WO2021117649A1 - 生検針及び組織採取装置 - Google Patents

生検針及び組織採取装置 Download PDF

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Publication number
WO2021117649A1
WO2021117649A1 PCT/JP2020/045362 JP2020045362W WO2021117649A1 WO 2021117649 A1 WO2021117649 A1 WO 2021117649A1 JP 2020045362 W JP2020045362 W JP 2020045362W WO 2021117649 A1 WO2021117649 A1 WO 2021117649A1
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WO
WIPO (PCT)
Prior art keywords
tube
blade
tip
biopsy needle
slit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2020/045362
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English (en)
French (fr)
Japanese (ja)
Inventor
哲矢 西村
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fujifilm Corp
Original Assignee
Fujifilm Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fujifilm Corp filed Critical Fujifilm Corp
Priority to IL293098A priority Critical patent/IL293098B1/en
Priority to JP2021563932A priority patent/JP7315707B2/ja
Priority to EP20898049.0A priority patent/EP4074264B1/en
Priority to CN202080082951.1A priority patent/CN114746024B/zh
Publication of WO2021117649A1 publication Critical patent/WO2021117649A1/ja
Priority to US17/745,437 priority patent/US20220273274A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/06—Biopsy forceps, e.g. with cup-shaped jaws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • A61B2010/045—Needles

Definitions

  • the present invention relates to a biopsy needle and a tissue collection device, and more particularly to a biopsy needle and a tissue collection device used for collecting a living tissue.
  • a needle tube has been introduced into the body cavity via the endoscopic ultrasonography treatment tool insertion channel, and the needle tube is guided to the observation site under ultrasonic tomographic image observation with an ultrasonic endoscope and inserted into the lesion tissue.
  • Diagnosis to confirm the pathology is made by collecting living tissue.
  • the tissue sampling device of Patent Document 1 includes a sheath having flexibility that can be inserted into a treatment tool insertion channel of an endoscope, a needle tube that is freely inserted into the sheath and punctured into a living tissue, and a sheath. It is provided with an operation unit connected to a base end portion to operate the advance / retreat of the needle tube, and a syringe connected to the operation unit to apply a negative pressure to the needle tube.
  • the needle tube disclosed in Patent Document 1 is provided with a slit extending from the tip opening toward the proximal end side, and the radius of curvature of the first edge portion provided on both sides of the slit is set from the radius of curvature of the second edge portion.
  • the needle tube after inserting the needle tube into the lesion tissue, the needle tube is rotated to take in the living tissue into the tip of the tube through the gap of the step, and then the needle tube is further rotated. , The above-mentioned incorporated biological tissue is excised by the edge of the slit. As a result, a sufficient amount of biological tissue can be collected for making a definitive diagnosis of pathology.
  • the needle tube of Patent Document 1 (hereinafter referred to as a biopsy needle) has a complicated structure having a first edge portion and a second edge portion having different radii of curvature, the outer diameter is, for example, a small diameter of 3 mm or less. There was a problem that it was difficult to manufacture a biopsy needle.
  • the biopsy needle when the biological tissue is taken in and excised by the biopsy needle, the biopsy needle is rotated about the axis of the biopsy needle, but in this case, the operation unit is rotated together with the syringe. It may be a burden to the practitioner because it has to be done.
  • the present invention has been made in view of such circumstances, and is a biopsy needle and a tissue collection device capable of collecting a sufficient amount of biological tissue for making a definitive diagnosis of pathology with a simple structure and a simple operation.
  • the purpose is to provide.
  • the biopsy needle according to the present invention is a biopsy needle inserted into an endoscopic forceps channel, has a tip opening and a proximal opening, and has a tip opening and a tip opening.
  • a hollow tube is provided with a proximal opening communicated with the tube, which is provided at the distal end of the tube and extends from the distal opening toward the proximal opening with a puncture portion having at least one blade tip point. It has a slit and a tissue excision cutter provided at the base end of the slit and tapered from the base end of the slit toward the tip of the slit.
  • the tissue excision cutter has at least one inclined blade surface inclined so as to approach the central axis of the tube from the base end of the slit toward the tip end of the slit. ..
  • a sharp blade is formed on the inclined blade surface, and the blade is formed at a position where the blade does not protrude from the outer peripheral surface of the tube to the outside of the tube.
  • the biopsy needle when the tube is viewed from the axial direction of the tube, it is preferable that at least one blade tip point and the slit are arranged to face each other in the radial direction of the tube.
  • the biopsy needle according to the present invention preferably has at least one blade tip point formed on the tip side of the tube with respect to the slit in the axial direction of the tube.
  • the puncture portion of the biopsy needle has a first blade tip point, a second blade tip point, and a third blade tip point, and the first blade tip point, the second blade tip point, and the third blade tip point are Each is formed on the inner peripheral surface of the tube, and when the tube is viewed from a direction orthogonal to the axial direction of the tube, the first blade end point is formed on the tip side of the tube with respect to the second blade end point and the third blade end point.
  • the first blade end points are arranged to face the slit in the radial direction of the tube, and the second blade end points and the third blade end points are arranged to face each other with the slit in between. Is preferable.
  • the tip portion of the tube is a first blade surface connecting the outer peripheral surface of the tube with the first blade tip point and the second blade tip point, and is a component that goes outward in the radial direction of the tube.
  • At least one blade tip point is formed on the inner peripheral surface of the tube.
  • the biopsy needle according to the present invention preferably has a length from the tip point of the first blade to the tip of the tissue excision cutter in the axial direction of the tube of 0.5 mm or more and 25.0 mm or less.
  • the width of the slit in the circumferential direction of the tube is smaller than the inner diameter of the tube.
  • the outer diameter of the tube is 0.3 mm or more and 3.0 mm or less.
  • the inner diameter of the tube is 0.1 mm or more and 2.5 mm or less.
  • the biopsy needle according to the present invention is provided with an echo marker on the outer peripheral surface of the tube, which can visually display the position of the tube under an ultrasonic image.
  • the echo marker is provided only in the periphery including the base end of the slit.
  • the echo marker is provided in the region on the tip end side of the tube starting from the periphery including the base end of the slit.
  • the echo marker is provided in the region on the proximal end side of the tube starting from the periphery including the proximal end of the slit.
  • the echo marker is formed in an uneven shape.
  • the tube is made of stainless steel, nickel titanium alloy, nickel chrome alloy or cobalt chrome alloy.
  • the tissue sampling apparatus includes the biopsy needle of the present invention, a suction member which is communicated with the base end opening of the biopsy needle and creates a negative pressure inside the biopsy needle. To be equipped.
  • Cross-sectional view showing the overall configuration of the tissue sampling device
  • Cross-sectional view of the insertion part where the biopsy needle is immersed inside the sheath
  • Enlarged perspective view showing the configuration of the tip of the tube constituting the tissue sampling device.
  • Enlarged perspective view showing the configuration of the tip of the tube constituting the tissue sampling device.
  • Enlarged perspective view showing the configuration of the tip of the tube constituting the tissue sampling device.
  • the tissue sampling device for puncture to which the present invention is applied will be described as being configured to be inserted into the body cavity via a treatment tool insertion channel formed in an ultrasonic endoscope that performs electronic convex scanning.
  • a treatment tool insertion channel formed in an ultrasonic endoscope that performs electronic convex scanning.
  • other scanning type ultrasonic endoscopes, treatment tool insertion channels of ordinary endoscopes not provided with an ultrasonic diagnostic mechanism, tracals, etc. may be used as guide means. It can be inserted into a tracal, and the whole can be made of a hard member.
  • Fig. 1 shows the configuration of the tip of the ultrasonic endoscope that guides the tissue sampling device.
  • reference numeral 10 is an insertion portion into the body cavity, and the insertion portion 10 is formed by connecting the tip portion main body 12 to the tip of the angle portion 11, and the tip portion main body 12 has a proximal end side.
  • An endoscopic observation unit 13 is provided on the surface, and an ultrasonic observation unit 14 is provided on the distal end side.
  • the endoscopic observation unit 13 is provided on an inclined portion 12a on the base end side of the tip portion main body 12, and comprises an observation field of view directed obliquely forward.
  • FIG. 1 shows an illumination mechanism 15 provided with a light guide constituting the endoscope observation unit 13, and an observation mechanism is provided adjacent to the illumination mechanism 15, but the illustration of the observation mechanism is omitted. ..
  • the observation mechanism a solid-state image sensor or an image guide can be used.
  • the ultrasonic observation unit 14 has an ultrasonic transducer unit 16 mounted in an opening 12b provided at the tip of the tip body 12.
  • the ultrasonic transducer unit 16 performs electron convex scanning, and is composed of a large number of strip-shaped ultrasonic transducers 17 arranged in an arc shape.
  • a treatment tool lead-out unit 18 is formed at a position between the endoscopic observation unit 13 and the ultrasonic observation unit 14.
  • the treatment tool lead-out portion 18 is a passage having a predetermined inner diameter formed in the tip portion main body 12, and a connection pipe 19 is connected to the treatment tool lead-out portion 18.
  • the connecting pipe 19 is bent at a predetermined angle, and a flexible tube 20 is connected to the base end portion thereof. Therefore, the treatment tool insertion channel 21 is composed of the treatment tool lead-out portion 18, the connection pipe 19, and the flexible tube 20, and the treatment tool lead-out portion 18 extends obliquely forward with respect to the axis of the insertion portion 10.
  • the flexible tube 20 extends in the axial direction of the insertion portion 10, and the intermediate portion of the connecting pipe 19 is bent by a predetermined angle.
  • Reference numeral 30 is a tissue sampling device of the embodiment, and the tissue sampling device 30 is inserted into the treatment tool insertion channel 21 and can appear and disappear from the treatment tool extraction unit 18. Then, the tip body 12 is brought into contact with the inner wall S of the body cavity, the living tissue collection point T is placed in the ultrasonic observation field by the ultrasonic observation unit 14, and the tip of the tissue collection device 30 is removed from the treatment tool extraction unit 18. The living tissue can be collected after inserting through the inner wall S of the body cavity and guiding the tip portion to the tissue collection point T.
  • FIG. 2 is a cross-sectional view showing the overall configuration of the tissue sampling device 30.
  • the tissue sampling device 30 is composed of an insertion unit 31 and an operation unit 32, and a syringe 33 is detachably connected to the base end portion of the operation unit 32.
  • the syringe 33 is an example of a suction member.
  • the insertion portion 31 is at least longer than the total length of the treatment tool insertion channel 21, and is composed of a double tubular member as shown in FIGS. 3 and 4. That is, the insertion portion 31 is composed of a sheath 34 and a biopsy needle 35 inserted into the sheath 34 from the outermost peripheral side.
  • FIG. 3 is a cross-sectional view of the insertion portion 31 showing a state in which the biopsy needle 35 protrudes outward from the tip opening 34A of the sheath 34
  • FIG. 4 shows the biopsy needle 35 immersed inside the sheath 34. It is sectional drawing of the insertion part 31 which showed the state.
  • the sheath 34 is inserted into the treatment tool insertion channel 21 of the endoscope, and constitutes the exterior of the insertion portion 31.
  • the sheath 34 is made of a flexible tubular member, and is made of a resin member such as, for example, polyethersulfone, Teflon (registered trademark) or polyetheretherketone (PEEK).
  • the sheath 34 may be composed of a close contact coil or the like.
  • the biopsy needle 35 is punctured by a living tissue to collect a lesioned tissue or the like, and is inserted and relocated freely inside the sheath 34.
  • the detailed configuration of the biopsy needle 35 will be described later, but the biopsy needle 35 has a tube 54.
  • the tube 54 has a tip opening 50 and a proximal opening 52 (see FIG. 2), and the tip opening 50 and the proximal opening 52 are communicated with each other. Further, as shown in FIGS. 3 and 4, the tip portion 55 of the tube 54 is provided with a puncture portion 56, a slit 58, and a tissue excision cutter 60.
  • the above tube 54 must be hard because it is inserted into the body. Further, since the tube 54 is inserted into the treatment tool insertion channel 21, it passes through the bent connection pipe 19 and is inserted in the bending direction so that the tube 54 can be smoothly inserted even when the angle portion 11 is curved. Must be flexible. Therefore, the tube 54 is made of stainless steel, nickel-titanium alloy, nickel-chromium alloy or cobalt-chromium alloy having a small diameter and flexibility. Stainless steel is hard to rust, nickel titanium is a superelastic alloy, so it is hard to bend even if it is inserted through a bent connection pipe 19, and nickel chromium and cobalt chromium have high hardness, so they can be easily inserted into the living tissue collection point T. be able to.
  • the biopsy needle 35 may have a tip portion 55 including at least the puncture portion 56 formed of a hard pipe, and a portion other than the tip portion 55 may be formed of a flexible and flexible tube.
  • the tube 54 is inserted and retreated freely inside the sheath 34, and the retracted position (position in FIG. 4) in which the tube 54 is immersed in the sheath 34 and the operating position where the tube 54 protrudes from the tip opening 34A of the sheath 34 by a predetermined length. Move to (position in FIG. 3).
  • the base end portion of the tube 54 is connected to the operating portion 32, and by operating the operating portion 32, the tube 54 appears and disappears from the tip opening 34A of the sheath 34.
  • the specific configuration of the operation unit 32 is as shown in FIG.
  • the operation unit 32 includes a luer lock operation unit 39, a sheath position operation unit 40, a tube position operation unit 41, and a stopper ring 42. Further, the stylet 36 is inserted inside the tube 35.
  • the luer lock operation unit 39 is configured with a lure lock unit 39A at its tip, and the luer lock unit 39A is used for fixing to a treatment tool introduction port (not shown) of an ultrasonic endoscope, for example, a treatment. It is detachably connected to the pair of lure locks that exist at the tool introduction port.
  • the luer lock operation unit 39 is inserted into a hole of the sheath position operation unit 40, and the lure lock operation unit 39 and the sheath position operation unit 40 are relatively slidably attached along the axis P of the operation unit 32. Has been done.
  • the luer lock operation unit 39 and the sheath position operation unit 40 are fixed by a screw 43 screwed from the outer peripheral surface of the sheath position operation unit 40 toward the outer peripheral surface of the luer lock operation unit 39.
  • a stopper ring 42 is slidably provided on the outer peripheral surface of the sheath position operating portion 40 along the axis P, and the stopper ring 42 is provided from the outer peripheral surface of the stopper ring 42 to the outer peripheral surface of the sheath position operating portion 40. It is fixed by a screw 44 that is screwed toward it.
  • the sheath position operation unit 40 is inserted into a hole of the tube position operation unit 41, and the sheath position operation unit 40 and the tube position operation unit 41 are relatively slidably attached along the axis P.
  • the relative position of the sheath position operation unit 40 and the tube position operation unit 41 in the axis P direction is determined by the tip surface 41A of the tube position operation unit 41 coming into contact with the stopper ring 42.
  • the base side of the sheath 34 is inserted from the hole of the luer lock operation unit 39 into the hole of the sheath position operation unit 40, and the base end portion of the sheath position operation unit 40 is inserted. Is fixed to.
  • the base end opening 34B of the sheath 34 is opened to the base end portion of the sheath position operating portion 40.
  • the proximal end side of the tube 54 is inserted through the proximal end opening 34B of the sheath 34 into the hole of the tube position operating portion 41 and fixed to the proximal end portion of the tube position operating portion 41.
  • the base end opening 52 of the tube 54 is opened to the base end portion of the tube position operating portion 41.
  • a luer lock portion 45 communicating with the base end opening 52 is provided at the base end portion of the tube position operation portion 41, and between the lure lock portion 45 and a position protruding from the tube tip opening 50.
  • a stylet 36 is provided. The stylet 36 functions to protect the blade tip points 62, 64, 66, protect the sheath 34 from the blade tip points 62, 64, 66, and suppress foreign matter from entering the tube 34.
  • a syringe 33 having a pair of luer locks for suction and liquid pumping can be attached to and detached from the luer lock portion 45.
  • the sheath 34 through which the tube 35 is inserted is inserted into the treatment tool insertion channel 21 shown in FIG. 1 from the treatment tool introduction port of the ultrasonic endoscope.
  • the tip of the sheath 34 is shown in FIG.
  • the luer lock portion 39A of the luer lock operation unit 39 is fixed to the luer lock paired with the treatment tool introduction port at a position near the tip of the treatment tool lead-out unit 18.
  • the stylet 36 protruding from the tip opening 50 is slightly removed toward the base end side, and is immersed about 5 mm to 10 mm from the tip opening 50 of the tube. This makes it easier for the blade tip points 62, 64, and 66 to pierce the living tissue collection point T.
  • the tube position operation unit 41 is slid with respect to the sheath position operation unit 40 in the direction of arrow Q along the axis P.
  • the tip portion 55 of the tube 54 protrudes from the tip opening 34A of the sheath 34, and when the tip surface 41A of the tube position operation portion 41 comes into contact with the stopper ring 42, the tip portion 55 of the tube 54 is moved. Insert into the living tissue collection point T (see FIG. 1).
  • the syringe 33 can be attached to the luer lock portion 45 for suction.
  • the above is an example of using the tissue sampling device 30.
  • the tube 54 also functions as a fluid passage.
  • This fluid passage acts as a suction passage for applying a negative pressure and a passage for pumping physiological saline to discharge the biological tissue collected inside the tube 54.
  • FIG. 5 is an enlarged perspective view showing the configuration of the tip portion 55 of the tube 54, and is a perspective view of one side surface of the tip portion 55 viewed from the tip end side of the tube 54.
  • FIG. 6 is a perspective view of the other side surface of the tip portion 55 from the tip end side of the tube 54.
  • FIG. 7 is a front view of the tip portion 55 as viewed from the tip end side of the tube 54.
  • the tip portion 55 of the tube 54 has the puncture portion 56, the slit 58, and the tissue excision cutter 60 described above.
  • the slit 58 is an elongated through hole formed in a straight line extending in the Y ( ⁇ ) direction from the tip opening 50 toward the proximal opening 52 (see FIG. 2). At the time of tissue collection, it functions as an intake port for taking in a large amount of living tissue from the side surface of the tip portion 55 into the inside of the tube 54.
  • the slit 58 is formed by a gap between a pair of wall portions 58A and 58B facing each other in the X direction and along the Y direction.
  • the tissue excision cutter 60 is provided at the base end 58C of the slit 58.
  • the tissue excision cutter 60 is formed so as to taper from the base end 58C toward the tip end (Y (+) side) of the slit 58.
  • the tissue excision cutter 60 has an inclined blade surface 60B inclined so as to approach the central axis 54C of the tube 54 from the base end 58C of the slit 58 toward the tip end (Y (+) side) of the slit 58. ..
  • a sharp blade 60A is formed on the inclined blade surface 60B toward the tip (Y (+) side) of the slit 58, and the blade 60A is formed on the inner peripheral surface 54A of the tube 54.
  • the living tissue taken into the inside of the tip portion 55 through the slit 58 is operated in the Y (+) direction of the tube 54, that is, the living body. It can be excised by operating in the same direction as the puncture direction of the tube 54 with respect to the tissue collection point T. Since the tissue excision cutter 60 may be formed with the above-mentioned taper, the above-mentioned blade 60A does not necessarily have to be sharp, and may be thin enough to have a cutter function.
  • the puncture portion 56 is a portion that is inserted into the biological tissue collection point T (see FIG. 1) from the inner wall S of the body cavity (see FIG. 1) when the tube 54 moves in the Y (+) direction, and the biological tissue collection. This is the part that holds the location T.
  • the puncture portion 56 of this example has a blade tip point 62, a blade tip point 64, and a blade tip point 66 as an example. These blade tip points 62, 64, and 66 are each sharply formed so that the tips gradually become thinner toward the Y (+) direction. By configuring the puncture portion 56 with the plurality of blade tip points 62, 64, 66 in this way, the biological tissue collection point T can be reliably held inside the tube 54 without escaping to the outside of the tube 54.
  • the blade tip point 62 is an example of the first blade tip point
  • the blade tip point 64 is an example of the second blade tip point
  • the blade tip point 66 is an example of the third blade tip point.
  • the blade tip points 62, 64, and 66 are formed on the inner peripheral surface 54A of the tube 54, respectively.
  • the inner peripheral surface 54A refers to a surface (ZX surface) orthogonal to the axial direction (Y direction) of the tube 54, whose normal direction is toward the central axis 54C of the tube 54.
  • the blade tip point 62 is formed on the tip side of the tube 54 with respect to the blade tip points 64 and 66. .. Further, when the tube 54 is viewed from the axial direction (Y direction) of the tube 54, the blade tip point 62 is arranged to face the slit 58 in the radial direction (Z direction) of the tube 54, and the blade tip point 64 and the blade tip point 66 are , Are arranged so as to face each other in the X direction with the slit 58 interposed therebetween.
  • the blade tip point 64 and the blade tip point 66 are at the same position in the axial direction (Y direction) of the tube 54.
  • This is an example, and may be formed at positions deviated from each other in the axial direction (Y direction) of the tube 54.
  • blade tip points 62, 64, 66 By forming such blade tip points 62, 64, 66 at the tip 55, two blade surfaces 68, 70 are formed at the tip 55 of the tube 54.
  • the blade surface 68 is formed as a surface connecting the outer peripheral surface 54B of the tube 54, the blade tip point 62, and the blade tip point 64.
  • the blade surface 68 has a normal line including a component toward the outside in the radial direction (X ( ⁇ ) direction) of the tube 54 and a component toward the tip (Y (+)) side of the tube 54.
  • a sharp blade 68A is formed at a portion where the blade surface 68 and the inner peripheral surface 54A intersect.
  • the blade surface 68 is an example of the first blade surface.
  • the blade surface 70 is formed as a surface connecting the outer peripheral surface 54B of the tube 54, the blade tip point 62, and the blade tip point 66.
  • the blade surface 70 has a normal line including a component toward the outside in the radial direction (X (+) direction) of the tube 54 and a component toward the tip end (Y (+)) side of the tube 54.
  • a sharp blade 70A is formed at a portion where the blade surface 70 and the inner peripheral surface 54A intersect.
  • the blade surface 70 is an example of the second blade surface.
  • the tube 54 of the embodiment is configured to have a line-symmetrical shape having the Z axis passing through the central axis 54C of the tube 54 as the axis of symmetry, but the tube 54 is not limited to this shape. It may be configured in an asymmetrical shape.
  • the embodiment is configured as described above, and next, an example of a method of collecting a living tissue using this tissue collection device 30 will be described.
  • the tip body 12 of the ultrasonic endoscope is arranged at a predetermined position with respect to the inner wall S of the body cavity.
  • the insertion unit 31 of the tissue collection device 30 is inserted into the treatment tool insertion channel 21. ..
  • the sheath tip opening 34A is in a position where it does not protrude from the tip of the treatment tool lead-out portion 18.
  • the sheath position operating portion 40 is operated in the direction of arrow Q, the sheath tip opening 34A is projected from the tip of the treatment tool lead-out portion 18, and the position is fixed by the screw 43 at a position suitable for puncture.
  • the tip portion 55 of the tube 54 in the insertion portion 31 is covered with the sheath 34 (see FIG. 4).
  • the tip portion 55 of the tube 54 is Y (+) from the tip opening 34A of the sheath 34 as shown in the portion 100a of FIG. It protrudes in the direction.
  • the puncture portion 56 of the tip portion 55 punctures the tissue collection portion T from the body cavity inner wall S (see FIG. 1) as shown in the 100b portion of FIG. Enter.
  • the stylet 36 (see FIG. 2) is immersed about 5 mm to 10 mm from the tip opening 50, and then the tube tip 55 is projected to collect the tissue using the blade tip point. It is possible to insert into the location T. Further, by projecting the stylet 36 from the tube tip opening 50 again after 100b in FIG. 8, it is possible to discharge the stomach wall and other foreign substances mixed in at the time of insertion to the outside of the tube. This makes it possible to obtain only a sample more suitable for pathological diagnosis.
  • the blade tip point 62 located on the tip side of the blade tip points 62, 64, 66 functions as a cutting edge forming the starting point of insertion. Then, the blade tip points 64 and 66 following the blade tip point 62 are smoothly inserted into the tissue collection point T from the body cavity inner wall S while being guided by the blade surfaces 68 and 70 preceding the blade tip points 64 and 66, respectively. I will go.
  • the puncture portion 56 is composed of a plurality of blade tip points 62, 64, 66, the punctured tissue collection point T is securely held inside the tube 54 without escaping to the outside of the tube 54. can do. Further, since the insertion path of the tube 54 at this time is captured in the ultrasonic observation field of view, the insertion operation can be safely performed and the tissue collection point T can be reliably shot.
  • the puncture portion 56 pierces the living tissue (for example, a tumor) of the living tissue collection point T by the continuous protruding motion of the tube 54 in the Y (+) direction. Then, a part of the living tissue invades the inside of the tube 54 from the slit 58. Then, when the tube 54 further protrudes in the Y (+) direction in this state, the biological tissue invading the inside of the tube 54 is excised by the blade 60A of the tissue excision cutter 60, and the excised biological tissue is excised in the tube 54. It is collected inside the. As a result, a sufficient amount of biological tissue for making a definitive pathological diagnosis is collected by the tube 54.
  • the living tissue for example, a tumor
  • the first is a method using a syringe 33. After 100b in FIG. 8, the stylet 36 was completely removed from the luer lock portion 45 in the proximal direction, and then the syringe 33 was attached to the luer lock portion 45, and the inside of the tube 54 was held under negative pressure by operating the syringe 33. When carried out in this state, a suction force is generated in the slit 58, so that the amount of living tissue invading the slit 58 is further increased. Further, when the tube 54 is reciprocated inside the living tissue while the suction force is generated in the slit 58, the living tissue continuously invades the inside of the tube 54 through the slit 58, which is more. Living tissue can be efficiently collected.
  • the second suction method is a method using a stylet 36.
  • 100c in FIG. 8 is carried out while slowly pulling out the stylet 36 toward the base end of the luer lock portion 45, a slight negative pressure can be applied to the inside of the tube 54. This also makes it possible to obtain a large biological tissue.
  • the insertion portion 31 is extracted from the treatment tool insertion channel 21.
  • the tube 54 is moved in the Y ( ⁇ ) direction so that the tip portion 55 of the tube 54 is immersed in the sheath 34, and then the insertion portion is in this state. 31 may be extracted from the treatment tool insertion channel 21.
  • a syringe for pumping physiological saline for example, is connected to the luer lock portion 45 instead of the syringe 33 for suction, and the physiological saline is transferred from this syringe to the tube 54. Pump inside. As a result, the collected biological tissue can be transferred to a test tube or the like.
  • the stylet 36 can be reinserted from the luer lock portion 45 and protruded to the tube tip opening 50 to extrude and discharge the biological tissue inside the tube.
  • the tissue excision cutter 60 is provided at the base end 58C of the slit 58, so that the pathological definitive diagnosis can be made with a simple structure.
  • a sufficient amount of living tissue can be collected to perform the above.
  • the living tissue can be collected by the operation of moving the tube 54 in the Y (+) direction (the operation in the same direction as the puncture direction of the tube 54 with respect to the living tissue). It is possible to collect a living tissue by a simple operation as compared with the tissue collecting device of Patent Document 1 that rotates the tissue.
  • the blade 60A of the tissue excision cutter 60 is formed on the inner peripheral surface 54A of the tube 54, the blade 60A may pierce or get caught on the inner peripheral surface of the sheath 34 or the tip body 12.
  • the tube 54 can be smoothly moved forward and backward with respect to the inside of the sheath 34.
  • the blade 60A may be formed between the inner peripheral surface 54A and the outer peripheral surface 54B, for example. , May be formed on the same surface as the outer peripheral surface 54B. Further, the blade 60A may be formed at a position protruding outward from the tube 54 from the outer peripheral surface 54B. However, from the viewpoint of preventing the above-mentioned piercing and catching, it is preferable to form the blade 60A at a position where the blade 60A does not protrude from the outer peripheral surface 54B of the tube 54 to the outside of the tube 54.
  • the tissue excision cutter 60 since the tissue excision cutter 60 includes the above-mentioned inclined blade surface 60B, the biological tissue excised by the blade 60A can be reliably cut from the tissue collection point T by the inclined blade surface 60B.
  • the puncture portion 56 since the puncture portion 56 has a plurality of blade tip points 62, 64, 66, the puncture portion 56 can be easily inserted into the living tissue collection point T, and the punctured living body is inserted.
  • the tissue collection point T can be reliably held without escaping to the outside of the tube 54.
  • three blade tip points 62, 64, and 66 are illustrated, but at least one blade tip point is sufficient. However, it is preferable that a plurality of blade tip points are provided from the viewpoint of the above-mentioned insertion and holding.
  • a configuration is adopted in which the blade tip point 62 farthest from the slit 58 in the Y direction and the slit 58 are arranged to face each other in the radial direction (Z direction) of the tube 54. That is, since the structure is adopted in which the blade tip point 62 is sufficiently inserted into the living tissue collection point T and then the slit 58 is brought into contact with the living tissue, the living tissue can be appropriately collected.
  • a configuration in which the blade surfaces 68 and 70 are formed on the tip portion 55 of the tube 54 is adopted. That is, since the structure is adopted in which the inner peripheral surface 54A of the tube 54 always contacts the biological tissue collection point T before the outer peripheral surface 54B of the tube 54, the biological tissue can be appropriately collected.
  • the length L from the blade tip point 62 to the blade 60A of the tissue cutting cutter 60 is preferably 0.5 mm or more and 25.0 mm or less. ..
  • the starting point of insertion can be reliably formed by the blade tip point 62, and the entire length of the slit 58 can be easily inserted into the inside of the living tissue collection point T during the procedure, so that the living tissue is appropriately collected. can do.
  • the width B of the slit 58 in the circumferential direction of the tube 54 is smaller than the inner diameter ID (Inner Diameter) of the tube 54.
  • the outer diameter OD (Outer Diameter) of the tube 54 is preferably 0.3 mm or more and 3.0 mm or less. As a result, the tube 54 can be satisfactorily inserted into the sheath 34, and the degree of invasion to the patient can be suppressed.
  • the inner diameter ID of the tube 54 is preferably 0.1 mm or more and 2.5 mm or less. As a result, a large amount of biological tissue can be taken into the inside of the tube 54 while maintaining the strength of the tube 54.
  • the blade tip point 60C is formed on the blade 60A of the tissue cutting cutter 60.
  • the blade tip point 60C is formed in the blade 60A at the center of the tube 54 in the circumferential direction and is sharply formed toward the tip of the slit 58.
  • the blade tip point 60C functions as a cutting edge that forms the starting point of insertion with respect to the biological tissue that has invaded the inside of the tube 54 through the slit 58, and thus follows the blade tip point 60C.
  • the above-mentioned biological tissue can be smoothly excised by the blade 60A.
  • the tissue cutting cutter 60 shown in FIG. 9 has two inclined blade surfaces 60B and 60B connected on both sides in the X-axis direction with the blade tip point 60C interposed therebetween, and at least one inclined blade surface 60B is provided. You just have to prepare.
  • the blade tip point 62 is formed at the same position as the blade tip points 64 and 66 in the axial direction (Y direction) of the tube 54.
  • Other configurations are the same as the tube 54 shown in FIGS. 6-8.
  • the blade tip points 62, 64, and 66 are simultaneously inserted into the living tissue collection point T, but the inserted tissue is collected in the same manner as the tube 54 shown in FIGS. 6 to 8.
  • the portion T can be reliably held inside the tube 54 without escaping to the outside of the tube 54.
  • the position of the blade tip point 62 is not limited to the above position, and if the tissue collection point T can be prevented from escaping to the outside of the tube 54, the blade tip point 62 is larger than the blade tip points 64 and 66. It may be formed on the proximal end side of the tube 54.
  • the width B1 of the slit 58 is formed to be larger than the width B shown in FIG. Further, the width B1 is formed to be smaller than the inner diameter ID of the tube 54 (see FIG. 7).
  • the width B1 of the slit 58 is large, it is possible to allow more living tissue to penetrate into the tip portion 55.
  • the width B2 of the slit 58 is formed to be smaller than the width B shown in FIG. Further, the width B2 is formed to be smaller than the inner diameter ID of the tube 54 (see FIG. 7).
  • the biological tissue collection point T can be held by the blade tip point 62, and the biological tissue is inserted into the tip portion through the slit 58. It is possible to invade the inside of 55.
  • two blade tip points 72 and 74 are formed at the tip 55 of the tube 54.
  • the blade tip points 72 and 74 are formed on the extension lines of the inner peripheral surface 54A of the tube 54 in the Y (+) direction, respectively.
  • the blade tip points 72 and 74 are formed at the same positions in the axial direction (Y direction) of the tube 54. Has been done.
  • the blade tip points 72 and 74 are arranged to face each other in the radial direction (Z direction) of the tube 54, but with respect to the slit 58. Are not arranged to face each other, and are formed so as to be 90 degrees out of phase in the circumferential direction.
  • the biological tissue collection point T when the blade tip points 72 and 74 are inserted into the biological tissue collection point T, the biological tissue collection point T can be reliably held by the blade tip points 72 and 74, and the biological tissue collection point T can be reliably held through the slit 58. It is possible to allow the living tissue to invade the inside of the tip portion 55.
  • the seventh modification shown in FIG. 15 shows another modification in which the blade tip point 67 is provided and the blade tip point 67 is not arranged to face the slit 58 in the radial direction of the tube 54.
  • 200a in FIG. 15 is a perspective view of the tube 54
  • 200b in FIG. 15 is a side view of the tube 54 when the tube 54 is viewed from the X ( ⁇ ) direction side
  • 200c in FIG. 15 is a side view of the tube 54. Is a top view of the tube 54 as viewed from the Z (+) direction side.
  • the blade tip point 67 is formed on the tip side of the tube 54 with respect to the slit 58 in the axial direction (Y direction) of the tube 54. Further, the blade tip point 67 is formed on the blade tip point 66 side of the blade tip point 64 in the X direction, and extends from the blade tip point 66 toward the tip side of the tube 54 in the axial direction (Y direction) of the tube 54. Is formed in. Further, the blade tip point 67 is formed on the tip side of the tube 54 with respect to the blade tip points 66 and 68.
  • the blade tip point 67 is inserted into the living tissue collection point T prior to the blade tip points 64 and 66, but the tissue excision cutter 60 is provided at the base end 58C of the slit 58. Therefore, similarly to the tube 54 shown in FIG. 5, a sufficient amount of biological tissue can be collected for making a definitive diagnosis of pathology with a simple structure.
  • the tissue excision cutter 60 has an inclined blade surface 60D inclined so as to be separated from the central axis 54C of the tube 54 from the base end 58C of the slit 58 toward the tip of the slit 58. ing. Further, the blade 60A is formed at a position protruding outward from the tube 54 from the outer peripheral surface 54B of the tube 54.
  • the biological tissue that has invaded the inside of the tip portion 55 through the slit 58 is excised by the operation of the tube 54 in the Y (+) direction by the blade 60A of the tissue excision cutter 60. Can be collected inside the tip 55.
  • the inclined blade surface 60D functions as a guide surface for pushing the excised biological tissue into the tip portion 55.
  • the echo marker is a marker that makes it possible to visually display the position of the tube 54 under an ultrasonic image. By confirming this echo marker under the ultrasonic image, the position of the tip portion 55 of the tube 54 can be visually confirmed.
  • members that are the same as or similar to the tubes 54 shown in FIGS. 3 to 7 will be described with the same reference numerals.
  • the echo marker 76 provided on the outer peripheral surface 54B of the tube 54 is configured by densely forming a plurality of small-diameter recesses 78 on the outer peripheral surface 54B. As a result, unevenness is formed on the outer peripheral surface 54B, and the ultrasonic visibility is enhanced by this unevenness, so that the position of the tip portion 55 of the tube 54 can be confirmed under the ultrasonic image.
  • the echo marker 76 is provided only in the periphery including the base end 58C of the slit 58.
  • the position of the base end 58C of the slit 58 can be easily confirmed by confirming the position of the echo marker 76 under the ultrasonic image. As a result, it is possible to easily confirm whether or not the entire length of the slit 58 is stuck in the living tissue, so that a safe and reliable procedure can be realized.
  • the echo marker 76 is provided in the region on the distal end side (Y (+) direction side) of the tube 54 starting from the periphery including the proximal end 58C of the slit 58. Specifically, the echo marker 76 is provided on the entire outer peripheral surface 54B of the tube 54 from the above-mentioned starting point to the blade tip point 62. Although not shown in FIG. 18, the echo marker 76 is formed up to the Z ( ⁇ ) side surface of the blade tip point 62.
  • the position of the tip portion of the echo marker 76 under the ultrasonic image by confirming the position of the tip portion of the echo marker 76 under the ultrasonic image, the position of the tip portion 55 including the blade tip point 62 can be easily confirmed. Further, by confirming the position of the base end portion of the echo marker 76, the position of the base end 58C of the slit 58 can be easily confirmed. As a result, it is possible to easily confirm whether or not the entire length of the slit 58 is stuck in the living tissue, so that a safe and reliable procedure can be realized.
  • the echo marker 76 is provided in the region on the distal end side (Y (+) direction side) of the tube 54 starting from the periphery including the proximal end 58C of the slit 58. Specifically, the echo marker 76 is provided on the entire outer peripheral surface 54B of the tube 54 from the above-mentioned starting point to the blade tip points 64 and 66.
  • the position of the tip portion of the echo marker 76 by confirming the position of the tip portion of the echo marker 76 under the ultrasonic image, the position of the tip portion 55 including the blade tip points 64 and 66 can be easily confirmed, and the position of the tip portion 55 can be easily confirmed. Since the position of the base end 58C of the slit 58 can be confirmed by confirming the position of the base end portion of the echo marker 76, the same effect as in the second aspect can be obtained.
  • the echo marker 76 is provided in the region on the proximal end side (Y ( ⁇ ) direction side) of the tube 54 starting from the periphery including the proximal end 58C of the slit 58.
  • the position of the base end 58C of the slit 58 can be confirmed by confirming the position of the tip portion of the echo marker 76, so that the same effect as that of the first aspect can be obtained. ..
  • Each of the echo markers 76 shown in FIGS. 17 to 20 is configured so that the position of the base end 58C of the slit 58 can be confirmed, particularly in order to confirm whether or not the entire length of the slit 58 is stuck in the living tissue. It is a thing.
  • Such an echo marker 76 may be provided in the tubes 54 of the plurality of modifications shown in FIGS. 9 to 15.

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PCT/JP2020/045362 2019-12-13 2020-12-07 生検針及び組織採取装置 Ceased WO2021117649A1 (ja)

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IL293098A IL293098B1 (en) 2019-12-13 2020-12-07 Biopsy needle and tissue collection device
JP2021563932A JP7315707B2 (ja) 2019-12-13 2020-12-07 生検針及び組織採取装置
EP20898049.0A EP4074264B1 (en) 2019-12-13 2020-12-07 Biopsy needle and tissue collection device
CN202080082951.1A CN114746024B (zh) 2019-12-13 2020-12-07 活检针及组织采集装置
US17/745,437 US20220273274A1 (en) 2019-12-13 2022-05-16 Biopsy needle and tissue collecting device

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JP2019225567 2019-12-13

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WO2025069559A1 (ja) * 2023-09-29 2025-04-03 富士フイルム株式会社 システム

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CN116636885B (zh) * 2023-06-03 2025-08-29 中国医科大学附属盛京医院 一种消化科超声内窥镜穿刺活检针

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WO2025069559A1 (ja) * 2023-09-29 2025-04-03 富士フイルム株式会社 システム

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EP4074264A4 (en) 2023-01-11
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JP7315707B2 (ja) 2023-07-26
IL293098A (en) 2022-07-01
JPWO2021117649A1 (https=) 2021-06-17
EP4074264A1 (en) 2022-10-19
CN114746024B (zh) 2025-09-12
US20220273274A1 (en) 2022-09-01

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