WO2021029169A1 - 内視鏡用処置具およびその作動方法 - Google Patents

内視鏡用処置具およびその作動方法 Download PDF

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Publication number
WO2021029169A1
WO2021029169A1 PCT/JP2020/027023 JP2020027023W WO2021029169A1 WO 2021029169 A1 WO2021029169 A1 WO 2021029169A1 JP 2020027023 W JP2020027023 W JP 2020027023W WO 2021029169 A1 WO2021029169 A1 WO 2021029169A1
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WO
WIPO (PCT)
Prior art keywords
inner cylinder
needle
treatment tool
cylinder
endoscopic treatment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2020/027023
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English (en)
French (fr)
Japanese (ja)
Inventor
船村　重彰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kaneka Corp
Original Assignee
Kaneka Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kaneka Corp filed Critical Kaneka Corp
Priority to JP2021539170A priority Critical patent/JP7626703B2/ja
Publication of WO2021029169A1 publication Critical patent/WO2021029169A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to an endoscopic treatment tool and a method of operating the same.
  • the drug is injected into the tissue using a therapeutic instrument such as a drug injection catheter.
  • Patent Document 1 discloses a catheter that delivers a therapeutic agent within a substrate.
  • the catheter comprises one or more lumens and a curved delivery member including a hollow tube.
  • Patent Document 1 also discloses that the curved delivery member includes an opening at its distal end and that the curved delivery member is a hollow needle.
  • Patent Document 2 discloses a drainage catheter with an internal needle for puncturing and inserting into a body to suck and drain fluid and the like.
  • the needle of the device described in Patent Documents 1 and 2 is punctured into the affected area, and the drug is directly injected into the affected area from the needle.
  • a diagnostic instrument such as a biopsy needle for identifying an affected area
  • a therapeutic instrument such as a drug injection catheter have been separate bodies. Therefore, when the affected area is located in a deep organ of the body such as the lung, liver, pancreas, and biliary tract, it is not easy for the operator to visually check the affected area, and even if the affected area is identified by a diagnostic instrument, the affected area is not always present.
  • the present invention provides an endoscopic treatment tool capable of appropriately arranging a therapeutic instrument in the specified affected area even if the area specified as the affected area is deep in the body, and a method for operating the same. The purpose is.
  • One embodiment of the endoscopic treatment tool of the present invention that has achieved the above object is an endoscopic treatment tool inserted into a forceps channel of an endoscope, and has a first end in the longitudinal axis direction.
  • An outer cylinder having a second end and having an inner cavity extending in the longitudinal axis direction thereof, and an outer cylinder arranged in the inner cavity of the outer cylinder and movable in the longitudinal axis direction of the outer cylinder with respect to the outer cylinder.
  • the gist is that the inner cylinder having an inner cavity and the needle arranged in the inner cavity of the inner cylinder and movable in the longitudinal axis direction of the outer cylinder with respect to the inner cylinder are provided.
  • the needle can be moved proximally to the inner cylinder. Therefore, the needle can be removed while the inner cylinder is fixed to the target tissue, and an instrument other than the needle, for example, a treatment instrument can be inserted into the removed portion. As a result, the insertion position of the needle with respect to the target tissue can be matched with the insertion position of another instrument.
  • the treatment instrument By constructing the treatment tool for endoscopy in this way, even if the part identified as the affected part such as a tumor is a deep part of the body, the treatment instrument can be arranged in the specified affected part, which is appropriate. It becomes possible to perform treatment.
  • the needle can be removed from the inner cylinder in a state where the inner cylinder protrudes to the distal side from the outer cylinder.
  • the endoscopic treatment tool is further provided with a fluid feeder, and a fluid feeder that supplies fluid to the lumen of the inner cylinder is connected to the proximal portion of the inner cylinder, and the inner cylinder is inside at the distal end thereof. It is preferable to have a side hole that communicates the inner cavity of the cylinder with the outside of the inner cylinder.
  • the inner cylinder has a tapered portion whose outer diameter becomes smaller toward the distal side of the inner cylinder, and the tapered portion is located distal to the side hole. preferable.
  • the inner cylinder is located at a contact portion where the inner wall of the inner cylinder is in contact with the outer wall of the needle and proximal to the contact portion, and the inner wall of the inner cylinder is the outer wall of the needle. It is preferable to have a separation portion separated from the above.
  • the cross-sectional area of the distal end portion of the outer cylinder is larger than the cross-sectional area at the center position in the longitudinal axis direction of the outer cylinder.
  • the needle has an ultrasonic reflecting portion at its distal end.
  • the ultrasonic reflecting portion preferably has a first reflecting portion and a second reflecting portion located proximal to the first reflecting portion.
  • the first reflecting portion and the second reflecting portion have irregularities provided on the outer surface of the needle.
  • the needle has a hollow portion for collecting biological tissue at its distal portion.
  • an expandable portion is provided in a portion of the distal portion of the inner cylinder that can be exposed from the outer cylinder.
  • a first stopper protruding outward in the radial direction is provided in the proximal portion of the inner cylinder.
  • the inner cylinder has a small diameter portion whose distal end inner diameter is smaller than the central position in the longitudinal axis direction of the inner cylinder, and the needle has an outer diameter smaller than that of the small diameter portion. It is preferable to have a large engaging portion and the small diameter portion located distal to the engaging portion.
  • the needle can be removed from the inner cylinder, and the endoscopic treatment tool may be further provided with a therapeutic instrument that is arranged in the lumen of the inner cylinder and can be moved in the longitudinal direction of the outer cylinder with respect to the outer cylinder. preferable.
  • the present invention also provides a method of operating an endoscopic treatment tool.
  • One embodiment of the method of operating the endoscopic treatment tool of the present invention that has achieved the above object has a first end and a second end in the longitudinal axis direction, and extends in the longitudinal axis direction thereof. It is arranged in the outer cylinder having an inner cavity and the inner cavity of the outer cylinder, is movable in the longitudinal axis direction of the outer cylinder with respect to the outer cylinder, and is arranged in the inner cylinder having the inner cavity and the inner cavity of the inner cylinder.
  • the above operating method includes a step of inserting the treatment instrument into the lumen of the inner cylinder after the step of removing the needle from the inner cylinder, the insertion position of the needle with respect to the target tissue and the insertion position of the treatment instrument should be matched. Can be done. As a result, even if the affected part such as a tumor is a deep part of the body, the treatment instrument can be arranged in the specified affected part, so that appropriate treatment can be performed.
  • the needle can be moved proximally to the inner cylinder. Therefore, the needle can be removed while the inner cylinder is fixed to the target tissue, and an instrument other than the needle, for example, a treatment instrument can be inserted into the removed portion. As a result, the insertion position of the needle with respect to the target tissue can be matched with the insertion position of another instrument.
  • the above-mentioned operating method includes a step of inserting the treatment instrument into the lumen of the inner cylinder after the step of removing the needle from the inner cylinder, the insertion position of the needle with respect to the target tissue and the insertion position of the treatment instrument match. Can be made to. As a result, even if the affected part such as a tumor is a deep part of the body, the treatment instrument can be arranged in the specified affected part, so that appropriate treatment can be performed.
  • a cross-sectional view (partially a side view) of a treatment tool for an endoscope according to an embodiment of the present invention is shown.
  • a schematic view showing a state in which the inner cylinder and the needle of the endoscopic treatment tool shown in FIG. 1 are inserted into a living tissue is shown.
  • a schematic view showing a state in which the needle of the endoscopic treatment tool shown in FIG. 2 is removed is shown.
  • a schematic view showing a state in which the treatment instrument is inserted into the lumen of the inner cylinder of the endoscopic treatment tool shown in FIG. 2 is shown.
  • a cross-sectional view (partial side view) showing a modified example of the endoscopic treatment tool shown in FIG. 1 is shown.
  • a cross-sectional view (partial side view) showing another modified example of the endoscopic treatment tool shown in FIG. 1 is shown.
  • a cross-sectional view (partial side view) showing still another modification of the endoscopic treatment tool shown in FIG. 1 is shown.
  • a schematic view showing a state in which the inner cylinder and the needle of the endoscopic treatment tool shown in FIG. 7 are inserted into a living tissue is shown.
  • One embodiment of the endoscopic treatment tool of the present invention is an endoscopic treatment tool inserted into a forceps channel of an endoscope, the first end and the first in the longitudinal axis direction.
  • An outer cylinder having two ends and having an inner cavity extending in the longitudinal axis direction thereof, and an outer cylinder arranged in the inner cavity of the outer cylinder and movable in the longitudinal axis direction of the outer cylinder with respect to the outer cylinder.
  • the gist is that it includes an inner cylinder having an inner cavity and a needle arranged in the inner cavity of the inner cylinder and movable in the longitudinal axis direction of the outer cylinder with respect to the inner cylinder.
  • the needle can be moved proximally to the inner cylinder. Therefore, the needle can be removed while the inner cylinder is fixed to the target tissue, and an instrument other than the needle, for example, a treatment instrument can be inserted into the removed portion. As a result, the insertion position of the needle with respect to the target tissue can be matched with the insertion position of another instrument.
  • the treatment instrument By constructing the treatment tool for endoscopy in this way, even if the part identified as the affected part such as a tumor is a deep part of the body, the treatment instrument can be arranged in the specified affected part, which is appropriate. It becomes possible to perform treatment.
  • the treatment tool for endoscopy is used for collecting a target tissue in a body cavity in endoscopic surgery, injecting a drug into the target tissue, heating, cauterizing, phototherapy, ultrasonic therapy, shock wave therapy, etc. It is a treatment tool used to perform various treatments for.
  • the endoscopic treatment tool is inserted into a forceps channel of an endoscope (preferably an ultrasonic endoscope), placed in the body from the distal side of the forceps channel of the endoscope, and delivered to the treatment part.
  • Endoscopic treatment tools can be used to treat living tissues of any organ, but may be preferably used to treat tissues deep in the body, such as lungs, liver, pancreas, biliary tract. it can.
  • endoscopic ultrasonography treatment tools can be preferably used for various treatment methods such as gene therapy, photoimmunotherapy, photodynamic therapy, and anticancer drug local injection therapy, and endoscopic ultrasonography puncture suction method ( It can be particularly preferably used for Endoscopic UltraSound-guided Fine Needle Aspiration (EUS-FNA).
  • EUS-FNA Endoscopic UltraSound-guided Fine Needle Aspiration
  • FIG. 1 shows a cross-sectional view (partial side view) of a treatment tool for an endoscope according to an embodiment of the present invention.
  • FIG. 2 shows a schematic view showing a state in which the inner cylinder and the needle of the endoscopic treatment tool shown in FIG. 1 are inserted into a living tissue.
  • FIG. 3 shows a schematic view showing a state in which the needle of the endoscopic treatment tool shown in FIG. 2 is removed.
  • FIG. 4 shows a schematic view showing a state in which the treatment instrument is inserted into the lumen of the inner cylinder of the endoscopic treatment tool shown in FIG.
  • the endoscopic treatment tool 1 includes an outer cylinder 10, an inner cylinder 20, and a needle 30.
  • the distal side of the endoscopic treatment tool 1 refers to the first end side of the outer cylinder 10 in the longitudinal axis direction and the treatment target side.
  • the proximal side of the endoscopic treatment tool 1 refers to the second end side of the outer cylinder 10 in the longitudinal axis direction and the hand side of the user (operator).
  • the proximal side may be referred to as a proximal portion and the distal side may be referred to as a distal portion.
  • the inner side of the endoscopic treatment tool 1 refers to a direction toward the center of the longitudinal axis of the outer cylinder 10 in the radial direction of the outer cylinder 10, and the outer side refers to a radiation direction opposite to the inner side.
  • each member constituting the endoscopic treatment tool 1 has biocompatibility.
  • the outer cylinder 10 is a member having a first end and a second end in the longitudinal axis direction and having a lumen 11 extending in the longitudinal axis direction.
  • the first end corresponds to the distal end of the outer cylinder 10 and the second end corresponds to the proximal end of the outer cylinder 10.
  • the outer cylinder 10 has a tubular structure for arranging the inner cylinder 20 and the needle 30 in the lumen 11 of the outer cylinder 10 so as not to damage the non-treatment tissue site or the inside of the forceps channel of the endoscope. .. Further, since the outer cylinder 10 is inserted into the body, it preferably has flexibility.
  • the outer cylinder 10 communicates with the outside through an opening provided at its distal portion. When the inner cylinder 20 and the needle 30 are punctured into the target tissue, the inner cylinder 20 and the needle 30 are projected from the opening.
  • Examples of the outer cylinder 10 include a resin tube, a single wire or a plurality of wires, a tubular body formed by arranging stranded wires in a specific pattern, a metal pipe, or a combination thereof.
  • the resin tube can be manufactured, for example, by extrusion molding.
  • As the tubular body in which the wire rods are arranged in a specific pattern a tubular body having a mesh structure by simply intersecting or knitting the wire rods, or a coil in which the wire rod is wound is shown.
  • the type of network structure is not particularly limited, and the number of coil turns and the density are not particularly limited.
  • the network structure and the coil may be formed at a constant density throughout the axial direction, or may be formed at a different density depending on the position in the longitudinal axis direction.
  • a plurality of annular grooves or spiral grooves may be formed on the outer surface of the metal tube.
  • the groove is formed on the outer surface, particularly the outer peripheral surface, on the distal side of the center in the axial direction of the metal tube.
  • the outer cylinder 10 is preferably made of resin or metal.
  • the resin constituting the outer cylinder 10 include polyamide-based resin, polyester-based resin, polyurethane-based resin, polyolefin-based resin, fluorine-based resin, vinyl chloride-based resin, silicone-based resin, and natural rubber. Only one of these may be used, or two or more thereof may be used in combination. Of these, polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, and fluororesins are preferably used.
  • the metal constituting the outer cylinder 10 examples include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni—Ti alloy, Co—Cr alloy, or a combination thereof. Be done.
  • the wire made of Ni—Ti alloy is excellent in shape memory and high elasticity.
  • the wire rod may be a fiber material such as the above-mentioned metal, polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, PBO fiber, carbon fiber and the like. The fiber material may be monofilament or multifilament.
  • a tubular body made of resin on which a reinforcing material such as a metal wire is arranged may be used as the outer cylinder 10.
  • the outer cylinder 10 may be composed of a single layer or may be composed of a plurality of layers. Further, in the longitudinal direction, a part of the outer cylinder 10 may be composed of a single layer, and the other part may be composed of a plurality of layers.
  • the cross-sectional area of the distal end of the outer cylinder 10 is larger than the cross-sectional area of the outer cylinder 10 at the center position in the longitudinal axis direction.
  • the distal end portion of the outer cylinder 10 easily comes into contact with an organ in the body (for example, a body cavity wall), so that the position of the treatment tool 1 can be fixed in the body.
  • the inner cylinder 20 is arranged in the inner cavity 11 of the outer cylinder 10, is movable in the longitudinal axis direction of the outer cylinder 10 with respect to the outer cylinder 10, and has the inner cavity 21.
  • the inner cylinder 20 also has a distal portion and a proximal portion.
  • the inner cylinder 20 is inserted into the target tissue together with the needle 30 by puncture.
  • the inner cylinder 20 can fix the position of the treatment tool 1 in the body.
  • the inner cylinder 20 can be made of the resin or metal described as the constituent material of the outer cylinder 10 described above.
  • the material of the inner cylinder 20 may be the same as or different from the material of the outer cylinder 10.
  • the inner cylinder 20 uses a tubular body, a metal pipe, or a combination thereof formed by arranging a resin tube, a single wire or a plurality of wires, and a stranded wire in a specific pattern. be able to.
  • the shore hardness of the outer cylinder 10 is preferably larger than the shore hardness of the inner cylinder 20. As a result, it is possible to prevent excessive bending of the outer cylinder 10 while ensuring appropriate flexibility of the inner cylinder 20.
  • the shore hardness is measured based on the ISO868: 2003 plastic durometer hardness test method.
  • the inner cylinder 20 is configured to be movable with respect to the outer cylinder 10 in the longitudinal axis direction of the outer cylinder 10, it is preferable that the inner cylinder 20 and the outer cylinder 10 are not fixed to each other.
  • the longitudinal axis direction of the inner cylinder 20 is preferably parallel to the longitudinal axis direction of the outer cylinder 10. This makes it easier for the inner cylinder 20 to move along the longitudinal axis direction of the outer cylinder 10.
  • the distal end portion (more preferably, the portion including the distal end) of the inner cylinder 20 is provided with a tapered portion 23 whose outer diameter decreases toward the distal side of the inner cylinder 20. This makes it easier to insert the inner cylinder 20 together with the needle 30 into the target tissue by puncturing.
  • the needle 30 is arranged in the inner cavity 21 of the inner cylinder 20 and is movable with respect to the inner cylinder 20 in the longitudinal axis direction of the outer cylinder 10.
  • the needle 30 is preferably arranged in the lumen 21 of the inner cylinder 20 so that the tip 31 of the needle 30 is located on the distal side.
  • the needle 30 is inserted into the target tissue together with the inner cylinder 20 by puncture. By puncturing the target tissue with the needle 30, treatment such as collection of living tissue and injection of a drug becomes possible.
  • the insertion portion of the ultrasonic endoscope is inserted into the stomach, and the treatment tool 1 is projected from the distal opening of the forceps channel of the ultrasonic endoscope.
  • the inner cylinder 20 and the needle 30 are projected from the opening at the distal end of the outer cylinder 10, and the inner cylinder 20 and the needle 30 are punctured into the target tissue.
  • the target tissue is pancreatic tissue.
  • the first body cavity wall 61 is the stomach wall and the second body cavity wall 62 is the pancreatic wall.
  • the needle 30 can be removed with the inner cylinder 20 fixed to the target tissue as shown in FIG.
  • the needle 30 can function as a biopsy needle for collecting a living tissue.
  • the treatment instrument 70 is inserted into the place where the needle 30 is removed, that is, the lumen 21 of the inner cylinder 20 as shown in FIG.
  • the insertion position of the needle 30 with respect to the target tissue can be matched with the insertion position of the treatment instrument 70.
  • the treatment instrument 70 can be arranged in the specified affected part, so that appropriate treatment can be performed. Can be done.
  • the distal end of the needle 30 is not particularly limited as long as it is formed so as to easily puncture the tissue, but as shown in FIG. 1, the needle 30 has an opening edge 32 inclined to the distal end. Is preferable.
  • the tip 31 of the needle 30 can protrude from the opening on the distal side of the inner cylinder 20.
  • the tip 31 of the needle 30 becomes the inner cylinder 20. It is preferably located distal to the distal end.
  • the inner cylinder 20 has a small diameter portion 27 in which the inner diameter of the distal end thereof is smaller than the central position in the longitudinal axis direction of the inner cylinder 20, and the needle 30 has an engaging portion having a larger outer diameter than the small diameter portion 27. It is preferable that the portion 34 is provided and the small diameter portion 27 is located distal to the engaging portion 34. As a result, the position of the needle 30 in the longitudinal axis direction with respect to the inner cylinder 20 can be fixed, so that the needle 30 can be prevented from protruding too much from the opening at the distal end of the inner cylinder 20.
  • the maximum outer diameter of the engaging portion 34 of the needle 30 is preferably smaller than the maximum inner diameter of the inner cylinder 20. This makes it easier to move the inner cylinder 20 and the needle 30 relatively in the longitudinal axis direction of the inner cylinder 20.
  • the engaging portion 34 may be one or more protrusions provided on the outside of the needle 30. Further, the needle 30 may have a needle body extending in the longitudinal axis direction and a ring-shaped member provided on the outside of the needle body as an engaging portion 34.
  • the engaging portion 34 may be integrally formed with the needle body, or may be a member separate from the needle body. Therefore, the engaging portion 34 may be made of the same material as the needle body, or may be made of a material different from that of the needle body.
  • the needle 30 is configured to be movable with respect to the inner cylinder 20 in the longitudinal axis direction of the inner cylinder 20, it is preferable that the needle 30 and the inner cylinder 20 are not fixed to each other.
  • the longitudinal axis direction of the needle 30 is preferably parallel to the longitudinal axis direction of the inner cylinder 20. This makes it easier for the needle 30 to move along the longitudinal axis direction of the inner cylinder 20, so that when the needle 30 is projected from the opening on the distal side of the inner cylinder 20, the tip 31 of the needle 30 is far from the inner cylinder 20. It becomes difficult to contact the position end.
  • the needle 30 preferably has a hollow portion 33 for collecting biological tissue at its distal portion. This allows the target tissue to be retained in the hollow portion 33 for biopsy.
  • the needle 30 may have a solid state proximal to the hollow portion 33.
  • the target tissue can also be held by forming at least a part of the needle 30 in the longitudinal axis direction in the hollow portion 33 in this way.
  • the hollow portion 33 of the needle 30 may be provided over the entire length of the needle 30 in the longitudinal axis direction.
  • the needle 30 may be formed in a tubular shape such as a circular tubular or an oval tubular.
  • the oval tubular type includes a tube having an elliptical cross section, an egg shape, and a rectangular shape with rounded corners.
  • the shape of the cross section perpendicular to the longitudinal axis direction of the needle 30 is circular or oval in order to improve the flow of liquid in the hollow portion of the needle 30.
  • the oval shape includes an elliptical shape, an egg shape, and a rectangular shape with rounded corners. The same applies to the following description.
  • the resin material and the metal material mentioned as preferable materials for the outer cylinder 10 and the inner cylinder 20 can be used as the material constituting the needle 30.
  • the needle 30 is arranged over the entire longitudinal direction of the lumen 21 of the inner cylinder 20. Further, the proximal end of the needle 30 is preferably located proximal to the proximal end of the outer cylinder 10. Further, it is preferable that the proximal end of the needle 30 is located proximal to the proximal end of the inner cylinder 20. This facilitates the operation of moving the needle 30 with respect to the inner cylinder 20 in the longitudinal axis direction of the inner cylinder 20.
  • the needle 30 can be removed from the inner cylinder 20 in a state where the inner cylinder 20 protrudes distally to the outer cylinder 10.
  • the inner cylinder 20 can be fixed inside the body even after the needle 30 is pulled out from the inner cylinder 20, so that the insertion position of an instrument other than the needle 30 such as a treatment instrument can be fixed.
  • the needle 30 can be removed from the inner cylinder 20, and the endoscopic treatment tool 1 is arranged in the inner cavity 21 of the inner cylinder 20 and is movable with respect to the outer cylinder 10 in the longitudinal axis direction of the outer cylinder 10. It is preferable to provide additional equipment. As a result, it is possible to replace the inner cylinder 20 with an instrument different from the needle 30 while the inner cylinder 20 is fixed to the living tissue.
  • FIG. 4 shows an example in which the treatment instrument 70 is arranged in the lumen 21 of the inner cylinder 20 after the needle 30 is removed from the inner cylinder 20.
  • the therapeutic device is used to perform various treatments such as drug injection, heating, cauterization, phototherapy, ultrasonic therapy, and shock wave therapy for the target tissue.
  • the treatment instrument include a drug injection catheter, a high-frequency treatment tool provided with an electrode for heating or cauterization, an ultrasonic probe, a light irradiation probe, a laser probe, a shock wave probe, and forceps.
  • an operation unit 50 for the operator to grip the treatment tool 1 is provided in the proximal portion of the inner cylinder 20.
  • the operation unit 50 can be, for example, a single tubular body having one lumen 51, or a branched tubular tubular body having a plurality of branched lumens 51.
  • a fluid feeder 45 is preferably connected to the cavity 51 of the operating unit 50.
  • a drug such as a contrast medium can be supplied into the inner cylinder 20.
  • the operation unit 50 is a Y tube in which the lumen 51 is branched in two directions.
  • the inner cylinder 20 and the needle 30 may be provided with a stopper 54 for fixing the positions of the members in the longitudinal axis direction.
  • a tubular body can be used as the stopper 54. By inserting the inner cylinder 20 or the needle 30 into the lumen of the tubular body, the stopper 54 can be fixed to the outside of the inner cylinder 20 or the needle 30.
  • a first stopper 55 projecting outward in the radial direction is provided in the proximal portion of the inner cylinder 20.
  • the position of the inner cylinder 20 in the longitudinal axis direction with respect to the outer cylinder 10 can be fixed, so that the inner cylinder 20 can be prevented from protruding too much from the opening at the distal end of the outer cylinder 10.
  • the first stopper 55 may protrude outward in the radial direction from the inner cylinder 20, and may protrude outward in the radial direction from the outer cylinder 10. When the first stopper 55 abuts on the outer cylinder 10, it becomes easier to fix the position of the inner cylinder 20 in the longitudinal axis direction with respect to the outer cylinder 10.
  • the first stopper 55 is preferably arranged on the distal side of the distal end of the operating portion 50. This facilitates the operation of moving the inner cylinder 20 with respect to the outer cylinder 10 in the longitudinal axis direction.
  • the first check valve 58 is connected to the distal portion of the first stopper 55, and the first check valve 58 is in contact with the proximal end of the outer cylinder 10. In that case, it is more preferable that the first check valve 58 is in liquidtight contact with the proximal end of the outer cylinder 10. As a result, it is possible to prevent the body fluid mixed in the outer cylinder 10 from flowing back to the hand side.
  • a second stopper 56 projecting outward in the radial direction is provided in the proximal portion of the needle 30.
  • the second stopper 56 is arranged on the proximal side of the first stopper 55. This facilitates the operation of moving the needle 30 with respect to the inner cylinder 20 in the longitudinal axis direction.
  • the second check valve 59 is connected to the distal portion of the second stopper 56, and the second check valve 59 is in contact with the operating portion 50. In that case, it is more preferable that the second check valve 59 is in liquidtight contact with the operating portion 50. As a result, it is possible to prevent backflow of a drug such as a contrast medium supplied to the lumen 21 of the inner cylinder 20 toward the hand side.
  • a synthetic resin such as ABS or polycarbonate
  • foamed plastic such as polyurethane foam can also be used as a material for the operation unit 50 and the stopper 54.
  • the operation unit 50 and the inner cylinder 20, the first stopper 55 and the inner cylinder 20, or the second stopper 56 and the needle 30 can be joined by using a conventionally known joining means such as an adhesive or heat welding.
  • FIG. 5 is a cross-sectional view (partial side view) showing a modified example of the endoscopic treatment tool 1 shown in FIG.
  • the treatment tool 1 preferably further includes a fluid feeder 45.
  • a fluid feeder 45 that supplies fluid to the lumen 21 of the inner cylinder 20 is connected to the proximal portion of the inner cylinder 20, and the inner cylinder 20 is at its distal end (more preferably, its distal end).
  • the peripheral wall of the portion has a side hole 24 that communicates the inner cavity 21 of the inner cylinder 20 with the outside of the inner cylinder 20.
  • the fluid feeder 45 can be used to discharge a drug such as a contrast medium from the side hole 24, so that it is possible to grasp whether or not the needle 30 and the inner cylinder 20 have been inserted into the target tissue.
  • the side hole 24 is preferably located distal to the distal end of the outer cylinder 10. This makes it possible to release the drug into the target tissue.
  • the number of side holes 24 is not particularly limited, and only one or a plurality of side holes 24 may be provided. When a plurality of side holes 24 are provided, it is preferable that the plurality of side holes 24 are arranged side by side in the circumferential direction of the inner cylinder 20.
  • the shape of the side hole 24 is not particularly limited, and may be a circular shape, an oval shape, a polygonal shape, or a combination thereof.
  • a syringe or an injection pump controlled by a motor can be used as the fluid feeder 45.
  • the inner cylinder 20 has a tapered portion 23 whose outer diameter decreases toward the distal side of the inner cylinder 20, and the tapered portion 23 is located distal to the side hole 24.
  • This makes it easier to puncture the target tissue with the needle 30 and the inner cylinder 20, and it is possible to inject the contrast medium into the target tissue through the side hole 24 with these members punctured in the target tissue.
  • an image diagnostic device such as an ultrasonic endoscope, PET, MRI, or X-ray CT.
  • the inner cylinder 20 is located proximal to the contact portion 25 where the inner wall of the inner cylinder 20 is in contact with the outer wall of the needle 30, and the inner wall of the inner cylinder 20 is separated from the outer wall of the needle 30. It is preferable to have a separation portion 26 and the like. As a result, the needle 30 and the inner cylinder 20 can be brought into contact with each other, so that the leakage of the drug from the inner cylinder 20 can be prevented. It is more preferable that the contact portion 25 is a portion where the inner peripheral wall of the inner cylinder 25 is in contact with the outer peripheral wall of the needle 30. Further, it is more preferable that the separation portion 26 is located proximal to the contact portion 25 and the inner peripheral wall of the inner cylinder 20 is separated from the outer peripheral wall of the needle 30.
  • the contact portion 25 of the inner cylinder 20 is arranged at the distal end portion of the inner cylinder 20. This makes it possible to prevent the drug from leaking from the distal side of the inner cylinder 20.
  • the side hole 24 of the inner cylinder 20 is arranged in the separation portion 26.
  • a drug such as a contrast medium supplied to the lumen 21 of the inner cylinder 20 can be discharged to the outside through the side hole 24.
  • the side hole 24 of the inner cylinder 20 is preferably located proximal to the proximal end of the engaging portion 34.
  • the agent such as the contrast medium can flow toward the side hole 24 without passing through the portion where the cavity 21 of the inner cylinder 20 is narrowed due to the presence of the engaging portion 34. It becomes easier to release the drug from 24.
  • the inner cylinder 20 and the needle 30 can move with each other in the longitudinal axis direction of the inner cylinder 20, and the inner cylinder 20 and the needle 30 are in liquidtight contact at the distal end of the inner cylinder 20. .. This makes it possible to prevent the drug from leaking from the distal side of the inner cylinder 20.
  • FIG. 6 is a cross-sectional view (partial side view) showing another modification of the endoscopic treatment tool 1 shown in FIG.
  • the needle 30 preferably has an ultrasonic reflecting portion 35 at its distal end.
  • ultrasonic waves are irradiated toward the ultrasonic reflecting unit 35, and the time and intensity until the ultrasonic waves reflected by the ultrasonic reflecting unit 35 are returned are measured. By doing so, it is possible to grasp whether or not the needle 30 and the inner cylinder 20 have been inserted into the target tissue.
  • the ultrasonic reflection unit 35 preferably has a first reflection unit 35A and a second reflection unit 35B located proximal to the first reflection unit 35A.
  • the first reflective portion 35A is located distal to the distal end of the inner cylinder 20, and the second reflective portion 35B is inward. It is preferably located proximal to the distal end of the tube 20.
  • the first reflecting portion 35A and the second reflecting portion 35B preferably have irregularities 36 provided on the outer surface of the needle 30.
  • the unevenness 36 is preferably provided on the outer peripheral surface of the needle 30.
  • the unevenness 36 is a portion in which the concave portion 37 and the convex portion 38 are arranged alternately. It is preferable that a plurality of concave portions 37 and a plurality of convex portions 38 are provided.
  • the unevenness 36 is preferably provided at least in a part of the circumferential direction of the needle 30, and is preferably arranged over the entire circumferential direction of the needle 30.
  • the arrangement mode of the unevenness 36 is not particularly limited, but it is preferable that the concave portion 37 and the convex portion 38 are arranged side by side in the longitudinal axis direction or the circumferential direction of the needle 30, and are equally spaced in the longitudinal axis direction or the circumferential direction of the needle 30. It is more preferable that it is arranged in.
  • FIG. 6 shows an example in which the concave portion 37 and the convex portion 38 are arranged side by side in the longitudinal axis direction of the needle 30.
  • the convex portion 38 may extend along the longitudinal axis direction of the needle 30, or may extend along the circumferential direction of the needle 30. Further, a plurality of convex portions 38 may be arranged side by side in a striped shape.
  • the arrangement mode of the first reflection unit 35A and the second reflection unit 35B may be the same as each other.
  • the arrangement mode of the unevenness 36 of the first reflecting portion 35A and the second reflecting portion 35B may be different.
  • the arrangement interval of the concave portion 37 and the convex portion 38 in the first reflection portion 35A and the arrangement interval of the concave portion 37 and the convex portion 38 in the second reflection portion 35B may be different.
  • At least the portion of the needle 30 in the longitudinal axis direction where the ultrasonic wave reflecting portion 35 is provided is made of metal, and the needle 30 is made of metal over the entire longitudinal axis direction. It is more preferable that it is composed of.
  • the treatment tool 1 may include an ultrasonic transducer that converts an electric signal into ultrasonic waves and transmits and receives ultrasonic waves.
  • the ultrasonic transducer preferably includes a piezoelectric vibrator that vibrates when a voltage is applied, and the piezoelectric transducer may be made of, for example, piezoelectric ceramics or crystal.
  • FIG. 7 is a cross-sectional view (partial side view) showing still another modification of the endoscopic treatment tool 1 shown in FIG. 1, and FIG. 8 is an endoscopic treatment tool shown in FIG. 7.
  • a schematic diagram showing a state in which the inner cylinder 20 and the needle 30 of No. 1 are inserted into a living tissue is shown.
  • the expandable portion 40 is provided in the portion of the distal portion of the inner cylinder 20 that can be exposed from the outer cylinder 10.
  • the expandable portion 40 is expanded so that the position of the distal end of the inner cylinder 20 does not shift.
  • the expandable portion 40 can be, for example, a balloon 41 as shown in FIG.
  • the expandable portion may be an expansion wire or a basket composed of a plurality of elastic wires.
  • the balloon 41 is, in order from the distal side, a distal side fixing portion 42 fixed to the inner cylinder 20, an inflatable portion 43 not fixed to the inner cylinder 20, and a proximal side fixed to the inner cylinder 20. It has a fixed portion 44.
  • a side hole 24 is provided at a position corresponding to the expansion portion 43 of the balloon 41, and the fluid feeder 45 is connected to the proximal portion of the inner cylinder 20.
  • the balloon 41 is configured so that the pressure fluid is supplied from the fluid feeder 45 to the inside of the balloon 41 through the side hole 24 of the inner cylinder 20, and the pressure fluid is supplied to the inside of the balloon 41 to cause the balloon 41 to be supplied. It is expandable. On the other hand, the balloon 41 can be contracted by drawing the pressure fluid from the inside of the balloon 41.
  • the type of fluid supplied into the balloon 41 is not particularly limited, but for example, a liquid such as physiological saline, a contrast medium, or a mixture thereof, or a gas such as air, nitrogen, or carbon dioxide can be used.
  • the balloon 41 is preferably made of resin.
  • the resin constituting the balloon 41 include a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, a vinyl chloride resin, a silicone resin, and a natural rubber. Only one of these may be used, or two or more thereof may be used in combination. Of these, polyamide-based resins, polyester-based resins, and polyurethane-based resins are preferably used. As these resins, an elastomer resin can be used from the viewpoint of thinning the balloon 41 and flexibility.
  • the balloon 41 is wound around the outer side of the inner cylinder 20 in the contracted state of the balloon 41.
  • the outer diameter of the inner cylinder 20 when the balloon 41 is contracted can be reduced, so that the inner cylinder 20 can be easily inserted into the target tissue.
  • the distal side fixing portion 42 of the balloon 41 is preferably located proximal to the tapered portion 23 of the inner cylinder 20. This makes it easier to puncture the inner cylinder 20 into the target tissue.
  • An outer cylinder 10 having a first end and a second end in the longitudinal direction and an inner cavity 11 extending in the longitudinal direction, and an outer cylinder 11 of the outer cylinder 10 It is arranged in the inner cylinder 20 which is movable in the longitudinal axis direction of the outer cylinder 10 with respect to the outer cylinder 10 and has an inner cylinder 21, and is arranged in the inner cylinder 21 of the inner cylinder 20 with respect to the inner cylinder 20.
  • a method of operating the endoscopic treatment tool 1 provided with a needle 30 that can move in the longitudinal direction of the outer cylinder 10 will be described.
  • Insert the endoscopic treatment tool 1 into the forceps channel of the endoscope (step 1). Specifically, the distal side of the treatment tool 1 is inserted into the proximal opening of the forceps channel of the endoscope.
  • the endoscope is preferably an ultrasonic endoscope.
  • the needle 30 In order to collect a living tissue using the needle 30, the needle 30 preferably has a hollow portion 33.
  • the description of "1. Endoscopic treatment tool" can be referred to.
  • the inner cylinder 20 and the needle 30 are projected from the distal side of the outer cylinder 10 (step 2). Specifically, it is preferable to project the inner cylinder 20 and the needle 30 from the opening on the distal side of the outer cylinder 10. As a result, the inner cylinder 20 and the needle 30 can be punctured into the target tissue. Step 2 can be performed by moving the inner cylinder 20 and the needle 30 to the distal side with respect to the outer cylinder 10.
  • the inner cylinder 20 When the inner cylinder 20 is provided with the side hole 24, it is preferable to discharge the contrast medium from the side hole 24 of the inner cylinder 20 after step 2 (step 3). Thereby, it is possible to grasp whether or not the distal end portion of the inner cylinder 20 has been inserted into the target tissue by using an diagnostic imaging apparatus such as an ultrasonic endoscope, PET, MRI, and X-ray CT. Therefore, the distal end portion of the treatment instrument used in the subsequent step can be reliably placed in the target tissue, and the therapeutic effect can be enhanced.
  • an diagnostic imaging apparatus such as an ultrasonic endoscope, PET, MRI, and X-ray CT. Therefore, the distal end portion of the treatment instrument used in the subsequent step can be reliably placed in the target tissue, and the therapeutic effect can be enhanced.
  • step 4 When the needle 30 is provided with the ultrasonic reflecting portion 35, it is preferable to irradiate the ultrasonic reflecting portion 35 with ultrasonic waves (step 4). This step also makes it possible to know whether or not the distal end of the inner cylinder 20 has been inserted into the target tissue.
  • the expandable portion 40 When the inner cylinder 20 is provided with the expandable portion 40, it is preferable to expand the expandable portion 40 after step 2 (step 5). As a result, the expandable portion 40 can be arranged between the first body cavity wall 61 and the second body cavity wall 62, and the inner cylinder 20 can be fixed in the body so as not to be displaced.
  • the inner cylinder 20 is provided with the balloon 41 as the expandable portion 40, it is preferable that the balloon 41 is contracted and wound around the outer side of the inner cylinder 20 in step 2.
  • step 6 Remove the needle 30 from the inner cylinder 20 (step 6).
  • step 6 it is preferable to move the needle 30 to the proximal side with respect to the inner cylinder 20 and remove the needle 30 from the proximal side of the inner cylinder 20. This makes it possible to insert the treatment instrument 70 into the portion where the needle 30 was arranged in a later step. If the needle 30 has the hollow portion 33, the living tissue can be held by the hollow portion 33 of the needle 30, so that a definitive diagnosis of the living tissue can be performed after step 6.
  • the treatment instrument 70 is inserted into the lumen 21 of the inner cylinder 20 (step 7).
  • the therapeutic instrument 70 include therapeutic instruments such as a drug injection catheter, a catheter provided with electrodes for heating or incineration, an ultrasonic probe, a light irradiation probe, a laser probe, a shock wave probe, and forceps.
  • step 7 it is preferable to project the treatment instrument 70 from the distal side of the outer cylinder 10 (step 8). As a result, treatment can be performed using the treatment instrument 70.
  • the endoscopic treatment tool 1 is inserted into an endoscope placed in the body cavity (step 10).
  • the endoscope is preferably an ultrasonic endoscope.
  • the distal part of the endoscopic ultrasound is placed in the stomach.
  • the needle 30 and the inner cylinder 20 are punctured into the first body cavity wall 61 (step 11).
  • the first body cavity wall 61 is preferably the stomach wall.
  • the needle 30 and the inner cylinder 20 are punctured into the second body cavity wall 62 (step 12).
  • the second body cavity wall 62 is located distal to the first cavity wall 61.
  • the second body cavity wall 62 is preferably the pancreatic wall.
  • the expandable portion 40 When the inner cylinder 20 is provided with the expandable portion 40, it is preferable to expand the expandable portion 40 after step 12 (step 13). As a result, the expandable portion 40 can be arranged between the first body cavity wall 61 and the second body cavity wall 62, and the inner cylinder 20 can be fixed in the body so as not to be displaced.
  • the inner cylinder 20 is provided with the balloon 41 as the expandable portion 40, it is preferable that the balloon 41 is contracted and wound around the outer side of the inner cylinder 20 in steps 11 and 12. As a result, even if the balloon 41 is provided in the inner cylinder 20, the outer diameter of the inner cylinder 20 can be reduced, so that the inner cylinder 20 can be easily inserted into the target tissue.
  • the side hole 24 is arranged in the second organ (for example, the pancreas) after the step 12 (step 14).
  • a drug such as a contrast medium can be easily injected into the target tissue through the side hole 24.
  • step 15 When the inner cylinder 20 is provided with the side hole 24, it is preferable to inject the contrast medium into the target tissue through the side hole 24 of the inner cylinder 20 (step 15). Thereby, it is possible to grasp whether or not the distal end portion of the inner cylinder 20 has been inserted into the target tissue by using an diagnostic imaging apparatus such as an ultrasonic endoscope, PET, MRI, and X-ray CT. Therefore, the distal end portion of the treatment instrument 70 used in the subsequent step can be reliably placed in the target tissue, and the therapeutic effect can be enhanced. It is preferable that step 15 is performed at at least one of after step 11, after step 12, in the middle of step 11, and in the middle of step 12.
  • step 16 When the needle 30 is provided with the ultrasonic reflecting portion 35, it is preferable to irradiate the ultrasonic reflecting portion 35 with ultrasonic waves (step 16). This makes it possible to know whether or not the distal end of the inner cylinder 20 has been inserted into the target tissue. This step also makes it possible to know whether or not the distal end of the inner cylinder 20 has been inserted into the target tissue. Step 16 may be performed from at least one of the timings before step 11, in the middle of step 11, after step 11, before step 12, in the middle of step 12, and after step 12 to the completion of step 12. preferable. Further, step 16 can be performed together with or in place of step 15.
  • the needle 30 is removed from the first body cavity wall 61 and the second body cavity wall 62 (step 17).
  • a fluorescent spray can be used for definitive diagnosis.
  • Fluorescent sprays include fluorescent probes that fluoresce by reacting with specific enzymes such as ⁇ -glutamyl transpeptidase (GGT) in cancer cells.
  • Step 19 it is preferable to inject a therapeutic agent such as a virus preparation, a plasmid preparation, a photosensitizer, or an anticancer agent into the target tissue (step 19).
  • a therapeutic agent such as a virus preparation, a plasmid preparation, a photosensitizer, or an anticancer agent
  • Step 19 can be performed by inserting an instrument for injecting a drug into the cavity 21 of the inner cylinder 20.
  • step 19 it is preferable to irradiate the target tissue with ultrasonic waves (step 20).
  • step 20 This facilitates the penetration or diffusion of the therapeutic agent into the target tissue, making it possible to treat a wide range.
  • the number of injections of the drug and the amount of the drug used to obtain the same effect can be reduced as compared with the conventional treatment.
  • step 21 Insert the treatment instrument 70 into the lumen 21 of the inner cylinder 20 (step 21).
  • the explanation of "2. Operation method of the endoscopic treatment instrument” can be referred to.
  • a light irradiation probe can be adopted as the treatment instrument 70.
  • step 22 it is preferable to project the treatment instrument 70 from the distal side of the outer cylinder 10 (step 22).
  • Treatment is performed using the treatment instrument 70 (step 23).
  • the treatment instrument 70 For example, in the case of phototherapy, light is irradiated using a light irradiation probe.

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CN114343789A (zh) * 2022-03-17 2022-04-15 深圳锦帛方激光科技有限公司 一种多项可调节式超声针
JP2022149295A (ja) * 2021-03-25 2022-10-06 テルモ株式会社 送達デバイス
WO2025204561A1 (ja) * 2024-03-26 2025-10-02 テルモ株式会社 医療デバイスシステムおよび医療デバイスシステムの使用方法

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JPS5953043U (ja) * 1982-09-30 1984-04-07 住友ベークライト株式会社 内針付き医療用カテ−テル
JP2001161699A (ja) * 1999-12-14 2001-06-19 Asahi Optical Co Ltd 内視鏡用組織採取具の操作部
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JP2016168228A (ja) * 2015-03-13 2016-09-23 オリンパス株式会社 内視鏡用穿刺デバイス

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JP2022149295A (ja) * 2021-03-25 2022-10-06 テルモ株式会社 送達デバイス
JP7557405B2 (ja) 2021-03-25 2024-09-27 テルモ株式会社 送達デバイス
CN114343789A (zh) * 2022-03-17 2022-04-15 深圳锦帛方激光科技有限公司 一种多项可调节式超声针
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WO2025204561A1 (ja) * 2024-03-26 2025-10-02 テルモ株式会社 医療デバイスシステムおよび医療デバイスシステムの使用方法

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