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WO2016047202A1 - Endoscope puncture needle - Google Patents

Endoscope puncture needle Download PDF

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Publication number
WO2016047202A1
WO2016047202A1 PCT/JP2015/065312 JP2015065312W WO2016047202A1 WO 2016047202 A1 WO2016047202 A1 WO 2016047202A1 JP 2015065312 W JP2015065312 W JP 2015065312W WO 2016047202 A1 WO2016047202 A1 WO 2016047202A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
needle tube
tube
endoscope
puncture needle
Prior art date
Application number
PCT/JP2015/065312
Other languages
French (fr)
Japanese (ja)
Inventor
大史 江藤
Original Assignee
オリンパス株式会社
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 オリンパス株式会社 filed Critical オリンパス株式会社
Priority to JP2016520093A priority Critical patent/JPWO2016047202A1/en
Publication of WO2016047202A1 publication Critical patent/WO2016047202A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • 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

Definitions

  • the present invention relates to an endoscope puncture needle.
  • the present application claims priority based on Japanese Patent Application No. 2014-197106 filed in Japan on September 26, 2014, the contents of which are incorporated herein by reference.
  • biopsy in which a small amount of body tissue is collected and observed with a microscope, is known.
  • an inspection method in which a small amount of body tissue is collected and observed with a microscope.
  • an optical endoscope 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.
  • a tissue may be collected by inserting a puncture needle.
  • Patent Document 1 discloses a suction puncture needle that can be used for biopsy. Further, in Patent Document 2, in order to prevent the tip of the blade from being crushed when the biopsy puncture needle comes into contact with a tissue such as a bone, the tip of the puncture needle is not easily bent inside the puncture needle. It is disclosed to optimize the angle.
  • the puncture needle for endoscope When the puncture needle for endoscope is inserted through the channel of the endoscope, the puncture needle for endoscope is deformed into a curved shape following the shape of the channel.
  • the puncture needle for endoscope When the puncture needle for endoscope is moved to the tip side in the channel while the puncture needle for endoscope is deformed into a curved shape following the shape of the channel, it is plastic so that the cutting edge of the puncture needle for endoscope is turned up There is a possibility of deformation.
  • plastic deformation is performed so that the cutting edge of the endoscope puncture needle is turned over, the puncture performance of the cutting edge is lowered before the cutting edge of the puncture needle for endoscope is punctured into the tissue.
  • the puncture needle for endoscope is deformed into a curved shape following the shape of the channel, the cutting edge of the puncture needle for endoscope is likely to be pierced into the channel, and the endoscope may be damaged.
  • the present invention has been made in view of the above-described circumstances, and an object thereof is to provide an endoscope puncture needle that is unlikely to cause damage to the endoscope or a decrease in puncture performance.
  • a first aspect of the present invention is an endoscope puncture needle that is used by being attached to an endoscope having a bent channel, a needle tube that can be inserted into the channel, a needle tube that supports the needle tube, A needle slider that moves the needle tube in the direction of the center line, and the needle tube is located on the inner side of the outer peripheral surface of the needle tube when viewed from the center line direction of the needle tube and can be inserted into tissue.
  • the angle formed by the straight line connecting the insertion end, the outer edge of the distal end surface of the needle tube, and the insertion end and the center line of the needle tube is always inclined with respect to the proximal end portion of the bending portion of the channel.
  • a puncture needle for an endoscope having a blade surface extending from the insertion end to the outer edge in a state inclined more than an angle.
  • the blade surface may have a conical surface shape whose diameter gradually decreases from the outer edge toward the insertion end side of the needle tube. .
  • the blade surface is viewed from the first blade surface portion formed of a plane inclined with respect to the center line of the needle tube and the center line direction of the needle tube.
  • a second blade surface portion having a piercing end on a line of intersection with the first blade surface portion, which is formed on a plane that faces the first blade surface portion and intersects the first blade surface portion. May be.
  • the puncture needle for an endoscope has a cylindrical shape in which the needle tube is inserted and has an outer diameter of 60% or more of the inner diameter of the channel.
  • a sheath may be further provided.
  • the outer diameter of the needle tube may be 60% or more of the inner diameter of the sheath.
  • the sheath may be formed in a coil shape by winding a wire in a spiral shape.
  • FIG. 1 It is a figure showing a schematic structure of a biopsy system of this embodiment provided with a puncture needle for endoscopes and an ultrasonic endoscope of a 1st embodiment of the present invention.
  • FIG. 9 is a cross-sectional view taken along line A1-A1 of FIG. It is sectional drawing in the B1-B1 line
  • FIG. 1 is a diagram showing a schematic configuration of a biopsy system of this embodiment provided with an endoscope puncture needle and an ultrasonic endoscope.
  • FIG. 2 is a cross-sectional view of a distal end portion of an ultrasonic endoscope that is an endoscope of a biopsy system.
  • An endoscopic puncture needle 1 of the present embodiment shown in FIG. 1 (hereinafter simply referred to as “puncture needle 1”) is combined with an ultrasonic endoscope 100 as a part of a biopsy system 150 for biopsy. Is a biopsy needle used for
  • an example of an endoscope used with the puncture needle 1 of this embodiment will be described.
  • the structure of the endoscope which can be used with the puncture needle 1 of this embodiment is not specifically limited.
  • the ultrasonic endoscope 100 exemplified in the present embodiment is a small-diameter endoscope that is assumed to be applied to perform diagnosis and treatment for a respiratory organ.
  • 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 a universal cord 112 having one end connected to a side portion of the operation portion 109.
  • a light source device 113 connected to the other end of the universal cord 112 via a branch cable 112a, an optical observation unit 114 connected to the other end of the universal cord 112 via a branch cable 112b, and a universal cord 112 And an ultrasonic observation unit 115 connected to the other end via a branch cable 112c.
  • the insertion portion 101 is provided with a hard portion 102, a bending portion 105, and a flexible tube portion 106 arranged in this order from the distal end side.
  • the hard part 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 controls an imaging optical system whose field of view is directed obliquely forward of the hard 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.
  • an image sensor such as a CCD or CMOS that detects an image of a subject incident through the imaging optical system
  • Various configurations such as a CPU to perform 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 ultrasonic scanning mechanism 104 of the present embodiment is used to acquire an ultrasonic image of a tissue that is a biopsy target, and to acquire an ultrasonic image of the needle tube 3 in the course of a biopsy procedure.
  • the bending portion 105 is formed in a cylindrical shape, and is pulled in a predetermined direction by pulling the angle wire (not shown) that is fixed to the distal end 105a (see FIG. 2) of the bending portion 105 and extends to the operation portion 109. It is an active bending part which curves to the side.
  • the bending portion 105 of this embodiment can be bent in two directions along the ultrasonic scanning direction.
  • an endoscope having a thin outer diameter that can be bent in two directions is used for respiratory treatment.
  • the outer diameter is used.
  • an endoscope that can be bent in four directions with a high degree of freedom of operation may be used.
  • the flexible tube portion 106 is a cylindrical member that is formed flexibly so that the rigid portion 102 can be guided to a desired position in the lumen tissue or the body cavity. Inside each of the bending portion 105 and the flexible tube portion 106, a channel 107 and a conduit (not shown) for performing air supply / water supply and suction are provided.
  • the channel 107 shown in FIGS. 1 and 2 is a cylindrical portion for inserting the puncture needle 1.
  • One end of the channel 107 is opened in the vicinity of the distal end portion of the hard portion 102, and the other 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 puncture needle 1 used together with the ultrasonic endoscope 100 can be fixed to the proximal end cap 108.
  • the inner diameter of the channel 107 of this embodiment is 2.0 mm or more and 2.2 mm or less. This is smaller than the channel in a digestive endoscope.
  • the channel 107 has an axis C1 of the insertion portion 101 in the hard portion 102 (in this embodiment, as an example, the axis C1 of the insertion portion 101 coincides with the axis C3 of the channel tube 107c. ) Sloped slope portion 107a, a bent angle tube 107b connected to the base end of the slope portion 107a, and a channel tube 107c connected to the base end of the angle tube 107b.
  • the slope portion 107a is provided in the hard portion 102 by forming a through hole in the hard portion 102 with a straight line inclined with respect to the axis C1 of the insertion portion 101 as a center line.
  • the center line C2 of the through hole formed in the slope portion 107a is at a position included in the scanning surface (substantially the same as the curved surface described above) of the ultrasonic scanning mechanism 104. For this reason, when the puncture needle 1 is inserted into the slope portion 107a, the slope portion 107a guides the needle tube 3 of the puncture needle 1 to the above-described scanning plane and tilts with respect to the transducer of the ultrasonic scanning mechanism 104. Thus, the needle tube 3 can be protruded.
  • the inclination angle of the center line C2 of the slope portion 107a with respect to the axis C1 of the insertion portion 101 may be set as appropriate corresponding to the site to be treated.
  • the center line C2 of the slope portion 107a has an angle (for example, 23 ° or more and 28 ° or less) at which the needle tube 3 protrudes in a direction that can be acquired as an ultrasonic image with respect to the axis C1 of the insertion portion 101. Is inclined.
  • the inclination angle of the center line C2 of the slope portion 107a with respect to the axis C1 of the insertion portion 101 is defined by the angle tube 107b.
  • the inclination angle of the center line C2 of the slope portion 107a with respect to the axis C1 of the insertion portion 101 is set to the distal end side of the angle tube 107b with respect to the center line C3 of the channel tube 107c on the proximal end side of the angle tube 107b.
  • the angle tube 107b is bent at a predetermined angle in order to change the direction of the tip of the puncture needle 1 guided from the channel tube 107c to the slope portion 107a in a direction along the center line C2 of the slope portion 107a. It is a tube-like bent part.
  • the angle tube 107b connects the slope portion 107a and the channel tube 107c.
  • the angle tube 107b has an arc shape bent with a constant curvature.
  • the channel tube 107 c is a tube opened toward the distal end side of the insertion portion 101 in the vicinity of the proximal end of the hard portion 102.
  • the opening on the distal end side of the channel tube 107c is fixed to the proximal end of the angle tube 107b.
  • the center line C3 of the channel tube 107c is substantially parallel to the center line C1 of the insertion portion 101.
  • the center line C3 of the channel tube 107c coincides with the center line C1 of the insertion portion 101 as shown in FIG.
  • the base end of the channel tube 107 c is fixed to the base end cap 108.
  • the operation unit 109 shown in FIG. 1 has an outer surface formed so that an operator who uses the ultrasonic endoscope 100 can hold it in his / her hand, and pulls the angle wire to cause the bending unit 105 to bend.
  • 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 an image captured by the image sensor of the optical imaging mechanism 103 on the monitor 116.
  • the ultrasonic observation unit 115 receives a signal output from the ultrasonic scanning mechanism 104, generates an image based on the signal, and displays the image on the monitor 116.
  • FIG. 3 is a partial cross-sectional view of the puncture needle 1.
  • FIG. 4 is a plan view showing the distal end portion of the needle tube of the puncture needle 1.
  • FIG. 5 is a front view showing the distal end portion of the needle tube of the puncture needle 1.
  • FIG. 6 is a side view showing the distal end portion of the needle tube of the puncture needle 1.
  • FIG. 7 is a bottom view showing the distal end portion of the needle tube of the puncture needle 1.
  • FIG. 8 is a cross-sectional view showing a proximal end portion of the operation portion of the puncture needle 1.
  • FIG. 9 is a cross-sectional view taken along line A1-A1 of FIG. 10 is a cross-sectional view taken along line B1-B1 of FIG.
  • FIG. 11 is a plan view of the operation unit of the puncture needle 1.
  • the puncture needle 1 includes an insert 2 that is inserted into the body, an operation unit (treatment instrument operation unit) 8 for operating the insert 2, and a stylet (core metal) 27. Prepare.
  • the insert 2 is a long member that can be attached to the channel 107 so as to protrude from the distal end of the insertion portion 101 of the ultrasonic endoscope 100.
  • the insert 2 includes a needle tube 3 and a cylindrical sheath 7 into which the needle tube 3 is inserted.
  • the needle tube 3 includes a metal cylinder part 31 having a distal end and a base end, and a base member 36 fixed to the base end of the metal cylinder part 31.
  • the needle tube 3 is advanced and retracted in the sheath 7 by the operation unit 8.
  • the distal end of the needle tube 3 can project and retract from the opening of the distal end portion of the sheath 7.
  • the outer diameter of the needle tube 3 is 60% or more of the inner diameter of the sheath 7.
  • the metal cylinder portion 31 is a cylindrical member that has flexibility and elasticity that can be easily restored to a linear state even when bent by an external force.
  • an alloy material such as a stainless alloy, a nickel titanium alloy, or a cobalt chromium alloy can be employed as the material of the metal cylinder portion 31.
  • the distal end surface 32 of the metal cylinder portion 31 is sharpened to puncture the tissue with the needle tube 3 and is opened to suck the tissue into the needle tube 3.
  • the tip surface 32 of the metal cylinder part 31 includes a first blade surface 33 and a second blade surface 34 inclined obliquely with respect to the center line X1 of the metal cylinder part 31 itself, And a piercing end 35 configured on an intersection line X3 defined by the second blade surface 34.
  • the first blade surface 33 is an annular surface that surrounds the opening at the tip of the metal cylinder portion 31 among the tip surfaces 32 of the metal cylinder portion 31.
  • the first blade surface 33 is a plane that is inclined with respect to the center line X ⁇ b> 1 of the metal cylinder portion 31.
  • the second blade surface 34 is a surface formed at the tip portion of the metal cylinder portion 31 by backcut processing to a position facing the first blade surface 33.
  • the second blade surface 34 has two planes intersecting each other with a straight line inclined with respect to the center line X1 of the needle tube 3 as an intersection line X2 (right side surface 34a, left side surface 34b, “right” and “left” are notated. It is for convenience.)
  • the inclination angle of the distal end surface 32 is set based on the inclination angle ⁇ 1 (see FIG. 2) of the center line C2 of the slope portion 107a with respect to the axis C3 of the channel tube 107c located on the proximal end side of the angle tube 107b. That is, the inclination angle of the distal end surface 32 is set based on the shape of the angle tube 107b.
  • the inclination angle of the distal end surface 32, the inclination angle ⁇ 2 of the first blade surface 33 with respect to the center line X1 of the needle tube 3 and the inclination angle of the second blade surface 34 with respect to the center line X1 of the needle tube 3 (right inclination angle ⁇ 3a, left inclination)
  • the right side surface 34a and the left side surface 34b are set on the basis of the inclination angle ⁇ 1, respectively, so that the intersection line X2 between the right side surface 34a and the left side surface 34b in the second blade surface 34 is obtained.
  • the inclination angle ⁇ 4 with respect to the center line X1 of the needle tube 3 is an angle based on the inclination angle ⁇ 1.
  • the above inclination angles ⁇ 2, ⁇ 3a, ⁇ 3b, and ⁇ 4 are all greater than the inclination angle ⁇ 1 of the center line C2 of the slope portion 107a with respect to the axis C3 of the channel tube 107c.
  • the inclination angle ⁇ 1 of the center line C2 of the slope portion 107a with respect to the axis C1 of the insertion portion 101 is 23 ° and the channel tube 107c extends parallel to the insertion portion 101, the slope portion 107a with respect to the axis C3 of the channel tube 107c.
  • the inclination angles ⁇ 2, ⁇ 3a, ⁇ 3b, and ⁇ 4 with respect to the center line X1 of the needle tube 3 need only be larger than 23 °.
  • the inclination angles ⁇ 2, ⁇ 3a, ⁇ 3b, and ⁇ 4 with respect to the center line X1 of the needle tube 3 are set to 25 °, for example. Can do.
  • the inclination angles ⁇ 2, ⁇ 3a, ⁇ 3b, and ⁇ 4 may be equal to each other, the inclination angles ⁇ 2, ⁇ 3a, ⁇ 3b, and ⁇ 4 do not have to be equal to each other.
  • the magnitudes of the inclination angles ⁇ 2, ⁇ 3a, ⁇ 3b, and ⁇ 4 take into consideration the puncture performance of the needle tube 3 to the tissue.
  • the distal end surface 32 is composed of a plurality of planes inclined with respect to the center line X ⁇ b> 1 of the needle tube 3, but the outer edge 32 a of the distal end surface 32 of the needle tube 3 and
  • the angle formed by the straight line connecting the insertion end 35 and the center line X1 of the needle tube 3 (for example, the inclination angles ⁇ 2, ⁇ 3a, ⁇ 3b, ⁇ 4) is any position on the outer edge 32a of the distal end surface 32.
  • the inclination angle ⁇ 1 of the distal end portion of the angle tube 107b with respect to the proximal end portion of the angle tube 107b is always in a state of being largely inclined.
  • the cap member 36 is a substantially cylindrical member in which a through hole communicating with the inside of the metal tube portion 31 of the needle tube 3 is formed.
  • a lock part 37 for fixing the syringe to the base member 36 is formed at the base end of the base member 36.
  • a flange portion 38 is formed on the outer peripheral surface of the base member 36 so as to extend outward from the outer peripheral surface of the base member 36 in the radial direction of the needle tube 3. The flange portion 38 is fixed to a needle slider 23 of the operation unit 8 described later.
  • the sheath 7 is made of resin, metal, or the like.
  • the sheath 7 of the present embodiment is a coil sheath formed by winding a metal wire in a coil shape.
  • the distal end of the sheath 7 is opened so that the needle tube 3 can protrude.
  • the proximal end of the sheath 7 is fixed to the distal end portion of the operation unit 8.
  • the outer diameter of the sheath 7 is 60% or more of the inner diameter of the channel 107.
  • 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. Is provided.
  • the operation body 9 is made of, for example, ABS resin and has a lumen through which the needle tube 3 and the sheath 7 can be inserted.
  • the distal end side of the operation body 9 is inserted into a sheath adjuster 18 formed in a tubular shape.
  • the proximal end side of the operation body 9 is inserted into a needle slider 23 formed in a tubular shape.
  • the operation main body 9 and the sheath adjuster 18, and the operation main body 9 and the needle slider 23 are engaged with each other by a groove or a projection (not shown) formed on the outer peripheral surface, so that relative rotation around the axis is suppressed, and the axial direction Is slidable.
  • a slide lock 51 that can be attached to and detached from the proximal end cap 108 of the ultrasonic endoscope 100 is provided.
  • the operation unit 8 can be fixed to the ultrasonic endoscope 100.
  • a holder (fixed portion) 52 having a pair of wall portions 52 a and 52 b is provided on the distal end side of the slide lock 51.
  • the holder 52 is fixed to the sheath adjuster 18.
  • the pair of wall portions 52a and 52b of the holder 52 are substantially parallel, and the distance is set to a value that allows the distal end side of the operation unit 109 of the ultrasonic endoscope 100 to be accommodated without rattling.
  • the distal end portion of the support pipe 53 is inserted into the channel 107 when the puncture needle 1 is attached to the ultrasonic endoscope 100.
  • the support pipe 53 is inserted into the operation body 9.
  • the base end of the support pipe 53 is located closer to the base end side (for example, position P1 shown in FIG. 15) than the tip end of the needle slider 23 in a state where the needle slider 23 is most advanced with respect to the operation main body 9.
  • the sheath 7 is inserted into the support pipe 53, and the base end portion protrudes from the base end of the support pipe 53 and is fixed to the operation body 9 by adhesion or the like.
  • the fixing screw 54 is attached to the sheath adjuster 18.
  • the fixing screw 54 passes through the sheath adjuster 18 and is fitted in a screw hole (not shown) provided in the operation main body 9.
  • the fixing screw 54 is tightened with respect to the operation main body 9, the sheath adjuster 18 is pressed against the operation main body 9, and the sheath adjuster 18 and the operation main body 9 can be fixed in a non-slidable manner.
  • the protruding length of the sheath 7 from the channel 107 when the operation unit 8 is fixed to the ultrasonic endoscope 100 can be adjusted.
  • the protrusion length can be fixed by the screw 54.
  • the axis of the fixing screw 54 is preferably arranged so as to be directed to the axis of the operation unit 109 housed in the holder 52.
  • the fixing screw 54 since the fixing screw 54 is not biased left and right when the operation unit 8 is positioned in the front, it can be easily operated regardless of the operator's dominant hand.
  • the axis of the fixing screw 54 is directed toward the axis of the operation unit 109 accommodated in the holder 52, substantially the same effect can be obtained even if the fixing screw 54 is attached to the opposite side of FIG.
  • the outer peripheral surface of the distal end portion of the sheath adjuster 18 is provided with irregularities so that the operator can easily grasp it.
  • the needle slider 23 is a cylindrical member having a holding portion 24 for holding the cap member 36 of the needle tube 3 in a fixed state.
  • the proximal end side of the needle tube 3 protrudes from the proximal end of the sheath 7 and extends to the inside of the needle slider 23.
  • the needle slider 23 is connected to the operation main body 9 so as to be movable with respect to the operation main body 9.
  • the outer peripheral surface of the distal end portion of the needle slider 23 is provided with irregularities so that the operator can easily grasp it.
  • the proximal end portion of the cap member 36 of the needle tube 3 protrudes outside the needle slider 23.
  • the stylet 27 can be inserted from the opening on the base end side of the base member 36.
  • the holding unit 24 restricts the rotation of the needle tube 3 relative to the needle slider 23 around the center line X1 of the needle tube 3 and restricts linear movement of the needle tube 3 relative to the needle slider 23 in the direction of the center line X1 of the needle tube 3.
  • the holding portion 24 has a pair of wall portions 25 (distal end wall portions 25a, 25a, 25a, 25b) spaced apart from the distal end side and the proximal end side of the flange portion 38 so as to sandwich the flange portion 38 of the base member 36.
  • a proximal end wall portion 25b) and a rotation stop portion 26 that is disposed between the distal end wall portion 25a and the proximal end wall portion 25b and engages with the outer peripheral portion of the flange portion 38.
  • a stopper 61 is movably attached to the operation main body 9 on the distal end side of the needle slider 23.
  • the stopper 61 has a fixing screw 62 and can be fixed to the operation body 9 by tightening the fixing screw 62.
  • the axis of the fixing screw 62 is preferably arranged so as to be directed to the axis of the operation unit 109 housed in the holder 52.
  • the fixing screw 62 may be directed in the same direction as the fixing screw 54 described above, or may be directed in directions opposite to each other.
  • the maximum protrusion length of the needle tube 3 from the sheath 7 is adjusted by adjusting the fixing position of the stopper 61 with respect to the operation main body 9. can do.
  • the operation stroke length (maximum movement amount) L ⁇ b> 2 of the needle tube 3 by the needle slider 23 is 5% or more of the total length of the sheath 7.
  • the operation stroke length L2 of the needle tube 3 by the needle slider 23 is preferably 40 mm or more, although it is also affected by the position of the treatment target site.
  • the state where the needle slider 23 is at the position where the needle slider 23 has moved to the limit on the proximal end side of the operation body 9 is the initial state before the use of the puncture needle 1 is started.
  • the tip of the needle tube 3 is in the sheath 7.
  • the movement amount of the needle slider 23 relative to the operation body 9 substantially corresponds to the movement amount of the tip of the needle tube 3 relative to the sheath 7. That is, when the needle slider 23 moves the needle tube 3 relative to the sheath 7, the movement amount (relative stroke length L1) of the needle tube 3 with respect to the sheath 7 is changed to the actual movement amount (operation stroke length L2) of the needle slider 23. ) Plus the expansion or contraction of the needle tube 3.
  • the expansion or contraction of the needle tube 3 includes the stretchability (elasticity) of the needle tube 3 itself, the stretchability (elasticity) of the sheath 7 itself, the magnitude of the frictional resistance between the needle tube 3 and the sheath 7, and the sheath 7 within the channel 107. It is influenced by the meandering state and the meandering state of the needle tube 3 in the sheath 7.
  • the distal end of the needle tube 3 protrudes from the distal end of the sheath 7.
  • the protruding length of the needle tube 3 when the needle slider 23 is at the position where the needle slider 23 has moved to the limit on the distal end side of the operation body 9 is shorter than the operation stroke length L2 of the needle slider 23, but may be at least 40 mm. preferable.
  • the stylet 27 shown in FIG. 3 is a wire-like member that has a knob that can be attached to the lock portion 37 of the base member 36 and has a cross-sectional shape corresponding to the inner shape of the needle tube 3.
  • FIG. 12 is a perspective view showing a state where the puncture needle 1 is attached to the ultrasonic endoscope 100.
  • 13 to 19 are diagrams for explaining the operation of the puncture needle 1.
  • a biopsy procedure in which a needle tube 3 of the puncture needle 1 is inserted using a lesion located in the deep part of the lung as a target tissue and the cells of the lesion are collected through the needle tube 3 will be described as an example.
  • the operator inserts the insertion portion 101 of the ultrasonic endoscope 100 shown in FIG. 1 into the body, observes with the optical imaging mechanism 103, and appropriately inserts the insertion portion 101 to the vicinity of the target tissue while curving the bending portion 105. Introduce the tip. After the introduction, the surgeon determines a site to perform a biopsy based on the observation results by the optical imaging mechanism 103 and the ultrasonic scanning mechanism 104.
  • the operator inserts the insertion body 2 of the puncture needle 1 into the channel 107 from the proximal end base 108 provided in the operation unit 109 of the ultrasonic endoscope 100 from the distal end side. Further, as shown in FIG. 12, the operator moves the distal end side of the operation unit 109 between the pair of wall portions 52 a and 52 b of the holder 52, and then slides provided on the operation unit 8 of the puncture needle 1. 51 is engaged with the base end cap 108. Thereby, the operation part 8 of the puncture needle 1 is fixed to the ultrasonic endoscope 100 so as not to rotate with respect to the operation part 109.
  • the sheath 7 In the process of inserting the insertion body 2 into the insertion portion 101, when the meandering is canceled after the meandering is accumulated in the region between the base end cap 108 and the angle tube 107b, the sheath 7 is moved against the needle tube 3. It will move to the tip side relatively. In the process of inserting the insert 2 into the channel 107, the meandering of the sheath 7 is repeatedly accumulated and eliminated, so how much meander is accumulated when the sheath 7 protrudes from the tip of the channel 107. It is not constant. Further, as one of the triggers for eliminating the meandering of the sheath 7, there is an advance / retreat movement of the needle tube 3 with respect to the sheath 7.
  • the insertion end 35 is difficult to touch the inner surface of the sheath 7, and the needle tube 3 with respect to the sheath 7 in the process of inserting the insert 2 into the channel 107 is used. With slight movement, the needle tube 3 is unlikely to pierce the sheath 7.
  • the operator loosens the fixing screw 54, and observes the sheath 7 and the body by the optical imaging mechanism 103 and the ultrasonic scanning mechanism 104 while relatively moving the sheath adjuster 18 and the operation body 9.
  • the amount of protrusion of the sheath 7 from the distal end of the insertion portion 101 of the ultrasonic endoscope 100 is adjusted to an appropriate amount.
  • the operator tightens the fixing screw 54 to fix the protrusion amount.
  • the stopper 61 is moved in consideration of the distance to the target tissue T to be biopsied and fixed to the operation main body 9 at a desired position, and the maximum of the needle tube 3 is obtained. Adjust the protrusion length.
  • the surgeon advances the needle slider 23 toward the distal end side of the operation unit 8.
  • the needle tube 3 moves in the sheath 7 toward the distal end side of the sheath 7 with respect to the sheath 7 (see the two-dot chain line portion in FIG. 3).
  • the outer peripheral surface in the vicinity of the insertion end 35 is in contact with the inner surface of the sheath 7, and the distal end portion of the needle tube 3. Receives a pressing force from the inner surface of the sheath 7.
  • the tip surface of the needle tube 3 is in contact with the inner surface of the sheath 7 regardless of the direction in which the needle tube 3 enters the angle tube 107 b in the sheath 7.
  • the outer surfaces of 32 it is an outer edge 32a portion.
  • the tip surface 32 of the needle tube 3 has an inclination angle ⁇ 2, ⁇ 3a, ⁇ 3b, ⁇ 4 with respect to the center line X1 of the needle tube 3, all are larger than an inclination angle ⁇ 1 of the center line C2 of the slope portion 107a with respect to the axis C3 of the channel tube 107c.
  • the needle tube 3 is inserted into the insertion end from the inner surface of the sheath 7 positioned along the inner surface of the angle tube 107b no matter where the needle tube 3 is rotated about the center line X1 of the needle tube 3. 35 is in a separated state.
  • the distal end portion of the needle tube 3 After the distal end portion of the needle tube 3 passes through the angle tube 107b without touching the inner surface of the sheath 7, the distal end portion of the needle tube 3 is advanced toward the distal end side along the slope of the slope portion 107a. Projecting from the opening of the channel 107 and projecting from the opening at the tip of the sheath 7 to the outside of the sheath 7.
  • the operator After the needle tube 3 protrudes from the opening at the distal end of the sheath 7 to the outside of the sheath 7, the operator further advances the needle slider 23 toward the distal end side of the operation portion 8, so that as shown in FIG.
  • the insertion end 35 is punctured into the tissue and pushed forward to the target tissue T for biopsy.
  • 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.
  • the surgeon 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, as shown in FIG. 19, the operator causes the tip of the needle tube 3 to reach the target tissue T to be biopsied.
  • the surgeon pushes out the tissue that has entered the needle tube 3 and is not subject to biopsy with the stylet 27 (see FIG. 1). Further, the operator 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.
  • the surgeon connects a syringe or the like to the base member 36 disposed at the proximal end of the needle slider 23 to suck the inside of the needle tube 3 and suck the cells of the target tissue T to be biopsied from the tip of the needle tube 3. Collect.
  • the needle slider 23 is retracted toward the proximal end side of the operation unit 8 and the distal end of the needle tube 3 is accommodated in the sheath 7.
  • the needle tube 3 comes out of the tissue.
  • the slide lock 51 is removed from the proximal end cap 108 of the operation unit 109 of the ultrasonic endoscope 100, and the puncture needle 1 is removed from the channel 107.
  • the ultrasonic endoscope 100 is removed from the patient, and the series of treatments is completed.
  • the state where the insertion end 35 of the needle tube 3 is separated from the inner surface of the sheath 7 within the angle tube 107b that is a bent portion of the channel 107 is maintained.
  • the insertion end 35 is retracted to a position where the insertion end 35 is most unlikely to penetrate the inner surface of the sheath 7.
  • the possibility that the insertion end 35 of the needle tube 3 touches and deforms the inner surface of the sheath 7 can be kept low, and the puncture performance of the needle tube 3 into the tissue is unlikely to deteriorate.
  • the insertion end 35 of the needle tube 3 is prevented from breaking through the sheath 7 and further damaging the inner surface of the channel 107.
  • FIG. 20 is a plan view of the distal end portion of the needle tube of the puncture needle for an endoscope according to the present embodiment.
  • FIG. 21 is a front view of the distal end portion of the needle tube.
  • FIG. 22 is a side view of the distal end portion of the needle tube.
  • FIG. 23 is a bottom view of the distal end portion of the needle tube.
  • FIGS. 24 to 27 are diagrams for explaining the operation of the puncture needle for an endoscope.
  • This embodiment is different from the first embodiment in that a Menghini needle 3A shown in FIGS. 20 to 23 is provided instead of the needle tube 3 described in the first embodiment.
  • the Menghini needle 3A of the present embodiment is inserted into the Menghini needle 3A from the outer edge 32aA of the Menghini needle 3A along a conical surface having a vertex Q at a position spaced from the center line X1A of the Menghini needle 3A.
  • the blade surface 33A is curved in a conical surface with a diameter that gradually decreases toward the entry end 35 side.
  • the inner peripheral portion of the distal end surface 32A of the Menghini needle 3A is a blade for cutting the tissue.
  • the blade surface 33A formed on the distal end surface 32A of the Menghini needle 3A is at an angle greater than the inclination angle ⁇ 1 of the center line C2 of the slope portion 107a with respect to the axis C3 of the channel tube 107c with respect to the center line X1A of the Menghini needle 3A. Intersect.
  • the conical surface that defines the blade surface 33A of the Menghini needle 3A has a center line X3 that is separated from the center line X1A of the Menghini needle 3A so as to be parallel to the center line X3.
  • the insertion end 35 of the Menghini needle 3A has a slope portion 107a from the channel tube 107c through the angle tube 107b regardless of the positional relationship in the sheath 7. In the process of moving to, it becomes a state separated from the inner surface of the sheath 7 as in the first embodiment. For this reason, the Menghini needle 3A of the present embodiment is also less likely to deform the insertion end 35 as in the first embodiment, and the puncture performance is unlikely to deteriorate. Also in this embodiment, the Menghini needle 3A is unlikely to pierce the sheath 7 and damage the channel 107 as in the first embodiment.
  • the needle tube of the puncture needle for an endoscope of the present invention includes a insertion end positioned at the distal end of the needle tube,
  • the angle formed by the straight line connecting the outer edge of the distal end surface of the needle tube and the insertion end and the center line of the needle tube is always the bending of the channel.
  • the sharp insertion end is prevented from touching the sheath by being defined as a state inclined more than the inclination angle of the distal end portion of the bent portion with respect to the proximal end portion of the portion (the angle tube 107b in the above embodiment).
  • the present invention is applied to a needle tube with a backcut described in the first embodiment and a needle tube having a needle tip shape other than the Menghini needle described in the second embodiment. Can do.

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Abstract

The endoscope puncture needle comprises a needle tube (3) that is capable of being inserted into a channel, and a needle slider (23) that supports the needle tube (3) and moves the needle tube in the direction of the center line of the needle tube. The needle tube (3) includes: a penetrating tip (35) that can be penetrated into a tissue and is located inward from the outer peripheral surface of the needle tube (3) when seen from the direction of the center line of the needle tube (3); and edge surfaces (33, 34) that extend from the penetrating tip to an outer edge of the distal surface of the needle tube (3) in a state in which the angle between a straight line connecting the outer edge and the penetrating tip (35) and the center line of the needle tube (3) is inclined more than the angle of inclination of a distal portion of an angle tube of the channel with respect to a base portion of the angle tube.

Description

内視鏡用穿刺針Endoscopic puncture needle
　本発明は、内視鏡用穿刺針に関する。
　本願は、２０１４年９月２６日に、日本に出願された特願２０１４－１９７１０６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 an endoscope puncture needle.
The present application claims priority based on Japanese Patent Application No. 2014-197106 filed in Japan on September 26, 2014, 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当該臓器の超音波断層像を取得し、超音波観察下で当該臓器に穿刺針を刺入して組織を採取することがある。 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. A tissue may be collected by inserting a puncture needle.
　たとえば特許文献１には、生検に利用可能な吸引穿刺針が開示されている。また、特許文献２には、生検用の穿刺針が骨等の組織に当接した際の刃先潰れを予防するために、刃先が穿刺針の内側に折れ曲がりにくくなるように、穿刺針の刃先の角度を最適化することが開示されている。 For example, Patent Document 1 discloses a suction puncture needle that can be used for biopsy. Further, in Patent Document 2, in order to prevent the tip of the blade from being crushed when the biopsy puncture needle comes into contact with a tissue such as a bone, the tip of the puncture needle is not easily bent inside the puncture needle. It is disclosed to optimize the angle.
日本国特開２００５－３１２８２８号公報Japanese Unexamined Patent Publication No. 2005-312828 日本国特開２００１－２９２９９９号公報Japanese Unexamined Patent Publication No. 2001-292999
　内視鏡用穿刺針を内視鏡のチャンネルに挿通すると、内視鏡用穿刺針はチャンネルの形状に倣って湾曲形状に変形される。内視鏡用穿刺針がチャンネルの形状に倣って湾曲形状に変形された状態で内視鏡用穿刺針がチャンネル内を先端側へ移動すると、内視鏡用穿刺針の刃先がめくれるように塑性変形する可能性がある。内視鏡用穿刺針の刃先がめくれるように塑性変形した場合、内視鏡用穿刺針の刃先が組織に穿刺される前に、刃先の穿刺性能が低下した状態となってしまう。また、内視鏡用穿刺針がチャンネルの形状に倣って湾曲形状に変形された状態では、チャンネルに内視鏡用穿刺針の刃先が刺さりやすく、内視鏡を損傷させる虞がある。 When the puncture needle for endoscope is inserted through the channel of the endoscope, the puncture needle for endoscope is deformed into a curved shape following the shape of the channel. When the puncture needle for endoscope is moved to the tip side in the channel while the puncture needle for endoscope is deformed into a curved shape following the shape of the channel, it is plastic so that the cutting edge of the puncture needle for endoscope is turned up There is a possibility of deformation. When plastic deformation is performed so that the cutting edge of the endoscope puncture needle is turned over, the puncture performance of the cutting edge is lowered before the cutting edge of the puncture needle for endoscope is punctured into the tissue. In addition, when the puncture needle for endoscope is deformed into a curved shape following the shape of the channel, the cutting edge of the puncture needle for endoscope is likely to be pierced into the channel, and the endoscope may be damaged.
　本発明は、上述した事情に鑑みてなされたものであって、内視鏡の損傷や穿刺性能の低下が起こりにくい内視鏡用穿刺針を提供することを目的とする。 The present invention has been made in view of the above-described circumstances, and an object thereof is to provide an endoscope puncture needle that is unlikely to cause damage to the endoscope or a decrease in puncture performance.
　本発明の第一の態様は、屈曲したチャンネルを有する内視鏡に取り付けて使用される内視鏡用穿刺針であって、前記チャンネルに挿通可能な針管と、前記針管を支持し前記針管の中心線方向に前記針管を移動させる針スライダと、を有し、前記針管は、前記針管の中心線方向から見たときに前記針管の外周面よりも内側に位置し組織に刺入可能な刺入端と、前記針管の先端面の外縁と前記刺入端とを繋ぐ直線と前記針管の中心線とのなす角が常に前記チャンネルの屈曲部の基端部分に対する前記屈曲部の先端部分の傾斜角度よりも大きく傾斜した状態で前記刺入端から前記外縁まで延びる刃面と、を有する内視鏡用穿刺針である。 A first aspect of the present invention is an endoscope puncture needle that is used by being attached to an endoscope having a bent channel, a needle tube that can be inserted into the channel, a needle tube that supports the needle tube, A needle slider that moves the needle tube in the direction of the center line, and the needle tube is located on the inner side of the outer peripheral surface of the needle tube when viewed from the center line direction of the needle tube and can be inserted into tissue. The angle formed by the straight line connecting the insertion end, the outer edge of the distal end surface of the needle tube, and the insertion end and the center line of the needle tube is always inclined with respect to the proximal end portion of the bending portion of the channel. A puncture needle for an endoscope having a blade surface extending from the insertion end to the outer edge in a state inclined more than an angle.
　本発明の第二の態様によれば、第一の態様において、前記刃面は、前記外縁から前記針管の前記刺入端側へ行くに従って径が漸次小さくなる円錐面状をなしていてもよい。 According to a second aspect of the present invention, in the first aspect, the blade surface may have a conical surface shape whose diameter gradually decreases from the outer edge toward the insertion end side of the needle tube. .
　本発明の第三の態様によれば、第一に態様において、前記刃面は、前記針管の中心線に対して傾斜する平面からなる第一刃面部と、前記針管の中心線方向から見たときに第一刃面部と略反対側に向けられ前記第一刃面部と交差する平面からなり前記第一刃面部との交線上に前記刺入端を有する第二刃面部と、を有していてもよい。 According to a third aspect of the present invention, in the first aspect, the blade surface is viewed from the first blade surface portion formed of a plane inclined with respect to the center line of the needle tube and the center line direction of the needle tube. A second blade surface portion having a piercing end on a line of intersection with the first blade surface portion, which is formed on a plane that faces the first blade surface portion and intersects the first blade surface portion. May be.
　本発明の第四の態様によれば、上記各態様の内視鏡用穿刺針は、前記針管が内部に挿通され、前記チャンネルの内径の６０％以上の大きさの外径を有する筒状のシースをさらに備えていてもよい。 According to the fourth aspect of the present invention, the puncture needle for an endoscope according to each of the aspects described above has a cylindrical shape in which the needle tube is inserted and has an outer diameter of 60% or more of the inner diameter of the channel. A sheath may be further provided.
　本発明の第五の態様によれば、第四の態様において、前記針管の外径は、前記シースの内径の６０%以上の大きさであってもよい。 According to a fifth aspect of the present invention, in the fourth aspect, the outer diameter of the needle tube may be 60% or more of the inner diameter of the sheath.
　本発明の第六の態様によれば、第四の態様において、前記シースは、素線が螺旋状に巻かれてコイル形状をなしていてもよい。 According to a sixth aspect of the present invention, in the fourth aspect, the sheath may be formed in a coil shape by winding a wire in a spiral shape.
　上記各態様によれば、内視鏡の損傷や穿刺性能の低下が起こりにくい内視鏡用穿刺針を提供することができる。 According to each aspect described above, it is possible to provide an puncture needle for an endoscope that is unlikely to cause damage to the endoscope or a decrease in puncture performance.
本発明の第１実施形態の内視鏡用穿刺針および超音波内視鏡を備えた本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 showing a schematic structure of a biopsy system of this embodiment provided with a puncture needle for endoscopes and an ultrasonic endoscope of a 1st embodiment of the present invention. 同生検システムの内視鏡である超音波内視鏡の先端部分の断面図である。It is sectional drawing of the front-end | tip part of the ultrasonic endoscope which is an endoscope of the biopsy system. 同内視鏡用穿刺針の部分断面図である。It is a fragmentary sectional view of the puncture needle for endoscopes. 同内視鏡用穿刺針の針管の先端部分を示す平面図である。It is a top view which shows the front-end | tip part of the needle tube of the puncture needle for endoscopes. 同内視鏡用穿刺針の針管の先端部分を示す正面図である。It is a front view which shows the front-end | tip part of the needle tube of the puncture needle for endoscopes. 同内視鏡用穿刺針の針管の先端部分を示す側面図である。It is a side view which shows the front-end | tip part of the needle tube of the puncture needle for endoscopes. 同内視鏡用穿刺針の針管の先端部分を示す底面図である。It is a bottom view which shows the front-end | tip part of the needle tube of the puncture needle for endoscopes. 同内視鏡用穿刺針の操作部の基端部分を示す断面図である。It is sectional drawing which shows the base end part of the operation part of the puncture needle for endoscopes. 図８のＡ１－Ａ１線における断面図である。FIG. 9 is a cross-sectional view taken along line A1-A1 of FIG. 図８のＢ１－Ｂ１線における断面図である。It is sectional drawing in the B1-B1 line | wire of FIG. 同内視鏡用穿刺針の操作部の平面図である。It is a top view of the operation part of the puncture needle for endoscopes. 同内視鏡用穿刺針が内視鏡に取り付けられた状態を示す斜視図である。It is a perspective view showing the state where the puncture needle for the endoscope was attached to the endoscope. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes. 本発明の第２実施形態の内視鏡用穿刺針の針管の先端部分の平面図である。It is a top view of the front-end | tip part of the needle tube of the puncture needle for endoscopes of 2nd Embodiment of this invention. 同針管の先端部分の正面図である。It is a front view of the front-end | tip part of the needle tube. 同針管の先端部分の側面図である。It is a side view of the front-end | tip part of the needle tube. 同針管の先端部分の底面図である。It is a bottom view of the tip part of the needle tube. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes. 同内視鏡用穿刺針の作用を説明するための図である。It is a figure for demonstrating an effect | action of the puncture needle for endoscopes.
（第１実施形態）
　本発明の第１実施形態について説明する。図１は、内視鏡用穿刺針および超音波内視鏡を備えた本実施形態の生検システムの概略構成を示す図である。図２は、生検システムの内視鏡である超音波内視鏡の先端部分の断面図である。
　図１に示す本実施形態の内視鏡用穿刺針１（以下、単に「穿刺針１」と称する。）は、生検システム１５０の一部として、超音波内視鏡１００と組み合わせて生検に使用される生検針である。 (First embodiment)
A first embodiment of the present invention will be described. FIG. 1 is a diagram showing a schematic configuration of a biopsy system of this embodiment provided with an endoscope puncture needle and an ultrasonic endoscope. FIG. 2 is a cross-sectional view of a distal end portion of an ultrasonic endoscope that is an endoscope of a biopsy system.
An endoscopic puncture needle 1 of the present embodiment shown in FIG. 1 (hereinafter simply referred to as “puncture needle 1”) is combined with an ultrasonic endoscope 100 as a part of a biopsy system 150 for biopsy. Is a biopsy needle used for
　まず、本実施形態の穿刺針１とともに使用される内視鏡の一例について説明する。なお、本実施形態の穿刺針１とともに使用可能な内視鏡の構成は特に限定されない。 First, an example of an endoscope used with the puncture needle 1 of this embodiment will be described. In addition, the structure of the endoscope which can be used with the puncture needle 1 of this embodiment is not specifically limited.
　本実施形態で例示する超音波内視鏡１００は、呼吸器に対する診断や治療を行うために適用されることが想定された細径の内視鏡である。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。 The ultrasonic endoscope 100 exemplified in the present embodiment is a small-diameter endoscope that is assumed to be applied to perform diagnosis and treatment for a respiratory organ. 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 a universal cord 112 having one end connected to a side portion of the operation portion 109. A light source device 113 connected to the other end of the universal cord 112 via a branch cable 112a, an optical observation unit 114 connected to the other end of the universal cord 112 via a branch cable 112b, and a universal cord 112 And an ultrasonic observation unit 115 connected to the other end via a branch cable 112c.
　挿入部１０１は、硬質部１０２、湾曲部１０５、および可撓管部１０６が先端側からこの順に並べて設けられている。 The insertion portion 101 is provided with a hard portion 102, a bending portion 105, and a flexible tube portion 106 arranged in this order from the distal end side.
　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 hard part 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、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 controls an imaging optical system whose field of view is directed obliquely forward of the hard 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 configurations (not shown) such as a CPU to perform are provided.
　超音波走査機構（プローブ）１０４は、超音波を出射し、受信する図示しない超音波振動子を備える。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。本実施形態の超音波走査機構１０４は、生検対象となる組織の超音波画像を取得し、また、生検の手技の過程で針管３の超音波画像を取得するために使用される。 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. The ultrasonic scanning mechanism 104 of the present embodiment is used to acquire an ultrasonic image of a tissue that is a biopsy target, and to acquire an ultrasonic image of the needle tube 3 in the course of a biopsy procedure.
　湾曲部１０５は、筒状に形成されており、湾曲部１０５の先端１０５ａ（図２参照）に固定され操作部１０９まで延びる図示しないアングルワイヤを操作部１０９において牽引操作することによって、所定の方向へ湾曲する能動湾曲部である。本実施形態の湾曲部１０５は、超音波の走査方向に沿って２方向に湾曲可能である。
　本実施形態では、例えば呼吸器の治療のために、挿入部の外径が細く２方向に湾曲可能な内視鏡を用いているが、例えば消化器の処置を行う場合等には、外径は太いが操作自由度の高い４方向に湾曲可能な内視鏡を用いてもよい。 The bending portion 105 is formed in a cylindrical shape, and is pulled in a predetermined direction by pulling the angle wire (not shown) that is fixed to the distal end 105a (see FIG. 2) of the bending portion 105 and extends to the operation portion 109. It is an active bending part which curves to the side. The bending portion 105 of this embodiment can be bent in two directions along the ultrasonic scanning direction.
In the present embodiment, for example, an endoscope having a thin outer diameter that can be bent in two directions is used for respiratory treatment. However, for example, when performing digestive organ treatment, the outer diameter is used. However, an endoscope that can be bent in four directions with a high degree of freedom of operation may be used.
　可撓管部１０６は、管腔組織内や体腔内において硬質部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。
　湾曲部１０５と可撓管部１０６とのそれぞれの内部には、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。 The flexible tube portion 106 is a cylindrical member that is formed flexibly so that the rigid portion 102 can be guided to a desired position in the lumen tissue or the body cavity.
Inside each of the bending portion 105 and the flexible tube portion 106, a channel 107 and a conduit (not shown) for performing air supply / water supply and suction are provided.
　図１及び図２に示すチャンネル１０７は、穿刺針１を挿通するための筒状部である。
　チャンネル１０７の一端は硬質部１０２の先端部近傍に開口され、チャンネル１０７の他端は操作部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穿刺針１を固定することができる。本実施形態のチャンネル１０７の内径は、２．０ｍｍ以上２．２ｍｍ以下である。これは、消化器用の内視鏡におけるチャンネルよりも小さい。 The channel 107 shown in FIGS. 1 and 2 is a cylindrical portion for inserting the puncture needle 1.
One end of the channel 107 is opened in the vicinity of the distal end portion of the hard portion 102, and the other 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 puncture needle 1 used together with the ultrasonic endoscope 100 can be fixed to the proximal end cap 108. The inner diameter of the channel 107 of this embodiment is 2.0 mm or more and 2.2 mm or less. This is smaller than the channel in a digestive endoscope.
　チャンネル１０７は、図２に示すように、硬質部１０２内において挿入部１０１の軸線Ｃ１（本実施形態では、一例として、挿入部１０１の軸線Ｃ１はチャンネルチューブ１０７ｃの軸線Ｃ３と一致している。）に対して傾斜したスロープ部１０７ａと、スロープ部１０７ａの基端に接続された屈曲形状をなすアングルチューブ１０７ｂと、アングルチューブ１０７ｂの基端に接続されたチャンネルチューブ１０７ｃとを有する。 As shown in FIG. 2, the channel 107 has an axis C1 of the insertion portion 101 in the hard portion 102 (in this embodiment, as an example, the axis C1 of the insertion portion 101 coincides with the axis C3 of the channel tube 107c. ) Sloped slope portion 107a, a bent angle tube 107b connected to the base end of the slope portion 107a, and a channel tube 107c connected to the base end of the angle tube 107b.
　スロープ部１０７ａは、挿入部１０１の軸線Ｃ１に対して傾斜する直線を中心線とする貫通孔が硬質部１０２に形成されていることによって硬質部１０２に設けられている。スロープ部１０７ａに形成された貫通孔の中心線Ｃ２は、超音波走査機構１０４の走査面（上述の湾曲面と略同一）に含まれる位置にある。このため、スロープ部１０７ａに穿刺針１が挿通されたときに、スロープ部１０７ａは、穿刺針１の針管３を上述の走査面へと案内し超音波走査機構１０４の振動子に対して傾斜して針管３を突出させることができる。 The slope portion 107a is provided in the hard portion 102 by forming a through hole in the hard portion 102 with a straight line inclined with respect to the axis C1 of the insertion portion 101 as a center line. The center line C2 of the through hole formed in the slope portion 107a is at a position included in the scanning surface (substantially the same as the curved surface described above) of the ultrasonic scanning mechanism 104. For this reason, when the puncture needle 1 is inserted into the slope portion 107a, the slope portion 107a guides the needle tube 3 of the puncture needle 1 to the above-described scanning plane and tilts with respect to the transducer of the ultrasonic scanning mechanism 104. Thus, the needle tube 3 can be protruded.
　挿入部１０１の軸線Ｃ１に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度は、処置対象となる部位等に対応して適宜設定されてよい。本実施形態では、スロープ部１０７ａの中心線Ｃ２は、挿入部１０１の軸線Ｃ１に対して、針管３が超音波画像として取得可能な向きに突出する角度（たとえば２３°以上２８°以下）をなして傾斜している。挿入部１０１の軸線Ｃ１に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度は、アングルチューブ１０７ｂによって規定される。すなわち、本実施形態では、挿入部１０１の軸線Ｃ１に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度は、アングルチューブ１０７ｂの基端側にあるチャンネルチューブ１０７ｃの中心線Ｃ３に対するアングルチューブ１０７ｂの先端側にあるスロープ部１０７ａの中心線Ｃ２の傾斜角度θ１である。 The inclination angle of the center line C2 of the slope portion 107a with respect to the axis C1 of the insertion portion 101 may be set as appropriate corresponding to the site to be treated. In the present embodiment, the center line C2 of the slope portion 107a has an angle (for example, 23 ° or more and 28 ° or less) at which the needle tube 3 protrudes in a direction that can be acquired as an ultrasonic image with respect to the axis C1 of the insertion portion 101. Is inclined. The inclination angle of the center line C2 of the slope portion 107a with respect to the axis C1 of the insertion portion 101 is defined by the angle tube 107b. That is, in this embodiment, the inclination angle of the center line C2 of the slope portion 107a with respect to the axis C1 of the insertion portion 101 is set to the distal end side of the angle tube 107b with respect to the center line C3 of the channel tube 107c on the proximal end side of the angle tube 107b. The inclination angle θ1 of the center line C2 of a certain slope portion 107a.
　アングルチューブ１０７ｂは、チャンネルチューブ１０７ｃからスロープ部１０７ａへと案内される穿刺針１の先端の向きをスロープ部１０７ａの中心線Ｃ２に沿う方向へと変化させるために所定の角度を有して屈曲したチューブ状の屈曲部である。アングルチューブ１０７ｂは、スロープ部１０７ａとチャンネルチューブ１０７ｃとを繋ぐ。本実施形態では、アングルチューブ１０７ｂは、一定の曲率で曲げられた弧状である。 The angle tube 107b is bent at a predetermined angle in order to change the direction of the tip of the puncture needle 1 guided from the channel tube 107c to the slope portion 107a in a direction along the center line C2 of the slope portion 107a. It is a tube-like bent part. The angle tube 107b connects the slope portion 107a and the channel tube 107c. In the present embodiment, the angle tube 107b has an arc shape bent with a constant curvature.
　チャンネルチューブ１０７ｃは、硬質部１０２の基端近傍において挿入部１０１の先端側に向けて開口されたチューブである。チャンネルチューブ１０７ｃの先端側の開口はアングルチューブ１０７ｂの基端に固定されている。
　チャンネルチューブ１０７ｃの中心線Ｃ３は、挿入部１０１の中心線Ｃ１と略平行である。一例として、本実施形態では、チャンネルチューブ１０７ｃの中心線Ｃ３は、図２に示すように、挿入部１０１の中心線Ｃ１と一致している。チャンネルチューブ１０７ｃの基端は、基端口金１０８に固定されている。 The channel tube 107 c is a tube opened toward the distal end side of the insertion portion 101 in the vicinity of the proximal end of the hard portion 102. The opening on the distal end side of the channel tube 107c is fixed to the proximal end of the angle tube 107b.
The center line C3 of the channel tube 107c is substantially parallel to the center line C1 of the insertion portion 101. As an example, in the present embodiment, the center line C3 of the channel tube 107c coincides with the center line C1 of the insertion portion 101 as shown in FIG. The base end of the channel tube 107 c is fixed to the base end cap 108.
　図１に示す操作部１０９は、超音波内視鏡１００を使用する術者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 shown in FIG. 1 has an outer surface formed so that an operator who uses the ultrasonic endoscope 100 can hold it in his / her hand, and pulls the angle wire to cause the bending unit 105 to bend. A bending operation mechanism 110 and a plurality of switches 111 for supplying air, supplying water, or sucking through a pipeline.
　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 an 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に映し出すようになっている。 The ultrasonic observation unit 115 receives a signal output from the ultrasonic scanning mechanism 104, generates an image based on the signal, and displays the image on the monitor 116.
　次に、穿刺針１の構成について説明する。図３は、穿刺針１の部分断面図である。図４は、穿刺針１の針管の先端部分を示す平面図である。図５は、穿刺針１の針管の先端部分を示す正面図である。図６は、穿刺針１の針管の先端部分を示す側面図である。図７は、穿刺針１の針管の先端部分を示す底面図である。図８は、穿刺針１の操作部の基端部分を示す断面図である。図９は、図８のＡ１－Ａ１線における断面図である。図１０は、図８のＢ１－Ｂ１線における断面図である。図１１は、穿刺針１の操作部の平面図である。 Next, the configuration of the puncture needle 1 will be described. FIG. 3 is a partial cross-sectional view of the puncture needle 1. FIG. 4 is a plan view showing the distal end portion of the needle tube of the puncture needle 1. FIG. 5 is a front view showing the distal end portion of the needle tube of the puncture needle 1. FIG. 6 is a side view showing the distal end portion of the needle tube of the puncture needle 1. FIG. 7 is a bottom view showing the distal end portion of the needle tube of the puncture needle 1. FIG. 8 is a cross-sectional view showing a proximal end portion of the operation portion of the puncture needle 1. FIG. 9 is a cross-sectional view taken along line A1-A1 of FIG. 10 is a cross-sectional view taken along line B1-B1 of FIG. FIG. 11 is a plan view of the operation unit of the puncture needle 1.
　図３に示すように、穿刺針１は、体内に挿入される挿入体２と、挿入体２を操作するための操作部（処置具操作部）８と、スタイレット（芯金）２７とを備える。 As shown in FIG. 3, the puncture needle 1 includes an insert 2 that is inserted into the body, an operation unit (treatment instrument operation unit) 8 for operating the insert 2, and a stylet (core metal) 27. Prepare.
　挿入体２は、超音波内視鏡１００の挿入部１０１の先端から突出可能にチャンネル１０７に取り付け可能な長尺部材である。挿入体２は、針管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。 The insert 2 is a long member that can be attached to the channel 107 so as to protrude from the distal end of the insertion portion 101 of the ultrasonic endoscope 100. The insert 2 includes a needle tube 3 and a cylindrical sheath 7 into which the needle tube 3 is inserted.
　図３から図７までに示すように、針管３は、先端と基端とを有する金属筒部３１と、金属筒部３１の基端に固定された口金部材３６とを有する。針管３は、操作部８によりシース７内で進退操作される。針管３の先端は、シース７の先端部分の開口から突没可能である。針管３の外径は、シース７の内径の６０%以上の大きさである。 3 to 7, the needle tube 3 includes a metal cylinder part 31 having a distal end and a base end, and a base member 36 fixed to the base end of the metal cylinder part 31. The needle tube 3 is advanced and retracted in the sheath 7 by the operation unit 8. The distal end of the needle tube 3 can project and retract from the opening of the distal end portion of the sheath 7. The outer diameter of the needle tube 3 is 60% or more of the inner diameter of the sheath 7.
　金属筒部３１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筒状部材である。たとえば、金属筒部３１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。 The metal cylinder portion 31 is a cylindrical member that has flexibility and elasticity that can be easily restored to a linear state even when bent by an external force. For example, an alloy material such as a stainless alloy, a nickel titanium alloy, or a cobalt chromium alloy can be employed as the material of the metal cylinder portion 31.
　金属筒部３１の先端面３２は、組織に針管３を穿刺するために鋭利とされているとともに、針管３の内部に組織を吸引するために開口されている。
　本実施形態では、金属筒部３１の先端面３２は、金属筒部３１自身の中心線Ｘ１に対して斜めに傾斜した第一刃面３３及び第二刃面３４と、第一刃面３３及び第二刃面３４によって規定される交線Ｘ３上に構成された刺入端３５とを有する。 The distal end surface 32 of the metal cylinder portion 31 is sharpened to puncture the tissue with the needle tube 3 and is opened to suck the tissue into the needle tube 3.
In the present embodiment, the tip surface 32 of the metal cylinder part 31 includes a first blade surface 33 and a second blade surface 34 inclined obliquely with respect to the center line X1 of the metal cylinder part 31 itself, And a piercing end 35 configured on an intersection line X3 defined by the second blade surface 34.
　図４及び図５に示すように、第一刃面３３は、金属筒部３１の先端面３２のうち、金属筒部３１の先端の開口を囲む環状の面である。本実施形態では、第一刃面３３は、金属筒部３１の中心線Ｘ１に対して傾斜した平面である。 As shown in FIGS. 4 and 5, the first blade surface 33 is an annular surface that surrounds the opening at the tip of the metal cylinder portion 31 among the tip surfaces 32 of the metal cylinder portion 31. In the present embodiment, the first blade surface 33 is a plane that is inclined with respect to the center line X <b> 1 of the metal cylinder portion 31.
　図５，図６，及び図７に示すように、第二刃面３４は、第一刃面３３に対向する位置へのバックカット加工によって金属筒部３１の先端部分に形成された面である。第二刃面３４は、針管３の中心線Ｘ１に対して傾斜する直線を交線Ｘ２として互いに交差する２平面（右側面３４ａ、左側面３４ｂ，なお、“右”及び“左”の表記は便宜上のものである。）からなる。 As shown in FIGS. 5, 6, and 7, the second blade surface 34 is a surface formed at the tip portion of the metal cylinder portion 31 by backcut processing to a position facing the first blade surface 33. . The second blade surface 34 has two planes intersecting each other with a straight line inclined with respect to the center line X1 of the needle tube 3 as an intersection line X2 (right side surface 34a, left side surface 34b, “right” and “left” are notated. It is for convenience.)
　先端面３２の傾斜角度は、アングルチューブ１０７ｂの基端側に位置するチャンネルチューブ１０７ｃの軸線Ｃ３に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度θ１（図２参照）に基づいて設定される。すなわち、先端面３２の傾斜角度は、アングルチューブ１０７ｂの形状に基づいて設定される。
　先端面３２の傾斜角度としては、針管３の中心線Ｘ１に対する第一刃面３３の傾斜角度θ２と、針管３の中心線Ｘ１に対する第二刃面３４の傾斜角度（右側傾斜角度θ３ａ、左側傾斜角度θ３ｂ，なお、“右”及び“左”の表記は便宜上のものである。）とがある。
　なお、本実施形態では、右側面３４ａと左側面３４ｂとがそれぞれ上記の傾斜角度θ１に基づいて設定されていることにより、第二刃面３４における右側面３４ａと左側面３４ｂとの交線Ｘ２についても、針管３の中心線Ｘ１に対する傾斜角度θ４が、上記の傾斜角度θ１に基づいた角度になっている。 The inclination angle of the distal end surface 32 is set based on the inclination angle θ1 (see FIG. 2) of the center line C2 of the slope portion 107a with respect to the axis C3 of the channel tube 107c located on the proximal end side of the angle tube 107b. That is, the inclination angle of the distal end surface 32 is set based on the shape of the angle tube 107b.
As the inclination angle of the distal end surface 32, the inclination angle θ2 of the first blade surface 33 with respect to the center line X1 of the needle tube 3 and the inclination angle of the second blade surface 34 with respect to the center line X1 of the needle tube 3 (right inclination angle θ3a, left inclination) There is an angle θ3b, where “right” and “left” are for convenience.
In the present embodiment, the right side surface 34a and the left side surface 34b are set on the basis of the inclination angle θ1, respectively, so that the intersection line X2 between the right side surface 34a and the left side surface 34b in the second blade surface 34 is obtained. Also, the inclination angle θ4 with respect to the center line X1 of the needle tube 3 is an angle based on the inclination angle θ1.
　上記の傾斜角度θ２，θ３ａ，θ３ｂ，θ４は、いずれも、チャンネルチューブ１０７ｃの軸線Ｃ３に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度θ１よりも大きい。たとえば挿入部１０１の軸線Ｃ１に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度θ１が２３°であってチャンネルチューブ１０７ｃが挿入部１０１と平行に延びている場合、チャンネルチューブ１０７ｃの軸線Ｃ３に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度θ１は２３°であるから、このとき、針管３の中心線Ｘ１に対する上記の傾斜角度θ２，θ３ａ，θ３ｂ，θ４は２３°より大きければよい。チャンネルチューブ１０７ｃの軸線Ｃ３に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度θ１が２３°であるとき、針管３の中心線Ｘ１に対する上記の傾斜角度θ２，θ３ａ，θ３ｂ，θ４はたとえば２５°とすることができる。上記の傾斜角度θ２，θ３ａ，θ３ｂ，θ４は互いに等しい大きさでもよいが、上記の傾斜角度θ２，θ３ａ，θ３ｂ，θ４は互いに等しい大きさである必要はない。上記の傾斜角度θ２，θ３ａ，θ３ｂ，θ４の大きさは、組織への針管３の穿刺性能が考慮される。 The above inclination angles θ2, θ3a, θ3b, and θ4 are all greater than the inclination angle θ1 of the center line C2 of the slope portion 107a with respect to the axis C3 of the channel tube 107c. For example, when the inclination angle θ1 of the center line C2 of the slope portion 107a with respect to the axis C1 of the insertion portion 101 is 23 ° and the channel tube 107c extends parallel to the insertion portion 101, the slope portion 107a with respect to the axis C3 of the channel tube 107c. Since the inclination angle θ1 of the center line C2 is 23 °, the inclination angles θ2, θ3a, θ3b, and θ4 with respect to the center line X1 of the needle tube 3 need only be larger than 23 °. When the inclination angle θ1 of the center line C2 of the slope portion 107a with respect to the axis C3 of the channel tube 107c is 23 °, the inclination angles θ2, θ3a, θ3b, and θ4 with respect to the center line X1 of the needle tube 3 are set to 25 °, for example. Can do. Although the inclination angles θ2, θ3a, θ3b, and θ4 may be equal to each other, the inclination angles θ2, θ3a, θ3b, and θ4 do not have to be equal to each other. The magnitudes of the inclination angles θ2, θ3a, θ3b, and θ4 take into consideration the puncture performance of the needle tube 3 to the tissue.
　図４から図７までに示すように、本実施形態において先端面３２は針管３の中心線Ｘ１に対して傾斜する複数の平面から構成されているが、針管３の先端面３２の外縁３２ａと刺入端３５とを繋ぐ直線と針管３の中心線Ｘ１とのなす角（たとえば上記の傾斜角度θ２，θ３ａ，θ３ｂ，θ４）は、先端面３２の外縁３２ａ上のどの位置に対しても、アングルチューブ１０７ｂの基端部分に対するアングルチューブ１０７ｂの先端部分の傾斜角度θ１よりも常に大きく傾斜した状態となっている。 As shown in FIGS. 4 to 7, in the present embodiment, the distal end surface 32 is composed of a plurality of planes inclined with respect to the center line X <b> 1 of the needle tube 3, but the outer edge 32 a of the distal end surface 32 of the needle tube 3 and The angle formed by the straight line connecting the insertion end 35 and the center line X1 of the needle tube 3 (for example, the inclination angles θ2, θ3a, θ3b, θ4) is any position on the outer edge 32a of the distal end surface 32. The inclination angle θ1 of the distal end portion of the angle tube 107b with respect to the proximal end portion of the angle tube 107b is always in a state of being largely inclined.
　図８から図１０までに示すように、口金部材３６は、針管３の金属筒部３１の内部と連通する貫通孔が形成された略筒状の部材である。口金部材３６の基端には、口金部材３６にシリンジを固定するためのロック部３７が形成されている。口金部材３６の外周面には、針管３の径方向に口金部材３６の外周面から外側へ向かって広がるフランジ部３８が形成されている。フランジ部３８は、後述する操作部８の針スライダ２３に固定される。 As shown in FIG. 8 to FIG. 10, the cap member 36 is a substantially cylindrical member in which a through hole communicating with the inside of the metal tube portion 31 of the needle tube 3 is formed. A lock part 37 for fixing the syringe to the base member 36 is formed at the base end of the base member 36. A flange portion 38 is formed on the outer peripheral surface of the base member 36 so as to extend outward from the outer peripheral surface of the base member 36 in the radial direction of the needle tube 3. The flange portion 38 is fixed to a needle slider 23 of the operation unit 8 described later.
　図３に示すシース７は、針管３が内部に挿入された筒状部材である。シース７は、樹脂や金属等から構成されている。本実施形態のシース７は、金属線材がコイル状に巻かれて形成されるコイルシースである。シース７の先端は、針管３が突出することができるように開口されている。シース７の基端は、操作部８の先端部分に固定されている。シース７の外径は、チャンネル１０７の内径の６０％以上の大きさとされている。 3 is a cylindrical member in which the needle tube 3 is inserted. The sheath 7 is made of resin, metal, or the like. The sheath 7 of the present embodiment is a coil sheath formed by winding a metal wire in a coil shape. The distal end of the sheath 7 is opened so that the needle tube 3 can protrude. The proximal end of the sheath 7 is fixed to the distal end portion of the operation unit 8. The outer diameter of the sheath 7 is 60% or more of the inner diameter of the channel 107.
　図３及び図１１に示すように、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。 As shown in FIGS. 3 and 11, 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. Is provided.
　操作本体９は、例えばＡＢＳ樹脂等で形成されており、針管３およびシース７が挿通可能な管腔を有する。操作本体９の先端側は、管状に形成されたシースアジャスター１８に挿入されている。操作本体９の基端側は、管状に形成された針スライダ２３に挿入されている。操作本体９とシースアジャスター１８、および操作本体９と針スライダ２３は、外周面に形成された図示しない溝あるいは凸部等が互いに係合することにより、軸線まわりの相対回転が抑制されつつ軸線方向に摺動可能である。 The operation body 9 is made of, for example, ABS resin and has a lumen through which the needle tube 3 and the sheath 7 can be inserted. The distal end side of the operation body 9 is inserted into a sheath adjuster 18 formed in a tubular shape. The proximal end side of the operation body 9 is inserted into a needle slider 23 formed in a tubular shape. The operation main body 9 and the sheath adjuster 18, and the operation main body 9 and the needle slider 23 are engaged with each other by a groove or a projection (not shown) formed on the outer peripheral surface, so that relative rotation around the axis is suppressed, and the axial direction Is slidable.
　シースアジャスター１８の先端部には、超音波内視鏡１００の基端口金１０８に着脱可能なスライドロック５１が設けられている。スライドロック５１を操作部８の軸線に直交する方向にスライドして基端口金１０８と係合させることで、操作部８を超音波内視鏡１００に固定することができる。スライドロック５１の先端側には、一対の壁部５２ａ、５２ｂを有するホルダ（固定部）５２が設けられている。ホルダ５２は、シースアジャスター１８に対して固定されている。ホルダ５２の一対の壁部５２ａ、５２ｂは、略平行であり、その距離は、超音波内視鏡１００の操作部１０９の先端側がガタつかずに収まる程度の値に設定されている。 At the distal end of the sheath adjuster 18, a slide lock 51 that can be attached to and detached from the proximal end cap 108 of the ultrasonic endoscope 100 is provided. By sliding the slide lock 51 in a direction perpendicular to the axis of the operation unit 8 and engaging the base end base 108, the operation unit 8 can be fixed to the ultrasonic endoscope 100. A holder (fixed portion) 52 having a pair of wall portions 52 a and 52 b is provided on the distal end side of the slide lock 51. The holder 52 is fixed to the sheath adjuster 18. The pair of wall portions 52a and 52b of the holder 52 are substantially parallel, and the distance is set to a value that allows the distal end side of the operation unit 109 of the ultrasonic endoscope 100 to be accommodated without rattling.
　シースアジャスター１８の先端部からは、例えばステンレス製の支持パイプ５３が突出している。支持パイプ５３の先端部は、穿刺針１を超音波内視鏡１００に取り付ける際に、チャンネル１０７内に挿入される。支持パイプ５３は操作本体９内に挿入されている。支持パイプ５３の基端は、針スライダ２３が操作本体９に対して最も前進された状態において、針スライダ２３の先端よりも基端側（例えば図１５に示す位置Ｐ１）に位置している。シース７は支持パイプ５３内に挿通されており、基端部が支持パイプ５３の基端から突出して接着等により操作本体９に固定されている。 A support pipe 53 made of, for example, stainless steel protrudes from the tip of the sheath adjuster 18. The distal end portion of the support pipe 53 is inserted into the channel 107 when the puncture needle 1 is attached to the ultrasonic endoscope 100. The support pipe 53 is inserted into the operation body 9. The base end of the support pipe 53 is located closer to the base end side (for example, position P1 shown in FIG. 15) than the tip end of the needle slider 23 in a state where the needle slider 23 is most advanced with respect to the operation main body 9. The sheath 7 is inserted into the support pipe 53, and the base end portion protrudes from the base end of the support pipe 53 and is fixed to the operation body 9 by adhesion or the like.
　シースアジャスター１８には、固定ネジ５４が取り付けられている。固定ネジ５４は、シースアジャスター１８を貫通して操作本体９に設けられた図示しないネジ穴に嵌合している。固定ネジ５４を操作本体９に対して締め込むと、シースアジャスター１８が操作本体９に押し当てられてシースアジャスター１８と操作本体９とを摺動不能に固定することができる。シースアジャスター１８と操作本体９との位置関係を変化させることで、操作部８を超音波内視鏡１００に固定した際の、チャンネル１０７からのシース７の突出長を調節することができ、固定ネジ５４により当該突出長を固定することができる。 The fixing screw 54 is attached to the sheath adjuster 18. The fixing screw 54 passes through the sheath adjuster 18 and is fitted in a screw hole (not shown) provided in the operation main body 9. When the fixing screw 54 is tightened with respect to the operation main body 9, the sheath adjuster 18 is pressed against the operation main body 9, and the sheath adjuster 18 and the operation main body 9 can be fixed in a non-slidable manner. By changing the positional relationship between the sheath adjuster 18 and the operation main body 9, the protruding length of the sheath 7 from the channel 107 when the operation unit 8 is fixed to the ultrasonic endoscope 100 can be adjusted. The protrusion length can be fixed by the screw 54.
　図１に示すように、固定ネジ５４の軸線は、ホルダ５２に収まった操作部１０９の軸線に向かうように配置されるのが好ましい。これにより、操作部８を正面に位置させたときに固定ネジ５４が左右に偏らないため、術者の利き手によらず容易に操作することができる。固定ネジ５４の軸線がホルダ５２に収まった操作部１０９の軸線に向かっていれば、固定ネジ５４が図１と反対側に向いて取り付けられていても、概ね同様の効果を得ることができる。 As shown in FIG. 1, the axis of the fixing screw 54 is preferably arranged so as to be directed to the axis of the operation unit 109 housed in the holder 52. Thereby, since the fixing screw 54 is not biased left and right when the operation unit 8 is positioned in the front, it can be easily operated regardless of the operator's dominant hand. As long as the axis of the fixing screw 54 is directed toward the axis of the operation unit 109 accommodated in the holder 52, substantially the same effect can be obtained even if the fixing screw 54 is attached to the opposite side of FIG.
　シースアジャスター１８の先端部の外周面には、術者が把持しやすいように凹凸が設けられている。 The outer peripheral surface of the distal end portion of the sheath adjuster 18 is provided with irregularities so that the operator can easily grasp it.
　図８に示すように、針スライダ２３は、針管３の口金部材３６を固定状態で保持する保持部２４を内部に有する筒状部材である。針管３の基端側は、シース７の基端から突出して針スライダ２３の内部まで延びている。針スライダ２３は、操作本体９に対して移動可能となるように操作本体９に連結されている。
　針スライダ２３の先端部の外周面には、術者が把持しやすいように凹凸が設けられている。
　針スライダ２３の基端部では、針管３の口金部材３６の基端部分が針スライダ２３の外部に突出している。口金部材３６の基端側の開口からは、スタイレット２７を挿入することができる。 As shown in FIG. 8, the needle slider 23 is a cylindrical member having a holding portion 24 for holding the cap member 36 of the needle tube 3 in a fixed state. The proximal end side of the needle tube 3 protrudes from the proximal end of the sheath 7 and extends to the inside of the needle slider 23. The needle slider 23 is connected to the operation main body 9 so as to be movable with respect to the operation main body 9.
The outer peripheral surface of the distal end portion of the needle slider 23 is provided with irregularities so that the operator can easily grasp it.
At the proximal end portion of the needle slider 23, the proximal end portion of the cap member 36 of the needle tube 3 protrudes outside the needle slider 23. The stylet 27 can be inserted from the opening on the base end side of the base member 36.
　保持部２４は、針管３の中心線Ｘ１を回転中心とした針スライダ２３に対する針管３の回転を規制し、且つ、針管３の中心線Ｘ１方向への針スライダ２３に対する針管３の直線移動を規制する。本実施形態では、保持部２４は、口金部材３６のフランジ部３８を挟むようにフランジ部３８の先端側と基端側とに離間して配された一対の壁部２５（先端壁部２５ａ，基端壁部２５ｂ）と、先端壁部２５ａと基端壁部２５ｂとの間に配されフランジ部３８の外周部分と係合する回転止め部２６とを有している。 The holding unit 24 restricts the rotation of the needle tube 3 relative to the needle slider 23 around the center line X1 of the needle tube 3 and restricts linear movement of the needle tube 3 relative to the needle slider 23 in the direction of the center line X1 of the needle tube 3. To do. In the present embodiment, the holding portion 24 has a pair of wall portions 25 (distal end wall portions 25a, 25a, 25a, 25b) spaced apart from the distal end side and the proximal end side of the flange portion 38 so as to sandwich the flange portion 38 of the base member 36. A proximal end wall portion 25b) and a rotation stop portion 26 that is disposed between the distal end wall portion 25a and the proximal end wall portion 25b and engages with the outer peripheral portion of the flange portion 38.
　図３及び図１１に示すように、針スライダ２３の先端側において、ストッパ６１が操作本体９に対して移動可能に取り付けられている。ストッパ６１は固定ネジ６２を有し、固定ネジ６２を締め込むことで、操作本体９に対して固定することができる。図１に示すように、固定ネジ６２の軸線は、ホルダ５２に収まった操作部１０９の軸線に向かうように配置されるのが好ましい。これにより、操作部８を正面に位置させたときに固定ネジ６２が左右に偏らないため、術者の利き手によらず容易に操作することができる。固定ネジ６２の軸線がホルダ５２に収まった操作部１０９の軸線に向かっていれば、固定ネジ６２が図１と反対側に向いて取り付けられていても、概ね同様の効果を得ることができる。 As shown in FIGS. 3 and 11, a stopper 61 is movably attached to the operation main body 9 on the distal end side of the needle slider 23. The stopper 61 has a fixing screw 62 and can be fixed to the operation body 9 by tightening the fixing screw 62. As shown in FIG. 1, the axis of the fixing screw 62 is preferably arranged so as to be directed to the axis of the operation unit 109 housed in the holder 52. Thereby, since the fixing screw 62 is not biased left and right when the operation unit 8 is positioned in front, it can be easily operated regardless of the operator's dominant hand. As long as the axis of the fixing screw 62 is directed toward the axis of the operation unit 109 that is accommodated in the holder 52, substantially the same effect can be obtained even if the fixing screw 62 is attached facing the opposite side to FIG.
　固定ネジ６２は、上述の固定ネジ５４と同じ方向に向けられていてもよいし、互いに逆方向に向けられていてもよい。 The fixing screw 62 may be directed in the same direction as the fixing screw 54 described above, or may be directed in directions opposite to each other.
　針スライダ２３は、ストッパ６１と接触する位置までしか操作本体９に対して前進できないので、操作本体９に対するストッパ６１の固定位置を調節することで、針管３のシース７からの最大突出長を調節することができる。本実施形態では、図３に示すように、針スライダ２３による針管３の操作ストローク長（最大移動量）Ｌ２は、シース７の全長の５％以上の長さである。処置対象部位の位置にも影響されるが、本実施形態では、針スライダ２３による針管３の操作ストローク長Ｌ２は、４０ｍｍ以上であることが好ましい。 Since the needle slider 23 can only move forward with respect to the operation main body 9 until it comes into contact with the stopper 61, the maximum protrusion length of the needle tube 3 from the sheath 7 is adjusted by adjusting the fixing position of the stopper 61 with respect to the operation main body 9. can do. In the present embodiment, as shown in FIG. 3, the operation stroke length (maximum movement amount) L <b> 2 of the needle tube 3 by the needle slider 23 is 5% or more of the total length of the sheath 7. In this embodiment, the operation stroke length L2 of the needle tube 3 by the needle slider 23 is preferably 40 mm or more, although it is also affected by the position of the treatment target site.
　操作本体９の基端側に針スライダ２３が限界まで移動した位置に針スライダ２３がある状態が、穿刺針１の使用開始前における初期状態である。初期状態では、針管３の先端はシース７内にある。 The state where the needle slider 23 is at the position where the needle slider 23 has moved to the limit on the proximal end side of the operation body 9 is the initial state before the use of the puncture needle 1 is started. In the initial state, the tip of the needle tube 3 is in the sheath 7.
　操作本体９に対する針スライダ２３の移動量は、シース７に対する針管３の先端の移動量に略対応する。すなわち、針スライダ２３が針管３をシース７に対して移動させることで、シース７に対する針管３の先端の移動量（相対ストローク長Ｌ１）は、針スライダ２３の実際の移動量（操作ストローク長Ｌ２）に針管３の伸びあるいは縮みを加味した分となる。針管３の伸びあるいは縮みは、針管３自身の伸縮性（弾性）、シース７自身の伸縮性（弾性）、針管３とシース７との間の摩擦抵抗の大きさ、チャンネル１０７内におけるシース７の蛇行状態、及びシース７内における針管３の蛇行状態の影響を受ける。 The movement amount of the needle slider 23 relative to the operation body 9 substantially corresponds to the movement amount of the tip of the needle tube 3 relative to the sheath 7. That is, when the needle slider 23 moves the needle tube 3 relative to the sheath 7, the movement amount (relative stroke length L1) of the needle tube 3 with respect to the sheath 7 is changed to the actual movement amount (operation stroke length L2) of the needle slider 23. ) Plus the expansion or contraction of the needle tube 3. The expansion or contraction of the needle tube 3 includes the stretchability (elasticity) of the needle tube 3 itself, the stretchability (elasticity) of the sheath 7 itself, the magnitude of the frictional resistance between the needle tube 3 and the sheath 7, and the sheath 7 within the channel 107. It is influenced by the meandering state and the meandering state of the needle tube 3 in the sheath 7.
　操作本体９の先端側に針スライダ２３が限界まで移動した位置に針スライダ２３があるときに、針管３の先端はシース７の先端から突出されている。操作本体９の先端側に針スライダ２３が限界まで移動した位置に針スライダ２３があるときの針管３の突出長は、針スライダ２３の操作ストローク長Ｌ２よりは短くなるが、少なくとも４０ｍｍあることが好ましい。 When the needle slider 23 is at the position where the needle slider 23 has moved to the limit on the distal end side of the operation body 9, the distal end of the needle tube 3 protrudes from the distal end of the sheath 7. The protruding length of the needle tube 3 when the needle slider 23 is at the position where the needle slider 23 has moved to the limit on the distal end side of the operation body 9 is shorter than the operation stroke length L2 of the needle slider 23, but may be at least 40 mm. preferable.
　図３に示すスタイレット２７は、口金部材３６のロック部３７に取り付け可能なツマミを有し針管３の内面形状に対応した断面形状を有するワイヤ状部材である。 The stylet 27 shown in FIG. 3 is a wire-like member that has a knob that can be attached to the lock portion 37 of the base member 36 and has a cross-sectional shape corresponding to the inner shape of the needle tube 3.
　以上の構成を有する穿刺針１の使用時の動作について説明する。図１２は、穿刺針１が超音波内視鏡１００に取り付けられた状態を示す斜視図である。図１３から図１９までは、穿刺針１の作用を説明するための図である。
　以下では、肺の深部に位置する病変を対象組織として穿刺針１の針管３を刺入し、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。 Operation during use of the puncture needle 1 having the above configuration will be described. FIG. 12 is a perspective view showing a state where the puncture needle 1 is attached to the ultrasonic endoscope 100. 13 to 19 are diagrams for explaining the operation of the puncture needle 1.
In the following, a biopsy procedure in which a needle tube 3 of the puncture needle 1 is inserted using a lesion located in the deep part of the lung as a target tissue and the cells of the lesion are collected through the needle tube 3 will be described as an example.
　まず術者は、図１に示す超音波内視鏡１００の挿入部１０１を体内に挿入し、光学撮像機構１０３で観察しながら、適宜湾曲部１０５を湾曲させつつ対象組織の付近まで挿入部１０１の先端部を導入する。導入後、術者は、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。 First, the operator inserts the insertion portion 101 of the ultrasonic endoscope 100 shown in FIG. 1 into the body, observes with the optical imaging mechanism 103, and appropriately inserts the insertion portion 101 to the vicinity of the target tissue while curving the bending portion 105. Introduce the tip. After the introduction, the surgeon determines a site to perform a biopsy based on the observation results by the optical imaging mechanism 103 and the ultrasonic scanning mechanism 104.
　次に、術者は、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、穿刺針１の挿入体２を先端側から挿入する。さらに、術者は、図１２に示すように、操作部１０９の先端側をホルダ５２の一対の壁部５２ａ、５２ｂ間に進入させてから、穿刺針１の操作部８に設けられたスライドロック５１を基端口金１０８に係合させる。これにより、穿刺針１の操作部８は、操作部１０９に対して回転しないように超音波内視鏡１００に固定される。 Next, the operator inserts the insertion body 2 of the puncture needle 1 into the channel 107 from the proximal end base 108 provided in the operation unit 109 of the ultrasonic endoscope 100 from the distal end side. Further, as shown in FIG. 12, the operator moves the distal end side of the operation unit 109 between the pair of wall portions 52 a and 52 b of the holder 52, and then slides provided on the operation unit 8 of the puncture needle 1. 51 is engaged with the base end cap 108. Thereby, the operation part 8 of the puncture needle 1 is fixed to the ultrasonic endoscope 100 so as not to rotate with respect to the operation part 109.
　図３に示す穿刺針１の針管３は、シース７とともにチャンネル１０７に挿入されるので（図３の実線部を参照）、シース７に対して針管３の相対移動は、シース７や針管３の伸縮による相対移動の他はほとんど生じない。このため、挿入部１０１が湾曲していても、針管３の刺入端３５がシース７の内面に刺さることはなく挿入部１０１の先端部分まで挿入体２が案内される。 Since the needle tube 3 of the puncture needle 1 shown in FIG. 3 is inserted into the channel 107 together with the sheath 7 (see the solid line portion in FIG. 3), relative movement of the needle tube 3 with respect to the sheath 7 Other than relative movement due to expansion and contraction hardly occurs. For this reason, even if the insertion portion 101 is curved, the insertion end 35 of the needle tube 3 does not pierce the inner surface of the sheath 7, and the insertion body 2 is guided to the distal end portion of the insertion portion 101.
　挿入部１０１に挿入体２を挿入する過程で、基端口金１０８とアングルチューブ１０７ｂとの間の領域内に蛇行が蓄積された後にこの蛇行が解消されると、針管３に対してシース７が相対的に先端側へ移動することとなる。挿入体２をチャンネル１０７内に挿入する過程では、シース７の蛇行が蓄積されたり解消されたりを繰り返すこととなるので、チャンネル１０７の先端からシース７が突出された時点でどの程度蛇行が蓄積されているのかは一定ではない。また、シース７の蛇行が解消されるきっかけの一つとして、シース７に対する針管３の進退移動が挙げられる。
　本実施形態では、針管３にバックカット加工が施されているので、シース７の内面に刺入端３５が触れにくく、挿入体２をチャンネル１０７内に挿入する過程でのシース７に対する針管３のわずかな移動では、シース７に針管３が刺さりにくい。 In the process of inserting the insertion body 2 into the insertion portion 101, when the meandering is canceled after the meandering is accumulated in the region between the base end cap 108 and the angle tube 107b, the sheath 7 is moved against the needle tube 3. It will move to the tip side relatively. In the process of inserting the insert 2 into the channel 107, the meandering of the sheath 7 is repeatedly accumulated and eliminated, so how much meander is accumulated when the sheath 7 protrudes from the tip of the channel 107. It is not constant. Further, as one of the triggers for eliminating the meandering of the sheath 7, there is an advance / retreat movement of the needle tube 3 with respect to the sheath 7.
In this embodiment, since the needle tube 3 is subjected to backcut processing, the insertion end 35 is difficult to touch the inner surface of the sheath 7, and the needle tube 3 with respect to the sheath 7 in the process of inserting the insert 2 into the channel 107 is used. With slight movement, the needle tube 3 is unlikely to pierce the sheath 7.
　次に、術者は、図１３に示すように、固定ネジ５４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と操作本体９とを相対的に摺動させて、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。調整後、術者は固定ネジ５４を締め込んで当該突出量を固定する。 Next, as shown in FIG. 13, the operator loosens the fixing screw 54, and observes the sheath 7 and the body by the optical imaging mechanism 103 and the ultrasonic scanning mechanism 104 while relatively moving the sheath adjuster 18 and the operation body 9. The amount of protrusion of the sheath 7 from the distal end of the insertion portion 101 of the ultrasonic endoscope 100 is adjusted to an appropriate amount. After the adjustment, the operator tightens the fixing screw 54 to fix the protrusion 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までの距離を考慮しつつストッパ６１を移動させて所望の位置で操作本体９に固定し、針管３の最大突出長を調節する。 Next, based on the observation result by the ultrasonic scanning mechanism 104, the stopper 61 is moved in consideration of the distance to the target tissue T to be biopsied and fixed to the operation main body 9 at a desired position, and the maximum of the needle tube 3 is obtained. Adjust the protrusion length.
　次に、術者は、針スライダ２３を操作部８の先端側へと前進させる。すると、針管３がシース７内でシース７の先端側へとシース７に対して移動する（図３の二点鎖線部参照）。本実施形態では、図１４に示すように、針管３の刺入端３５がアングルチューブ１０７ｂを通過するときには、シース７の内面に刺入端３５近傍の外周面が接して、針管３の先端部分はシース７の内面から押圧力を受ける。
　図１４から図１７までに示すように、本実施形態でシース７の内面に接するのは、シース７内において針管３がどのような向きでアングルチューブ１０７ｂに進入しても、針管３の先端面３２の外面のうち、外縁３２ａ部分である。 Next, the surgeon advances the needle slider 23 toward the distal end side of the operation unit 8. Then, the needle tube 3 moves in the sheath 7 toward the distal end side of the sheath 7 with respect to the sheath 7 (see the two-dot chain line portion in FIG. 3). In this embodiment, as shown in FIG. 14, when the insertion end 35 of the needle tube 3 passes through the angle tube 107 b, the outer peripheral surface in the vicinity of the insertion end 35 is in contact with the inner surface of the sheath 7, and the distal end portion of the needle tube 3. Receives a pressing force from the inner surface of the sheath 7.
As shown in FIGS. 14 to 17, in this embodiment, the tip surface of the needle tube 3 is in contact with the inner surface of the sheath 7 regardless of the direction in which the needle tube 3 enters the angle tube 107 b in the sheath 7. Among the outer surfaces of 32, it is an outer edge 32a portion.
　針管３の先端面３２は針管３の中心線Ｘ１に対する傾斜角度θ２，θ３ａ，θ３ｂ，θ４が、いずれもチャンネルチューブ１０７ｃの軸線Ｃ３に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度θ１よりも大きいから、アングルチューブ１０７ｂ内では、針管３の中心線Ｘ１を回転中心として針管３がどの位置に回転していても、針管３は、アングルチューブ１０７ｂの内面に沿って位置するシース７の内面から刺入端３５が離間した状態となっている。 Since the tip surface 32 of the needle tube 3 has an inclination angle θ2, θ3a, θ3b, θ4 with respect to the center line X1 of the needle tube 3, all are larger than an inclination angle θ1 of the center line C2 of the slope portion 107a with respect to the axis C3 of the channel tube 107c. In the angle tube 107b, the needle tube 3 is inserted into the insertion end from the inner surface of the sheath 7 positioned along the inner surface of the angle tube 107b no matter where the needle tube 3 is rotated about the center line X1 of the needle tube 3. 35 is in a separated state.
　刺入端３５がシース７の内面に触れることなくアングルチューブ１０７ｂ内を針管３の先端部分が通過した後は、針管３の先端部分は、スロープ部１０７ａの傾斜に沿って先端側へと進められてチャンネル１０７の開口から突出し、シース７の先端の開口からシース７の外部へと突出する。 After the distal end portion of the needle tube 3 passes through the angle tube 107b without touching the inner surface of the sheath 7, the distal end portion of the needle tube 3 is advanced toward the distal end side along the slope of the slope portion 107a. Projecting from the opening of the channel 107 and projecting from the opening at the tip of the sheath 7 to the outside of the sheath 7.
　シース７の先端の開口からシース７の外部へと針管３が突出した後さらに針スライダ２３を操作部８の先端側へと術者が前進させることにより、図１８に示すように、針管３の刺入端３５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。 After the needle tube 3 protrudes from the opening at the distal end of the sheath 7 to the outside of the sheath 7, the operator further advances the needle slider 23 toward the distal end side of the operation portion 8, so that as shown in FIG. The insertion end 35 is punctured into the tissue and pushed forward to the target tissue T for biopsy. 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.
　術者は、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、術者は、図１９に示すように、針管３の先端を、生検を行う対象組織Ｔに到達させる。 The surgeon 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, as shown in FIG. 19, the operator causes the tip of the needle tube 3 to reach the target tissue T to be biopsied.
　次に、術者は、針管３内に入り込んだ生検対象でない組織をスタイレット２７（図１参照）で押し出す。さらに、術者は、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。術者は、針スライダ２３の基端に配された口金部材３６にシリンジ等を接続して針管３内を吸引し、生検を行う対象組織Ｔの細胞などを針管３の先端から吸引して採取する。 Next, the surgeon pushes out the tissue that has entered the needle tube 3 and is not subject to biopsy with the stylet 27 (see FIG. 1). Further, the operator 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. The surgeon connects a syringe or the like to the base member 36 disposed at the proximal end of the needle slider 23 to suck the inside of the needle tube 3 and suck the cells of the target tissue T to be biopsied from the tip of the needle tube 3. Collect.
　必要量の細胞などが採取できたら、針スライダ２３を操作部８の基端側に後退させ、針管３の先端をシース７内に収容する。針管３の先端をシース７内に収容することにより、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からスライドロック５１をはずし、穿刺針１をチャンネル１０７から抜去する。最後に超音波内視鏡１００を患者から抜去して一連の処置を終了する。 When a necessary amount of cells and the like have been collected, the needle slider 23 is retracted toward the proximal end side of the operation unit 8 and the distal end of the needle tube 3 is accommodated in the sheath 7. By accommodating the tip of the needle tube 3 in the sheath 7, the needle tube 3 comes out of the tissue. When the needle tube 3 comes out of the tissue, the slide lock 51 is removed from the proximal end cap 108 of the operation unit 109 of the ultrasonic endoscope 100, and the puncture needle 1 is removed from the channel 107. Finally, the ultrasonic endoscope 100 is removed from the patient, and the series of treatments is completed.
　以上に説明したように、本実施形態では、チャンネル１０７の屈曲部となるアングルチューブ１０７ｂ内で針管３の刺入端３５がシース７の内面から離間した状態が維持されるので、アングルチューブ１０７ｂを針管３の先端部分が通過する過程で、刺入端３５がシース７の内面に最も刺さりにくい位置に刺入端３５が退避した状態となっている。その結果、針管３の刺入端３５がシース７の内面に触れて変形する可能性を低く抑えることができ、針管３の組織への穿刺性能が悪化しにくい。さらに、針管３の刺入端３５がシース７を突き破ってさらにチャンネル１０７の内面を傷つけることが防止される。 As described above, in this embodiment, the state where the insertion end 35 of the needle tube 3 is separated from the inner surface of the sheath 7 within the angle tube 107b that is a bent portion of the channel 107 is maintained. In the process in which the distal end portion of the needle tube 3 passes, the insertion end 35 is retracted to a position where the insertion end 35 is most unlikely to penetrate the inner surface of the sheath 7. As a result, the possibility that the insertion end 35 of the needle tube 3 touches and deforms the inner surface of the sheath 7 can be kept low, and the puncture performance of the needle tube 3 into the tissue is unlikely to deteriorate. Further, the insertion end 35 of the needle tube 3 is prevented from breaking through the sheath 7 and further damaging the inner surface of the channel 107.
（第２実施形態）
　次に、本発明の第２実施形態について説明する。本実施形態では、上記第１実施形態ですでに説明された構成要素と同様の構成要素には、第１実施形態と同一の符号が付されている。図２０は、本実施形態の内視鏡用穿刺針の針管の先端部分の平面図である。図２１は、針管の先端部分の正面図である。図２２は、針管の先端部分の側面図である。図２３は、針管の先端部分の底面図である。図２４から図２７は、内視鏡用穿刺針の作用を説明するための図である。 (Second Embodiment)
Next, a second embodiment of the present invention will be described. In this embodiment, the same components as those already described in the first embodiment are denoted by the same reference numerals as those in the first embodiment. FIG. 20 is a plan view of the distal end portion of the needle tube of the puncture needle for an endoscope according to the present embodiment. FIG. 21 is a front view of the distal end portion of the needle tube. FIG. 22 is a side view of the distal end portion of the needle tube. FIG. 23 is a bottom view of the distal end portion of the needle tube. FIGS. 24 to 27 are diagrams for explaining the operation of the puncture needle for an endoscope.
　本実施形態では、上記第１実施形態で説明された針管３に代えて、図２０から図２３に示すメンギーニ針３Ａが設けられている点で、上記第１実施形態と構成が異なっている。 This embodiment is different from the first embodiment in that a Menghini needle 3A shown in FIGS. 20 to 23 is provided instead of the needle tube 3 described in the first embodiment.
　本実施形態のメンギーニ針３Ａは、図２２に示すように、メンギーニ針３Ａの中心線Ｘ１Ａから離間した位置に頂点Ｑを有する円錐面に沿って、メンギーニ針３Ａの外縁３２ａＡからメンギーニ針３Ａの刺入端３５側へ行くに従って径が漸次小さくなる円錐面状に湾曲した形状の刃面３３Ａを有している。メンギーニ針３Ａの先端面３２Ａの内周部分は組織を切離する刃となっている。 As shown in FIG. 22, the Menghini needle 3A of the present embodiment is inserted into the Menghini needle 3A from the outer edge 32aA of the Menghini needle 3A along a conical surface having a vertex Q at a position spaced from the center line X1A of the Menghini needle 3A. The blade surface 33A is curved in a conical surface with a diameter that gradually decreases toward the entry end 35 side. The inner peripheral portion of the distal end surface 32A of the Menghini needle 3A is a blade for cutting the tissue.
　メンギーニ針３Ａの先端面３２Ａに形成された刃面３３Ａは、メンギーニ針３Ａの中心線Ｘ１Ａに対して、チャンネルチューブ１０７ｃの軸線Ｃ３に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度θ１よりも大きな角度で交差する。 The blade surface 33A formed on the distal end surface 32A of the Menghini needle 3A is at an angle greater than the inclination angle θ1 of the center line C2 of the slope portion 107a with respect to the axis C3 of the channel tube 107c with respect to the center line X1A of the Menghini needle 3A. Intersect.
　本実施形態では、メンギーニ針３Ａの刃面３３Ａを規定する円錐面は、メンギーニ針３Ａの中心線Ｘ１Ａに対して平行となるように離間した中心線Ｘ３を有し、この中心線Ｘ３に対して、チャンネルチューブ１０７ｃの軸線Ｃ３に対するスロープ部１０７ａの中心線Ｃ２の傾斜角度θ１よりも大きな角度で交差する直線を母線とする円錐面である。 In the present embodiment, the conical surface that defines the blade surface 33A of the Menghini needle 3A has a center line X3 that is separated from the center line X1A of the Menghini needle 3A so as to be parallel to the center line X3. A conical surface having a straight line that intersects at an angle larger than the inclination angle θ1 of the center line C2 of the slope portion 107a with respect to the axis C3 of the channel tube 107c as a generating line.
　図２４から図２７に示すように、本実施形態でも、メンギーニ針３Ａの刺入端３５は、シース７内でどのような位置関係にあっても、チャンネルチューブ１０７ｃからアングルチューブ１０７ｂを通じてスロープ部１０７ａへと移動する過程で、シース７の内面から第１実施形態と同様に離間した状態となる。そのため、本実施形態のメンギーニ針３Ａも第１実施形態と同様に刺入端３５が変形しにくく穿刺性能の低下が起こりにくい。
　また、本実施形態でもメンギーニ針３Ａが第１実施形態と同様にシース７を突き破りにくく、チャンネル１０７を傷つけにくい。 As shown in FIGS. 24 to 27, also in this embodiment, the insertion end 35 of the Menghini needle 3A has a slope portion 107a from the channel tube 107c through the angle tube 107b regardless of the positional relationship in the sheath 7. In the process of moving to, it becomes a state separated from the inner surface of the sheath 7 as in the first embodiment. For this reason, the Menghini needle 3A of the present embodiment is also less likely to deform the insertion end 35 as in the first embodiment, and the puncture performance is unlikely to deteriorate.
Also in this embodiment, the Menghini needle 3A is unlikely to pierce the sheath 7 and damage the channel 107 as in the first embodiment.
　以上、本発明の実施形態について図面を参照して詳述したが、上記各実施形態に示すように、本発明の内視鏡用穿刺針の針管は、針管の先端に位置する刺入端と、この刺入端の基端側に位置する傾斜した刃面との位置関係が、針管の先端面の外縁と刺入端とを繋ぐ直線と針管の中心線とのなす角が常にチャンネルの屈曲部（上記実施形態ではアングルチューブ１０７ｂ）の基端部分に対する屈曲部の先端部分の傾斜角度よりも大きく傾斜した状態と規定されることで、鋭利な刺入端がシースに触れないようになっている。このような位置関係を満たすことで、上記第１実施形態で説明したバックカット付の針管や上記第２実施形態で説明したメンギーニ針以外の針先形状を有する針管にも本発明を適用することができる。 As described above, the embodiments of the present invention have been described in detail with reference to the drawings. As shown in each of the above embodiments, the needle tube of the puncture needle for an endoscope of the present invention includes a insertion end positioned at the distal end of the needle tube, The angle formed by the straight line connecting the outer edge of the distal end surface of the needle tube and the insertion end and the center line of the needle tube is always the bending of the channel. The sharp insertion end is prevented from touching the sheath by being defined as a state inclined more than the inclination angle of the distal end portion of the bent portion with respect to the proximal end portion of the portion (the angle tube 107b in the above embodiment). Yes. By satisfying such a positional relationship, the present invention is applied to a needle tube with a backcut described in the first embodiment and a needle tube having a needle tip shape other than the Menghini needle described in the second embodiment. Can do.
　以上、本発明の実施形態について図面を参照して詳述したが、具体的な構成はこの実施形態に限られるものではなく、本発明の要旨を逸脱しない範囲の設計変更等も含まれる。
　また、上述の各実施形態において示した構成要素は適宜に組み合わせて構成することが可能である。 As mentioned above, although embodiment of this invention was explained in full detail with reference to drawings, the concrete structure is not restricted to this embodiment, The design change etc. of the range which does not deviate from the summary of this invention are included.
In addition, the constituent elements shown in the above-described embodiments can be combined as appropriate.
　上記各実施形態によれば、内視鏡の損傷や穿刺性能の低下が起こりにくい内視鏡用穿刺針を提供することができる。 According to each of the above embodiments, it is possible to provide an puncture needle for an endoscope that is unlikely to cause damage to the endoscope or a decrease in puncture performance.
　１　内視鏡用穿刺針
　２　挿入体
　３　針管
　３１　金属筒部
　３２　先端面
　３２ａ　先端面の外縁
　３３　第一刃面
　３４　第二刃面
　３５　刺入端
　３６　口金部材
　３７　ロック部
　３８　フランジ部
　７　シース
　８　操作部
　９　操作本体
　１８　シースアジャスター
　２３　針スライダ
　２４　保持部
　２５　一対の壁部
　２５ａ　先端壁部
　２５ｂ　基端壁部
　２６　回転止め部
　２７　スタイレット
　２７ａ　ツマミ
　２７ｂ　芯
　５１　スライドロック
　５２　ホルダ
　５２ａ、５２ｂ　一対の壁部
　５３　支持パイプ
　５４　固定ネジ
　６１　ストッパ
　６２　固定ネジ
　１００　超音波内視鏡
　１０１　挿入部
　１０２　硬質部
　１０３　光学撮像機構
　１０４　超音波走査機構
　１０５　湾曲部
　１０５ａ　先端
　１０５ｂ　基端
　１０６　可撓管部
　１０７　チャンネル
　１０７ａ　スロープ部
　１０７ｂ　アングルチューブ
　１０７ｃ　チャンネルチューブ
　１０８　基端口金
　１０９　操作部
　１１０　湾曲操作機構
　１１１　複数のスイッチ
　１１２　ユニバーサルコード
　１１２ａ　分岐ケーブル
　１１２ｂ　分岐ケーブル
　１１２ｃ　分岐ケーブル
　１１３　光源装置
　１１４　光学的観察部
　１１５　超音波観察部
　１１６　モニター DESCRIPTION OF SYMBOLS 1 Endoscopic puncture needle 2 Insert 3 Needle tube 31 Metal cylinder part 32 Tip surface 32a Outer edge of tip face 33 First blade surface 34 Second blade surface 35 Insertion end 36 Base member 37 Lock part 38 Flange part 7 Sheath 8 Operation part 9 Operation body 18 Sheath adjuster 23 Needle slider 24 Holding part 25 Pair of wall parts 25a Tip wall part 25b Base end wall part 26 Anti-rotation part 27 Stylet 27a Knob 27b Core 51 Slide lock 52 Holder 52a, 52b Pair of walls Part 53 Support pipe 54 Fixing screw 61 Stopper 62 Fixing screw 100 Ultrasound endoscope 101 Insertion part 102 Hard part 103 Optical imaging mechanism 104 Ultrasonic scanning mechanism 105 Bending part 105a Tip 105b Base end 106 Flexible pipe part 107 Channel 107a Slope Part 107b Angle tube 107c H Down channel tube 108 proximal cap 109 operating portion 110 bending operation mechanism 111 a plurality of switches 112 universal cord 112a branch cable 112b branch cable 112c branch cable 113 light source apparatus 114 optical observation unit 115 ultrasonic observation unit 116 monitors

Claims (6)

  1. 　屈曲したチャンネルを有する内視鏡に取り付けて使用される内視鏡用穿刺針であって、
    　前記チャンネルに挿通可能な針管と、
    　前記針管を支持し前記針管の中心線方向に前記針管を移動させる針スライダと、
    　を有し、
    　前記針管は、
    　　前記針管の中心線方向から見たときに前記針管の外周面よりも内側に位置し組織に刺入可能な刺入端と、
    　　前記針管の先端面の外縁と前記刺入端とを繋ぐ直線と前記針管の中心線とのなす角が常に前記チャンネルの屈曲部の基端部分に対する前記屈曲部の先端部分の傾斜角度よりも大きく傾斜した状態で前記刺入端から前記外縁まで延びる刃面と、
    　　を有する
    　内視鏡用穿刺針。     An puncture needle for an endoscope used by being attached to an endoscope having a bent channel,
    A needle tube that can be inserted into the channel;
    A needle slider that supports the needle tube and moves the needle tube in the direction of the center line of the needle tube;
    Have
    The needle tube is
    A piercing end that is located on the inner side of the outer peripheral surface of the needle tube when viewed from the center line direction of the needle tube and can be inserted into a tissue;
    The angle formed by the straight line connecting the outer edge of the distal end surface of the needle tube and the insertion end and the center line of the needle tube is always larger than the inclination angle of the distal end portion of the bent portion with respect to the proximal end portion of the bent portion of the channel. A blade surface extending from the insertion end to the outer edge in an inclined state;
    A puncture needle for an endoscope.
  2. 　請求項１に記載の内視鏡用穿刺針であって、
    　前記刃面は、前記外縁から前記針管の前記刺入端側へ行くに従って径が漸次小さくなる円錐面状をなしている
    　内視鏡用穿刺針。     The puncture needle for an endoscope according to claim 1,
    The puncture needle for an endoscope, wherein the blade surface has a conical surface shape whose diameter gradually decreases from the outer edge toward the insertion end side of the needle tube.
  3. 　請求項１に記載の内視鏡用穿刺針であって、
    　前記刃面は、
    　　前記針管の中心線に対して傾斜する平面からなる第一刃面部と、
    　　前記針管の中心線方向から見たときに第一刃面部と略反対側に向けられ前記第一刃面部と交差する平面からなり前記第一刃面部との交線上に前記刺入端を有する第二刃面部と、
    　　を有する
    　内視鏡用穿刺針。     The puncture needle for an endoscope according to claim 1,
    The blade surface is
    A first blade surface portion comprising a plane inclined with respect to the center line of the needle tube;
    When viewed from the direction of the center line of the needle tube, the first end surface is formed on a plane that is substantially opposite to the first blade surface portion and intersects the first blade surface portion, and has the insertion end on the intersection line with the first blade surface portion. A double-edged surface,
    A puncture needle for an endoscope.
  4. 　請求項１に記載の内視鏡用穿刺針であって、
    　前記針管が内部に挿通され、前記チャンネルの内径の６０％以上の大きさの外径を有する筒状のシースをさらに備える
    　内視鏡用穿刺針。     The puncture needle for an endoscope according to claim 1,
    An endoscope puncture needle further comprising a cylindrical sheath having the outer diameter of 60% or more of the inner diameter of the channel through which the needle tube is inserted.
  5. 　請求項４に記載の内視鏡用穿刺針であって、
    　前記針管の外径は、前記シースの内径の６０%以上の大きさである
    　内視鏡用穿刺針。     The puncture needle for an endoscope according to claim 4,
    The puncture needle for an endoscope, wherein the outer diameter of the needle tube is 60% or more of the inner diameter of the sheath.
  6. 　請求項４または請求項５に記載の内視鏡用穿刺針であって、
    　前記シースは、素線が螺旋状に巻かれてコイル形状をなしている
    　内視鏡用穿刺針。     The puncture needle for an endoscope according to claim 4 or 5,
    The sheath is a puncture needle for an endoscope, in which an element wire is spirally wound to form a coil shape.
PCT/JP2015/065312 2014-09-26 2015-05-27 Endoscope puncture needle WO2016047202A1 (en)

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