、挿入体２の軸方向に沿った断面図である。
図２に示すように、処置具１は、挿入体２と、操作部８と、スタイレット２７とを備える。 Next, with reference to FIG. 2 to FIG. 12, the configuration of the treatment instrument 1 of the present embodiment used together with the ultrasonic endoscope 100 will be described.
FIG. 2 is a side view showing the treatment instrument 1 in a partial sectional view. FIG. 3 is a diagram showing the configuration of the distal end side of the insert 2 and is a cross-sectional view along the axial direction of the insert 2.
As shown in FIG. 2, the treatment instrument 1 includes an insertion body 2, an operation unit 8, and a stylet 27.
図３に示すように、挿入体２は、先端と基端とを有する筒状の針管（生検針）３と、針管３が内部に挿通された筒状のシース７とを備える。
針管３の材質としては、可撓性を有しているとともに、外力により曲げられても容易に直線状態に復元する弾性を有する材質であることが好ましい。たとえば、針管３の材料（第一の材料）としては、ステンレス合金、ニッケルチタン合金、コバルトクロム合金などの合金材料を採用することができる。 As shown in FIG. 3, the insert 2 includes a cylindrical needle tube (biopsy needle) 3 having a distal end and a proximal end, and a cylindrical sheath 7 into which the needle tube 3 is inserted.
The material of the needle tube 3 is preferably a material that has flexibility and elasticity that can be easily restored to a linear state even when bent by an external force. For example, as a material (first material) of the needle tube 3, an alloy material such as a stainless alloy, a nickel titanium alloy, and a cobalt chromium alloy can be employed.
図４は、針管３の先端部分の拡大平面図であり、図５は、同先端部分の拡大断面図である。針管３の先端に設けられた開口３１は、針管を形成する管状部材の先端を管状部材の軸線に対して一以上の面で斜めに切り落とすことにより形成されており、生体組織に刺入できるように鋭利に形成されている。開口３１の具体的形状は、対象とする組織等を考慮して公知の各種形状から適宜選択されてよい。 FIG. 4 is an enlarged plan view of the distal end portion of the needle tube 3, and FIG. 5 is an enlarged sectional view of the distal end portion. The opening 31 provided at the distal end of the needle tube 3 is formed by cutting off the distal end of the tubular member forming the needle tube obliquely at one or more planes with respect to the axis of the tubular member so that it can be inserted into a living tissue. It is sharply formed. The specific shape of the opening 31 may be appropriately selected from various known shapes in consideration of the target tissue and the like.
針管３の外周面には、超音波に対する反射特性を向上させるために、微小な凹部（反射溝）３２が複数設けられている。各凹部３２は、針管３の外周面上において、周方向に略等間隔で形成されており、かつ針管３の長手方向において隣接する凹部とは、周方向における位相が異なるように形成されている。ただし、この配置態様は一例であり、凹部の配置態様はこれに限られない。 A plurality of minute recesses (reflection grooves) 32 are provided on the outer peripheral surface of the needle tube 3 in order to improve reflection characteristics with respect to ultrasonic waves. The recesses 32 are formed on the outer peripheral surface of the needle tube 3 at substantially equal intervals in the circumferential direction, and are formed so that the phase in the circumferential direction is different from the recesses adjacent in the longitudinal direction of the needle tube 3. . However, this arrangement | positioning aspect is an example and the arrangement | positioning aspect of a recessed part is not restricted to this.
図４および図５に示すように、本実施形態における凹部３２は、環状に形成されており、凹部３２には、第二の材料３３が充填されて配置されている。第二の材料３３の音響インピーダンス（第二の音響インピーダンス）は、針管３の材料（第一の材料）の音響インピーダンス（第一の音響インピーダンス）と異なる。これにより、凹部３２は第二の材料３３で埋められており、第二の材料３３からなる接触補助層３５が針管３の外周面における凹部３２上に形成されている。 As shown in FIGS. 4 and 5, the recess 32 in the present embodiment is formed in an annular shape, and the recess 32 is disposed by being filled with a second material 33. The acoustic impedance (second acoustic impedance) of the second material 33 is different from the acoustic impedance (first acoustic impedance) of the material (first material) of the needle tube 3. Thereby, the recess 32 is filled with the second material 33, and the contact auxiliary layer 35 made of the second material 33 is formed on the recess 32 on the outer peripheral surface of the needle tube 3.
第二の材料３３は、針管３の材料（第一の材料）よりも低い音響インピーダンスを有することが好ましく、生検が行われる組織の音響インピーダンスと同等の音響インピーダンスを有していることがさらに好ましい。例えば各種の樹脂材料やゴム等は、第一の材料として用いられる金属よりも硬度が低く、音響インピーダンスが体組織により近くなるため、第二の材料として好適に用いることができる。 The second material 33 preferably has an acoustic impedance lower than that of the needle tube 3 material (first material), and further has an acoustic impedance equivalent to the acoustic impedance of the tissue to be biopsied. preferable. For example, various resin materials, rubber, and the like can be suitably used as the second material because the hardness is lower than that of the metal used as the first material and the acoustic impedance is closer to the body tissue.
図２に示すように、シース７は、例えば金属コイルや樹脂などの可撓性の管状部材を有し、操作部８の先端から延出している。シース７の材料として使用可能な樹脂の例としては、ポリエーテルエーテルケトン（ＰＥＥＫ）、フッ素系樹脂、オレフィン系樹脂、ウレタン系樹脂、およびナイロン系（ポリアミド系）樹脂等を挙げることができる。シース７の基端は、操作部８の内部で後述する操作本体９に固定されている。 As shown in FIG. 2, the sheath 7 has a flexible tubular member such as a metal coil or resin, and extends from the distal end of the operation unit 8. Examples of the resin that can be used as the material of the sheath 7 include polyether ether ketone (PEEK), fluorine resin, olefin resin, urethane resin, and nylon (polyamide) resin. The proximal end of the sheath 7 is fixed to an operation body 9 described later inside the operation unit 8.
操作部８は、操作本体９と、操作本体９の先端側に設けられたシースアジャスター１８と、操作本体９の基端側に設けられた針スライダ２３とを備える。
操作本体９は、シース７の突出長を調整するためのシーススライダ１０と、操作部８の基端側へ向かってシーススライダ１０から延びるスライドレール１３と、スライドレール１３に設けられたスライダストッパ１４とを備える。 The operation unit 8 includes an operation main body 9, a sheath adjuster 18 provided on the distal end side of the operation main body 9, and a needle slider 23 provided on the proximal end side of the operation main body 9.
The operation body 9 includes a sheath slider 10 for adjusting the protruding length of the sheath 7, a slide rail 13 extending from the sheath slider 10 toward the proximal end side of the operation portion 8, and a slider stopper 14 provided on the slide rail 13. With.
図６は、図２のＡ－Ａ線における断面図である。
図２および図６に示すように、シーススライダ１０は、略円筒状に形成されており、その外面には、シースアジャスター１８を固定するねじ１１を取り付けるためにシーススライダ１０の厚さ方向に貫通するねじ孔１０ａが形成されている。また、シーススライダ１０の内部には、シースアジャスター１８の後述するスライドレール２２の溝に嵌る一対の突起１０ｂ、１０ｃが形成されている。 6 is a cross-sectional view taken along line AA in FIG.
As shown in FIGS. 2 and 6, the sheath slider 10 is formed in a substantially cylindrical shape, and penetrates in the thickness direction of the sheath slider 10 to attach a screw 11 for fixing the sheath adjuster 18 to the outer surface thereof. A screw hole 10a is formed. In addition, a pair of protrusions 10b and 10c are formed inside the sheath slider 10 so as to fit into a groove of a slide rail 22 described later of the sheath adjuster 18.
ねじ１１の先端は、後述するスライドレール２２の外面に当接可能であり、頭部には軸よりも大径に形成された大径部１２が設けられている。さらに、大径部１２の外周には複数の溝が形成されている。これにより、ねじ１１は容易に手で回すことができる。 The tip of the screw 11 can abut on the outer surface of a slide rail 22 to be described later, and a large-diameter portion 12 having a larger diameter than the shaft is provided on the head. Further, a plurality of grooves are formed on the outer periphery of the large diameter portion 12. Thereby, the screw 11 can be easily turned by hand.
図７は、図２のＢ－Ｂ線における断面図である。
図２および図７に示すように、スライドレール１３は、針スライダ２３をその中心軸線方向に進退動作させるための略円筒状の部材であり、外面には、中心軸線と平行に延びる溝１３ａ、溝１３ｂが形成されている。溝１３ａと溝１３ｂとは、スライドレール１３の径方向に対向する位置にそれぞれ配置されている。また、スライドレール１３の外周面のうち、後述するねじ１６の先端を当接させる部分は平坦に形成されている。 FIG. 7 is a cross-sectional view taken along line BB in FIG.
As shown in FIGS. 2 and 7, the slide rail 13 is a substantially cylindrical member for moving the needle slider 23 back and forth in the direction of the central axis, and a groove 13a extending parallel to the central axis is formed on the outer surface. A groove 13b is formed. The groove 13a and the groove 13b are respectively disposed at positions facing the slide rail 13 in the radial direction. Moreover, the part which contact | abuts the front-end | tip of the screw | thread 16 mentioned later among the outer peripheral surfaces of the slide rail 13 is formed flat.
スライダストッパ１４は、厚さ方向に貫通するねじ孔１５ａが形成されスライドレール１３が内部に挿通された環部材１５と、環部材１５のねじ孔１５ａにねじ込まれたねじ１６とを有する。 The slider stopper 14 has a ring member 15 in which a screw hole 15 a penetrating in the thickness direction is formed and the slide rail 13 is inserted therein, and a screw 16 screwed into the screw hole 15 a of the ring member 15.
環部材１５は、スライドレール１３の直径よりも僅かに大きな内径を有しており、スライドレール１３の中心軸線方向に進退動作可能にスライドレール１３に取り付けられている。環部材１５には、溝１３ａ、溝１３ｂに挿入された突起１５ｂ、１５ｃが形成されており、環部材１５はスライドレール１３の周方向には回らない。 The ring member 15 has an inner diameter slightly larger than the diameter of the slide rail 13, and is attached to the slide rail 13 so as to be able to advance and retract in the direction of the central axis of the slide rail 13. The ring member 15 is formed with protrusions 15 b and 15 c inserted into the groove 13 a and the groove 13 b, and the ring member 15 does not rotate in the circumferential direction of the slide rail 13.
ねじ１６の先端は、スライドレール１３の外周面に当接可能であり、環部材１５のねじ孔１５ａにねじ１６をねじ込むことにより環部材１５をスライドレール１３に固定することができる。また、ねじ１６の基端には大径に形成された大径部１７が設けられており、大径部１７の外周には複数の溝が形成されている。これにより、ねじ１６は容易に手で回すことができる。 The tip of the screw 16 can contact the outer peripheral surface of the slide rail 13, and the ring member 15 can be fixed to the slide rail 13 by screwing the screw 16 into the screw hole 15 a of the ring member 15. A large diameter portion 17 having a large diameter is provided at the base end of the screw 16, and a plurality of grooves are formed on the outer periphery of the large diameter portion 17. Thereby, the screw 16 can be easily turned by hand.
図８は、操作部８におけるシースアジャスター１８近傍を示す半断面図である。
シースアジャスター１８は、図１に示すように超音波内視鏡１００のチャンネル１０７の先端からのシース７の突出量を調整するために設けられている。図８に示すように、シースアジャスター１８は、超音波内視鏡１００の基端口金１０８に固定される固定ねじ部１９と、固定ねじ部１９に固定されシーススライダ１０の内部に挿入されたスライドレール２２とを備える。 FIG. 8 is a half sectional view showing the vicinity of the sheath adjuster 18 in the operation unit 8.
The sheath adjuster 18 is provided to adjust the amount of projection of the sheath 7 from the tip of the channel 107 of the ultrasonic endoscope 100 as shown in FIG. As shown in FIG. 8, the sheath adjuster 18 includes a fixed screw portion 19 fixed to the proximal end cap 108 of the ultrasonic endoscope 100 and a slide fixed to the fixed screw portion 19 and inserted into the sheath slider 10. Rail 22.
固定ねじ部１９には、シース７が挿通される貫通孔２０と、基端口金１０８に固定ねじ部１９を取り付けるためのねじ溝２１とが形成されている。また、固定ねじ部１９の外周面には、固定ねじ部１９を基端口金１０８に取り付けたり基端口金１０８から固定ねじ部１９を取り外したりするときに滑り止めとして機能する凹凸が形成されている。 The fixing screw portion 19 is formed with a through hole 20 through which the sheath 7 is inserted and a screw groove 21 for attaching the fixing screw portion 19 to the base end cap 108. Further, on the outer peripheral surface of the fixing screw portion 19, an unevenness functioning as a slip stopper is formed when the fixing screw portion 19 is attached to the base end base 108 or the fixing screw portion 19 is removed from the base end base 108. .
図６および図８に示すように、スライドレール２２は、中心軸線と平行に延びる一対の溝が形成された円筒部材であり、内部にシース７および針管３が挿通されている。スライドレール２２の先端は固定ねじ部１９に固定されており、スライドレール２２はシーススライダ１０の内部に差し込まれている。スライドレール２２の外周面には、径方向に対向し軸方向に長い一対の溝２２ａ、２２ｂが形成されている。溝２２ａｂには、シーススライダ１０に形成された突起１０ｂが嵌め込まれている。溝２２ｂには、シーススライダ１０に形成された突起１０ｃが嵌め込まれている。 As shown in FIGS. 6 and 8, the slide rail 22 is a cylindrical member in which a pair of grooves extending in parallel with the central axis is formed, and the sheath 7 and the needle tube 3 are inserted therein. The front end of the slide rail 22 is fixed to the fixing screw portion 19, and the slide rail 22 is inserted into the sheath slider 10. On the outer peripheral surface of the slide rail 22, a pair of grooves 22 a and 22 b that are opposed to each other in the radial direction and are long in the axial direction are formed. A protrusion 10b formed on the sheath slider 10 is fitted into the groove 22ab. A protrusion 10c formed on the sheath slider 10 is fitted in the groove 22b.
シーススライダ１０の内部において、スライドレール２２の外面には、シーススライダ１０のねじ孔１０ａにねじ込まれたねじ１１の先端が当接可能である。これにより、ねじ１１をシーススライダ１０にねじ込んだときには、ねじ１１の先端がスライドレール２２の外面に押し付けられることによってスライドレール２２とシーススライダ１０とは固定される。また、このねじ１１を緩めたときには、シースアジャスター１８のスライドレール２２とシーススライダ１０とは溝の長手方向に沿って相対移動できる。 Inside the sheath slider 10, the tip end of the screw 11 screwed into the screw hole 10 a of the sheath slider 10 can come into contact with the outer surface of the slide rail 22. Thus, when the screw 11 is screwed into the sheath slider 10, the slide rail 22 and the sheath slider 10 are fixed by pressing the tip of the screw 11 against the outer surface of the slide rail 22. When the screw 11 is loosened, the slide rail 22 of the sheath adjuster 18 and the sheath slider 10 can move relative to each other along the longitudinal direction of the groove.
図９は、操作部８における針スライダ２３を拡大して示す半断面図である。図１０は、操作部８における針スライダ２３を拡大して示す図で、図２のＣ矢視図である。
図９に示すように、針スライダ２３は、操作本体９のスライドレール１３が内部に挿入された筒状部材であり、スライドレール１３の溝１３ａおよび溝１３ｂに嵌る一対の突起２３ａ（２つの突起２３ａのうち一方は不図示）が形成されている。針スライダ２３の先端は、スライダストッパ１４の基端に当接可能になっている。針スライダ２３の基端には、後述するつまみ２８およびシリンジ１２０をねじ込むためのねじ山２３ｃが形成されている。 FIG. 9 is an enlarged half sectional view showing the needle slider 23 in the operation unit 8. FIG. 10 is an enlarged view of the needle slider 23 in the operation unit 8, and is a view taken in the direction of arrow C in FIG.
As shown in FIG. 9, the needle slider 23 is a cylindrical member into which the slide rail 13 of the operation main body 9 is inserted, and a pair of protrusions 23 a (two protrusions) that fit into the grooves 13 a and 13 b of the slide rail 13. One of the 23a is not shown). The distal end of the needle slider 23 can come into contact with the proximal end of the slider stopper 14. A screw thread 23c for screwing a knob 28 and a syringe 120, which will be described later, is formed at the proximal end of the needle slider 23.
針スライダ２３の外面形状は、処置具１を使用するユーザが把持することができるように円柱面状である。さらに、図１０に示すように、針スライダ２３の外面には、針管３の直径を示すゲージ数が刻印などによって表示されたゲージ数表示部２４が形成されている。 The outer surface shape of the needle slider 23 is a cylindrical surface so that a user using the treatment instrument 1 can hold it. Further, as shown in FIG. 10, a gauge number display section 24 is formed on the outer surface of the needle slider 23, in which a gauge number indicating the diameter of the needle tube 3 is displayed by engraving or the like.
詳細は図示しないが、針スライダ２３の内部には針管３の基端が固定されている。針スライダ２３に固定された針管３の基端からは、後述するスタイレット２７を挿入できる。スライドレール１３の溝１３ａ、溝１３ｂ（図７参照）に沿って針スライダ２３をその中心軸線方向へ移動させることによって、針管３をシース７から突没させることができる。 Although not shown in detail, the proximal end of the needle tube 3 is fixed inside the needle slider 23. A stylet 27 described later can be inserted from the proximal end of the needle tube 3 fixed to the needle slider 23. By moving the needle slider 23 in the direction of the central axis along the grooves 13a and 13b (see FIG. 7) of the slide rail 13, the needle tube 3 can protrude and retract from the sheath 7.
また、針スライダ２３とスライドレール１３とは、スライドレール１３の基端側へ針スライダ２３を移動させたときに針スライダ２３とスライドレール１３とが外れないように連結されている。スライドレール１３の基端側へいっぱいまで針スライダ２３を移動させた状態では、針スライダ２３に固定された針管３の先端は、シース７の先端の内部に引き込まれ、シース７によって覆われた位置にある。 Further, the needle slider 23 and the slide rail 13 are coupled so that the needle slider 23 and the slide rail 13 are not detached when the needle slider 23 is moved to the proximal end side of the slide rail 13. In a state in which the needle slider 23 is moved to the proximal end side of the slide rail 13 to the full, the distal end of the needle tube 3 fixed to the needle slider 23 is drawn into the distal end of the sheath 7 and is covered by the sheath 7. It is in.
図１１Ａは、スタイレット２７の側面図である。図１２は、図１１ＡのＤ－Ｄ線における断面図である。
図１１Ａおよび図１２に示すように、スタイレット２７は、金属線材であり、針管３の内部に進退自在に挿通可能である。すなわち、針管３の内径より、スタイレット２７の外径の方が小さい。スタイレット２７の先端は鋭利に形成され、スタイレット２７の基端には樹脂などによって形成されたつまみ２８が設けられている。図１１Ｂに示すように、スタイレット２７Ａの先端は略半球形状に形成されていてもよい。 FIG. 11A is a side view of the stylet 27. 12 is a cross-sectional view taken along the line DD of FIG. 11A.
As shown in FIGS. 11A and 12, the stylet 27 is a metal wire, and can be inserted into the needle tube 3 so as to advance and retract. That is, the outer diameter of the stylet 27 is smaller than the inner diameter of the needle tube 3. The tip of the stylet 27 is sharply formed, and a knob 28 made of resin or the like is provided at the base end of the stylet 27. As shown in FIG. 11B, the tip of the stylet 27A may be formed in a substantially hemispherical shape.
スタイレット２７の基端に設けられたつまみ２８には、スタイレット２７が好適に挿入可能な針管３のゲージ数が刻印などによって表示されたゲージ数表示部２９が形成されている。すなわち、針スライダ２３に設けられたゲージ数表示部２４に表示されたゲージ数と同じ数値がつまみ２８に表示されたスタイレット２７であれば、そのスタイレット２７は針管３内に好適に挿入して使用することができる。これにより、針管３およびスタイレット２７の径が異なる複数の処置具１を１つの手技で使用する場合における取違を避けることができる。 The knob 28 provided at the base end of the stylet 27 is formed with a gauge number display portion 29 in which the gauge number of the needle tube 3 into which the stylet 27 can be suitably inserted is displayed by engraving or the like. That is, if the stylet 27 has the same numerical value as the gauge number displayed on the gauge number display section 24 provided on the needle slider 23 displayed on the knob 28, the stylet 27 is preferably inserted into the needle tube 3. Can be used. Thereby, the mistake in the case of using the some treatment tool 1 from which the diameter of the needle tube 3 and the stylet 27 differs can be avoided by one procedure.
図１２に示すように、つまみ２８には、針スライダ２３の基端に形成されたねじ山２３ｃ（図９参照）に嵌るねじ溝２８ａが形成されている。針スライダ２３のねじ山２３ｃにつまみ２８のねじ溝２８ａをあわせてねじ込むことによって、スタイレット２７を針スライダ２３に固定することができる。このとき、スタイレット２７の先端は、針管３の先端からわずかに突出した位置になるように設定されている（図３参照）。 As shown in FIG. 12, the knob 28 is formed with a thread groove 28 a that fits into a thread 23 c (see FIG. 9) formed at the proximal end of the needle slider 23. The stylet 27 can be fixed to the needle slider 23 by screwing the screw groove 28 a of the knob 28 with the screw thread 23 c of the needle slider 23. At this time, the tip of the stylet 27 is set so as to slightly protrude from the tip of the needle tube 3 (see FIG. 3).
以上に説明した構成の生検システム１５０の使用方法および使用時の動作について説明する。図１３から図１８は、処置具１の使用時の動作を説明するための動作説明図である。
本実施形態では、図１３に示すように、体内の組織の深部に位置する病変などの組織に対して処置具１の針管３を差込み、針管３の内部を通じて病変の細胞などを回収する生検の処置を例に説明する。 A method of using the biopsy system 150 having the above-described configuration and an operation during use will be described. FIG. 13 to FIG. 18 are operation explanatory views for explaining the operation at the time of using the treatment instrument 1.
In the present embodiment, as shown in FIG. 13, a biopsy in which the needle tube 3 of the treatment instrument 1 is inserted into a tissue such as a lesion located in the deep part of the body tissue and the cells of the lesion are collected through the inside of the needle tube 3. This will be described as an example.
図１３に示すように、ユーザは、超音波内視鏡１００の挿入部１０１を体内に挿入し、光学撮像機構１０３を用いて、処置を行う部位を光学的に観察する。また、超音波走査機構１０４を用いて、処置を行う部位の深部を観察することもできる。 As illustrated in FIG. 13, the user inserts the insertion portion 101 of the ultrasonic endoscope 100 into the body, and optically observes a site to be treated using the optical imaging mechanism 103. Further, the ultrasonic scanning mechanism 104 can be used to observe the deep part of the site to be treated.
次に、光学撮像機構１０３および超音波走査機構１０４による観察結果に基づいて、生検を行う部位を決定する。
次に、ユーザは、超音波内視鏡１００の操作部１０９に設けられた基端口金１０８からチャンネル１０７の内部へ、処置具１の挿入体２を先端側から挿入する。さらに、ユーザは、処置具１の操作部８に設けられた固定ねじ部１９を基端口金１０８に固定する。これにより、処置具１は超音波内視鏡１００に固定される。 Next, based on the observation results by the optical imaging mechanism 103 and the ultrasonic scanning mechanism 104, a part to be biopsied is determined.
Next, the user inserts the insertion body 2 of the treatment instrument 1 from the distal end side into the channel 107 from the proximal end cap 108 provided in the operation unit 109 of the ultrasonic endoscope 100. Further, the user fixes the fixing screw portion 19 provided in the operation unit 8 of the treatment instrument 1 to the base end cap 108. Thereby, the treatment tool 1 is fixed to the ultrasonic endoscope 100.
次に、ユーザは、シーススライダ１０に設けられたねじ１１を緩め、光学撮像機構１０３および超音波走査機構１０４によってシース７および体内を観察しながら、シースアジャスター１８を用いて超音波内視鏡１００の挿入部１０１の先端からのシース７の突出量を適切な量に調整する。 Next, the user loosens the screw 11 provided on the sheath slider 10 and observes the sheath 7 and the body by the optical imaging mechanism 103 and the ultrasonic scanning mechanism 104 while using the sheath adjuster 18 to set the ultrasonic endoscope 100. The amount of protrusion of the sheath 7 from the distal end of the insertion portion 101 is adjusted to an appropriate amount.
次に、超音波走査機構１０４による観察結果に基づいて、生検を行う対象組織Ｔの位置に合わせてスライダストッパ１４を移動させてスライドレール１３に固定する。これにより、シース７から針管３が突出可能な最大長さは、針スライダ２３がスライダストッパ１４に当接するまでの長さに制限される。 Next, based on the observation result by the ultrasonic scanning mechanism 104, the slider stopper 14 is moved according to the position of the target tissue T to be biopsied and fixed to the slide rail 13. As a result, the maximum length by which the needle tube 3 can protrude from the sheath 7 is limited to the length until the needle slider 23 comes into contact with the slider stopper 14.
次に、図１４に示すように、ユーザは、針スライダ２３を操作部８の先端側へと押し込む。すると、図１５に示すように、針管３がシース７から突出する。さらに、図１６に示すように、針管３の先端は組織に穿刺され、生検を行う対象組織Ｔへと押し進められる。このとき、組織の表面から外部に露出している針管３は光学撮像機構１０３によって観察することができ、組織の内部に差し込まれた針管３の先端側部分は超音波走査機構１０４によって観察することができる。 Next, as shown in FIG. 14, the user pushes the needle slider 23 toward the distal end side of the operation unit 8. Then, the needle tube 3 protrudes from the sheath 7 as shown in FIG. Further, as shown in FIG. 16, the distal end of the needle tube 3 is punctured into the tissue and pushed forward to the target tissue T to be biopsied. At this time, the needle tube 3 exposed to the outside from the surface of the tissue can be observed by the optical imaging mechanism 103, and the tip side portion of the needle tube 3 inserted into the tissue is observed by the ultrasonic scanning mechanism 104. Can do.
図１７は、組織内における針管３の断面を拡大して示す図である。針管３の外周面は、超音波走査機構１０４から出射された超音波を超音波操作機構１０４に向かって反射しにくい角度を有しているが、外周面に形成された凹部３２の内面の一部は、超音波走査機構１０４から出射された超音波を超音波操作機構１０４に向かって反射しやすい角度を有している。その結果、超音波走査機構１０４が受信する超音波が増加し、針管３の先端部が超音波観察部１１５に鮮明に映し出される。ここで、凹部３２上には接触補助層３５が形成されているため、針管３を組織に刺入した際に、凹部３２内に空気が残存することはほとんどなく、針管３と組織とが隙間なく好適に接触した状態が接触補助層３５により確保される。 FIG. 17 is an enlarged view showing a cross section of the needle tube 3 in the tissue. The outer peripheral surface of the needle tube 3 has an angle at which it is difficult to reflect the ultrasonic wave emitted from the ultrasonic scanning mechanism 104 toward the ultrasonic operation mechanism 104, but one of the inner surfaces of the recesses 32 formed on the outer peripheral surface. The unit has an angle at which the ultrasonic wave emitted from the ultrasonic scanning mechanism 104 is easily reflected toward the ultrasonic operation mechanism 104. As a result, the number of ultrasonic waves received by the ultrasonic scanning mechanism 104 increases, and the tip of the needle tube 3 is clearly projected on the ultrasonic observation unit 115. Here, since the contact assisting layer 35 is formed on the concave portion 32, air hardly remains in the concave portion 32 when the needle tube 3 is inserted into the tissue, and there is no gap between the needle tube 3 and the tissue. The contact assisting layer 35 secures a suitable contact state.
ユーザは、超音波走査機構１０４において受信された超音波に基づく超音波画像を図１に示す超音波観察部１１５によって観察することができる。超音波観察部１１５に鮮明に映し出された針管３の像を参照し、ユーザは、針管３の先端を、生検を行う対象組織Ｔに到達させる。なお、生検を行う対象組織Ｔに針管３の先端が到達した段階では、針管３内にはスタイレット２７が挿入されているので、針管３内に組織が入り込むことはない。 The user can observe an ultrasonic image based on the ultrasonic wave received by the ultrasonic scanning mechanism 104 with the ultrasonic observation unit 115 shown in FIG. With reference to the image of the needle tube 3 clearly displayed on the ultrasonic observation unit 115, the user causes the tip of the needle tube 3 to reach the target tissue T on which biopsy is performed. Note that when the tip of the needle tube 3 reaches the target tissue T to be biopsied, the stylet 27 is inserted into the needle tube 3, so that the tissue does not enter the needle tube 3.
次に、ユーザは、図２に示すスタイレット２７のつまみ２８を回して針スライダ２３からつまみ２８を取り外し、挿入体２および操作部８からスタイレット２７を引き抜く。これにより、針管３の先端から針スライダ２３の基端まで延びる貫通孔が生じる。ユーザは、図１８に示すように、針スライダ２３の基端に形成されたねじ山２３ｃに嵌合する先端を有する適宜のシリンジ１２０を、ねじ山２３ｃに固定する。さらに、シリンジ１２０によって針管３内を吸引し、針管３の先端から生検を行う対象組織Ｔの細胞などをシリンジ１２０内に吸引する。 Next, the user turns the knob 28 of the stylet 27 shown in FIG. 2 to remove the knob 28 from the needle slider 23, and pulls out the stylet 27 from the insert 2 and the operation unit 8. Thereby, a through hole extending from the distal end of the needle tube 3 to the proximal end of the needle slider 23 is generated. As shown in FIG. 18, the user fixes an appropriate syringe 120 having a distal end fitted to a thread 23 c formed at the proximal end of the needle slider 23 to the thread 23 c. Further, the inside of the needle tube 3 is sucked by the syringe 120, and the cells of the target tissue T to be biopsied from the tip of the needle tube 3 are sucked into the syringe 120.
必要量の細胞などがシリンジ１２０内に吸引されたら、針スライダ２３を操作部８の基端側へいっぱいまで引き込み、針管３の先端をシース７内に収容する。これにより、針管３は組織から抜ける。針管３が組織から抜けたら、超音波内視鏡１００の操作部１０９の基端口金１０８から固定ねじ部１９をはずし、処置具１をチャンネル１０７から抜去する。以上で一連の処置を終了する。 When a necessary amount of cells and the like are sucked into the syringe 120, the needle slider 23 is pulled to the base end side of the operation unit 8 to the full, and the distal end of the needle tube 3 is accommodated in the sheath 7. Thereby, the needle tube 3 comes out of the tissue. When the needle tube 3 comes out of the tissue, the fixing screw portion 19 is removed from the base end cap 108 of the operation portion 109 of the ultrasonic endoscope 100, and the treatment tool 1 is removed from the channel 107. The series of treatments is thus completed.
本実施形態の針管３では、複数の凹部３２上に第二の材料３３からなる接触補助層３５が設けられて凹部３２内が埋められているため、凹部３２内に空気が残存することがなく、上述した凹部と組織との境界の状態のバラつきが抑えられる。その結果、針管３の外周面において凹部３２が設けられた部位における超音波の反射態様が均一化されてより確実に超音波が超音波走査機構１０４に反射され、超音波観察部１１５の画像における針管３の像を安定化させることができる。 In the needle tube 3 of the present embodiment, since the contact auxiliary layer 35 made of the second material 33 is provided on the plurality of recesses 32 and the recesses 32 are filled, air does not remain in the recesses 32. The above-described variation in the state of the boundary between the recess and the tissue can be suppressed. As a result, the reflection mode of the ultrasonic wave at the portion where the concave portion 32 is provided on the outer peripheral surface of the needle tube 3 is made uniform, and the ultrasonic wave is more reliably reflected to the ultrasonic scanning mechanism 104, so The image of the needle tube 3 can be stabilized.
また、接触補助層３５を形成する第二の材料３３が、針管３を形成する第一の材料と異なる音響インピーダンスを有するため、第一の材料と第二の材料との界面となる凹部３２の内面で好適に超音波の反射が起きる。したがって、凹部３２の内面形状に従い確実に超音波走査機構１０４へ超音波を返すことができる。 In addition, since the second material 33 forming the contact assisting layer 35 has an acoustic impedance different from that of the first material forming the needle tube 3, the recess 32 serving as an interface between the first material and the second material is formed. Ultrasonic reflection preferably occurs on the inner surface. Therefore, it is possible to reliably return ultrasonic waves to the ultrasonic scanning mechanism 104 according to the inner surface shape of the recess 32.
なお、第二の材料が、針管３が刺入される組織と同等の音響インピーダンスを有していると、第二の材料と組織との界面における超音波の反射を抑えることができる。第二の材料と組織との界面において超音波が反射すると、実質的に針管の外周面で反射するのと同等の方向に反射するため、超音波画像における視認性の向上に寄与しにくい。したがって、第二の材料は、針管が刺入される組織とできるだけ近い音響インピーダンスを有するのが好ましい。 If the second material has an acoustic impedance equivalent to that of the tissue into which the needle tube 3 is inserted, reflection of ultrasonic waves at the interface between the second material and the tissue can be suppressed. When the ultrasonic wave is reflected at the interface between the second material and the tissue, it is reflected in a direction substantially equivalent to that reflected by the outer peripheral surface of the needle tube, so that it is difficult to contribute to the improvement of the visibility in the ultrasonic image. Therefore, the second material preferably has an acoustic impedance as close as possible to the tissue into which the needle tube is inserted.
本発明において、接触補助層の反射溝の形状は、上述の環状に限られない。例えば、図１９Ａに示すように、外周面上における形状が円形で所定の深さを有する溝３２ａでもよいし、図１９Ｂに示すように、針管３の周方向にわたる溝３２ｂを、針管３の長手方向に間隔を空けて複数形成してもよい。なお、図１９Ａおよび図１９Ｂは、それぞれ溝３２ａおよび３２ｂの断面形状を拡大して示している。 In the present invention, the shape of the reflection groove of the contact auxiliary layer is not limited to the above-described ring shape. For example, as shown in FIG. 19A, a groove 32a having a circular shape on the outer peripheral surface and having a predetermined depth may be used. As shown in FIG. 19B, a groove 32b extending in the circumferential direction of the needle tube 3 is formed in the longitudinal direction of the needle tube 3. A plurality may be formed at intervals in the direction. 19A and 19B show enlarged cross-sectional shapes of the grooves 32a and 32b, respectively.
次に、本発明の第二実施形態について、図２０から図２２を参照して説明する。本実施形態の生検針と第一実施形態の生検針との異なるところは、接触補助層における第二の材料の配置態様である。なお、以降の説明において、すでに説明したものと共通する構成については、同一の符号を付して重複する説明を省略する。 Next, a second embodiment of the present invention will be described with reference to FIGS. The difference between the biopsy needle of the present embodiment and the biopsy needle of the first embodiment is the arrangement of the second material in the contact auxiliary layer. In the following description, components that are the same as those already described are assigned the same reference numerals and redundant description is omitted.
図２０は、本実施形態の針管５０の先端部断面を拡大して示す図である。針管５０の外周面に設けられた凹部５２は、内面が球面状に形成されており、接触補助層５５を形成する第二の材料５３は、凹部５２の内面上に所定の厚さｔとなるように配置されている。なお、本発明においては、凹部５２の内面の所定の位置において、この位置で内面に接する接線と直交する方向における寸法を所定の位置における「厚さ」と定義する。 FIG. 20 is an enlarged view showing a cross section of the distal end portion of the needle tube 50 of the present embodiment. The concave portion 52 provided on the outer peripheral surface of the needle tube 50 has a spherical inner surface, and the second material 53 forming the contact assisting layer 55 has a predetermined thickness t on the inner surface of the concave portion 52. Are arranged as follows. In the present invention, at a predetermined position on the inner surface of the recess 52, a dimension in a direction orthogonal to a tangent line that contacts the inner surface at this position is defined as “thickness” at the predetermined position.
上記所定の厚さｔは、超音波走査機構１０４から出射される超音波の波長の２分の１の整数倍とされている。すなわち、出射される超音波の波長をｌとすると厚さｔは、ｎ／２×ｌ（ただし、ｎは自然数）で表すことができる。 The predetermined thickness t is an integral multiple of one half of the wavelength of the ultrasonic wave emitted from the ultrasonic scanning mechanism 104. That is, when the wavelength of the emitted ultrasonic wave is 1, the thickness t can be expressed by n / 2 × l (where n is a natural number).
本実施形態において、第二の材料５３の音響インピーダンスは、第一の材料と異なるとともに、針管５０が刺入される組織の音響インピーダンス（第三の音響インピーダンス）とも異なっている。 In the present embodiment, the acoustic impedance of the second material 53 is different from that of the first material, and is also different from the acoustic impedance of the tissue into which the needle tube 50 is inserted (third acoustic impedance).
本実施形態の針管５０においても、完全ではないものの凹部５２の一部が第二の材料５３からなる接触補助層５５で埋められているため、凹部５２内に空気が残存しにくく、凹部と組織との境界の状態のバラつきが抑えられる。その結果、針管５０を備えた生検システムにおいては、超音波観察部１１５の画像における針管３の像を安定化させることができる。 Even in the needle tube 50 of the present embodiment, although not complete, a part of the concave portion 52 is filled with the contact auxiliary layer 55 made of the second material 53, so that air hardly remains in the concave portion 52, and the concave portion and the tissue. The variation in the state of the boundary between and can be suppressed. As a result, in the biopsy system provided with the needle tube 50, the image of the needle tube 3 in the image of the ultrasonic observation unit 115 can be stabilized.
また、第二の材料５３の音響インピーダンスが、第一の材料および組織のいずれとも異なっているため、超音波走査機構１０４から出射される超音波は、図２１に示すように組織と接触補助層５５との界面、および接触補助層と凹部５２との界面において反射される。そして、超音波が凹部５２の内面に対して垂直に入射したとき、組織と接触補助層５５との界面で反射した超音波と接触補助層と凹部５２との界面で反射した超音波との経路の差は、接触補助層の厚さｔの２倍、すなわち超音波の波長の整数倍となる。したがって、両者は位相が一致した状態で超音波走査機構１０４に戻るため、反射する超音波が減衰せず、増幅されて超音波走査機構１０４で受信される。その結果、超音波画像上でより鮮明に先端部を確認することができる。 Further, since the acoustic impedance of the second material 53 is different from that of either the first material or the tissue, the ultrasonic wave emitted from the ultrasonic scanning mechanism 104 is transmitted between the tissue and the contact auxiliary layer as shown in FIG. Reflected at the interface with 55 and the interface between the contact auxiliary layer and the recess 52. Then, when the ultrasonic wave enters perpendicularly to the inner surface of the concave portion 52, the path between the ultrasonic wave reflected at the interface between the tissue and the contact auxiliary layer 55 and the ultrasonic wave reflected at the interface between the contact auxiliary layer and the concave portion 52. Is twice the thickness t of the contact auxiliary layer, that is, an integral multiple of the wavelength of the ultrasonic wave. Therefore, since both return to the ultrasonic scanning mechanism 104 in a state where the phases match, the reflected ultrasonic waves are not attenuated but are amplified and received by the ultrasonic scanning mechanism 104. As a result, the tip portion can be confirmed more clearly on the ultrasonic image.
本実施形態では、凹部の内面が球面状である例を説明したが、凹部内面の形状はこれには限られず、例えば図２２に示す凹部５７のように平坦な部位を含んでもよい。このような場合でも、接触補助層５５の厚さｔを均一かつ超音波の波長の２分の１の整数倍の値とすることで、同様の効果を得ることができる。 In the present embodiment, an example in which the inner surface of the concave portion is spherical has been described. However, the shape of the inner surface of the concave portion is not limited to this, and may include a flat portion such as the concave portion 57 shown in FIG. Even in such a case, the same effect can be obtained by setting the thickness t of the contact auxiliary layer 55 to a value that is uniform and an integral multiple of one half of the wavelength of the ultrasonic wave.
以上、本発明の各実施形態について説明したが、具体的な構成はこれらの実施形態に限られるものではなく、本発明の趣旨を逸脱しない範囲で、構成の付加、省略、置換、各実施形態の内容の組み合わせ、およびその他の変更が可能である。 The embodiments of the present invention have been described above. However, the specific configuration is not limited to these embodiments, and additions, omissions, and substitutions of configurations are possible without departing from the spirit of the present invention. Combinations of the above and other changes are possible.
上記本発明の各実施形態によれば、針管の外周面において凹部が設けられた部位における超音波の反射態様が均一化されてより確実に超音波が超音波走査機構に反射され、超音波観察部の画像における針管の像を安定化させることができる生検針を提供できる。 According to each of the embodiments of the present invention described above, the ultrasonic reflection mode at the site where the concave portion is provided on the outer peripheral surface of the needle tube is made uniform, and the ultrasonic wave is more reliably reflected to the ultrasonic scanning mechanism, so that the ultrasonic observation is performed. It is possible to provide a biopsy needle that can stabilize the image of the needle tube in the image of the part.
１　　処置具
２　　挿入体
３，５０　　針管
３１　　開口
３２，５２，５７　　凹部
３３　　第二の材料
３５　　接触補助層
１０１　　超音波内視鏡
１０４　　超音波走査機構
１５０　　生検システム DESCRIPTION OF SYMBOLS 1 Treatment tool 2 Insert 3, 50 Needle tube 31 Opening 32, 52, 57 Recess 33 Second material 35 Contact auxiliary layer 101 Ultrasound endoscope 104 Ultrasound scanning mechanism 150 Biopsy system

Claims (3)

  1. 第一の材料を用いて中空に形成され、外周面に反射溝を有する針本体と、
    　前記反射溝内に前記第一の材料の第一の音響インピーダンスと異なる第二の音響インピーダンスを有する第二の材料を用いて形成された接触補助層と、
    　を備える生検針。     A needle body formed hollow using a first material and having a reflective groove on the outer peripheral surface;
    A contact assistant layer formed in the reflective groove using a second material having a second acoustic impedance different from the first acoustic impedance of the first material;
    Biopsy needle with.
  2. 　前記第二の音響インピーダンスは、前記針本体が刺入される組織の第三の音響インピーダンスと実質的に同等である請求項１に記載の生検針。 The biopsy needle according to claim 1, wherein the second acoustic impedance is substantially equal to a third acoustic impedance of a tissue into which the needle body is inserted.
  3. 　請求項１に記載の生検針と、
    超音波を出射するプローブを有する内視鏡と
    を備え、
    　前記第二の音響インピーダンスは、前記第三の音響インピーダンスと異なり、
    　前記接触補助層の厚さは前記プローブから出射される超音波の波長の２分の１の整数倍である生検システム。     A biopsy needle according to claim 1;
    An endoscope having a probe for emitting ultrasonic waves,
    The second acoustic impedance is different from the third acoustic impedance,
    The biopsy system, wherein the thickness of the auxiliary contact layer is an integral multiple of one half of the wavelength of the ultrasonic wave emitted from the probe.
PCT/JP2013/068498 2012-09-21 2013-07-05 Biopsy needle and biopsy system WO2014045677A1 (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107343812A (en) * 2016-05-05 2017-11-14 上海安久生物科技有限公司 Ultrasound guided puncture pin and preparation method
EP3260050A4 (en) * 2015-02-19 2018-11-14 Olympus Corporation Biopsy needle
WO2023040471A1 (en) * 2021-09-14 2023-03-23 贝普医疗科技股份有限公司 Ultrasound-guided nerve block needle

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08206118A (en) * 1994-04-14 1996-08-13 Yasuo Majima Puncturing needle for medical treatment
JP2006271874A (en) * 2005-03-30 2006-10-12 Toshiba Corp Ultrasonically guided puncture needle
WO2007013130A1 (en) * 2005-07-25 2007-02-01 Hakko Co., Ltd. Ultrasonic piercing needle
JP2012513833A (en) * 2008-12-30 2012-06-21 ボストン サイエンティフィック サイムド， インコーポレイテッド Enhanced echo generation for needles

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08206118A (en) * 1994-04-14 1996-08-13 Yasuo Majima Puncturing needle for medical treatment
JP2006271874A (en) * 2005-03-30 2006-10-12 Toshiba Corp Ultrasonically guided puncture needle
WO2007013130A1 (en) * 2005-07-25 2007-02-01 Hakko Co., Ltd. Ultrasonic piercing needle
JP2012513833A (en) * 2008-12-30 2012-06-21 ボストン サイエンティフィック サイムド， インコーポレイテッド Enhanced echo generation for needles

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3260050A4 (en) * 2015-02-19 2018-11-14 Olympus Corporation Biopsy needle
CN107343812A (en) * 2016-05-05 2017-11-14 上海安久生物科技有限公司 Ultrasound guided puncture pin and preparation method
WO2023040471A1 (en) * 2021-09-14 2023-03-23 贝普医疗科技股份有限公司 Ultrasound-guided nerve block needle

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