WO2023054657A1 - Medical device and method for collecting tissue - Google Patents

Medical device and method for collecting tissue Download PDF

Info

Publication number
WO2023054657A1
WO2023054657A1 PCT/JP2022/036629 JP2022036629W WO2023054657A1 WO 2023054657 A1 WO2023054657 A1 WO 2023054657A1 JP 2022036629 W JP2022036629 W JP 2022036629W WO 2023054657 A1 WO2023054657 A1 WO 2023054657A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
medical device
cutting
cells
cut
Prior art date
Application number
PCT/JP2022/036629
Other languages
French (fr)
Japanese (ja)
Inventor
早川浩一
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023054657A1 publication Critical patent/WO2023054657A1/en

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor

Definitions

  • the present invention relates to a medical device and method for collecting tissue.
  • a sheet-like cell culture is obtained by culturing and processing cells using a human tissue or the like as a raw material.
  • the human body is incised with a scalpel or the like to collect the tissue.
  • Japanese Unexamined Patent Application Publication No. 2012-235878 discloses a biopsy device that includes a tubular sheath and a core shaft that constitutes a needle body having a helical groove at the distal end. This device attempts to trap tissue in a helical groove by inserting a core shaft into and out of a sheath.
  • Japanese Unexamined Patent Publication No. 2015-85141 discloses a puncture needle that includes a sheath member, a needle tube, and a needle member provided with a rotary blade, and in which a scale is provided on the outer periphery of the needle member operating portion and the needle tube operating portion. It is This puncture needle is intended to adjust the protruding length of the needle member with a scale.
  • the present inventor faced the fact that the required amount of tissue could not be obtained with a conventional biopsy device that collects a small amount of tissue by advancing and retracting a needle-like body. SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to solve such problems and to provide a medical device capable of quantitatively sampling tissue with a simple mechanism and a simple operation.
  • the inventors of the present invention discovered for the first time that it is possible to collect tissue quantitatively by a simple operation of pulling the tissue into the cylindrical body and cutting it, while conducting intensive research in order to solve the above problems. As a result of further research based on the results, the present invention was completed.
  • a medical device for collecting tissue comprising a long body having an engaging portion that engages tissue, and engaging with the engaging portion by drawing the long body into the interior of the long body.
  • a medical device comprising a tubular body for containing tissue and a cutting body having a cutting portion for cutting the retracted tissue.
  • the elongated body and the cut body are connected, and cutting by the cut body occurs in conjunction with the operation of pulling the elongated body into the cylindrical body.
  • the medical device according to any one of [3].
  • tissue can be collected quantitatively with a simple mechanism and simple operation, so there are great advantages in terms of operability and manufacturing cost.
  • FIG. 1A is a conceptual diagram showing a medical device according to a first embodiment of the present invention
  • FIG. 1B is an explanatory diagram showing a method of collecting tissue using the medical device of FIG. 1A
  • FIG. 2A is a conceptual diagram showing a medical device according to a second embodiment of the present invention
  • FIG. 2B is an explanatory diagram showing a tissue sampling method using the medical device of FIG. 2A
  • 3A is a perspective view of a medical device according to a second embodiment of the invention
  • FIG. 3B is a cross-sectional view of the medical device of FIG. 3A.
  • tissue refers to a biological tissue containing cells used for producing sheet-like cell cultures.
  • cells include myoblasts (e.g., skeletal myoblasts, etc.), mesenchymal stem cells (e.g., bone marrow, adipose tissue, peripheral blood, skin, hair roots, muscle tissue, endometrium, placenta , umbilical cord blood-derived, etc.), cardiomyocytes, fibroblasts, cardiac stem cells, embryonic stem cells, iPS cells, synovial cells, chondrocytes, epithelial cells (e.g., oral mucosal epithelial cells, retinal pigment epithelial cells, nasal mucosa epithelial cells, etc.), endothelial cells (e.g., vascular endothelial cells, etc.), hepatocytes (e.g., liver parenchymal cells, etc.), pancreatic cells (e.g., pancreatic cells (e.g., pancreatic cells (
  • Non-limiting examples of iPS cell-derived adhesive cells include iPS cell-derived cardiomyocytes, fibroblasts, epithelial cells, endothelial cells, hepatocytes, pancreatic cells, renal cells, adrenal cells, periodontal ligament cells, gingival cells, and periosteal cells. , skin cells, synovial cells, chondrocytes, and the like.
  • the biological tissue is muscle tissue and the cells are adherent cells, preferably skeletal myoblasts.
  • medical device means a machine intended to be used for the diagnosis, treatment or prevention of diseases in humans or animals, or to affect the structure or function of the human or animal body. It refers to equipment, etc.
  • the term "long body” refers to a long member having an engaging portion that engages tissue at its tip.
  • the engagement includes hooking
  • the engagement portion includes a hook-shaped one.
  • the hook shape refers to a shape in which the tip of a rod-like body is bent like a hook, and can be suitably hooked to muscle fibers such as muscle tissue with a simple operation.
  • a "cylindrical body” refers to a pipe-shaped long member that can accommodate a long body therein.
  • the tubular body can accommodate the tissue engaged with the engaging portion by pulling the elongated body inside.
  • the tubular body has an inner surface on the inside and an outer surface on the outside, and the recessed inside of the tubular body is referred to as the inner surface, the concave surface, the interior, and the lumen, and the protruding outside of the tubular body. is sometimes referred to as the outer surface, convex surface, or external surface.
  • the tubular body may be of any shape as long as it can accommodate the elongated body and the tissue therein, and the cross section can be freely designed such as circular, square, and polygonal.
  • the tubular body may have a tapered portion or a stepped portion in the axial direction, or may have an inner diameter and an outer diameter that vary stepwise.
  • the volume of the cylindrical body can be 2 to 10 ml, more preferably 4 to 5 ml.
  • the cylindrical body is not particularly limited as long as it has rigidity enough to protect the tissue from external force, and any one including commercially available cylindrical bodies can be used.
  • Materials for the cylindrical body include, for example, polyethylene, polypropylene, fluororesin, polyethylene terephthalate, polymethyl methacrylate, polyamide resin, polystyrene, polycarbonate, polyimide, polyetherimide, polyetheretherketone, glass, metal (eg, iron, stainless steel, aluminum, titanium) and the like, but are not limited to these.
  • the term "cutting body” refers to a long member having a cutting portion for cutting tissue at its tip.
  • the cut portion may be snare loop-shaped.
  • a snare loop is a wire that is looped and both ends are stored in a sheath so that it can move back and forth.
  • a structure that can reduce That is, the cutting part has a structure that can cut like a lasso by enlarging the loop of the wire, hooking it to the root of the tissue, and reducing (squeezing) the loop.
  • the cut body can be cut by squeezing the tissue by squeezing the loop, and then applying a high-frequency current to the wire to cauterize the tissue and cut it, or adopt a method of squeezing the tissue with a wire without passing a high-frequency current to the wire. can be done.
  • the “sliding body” refers to a belt-shaped body that can slide along the surface of a cylindrical body.
  • the strip has a cylindrical shape that can slide along the surface shape of the cylindrical body.
  • the sliding body slides along the longitudinal direction of the cylindrical body and is folded back at the tip of the cylindrical body, thereby moving from the inner surface to the outer surface and from the outer surface to the inner surface. That is, the sliding body moves from the outer surface of the cylindrical body to the inner surface by folding back at the leading end, thereby sliding on the cylindrical body like a belt conveyor, and moving the tissue in contact with the cylindrical body to the inner surface of the cylindrical body. It can be rolled inside.
  • FIG. 1A is a conceptual diagram showing a medical device according to a first embodiment of the present invention
  • FIG. 2A is a conceptual diagram showing a medical device according to a second embodiment of the present invention.
  • the size of each member is appropriately emphasized for ease of explanation, and each member shown does not indicate the actual size.
  • a medical device 1 includes an elongated body 2, a tubular body 3 and a cut body 4.
  • the elongated body 2 has an engaging portion 21 and a body portion 22 pointing to the engaging portion 21 .
  • the body portion 22 is an elongated rod-shaped member. The base end of the body portion 22 is gripped by the user and receives the user's operation force.
  • the elongated body 2 has a hook-shaped engaging portion 21 that engages with the tissue T at the distal end of the body portion 22 .
  • the engaging portion 21 has a bar-shaped body bent like a hook.
  • the base of the engaging portion 21 is joined to the tip of the body portion 22 .
  • the engaging portion 21 may be curved in a C-shape, J-shape, L-shape or U-shape, for example.
  • the tubular body 3 is a pipe-shaped member.
  • the tubular body 3 has an inner inner surface 3a, an outer outer surface 3b, and a tip portion 3c.
  • the tubular body 3 has an inner diameter that allows the elongated body 2 to be accommodated therein.
  • the inner diameter of the cylindrical body 3 has a dimension that allows the sheath 42 described later to be accommodated together with the elongated body 2 .
  • the tubular body 3 has a length that can accommodate most of the elongated body 2 except for the proximal end.
  • the cylindrical body 3 has a predetermined volume in its inner portion.
  • the volume of the tubular body 3 is, for example, 2 to 10 mm. More preferably, it can be 4 to 5 mm.
  • the volume of the tubular body 3 is substantially equal to the maximum amount of the tissue T accommodated inside the tubular body 3 .
  • the cutting body 4 is a long member having a cutting portion 41 capable of cutting the tissue T, a sheath 42 and a wire 43 at its tip.
  • the cutting part 41 is located at the tip of the wire 43 .
  • the wire 43 has a tip formed in a snare loop shape. That is, the wire 43 has a looped portion 43a at its tip. Both ends of the loop-shaped portion 43a of the wire 43 are accommodated in the sheath 42 so as to be able to move forward and backward. As the loop-shaped portion 43a advances from the distal end of the sheath 42, its inner diameter increases. Conversely, when the loop-shaped portion 43a retreats into the sheath 42, its inner diameter becomes smaller.
  • the proximal side of the wire 43 extends from the proximal side of the sheath 42 .
  • the base end side of the wire 43 is gripped by the user and an operating force is input. The forward and backward movement of the loop-shaped portion 43 a is performed by manipulating the proximal end side of the wire 43 .
  • a metal wire for example, can be used for the wire 43 .
  • the loop-shaped portion 43a is expanded to have a diameter larger than that of the cylindrical body 3, and is attached by obliquely wrapping around the outer surface 3b of the cylindrical body 3, as shown in the figure. ing.
  • the sheath 42 has its distal end arranged at the same axial position as the distal end portion 3 c of the cylindrical body 3 .
  • the cutting section 41 cuts the tissue T at the tip 3c of the cylindrical body 3. As shown in FIG.
  • the sheath 42 is arranged inside the tubular body 3 . Therefore, the cut body 4 is arranged inside the tubular body 3 .
  • this aspect is not limited to this, and the cut body 4 can also be arranged outside the cylindrical body 3 together with the sheath 42 (see FIG. 2A).
  • the cylindrical body 3 can have a structure having a main lumen that houses the elongated body 2 and a sub-lumen (as the lumen of the sheath 42) that houses the cut body 4.
  • a sub-lumen as the lumen of the sheath 42
  • the skin portion S covering the tissue T is incised, and the hook-shaped engaging portion 21 is engaged (hooked) on the tissue T.
  • the hook-shaped engaging portion 21 has a hook-like bent shape, and can be hooked to muscle fibers such as muscle tissue with a simple operation.
  • the cut portion 41 is advanced from the sheath 42 so that the loop-shaped portion 43 a is widened larger than the diameter of the cylindrical body 3 .
  • the engaging portion 21 engages the tissue T by passing through the inside of the loop-shaped portion 43a.
  • the elongated body 2 is pulled (pulled) to the proximal end of the cylindrical body 3, and the tissue T engaged with the engaging portion 21 is pulled into the cylindrical body 3. housed in At this time, the tissue T passes through the widened loop-shaped portion 43a (cutting portion 41) to reach the base end side of the tubular body 3, and is stretched from the distal end to the proximal end of the tubular body 3.
  • the tissue T passes through the widened loop-shaped portion 43a (cutting portion 41) to reach the base end side of the tubular body 3, and is stretched from the distal end to the proximal end of the tubular body 3.
  • a muscle fiber hooked by the engaging portion 21 is arranged near the proximal end of the tubular body 3. It is positioned to turn around.
  • the widened cutting portion 41 is arranged so as to surround the base of the stretched tissue T. As shown in FIG.
  • the base of the stretched tissue T is cut in the vicinity of the distal end portion 3c of the tubular body 3, and the tissue T is formed into a tubular shape. It can be collected while housed in the body 3 . Since the amount of the tissue T to be collected depends on the distance by which the elongated body 2 is pulled into the proximal end of the cylindrical body 3, the tissue T can be quantitatively collected.
  • a high-frequency current is applied to the wire 43 to squeeze and cauterize the tissue T, thereby preventing the tissue T remaining in the living body from being left in a cut state, thereby reducing the cut muscle fibers.
  • the jointed surfaces can be joined (coalesced).
  • the base of the tissue T is ligated, and the loop-shaped portion 43a is squeezed to squeeze out the tissue T without applying a high-frequency current to the wire 43. Since muscle fibers can be left in a ligated state, it is possible to prevent the loss of muscle fibers and stop bleeding.
  • the elongated body 2 is pushed out to the distal end side of the tubular body 3, and the tissue T engaged with the engaging portion 21 is removed.
  • the medical device 1 can be configured such that cutting by the cutting body 4 occurs in conjunction with the operation of pulling the elongated body 2 to the proximal end of the tubular body 3 .
  • the wires 43 of the long body 2 and the cut body 4 are connected at the base end side, and the connected wires 43 are interlocked with the operation of pulling the long body 2 to the base end of the cylindrical body 3. It can be realized by a mechanism in which cutting occurs when the loop-shaped portion 43a (cutting portion 41) of the cut body 4 is pulled into the sheath 42 and becomes smaller.
  • FIG. 2A is a diagram showing a medical device 1A according to a second embodiment of the invention.
  • the medical device 1A further includes a sliding body 5 that can slide along the inner surface 3a and the outer surface 3b of the tubular body 3.
  • the sliding body 5 is a flexible tubular sheet-like member.
  • the sliding body 5 can be made of a flexible resin sheet, elastomer sheet, woven fabric sheet, or non-woven fabric sheet.
  • the outer end 52 of the slide 5 is located on the outer surface 3b and the inner end 51 of the slide 5 is located on the inner surface 3a.
  • the inner end 51 is joined to the elongated body 2 .
  • the sliding body 5 By pulling the inner end portion 51 or the outer end portion 52, the sliding body 5 can be slid so that the outer surface 3b and the inner surface 3a of the cylindrical body 3 are folded back.
  • the sliding body 5 deforms along the shape of the outer surface 3b and the shape of the inner surface 3a of the cylindrical body 3.
  • a distal end portion 3c of the cylindrical body 3 is a portion where the sliding body 5 is folded.
  • the tip portion 3c has an R-shaped cross section (chamfered).
  • the sliding body 5 has a cylindrical shape that can slide along the surface shape of the cylindrical body 3.
  • the sliding body 5 is passed from the base end side of the cylindrical body 3 (upper side in FIG. 2A) to the outside and toward the distal end (lower side in FIG. 2A). ), folded inward at the distal end portion 3c of the tubular body 3, and pulled in the proximal direction at the folded portion, the inner and outer surfaces of the tubular body 3 can be covered.
  • the sliding member 5 By pulling the inner end portion 51 of the sliding member 5 toward the base end of the tubular member 3, the sliding member 5 can be slid from the outer surface to the inner surface of the tubular member 3 so as to be folded like a belt conveyor. can.
  • the sheath 42 is arranged outside the tubular body 3 . Since the sheath 42 and the wire 43 are spaced outside the sliding body 5 , they do not interfere with the operation of the sliding body 5 .
  • the elongated body 2 is attached to the proximal end of the tubular body 3 by fixing the inner end 51 of the slide body 5 to the distal end of the main body 22 of the elongated body 2 . It is also possible to construct such that the inner end portion 51 of the sliding body 5 is pulled into the cylindrical body 3 in conjunction with the pulling operation. According to this configuration, the tissue T can be accommodated in the tubular body 3 in a state where the tissue T is drawn into the tubular body 3 while being in contact with the sliding body 5, so that the tissue T is caught (sandwiched) by the sliding body 5. . As a result, the load on the engaging portion 21 due to traction can be distributed to the sliding body 5, so that the tissue T can be prevented from being broken.
  • the cut body 4 is arranged outside the cylindrical body 3, but the embodiment is not limited to this configuration example, and the cut body 4 is arranged either inside or outside. be able to.
  • the medical device 1B of this embodiment arranges the cutting body 4 inside the sliding body 5 .
  • the long body 2A has a pipe-like shape.
  • the cutting body 4 and the sheath 42 are housed inside the elongated body 2A. In this configuration, the sheath 42 is arranged to protrude from the distal end of the elongated body 2A by the length of the tubular body 3 .
  • the distal end of the sheath 42 is arranged at the same position as the distal end portion 3c of the tubular body 3 in the axial direction.
  • the cutting part 41 is arranged so as to surround the root of the tissue T in the stretched state.
  • the long body 2A and the wire 43 of the cut body 4 are connected at the base end side.
  • Use of the medical device of the present invention can be performed, for example, by the following steps. (1) Providing a medical device (2) Engaging the engaging portion with the tissue (3) Pulling the elongate body into the cylindrical body (4) Cutting the pulled tissue
  • the tissue T is cauterized by applying a high-frequency current to the wire 43, or by ligating the base of the tissue T and squeezing it with the wire 43 without applying a high-frequency current to the wire 43.
  • the tissue T can be cut.

Abstract

A medical device (1) for collecting tissue (T) includes a long body (2) having an engagement part (21) that engages with tissue (T), a cylindrical body (3) that accommodates the tissue (T) engaged with the engagement part (21) by drawing the long body (2) inside, and a cutting body (4) having a cutting part (41) that cuts the tissue (T) that has been drawn in.

Description

組織の採取を行うための医療機器および方法Medical device and method for performing tissue harvesting
　本発明は、組織の採取を行うための医療機器および方法に関する。 The present invention relates to a medical device and method for collecting tissue.
　近年、損傷した組織等の修復のために、種々の細胞を移植する試みが行われている。例えば、狭心症、心筋梗塞などの虚血性心疾患により損傷した心筋組織の修復のために、胎児心筋細胞、骨格筋芽細胞、間葉系幹細胞、心臓幹細胞、ＥＳ細胞、ｉＰＳ細胞等の利用が試みられている（Haraguchi et al., Stem Cells Transl Med. 2012 Feb;1(2):136-141）。 In recent years, attempts have been made to transplant various cells to repair damaged tissues. For example, use of fetal myocardial cells, skeletal myoblasts, mesenchymal stem cells, cardiac stem cells, ES cells, iPS cells, etc. for the repair of myocardial tissue damaged by ischemic heart diseases such as angina pectoris and myocardial infarction. has been attempted (Haraguchi et al., Stem Cells Transl Med. 2012 Feb;1(2):136-141).
　このような試みの一環として、スキャフォールドを利用して形成した細胞構造物や、細胞をシート状に形成したシート状細胞培養物が開発されてきた（Sawa et al., Surg Today. 2012 Jan;42(2):181-4）。シート状細胞培養物は、ヒト組織などを原料として細胞を培養して加工を施したものである。シート状細胞培養物を作製するためには、作製に必要な量の組織を確保する必要があるため、人体をメスなどで切開して組織を採取している。 As part of such attempts, cell structures formed using scaffolds and sheet-like cell cultures in which cells are formed into sheets have been developed (Sawa et al., Surg Today. 2012 Jan; 42(2):181-4). A sheet-like cell culture is obtained by culturing and processing cells using a human tissue or the like as a raw material. In order to prepare a sheet-like cell culture, it is necessary to secure an amount of tissue necessary for the preparation, so the human body is incised with a scalpel or the like to collect the tissue.
　特開２０１２－２３５８７８号公報には、管状のシースと、先端部に螺旋状の溝を有する針本体を構成するコアシャフトとを備えた、生検デバイスが開示されている。このデバイスは、コアシャフトをシース内に挿通して出し入れさせることで、螺旋状の溝に組織を捕捉しようとするものである。 Japanese Unexamined Patent Application Publication No. 2012-235878 discloses a biopsy device that includes a tubular sheath and a core shaft that constitutes a needle body having a helical groove at the distal end. This device attempts to trap tissue in a helical groove by inserting a core shaft into and out of a sheath.
　特開２０１５－８５１４１号公報には、鞘部材と、針管と、回転刃が設けられた針部材とを備え、針部材操作部および針管操作部の外周に目盛りが設けられた、穿刺針が開示されている。この穿刺針は、目盛りによって、針部材の突出する長さを調整しようとするものである。 Japanese Unexamined Patent Publication No. 2015-85141 discloses a puncture needle that includes a sheath member, a needle tube, and a needle member provided with a rotary blade, and in which a scale is provided on the outer periphery of the needle member operating portion and the needle tube operating portion. It is This puncture needle is intended to adjust the protruding length of the needle member with a scale.
　本発明者は、針状体の進退により少量の組織を採取する従来の生検デバイスでは、必要な量の組織を確保できないことに直面した。したがって、本発明の目的は、そのような問題を解決し、簡単な機構と、簡単な操作で、定量的に組織を採取することができる医療機器を提供することにある。 The present inventor faced the fact that the required amount of tissue could not be obtained with a conventional biopsy device that collects a small amount of tissue by advancing and retracting a needle-like body. SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to solve such problems and to provide a medical device capable of quantitatively sampling tissue with a simple mechanism and a simple operation.
　本発明者らは、上記課題を解決するために鋭意研究を進める中で、組織を筒状体内に引き込んで切断するという、簡単な操作で定量的に組織を採取できることを初めて見出し、かかる知見に基づいてさらに研究を続けた結果、本発明を完成させるに至った。 The inventors of the present invention discovered for the first time that it is possible to collect tissue quantitatively by a simple operation of pulling the tissue into the cylindrical body and cutting it, while conducting intensive research in order to solve the above problems. As a result of further research based on the results, the present invention was completed.
　すなわち本発明は、以下に関する。
［１］組織の採取を行うための医療機器であって、組織に係合する係合部を有する長尺体と、前記長尺体をその内部に引き込むことで前記係合部に係合した組織を収容する筒状体と、引き込まれた組織を切断する切断部を有する切断体と、を含む、医療機器。
［２］前記係合部が、フック状である、［１］に記載の医療機器。
［３］前記切断部が、スネアループ状である、［１］または［２］に記載の医療機器。
［４］前記長尺体と前記切断体とが連結され、前記長尺体を前記筒状体の内部に引き込む操作に連動して、前記切断体による切断が起こるように構成されている、［１］～［３］のいずれか一項に記載の医療機器。 That is, the present invention relates to the following.
[1] A medical device for collecting tissue, comprising a long body having an engaging portion that engages tissue, and engaging with the engaging portion by drawing the long body into the interior of the long body. A medical device, comprising a tubular body for containing tissue and a cutting body having a cutting portion for cutting the retracted tissue.
[2] The medical device according to [1], wherein the engaging portion is hook-shaped.
[3] The medical device according to [1] or [2], wherein the cut section has a snare loop shape.
[4] The elongated body and the cut body are connected, and cutting by the cut body occurs in conjunction with the operation of pulling the elongated body into the cylindrical body. 1] The medical device according to any one of [3].
［５］前記筒状体の外表面および内表面を折り返すように摺動する摺動体をさらに含む、［１］～［４］のいずれか一項に記載の医療機器。
［６］［１］～［５］のいずれか一項に記載の医療機器による採取方法であって、前記係合部が対象物に係合するステップと、前記長尺体が前記対象物を筒状体の内部に引き込むステップと、前記切断体が前記筒状体の内部に引き込まれた前記対象物を切断するステップと、を含む、方法。
［７］前記切断するステップは、前記切断部が前記対象物を焼灼することで切断面を接合するステップを含む、［６］に記載の方法。 [5] The medical device according to any one of [1] to [4], further comprising a sliding body that slides so as to fold back the outer surface and the inner surface of the cylindrical body.
[6] The collection method using a medical device according to any one of [1] to [5], wherein the engaging portion engages an object; A method comprising: drawing inside a tubular body; and cutting the object with the cutting body pulled inside the tubular body.
[7] The method according to [6], wherein the step of cutting includes a step of joining cut surfaces by cauterizing the object with the cutting unit.
　本発明によれば、簡単な機構と、簡単な操作で、定量的に組織を採取することができるため、操作性や製造コストの点において大きなメリットがある。 According to the present invention, tissue can be collected quantitatively with a simple mechanism and simple operation, so there are great advantages in terms of operability and manufacturing cost.
図１Ａは、本発明の第１実施態様に係る医療機器を示す概念図であり、図１Ｂは図１Ａの医療機器を用いた組織の採取方法を示す説明図である。FIG. 1A is a conceptual diagram showing a medical device according to a first embodiment of the present invention, and FIG. 1B is an explanatory diagram showing a method of collecting tissue using the medical device of FIG. 1A. 図２Ａは、本発明の第２実施態様に係る医療機器を示す概念図であり、図２Ｂは図２Ａの医療機器を用いた組織の採取方法を示す説明図である。FIG. 2A is a conceptual diagram showing a medical device according to a second embodiment of the present invention, and FIG. 2B is an explanatory diagram showing a tissue sampling method using the medical device of FIG. 2A. 図３Ａは、本発明の第２実施態様に係る医療機器の斜視図であり、図３Ｂは図３Ａの医療機器の断面図である。3A is a perspective view of a medical device according to a second embodiment of the invention, and FIG. 3B is a cross-sectional view of the medical device of FIG. 3A.
　本発明において、「組織」とは、シート状細胞培養物の作製に使用する細胞を含む生体組織をいう。
　細胞の非限定例としては、例えば、筋芽細胞（例えば、骨格筋芽細胞など）、間葉系幹細胞（例えば、骨髄、脂肪組織、末梢血、皮膚、毛根、筋組織、子宮内膜、胎盤、臍帯血由来のものなど）、心筋細胞、線維芽細胞、心臓幹細胞、胚性幹細胞、ｉＰＳ細胞、滑膜細胞、軟骨細胞、上皮細胞（例えば、口腔粘膜上皮細胞、網膜色素上皮細胞、鼻粘膜上皮細胞など）、内皮細胞（例えば、血管内皮細胞など）、肝細胞（例えば、肝実質細胞など）、膵細胞（例えば、膵島細胞など）、腎細胞、副腎細胞、歯根膜細胞、歯肉細胞、骨膜細胞、皮膚細胞等が挙げられる。ｉＰＳ細胞由来接着細胞の非限定例としては、ｉＰＳ細胞由来の心筋細胞、線維芽細胞、上皮細胞、内皮細胞、肝細胞、膵細胞、腎細胞、副腎細胞、歯根膜細胞、歯肉細胞、骨膜細胞、皮膚細胞、滑膜細胞、軟骨細胞などが挙げられる。
　典型的には、生体組織は筋肉組織であり、細胞は接着細胞、好ましくは骨格筋芽細胞である。 In the present invention, the term "tissue" refers to a biological tissue containing cells used for producing sheet-like cell cultures.
Non-limiting examples of cells include myoblasts (e.g., skeletal myoblasts, etc.), mesenchymal stem cells (e.g., bone marrow, adipose tissue, peripheral blood, skin, hair roots, muscle tissue, endometrium, placenta , umbilical cord blood-derived, etc.), cardiomyocytes, fibroblasts, cardiac stem cells, embryonic stem cells, iPS cells, synovial cells, chondrocytes, epithelial cells (e.g., oral mucosal epithelial cells, retinal pigment epithelial cells, nasal mucosa epithelial cells, etc.), endothelial cells (e.g., vascular endothelial cells, etc.), hepatocytes (e.g., liver parenchymal cells, etc.), pancreatic cells (e.g., pancreatic islet cells, etc.), renal cells, adrenal cells, periodontal ligament cells, gingival cells, Examples include periosteal cells, skin cells, and the like. Non-limiting examples of iPS cell-derived adhesive cells include iPS cell-derived cardiomyocytes, fibroblasts, epithelial cells, endothelial cells, hepatocytes, pancreatic cells, renal cells, adrenal cells, periodontal ligament cells, gingival cells, and periosteal cells. , skin cells, synovial cells, chondrocytes, and the like.
Typically, the biological tissue is muscle tissue and the cells are adherent cells, preferably skeletal myoblasts.
　本発明において、「医療機器」とは、ヒトもしくは動物の疾病の診断、治療もしくは予防に使用されること、またはヒトもしくは動物の身体の構造もしくは機能に影響を及ぼすことが目的とされている機械器具等を指す。 In the present invention, "medical device" means a machine intended to be used for the diagnosis, treatment or prevention of diseases in humans or animals, or to affect the structure or function of the human or animal body. It refers to equipment, etc.
　本発明において、「長尺体」とは、その先端に組織と係合する係合部を有する長尺の部材をいう。係合としては、例えば、引っ掛けることが挙げられ、係合部としては、フック状のものが挙げられる。フック状とは、棒状体の先端が鉤状に曲がった形状をいい、簡単な操作で、筋肉組織などの筋線維に好適に引っ掛けることができる。 In the present invention, the term "long body" refers to a long member having an engaging portion that engages tissue at its tip. For example, the engagement includes hooking, and the engagement portion includes a hook-shaped one. The hook shape refers to a shape in which the tip of a rod-like body is bent like a hook, and can be suitably hooked to muscle fibers such as muscle tissue with a simple operation.
　本発明において、「筒状体」とは、長尺体をその内部に収容することができるパイプ状の長尺の部材をいう。筒状体は、長尺体を内部に引き込むことで係合部に係合した組織を収容することができる。本発明において、筒状体は、内側に内表面を外側に外表面を有し、筒状体の凹んでいる内側を内面、凹面、内部、内腔といい、筒状体の突出している外側を外面、凸面、外部という場合がある。筒状体は、その内部に長尺体と組織を収容できればどのような形状でもよく、断面が円形、四角形、多角形など自由に設計することができる。筒状体は、軸方向にテーパ部分や段差を有したり段階的に異なる内径、外径を有していてもよい。筒状体の容積としては、２～１０ｍｌ、より好ましくは４～５ｍｌとすることができる。 In the present invention, a "cylindrical body" refers to a pipe-shaped long member that can accommodate a long body therein. The tubular body can accommodate the tissue engaged with the engaging portion by pulling the elongated body inside. In the present invention, the tubular body has an inner surface on the inside and an outer surface on the outside, and the recessed inside of the tubular body is referred to as the inner surface, the concave surface, the interior, and the lumen, and the protruding outside of the tubular body. is sometimes referred to as the outer surface, convex surface, or external surface. The tubular body may be of any shape as long as it can accommodate the elongated body and the tissue therein, and the cross section can be freely designed such as circular, square, and polygonal. The tubular body may have a tapered portion or a stepped portion in the axial direction, or may have an inner diameter and an outer diameter that vary stepwise. The volume of the cylindrical body can be 2 to 10 ml, more preferably 4 to 5 ml.
　筒状体としては、組織を外力から保護できる程度の剛性を有するものであればとくに限定されず、市販の筒状体を含む任意のものを用いることができる。筒状体の材料としては、例えば、ポリエチレン、ポリプロピレン、フッ素樹脂、ポリエチレンテレフタレート、ポリメチルメタクリレート、ポリアミド樹脂、ポリスチレン、ポリカーボネート、ポリイミド、ポリエーテルイミド、ポリエーテルエーテルケトン、ガラス、金属（例えば、鉄、ステンレス、アルミニウム、チタン）等が挙げられるがこれに限定されない。 The cylindrical body is not particularly limited as long as it has rigidity enough to protect the tissue from external force, and any one including commercially available cylindrical bodies can be used. Materials for the cylindrical body include, for example, polyethylene, polypropylene, fluororesin, polyethylene terephthalate, polymethyl methacrylate, polyamide resin, polystyrene, polycarbonate, polyimide, polyetherimide, polyetheretherketone, glass, metal (eg, iron, stainless steel, aluminum, titanium) and the like, but are not limited to these.
　本発明において、「切断体」とは、その先端に組織を切断する切断部を有する長尺の部材をいう。切断部としては、スネアループ状のものが挙げられる。スネアループ状とは、ループ状にしたワイヤーの両端をシース内に進退可能に収容し、シースの先端からループ状の部分を進出させることでループを大きく、逆にシース内に後退させることでループを小さくすることができる構造をいう。すなわち、切断部は、ワイヤーのループを大きくして組織の根元に掛け、ループを小さくする（絞る）ことで投げなわのように切断することができる構造を有する。切断体は、ループを絞って組織を絞った上で、ワイヤーに高周波電流を流し、組織を焼灼して切る方法や、ワイヤーに高周波電流を流さずに、組織をワイヤーで絞り切る方法を採ることができる。 In the present invention, the term "cutting body" refers to a long member having a cutting portion for cutting tissue at its tip. The cut portion may be snare loop-shaped. A snare loop is a wire that is looped and both ends are stored in a sheath so that it can move back and forth. A structure that can reduce That is, the cutting part has a structure that can cut like a lasso by enlarging the loop of the wire, hooking it to the root of the tissue, and reducing (squeezing) the loop. The cut body can be cut by squeezing the tissue by squeezing the loop, and then applying a high-frequency current to the wire to cauterize the tissue and cut it, or adopt a method of squeezing the tissue with a wire without passing a high-frequency current to the wire. can be done.
　本発明において、「摺動体」とは、筒状体の表面に沿って摺動することができる帯状体をいう。一態様において、帯状体は、筒状体の面形状に沿って摺動できる筒形状を有する。摺動体は、筒状体の長軸方向に沿って摺動し、筒状体の先端部で折り返されることで、内面から外面、外面から内面に移動する。すなわち、摺動体は、筒状体の外面から先端部で折り返されて内面に移動することで、筒状体上をベルトコンベアの様に摺動し、摺動体に接触した組織を筒状体の内部に巻き込むことができる。 In the present invention, the "sliding body" refers to a belt-shaped body that can slide along the surface of a cylindrical body. In one aspect, the strip has a cylindrical shape that can slide along the surface shape of the cylindrical body. The sliding body slides along the longitudinal direction of the cylindrical body and is folded back at the tip of the cylindrical body, thereby moving from the inner surface to the outer surface and from the outer surface to the inner surface. That is, the sliding body moves from the outer surface of the cylindrical body to the inner surface by folding back at the leading end, thereby sliding on the cylindrical body like a belt conveyor, and moving the tissue in contact with the cylindrical body to the inner surface of the cylindrical body. It can be rolled inside.
　以下、本発明の好適な実施態様に係る医療機器について、図面を参照しつつ詳細に説明する。図１Ａは、本発明の第１実施態様に係る医療機器を示す概念図、図２Ａは、本発明の第２実施態様に係る医療機器を示す概念図である。
　なお、本願における各図において、説明を容易とするため、各部材の大きさは、適宜強調されており、図示の各部材は、実際の大きさを示すものではない。 A medical device according to a preferred embodiment of the present invention will be described in detail below with reference to the drawings. FIG. 1A is a conceptual diagram showing a medical device according to a first embodiment of the present invention, and FIG. 2A is a conceptual diagram showing a medical device according to a second embodiment of the present invention.
In addition, in each drawing in the present application, the size of each member is appropriately emphasized for ease of explanation, and each member shown does not indicate the actual size.
　（第１実施態様）
　まず、本発明の第１実施態様について説明する。
　図１Ａに示されるように、本発明の第１実施態様に係る医療機器１は、長尺体２、筒状体３および切断体４を含む。長尺体２は、係合部２１と、係合部２１を指示する本体部２２とを有する。本体部２２は、長尺な棒状の部材である。本体部２２は、その基端が使用者によって把持され、使用者の操作力を受け付ける。長尺体２は、本体部２２の先端に組織Ｔと係合するフック状の係合部２１を有する。係合部２１は、鉤状に曲がった棒状体を有する。係合部２１の基部は本体部２２の先端に接合されている。係合部２１は、例えばＣ字状、Ｊ字状、Ｌ字状またはＵ字状に湾曲してもよい。 (First embodiment)
First, the first embodiment of the invention will be described.
As shown in FIG. 1A, a medical device 1 according to a first embodiment of the present invention includes an elongated body 2, a tubular body 3 and a cut body 4. As shown in FIG. The elongated body 2 has an engaging portion 21 and a body portion 22 pointing to the engaging portion 21 . The body portion 22 is an elongated rod-shaped member. The base end of the body portion 22 is gripped by the user and receives the user's operation force. The elongated body 2 has a hook-shaped engaging portion 21 that engages with the tissue T at the distal end of the body portion 22 . The engaging portion 21 has a bar-shaped body bent like a hook. The base of the engaging portion 21 is joined to the tip of the body portion 22 . The engaging portion 21 may be curved in a C-shape, J-shape, L-shape or U-shape, for example.
　筒状体３は、パイプ状の部材である。筒状体３は、内側の内表面３ａと、外側の外表面３ｂと、先端部３ｃとを有する。筒状体３は、長尺体２をその内部に収容することができる内径を有する。筒状体３の内径は、後述するシース４２を長尺体２と共に収容可能な寸法を有する。筒状体３は、長尺体２の基端を除く大部分を収容可能な長さを有する。筒状体３は、内側の部分が所定の容積を有する。筒状体３の容積は、例えば、２～１０ｍｍである。より好ましくは、４～５ｍｍとすることができる。筒状体３の容積は、筒状体３の内部に収容される組織Ｔの量の最大値に略等しい。切断体４は、その先端に組織Ｔを切断することができる切断部４１と、シース４２と、ワイヤー４３と、を有する長尺の部材である。 The tubular body 3 is a pipe-shaped member. The tubular body 3 has an inner inner surface 3a, an outer outer surface 3b, and a tip portion 3c. The tubular body 3 has an inner diameter that allows the elongated body 2 to be accommodated therein. The inner diameter of the cylindrical body 3 has a dimension that allows the sheath 42 described later to be accommodated together with the elongated body 2 . The tubular body 3 has a length that can accommodate most of the elongated body 2 except for the proximal end. The cylindrical body 3 has a predetermined volume in its inner portion. The volume of the tubular body 3 is, for example, 2 to 10 mm. More preferably, it can be 4 to 5 mm. The volume of the tubular body 3 is substantially equal to the maximum amount of the tissue T accommodated inside the tubular body 3 . The cutting body 4 is a long member having a cutting portion 41 capable of cutting the tissue T, a sheath 42 and a wire 43 at its tip.
　切断部４１は、ワイヤー４３の先端に位置する。ワイヤー４３は、先端がスネアループ状に形成されている。すなわち、ワイヤー４３は、先端にループ状にしたループ状部４３ａを有する。ワイヤー４３のループ状部４３ａの両端は、シース４２内に進退可能に収容されている。ループ状部４３ａは、シース４２の先端から進出すると、その内径が大きくなる。逆にループ状部４３ａは、シース４２内に後退すると、その内径が小さくなる。ワイヤー４３の基端側は、シース４２の基端側から延び出ている。ワイヤー４３の基端側は、使用者によって把持され、操作力が入力される。ループ状部４３ａの進退は、ワイヤー４３の基端側の操作を通じて行われる。ワイヤー４３は、例えば金属ワイヤーを用いることができる。 The cutting part 41 is located at the tip of the wire 43 . The wire 43 has a tip formed in a snare loop shape. That is, the wire 43 has a looped portion 43a at its tip. Both ends of the loop-shaped portion 43a of the wire 43 are accommodated in the sheath 42 so as to be able to move forward and backward. As the loop-shaped portion 43a advances from the distal end of the sheath 42, its inner diameter increases. Conversely, when the loop-shaped portion 43a retreats into the sheath 42, its inner diameter becomes smaller. The proximal side of the wire 43 extends from the proximal side of the sheath 42 . The base end side of the wire 43 is gripped by the user and an operating force is input. The forward and backward movement of the loop-shaped portion 43 a is performed by manipulating the proximal end side of the wire 43 . A metal wire, for example, can be used for the wire 43 .
　使用開始前の初期状態において、ループ状部４３ａは、筒状体３よりも大きな径に広げられており、図示のように、筒状体３の外表面３ｂに斜めに巻き付けるようにして取り付けられている。シース４２は、その先端が筒状体３の先端部３ｃと同じ軸線方向の位置に配置される。ワイヤー４３を引き込むと、切断部４１は、筒状体３の先端部３ｃの位置で組織Ｔを切断する。 In the initial state before the start of use, the loop-shaped portion 43a is expanded to have a diameter larger than that of the cylindrical body 3, and is attached by obliquely wrapping around the outer surface 3b of the cylindrical body 3, as shown in the figure. ing. The sheath 42 has its distal end arranged at the same axial position as the distal end portion 3 c of the cylindrical body 3 . When the wire 43 is pulled in, the cutting section 41 cuts the tissue T at the tip 3c of the cylindrical body 3. As shown in FIG.
　本態様において、シース４２は、筒状体３の内側に配置される。したがって、切断体４は、筒状体３の内側に配置される。ただし、本態様はこれに限定されず、切断体４は、シース４２と共に筒状体３の外側に配置することもできる（図２Ａ参照）。図１Ａの態様では、筒状体３は、長尺体２を収容するメインルーメンと、切断体４を収容する（シース４２の内腔としての）サブルーメンとを有する構造とすることができる。 In this aspect, the sheath 42 is arranged inside the tubular body 3 . Therefore, the cut body 4 is arranged inside the tubular body 3 . However, this aspect is not limited to this, and the cut body 4 can also be arranged outside the cylindrical body 3 together with the sheath 42 (see FIG. 2A). In the embodiment of FIG. 1A, the cylindrical body 3 can have a structure having a main lumen that houses the elongated body 2 and a sub-lumen (as the lumen of the sheath 42) that houses the cut body 4. In the embodiment of FIG.
　図１Ａに示されるように、本発明の医療機器１に使用する際は、まず、組織Ｔを覆う皮膚部分Ｓを切開し、フック状の係合部２１を組織Ｔに係合させる（引っ掛ける）。フック状の係合部２１は、鉤状に曲がった形状を有しており、例えば、筋肉組織などの筋線維に対して簡単な操作で引っ掛けることができる。この際に、切断部４１をシース４２から進出させることで、ループ状部４３ａを筒状体３の直径より大きく広げておく。係合部２１は、ループ状部４３ａの内側を通過して、組織Ｔに係合する。 As shown in FIG. 1A, when using the medical device 1 of the present invention, first, the skin portion S covering the tissue T is incised, and the hook-shaped engaging portion 21 is engaged (hooked) on the tissue T. . The hook-shaped engaging portion 21 has a hook-like bent shape, and can be hooked to muscle fibers such as muscle tissue with a simple operation. At this time, the cut portion 41 is advanced from the sheath 42 so that the loop-shaped portion 43 a is widened larger than the diameter of the cylindrical body 3 . The engaging portion 21 engages the tissue T by passing through the inside of the loop-shaped portion 43a.
　次に、図１Ｂに示されるように、長尺体２を筒状体３の基端に引き込んで（牽引して）、係合部２１に係合された組織Ｔを筒状体３の内部に収容する。この際に、組織Ｔは広げられたループ状部４３ａ（切断部４１）の内側をくぐり抜けて筒状体３の基端側に達し、筒状体３の先端から基端にかけて引き伸ばされた状態になる。すなわち、筒状体３の先端付近では２つの筋線維が筒状体３の軸方向に並列するように配置され、筒状体３の基端付近では係合部２１に引っ掛けられた筋線維が折り返すように位置している。そして、筒状体３の先端付近には、広げられた切断部４１が引き伸ばされた組織Ｔの根元を取り囲むように配置されることになる。 Next, as shown in FIG. 1B, the elongated body 2 is pulled (pulled) to the proximal end of the cylindrical body 3, and the tissue T engaged with the engaging portion 21 is pulled into the cylindrical body 3. housed in At this time, the tissue T passes through the widened loop-shaped portion 43a (cutting portion 41) to reach the base end side of the tubular body 3, and is stretched from the distal end to the proximal end of the tubular body 3. Become. That is, two muscle fibers are arranged in parallel in the axial direction of the tubular body 3 near the distal end of the tubular body 3, and a muscle fiber hooked by the engaging portion 21 is arranged near the proximal end of the tubular body 3. It is positioned to turn around. Then, in the vicinity of the distal end of the cylindrical body 3, the widened cutting portion 41 is arranged so as to surround the base of the stretched tissue T. As shown in FIG.
　そして、切断部４１をシース４２内に後退させてループ状部４３ａを小さくすることで、筒状体３の先端部３ｃの付近において引き伸ばされた組織Ｔの根元を切断し、組織Ｔを筒状体３内に収容した状態で採取することができる。組織Ｔの採取量は、長尺体２を筒状体３の基端に引き込む距離に依存するため、定量的に組織Ｔを採取することができる。一態様として、組織Ｔを切断する際は、ワイヤー４３に高周波電流を流して組織Ｔを絞って焼灼することで、生体に残る組織Ｔを切断状態のまま放置することなく、切断した筋線維の接断面を接合（癒着）させることができる。 By retracting the cutting portion 41 into the sheath 42 to reduce the size of the loop portion 43a, the base of the stretched tissue T is cut in the vicinity of the distal end portion 3c of the tubular body 3, and the tissue T is formed into a tubular shape. It can be collected while housed in the body 3 . Since the amount of the tissue T to be collected depends on the distance by which the elongated body 2 is pulled into the proximal end of the cylindrical body 3, the tissue T can be quantitatively collected. As one mode, when the tissue T is cut, a high-frequency current is applied to the wire 43 to squeeze and cauterize the tissue T, thereby preventing the tissue T remaining in the living body from being left in a cut state, thereby reducing the cut muscle fibers. The jointed surfaces can be joined (coalesced).
　また、別の態様として、組織Ｔを切断する際は、組織Ｔの根元を結紮し、ワイヤー４３に高周波電流を流さずに、ループ状部４３ａを絞って組織Ｔを絞り切ることで、生体側には筋線維を結紮した状態で残すことができるため、筋線維などの散逸を防止したり、止血を行ったりすることもできる。筒状体３に収容された組織Ｔを使用する際は、長尺体２を筒状体３の先端側に押し出して、係合部２１に係合されている組織Ｔを取り外す。 As another aspect, when cutting the tissue T, the base of the tissue T is ligated, and the loop-shaped portion 43a is squeezed to squeeze out the tissue T without applying a high-frequency current to the wire 43. Since muscle fibers can be left in a ligated state, it is possible to prevent the loss of muscle fibers and stop bleeding. When using the tissue T housed in the tubular body 3, the elongated body 2 is pushed out to the distal end side of the tubular body 3, and the tissue T engaged with the engaging portion 21 is removed.
　一態様において、医療機器１は、長尺体２を筒状体３の基端に引き込む操作に連動して、切断体４による切断が起こるように構成することもできる。これは、例えば、長尺体２と切断体４のワイヤー４３を基端側で連結し、長尺体２を筒状体３の基端に引き込む操作に連動して、連結されたワイヤー４３がシース４２の内部に引き込まれ、切断体４のループ状部４３ａ（切断部４１）が小さくなることで切断が起こるような機構で実現することができる。 In one aspect, the medical device 1 can be configured such that cutting by the cutting body 4 occurs in conjunction with the operation of pulling the elongated body 2 to the proximal end of the tubular body 3 . For example, the wires 43 of the long body 2 and the cut body 4 are connected at the base end side, and the connected wires 43 are interlocked with the operation of pulling the long body 2 to the base end of the cylindrical body 3. It can be realized by a mechanism in which cutting occurs when the loop-shaped portion 43a (cutting portion 41) of the cut body 4 is pulled into the sheath 42 and becomes smaller.
　（第２実施態様）
　図２Ａは、本発明の第２実施態様に係る医療機器１Ａを示す図である。本実施態様において、医療機器１Ａは、筒状体３の内表面３ａおよび外表面３ｂに沿って摺動できる摺動体５をさらに含む。摺動体５は、柔軟な筒状のシート状の部材である。摺動体５は、可撓性を有する樹脂シート、エラストマーシート、織布シートまたは不織布シートにより構成され得る。初期状態において、摺動体５の外側端部５２は外表面３ｂの上に位置し、摺動体５の内側端部５１は内表面３ａに位置する。内側端部５１は、長尺体２に接合されている。摺動体５は、内側端部５１または外側端部５２を引っ張ることで、筒状体３の外表面３ｂおよび内表面３ａを折り返すように摺動させることができる。摺動体５は、筒状体３の外表面３ｂの形状および内表面３ａの形状に沿って変形する。筒状体３の先端部３ｃは、摺動体５が折り返される部分である。摺動体５の摺動を円滑にして摺動体５の摩耗を抑えるため、先端部３ｃは、その断面がＲ形状をなしている（面取りされている）ことが望ましい。 (Second embodiment)
FIG. 2A is a diagram showing a medical device 1A according to a second embodiment of the invention. In this embodiment, the medical device 1A further includes a sliding body 5 that can slide along the inner surface 3a and the outer surface 3b of the tubular body 3. As shown in FIG. The sliding body 5 is a flexible tubular sheet-like member. The sliding body 5 can be made of a flexible resin sheet, elastomer sheet, woven fabric sheet, or non-woven fabric sheet. In the initial state, the outer end 52 of the slide 5 is located on the outer surface 3b and the inner end 51 of the slide 5 is located on the inner surface 3a. The inner end 51 is joined to the elongated body 2 . By pulling the inner end portion 51 or the outer end portion 52, the sliding body 5 can be slid so that the outer surface 3b and the inner surface 3a of the cylindrical body 3 are folded back. The sliding body 5 deforms along the shape of the outer surface 3b and the shape of the inner surface 3a of the cylindrical body 3. As shown in FIG. A distal end portion 3c of the cylindrical body 3 is a portion where the sliding body 5 is folded. In order to allow the slide body 5 to slide smoothly and to suppress wear of the slide body 5, it is desirable that the tip portion 3c has an R-shaped cross section (chamfered).
　摺動体５は、筒状体３の面形状に沿って摺動できる筒形状を有し、例えば、筒状体３の基端側（図２Ａ上側）から外側に通し、先端方向（図２Ａ下方向）に引っ張り、筒状体３の先端部３ｃで内側に折り返し、折り返された部分を基端方向に引っ張ることで、筒状体３の内面および外面を覆うことができる。そして、摺動体５の内側端部５１を筒状体３の基端方向に引っ張ることで、摺動体５を筒状体３の外面から内面にベルトコンベアの様に折り返すように摺動させることができる。 The sliding body 5 has a cylindrical shape that can slide along the surface shape of the cylindrical body 3. For example, the sliding body 5 is passed from the base end side of the cylindrical body 3 (upper side in FIG. 2A) to the outside and toward the distal end (lower side in FIG. 2A). ), folded inward at the distal end portion 3c of the tubular body 3, and pulled in the proximal direction at the folded portion, the inner and outer surfaces of the tubular body 3 can be covered. By pulling the inner end portion 51 of the sliding member 5 toward the base end of the tubular member 3, the sliding member 5 can be slid from the outer surface to the inner surface of the tubular member 3 so as to be folded like a belt conveyor. can.
　本実施態様において、シース４２は、筒状体３の外側に配置される。シース４２およびワイヤー４３は、摺動体５の外方に離間しているため、摺動体５の動作に干渉しない。 In this embodiment, the sheath 42 is arranged outside the tubular body 3 . Since the sheath 42 and the wire 43 are spaced outside the sliding body 5 , they do not interfere with the operation of the sliding body 5 .
　一態様において、図２Ｂに示されるように、摺動体５の内側端部５１を長尺体２の本体部２２の先端に固定することで、長尺体２を筒状体３の基端に引き込む操作に連動して、摺動体５の内側端部５１が筒状体３の内部に引き込まれるように構成することもできる。この構成によれば、組織Ｔを摺動体５に接触させた状態で筒状体３の内部に引き込むことで、組織Ｔを摺動体５で巻き込む（挟み込む）ようにして筒状体３に収容できる。これにより、牽引による係合部２１への負荷を摺動体５に分散できるため、組織Ｔの破断などを防止することができる。 In one aspect, as shown in FIG. 2B, the elongated body 2 is attached to the proximal end of the tubular body 3 by fixing the inner end 51 of the slide body 5 to the distal end of the main body 22 of the elongated body 2 . It is also possible to construct such that the inner end portion 51 of the sliding body 5 is pulled into the cylindrical body 3 in conjunction with the pulling operation. According to this configuration, the tissue T can be accommodated in the tubular body 3 in a state where the tissue T is drawn into the tubular body 3 while being in contact with the sliding body 5, so that the tissue T is caught (sandwiched) by the sliding body 5. . As a result, the load on the engaging portion 21 due to traction can be distributed to the sliding body 5, so that the tissue T can be prevented from being broken.
　（第３実施態様）
　第２実施態様において、切断体４は、筒状体３の外側に配置されているが、実施態様はこの構成例に限定されず、切断体４は、内側、外側のどちら側にも配置することができる。図３Ａおよび図３Ｂに示されるように、本実施態様の医療機器１Ｂは、切断体４を摺動体５の内側に配置する。医療機器１Ｂにおいて、長尺体２Ａは、パイプ状の形状を有する。切断体４およびシース４２は、長尺体２Ａの内側に収容される。この構成では、シース４２は、長尺体２Ａの先端から筒状体３の長さ分だけ進出するように配置される。シース４２の先端は、軸線方向において筒状体３の先端部３ｃと同じ位置に配置される。切断部４１は、引き伸ばされた状態の組織Ｔの根元を取り囲む位置に来るように配置される。そして、長尺体２Ａと切断体４のワイヤー４３とは、基端側で連結される。長尺体２Ａを筒状体３の内部に引き込む操作が行われると、長尺体２Ａに連動してワイヤー４３がシース４２の内部に引き込まれる。その結果、ループ状部４３ａの内径が縮小して、切断体４により組織Ｔが切断される。 (Third embodiment)
In the second embodiment, the cut body 4 is arranged outside the cylindrical body 3, but the embodiment is not limited to this configuration example, and the cut body 4 is arranged either inside or outside. be able to. As shown in FIGS. 3A and 3B, the medical device 1B of this embodiment arranges the cutting body 4 inside the sliding body 5 . In the medical device 1B, the long body 2A has a pipe-like shape. The cutting body 4 and the sheath 42 are housed inside the elongated body 2A. In this configuration, the sheath 42 is arranged to protrude from the distal end of the elongated body 2A by the length of the tubular body 3 . The distal end of the sheath 42 is arranged at the same position as the distal end portion 3c of the tubular body 3 in the axial direction. The cutting part 41 is arranged so as to surround the root of the tissue T in the stretched state. The long body 2A and the wire 43 of the cut body 4 are connected at the base end side. When an operation is performed to pull the long body 2A into the cylindrical body 3, the wire 43 is pulled into the sheath 42 in conjunction with the long body 2A. As a result, the inner diameter of the loop-shaped portion 43a is reduced, and the tissue T is cut by the cutting body 4. As shown in FIG.
　本発明の医療機器の使用は、例えば、以下の工程によって順次行うことができる。
（１）医療機器を提供する
（２）組織に係合部を係合させる
（３）長尺体を筒状体内部に引き込む
（４）引き込まれた組織を切断する Use of the medical device of the present invention can be performed, for example, by the following steps.
(1) Providing a medical device (2) Engaging the engaging portion with the tissue (3) Pulling the elongate body into the cylindrical body (4) Cutting the pulled tissue
　（３）において、長尺体２に接続された摺動体５を使用することで、係合部２１による組織Ｔの牽引と摺動体５による組織Ｔの巻き込みとを同時に行うこともできる。（４）において、ワイヤー４３に高周波電流を流して組織Ｔを焼灼すること、または、ワイヤー４３に高周波電流を流さずに、組織Ｔの根元を結紮してワイヤー４３で絞り切ることで、引き込まれた組織Ｔを切断することができる。 In (3), by using the sliding body 5 connected to the elongated body 2, the pulling of the tissue T by the engaging portion 21 and the winding of the tissue T by the sliding body 5 can be performed at the same time. In (4), the tissue T is cauterized by applying a high-frequency current to the wire 43, or by ligating the base of the tissue T and squeezing it with the wire 43 without applying a high-frequency current to the wire 43. The tissue T can be cut.

Claims (7)

  1. 　組織の採取を行うための医療機器であって、
    　組織に係合する係合部を有する長尺体と、
    　前記長尺体をその内部に引き込むことで前記係合部に係合した組織を収容する筒状体と、
    　引き込まれた組織を切断する切断部を有する切断体と、を含む、医療機器。     A medical device for collecting tissue,
    an elongate body having an engaging portion that engages tissue;
    a tubular body that accommodates the tissue engaged with the engaging portion by drawing the elongated body into its interior;
    a cutting body having a cutting portion that cuts retracted tissue.
  2. 　前記係合部が、フック状である、請求項１に記載の医療機器。 The medical device according to claim 1, wherein the engaging portion is hook-shaped.
  3. 　前記切断部が、スネアループ状である、請求項１または２に記載の医療機器。 The medical device according to claim 1 or 2, wherein the cut portion has a snare loop shape.
  4. 　前記長尺体と前記切断体とが連結され、前記長尺体を前記筒状体の内部に引き込む操作に連動して、前記切断体による切断が起こるように構成されている、請求項１に記載の医療機器。 2. According to claim 1, wherein the elongated body and the cut body are connected, and cutting by the cut body occurs in conjunction with an operation of drawing the elongated body into the cylindrical body. A medical device as described.
  5. 　前記筒状体の外表面および内表面を折り返すように摺動する摺動体をさらに含む、請求項１に記載の医療機器。 The medical device according to claim 1, further comprising a sliding body that slides so as to fold back the outer surface and the inner surface of the cylindrical body.
  6. 　請求項１～５のいずれか一項に記載の医療機器による組織の採取を行うための方法であって、
    　前記係合部が対象物に係合するステップと、
    　前記長尺体が前記対象物を前記筒状体の内部に引き込むステップと、
    　前記切断体が前記筒状体の内部に引き込まれた前記対象物を切断するステップと、
    　を含む、方法。     A method for collecting tissue using the medical device according to any one of claims 1 to 5,
    a step of engaging the engaging portion with an object;
    a step in which the elongate body draws the object into the interior of the tubular body;
    a step of cutting the object with the cutting body drawn into the cylindrical body;
    A method, including
  7. 　前記切断するステップは、前記切断部が前記対象物を焼灼することで切断面を接合するステップを含む、請求項６に記載の方法。 7. The method of claim 6, wherein the step of cutting includes the step of joining cut surfaces by cauterizing the object with the cutting portion.
PCT/JP2022/036629 2021-09-30 2022-09-30 Medical device and method for collecting tissue WO2023054657A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2021160320 2021-09-30
JP2021-160320 2021-09-30

Publications (1)

Publication Number Publication Date
WO2023054657A1 true WO2023054657A1 (en) 2023-04-06

Family

ID=85782963

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2022/036629 WO2023054657A1 (en) 2021-09-30 2022-09-30 Medical device and method for collecting tissue

Country Status (1)

Country Link
WO (1) WO2023054657A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09504451A (en) * 1993-09-20 1997-05-06 ボストン・サイエンティフィック・コーポレーション Multiple biopsy specimen withdrawal device
JPH11226024A (en) * 1998-02-17 1999-08-24 Olympus Optical Co Ltd Treating implement for endoscope
US20180028219A1 (en) * 2016-07-28 2018-02-01 Boston Scientific Scimed, Inc. Polypectomy snare devices

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09504451A (en) * 1993-09-20 1997-05-06 ボストン・サイエンティフィック・コーポレーション Multiple biopsy specimen withdrawal device
JPH11226024A (en) * 1998-02-17 1999-08-24 Olympus Optical Co Ltd Treating implement for endoscope
US20180028219A1 (en) * 2016-07-28 2018-02-01 Boston Scientific Scimed, Inc. Polypectomy snare devices

Similar Documents

Publication Publication Date Title
JP3607702B2 (en) Multiple biopsy sampling equipment
AU2015201540B2 (en) Devices, systems, and methods for obtaining a tissue sample using a biopsy tool
KR101527734B1 (en) Flexible endoscopic suture anchor applier
US8449478B2 (en) Biopsy device
JP5981927B2 (en) Improved cytology brush instrument
US8696683B2 (en) Apparatus for removing an object from a lumen
US6419640B1 (en) Multiple-specimen, endoscopic biopsy forceps
JPH11285500A (en) Basket type grip forceps
WO2015129491A1 (en) Surgical tool for atrial appendage ligation
KR20120139760A (en) Follicular unit removal tool with pivoting retention member
US20220346761A1 (en) Biopsy device
JP4628637B2 (en) Biopsy equipment
WO2023054657A1 (en) Medical device and method for collecting tissue
US20160015372A1 (en) Expanding biopsy catheter
JP2002119514A (en) Biopsy forceps for endoscope
JP2002011014A (en) Resected tissue collecting tool and collecting method of the same
CN217611196U (en) Disposable tissue puncture suspension fixator
JP2000201939A (en) Medical implement
JP7144789B2 (en) grasping forceps
CN216021203U (en) Medical traction device
CN210541727U (en) Anchoring clamp
CN213910332U (en) Side sampling biopsy forceps
CN114831676A (en) Disposable tissue puncture suspension fixator
CN212661878U (en) Improved snare
US20210085298A1 (en) Core biopsy instrument

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22876520

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2023551888

Country of ref document: JP