WO2023191057A1 - Clip médical et ensemble clip médical - Google Patents

Clip médical et ensemble clip médical Download PDF

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Publication number
WO2023191057A1
WO2023191057A1 PCT/JP2023/013567 JP2023013567W WO2023191057A1 WO 2023191057 A1 WO2023191057 A1 WO 2023191057A1 JP 2023013567 W JP2023013567 W JP 2023013567W WO 2023191057 A1 WO2023191057 A1 WO 2023191057A1
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WO
WIPO (PCT)
Prior art keywords
arm plate
medical clip
insertion hole
pair
forming member
Prior art date
Application number
PCT/JP2023/013567
Other languages
English (en)
Japanese (ja)
Inventor
晴洋 井上
竜朗 杉谷
Original Assignee
日本ゼオン株式会社
晴洋 井上
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 日本ゼオン株式会社, 晴洋 井上 filed Critical 日本ゼオン株式会社
Publication of WO2023191057A1 publication Critical patent/WO2023191057A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord

Definitions

  • the present invention relates to a medical clip and a medical clip set that are inserted into a hollow organ such as the digestive tract in the body using an endoscope and used to close an excision wound created after excision of a lesion.
  • ESD endoscopic submucosal dissection
  • EFTR endoscopic full-thickness resection
  • Patent Document 1 describes a gripping part that grips internal tissue in response to an operation outside the body, and a gripping part that engages with another gripping part other than the gripping part, and a gripping part that grips internal tissue while being engaged with another gripping part. and an engaging part capable of grasping tissue, and the engaging part deforms into a shape that allows other grasping parts to easily engage when inserted into the body through a forceps channel of an endoscope.
  • a medical grasping tool is described which is characterized by the following.
  • the present invention has been made in view of the above-mentioned problems, and an object of the present invention is to provide a medical clip and a medical clip set that make it possible to more appropriately close an excision wound that occurs after excision of a lesion. .
  • the medical clip according to the present invention includes a pair of arm plate portions that are elastically spread in a substantially V-shape; a fastening member that is movably attached to the pair of arm plate parts along the longitudinal direction of the pair of arm plate parts and closes the pair of arm plate parts by moving toward the distal end of the arm plate parts; , An insertion hole extending along the longitudinal direction of one of the pair of arm plate parts and into which an arm plate part of a medical clip separate from the medical clip can be inserted is provided in one of the pair of arm plate parts.
  • an insertion hole forming member formed on the outer surface side of the arm plate portion It is characterized by having the following.
  • the medical clip of the present invention sandwiches and fixes the body tissue between the pair of arm plate portions, and the arm plate of the separate medical clip is inserted into the insertion hole formed in the medical clip of the present invention.
  • body tissue can be fixed between the pair of arm plate parts using a separate medical clip, and the arm plate part of the medical clip of the present invention and the separate medical clip The body tissue can be fixed in surface contact with the arm plate while maintaining the parallel state.
  • the pair of arm plate portions each have a fastening member locking portion that locks the fastening member when the pair of arm plate portions are closed
  • the insertion hole forming member may form the insertion hole on the distal end side of the fastening member locking portion of the one arm plate portion.
  • the insertion hole forming member can be placed at a position where it does not hinder movement of the fastening member when closing the pair of arm plate parts.
  • the insertion hole forming member may be provided at a position separated from the distal end of the one arm plate portion by a predetermined distance toward the proximal end.
  • the insertion hole forming member can be placed at a position where it does not interfere with the grasping of the body tissue by the pair of arm plate parts.
  • the insertion hole forming member has a semi-cylindrical shape, and the inner circumferential surface of the insertion hole forming member and the outer surface of the one arm plate portion face each other.
  • the insertion hole may be surrounded by an inner circumferential surface of the insertion hole forming member and an outer surface of the one arm plate portion.
  • the insertion hole surrounded by the inner peripheral surface of the semi-cylindrical insertion hole forming member and the outer surface of the arm plate part can be formed on the outer surface side of the arm plate part.
  • the distal end surface of the insertion hole forming member may be sloped downward toward the distal end side of the one arm plate portion.
  • the medical clip when inserting the medical clip at the proximal side forceps port, which is the proximal side exit of the forceps channel of the endoscope, the medical clip can be smoothly passed through.
  • the proximal end surface of the insertion hole forming member may be sloped downward toward the proximal end side of the one arm plate portion.
  • the medical clip when re-accommodating the medical clip at the distal side forceps port, which is the distal side exit of the forceps channel of the endoscope, the medical clip can be smoothly passed through.
  • the insertion hole forming member may be made of metal.
  • the hardness of the insertion hole forming member can be ensured to prevent the insertion hole forming member from being deformed when the arm plate portion of the separate medical clip is inserted, and the insertion hole forming member can be more reliably
  • the arm plate portion of the medical clip of the present invention and the arm plate portion of the separate medical clip can be maintained in a parallel state and the body tissues can be brought into surface contact and fixed.
  • the insertion hole is formed in the other arm plate portion, which is different from the one arm plate portion in which the insertion hole is formed on the outer surface side, similarly to the medical clip.
  • the medical clip may have an engaging portion that can engage with the insertion hole forming member of the medical clip provided with the member.
  • the engagement portion can be provided in the other arm plate portion that is different from the one arm plate portion in which the insertion hole is formed on the outer surface side.
  • the engaging portion is provided at a distal end portion of the other arm plate portion that is different from the one arm plate portion in which the insertion hole is formed on the outer surface side.
  • the engaging portion may include a bent portion bent toward the one arm plate portion.
  • a barb-shaped engagement portion can be provided at the tip of the other arm plate portion, which is different from the one arm plate portion in which the insertion hole is formed on the outer surface side.
  • a dimension of the bent portion in an extending direction toward the one arm plate portion may be set to a dimension that allows it to pass through the insertion hole.
  • the medical clip A according to the present invention can securely hold the body tissue between the pair of arm plate portions.
  • the other arm plate portion of the medical clip B (separate medical clip) according to the present invention can be easily inserted into the insertion hole of the medical clip A.
  • the medical clip set according to the present invention is a medical clip set including a first medical clip and a second medical clip,
  • the first medical clip a pair of first arm plate parts that open into a substantially V-shape with elasticity;
  • the pair of first arms is attached to the pair of first arm plate parts so as to be movable along the longitudinal direction of the pair of first arm plate parts, and is moved in the direction of the distal ends of the first arm plate parts.
  • a first fastening member that closes the plate portion; a second arm of one of the pair of second arm plate parts of the second medical clip extending along the longitudinal direction of one first arm plate part of the pair of first arm plate parts; an insertion hole forming member forming an insertion hole through which the plate part can be inserted on the outer surface side of the one first arm plate part;
  • the second medical clip a pair of second arm plate parts that open into a substantially V-shape with elasticity; an engaging portion provided on one of the pair of second arm plate portions and capable of engaging with the insertion hole forming member of the first medical clip;
  • the pair of second arms is attached to the pair of second arm plate parts so as to be movable along the longitudinal direction of the pair of second arm plate parts, and is moved in the direction of the distal ends of the second arm plate parts.
  • a second fastening member for closing the plate portion for closing the plate portion.
  • the first medical clip included in the medical clip set of the present invention secures the body tissue by sandwiching it between the pair of arm plate portions, and the insertion hole formed in the first medical clip of the present invention
  • the arm plate part of the second medical clip included in the medical clip set of the present invention inserted into the hole
  • the body tissue can be fixed by being sandwiched between the pair of arm plate parts by the second medical clip.
  • the arm plate portion of the first medical clip and the arm plate portion of the second medical clip included in the medical clip set of the present invention maintain a parallel state and bring the body tissue into surface contact and fix the body tissue. I can do it.
  • FIG. 2 is a perspective view showing a state in which the arm plate portion of the medical clip according to the embodiment of the present invention is opened.
  • FIG. 2 is a front view of the medical clip shown in FIG. 1.
  • FIG. FIG. 2 is a perspective view showing a state in which the arm plate portion of the medical clip according to the embodiment of the present invention is closed.
  • 4 is a front view of the medical clip shown in FIG. 3.
  • FIG. 1 is a diagram showing the appearance of a clip device used in an embodiment of the present invention. 6 is a sectional view taken along line AA in FIG. 5.
  • FIG. FIG. 6 is a diagram showing a state in which the medical clip according to the embodiment of the present invention is projected from the distal end of the clip device shown in FIG. 5.
  • FIG. 1 is a diagram showing the appearance of a clip device used in an embodiment of the present invention.
  • 6 is a sectional view taken along line AA in FIG. 5.
  • FIG. FIG. 6 is a diagram showing a state in which the
  • FIG. 6 is a diagram showing a state in which the medical clip according to the embodiment of the present invention is housed in the distal end portion of the clip device shown in FIG. 5.
  • FIG. FIG. 2 is a diagram schematically showing an excision wound created on the inner wall of the digestive tract to which a medical clip according to an embodiment of the present invention can be applied.
  • FIG. 3 is a diagram schematically showing a state in which the first medical clip pinches the edge of a resection wound in order to close the resection wound in an embodiment of the present invention.
  • the tip of the second arm plate portion of the second medical clip is inserted into the insertion hole formed by the insertion hole forming member of the first medical clip.
  • FIG. in order to close an excision wound, FIG. be.
  • a first medical clip and a second medical clip are fixed in close proximity to each other with the edges of the resection wound sandwiched therebetween in order to close the resection wound. It is a diagram.
  • the medical clip 1 includes a clip main body 10 and a tightening ring 60.
  • the tightening ring 60 constitutes the fastening member of the present invention.
  • the tightening ring 60 is provided so as to be slidable with respect to the pair of arm plate parts 30 and 40 of the clip main body 10.
  • the clip main body 10 opens as shown in FIGS.
  • the clip main body 10 is configured to close when the parts 30, 40 are slid toward the distal end side, as shown in FIGS. 3 and 4.
  • the clip main body 10 includes a connecting plate portion 20 and a pair of arm plate portions 30 and 40.
  • an insertion hole forming member 50 is provided in one arm plate part 30 of the pair of arm plate parts 30 and 40.
  • the arm plate part 30 provided with the insertion hole forming member 50 is referred to as a first arm plate part 30, and the arm plate part 40 not provided with the insertion hole forming member 50 is referred to as a second arm plate part. It may be written as 40.
  • the connecting plate portion 20 has a substantially U-shaped bent shape.
  • the substantially U-shaped connecting plate portion 20 has a first wide portion 21 and a second wide portion 22 on its distal end side.
  • a pair of arm plate parts 30 and 40 are integrally formed at each end of the substantially U-shaped connecting plate part 20, and are arranged so as to open in a substantially V-shape toward the distal end thereof. . That is, the pair of arm plate parts 30 and 40 are connected via the connecting plate part 20 on the base end side, and can be opened and closed in a substantially V-shape using the connecting plate part 20 as a fulcrum.
  • a pair of locking step portions 21a and 22a are formed at both ends of the first wide portion 21 and the second wide portion 22 on the distal end side in the width direction, respectively.
  • the first arm plate part 30 includes a first arm proximal end part 31 formed on the proximal end side continuously from the first wide part 21 of the connecting plate part 20, and a distal end part continuous with the first arm proximal end part 31. It has a first arm gripping part 32 formed on the side.
  • the first arm base end portion 31 of the first arm plate portion 30 is formed in a curved shape so as to move away from the second arm base end portion 41 of the second arm plate portion 40 toward the distal end side.
  • the first arm gripping portion 32 of the first arm plate portion 30 has a first ring locking portion 33 formed on the proximal end side continuously from the first arm base end portion 31, and a first ring locking portion 33 that is connected to the first ring locking portion 33. It has a first intermediate narrow portion 34 that is continuously formed, and a first arm wide portion 35 that is continuously formed on the distal end side of the first intermediate narrow portion 34.
  • a claw portion 36 is integrally formed at the tip of the first arm wide portion 35 (that is, the tip of the first arm plate portion 30).
  • the claw portion 36 is formed at the tip of the first arm plate portion 30 by being bent in a direction toward the second arm plate portion 40 side.
  • a concave notch 36a is formed in the center of the tip edge of the claw 36.
  • a pair of locking step portions 35a are formed at both widthwise ends of the proximal end edge of the first arm wide portion 35.
  • an insertion hole forming member 50 is provided on the outer surface 35b side of the first arm wide portion 35.
  • the second arm plate part 40 includes a second arm proximal end part 41 formed on the proximal end side continuous to the second wide part 22 of the connecting plate part 20, and a distal end part continuous to the second arm proximal end part 41. It has a second arm gripping part 42 formed on the side.
  • the second arm base end portion 41 of the second arm plate portion 40 is formed in a curved shape so as to move away from the first arm base end portion 31 of the first arm plate portion 30 toward the distal end side.
  • the second arm gripping portion 42 of the second arm plate portion 40 has a second ring locking portion 43 formed on the base end side continuously from the second arm base end portion 41, and a second ring locking portion 43 that is connected to the second arm base end portion 41.
  • a second intermediate narrow portion 44 is formed continuously
  • a second arm wide portion 45 is formed continuously from the second intermediate narrow portion 44
  • a second arm wide portion 45 is continuously formed from the second intermediate narrow portion 44 to the distal end side. It has a second arm narrow portion 46 formed therein.
  • a pair of locking step portions 45a are formed at both ends of the second arm wide portion 45 on the base end side in the width direction.
  • An engaging portion 47 is integrally formed at the tip of the second arm narrow portion 46 (that is, the tip of the second arm plate portion 40).
  • the engaging portion 47 in this embodiment includes a bent intermediate portion 47a bent in a direction toward the first arm plate portion 30 at the distal end of the second arm plate portion 40, and a bent intermediate portion 47a bent from the distal end of the bent intermediate portion 47a.
  • the bent end portion 47b is further bent back toward the base end side of the second arm plate portion 40.
  • the tightening ring 60 is composed of a substantially cylindrical member.
  • the first arm plate part 30 and the second arm plate part 40 are inserted into the inner space of the tightening ring 60, and when the tightening ring 60 is fitted onto the first arm plate part 30 and the second arm plate part 40, the first arm plate part 30 and the second arm plate part 40 are inserted. It is configured to be able to slide toward the distal end and the proximal end in the extending direction of the first arm plate portion 30 and the second arm plate portion 40.
  • the tightening ring 60 may be configured with a coil spring formed by winding a wire into a coil.
  • the connecting plate part 20, the first arm plate part 30 and the claw part 36 at its tip, and the second arm plate 40 and the engaging part 47 at its tip, which constitute the clip body 10, are made of a single piece of elastic material. It is formed by bending and plastically deforming a thin and elongated plate.
  • the plate material forming the clip body 10 is formed so that the first arm plate part 30 and the second arm plate part 40 are opened when no external load is applied.
  • the thickness of the plate material is not particularly limited, but is preferably 0.10 to 0.30 mm.
  • the plate material is preferably an elastic metal plate, and for example, a stainless steel plate can be used.
  • the width of the plate material is determined by the fact that the tightening ring 60 fitted onto the first arm plate part 30 and the second arm plate part 40 slides toward the distal end and the proximal end.
  • the plate portion 40 is set so that the legs can be opened and closed.
  • first locking step portion 21a and the locking step portion 22a of the connecting plate portion 20 the locking step portion 35a of the first arm plate portion 30, and the locking step portion 45a of the second arm plate portion 40.
  • the plate material between is set to a width that allows it to be inserted into the internal space of the tightening ring 60.
  • the first ring locking portion of the first arm plate portion 30 is located at a position disposed within the internal space of the tightening ring 60.
  • 33 and a second ring locking portion 43 of the second arm plate portion 40 are formed.
  • the first ring locking portion 33 is formed to be wider than the first arm proximal end portion 31 on the proximal side thereof and the first intermediate narrow portion 34 on the distal side thereof.
  • the second ring locking portion 43 is formed wider than the second arm base end portion 41 connected to the base end side thereof and the second intermediate narrow portion 44 connected to the distal end side thereof.
  • the first and second ring locking parts 33 and 43 are press-fitted into the tightening ring 60.
  • the tightening ring 60 is locked to the first and second ring locking portions 33 and 43, and the clip main body 10 is maintained in the closed state.
  • an insertion hole forming member 50 is provided integrally with the first arm plate 30.
  • the insertion hole forming member 50 forms an insertion hole H1 extending along the longitudinal direction of the first arm plate portion 30.
  • the insertion hole H1 formed by the insertion hole forming member 50 is connected to the second arm plate portion 40 of a separate medical clip 1 different from the medical clip 1 (separate second arm plate portion 40). ) is used for inserting.
  • the hole diameter of the insertion hole H1 formed by the insertion hole forming member 50 is preferably set to a hole diameter through which the separate second arm plate portion 40 can be inserted.
  • the shape of the insertion hole forming member 50 is not particularly limited as long as it forms the insertion hole H1, but in this embodiment, as an example, it has a semi-cylindrical shape.
  • the semi-cylindrical insertion hole forming member 50 covers, for example, the outer surface 35b of the first arm plate 30, so that the inner circumferential surface 51 of the insertion hole forming member 50 and the outer surface 35b of the first arm plate 30 face each other. It is arranged like this.
  • the insertion hole H1 is formed by a space surrounded by the inner circumferential surface 51 of the insertion hole forming member 50 and the outer surface 35b of the first arm plate portion 30.
  • the length of the insertion hole forming member 50 is not particularly limited, but it is easy to operate when inserting the separate second arm plate 40 and maintain a parallel fixed state with the separate second arm plate 40. From this point of view, it is preferably 0.5 to 10 mm. Note that the length of the insertion hole forming member 50 is the dimension of the insertion hole forming member 50 along the longitudinal direction of the first arm plate portion 30 on which the insertion hole forming member 50 is provided, The length of the insertion hole forming member 50 in the portion where the separate second arm plate part 40 is restrained when the second arm plate part 40 is inserted and the body tissues are brought into surface contact and fixed is intended. It is something.
  • the insertion hole forming member 50 may be formed integrally over the entire length of the insertion hole forming member 50 as in the present embodiment, or a plurality of insertion hole forming members 50 may be formed by providing a defective portion in the middle of the entire length of the insertion hole forming member 50. It may also be formed by a separate body.
  • the distal end surface 52 of the insertion hole forming member 50 in this embodiment may be formed in a shape that slopes downward toward the distal end side of the first arm plate portion 30, as shown in FIGS. 1 to 4. This tapered shape is particularly useful when the insertion hole forming member 50 is disposed outside the distal end of the outer sheath 254 when attached to the clip device 200, as shown in FIG.
  • the medical clip 1 is used to close an excision wound and is delivered into the body through the forceps channel of the endoscope.
  • the distal end surface 52 of the insertion hole forming member 50 has a downwardly sloping shape, it can be attached to the proximal side forceps opening which is the opening on the proximal side (hand side of the operator) of the forceps channel of the endoscope.
  • the medical clip 1 can be smoothly passed through the proximal forceps port.
  • the proximal end surface 53 of the insertion hole forming member 50 in this embodiment may be formed in a shape that slopes downward toward the proximal end side of the first arm plate portion 30, as shown in FIGS. 1 to 4. good.
  • This tapered shape is also useful particularly when the insertion hole forming member 50 is disposed outside the distal end of the outer sheath 254 when attached to the clip device 200, as shown in FIG. Since the proximal end surface 53 of the insertion hole forming member 50 has a downwardly sloping shape, it can be attached to the distal side forceps opening which is the opening on the distal side (the side inserted into the body) of the forceps channel of the endoscope. When storing the medical clip 1 again, the medical clip 1 can be smoothly passed through the tip end side forceps opening.
  • the insertion hole forming member 50 is arranged in the first arm wide portion 35 located on the distal end side of the first arm plate portion 30 where the tightening ring 60 does not come into contact when the pair of arm plate portions 30, 40 are closed. It is preferable. Specifically, when the pair of arm plate portions 30, 40 are closed, the tightening ring 60 engages with the first and second ring locking portions 33, 34, and the distal end surface of the tightening ring 60 engages with the locking stepped portion 35a. , 45a, but the insertion hole forming member 50 has a tightening ring locking portion (a fastening member locking portion of the present invention) constituted by the first and second ring locking portions 33, 34 and locking step portions 35a, 45a. (corresponding to the stop portion) is preferably disposed on the distal side. Thereby, the insertion hole forming member 50 can be provided at a position that does not interfere with the sliding of the tightening ring 60.
  • a tightening ring locking portion constituted by the first and
  • the insertion hole forming member 50 may be placed at a position spaced apart from the distal end of the first arm plate 30 by a predetermined distance L1 toward the proximal end. For example, by setting the predetermined distance L1 to about 0.2 to 5 mm, when a body tissue is grasped with the medical clip 1, the insertion hole forming member 50 does not hit the body tissue to be grasped, and only by the predetermined distance L1. You will be able to create gaps. Thereby, the insertion hole forming member 50 can be placed at a position that does not interfere with the gripping of the body tissue by the pair of arm plate parts 30 and 40.
  • the second arm plate part 40 (separate second arm plate part 40) of the separate medical clip 1 is inserted into the insertion hole H1 of the insertion hole forming member 50 in this state, the separate second arm The engaging portion 47 of the plate portion 40 is exposed from the distal end surface 52 of the insertion hole forming member 50 toward the distal end side, so that it becomes easier to engage with the insertion hole forming member 50.
  • the insertion hole forming member 50 be made of a material with high hardness so that the insertion hole forming member 50 and the first arm plate part 30 are stable in a parallel state.
  • a metal such as stainless steel.
  • the insertion hole forming member 50 is made of metal, for example, when the first arm plate part 30 is also made of metal, the insertion hole forming member 50 is fixed to the outer surface 35b side of the first arm plate part 30 by laser welding or the like. By doing so, the insertion hole forming member 50 can be provided on the outer surface 35b side of the first arm plate portion 30.
  • the engagement portion 47 is provided at the tip of the second arm plate portion 40.
  • the engaging portion 47 is an insertion hole provided in the first arm plate portion 30 (separate first arm plate portion 30) of a separate medical clip 1 different from the medical clip 1.
  • the second arm narrow portion 46 of the second arm plate portion 40 is inserted into the insertion hole H1 formed by the forming member 50, the second arm plate portion 40 is inserted into the separate first arm plate portion 30. It is provided so that it can be reliably engaged with the insertion hole forming member 50. Therefore, the dimensions of the engaging portion 47 and the dimensions of the second arm narrow portion 46 are set to dimensions that allow the second arm to pass through the insertion hole H1 formed by the insertion hole forming member 50.
  • the shape of the engaging portion 47 is not particularly limited as long as it can engage with the insertion hole forming member 50 of the separate first arm plate portion 30, but in this embodiment, as an example, An engaging portion 47 is provided which is formed into a bent shape (U-shape) by a bent tip portion 47b.
  • the U-shaped engagement portion 47 passes through the insertion hole H1 formed by the insertion hole formation member 50 of the separate first arm plate portion 30 and connects to the end surface (for example, the tip surface 52) of the insertion hole formation member 50. It is designed so that it can be engaged so as to be caught on it.
  • a bent portion at the distal end of the second arm plate portion 40 is bent toward the first arm plate portion 30 side and toward the proximal end side.
  • An example of this is the turned shape (reverse shape).
  • the maximum dimension of the engaging portion 47 in the substantially vertical direction of the second arm plate portion 40 is set to a dimension that allows it to pass through the insertion hole H1. It is preferable.
  • the medical clip 1 in this embodiment is transported to the inside of the gastrointestinal tract using, for example, an endoscope and a clip device 200 shown in FIG. used for.
  • at least two medical clips 1 are used in one set when closing an excision wound.
  • FIG. 5 is a diagram showing the appearance of the clip device 200 used in the embodiment of the present invention.
  • the clip device 200 shown in FIG. 5 includes a connecting hook 251, an inner sheath 252, a drive wire 253, an outer sheath 254, a reinforcing coil 255, a first slider section 256, a base section 257, and a second slider section 258. .
  • FIG. 6 is a cross-sectional view taken along line AA in FIG. 5.
  • a tubular outer sheath 254 is passed through an inner sheath 252, which is also tubular, and a drive wire 253 is passed through the inner sheath 252.
  • the inner sheath 252 is slidable within the outer sheath 254, and the drive wire 253 is slidable within the inner sheath 252.
  • the outer sheath 254 is made of a flexible hollow tube, and for example, a coiled tube can be used.
  • a coil tube a flat wire coil tube formed by spirally winding a long flat plate made of metal (stainless steel) or the like can be used, but a round wire coil tube or a flat internal coil tube may also be used.
  • the inner diameter of the distal end of the outer sheath 254 is approximately 2 to 3 mm.
  • the inner sheath 252 is made of a flexible hollow tube, and for example, a wire tube can be used.
  • a wire tube is a hollow stranded tube made by twisting a plurality of wires made of, for example, metal (stainless steel) in a spiral shape so that the wires are hollow.
  • the inner sheath 252 may be mainly made of a wire tube, with only a portion of the distal end thereof being a coiled tube.
  • the inner diameter of the distal end of the inner sheath 252 is approximately 0.5 to 2.5 mm.
  • the drive wire 253 is made of a flexible wire, and for example, a wire rope can be used.
  • a wire rope is a stranded wire formed by spirally twisting a plurality of wires made of metal (stainless steel), for example.
  • a wire tube similar to the inner sheath 252 may be used.
  • a connecting hook 251 disposed at the distal end of the clip device 200 shown in FIG. 5 has a pair of arm portions 251a made of an elastic body and arranged in a substantially V-shape toward its tip.
  • the connecting hook 251 can take two states, a state in which the legs are opened and a state in which the legs are closed, by cooperation with the inner sheath 252.
  • a claw portion is formed at the distal end of the arm portion 251a of the connecting hook 251 by being bent inward (to sides facing each other), and the connecting plate portion 20 of the clip body 10 can be grasped and connected. ing.
  • the base end of the connecting hook 251 is a U-shaped part that is continuous with the base ends of the pair of arm parts 251a and is formed in a substantially U-shape.
  • the connecting hook 251 can be formed by appropriately bending and plastically deforming one elongated plate made of an elastic body.
  • the thickness of the plate material constituting the connecting hook 251 is not particularly limited, but is approximately 0.1 to 0.3 mm, and the width is approximately 0.6 mm.
  • stainless steel can be used as the plate material.
  • the proximal end of the connecting hook 251 is fixed to the tip (distal end) of a drive wire 253 slidably inserted into the inner sheath 252 by laser welding or the like.
  • a substantially circular annular member is fixed to the distal end of the drive wire 253 by laser welding or the like, and the U-shaped portion of the connecting hook 251 is passed through the annular member, thereby attaching the connecting hook 251 to the driving wire 253. It may also be possible to swing the head.
  • the vicinity of the base end (proximal end) of the outer sheath 254 is inserted into a reinforcing coil 255 and is integrally fixed to the reinforcing coil 255.
  • the reinforcing coil 255 is integrally fixed to the first slider section 256
  • a distal end portion of the base section 257 is inserted into the first slider section 256 .
  • the first slider section 256 slides in a positionable manner relative to the base section 257 between two positions: a position moved toward the tip (distal end) side and a position moved toward the base end (proximal end) side. I'm starting to get it.
  • a second slider portion 258 is slidably held on the base portion 257, and an inner sheath 252 is fixed to the base portion 257.
  • the proximal end of the drive wire 253 is fixed to the second slider section 258.
  • the inner sheath 252 is pulled into the drive wire 253, and the connecting hook 251 at the tip of the drive wire 253 is inserted into the inner sheath 252. It protrudes from the tip of the sheath 252 and opens its legs due to its own elasticity.
  • the second slider section 258 is slid toward the base end (proximal end) with respect to the base section 257, the drive wire 253 is pulled into the inner sheath 252, and the connecting hook 251 at the distal end of the drive wire 253 is pulled into the inner sheath 252.
  • the legs are gradually closed while entering the inner sheath 252, and the legs are completely closed by being buried in the inner sheath 252.
  • the inner sheath 252 can be made to protrude from the distal end of the outer sheath 254.
  • the first slider section 256 is slid to a position on the distal side with respect to the base section 257, the distal end of the inner sheath 252 can be accommodated in the outer sheath 254.
  • a method for attaching the medical clip 1 to the clip device 200 will be described with reference to FIGS. 7 and 8.
  • the connecting hook 251 of the clip device 200 is engaged with the connecting plate portion 20 of the clip body 10, and the connecting hook 251 is drawn into the inner sheath 252. As a result, the connecting hook 251 is closed, and the clip body 10 of the medical clip 1 is attached to the distal end of the inner sheath 252 (see FIG. 7).
  • the distal end of the inner sheath 252 to which the medical clip 1 is connected is drawn into the outer sheath 254, and the medical clip 1 is housed inside the distal end of the outer sheath 254 (see FIG. 8).
  • the tightening ring 60 is located on the proximal end side (near the connecting plate part 20), and the pair of arm plate parts 30 and 40 are closed by the action of the inner wall of the outer sheath 254.
  • the medical clip 1 is attached to a clip device 200 and is transported to the vicinity of a resection wound generated after lesion resection by ESD, EFTR, or the like.
  • the insertion hole forming member 50 of the medical clip 1 is not housed inside the distal end of the outer sheath 254 but is placed outside.
  • the dimension (maximum dimension in the cross-sectional direction) of the arrangement position of the insertion hole forming member 50 is larger than the outer diameter of the outer sheath 254.
  • the channel diameter (forceps channel diameter) of the adapted endoscope is preferably set in accordance with the size of the placement position of the insertion hole forming member 50.
  • the distal end surface 52 and the proximal end surface 53 of the insertion hole forming member 50 are formed in a tapered shape, it is possible to smoothly pass through the proximal end forceps port and the distal end side forceps port of the endoscope, respectively.
  • the height dimension of the medical clip 1 or the inner diameter of the outer sheath 254 is adjusted so that the entire medical clip 1 including the insertion hole forming member 50 is accommodated inside the distal end of the outer sheath 254. You can also do this.
  • FIGS. 9 to 13 A method for closing an excision wound using the medical clip 1 in this embodiment will be described with reference to FIGS. 9 to 13. Note that in FIGS. 9 to 13, the endoscope and the clip device 200 are not shown, and only the symbols necessary for explaining the method of closing the resection wound are provided.
  • At least two medical clips 1 are used as a set to close the resection wound.
  • the medical clip 1 that is first inserted and placed in the gastrointestinal tract is referred to as a first medical clip 1A
  • the medical clip 1 that is later inserted and placed in the gastrointestinal tract is referred to as a second medical clip 1B. do.
  • the same type of medical clip 1 having the configuration shown in FIGS. 1 to 4 is used as both the first medical clip 1A and the second medical clip 1B.
  • FIG. 9 schematically shows an excision wound W generated on the inner wall of the digestive tract to which the medical clip 1 of this embodiment can be applied.
  • FIG. 9 depicts an excision wound W that is generated after a lesion is excised by peeling off the submucosal layer that constitutes the lumen of the digestive tract. At the edge E of the resection wound W, a cross section of the submucosal layer is exposed.
  • a clip device 200 to which the first medical clip 1A is attached is prepared. Then, using an endoscope (not shown), the distal end of the outer sheath 254 of the clip device 200, to which the first medical clip 1A is attached, is transported to the vicinity of the resection wound W created on the inner wall of the digestive tract. Next, by sliding the outer sheath 254 toward the proximal end, the first medical clip 1A is made to protrude from the distal end of the outer sheath 254. As a result, as shown in FIG. 7, the pair of arm plate parts 30 and 40 are in a state where their legs are opened due to their own elasticity.
  • the tightening ring 60 further slides toward the distal end and engages with the first and second ring locking portions 33, 43, and the pair of The arm plate parts 30, 40 can be completely closed.
  • the inner sheath 252 is slid toward the proximal end with respect to the drive wire 253, the connecting hook 251 is pushed out from the distal end of the inner sheath 252, and the legs are opened. Release grip (engagement).
  • the first medical clip 1A is fixed with the edge E of the resection wound W sandwiched therebetween.
  • the second medical clip 1B is attached to the distal end of the clip device 200. Then, the distal end of the outer sheath 254 of the clip device 200 to which the second medical clip 1B is attached is fixed to the first medical device with the edge E of the resection wound W generated on the inner wall of the gastrointestinal tract sandwiched therebetween. transport to the vicinity of the clip 1A.
  • the pair of arm plate parts 30 and 40 of the second medical clip 1B are opened, and the insertion hole H1 formed by the insertion hole forming member 50 of the first medical clip 1A is opened. , the tip of the second arm plate portion 40 of the second medical clip 1B is inserted.
  • the second medical clip 1B is positioned so as to sandwich the edge E of the resection wound W, which is different from the position sandwiched by the first medical clip 1A. It is preferable that the second medical clip 1B is positioned so as to sandwich a position on the opposite side (an opposing position) of the resection wound W with respect to a position already sandwiched by the first medical clip 1A.
  • the first medical clip 1A and the second medical clip 1B are fixed close to each other with the edge E of the resection wound W sandwiched therebetween.
  • the second arm plate portion 40 of the second medical clip 1B is inserted into the insertion hole H1 formed by the insertion hole forming member 50 of the first medical clip 1A.
  • the insertion hole H1 is formed to extend along the longitudinal direction of the first arm plate portion 30 of the first medical clip 1A. Further, the insertion hole forming member 50 is made of a material with high hardness such as metal, and is configured not to be deformed by the pulling force of the second medical clip 1B. Thereby, the first arm plate part 30 of the first medical clip 1A and the second arm plate part 40 of the second medical clip 1B are maintained in a parallel state.
  • the tissue gripped by the first medical clip 1A and the tissue gripped by the second medical clip 1B are placed on the distal side of the first medical clip 1A and the second medical clip 1B.
  • Area S in FIG. 13 can be fixed in a state of surface contact.
  • Another set (two medical clips 1) is used to close the edge E of the excision wound W once or multiple times in succession, and the edge E of the excision wound W is closed using multiple sets.
  • suturing using a suturing device may be additionally performed.
  • the medical clip 1 in the embodiment described above is configured to have the insertion hole forming member 50 on the first arm plate portion 30 and the engaging portion 47 on the second arm plate portion 40.
  • the excision wound can be closed using two medical clips 1 (clip set) of the same type.
  • the desired resection wound can be closed by preparing only the required number of one type of medical clip 1, which simplifies preparation for the procedure.
  • the first medical clip 1A which is first inserted and placed in the digestive tract when closing a resection wound, has the insertion hole forming member 50 in the first arm plate part 30, it does not necessarily have a second arm plate part. 40 may not have the engaging portion 47.
  • the dimensions of the distal end of the second arm plate portion 40 are as follows. It is sufficient that the first arm plate portion 30 does not necessarily have the insertion hole forming member 50, as long as it is set to a size that allows it to pass through the insertion hole H1 of the first medical clip 1A that has been previously placed.
  • a clip set used for closing an excision wound is, for example, the first medical clip 1A in which the first arm plate part 30 has the insertion hole forming member 50 and the second arm plate part 40 has an arbitrary configuration.
  • two different types of medical clips 1B in which the second arm plate part 40 has an engaging part 47 and a second arm narrow part 46, and the first arm plate part 30 has an arbitrary configuration. It may be clip 1. Even when these different types of medical clips 1 are used, the arm plate portion 30 of the first medical clip 1A and the arm plate portion 40 of the second medical clip 1B are parallel to each other when the resection wound is closed. This state can be maintained and the internal tissues brought into face-to-face contact and fixed.
  • the clip set also includes a first medical clip that has the insertion hole forming member 50 and does not have the engagement portion 47, and a second medical clip that has the engagement portion 47 and does not have the insertion hole formation member 50. It may be used in combination with a clip for use. In this case, although it is necessary to prepare two types of medical clips, reliable engagement is achieved using the insertion hole forming member 50 and the engaging portion 47, and each medical clip is connected to the channel of the endoscope. (Forceps channel) It becomes easy to configure the size to be able to pass through, and it becomes easy to improve the productivity of each medical clip.
  • an insertion hole forming member is provided on the outer surface side of the first arm plate portion 30.
  • the insertion hole forming member 50 extends along the longitudinal direction of the first arm plate part 30, and forms an insertion hole H1 through which the second arm plate part 40 of the separate medical clip 1 can be inserted.
  • the medical clip 1 of the present embodiment secures the body tissue by sandwiching it between the pair of arm plate parts 30 and 40, and also inserts the tissue into the insertion hole H1 formed on the outer surface side of the first arm plate part 30.
  • internal tissue can be fixed by the separate medical clip 1 with the pair of arm plate parts 30 and 40 interposed therebetween.
  • the arm plate portion 30 of the medical clip 1 and the arm plate portion 40 of the separate medical clip 1 can be maintained in a parallel state, and the internal tissue can be fixed in surface contact. .
  • the insertion hole forming member 50 is preferably disposed at a position where it does not interfere with the sliding of the tightening member 60, such as on the distal end side of the first arm plate portion 30. Furthermore, it is preferable that the insertion hole forming member 50 be provided at a position a predetermined distance from the distal end of the first arm plate portion 30 on the proximal side.
  • the insertion hole forming member 50 is made of metal so that the arm plate portions 30 and 40 of the two medical clips 1 can be maintained in a parallel state when placed at the edge E of the resection wound W. is preferred.
  • the insertion hole forming member 50 has a distal end surface 52 that slopes downward toward the distal end, and a proximal end surface 53 that slopes downward toward the proximal end in order to smoothly transport the insertion hole forming member 50 when it is inserted into the body or recovered from the body. Preferably, it slopes downward.
  • the medical clip set 1 in this embodiment includes a medical clip 1A that is first inserted and left in the body, and a medical clip 1B that is inserted and left in the body later.
  • the medical clips 1A and 1B included in the medical clip set 1 may be of the same type or of different types.
  • the medical clip 1A has an insertion hole forming member 50 in the first arm plate part 30, and the medical clip 1B has a second arm plate part 40 formed by the insertion hole forming member 50 of the medical clip 1A. It is configured so that it can be inserted into the insertion hole.
  • the present invention is applicable to a technique for closing an excision wound that occurs after excision of a lesion, and makes it possible to more appropriately close an excision wound that occurs after excision of a lesion.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Afin de permettre une fermeture plus appropriée des plaies de résection qui se produisent suite à une excision de lésion, ce clip médical 1 comprend : une paire de sections de plaque de bras 30, 40 qui s'ouvrent sous une forme approximative en V sous l'effet d'une force élastique ; un élément de fixation 60 qui est fixé à la paire de sections de plaque de bras 30, 40 de façon à pouvoir être déplacé dans une direction longitudinale de la paire de sections de plaque de bras 30, 40, et qui ferme la paire de sections de plaque de bras 30, 40 lorsqu'il est déplacé vers l'extrémité de pointe des sections de plaque de bras 30, 40 ; et un élément de formation de trou d'insertion 50 qui s'étend dans la direction longitudinale de la section de plaque de bras 30 de la paire de sections de plaque de bras 30, 40 et qui forme, sur le côté de surface externe de la section de plaque de bras 30, un trou d'insertion H1 à travers lequel une section de plaque de bras d'un clip médical qui est une pièce différente du clip médical 1 peut être insérée,
PCT/JP2023/013567 2022-03-31 2023-03-31 Clip médical et ensemble clip médical WO2023191057A1 (fr)

Applications Claiming Priority (2)

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JP2022-058745 2022-03-31
JP2022058745 2022-03-31

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005334002A (ja) * 2004-05-24 2005-12-08 Pentax Corp 内視鏡用クリップ装置
JP2020065637A (ja) * 2018-10-23 2020-04-30 日本ゼオン株式会社 管腔内留置クリップ

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005334002A (ja) * 2004-05-24 2005-12-08 Pentax Corp 内視鏡用クリップ装置
JP2020065637A (ja) * 2018-10-23 2020-04-30 日本ゼオン株式会社 管腔内留置クリップ

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