WO2023176531A1 - Lymphangiogenesis-inducing device - Google Patents

Lymphangiogenesis-inducing device Download PDF

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Publication number
WO2023176531A1
WO2023176531A1 PCT/JP2023/008208 JP2023008208W WO2023176531A1 WO 2023176531 A1 WO2023176531 A1 WO 2023176531A1 JP 2023008208 W JP2023008208 W JP 2023008208W WO 2023176531 A1 WO2023176531 A1 WO 2023176531A1
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WO
WIPO (PCT)
Prior art keywords
lymphangiogenesis
rod
shaped body
hub
inducing device
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PCT/JP2023/008208
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French (fr)
Japanese (ja)
Inventor
川▲崎▼麻奈美
石田昌弘
大沢航介
Original Assignee
テルモ株式会社
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Publication of WO2023176531A1 publication Critical patent/WO2023176531A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other 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
    • A61B10/02Instruments for taking cell samples or for biopsy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles

Definitions

  • the present invention relates to a lymphangiogenesis inducing device used in a procedure for inducing lymphangiogenesis.
  • Lymph vessels are one of the routes for collecting interstitial fluid in living bodies. When lymphatic vessels are blocked, interstitial fluid may accumulate, leading to lymphedema, which is associated with functional decline such as swelling and numbness in limbs such as arms and legs. Lymphedema is said to often develop due to lymph node dissection or radiation therapy performed as part of cancer treatment such as breast cancer treatment.
  • Lymphedema is a disease that is difficult to completely cure once it develops. Once it becomes chronic, it is difficult to improve easily, and if left untreated, it can become even more severe.
  • a treatment for such lymphedema a method of embedding filamentous substances into the subcutaneous tissue has been proposed.
  • Specially opened 2020-127607 Public Bill International Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Bulletin, Special Open 2021-104161 Public Bulletin, and “Brorson H. LipOSUCTION GIVES COMPLETE REDUCTE REDUCTION OF CHRONIC LARGE ARGE ARGE ARMP LYMP Hedema After Breast Cancer. ACTA Oncologica, 2000; 39 (3):407-20.”
  • lymphangiogenesis inducing device In procedures for inducing lymphangiogenesis, a more effective lymphangiogenesis inducing device is desired.
  • the present invention aims to solve the above problems.
  • a puncturing member having a distal end portion that can be inserted into living tissue, and a lumen extending in the axial direction from the distal end portion toward a proximal end; a rod-shaped body having a small outer diameter, inserted through the inner cavity while forming a gap between the rod-shaped body and displaceable in the front-rear direction along the inner cavity of the puncturing member; a closing part that is joined to the tip, has a larger cross section than the rod-like body, closes the inner cavity, and can protrude from the tip of the puncture member as the rod-like body is displaced;
  • the occlusion section is in a lymphangiogenesis inducing device that includes a wound forming section that inflicts a wound on the target site of the biological tissue.
  • the lymphangiogenesis inducing device of the above aspect allows the rod-shaped body and the occluding portion to reliably protrude from the puncturing member because the occluding portion prevents tissue fragments from entering the inner cavity of the puncturing member. Therefore, the lymphangiogenesis-inducing device can reliably form a wound that induces lymphangiogenesis at the target site.
  • FIG. 1 is a longitudinal cross-sectional view of the lymphangiogenesis-inducing device according to the first embodiment.
  • FIG. 2A is a cross-sectional view showing the relationship between the diameters of the occlusion part and the puncture member of the lymphangiogenesis-inducing device of FIG. 1, and
  • FIG. 2B is an enlarged sectional view of the rod-shaped body and the occlusion part.
  • FIG. 3A is an explanatory diagram of the step of puncturing the lymphangiogenesis-inducing device of FIG. 1 into living tissue
  • FIG. 3B is an explanatory diagram of the step of moving the lymphangiogenesis-inducing device of FIG. 1 to a target site.
  • FIG. 3A is an explanatory diagram of the step of puncturing the lymphangiogenesis-inducing device of FIG. 1 into living tissue
  • FIG. 3B is an explanatory diagram of the step of moving the lymphangiogenesis-inducing device of FIG. 1 to a target site.
  • FIG. 4A is an explanatory diagram of the step of protruding the rod-shaped body and the occlusion part from the puncture member in FIG. It is an explanatory view of the step of providing.
  • FIG. 5A is a cross-sectional view of the vicinity of the distal end of the lymphangiogenesis-inducing device according to the second embodiment
  • FIG. 5B is a perspective view of the rod-shaped body and the occluding portion of FIG. 5A
  • FIG. 6A is a cross-sectional view of the vicinity of the tip of the lymphangiogenesis-inducing device according to the third embodiment
  • FIG. 6B is a perspective view of the vicinity of the tip of the lymphangiogenesis-guiding device of FIG. 6A.
  • FIG. 7A is a perspective view of the closure part according to the fourth embodiment
  • FIG. 7B is a perspective view of the closure part according to the fifth embodiment
  • FIG. 8 is a cross-sectional view of the lymphangiogenesis-inducing device according to the sixth embodiment.
  • Lymphedema is said to be caused by lymphatic vessel dysfunction.
  • the blockage site forms a thick and enlarged wall of the vessel.
  • Such a vessel wall narrows or obstructs the flow path of the collecting lymphatic vessel, inhibits drainage of interstitial fluid of the lymphatic vessel, and causes swelling of the extremities.
  • the lymphangiogenesis-inducing device 10 is used to treat lymphatic tissue having the above-mentioned dysfunction.
  • This lymphangiogenesis inducing device 10 promotes the generation of new lymphatic vessels by creating a linear wound at a site that serves as a detour around the blocked site.
  • the lymphangiogenesis inducing device 10 includes a puncture member 12, a rod-shaped body 14, a blocking portion 16, a puncture member hub 18, and a rod-shaped body hub 20.
  • the puncture member 12 has an elongated cylindrical shape.
  • a puncturing member hub 18 is connected to the proximal end 12b of the puncturing member 12.
  • the puncturing member hub 18 has a shape that is easy to grasp, and is used to operate the puncturing member 12. An operator such as a doctor can operate the puncturing member 12 by holding the puncturing member hub 18.
  • the puncturing member 12 further includes a needle tip 121 and a lumen 122.
  • the needle tip 121 is formed at the tip 12a of the puncturing member 12.
  • the needle tip 121 has a blade surface 123 cut out diagonally with respect to the extending direction of the puncturing member 12 .
  • a sharp tip 124 that can puncture the living tissue 90 is formed at the tip of the blade surface 123 .
  • a lumen 122 is formed inside the puncture member 12.
  • the lumen 122 extends along the central axis of the puncture member 12, and passes through the puncture member 12 from the distal end 12a to the proximal end 12b in the axial direction.
  • the tip of the inner cavity 122 opens into a blade surface 123 .
  • a proximal end of lumen 122 opens into the interior of puncture member hub 18 .
  • Puncturing member hub 18 has a hollow portion 181 therein that communicates with lumen 122 .
  • the puncture member 12 and the lumen 122 have a circular cross section.
  • the cross-sectional shapes of the puncture member 12 and the lumen 122 are not limited to circular shapes, but may be rectangular or polygonal.
  • the piercing member 12 can be made of a metal material such as stainless steel, aluminum or an aluminum alloy, titanium, or a titanium alloy (for example, a nickel-titanium alloy).
  • the material of the puncture member 12 may be hard resin, ceramics, or the like.
  • the outer diameter D1 of the puncture member 12 is, for example, about 0.5 to 4.0 mm, and the inner diameter ⁇ of the inner cavity 122 is, for example, about 0.25 to 3.5 mm.
  • the rod-shaped body 14 is inserted into the inner cavity 122 of the puncture member 12.
  • the rod-shaped body 14 is an elongated cylindrical member that is approximately the same as or longer than the entire length of the puncture member 12 .
  • the rod-shaped body 14 may have a solid cylindrical shape, a prismatic tube shape, or a prismatic shape.
  • the proximal end portion 14b of the rod-shaped body 14 protrudes more proximally than the puncturing member 12.
  • a rod-shaped body hub 20 is connected to the base end portion 14b of the rod-shaped body 14.
  • the rod-shaped body hub 20 has a larger outer diameter than the rod-shaped body 14.
  • the operator can grasp the rod-shaped body hub 20 and perform an operation to move the rod-shaped body 14 forward (displaced toward the distal end) or backward (displaced toward the proximal end) in the axial direction.
  • the rod-shaped body 14 has an outer diameter D2 smaller than the inner diameter ⁇ of the inner cavity 122.
  • a gap 15 is formed between the rod-shaped body 14 and the inner cavity 122 .
  • the gap 15 is larger in the radial direction than the gap 13 described later.
  • the gap 15 reduces the contact area between the rod-like body 14 and the inner cavity 122, so that the rod-like body 14 can move forward or backward inside the inner cavity 122 with small sliding resistance.
  • the rod-shaped body 14 has a closing portion 16 at its tip 14a.
  • the occlusion part 16 constitutes the wound forming part 22 of the lymphangiogenesis inducing device 10 of this embodiment.
  • the closing portion 16 of this embodiment has a disk shape.
  • the closing portion 16 is oriented substantially perpendicular to the direction in which the rod-shaped body 14 extends.
  • the closing portion 16 is joined to the tip portion 14a of the rod-shaped body 14 by various methods such as welding, brazing, adhesion, and caulking. Therefore, the closing portion 16 is displaced integrally with the rod-shaped body 14.
  • the outer diameter D3 of the closing portion 16 is slightly smaller than the inner diameter ⁇ of the inner cavity 122 of the puncture member 12.
  • the difference between the outer diameter D3 of the closed portion 16 and the inner diameter ⁇ of the inner cavity 122 is, for example, 0.005 to 0.2 mm. In this way, most of the lumen 122 is occluded by the occluder 16.
  • a narrow gap 13 is formed between the inner cavity 122 and the closed portion 16.
  • This gap 13 is a gap between the closing portion 16 and the inner cavity 122, and is distinguished from the gap 15 between the rod-shaped body 14 and the inner cavity 122. The gap 13 prevents the passage of tissue fragments, thereby preventing the tissue fragments from clogging the lumen 122 on the proximal side of the closing portion 16.
  • the closing portion 16 extends in the axial direction with a length L1.
  • the dimension in the length L1 direction of the closing part 16 can be set as appropriate within a range where the forward movement of the closing part 16 is not hindered even if a piece of tissue enters the gap 13.
  • An example of the length L1 of the closing portion 16 can be three times or less the length of the blade surface 123 of the puncturing member 12 in the axial direction. More preferably, it can be made smaller than the inner diameter ⁇ of the inner cavity 122.
  • the length L1 of the closing portion 16 is smaller than the inner diameter ⁇ of the inner cavity 122, malfunction of the closing portion 16 is prevented even if a piece of tissue enters the gap 13.
  • Another example of the length L1 may be 0.2 to 3.49 mm. Note that if the length L1 of the closing portion 16 is made too small, the rigidity of the closing portion 16 will decrease and deformation will easily occur.
  • the closing part 16 of this embodiment has an edge 24 as a wound forming part 22.
  • the edge 24 is located at the outer periphery of the closure portion 16.
  • the closing portion 16 has edges 24 at the distal and proximal corners of the outer periphery, respectively.
  • the edge 24 is formed over the entire circumferential area of the closing portion 16 .
  • the edge 24 has a small radius of curvature of 0.5 mm or less, preferably 0.001 mm or more and 0.5 mm or less. When such an edge 24 moves forward or backward within the living tissue 90, it can form a wound in the living tissue 90.
  • the lymphangiogenesis inducing device 10 of this embodiment is configured as described above.
  • the procedure using the lymphangiogenesis inducing device 10 has the following steps.
  • the operator Prior to puncturing with the lymphangiogenesis inducing device 10, the operator confirms the occluded site of the lymphatic vessel in advance.
  • the site of lymphatic occlusion can be confirmed by methods such as ICG lymphatic angiography, lymphoscintigraphy, MRI, CT, and ultrasound imaging.
  • the operator confirms the new route of lymph vessels. For example, the operator identifies a blocked site of a lymphatic vessel and determines a route that connects to an unoccluded lymphatic vessel adjacent to the blocked site. Further, for example, the operator determines a route that bypasses the blocked site of the lymphatic vessel.
  • a step of puncturing the lymphangiogenesis inducing device 10 is performed.
  • the lymphangiogenesis inducing device 10 punctures the target site from the needle tip 121 of the puncture member 12.
  • the occlusion 16 is positioned near the distal end of the lumen 122 of the puncture member 12.
  • a step of advancing the lymphangiogenesis inducing device 10 to a predetermined site of the living tissue 90 is performed.
  • the needle tip 121 of the puncture member 12 is placed at a predetermined site where wounding is to be started.
  • a portion of the living tissue 90 enters the lumen 122.
  • Occlusion 16 prevents tissue debris from entering lumen 122 .
  • the tissue piece is prevented from entering into the proximal side of the closing part 16 . This can prevent the occurrence of a problem in which the gap 15 between the rod-shaped body 14 and the inner cavity 122 is clogged with tissue pieces and the rod-shaped body 14 cannot move forward.
  • a step of creating a wound using the occluding portion 16 is performed.
  • the rod-shaped body 14 and the closure part 16 are advanced toward the distal end with respect to the puncture member 12.
  • the above operation is performed by pushing the rod-shaped hub 20 toward the tip.
  • This step may be an operation of retracting the puncture member 12 to the proximal end.
  • an operation of pulling the puncture member 12 toward the proximal end and an operation of pushing the puncture member 12 toward the distal end may be performed alternately.
  • the closed portion 16 is exposed inside the living tissue 90 as shown in the figure.
  • a step of retracting the occluding portion 16 toward the proximal end or advancing the occluding portion 16 toward the distal end is performed inside the living tissue 90.
  • the closing portion 16 may be moved forward and backward multiple times. This step causes the edge 24 of the closure part 16 to rub against the living tissue 90.
  • many minute wounds are formed in the living tissue 90 by the edges 24 of the closed portion 16. Fine wounds are formed along the path along which the occlusion section 16 moves.
  • This step includes an operation of retracting the puncture member 12 proximally. This step is completed when the puncture member 12 and the closure part 16 are completely withdrawn from the living tissue 90.
  • wounding at one location is completed.
  • wounds are formed for all desired routes, and the procedure using the lymphangiogenesis inducing device 10 of this embodiment is completed.
  • the lymphangiogenesis-inducing device 10 of this embodiment can induce lymphangiogenesis.
  • the lymphangiogenesis inducing device 10A of this embodiment has a rod-shaped body 14A and an occlusion part 16 connected to form an L-shape when viewed from the side.
  • the same components as the lymphangiogenesis inducing device 10 of FIG. the puncture member hub 18 and the rod-shaped body hub 20 are the same as those in FIG. 1, so illustration and description thereof will be omitted.
  • the rod-shaped body 14A has an arcuate cross-sectional shape.
  • the rod-shaped body 14A has a thin plate shape that is curved along the inner cavity 122 of the puncture member 12.
  • the closing portion 16 is integrally connected to the rod-shaped body 14A.
  • the closing portion 16 is connected to the rod-shaped body 14A via a bent portion 161.
  • the lymphangiogenesis inducing device 10A of this embodiment is configured as described above.
  • the lymphangiogenesis inducing device 10A has the same effects as the lymphangiogenesis inducing device 10 of the first embodiment.
  • the rod-shaped body 14A and the closing portion 16 can be formed by pressing a single metal plate, simplifying the structure and manufacturing process.
  • the lymphangiogenesis inducing device 10B of this embodiment has a closing portion 16A that is inclined with respect to the central axis of the puncture member 12, as shown in FIG. 6A.
  • symbol is attached
  • the puncture member hub 18 and the rod-shaped body hub 20 are the same as those in FIG. 1, so illustration and description thereof will be omitted.
  • the obstructing portion 16A has an inclination angle with respect to the axial direction that is equal to the inclination angle of the blade surface 123 of the puncturing member 12 with respect to the axial direction.
  • the closing portion 16A is arranged at the same position as the needle tip 121, and the closing portion 16A forms the same plane as the blade surface 123.
  • the closing portion 16A has an edge 24A at a corner of the outer periphery. The closing portion 16A inflicts a wound on the living tissue 90 by the edge 24A.
  • the lymphangiogenesis inducing device 10B of this embodiment has the same effects as the lymphangiogenesis inducing device 10 of FIG. 1. Furthermore, the lymphangiogenesis-inducing device 10B of this embodiment can further reduce the amount of tissue debris that invades the lumen 122. Thereby, the lymphangiogenesis inducing device 10B can more effectively prevent malfunctions due to clogging of the lumen 122 with tissue debris. Further, since the closing portion 16A is inclined with respect to the rod-shaped body 14, when the closing portion 16A is advanced through the rod-shaped body 14, it is less likely to receive resistance inside the living tissue 90, and the forward operation can be performed easily.
  • the closing portion 16B of this embodiment has a side cutter.
  • the closing portion 16B has a plurality of sawtooths 26 on the tip and outer periphery. This closing portion 16B can be used in place of the closing portion 16 in FIG. 1.
  • the closing portion 16B has a plurality of sawtooths 26a extending radially in the radial direction toward the distal end, and sawtooth teeth 26b extending toward the outer periphery.
  • the saw teeth 26b protrude toward the outer periphery.
  • the sharp ridgeline portions of these sawtooths 26a and 26b constitute the edge 24B of this embodiment.
  • the sawtooth 26b has an inclined surface that generates a directional force that moves forward or backward when the closing portion 16B is rotated.
  • the closing portion 16B of this embodiment can inflict fine wounds on the living tissue 90 not only by forward and backward movement but also by rotational movement. Moreover, the closing part 16B moves forward by the rotational movement, and can inflict a wound on the living tissue 90 as the closing part 16B moves forward.
  • the closing portion 16C of this embodiment has a conical surface 162 on the outer periphery.
  • This closing portion 16C can replace the closing portion 16 in FIG. 1.
  • the closing portion 16C has a conical surface 162 whose outer diameter gradually decreases toward the tip.
  • the closed portion 16C has the largest outer diameter at the proximal end.
  • the closing portion 16C blocks the lumen 122 (see FIG. 1) at the proximal end, thereby preventing tissue fragments from entering the lumen 122.
  • closing portion 16C of this embodiment may have a completely conical shape without having a flat surface at the tip. Further, the closing portion 16C may have a conical surface having the largest outer diameter on the distal end side and gradually decreasing the outer diameter toward the proximal end side.
  • the lymphangiogenesis inducing device 10C of the present embodiment includes a puncture member 12, a rod-shaped body 14A, a blocking portion 16, a puncture member hub 18, a rod-shaped body hub 20, a wire 28, It has a wire hub 30.
  • the puncture member 12, the puncture member hub 18, and the rod-shaped body hub 20 are the same as the puncture member 12, the puncture member hub 18, and the rod-shaped body hub 20 in FIG.
  • the rod-shaped body 14A and the occlusion part 16 are the same as the rod-shaped body 14A and the occlusion part 16 shown in FIGS. 5A and 5B.
  • the wire 28 is made of, for example, a metal wire.
  • the wire 28 has one end 28a connected to the closure part 16.
  • the wire 28 may be connected to the tip side of the rod-shaped body 14A. That is, one end 28a of the wire 28 is connected to a portion of the rod-shaped body 14A or the closure portion 16 that can protrude from the puncture member 12. A portion of the wire 28 on the other end 28b side is accommodated in the gap 15 between the inner cavity 122 of the puncture member 12 and the rod-shaped body 14A.
  • the other end 28b of the wire 28 is joined to a wire hub 30.
  • the wire hub 30 is attached to the rod-shaped body hub 20.
  • the wire hub 30 is movable relative to the puncture member hub 18 and the rod-shaped body hub 20 in the axial direction.
  • the lymphangiogenesis inducing device 10C of this embodiment can repeatedly relax and tension the wire 28 by operating the wire hub 30 inside the living tissue 90.
  • the subcutaneous tissue mainly adipose tissue
  • the subcutaneous tissue in which interstitial fluid accumulates is flexible.
  • the wire 28 is relaxed, the biological tissue 90 enters the gap 13 between the wire 28 and the rod-shaped body 14A.
  • the wire hub 30 retreats, the wire 28 is tensed, and the flexible living tissue 90 (mainly fat tissue) that has entered between the wire 28 and the rod-shaped body 14A is cut, thereby creating a wound.
  • Such a wound induces new lymphatic vessel formation during the healing process.
  • the lymphangiogenesis inducing device 10C of this embodiment is capable of inflicting a wound by relaxing and tensioning the wire 28 in addition to inflicting a wound by advancing and retracting the rod-shaped body 14A and the occlusion part 16. .
  • the wound can be applied by the wire 28 over a wider range than the movement range of the closure part 16. Therefore, the lymphangiogenesis inducing device 10C can more effectively promote the generation of lymphatic vessels.
  • lymphangiogenesis inducing devices 10, 10A, 10B, and 10C are summarized as follows.
  • Lymphangiogenesis induction devices 10, 10A, 10B, 10C include a puncture member 12 having a distal end 12a that can be inserted into living tissue 90, and a lumen 122 extending in the axial direction from the distal end toward the proximal end. , having an outer diameter smaller than the inner cavity of the puncturing member, passing through the internal cavity while forming a gap 15 between the puncturing member and extending in the front-rear direction along the internal cavity of the puncturing member.
  • a displaceable rod-shaped body 14 is joined to the tip of the rod-shaped body and has a larger cross section than the rod-shaped body to close the inner cavity, and as the rod-shaped body is displaced, the tip of the puncturing member occlusion parts 16, 16A, 16B, and 16C that can protrude from the body tissue, and the occlusion part has a wound forming part 22 that inflicts a wound on the target part of the living tissue.
  • the rod-shaped body and the occluding portion can reliably protrude from the puncturing member because the occluding portion prevents tissue fragments from entering the inner lumen of the puncturing member. Therefore, the lymphangiogenesis-inducing device can reliably form a wound that induces lymphangiogenesis at the target site.
  • the wound forming part may have sharp edges 24, 24A, and 24B formed on the outer periphery of the occlusion part.
  • This lymphangiogenesis inducing device can create a wound that induces new lymphatic vessel generation at a predetermined site by moving the occluded part within the living tissue.
  • the wound forming part may have an uneven shape formed on the surface of the occluding part.
  • This lymphangiogenesis inducing device can form minute wounds by rubbing the uneven shape against living tissue.
  • the wound forming section may have a side cutter formed in the occlusion section.
  • This lymphangiogenesis-inducing device can efficiently form a wound in living tissue with a large number of saw teeth.
  • the occlusion portion may have a disk shape.
  • This lymphangiogenesis-inducing device can simplify the structure and manufacturing process, making it easy to manufacture.
  • the wound forming section may include a wire 28 that has one end 28a attached to the occlusion section and that is inserted through the inside of the lumen.
  • This lymphangiogenesis-inducing device can form a wound in a wider range by relaxing and tensioning the wire 28.
  • the rod-shaped body may be movable in the axial direction while being rotated around the axis.
  • This lymphangiogenesis-inducing device can efficiently inflict a large number of wounds by moving in the axial direction with rotational motion.
  • the above-mentioned lymphangiogenesis inducing device includes a puncture member hub 18 that supports the proximal end of the puncture member, and a rod-shaped body hub 20 that supports the base end of the rod-shaped body, and the rod-shaped body hub supports the puncture member.
  • the rod-shaped body By moving the rod-shaped body relative to the member hub, the rod-shaped body may be able to be protruded from and retracted from the distal end portion of the puncturing member.
  • This lymphangiogenesis inducing device allows the rod-shaped body and the obstruction portion to protrude through the rod-shaped body hub, and has excellent operability.
  • the above-mentioned lymphangiogenesis inducing device includes a puncture member hub that supports the proximal end of the puncture member, a rod-shaped body hub that supports the base end of the rod-shaped body, and a wire hub 30 joined to the other end 28b of the wire.
  • the rod-shaped body hub is moved relative to the puncturing member hub so that the rod-shaped body can be protruded and retracted from the tip of the puncturing member, and the wire hub is moved relative to the puncturing member hub.
  • the wire may be relaxed or tensioned by moving it relative to the wire.
  • This lymphangiogenesis inducing device can manipulate the relaxation and tension of the wire through the wire hub, and has excellent operability.

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Abstract

This lymphangiogenesis-inducing device (10) comprises: a puncture member (12) that can be inserted into biological tissue (90); a rod-shaped body (14) inserted through the lumen (122) of the puncture member (12); and a closing part (16) that is joined to the distal end of the rod-shaped body (14) and has a cross-section larger than that of the rod-shaped body (14) to thereby close the lumen (122), the closing part (16) being capable of projecting from a distal-end part (12a) of the puncture member (12) in association with displacement of the rod-shaped body (14). The closing part (16) has a cut formation part (22) for forming a cut at a target site of the biological tissue (90).

Description

リンパ管新生誘導デバイスLymphangiogenesis induction device
 本発明は、リンパ管新生を誘導する手技に用いるリンパ管新生誘導デバイスに関する。 The present invention relates to a lymphangiogenesis inducing device used in a procedure for inducing lymphangiogenesis.
 生体内の組織間液を回収する経路の一つとしてリンパ管がある。リンパ管が閉塞すると、組織間液が滞留して腕や足等の四肢がむくみや感覚麻痺等の機能低下を伴うリンパ浮腫を発症することがある。リンパ浮腫は、乳癌治療等の癌治療の一環として行われるリンパ節郭清や放射線治療によって発症することが多いとされる。 Lymph vessels are one of the routes for collecting interstitial fluid in living bodies. When lymphatic vessels are blocked, interstitial fluid may accumulate, leading to lymphedema, which is associated with functional decline such as swelling and numbness in limbs such as arms and legs. Lymphedema is said to often develop due to lymph node dissection or radiation therapy performed as part of cancer treatment such as breast cancer treatment.
 リンパ浮腫は、いったん発症すると完治させることが困難な疾患である。慢性化させると、簡単には改善し難く、放置するとさらに重症化するとされる。このようなリンパ浮腫の治療法として、皮下組織に糸状物質を埋め込む方法が提案されている。例えば、特開2020-127607号公報、国際公開第2020/189157号、特開2021-104161号公報、及び“Brorson H. Liposuction Gives Complete Reduction of Chronic Large Arm Lymphedema After Breast Cancer. Acta Oncologica, 2000; 39(3):407-20.”がある。 Lymphedema is a disease that is difficult to completely cure once it develops. Once it becomes chronic, it is difficult to improve easily, and if left untreated, it can become even more severe. As a treatment for such lymphedema, a method of embedding filamentous substances into the subcutaneous tissue has been proposed. For example, Specially opened 2020-127607 Public Bill, International Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Public Bulletin, Special Open 2021-104161 Public Bulletin, and “Brorson H. LipOSUCTION GIVES COMPLETE REDUCTE REDUCTION OF CHRONIC LARGE ARGE ARGE ARMP LYMP Hedema After Breast Cancer. ACTA Oncologica, 2000; 39 (3):407-20.”
 また、“Joseph MR et al., Characterization of lymphangiogenesis in a model of adult skin regeneration. Am J Physiol Heart Circ Physiol. 2006 Sep; 291(3): H1402-H1410.”及び“Tammela & Alitalo, Lymphangiogenesis: Molecular mechanisms and future promise. Cell. 2010 Feb 19; 140(4): 460-76.”は、一般的な創傷の治癒過程で生じるリンパ管の新生の機序について報告する。上記のJoseph MR et alは、創傷に対する免疫反応によりマクロファージが集積し、集積したマクロファージがVEGF-C(血管内皮増殖因子C)を生産することで、リンパ管の新生が誘導されることを報告する。また、上記のTammela & Alitaloは、リンパ管の新生は、既存のリンパ管を起点にして、既存のリンパ管から出芽するように生じることを報告する。 291(3): H1402-H1410.” and “Tammela & Alitalo, Lymphangiogenesis: Molecular mechanism.” s and future promise. Cell. 2010 Feb 19; 140(4): 460-76.” reports on the mechanism of lymphatic vessel formation that occurs during the healing process of common wounds. Joseph MR et al, mentioned above, reported that macrophages accumulate as a result of the immune response to a wound, and that the accumulated macrophages produce VEGF-C (vascular endothelial growth factor C), which induces the generation of lymphatic vessels. . Additionally, Tammela & Alitalo mentioned above report that new lymphatic vessels originate from existing lymphatic vessels and appear to bud from the existing lymphatic vessels.
 リンパ管新生を誘導する手技において、さらに効果の高いリンパ管新生誘導デバイスが望まれる。 In procedures for inducing lymphangiogenesis, a more effective lymphangiogenesis inducing device is desired.
 本発明は、上記した課題を解決することを目的とする。 The present invention aims to solve the above problems.
 以下の開示の一観点は、生体組織に挿入可能な先端部と、前記先端部から基端に向けて軸線方向に延びる内腔と、を有する穿刺部材と、前記穿刺部材の前記内腔よりも小さな外径を有し、前記内腔との間に隙間を形成しつつ前記内腔を挿通し、前記穿刺部材の前記内腔に沿って前後方向に変位可能な棒状体と、前記棒状体の先端に接合され、前記棒状体よりも大きな断面を有することで前記内腔を閉塞するとともに、前記棒状体の変位に伴って前記穿刺部材の前記先端部から突出可能な閉塞部と、を備え、前記閉塞部は、前記生体組織の対象部位に創傷を与える創傷形成部を有する、リンパ管新生誘導デバイスにある。 One aspect of the following disclosure provides a puncturing member having a distal end portion that can be inserted into living tissue, and a lumen extending in the axial direction from the distal end portion toward a proximal end; a rod-shaped body having a small outer diameter, inserted through the inner cavity while forming a gap between the rod-shaped body and displaceable in the front-rear direction along the inner cavity of the puncturing member; a closing part that is joined to the tip, has a larger cross section than the rod-like body, closes the inner cavity, and can protrude from the tip of the puncture member as the rod-like body is displaced; The occlusion section is in a lymphangiogenesis inducing device that includes a wound forming section that inflicts a wound on the target site of the biological tissue.
 上記観点のリンパ管新生誘導デバイスは、閉塞部が穿刺部材の内腔への組織片の侵入を阻止することで、棒状体及び閉塞部の穿刺部材からの突出動作を確実に行える。したがって、リンパ管新生誘導デバイスは、対象部位にリンパ管の新生を誘導する創傷を確実に形成できる。 The lymphangiogenesis inducing device of the above aspect allows the rod-shaped body and the occluding portion to reliably protrude from the puncturing member because the occluding portion prevents tissue fragments from entering the inner cavity of the puncturing member. Therefore, the lymphangiogenesis-inducing device can reliably form a wound that induces lymphangiogenesis at the target site.
図1は、第1実施形態に係るリンパ管新生誘導デバイスの縦断面図である。FIG. 1 is a longitudinal cross-sectional view of the lymphangiogenesis-inducing device according to the first embodiment. 図2Aは、図1のリンパ管新生誘導デバイスの閉塞部と穿刺部材との径の関係を示す横断面図であり、図2Bは棒状体及び閉塞部の拡大断面図である。FIG. 2A is a cross-sectional view showing the relationship between the diameters of the occlusion part and the puncture member of the lymphangiogenesis-inducing device of FIG. 1, and FIG. 2B is an enlarged sectional view of the rod-shaped body and the occlusion part. 図3Aは、図1のリンパ管新生誘導デバイスを生体組織へ穿刺するステップの説明図であり、図3Bは図1のリンパ管新生誘導デバイスを目的部位に移動させるステップの説明図である。FIG. 3A is an explanatory diagram of the step of puncturing the lymphangiogenesis-inducing device of FIG. 1 into living tissue, and FIG. 3B is an explanatory diagram of the step of moving the lymphangiogenesis-inducing device of FIG. 1 to a target site. 図4Aは、図1の棒状体及び閉塞部を穿刺部材から突出させるステップの説明図であり、図4Bは棒状体及び閉塞部を生体組織の内部で移動させて生体組織に線状の創傷を付与するステップの説明図である。FIG. 4A is an explanatory diagram of the step of protruding the rod-shaped body and the occlusion part from the puncture member in FIG. It is an explanatory view of the step of providing. 図5Aは、第2実施形態に係るリンパ管新生誘導デバイスの先端付近の断面図であり、図5Bは図5Aの棒状体及び閉塞部の斜視図である。FIG. 5A is a cross-sectional view of the vicinity of the distal end of the lymphangiogenesis-inducing device according to the second embodiment, and FIG. 5B is a perspective view of the rod-shaped body and the occluding portion of FIG. 5A. 図6Aは、第3実施形態に係るリンパ管新生誘導デバイスの先端付近の断面図であり、図6Bは、図6Aのリンパ管新生誘導デバイスの先端付近の斜視図である。FIG. 6A is a cross-sectional view of the vicinity of the tip of the lymphangiogenesis-inducing device according to the third embodiment, and FIG. 6B is a perspective view of the vicinity of the tip of the lymphangiogenesis-guiding device of FIG. 6A. 図7Aは、第4実施形態に係る閉塞部の斜視図であり、図7Bは、第5実施形態に係る閉塞部の斜視図である。FIG. 7A is a perspective view of the closure part according to the fourth embodiment, and FIG. 7B is a perspective view of the closure part according to the fifth embodiment. 図8は、第6実施形態に係るリンパ管新生誘導デバイスの断面図である。FIG. 8 is a cross-sectional view of the lymphangiogenesis-inducing device according to the sixth embodiment.
(第1実施形態)
 リンパ浮腫は、リンパ管の機能障害によって生じるとされる。リンパ管に閉塞部位が発生すると、閉塞部位は、厚く肥大した管壁を形成する。このような管壁は、集合リンパ管の流路を狭窄又は閉塞し、リンパ管の組織間液の排出を阻害し、四肢のむくみを生じさせる。
(First embodiment)
Lymphedema is said to be caused by lymphatic vessel dysfunction. When a blockage site occurs in a lymphatic vessel, the blockage site forms a thick and enlarged wall of the vessel. Such a vessel wall narrows or obstructs the flow path of the collecting lymphatic vessel, inhibits drainage of interstitial fluid of the lymphatic vessel, and causes swelling of the extremities.
 本実施形態に係るリンパ管新生誘導デバイス10は、上記の機能障害を有するリンパ管組織に対する治療に用いられる。このリンパ管新生誘導デバイス10は、閉塞部位の迂回路となる部位に線状の創傷を付与することで、新たなリンパ管の新生を促す。 The lymphangiogenesis-inducing device 10 according to the present embodiment is used to treat lymphatic tissue having the above-mentioned dysfunction. This lymphangiogenesis inducing device 10 promotes the generation of new lymphatic vessels by creating a linear wound at a site that serves as a detour around the blocked site.
 図1に示すように、リンパ管新生誘導デバイス10は、穿刺部材12と、棒状体14と、閉塞部16と、穿刺部材ハブ18と、棒状体ハブ20とを有する。穿刺部材12は、長尺な筒状の形状を有する。穿刺部材12の基端部12bには、穿刺部材ハブ18が接続されている。穿刺部材ハブ18は、把持しやすい形状を有しており、穿刺部材12の操作に用いられる。医師等の操作者は、穿刺部材ハブ18を持って、穿刺部材12の操作を行うことができる。 As shown in FIG. 1, the lymphangiogenesis inducing device 10 includes a puncture member 12, a rod-shaped body 14, a blocking portion 16, a puncture member hub 18, and a rod-shaped body hub 20. The puncture member 12 has an elongated cylindrical shape. A puncturing member hub 18 is connected to the proximal end 12b of the puncturing member 12. The puncturing member hub 18 has a shape that is easy to grasp, and is used to operate the puncturing member 12. An operator such as a doctor can operate the puncturing member 12 by holding the puncturing member hub 18.
 穿刺部材12は、さらに針先121と内腔122とを有する。針先121は、穿刺部材12の先端部12aに形成されている。針先121は、穿刺部材12の延在方向に対して斜めに切り欠かれた刃面123を有する。刃面123の先端には、生体組織90に穿刺可能な鋭利なチップ124が形成される。 The puncturing member 12 further includes a needle tip 121 and a lumen 122. The needle tip 121 is formed at the tip 12a of the puncturing member 12. The needle tip 121 has a blade surface 123 cut out diagonally with respect to the extending direction of the puncturing member 12 . A sharp tip 124 that can puncture the living tissue 90 is formed at the tip of the blade surface 123 .
 内腔122は、穿刺部材12の内部に形成される。内腔122は、穿刺部材12の中心軸線に沿って延びており、穿刺部材12の先端部12aから基端部12bまでを軸線方向に貫通する。内腔122の先端は、刃面123に開口する。内腔122の基端は、穿刺部材ハブ18の内部に開口する。穿刺部材ハブ18は、内部に内腔122と連通する中空部181を有する。図2Aに示すように、穿刺部材12及び内腔122は、断面が円形に形成されている。穿刺部材12及び内腔122の断面形状は円形に限定されるものではなく、矩形又は多角形状であってもよい。 A lumen 122 is formed inside the puncture member 12. The lumen 122 extends along the central axis of the puncture member 12, and passes through the puncture member 12 from the distal end 12a to the proximal end 12b in the axial direction. The tip of the inner cavity 122 opens into a blade surface 123 . A proximal end of lumen 122 opens into the interior of puncture member hub 18 . Puncturing member hub 18 has a hollow portion 181 therein that communicates with lumen 122 . As shown in FIG. 2A, the puncture member 12 and the lumen 122 have a circular cross section. The cross-sectional shapes of the puncture member 12 and the lumen 122 are not limited to circular shapes, but may be rectangular or polygonal.
 穿刺部材12は、例えば、ステンレス鋼、アルミニウム又はアルミニウム合金、チタン、チタン合金(例えば、ニッケルチタン合金)のような金属材料で形成できる。穿刺部材12の材料は、硬質樹脂又はセラミックス等であってもよい。穿刺部材12の外径D1は、例えば、0.5~4.0mm程度であり、内腔122の内径φは、例えば、0.25~3.5mm程度である。 The piercing member 12 can be made of a metal material such as stainless steel, aluminum or an aluminum alloy, titanium, or a titanium alloy (for example, a nickel-titanium alloy). The material of the puncture member 12 may be hard resin, ceramics, or the like. The outer diameter D1 of the puncture member 12 is, for example, about 0.5 to 4.0 mm, and the inner diameter φ of the inner cavity 122 is, for example, about 0.25 to 3.5 mm.
 図1に示すように、棒状体14は、穿刺部材12の内腔122に挿入されている。棒状体14は、穿刺部材12の全長と同程度又はこれよりも長い長尺な円筒状の部材である。棒状体14は、中実な円柱状であってもよく、角筒状又は角柱状であってもよい。棒状体14の基端部14bは、穿刺部材12よりも基端側に突出する。棒状体14の基端部14bには、棒状体ハブ20が接続されている。棒状体ハブ20は、棒状体14よりも大きな外径を有している。操作者は、棒状体ハブ20を把持して棒状体14を軸線方向に前進(先端側に向けた変位)又は後退(基端側に向けた変位)させる操作を行うことができる。図2Aに示すように、棒状体14は、その外径D2が内腔122の内径φよりも小さい。棒状体14は、内腔122との間に隙間15を形成する。隙間15は、後述する隙間13よりも径方向に大きい。隙間15は、棒状体14と内腔122との接触部分を減らして棒状体14を内腔122の内部で小さな摺動抵抗で前進又は後退できる。 As shown in FIG. 1, the rod-shaped body 14 is inserted into the inner cavity 122 of the puncture member 12. The rod-shaped body 14 is an elongated cylindrical member that is approximately the same as or longer than the entire length of the puncture member 12 . The rod-shaped body 14 may have a solid cylindrical shape, a prismatic tube shape, or a prismatic shape. The proximal end portion 14b of the rod-shaped body 14 protrudes more proximally than the puncturing member 12. A rod-shaped body hub 20 is connected to the base end portion 14b of the rod-shaped body 14. The rod-shaped body hub 20 has a larger outer diameter than the rod-shaped body 14. The operator can grasp the rod-shaped body hub 20 and perform an operation to move the rod-shaped body 14 forward (displaced toward the distal end) or backward (displaced toward the proximal end) in the axial direction. As shown in FIG. 2A, the rod-shaped body 14 has an outer diameter D2 smaller than the inner diameter φ of the inner cavity 122. A gap 15 is formed between the rod-shaped body 14 and the inner cavity 122 . The gap 15 is larger in the radial direction than the gap 13 described later. The gap 15 reduces the contact area between the rod-like body 14 and the inner cavity 122, so that the rod-like body 14 can move forward or backward inside the inner cavity 122 with small sliding resistance.
 図1に示すように、棒状体14は、その先端部14aに閉塞部16を有する。閉塞部16は、本実施形態のリンパ管新生誘導デバイス10の創傷形成部22を構成する。本実施形態の閉塞部16は、ディスク形状を有する。閉塞部16は、棒状体14の延在方向に対して略垂直を向いている。閉塞部16は、棒状体14の先端部14aに溶接、ろう付け、接着、カシメ等の種々の方法により接合されている。したがって、閉塞部16は、棒状体14と一体的に変位する。 As shown in FIG. 1, the rod-shaped body 14 has a closing portion 16 at its tip 14a. The occlusion part 16 constitutes the wound forming part 22 of the lymphangiogenesis inducing device 10 of this embodiment. The closing portion 16 of this embodiment has a disk shape. The closing portion 16 is oriented substantially perpendicular to the direction in which the rod-shaped body 14 extends. The closing portion 16 is joined to the tip portion 14a of the rod-shaped body 14 by various methods such as welding, brazing, adhesion, and caulking. Therefore, the closing portion 16 is displaced integrally with the rod-shaped body 14.
 図2Aに示すように、閉塞部16の外径D3は、穿刺部材12の内腔122の内径φよりも僅かに小さい。閉塞部16の外径D3と、内腔122の内径φとの差は、例えば、0.005~0.2mmである。このように、内腔122の大部分は、閉塞部16によって閉塞される。内腔122と閉塞部16との間には、狭い隙間13が形成される。この隙間13は、閉塞部16と内腔122との間の隙間であり、棒状体14と内腔122との隙間15と区別される。隙間13は、組織片の通過を阻止することで、閉塞部16より基端側の内腔122の組織片による閉塞を阻止する。 As shown in FIG. 2A, the outer diameter D3 of the closing portion 16 is slightly smaller than the inner diameter φ of the inner cavity 122 of the puncture member 12. The difference between the outer diameter D3 of the closed portion 16 and the inner diameter φ of the inner cavity 122 is, for example, 0.005 to 0.2 mm. In this way, most of the lumen 122 is occluded by the occluder 16. A narrow gap 13 is formed between the inner cavity 122 and the closed portion 16. This gap 13 is a gap between the closing portion 16 and the inner cavity 122, and is distinguished from the gap 15 between the rod-shaped body 14 and the inner cavity 122. The gap 13 prevents the passage of tissue fragments, thereby preventing the tissue fragments from clogging the lumen 122 on the proximal side of the closing portion 16.
 図2Bに示すように、閉塞部16は、軸線方向に長さL1で延在する。閉塞部16の長さL1方向の寸法は、隙間13に組織片が入り込んだ場合であっても、閉塞部16の前進が妨げられない範囲で、適宜設定し得る。閉塞部16の長さL1の一例は、穿刺部材12の刃面123の軸線方向の長さの3倍以下とすることができる。より好ましくは、内腔122の内径φの寸法よりも小さくすることができる。閉塞部16の長さL1が内腔122の内径φよりも小さいと、隙間13に組織片が入り込んだ場合であっても、閉塞部16の動作不良が防止される。長さL1の別の一例は、0.2~3.49mmとすることができる。なお、閉塞部16の長さL1を小さくしすぎると、閉塞部16の剛性が低下し、変形を生じやすくなる。 As shown in FIG. 2B, the closing portion 16 extends in the axial direction with a length L1. The dimension in the length L1 direction of the closing part 16 can be set as appropriate within a range where the forward movement of the closing part 16 is not hindered even if a piece of tissue enters the gap 13. An example of the length L1 of the closing portion 16 can be three times or less the length of the blade surface 123 of the puncturing member 12 in the axial direction. More preferably, it can be made smaller than the inner diameter φ of the inner cavity 122. When the length L1 of the closing portion 16 is smaller than the inner diameter φ of the inner cavity 122, malfunction of the closing portion 16 is prevented even if a piece of tissue enters the gap 13. Another example of the length L1 may be 0.2 to 3.49 mm. Note that if the length L1 of the closing portion 16 is made too small, the rigidity of the closing portion 16 will decrease and deformation will easily occur.
 本実施形態の閉塞部16は、創傷形成部22として、エッジ24を有する。エッジ24は、閉塞部16の外周部に位置する。具体的には、閉塞部16は、外周部の先端側及び基端側の角部にそれぞれエッジ24を有する。エッジ24は、閉塞部16の周方向の全域に亘って形成される。エッジ24は、曲率半径が0.5mm以下、好ましくは0.001mm以上0.5mm以下と小さな曲率半径を有する。このようなエッジ24は、生体組織90の内部で前進又は後退したときに、生体組織90に創傷を形成できる。 The closing part 16 of this embodiment has an edge 24 as a wound forming part 22. The edge 24 is located at the outer periphery of the closure portion 16. Specifically, the closing portion 16 has edges 24 at the distal and proximal corners of the outer periphery, respectively. The edge 24 is formed over the entire circumferential area of the closing portion 16 . The edge 24 has a small radius of curvature of 0.5 mm or less, preferably 0.001 mm or more and 0.5 mm or less. When such an edge 24 moves forward or backward within the living tissue 90, it can form a wound in the living tissue 90.
 本実施形態のリンパ管新生誘導デバイス10は以上のように構成される。リンパ管新生誘導デバイス10を用いた手技は、以下のステップを有する。 The lymphangiogenesis inducing device 10 of this embodiment is configured as described above. The procedure using the lymphangiogenesis inducing device 10 has the following steps.
 リンパ管新生誘導デバイス10の穿刺に先立って、操作者は予めリンパ管の閉塞部位の確認を行う。リンパ管の閉塞部位の確認は、ICGリンパ管蛍光造影法又はリンパシンチグラフィ、MRI、CT、超音波画像診断等の方法で実施できる。次に、操作者は、リンパ管の新生ルートを確認する。例えば、操作者は、リンパ管の閉塞部位を特定し、その閉塞部位に隣接する閉塞していないリンパ管に繋がる経路を決定する。また、例えば、操作者は、リンパ管の閉塞部位を迂回する経路を決定する。 Prior to puncturing with the lymphangiogenesis inducing device 10, the operator confirms the occluded site of the lymphatic vessel in advance. The site of lymphatic occlusion can be confirmed by methods such as ICG lymphatic angiography, lymphoscintigraphy, MRI, CT, and ultrasound imaging. Next, the operator confirms the new route of lymph vessels. For example, the operator identifies a blocked site of a lymphatic vessel and determines a route that connects to an unoccluded lymphatic vessel adjacent to the blocked site. Further, for example, the operator determines a route that bypasses the blocked site of the lymphatic vessel.
 次に、図3Aに示すように、リンパ管新生誘導デバイス10を穿刺するステップが行われる。リンパ管新生誘導デバイス10は、穿刺部材12の針先121から対象部位に穿刺する。穿刺部材12の内腔122への組織片の侵入を防ぐために、閉塞部16は、穿刺部材12の内腔122の先端付近に配置される。 Next, as shown in FIG. 3A, a step of puncturing the lymphangiogenesis inducing device 10 is performed. The lymphangiogenesis inducing device 10 punctures the target site from the needle tip 121 of the puncture member 12. To prevent tissue debris from entering the lumen 122 of the puncture member 12, the occlusion 16 is positioned near the distal end of the lumen 122 of the puncture member 12.
 次に、図3Bに示すように、リンパ管新生誘導デバイス10を生体組織90の所定部位に前進させるステップが行われる。このステップにより、穿刺部材12の針先121が、創傷付与を開始する所定部位に配置される。穿刺部材12を前進させる間に、生体組織90の一部が、内腔122に入り込む。閉塞部16は、組織片の内腔122への侵入を阻止する。すなわち、閉塞部16よりも基端側への組織片の侵入は、閉塞部16によって阻止される。これにより、棒状体14と内腔122との隙間15に組織片が詰まって、棒状体14が前進できなくなる不具合の発生を防止できる。 Next, as shown in FIG. 3B, a step of advancing the lymphangiogenesis inducing device 10 to a predetermined site of the living tissue 90 is performed. Through this step, the needle tip 121 of the puncture member 12 is placed at a predetermined site where wounding is to be started. While advancing the puncture member 12, a portion of the living tissue 90 enters the lumen 122. Occlusion 16 prevents tissue debris from entering lumen 122 . In other words, the tissue piece is prevented from entering into the proximal side of the closing part 16 . This can prevent the occurrence of a problem in which the gap 15 between the rod-shaped body 14 and the inner cavity 122 is clogged with tissue pieces and the rod-shaped body 14 cannot move forward.
 次に、図4Aに示すように、閉塞部16により創傷を付与するステップが行われる。このステップは、棒状体14及び閉塞部16を穿刺部材12に対して先端側に前進させる。上記の操作は、棒状体ハブ20を先端に向けて押し込む方法で行われる。このステップは、穿刺部材12を基端に引き込む操作であってもよい。または、このステップは、穿刺部材12を基端側に引き込む操作と穿刺部材12を先端に向けて押し込む操作が交互に行われてもよい。これにより、図示のように、生体組織90の内部に閉塞部16が露出する。 Next, as shown in FIG. 4A, a step of creating a wound using the occluding portion 16 is performed. In this step, the rod-shaped body 14 and the closure part 16 are advanced toward the distal end with respect to the puncture member 12. The above operation is performed by pushing the rod-shaped hub 20 toward the tip. This step may be an operation of retracting the puncture member 12 to the proximal end. Alternatively, in this step, an operation of pulling the puncture member 12 toward the proximal end and an operation of pushing the puncture member 12 toward the distal end may be performed alternately. As a result, the closed portion 16 is exposed inside the living tissue 90 as shown in the figure.
 次に、図4Bに示すように、生体組織90の内部で、閉塞部16を基端側に後退させ、あるいは閉塞部16を先端側に前進させるステップが行われる。必要に応じて、閉塞部16の前進及び後退を複数回繰り返してもよい。このステップにより、閉塞部16のエッジ24が生体組織90と擦過する。その結果、生体組織90には、閉塞部16のエッジ24によって微細な創傷が多数形成される。微細な創傷は、閉塞部16が移動する経路に沿って形成される。より確実に創傷を形成するために、必要に応じて、棒状体14を前進させる動作や、棒状体14及び閉塞部16を回転させる動作が行われてもよい。このステップは、穿刺部材12を基端側に後退させる操作を含む。穿刺部材12及び閉塞部16が、生体組織90から完全に引き抜かれることでこのステップが完了する。 Next, as shown in FIG. 4B, inside the living tissue 90, a step of retracting the occluding portion 16 toward the proximal end or advancing the occluding portion 16 toward the distal end is performed. If necessary, the closing portion 16 may be moved forward and backward multiple times. This step causes the edge 24 of the closure part 16 to rub against the living tissue 90. As a result, many minute wounds are formed in the living tissue 90 by the edges 24 of the closed portion 16. Fine wounds are formed along the path along which the occlusion section 16 moves. In order to form a wound more reliably, an operation of advancing the rod-shaped body 14 or an operation of rotating the rod-shaped body 14 and the closure part 16 may be performed as necessary. This step includes an operation of retracting the puncture member 12 proximally. This step is completed when the puncture member 12 and the closure part 16 are completely withdrawn from the living tissue 90.
 以上により、1箇所に対する創傷の付与が完了する。他の経路に対しても、上記のステップが繰り返し行われることにより、所望の全ての経路に対して創傷が形成されて、本実施形態のリンパ管新生誘導デバイス10を用いた手技が完了する。 Through the above steps, wounding at one location is completed. By repeating the above steps for other routes, wounds are formed for all desired routes, and the procedure using the lymphangiogenesis inducing device 10 of this embodiment is completed.
 以上の手技によれば、線状の創傷の治癒過程において、創傷に対する免疫反応により、創傷に免疫細胞が集積する。集積した免疫細胞は、リンパ管成長因子の発現を亢進させる。そのため、本実施形態のリンパ管新生誘導デバイス10は、リンパ管の新生を誘導できる。 According to the above procedure, during the healing process of a linear wound, immune cells accumulate in the wound due to an immune response to the wound. The accumulated immune cells enhance the expression of lymphatic growth factors. Therefore, the lymphangiogenesis-inducing device 10 of this embodiment can induce lymphangiogenesis.
(第2実施形態)
 本実施形態のリンパ管新生誘導デバイス10Aは、図5Aに示すように、側面視でL字型となるように、棒状体14A及び閉塞部16が接続されている。なお、本実施形態のリンパ管新生誘導デバイス10Aにおいて、図1のリンパ管新生誘導デバイス10と同様の構成は、同一符号が付されてその詳細な説明は省略される。また、図5Aのリンパ管新生誘導デバイス10Aにおいて、穿刺部材ハブ18及び棒状体ハブ20は、図1と同様なので図示及び説明は省略される。
(Second embodiment)
As shown in FIG. 5A, the lymphangiogenesis inducing device 10A of this embodiment has a rod-shaped body 14A and an occlusion part 16 connected to form an L-shape when viewed from the side. In addition, in the lymphangiogenesis inducing device 10A of this embodiment, the same components as the lymphangiogenesis inducing device 10 of FIG. Furthermore, in the lymphangiogenesis inducing device 10A of FIG. 5A, the puncture member hub 18 and the rod-shaped body hub 20 are the same as those in FIG. 1, so illustration and description thereof will be omitted.
 図5Bに示すように、棒状体14Aは、弧状の断面形状を有する。棒状体14Aは、穿刺部材12の内腔122に沿うように湾曲した薄板形状を有する。閉塞部16は、棒状体14Aに対して一体的に繋がる。閉塞部16は、棒状体14Aと折曲部161を介して繋がる。 As shown in FIG. 5B, the rod-shaped body 14A has an arcuate cross-sectional shape. The rod-shaped body 14A has a thin plate shape that is curved along the inner cavity 122 of the puncture member 12. The closing portion 16 is integrally connected to the rod-shaped body 14A. The closing portion 16 is connected to the rod-shaped body 14A via a bent portion 161.
 本実施形態のリンパ管新生誘導デバイス10Aは、以上のように構成される。リンパ管新生誘導デバイス10Aは、第1実施形態のリンパ管新生誘導デバイス10と同様の効果を奏する。さらに、本実施形態は、棒状体14Aと、閉塞部16とは、1枚の金属板をプレス加工することで形成でき、構造及び製造工程が簡素化される。 The lymphangiogenesis inducing device 10A of this embodiment is configured as described above. The lymphangiogenesis inducing device 10A has the same effects as the lymphangiogenesis inducing device 10 of the first embodiment. Furthermore, in this embodiment, the rod-shaped body 14A and the closing portion 16 can be formed by pressing a single metal plate, simplifying the structure and manufacturing process.
(第3実施形態)
 本実施形態のリンパ管新生誘導デバイス10Bは、図6Aに示すように、穿刺部材12の中心軸線に対して傾斜した閉塞部16Aを有する。なお、本実施形態のリンパ管新生誘導デバイス10Bにおいて、図1のリンパ管新生誘導デバイス10と同様の構成には、同一符号が付されてその詳細な説明は省略される。また、図6Aのリンパ管新生誘導デバイス10Bにおいて、穿刺部材ハブ18及び棒状体ハブ20は、図1と同様なので図示及び説明は省略される。
(Third embodiment)
The lymphangiogenesis inducing device 10B of this embodiment has a closing portion 16A that is inclined with respect to the central axis of the puncture member 12, as shown in FIG. 6A. In addition, in the lymphangiogenesis induction device 10B of this embodiment, the same code|symbol is attached|subjected to the structure similar to the lymphangiogenesis induction device 10 of FIG. 1, and the detailed description is abbreviate|omitted. Furthermore, in the lymphangiogenesis inducing device 10B of FIG. 6A, the puncture member hub 18 and the rod-shaped body hub 20 are the same as those in FIG. 1, so illustration and description thereof will be omitted.
 図6Bに示すように、閉塞部16Aは、軸線方向に対する傾斜角度が、穿刺部材12の刃面123の軸線方向に対する傾斜角度と等しい。初期状態において、閉塞部16Aは、針先121と同じ位置に配置されており、閉塞部16Aは、刃面123と同一平面を形成する。閉塞部16Aは、外周部の角部に、エッジ24Aを有する。閉塞部16Aは、エッジ24Aによって、生体組織90に創傷を付与する。 As shown in FIG. 6B, the obstructing portion 16A has an inclination angle with respect to the axial direction that is equal to the inclination angle of the blade surface 123 of the puncturing member 12 with respect to the axial direction. In the initial state, the closing portion 16A is arranged at the same position as the needle tip 121, and the closing portion 16A forms the same plane as the blade surface 123. The closing portion 16A has an edge 24A at a corner of the outer periphery. The closing portion 16A inflicts a wound on the living tissue 90 by the edge 24A.
 本実施形態のリンパ管新生誘導デバイス10Bは、図1のリンパ管新生誘導デバイス10と同様の効果を奏する。さらに、本実施形態のリンパ管新生誘導デバイス10Bは、内腔122に侵入する組織片の量をさらに減少させることができる。これにより、リンパ管新生誘導デバイス10Bは、内腔122の組織片による詰まりによる動作不良をより効果的に防止できる。また、閉塞部16Aは、棒状体14に対して傾斜するため、棒状体14を通じて閉塞部16Aを前進させたときに生体組織90の内部で抵抗を受けにくくなり、前進操作を容易に行える。 The lymphangiogenesis inducing device 10B of this embodiment has the same effects as the lymphangiogenesis inducing device 10 of FIG. 1. Furthermore, the lymphangiogenesis-inducing device 10B of this embodiment can further reduce the amount of tissue debris that invades the lumen 122. Thereby, the lymphangiogenesis inducing device 10B can more effectively prevent malfunctions due to clogging of the lumen 122 with tissue debris. Further, since the closing portion 16A is inclined with respect to the rod-shaped body 14, when the closing portion 16A is advanced through the rod-shaped body 14, it is less likely to receive resistance inside the living tissue 90, and the forward operation can be performed easily.
(第4実施形態)
 図7Aに示すように、本実施形態の閉塞部16Bは、サイドカッターを有する。閉塞部16Bは、先端及び外周に複数のノコギリ歯26を有する。この閉塞部16Bは、図1の閉塞部16に置き換えて使用できる。図7Aに示すように、閉塞部16Bは、先端側に径方向に放射状に延びる複数のノコギリ歯26aと、外周部に延在するノコギリ歯26bとを有する。ノコギリ歯26bは、外周部に突出する。これらのノコギリ歯26a、26bの鋭利な稜線部分は、本実施形態のエッジ24Bを構成する。また、ノコギリ歯26bは、閉塞部16Bを回転させた際に、前進又は後退する方向力を発生させる傾斜面を有する。
(Fourth embodiment)
As shown in FIG. 7A, the closing portion 16B of this embodiment has a side cutter. The closing portion 16B has a plurality of sawtooths 26 on the tip and outer periphery. This closing portion 16B can be used in place of the closing portion 16 in FIG. 1. As shown in FIG. 7A, the closing portion 16B has a plurality of sawtooths 26a extending radially in the radial direction toward the distal end, and sawtooth teeth 26b extending toward the outer periphery. The saw teeth 26b protrude toward the outer periphery. The sharp ridgeline portions of these sawtooths 26a and 26b constitute the edge 24B of this embodiment. Moreover, the sawtooth 26b has an inclined surface that generates a directional force that moves forward or backward when the closing portion 16B is rotated.
 本実施形態の閉塞部16Bは、前進及び後退だけでなく、回転動作によっても生体組織90に微細な創傷を付与できる。また、閉塞部16Bは、回転動作によって前進し、閉塞部16Bの前進に伴って生体組織90に創傷を付与できる。 The closing portion 16B of this embodiment can inflict fine wounds on the living tissue 90 not only by forward and backward movement but also by rotational movement. Moreover, the closing part 16B moves forward by the rotational movement, and can inflict a wound on the living tissue 90 as the closing part 16B moves forward.
(第5実施形態)
 図7Bに示すように、本実施形態の閉塞部16Cは、外周部に円錐面162を有する。この閉塞部16Cは、図1の閉塞部16を置き換えることができる。閉塞部16Cは、先端に向けて徐々に外径が減少する円錐面162を有する。閉塞部16Cは、基端部が最も大きな外径を有している。閉塞部16Cは、基端部において内腔122(図1参照)を閉塞することで、組織片の内腔122への侵入を阻止する。
(Fifth embodiment)
As shown in FIG. 7B, the closing portion 16C of this embodiment has a conical surface 162 on the outer periphery. This closing portion 16C can replace the closing portion 16 in FIG. 1. The closing portion 16C has a conical surface 162 whose outer diameter gradually decreases toward the tip. The closed portion 16C has the largest outer diameter at the proximal end. The closing portion 16C blocks the lumen 122 (see FIG. 1) at the proximal end, thereby preventing tissue fragments from entering the lumen 122.
 なお、本実施形態の閉塞部16Cは、先端に平坦面を有さずに完全に円錐形状であってもよい。また、閉塞部16Cは、先端側が最も大きな外径を有し、基端側に向かうにつれて徐々に外径が減少する円錐面を有してもよい。 Note that the closing portion 16C of this embodiment may have a completely conical shape without having a flat surface at the tip. Further, the closing portion 16C may have a conical surface having the largest outer diameter on the distal end side and gradually decreasing the outer diameter toward the proximal end side.
(第6実施形態)
 図8に示すように、本実施形態のリンパ管新生誘導デバイス10Cは、穿刺部材12と、棒状体14Aと、閉塞部16と、穿刺部材ハブ18と、棒状体ハブ20と、ワイヤ28と、ワイヤハブ30とを有する。なお、本実施形態のリンパ管新生誘導デバイス10Cにおいて、穿刺部材12と、穿刺部材ハブ18と、棒状体ハブ20とは、図1の穿刺部材12と、穿刺部材ハブ18と、棒状体ハブ20と同様である。また、リンパ管新生誘導デバイス10Cにおいて、棒状体14Aと、閉塞部16とは、図5A及び図5Bに示す棒状体14Aと、閉塞部16と同様である。
(Sixth embodiment)
As shown in FIG. 8, the lymphangiogenesis inducing device 10C of the present embodiment includes a puncture member 12, a rod-shaped body 14A, a blocking portion 16, a puncture member hub 18, a rod-shaped body hub 20, a wire 28, It has a wire hub 30. In addition, in the lymphangiogenesis induction device 10C of this embodiment, the puncture member 12, the puncture member hub 18, and the rod-shaped body hub 20 are the same as the puncture member 12, the puncture member hub 18, and the rod-shaped body hub 20 in FIG. It is similar to Moreover, in the lymphangiogenesis induction device 10C, the rod-shaped body 14A and the occlusion part 16 are the same as the rod-shaped body 14A and the occlusion part 16 shown in FIGS. 5A and 5B.
 ワイヤ28は、例えば金属線よりなる。例えば、ワイヤ28は、一端28aが閉塞部16に接続されている。ワイヤ28は、棒状体14Aの先端側に接続されてもよい。すなわち、ワイヤ28の一端28aは、棒状体14A又は閉塞部16の穿刺部材12から突出可能な部位に接続されている。ワイヤ28の他端28b側の一部は、穿刺部材12の内腔122と棒状体14Aとの隙間15に収容されている。ワイヤ28の他端28bは、ワイヤハブ30に接合されている。ワイヤハブ30は、棒状体ハブ20に取り付けられている。ワイヤハブ30は、穿刺部材ハブ18及び棒状体ハブ20に対して軸線方向に相対的に変位可能となっている。 The wire 28 is made of, for example, a metal wire. For example, the wire 28 has one end 28a connected to the closure part 16. The wire 28 may be connected to the tip side of the rod-shaped body 14A. That is, one end 28a of the wire 28 is connected to a portion of the rod-shaped body 14A or the closure portion 16 that can protrude from the puncture member 12. A portion of the wire 28 on the other end 28b side is accommodated in the gap 15 between the inner cavity 122 of the puncture member 12 and the rod-shaped body 14A. The other end 28b of the wire 28 is joined to a wire hub 30. The wire hub 30 is attached to the rod-shaped body hub 20. The wire hub 30 is movable relative to the puncture member hub 18 and the rod-shaped body hub 20 in the axial direction.
 図示のように、閉塞部16を穿刺部材12の先端部12aから先端側に突出させた状態において、ワイヤハブ30を前進させると、ワイヤ28は穿刺部材12から露出した部分が弛んで、軸線方向の外側に広がる。ワイヤハブ30を基端側に引っ張ると、ワイヤ28は、基端側に引き込まれて緊張し、棒状体14Aの近傍で棒状体14Aを平行に配置する。 As shown in the figure, when the wire hub 30 is advanced with the closing portion 16 protruding toward the distal end from the distal end 12a of the puncture member 12, the portion of the wire 28 exposed from the puncture member 12 is loosened, and the wire 28 is rotated in the axial direction. spread outward. When the wire hub 30 is pulled toward the proximal end, the wire 28 is pulled toward the proximal end and becomes taut, thereby arranging the rod-like bodies 14A in parallel in the vicinity of the rod-like bodies 14A.
 本実施形態のリンパ管新生誘導デバイス10Cは、生体組織90の内部で、ワイヤハブ30を操作することで、ワイヤ28の弛緩及び緊張を繰り返し行うことができる。組織間液が貯留する皮下組織(主に脂肪組織)は、柔軟である。ワイヤ28が弛緩すると、生体組織90は、ワイヤ28と棒状体14Aとの隙間13に入り込む。その後、ワイヤハブ30が後退すると、ワイヤ28が緊張し、ワイヤ28と棒状体14Aとの間に入り込んだ柔軟な生体組織90(主に脂肪組織)が切断されて、創傷が付与される。このような創傷は、治癒過程で、リンパ管の新生を誘導する。 The lymphangiogenesis inducing device 10C of this embodiment can repeatedly relax and tension the wire 28 by operating the wire hub 30 inside the living tissue 90. The subcutaneous tissue (mainly adipose tissue) in which interstitial fluid accumulates is flexible. When the wire 28 is relaxed, the biological tissue 90 enters the gap 13 between the wire 28 and the rod-shaped body 14A. Thereafter, when the wire hub 30 retreats, the wire 28 is tensed, and the flexible living tissue 90 (mainly fat tissue) that has entered between the wire 28 and the rod-shaped body 14A is cut, thereby creating a wound. Such a wound induces new lymphatic vessel formation during the healing process.
 上記のように、本実施形態のリンパ管新生誘導デバイス10Cは、棒状体14A及び閉塞部16の前進及び後退による創傷の付与に加えて、ワイヤ28の弛緩及び緊張による創傷の付与が可能である。ワイヤ28による創傷の付与は、閉塞部16の移動範囲よりも広い範囲に亘って創傷を付与できる。そのため、リンパ管新生誘導デバイス10Cは、より効果的に、リンパ管の新生を促すことができる。 As described above, the lymphangiogenesis inducing device 10C of this embodiment is capable of inflicting a wound by relaxing and tensioning the wire 28 in addition to inflicting a wound by advancing and retracting the rod-shaped body 14A and the occlusion part 16. . The wound can be applied by the wire 28 over a wider range than the movement range of the closure part 16. Therefore, the lymphangiogenesis inducing device 10C can more effectively promote the generation of lymphatic vessels.
 上記のリンパ管新生誘導デバイス10、10A、10B、10Cは、以下のようにまとめられる。 The above lymphangiogenesis inducing devices 10, 10A, 10B, and 10C are summarized as follows.
 リンパ管新生誘導デバイス10、10A、10B、10Cは、生体組織90に挿入可能な先端部12aと、前記先端部から基端に向けて軸線方向に延びる内腔122と、を有する穿刺部材12と、前記穿刺部材の前記内腔よりも小さな外径を有し、前記内腔との間に隙間15を形成しつつ前記内腔を挿通し、前記穿刺部材の前記内腔に沿って前後方向に変位可能な棒状体14と、前記棒状体の先端に接合され、前記棒状体よりも大きな断面を有することで前記内腔を閉塞するとともに、前記棒状体の変位に伴って前記穿刺部材の前記先端部から突出可能な閉塞部16、16A、16B、16Cと、を備え、前記閉塞部は、前記生体組織の対象部位に創傷を与える創傷形成部22を有する。 Lymphangiogenesis induction devices 10, 10A, 10B, 10C include a puncture member 12 having a distal end 12a that can be inserted into living tissue 90, and a lumen 122 extending in the axial direction from the distal end toward the proximal end. , having an outer diameter smaller than the inner cavity of the puncturing member, passing through the internal cavity while forming a gap 15 between the puncturing member and extending in the front-rear direction along the internal cavity of the puncturing member. A displaceable rod-shaped body 14 is joined to the tip of the rod-shaped body and has a larger cross section than the rod-shaped body to close the inner cavity, and as the rod-shaped body is displaced, the tip of the puncturing member occlusion parts 16, 16A, 16B, and 16C that can protrude from the body tissue, and the occlusion part has a wound forming part 22 that inflicts a wound on the target part of the living tissue.
 上記のリンパ管新生誘導デバイスは、閉塞部が穿刺部材の内腔への組織片の侵入を阻止することで、棒状体及び閉塞部の穿刺部材からの突出動作を確実に行える。したがって、リンパ管新生誘導デバイスは、対象部位にリンパ管の新生を誘導する創傷を確実に形成できる。 In the above-mentioned lymphangiogenesis inducing device, the rod-shaped body and the occluding portion can reliably protrude from the puncturing member because the occluding portion prevents tissue fragments from entering the inner lumen of the puncturing member. Therefore, the lymphangiogenesis-inducing device can reliably form a wound that induces lymphangiogenesis at the target site.
 上記のリンパ管新生誘導デバイスにおいて、前記創傷形成部は、前記閉塞部の外周に形成された鋭利なエッジ24、24A、24Bを有してもよい。このリンパ管新生誘導デバイスは、閉塞部を生体組織内で移動させることでリンパ管の新生を誘導する創傷を所定部位に付与できる。 In the above lymphangiogenesis inducing device, the wound forming part may have sharp edges 24, 24A, and 24B formed on the outer periphery of the occlusion part. This lymphangiogenesis inducing device can create a wound that induces new lymphatic vessel generation at a predetermined site by moving the occluded part within the living tissue.
 上記のリンパ管新生誘導デバイスにおいて、前記創傷形成部は、前記閉塞部の表面に形成された凹凸形状を有してもよい。このリンパ管新生誘導デバイスは、凹凸形状と生体組織との擦過により、微細な創傷を形成できる。 In the above lymphangiogenesis inducing device, the wound forming part may have an uneven shape formed on the surface of the occluding part. This lymphangiogenesis inducing device can form minute wounds by rubbing the uneven shape against living tissue.
 上記のリンパ管新生誘導デバイスにおいて、前記創傷形成部は、前記閉塞部に形成されたサイドカッターを有してもよい。このリンパ管新生誘導デバイスは、多数のノコギリ歯で効率よく生体組織に創傷を形成できる。 In the above lymphangiogenesis inducing device, the wound forming section may have a side cutter formed in the occlusion section. This lymphangiogenesis-inducing device can efficiently form a wound in living tissue with a large number of saw teeth.
 上記のリンパ管新生誘導デバイスにおいて、前記閉塞部はディスク形状を有してもよい。このリンパ管新生誘導デバイスは、構造及び製造工程を簡素化でき、製造を容易にする。 In the above lymphangiogenesis inducing device, the occlusion portion may have a disk shape. This lymphangiogenesis-inducing device can simplify the structure and manufacturing process, making it easy to manufacture.
 上記のリンパ管新生誘導デバイスにおいて、前記創傷形成部は、一端28aが前記閉塞部に取り付けられ、前記内腔の内部を挿通するワイヤ28を有してもよい。このリンパ管新生誘導デバイスは、ワイヤ28の弛緩及び緊張を通じてより広い範囲に創傷を形成できる。 In the above-described lymphangiogenesis inducing device, the wound forming section may include a wire 28 that has one end 28a attached to the occlusion section and that is inserted through the inside of the lumen. This lymphangiogenesis-inducing device can form a wound in a wider range by relaxing and tensioning the wire 28.
 上記のリンパ管新生誘導デバイスにおいて、前記棒状体は、軸線回りに回転させながら前記軸線方向に移動可能であってもよい。このリンパ管新生誘導デバイスは、回転動作を伴う軸線方向の移動によって多数の創傷を効率よく付与できる。 In the above lymphangiogenesis inducing device, the rod-shaped body may be movable in the axial direction while being rotated around the axis. This lymphangiogenesis-inducing device can efficiently inflict a large number of wounds by moving in the axial direction with rotational motion.
 上記のリンパ管新生誘導デバイスにおいて、前記穿刺部材の基端を支持する穿刺部材ハブ18と、前記棒状体の基端を支持する棒状体ハブ20とを有し、前記棒状体ハブは、前記穿刺部材ハブに対して相対移動させることで、前記棒状体を前記穿刺部材の前記先端部から突出及び引込み可能としてもよい。このリンパ管新生誘導デバイスは、棒状体ハブを通じて棒状体及び閉塞部を突出させることができ、操作性に優れる。 The above-mentioned lymphangiogenesis inducing device includes a puncture member hub 18 that supports the proximal end of the puncture member, and a rod-shaped body hub 20 that supports the base end of the rod-shaped body, and the rod-shaped body hub supports the puncture member. By moving the rod-shaped body relative to the member hub, the rod-shaped body may be able to be protruded from and retracted from the distal end portion of the puncturing member. This lymphangiogenesis inducing device allows the rod-shaped body and the obstruction portion to protrude through the rod-shaped body hub, and has excellent operability.
 上記のリンパ管新生誘導デバイスにおいて、前記穿刺部材の基端を支持する穿刺部材ハブと、前記棒状体の基端を支持する棒状体ハブと、前記ワイヤの他端28bに接合されたワイヤハブ30と、を有し、前記棒状体ハブは、前記穿刺部材ハブに対して相対移動させることで、前記棒状体を前記穿刺部材の前記先端部から突出及び引込み可能とし、前記ワイヤハブは、前記棒状体ハブに対して相対移動させることで、前記ワイヤを弛緩又は緊張させてもよい。このリンパ管新生誘導デバイスは、ワイヤハブを通じてワイヤの弛緩及び緊張を操作することができ、操作性に優れる。 The above-mentioned lymphangiogenesis inducing device includes a puncture member hub that supports the proximal end of the puncture member, a rod-shaped body hub that supports the base end of the rod-shaped body, and a wire hub 30 joined to the other end 28b of the wire. , the rod-shaped body hub is moved relative to the puncturing member hub so that the rod-shaped body can be protruded and retracted from the tip of the puncturing member, and the wire hub is moved relative to the puncturing member hub. The wire may be relaxed or tensioned by moving it relative to the wire. This lymphangiogenesis inducing device can manipulate the relaxation and tension of the wire through the wire hub, and has excellent operability.
 なお、本発明は、上記した実施形態に限らず、本発明の要旨を逸脱することなく、種々の構成を採り得る。 Note that the present invention is not limited to the embodiments described above, and can take various configurations without departing from the gist of the present invention.

Claims (9)

  1.  生体組織に挿入可能な先端部と、前記先端部から基端に向けて軸線方向に延びる内腔と、を有する穿刺部材と、
     前記穿刺部材の前記内腔よりも小さな外径を有し、前記内腔との間に隙間を形成しつつ前記内腔を挿通し、前記穿刺部材の前記内腔に沿って前後方向に変位可能な棒状体と、
     前記棒状体の先端に接合され、前記棒状体よりも大きな断面を有することで前記内腔を閉塞するとともに、前記棒状体の変位に伴って前記穿刺部材の前記先端部から突出可能な閉塞部と、を備え、
     前記閉塞部は、前記生体組織の対象部位に創傷を与える創傷形成部を有する、
     リンパ管新生誘導デバイス。
    a puncture member having a distal end that can be inserted into living tissue, and a lumen that extends in the axial direction from the distal end toward the proximal end;
    It has an outer diameter smaller than the inner cavity of the puncturing member, is inserted through the internal cavity while forming a gap with the internal cavity, and is movable in the front-rear direction along the internal cavity of the puncturing member. A rod-shaped body,
    a closing part that is joined to the tip of the rod-shaped body, has a larger cross section than the rod-shaped body, closes the inner cavity, and can protrude from the tip of the puncture member as the rod-shaped body is displaced; , comprising;
    The closing part has a wound forming part that applies a wound to the target site of the living tissue.
    Lymphangiogenesis induction device.
  2.  請求項1記載のリンパ管新生誘導デバイスであって、前記創傷形成部は、前記閉塞部の外周に形成された鋭利なエッジを有する、
     リンパ管新生誘導デバイス。
    The lymphangiogenesis inducing device according to claim 1, wherein the wound forming part has a sharp edge formed on the outer periphery of the occluded part.
    Lymphangiogenesis induction device.
  3.  請求項1又は2記載のリンパ管新生誘導デバイスであって、前記創傷形成部は、前記閉塞部の表面に形成された凹凸形状を有する、
     リンパ管新生誘導デバイス。
    The lymphangiogenesis inducing device according to claim 1 or 2, wherein the wound forming part has an uneven shape formed on the surface of the occluding part.
    Lymphangiogenesis induction device.
  4.  請求項1~3のいずれか1項に記載のリンパ管新生誘導デバイスであって、前記創傷形成部は、前記閉塞部に形成されたサイドカッターを有する、
     リンパ管新生誘導デバイス。
    The lymphangiogenesis inducing device according to any one of claims 1 to 3, wherein the wound forming part has a side cutter formed in the occluding part.
    Lymphangiogenesis induction device.
  5.  請求項1~4のいずれか1項に記載のリンパ管新生誘導デバイスであって、前記閉塞部はディスク形状を有する、
     リンパ管新生誘導デバイス。
    The lymphangiogenesis inducing device according to any one of claims 1 to 4, wherein the occlusion part has a disk shape.
    Lymphangiogenesis induction device.
  6.  請求項1~5のいずれか1項に記載のリンパ管新生誘導デバイスであって、前記創傷形成部は、一端が前記閉塞部に取り付けられ、前記内腔の内部を挿通するワイヤを有する、
     リンパ管新生誘導デバイス。
    The lymphangiogenesis inducing device according to any one of claims 1 to 5, wherein the wound forming section has a wire that is attached at one end to the occlusion section and that is inserted through the interior of the lumen.
    Lymphangiogenesis induction device.
  7.  請求項1~6のいずれか1項に記載のリンパ管新生誘導デバイスであって、前記棒状体は、軸線回りに回転させながら前記軸線方向に移動可能である、
     リンパ管新生誘導デバイス。
    The lymphangiogenesis inducing device according to any one of claims 1 to 6, wherein the rod-shaped body is movable in the axial direction while being rotated around the axis.
    Lymphangiogenesis induction device.
  8.  請求項1~7のいずれか1項に記載のリンパ管新生誘導デバイスであって、前記穿刺部材の基端を支持する穿刺部材ハブと、前記棒状体の基端を支持する棒状体ハブとを有し、
     前記棒状体ハブは、前記穿刺部材ハブに対して相対移動させることで、前記棒状体を前記穿刺部材の前記先端部から突出及び引込み可能とする、
     リンパ管新生誘導デバイス。
    The lymphangiogenesis inducing device according to any one of claims 1 to 7, comprising: a puncture member hub that supports the proximal end of the puncture member; and a rod-shaped body hub that supports the proximal end of the rod-shaped body. have,
    The rod-shaped body hub is moved relative to the puncturing member hub so that the rod-shaped body can be protruded from and retracted from the distal end portion of the puncturing member.
    Lymphangiogenesis induction device.
  9.  請求項6記載のリンパ管新生誘導デバイスであって、前記穿刺部材の基端を支持する穿刺部材ハブと、前記棒状体の基端を支持する棒状体ハブと、前記ワイヤの他端に接合されたワイヤハブと、を有し、
     前記棒状体ハブは、前記穿刺部材ハブに対して相対移動させることで、前記棒状体を前記穿刺部材の前記先端部から突出及び引込み可能とし、
     前記ワイヤハブは、前記棒状体ハブに対して相対移動させることで、前記ワイヤを弛緩又は緊張させる、
     リンパ管新生誘導デバイス。
    7. The lymphangiogenesis inducing device according to claim 6, wherein a puncture member hub that supports the proximal end of the puncture member, a rod-shaped body hub that supports the proximal end of the rod-shaped body, and a puncture member hub that is joined to the other end of the wire. a wire hub;
    The rod-shaped body hub is moved relative to the puncturing member hub to allow the rod-shaped body to protrude and retract from the tip of the puncturing member,
    The wire hub relaxes or tensions the wire by moving it relative to the rod-shaped body hub.
    Lymphangiogenesis induction device.
PCT/JP2023/008208 2022-03-18 2023-03-06 Lymphangiogenesis-inducing device WO2023176531A1 (en)

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US5916232A (en) * 1997-10-10 1999-06-29 Applied Medical Resources Corporation Asymmetrical obturator
US20160100854A1 (en) * 2014-10-09 2016-04-14 Elwha Llc Systems and Devices for Cutting Tissue
CN205163121U (en) * 2015-12-01 2016-04-20 苏州爱得科技发展股份有限公司 Biopsy function percutaneous aspiration ware is got in area
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