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WO2025197290A1 - Aiguille d'échantillonnage de tissu - Google Patents

Aiguille d'échantillonnage de tissu

Info

Publication number
WO2025197290A1
WO2025197290A1 PCT/JP2025/002042 JP2025002042W WO2025197290A1 WO 2025197290 A1 WO2025197290 A1 WO 2025197290A1 JP 2025002042 W JP2025002042 W JP 2025002042W WO 2025197290 A1 WO2025197290 A1 WO 2025197290A1
Authority
WO
WIPO (PCT)
Prior art keywords
blade surface
surface portion
tissue collection
collection needle
tip
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.)
Pending
Application number
PCT/JP2025/002042
Other languages
English (en)
Japanese (ja)
Inventor
智弘 福田
佳世 神原
常生 藤木
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.)
Terumo Corp
Original Assignee
Terumo 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 Terumo Corp filed Critical Terumo Corp
Publication of WO2025197290A1 publication Critical patent/WO2025197290A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/42—Gynaecological or obstetrical instruments or methods

Definitions

  • the present invention relates to a tissue sampling needle.
  • Examples of the above procedures include transvaginal oocyte collection from the ovaries in infertility treatment, and percutaneous aspirating and observing cells from the lesion to diagnose the lesion.
  • one blade surface is tapered and linear, constructed by cutting a hollow member at an angle.
  • the medium sucked through the opening in the blade surface forms a flow field that is largely detached from the base end of the opening.
  • Cells sucked in along with the medium collide with the inner wall on the opposite side of the blade surface, which can impose stress on the cells.
  • the axial length of the blade surface becomes relatively long, making it difficult to properly position the blade surface relative to the target to be punctured.
  • the present invention aims to solve the above problems and provide a tissue collection needle that can reduce the load on cells when they are aspirated through the opening in the blade surface, and that can shorten the axial length of the blade surface.
  • a hollow body portion extending in an axial direction; a plurality of blade surface portions formed in a curved shape at the tip of the main body; an opening provided in the blade surface.
  • tissue sampling needle according to (1) further comprising a reduction portion provided on at least a part of the edge of the blade surface portion, which reduces separation of the suction flow from the blade surface portion.
  • the blade surface portion is When viewed from the front, the spline curve has specified tangent angles at two points on the tip end side and the base end side, The angle formed by the tangent on the tip side and the central axis is 1 to 20 degrees, The tissue sampling needle according to (1) or (2), wherein the angle formed by the tangent on the base end side and the central axis is 10 to 45 degrees.
  • a tissue collection needle configured as described above, multiple blade surface portions with openings are provided along the circumferential direction, so cells sucked through the opening of one blade surface portion are prevented from colliding with the inner wall of the main body portion due to cells sucked through the openings of other blade surface portions, and the flow of cells is directed along the central axis. This reduces the load on the cells when they are sucked through the openings of the blade surface portion. Furthermore, because the blade surface portion is formed in a curved shape, the axial length of the blade surface portion can be made shorter than with tissue collection needles whose blade surface portion is configured to be tapered and linear.
  • FIG. 1 is a front view showing a tissue collection needle according to an embodiment of the present invention.
  • FIG. 2 is a perspective view showing the vicinity of the tip of the tissue sampling needle according to the present embodiment.
  • FIG. 2 is a front cross-sectional view showing the vicinity of the tip of the tissue sampling needle according to the present embodiment.
  • FIG. 1 is a perspective view showing the vicinity of the tip of the tissue sampling needle according to the present embodiment, illustrating the region where the first reduction portion and the second reduction portion are provided.
  • 10 is a simulation result showing the flow lines of the suction flow of the tissue collection needle according to the present embodiment.
  • FIG. 10 is a perspective view showing a tissue sampling needle according to a comparative example.
  • 10 is a simulation result showing the flow lines of the suction flow of the tissue collection needle according to the comparative example.
  • FIG. 10 is a perspective view showing the vicinity of the tip of a tissue sampling needle according to a modified example.
  • FIG. 1 is a front view showing a tissue collection needle 1 according to an embodiment of the present invention.
  • Figure 2 is a perspective view showing the vicinity 1A of the tip of the tissue collection needle 1 according to this embodiment.
  • Figure 3 is a front cross-sectional view showing the vicinity 1A of the tip of the tissue collection needle 1 according to this embodiment.
  • Figure 4 is a perspective view showing the vicinity 1A of the tip of the tissue collection needle 1 according to this embodiment, and is a diagram for explaining the areas where the first reduction section 23 and the second reduction section 33 are provided.
  • the direction in which the tissue collection needle 1 extends is defined as the axial direction.
  • the side of the tissue collection needle 1 that is inserted into the living body is defined as the tip side, and the side opposite the tip side that is operated by the hand is defined as the base side.
  • the tissue collection needle 1 is inserted into biological tissue and collects cells by aspirating them through the first opening 22 of the first blade surface 20 and the second opening 32 of the second blade surface 30 of the tissue collection needle 1.
  • the tissue collection needle 1 according to this embodiment is used, for example, in procedures for transvaginally collecting eggs from ovaries in infertility treatment, and in procedures for diagnosing lesions by percutaneously aspirating and observing cells from the lesion.
  • the tissue collection needle 1 has a main body portion 10 extending in the axial direction, and a first blade surface portion (corresponding to the blade surface portion) 20 and a second blade surface portion (corresponding to the blade surface portion) 30 provided at the tip of the main body portion 10.
  • the second blade surface portion 30 is provided 180 degrees opposite the first blade surface portion 20 in the radial direction of the main body portion 10.
  • the main body 10 is configured as a hollow pipe.
  • the axial length of the main body 10 is, for example, 30 to 400 mm.
  • the outer diameter of the main body 10 is, for example, 0.3 to 5.2 mm.
  • the inner diameter of the main body 10 is, for example, 0.1 to 5.0 mm.
  • the first cutting edge portion 20 is formed in a tapered and curved shape. Specifically, as shown in Figure 1, the first cutting edge portion 20 is formed in a tapered shape that slopes downward and to the left as it approaches the tip and reaches the central axis C.
  • the first blade surface portion 20 has a first edge 21 formed along the circumferential direction, a first opening 22 provided on the inner circumference of the first edge 21, and a first reduction portion 23 provided on at least a portion of the first edge 21.
  • the first reduction portion 23 is formed to reduce separation of the suction flow from the first blade surface portion 20.
  • the first reduction section 23 has a fillet shape.
  • the radius of the fillet-shaped first reduction section 23 is not particularly limited, but is preferably 0.01 mm or greater. Furthermore, the radius of the fillet-shaped first reduction section 23 is preferably 20% or greater, and more preferably 45% or greater, of the thickness d of the main body section 10 (see Figure 3). With this configuration, detachment of the suction flow in the first reduction section 23 can be more effectively suppressed, and the load on the cells can be reduced.
  • the fillet-shaped first reduction portion 23 is preferably configured so that the fillet radius gradually increases from a position 75% from the tip 20A of the first opening 22 of the first blade surface portion 20 toward the base end 20B of the first opening 22 of the first blade surface portion 20. More preferably, the fillet radius gradually increases from a position P1 50% from the tip 20A of the first opening 22 of the first blade surface portion 20 toward the base end 20B of the first opening 22 of the first blade surface portion 20. Note that FIG. 4 illustrates a configuration in which the fillet radius gradually increases from a position 50% from the tip 20A of the first opening 22 of the first blade surface portion 20 toward the base end 20B of the opening 22 of the first blade surface portion 20. With this configuration, the first reduction portion 23 can more effectively reduce separation of the suction flow from the first blade surface portion 20.
  • the first cutting edge portion 20 is formed into a curved surface. Specifically, as shown in Figure 3, when viewed from the front, the first cutting edge portion 20 has a spline curve with specified tangent angles at two points on the distal end and proximal end. A more detailed explanation is provided below.
  • the angle ⁇ 1 between the tangent line L1 on the tip side and the central axis C is, for example, 1 to 20 degrees, and preferably 5 to 10 degrees. Note that the angle ⁇ 1 between the tangent line L1 on the tip side and the central axis C is not limited to the angle described above.
  • the angle ⁇ 2 between the tangent line L2 on the base end side and the central axis C is, for example, 0 to 60 degrees, preferably 10 to 45 degrees, and more preferably 20 to 30 degrees. Note that the angle ⁇ 2 between the tangent line L2 on the base end side and the central axis C is not limited to the angle described above. By setting the angle within the above range, the cutting surface length L3 of the first cutting surface portion 20 can be shortened and the first cutting surface portion 20 can be made to have a gentle curve.
  • the blade surface length L3 of the first blade surface portion 20 is, for example, no more than six times the outer diameter of the main body portion 10.
  • the blade surface length L3 of the first blade surface portion 20 is preferably no more than five times the outer diameter of the main body portion 10, and more preferably no more than four times.
  • the second blade surface portion 30 is provided on the opposite side of the main body portion 10 from the first blade surface portion 20 in the radial direction.
  • the second blade surface portion 30 has the same shape as the first blade surface portion 20, so its description will be omitted as appropriate.
  • the second cutting edge portion 30 is formed in a tapered and curved shape. Specifically, as shown in Figure 1, the second cutting edge portion 30 is formed in a tapered shape that slopes upward and to the left toward the tip and the central axis.
  • the second blade surface portion 30 has a second edge 31 formed along the circumferential direction, a second opening 32 provided on the inner circumference of the second edge 31, and a second reduction portion 33 provided on at least a portion of the second edge 31.
  • the second reduction portion 33 is formed to reduce separation of the suction flow from the second blade surface portion 30.
  • the material that can be used to compose the main body 10 includes metal materials such as stainless steel, aluminum, aluminum alloys, titanium, and titanium alloys, and resin materials such as polyethylene, polypropylene, polymethyl methacrylate, polycarbonate, polyamide, and polyethylene terephthalate.
  • metal materials such as stainless steel, aluminum, aluminum alloys, titanium, and titanium alloys
  • resin materials such as polyethylene, polypropylene, polymethyl methacrylate, polycarbonate, polyamide, and polyethylene terephthalate.
  • the second reduction section 33 has a fillet shape.
  • the radius of the fillet-shaped second reduction section 33 is preferably the same as the radius of the first reduction section 23. This configuration more effectively suppresses detachment of the suction flow in the second reduction section 33, thereby reducing the load on the cells.
  • the area where the second reduction section 33 is provided is the same as the area where the first reduction section 23 is provided. With this configuration, the second reduction section 33 can more effectively reduce separation of the suction flow from the second blade surface section 30.
  • the second blade surface portion 30 is formed with a curved surface.
  • the second blade surface portion 30 has a spline curve with specified tangent angles at two points on the distal and proximal ends when viewed from the front.
  • the angles formed by the tangent lines on the distal and proximal ends of the second blade surface portion 30 with the central axis can be the same as those of the first blade surface portion 20.
  • the blade surface length (not shown) of the second blade surface portion 30 can be shortened and the second blade surface portion 30 can be made to have a gentle curve.
  • the blade surface length of the second blade surface portion 30 can be the same as the blade surface length L3 of the first blade surface portion 20. By shortening the blade surface length in this way, it becomes easier to appropriately position the second blade surface portion 30 relative to the target to be punctured.
  • the leading edge 50 of the first blade surface portion 20 and the second blade surface portion 30 is formed in a pyramidal shape.
  • the pyramidal shape is not particularly limited, but may be a triangular pyramid or a square pyramid. This configuration can improve the puncture performance of the tissue collection needle 1.
  • Figure 5 shows the results of a simulation showing the flow lines of the suction flow of the tissue collection needle 1 according to this embodiment.
  • Figure 6 is a perspective view showing the vicinity of the tip of the tissue collection needle 900 according to the comparative example.
  • Figure 7 shows the results of a simulation showing the flow lines of the suction flow of the tissue collection needle 900 according to the comparative example.
  • the tissue collection needle 900 of the comparative example has a blade surface 920 formed by cutting a pipe diagonally, and does not have multiple blade surfaces.
  • the flow of medium sucked in through the first opening 22 of the first blade surface 20 prevents cells from colliding with the lower inner wall of the main body 10 due to the flow of medium sucked in through the second opening 32 of the second blade surface 30, and the flow of cells is directed along the central axis.
  • the first reduction section 23 and the second reduction section 33 are provided, thereby reducing separation of the suction flow from the first blade surface 20 and the second blade surface 30.
  • the first reduction section 23 and the second reduction section 33 are fillet-shaped, eliminating any sharp edges and reducing the load on the cells.
  • the axial length of the blade surface can be shorter than in a tissue collection needle with a tapered, linear blade surface.
  • the blade surface portion is provided on only one surface, and therefore the medium sucked from the blade surface portion 920 is largely detached from the base end 920B of the blade surface portion 920, as shown in Figure 7.
  • the cells sucked in along with the medium collide with the inner wall on the lower side of the main body portion 910, causing a load to be placed on the cells.
  • the base end 920B of the blade surface portion 920 is sharp, and therefore when cells are sucked from the blade surface portion 920, the cells come into contact with the sharp base end 920B, causing a load to be placed on the cells.
  • tissue collection needles 1 and 2 according to the present invention have been described above through the embodiments, but the present invention is not limited to the configurations described in the specification and can be modified as appropriate based on the claims.
  • the first reduction portion 23 and the second reduction portion 33 have a fillet shape, but the reduction portion is not limited to a fillet shape and may have a chamfered shape or a rectangular shape. Furthermore, the first reduction portion 23 and the second reduction portion 33 do not necessarily have to be provided.
  • the tissue collection needle 1 has two blade surface portions 20, 30, but the tissue collection needle 2 may have three blade surface portions 120, 130, 140, as shown in FIG. 8. It may also have a configuration with four or more blade surface portions.
  • first blade surface portion 20 and the second blade surface portion 30 have the same shape, but they may also have different shapes.
  • 1, 2 Tissue collection needle 10 main body, 20 first blade surface part (blade surface part), 21 First Edge (Edge), 22 first opening (opening), 23 first reduction section, 30 second blade surface part (blade surface part), 31 Second Edge (Edge), 32 second opening (opening), 33 second reduction section, 50 cutting edge, 120, 130, 140 blade surface part, C central axis, L1: tangent to the tip L2 Proximal tangent.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Le problème décrit par la présente invention est de fournir une aiguille d'échantillonnage de tissu qui est conçue pour supprimer la charge sur des cellules lors de l'aspiration de cellules à travers une ouverture dans une surface de lame et pour raccourcir la longueur de direction axiale de la surface de lame. La solution selon l'invention porte sur une aiguille d'échantillonnage de tissu 1 qui comprend : un corps 10 qui est creux et s'étend dans la direction axiale ; une pluralité de surfaces de lame 20, 30 qui sont disposées au niveau de la pointe distale du corps et constituées de plans incurvés ; et des ouvertures 22, 32 qui sont ménagées sur les surfaces de lame.
PCT/JP2025/002042 2024-03-18 2025-01-23 Aiguille d'échantillonnage de tissu Pending WO2025197290A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2024042521 2024-03-18
JP2024-042521 2024-03-18

Publications (1)

Publication Number Publication Date
WO2025197290A1 true WO2025197290A1 (fr) 2025-09-25

Family

ID=97139195

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2025/002042 Pending WO2025197290A1 (fr) 2024-03-18 2025-01-23 Aiguille d'échantillonnage de tissu

Country Status (1)

Country Link
WO (1) WO2025197290A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040191897A1 (en) * 2003-03-31 2004-09-30 The Cleveland Clinic Foundation Apparatus and method for harvesting bone marrow
US20100185117A1 (en) * 2007-09-04 2010-07-22 Lyon Thomas R Spinal aspiration apparatus
WO2016027854A1 (fr) * 2014-08-20 2016-02-25 オリンパス株式会社 Tube d'aiguille
JP2019528807A (ja) * 2016-07-01 2019-10-17 スワン サイトロジックス インコーポレイテッド 実体物の抽出および送達のための方法および装置
US20220287693A1 (en) * 2019-09-10 2022-09-15 Lenkbar, Llc Cutting head for tissue collection device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040191897A1 (en) * 2003-03-31 2004-09-30 The Cleveland Clinic Foundation Apparatus and method for harvesting bone marrow
US20100185117A1 (en) * 2007-09-04 2010-07-22 Lyon Thomas R Spinal aspiration apparatus
WO2016027854A1 (fr) * 2014-08-20 2016-02-25 オリンパス株式会社 Tube d'aiguille
JP2019528807A (ja) * 2016-07-01 2019-10-17 スワン サイトロジックス インコーポレイテッド 実体物の抽出および送達のための方法および装置
US20220287693A1 (en) * 2019-09-10 2022-09-15 Lenkbar, Llc Cutting head for tissue collection device

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