Clip unit

Abstract

Provided is a clip unit comprising: a clip including a first arm and a second arm which can be opened and closed toward a distal end side; and a tubular member capable of storing at least a part of the clip. The first arm has a first claw extending toward a closing side in an opening / closing direction at the distal end and the first claw has a first anchor.

Description

Clip Unit

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 508,592, filed Jun. 16, 2023, the entire contents of which are incorporated herein by reference.

[0002] In endoscopic treatment, a clip unit is used that can ligate the excision site after treatment to stop bleeding, etc. The clip unit includes a clip that clamps the excision site, etc., and a pressure tube that houses the clip and locks it in a closed state. The clip unit is introduced to the treatment site by a clip introducer that can be inserted through the channel of the endoscope.

[0003] Patent Document 1 describes a treatment tool that punctures biological tissue. The treatment tool described in Patent Document 1 can be left in the body while punctured into biological tissue.

[0004] Japanese Patent Application Publication No. 9-38093

[0005] However, the treatment tool described in Patent Document 1 is not necessarily the most suitable treatment tool for performing treatments such as suturing a resected portion or a defective portion of tissue.

[0006] In view of the above circumstances, an object of the present invention is to provide a clip system that is optimal for a procedure for suturing biological tissue.

[0007] In order to solve the above problems, the present invention proposes the following means: A clip unit according to a first aspect of the present invention includes a clip having a first arm and a second arm that can be opened and closed toward a distal end, and a tubular member that can store at least a portion of the clip, wherein the first arm has a first claw at its distal end that extends toward a closing side in an opening and closing direction, and the first claw has a first anchor.

[0008] The clip unit of the present invention can be suitably used for, for example, suturing a cut or defect portion.

[0009] 1 is a perspective view of a clip introduction device of a clip delivery device according to a first embodiment. FIG. 2 is a perspective view of a clip unit of the clip delivery device. FIG. 3 is a perspective view of the clip unit with the presser member shown in transparency. FIG. 4 is a view of a pair of arms of the clip unit in a closed state, viewed from the longitudinal direction. FIG. 5 is a view of a modified first anchor. FIG. 6 is a view of a modified first anchor. FIG. 7 is a view of the pair of arms in a closed state, viewed from the opposing direction. FIG. 8 is a view of the pair of arms in a closed state, viewed from the opening and closing direction. FIG. 9 is a cross-sectional view of the presser member in the longitudinal direction. FIG. 10 is a perspective view of a connecting member of the clip unit. FIG. 11 is a view of the clip unit loaded in the clip introduction device. FIG. 12 is a view of the clip unit introduced into a body. FIG. 13 is a view of the clip unit gripping a first mucous membrane. FIG. 14 is a view of the first mucous membrane gripped by the pair of arms. FIG. 15 is a view of the clip unit with the second claws removed from the first mucous membrane. FIG. 16 is a view of the first mucous membrane with the second claws removed. FIG. 17 is a view of the clip unit gripping a second mucous membrane. FIG. 18 is a view of the clip unit with the pair of arms closed. FIG. 19 is a view of the clip unit with the clip locked. FIG. 19 is a view of the clip unit with the clip separated. FIG. 19 is a view of the clip unit after breaking. FIG. 1 is a diagram showing a modified example of the second claw. FIG. 2 is a diagram showing a modified example of the first claw and the second claw. FIG. 3 is a diagram showing a modified example of the presser member and a modified example of the pair of arms. FIG. 4 is a diagram showing a modified example of the presser member and a modified example of the pair of arms. FIG. 5 is a diagram showing a modified example of the presser member and a modified example of the pair of arms. FIG. 6 is a diagram showing a clip unit according to a second embodiment. FIG. 7 is a diagram showing the clip unit. FIG. 8 is a diagram showing a modified example of the clip of the clip unit. FIG. 9 is a diagram showing a modified example of the clip. FIG. 10 is a diagram showing a modified example of the clip. FIG. 11 is a diagram showing a clip unit according to a third embodiment. FIG. 12 is a diagram showing the clip unit. FIG. 13 is a diagram showing a modified example of the clip of the clip unit. FIG. 14 is a diagram showing a clip unit according to a fourth embodiment. FIG. 15 is a diagram showing the clip unit. FIG. 16 is a diagram showing the clip unit.Fig. 10 is a diagram showing a modified example of an inner surface anchor;Fig. 11 is a diagram showing a modified example of a clip;Fig. 12 is a diagram showing a modified example of a first claw and a second claw;Fig. 13 is a diagram showing a modified example of a first claw and a second claw;Fig. 14 is a diagram showing a modified example of a first claw and a second claw.

[0010] First Embodiment A clip delivery device 300 according to a first embodiment of the present invention will be described with reference to FIGS. 1 to 21. FIG.

[0011] [Clip Delivery Device 300] The clip delivery device (clip system) 300 includes a clip introduction device (applicator) 200 and a clip unit 100. The clip unit 100 is loaded into the clip introduction device 200.

[0012] [Clip Introducing Device 200] Fig. 1 is a perspective view of the clip introducing device 200. The clip introducing device (applicator) 200 includes a sheath 220, a manipulation wire 230, and a manipulation section 240. The clip introducing device 200 is inserted, for example, into a treatment tool insertion channel of an endoscope and used in combination with the endoscope. For this reason, the sheath 220 is formed to be sufficiently longer than the length of the treatment tool insertion channel of the endoscope. The sheath 220 is flexible and bends in accordance with the curvature of the insertion section of the endoscope.

[0013] The sheath 220 is formed in an elongated tubular shape as a whole and includes a distal tip 221, a distal coil 222, and a proximal coil 224. The distal coil 222 is disposed on the distal end side of the sheath 220. The distal tip 221 is disposed at the distal end of the distal coil 222.

[0014] As shown in FIG. 1, the operating wire (power transmission unit) 230 includes an arrowhead hook portion (connection portion) 231 connected to the clip unit 100 and a wire 232 that operates the arrowhead hook portion 231 .

[0015] The arrowhead hook portion 231 includes a substantially conical engaging portion 231a that engages with the clip unit 100, and a wire connecting portion 231b that is provided at the base end of the engaging portion 231a. The arrowhead hook portion 231 is formed of a metal material such as stainless steel.

[0016] The wire 232 is inserted so as to be able to move forward and backward relative to the sheath 220. The distal end of the wire 232 is fixed to the proximal end of the wire connecting portion 231b by, for example, welding.

[0017] 1, the operation unit 240 includes an operation unit main body 241, a slider 242, and a thumb ring 248. The operation unit main body 241 is injection molded from, for example, a resin material. The operation unit main body 241 includes a slit portion 241a and a rotating grip 241b on the tip side. The slit portion 241a supports the slider 242 so that the slider 242 can move forward and backward.

[0018] The slider 242 is attached to the operation portion main body 241 so as to be movable forward and backward in the longitudinal axis direction, and has the base end of the wire 232 attached thereto. When the slider 242 moves forward and backward along the operation portion main body 241, the wire 232 moves forward and backward relative to the sheath 220, and the arrowhead hook portion 231 moves forward and backward.

[0019] The thumb ring 248 is attached to the base end of the operation portion body 241 so as to be rotatable around the longitudinal axis of the operation portion body 241 .

[0020] [Clip unit 100] Fig. 2 is a perspective view of the clip unit 100. Fig. 3 is a perspective view of the clip unit 100 with the pressing member 3 being transparently displayed. The clip unit 100 includes a clip 2, the pressing member 3, and a connecting member 4.

[0021] In the following description, the clip 2 side in the longitudinal direction A of the clip unit 100 will be referred to as the tip side (distal side) A1 of the clip unit 100, and the connecting member 4 side will be referred to as the base side (proximal side) A2 of the clip unit 100.

[0022] The clip 2 is formed by bending a metal plate at the center. The clip 2 has a pair of arms 21 that can open and close toward a distal end side A1, and a proximal end 28 that connects the pair of arms 21. The proximal end side A2 of the clip 2 is inserted into an internal space 38 of the pressing member 3 (see FIG. 9 ).

[0023] The pair of arms 21 includes a first arm 211 and a second arm 212. The first arm 211 and the second arm 212 are arranged on either side of a central axis O1 in the longitudinal direction A of the clip unit 100. Note that the clip 2 may have three or more arms.

[0024] The first arm 211 has, from the distal end side A1 to the proximal end side A2, a first claw 261, a flat plate-shaped gripping portion 23, a sliding portion 24, and an engaging portion 25.

[0025] The second arm 212 has, from the distal end side A1 to the proximal end side A2, a second claw 262, a flat plate-shaped gripping portion 23, a sliding portion 24, and an engaging portion 25.

[0026] 4 is a view of the pair of arms 21 in the closed state as viewed from the longitudinal direction A. Here, when the pair of arms 21 are in the closed state, the direction in which the first claw 261 and the second claw 262 face each other is also referred to as the "facing direction C." In addition, the plane that passes through the central axis O1 and is horizontal to the opening / closing direction B is also referred to as the "facing surface CS."

[0027] In this embodiment, the opposing direction C is perpendicular to the opening / closing direction B of the pair of arms 21. However, the opposing direction C does not have to be perpendicular to the opening / closing direction B, as long as it is a direction that intersects with the opening / closing direction B. In this embodiment, the longitudinal direction A is perpendicular to the opening / closing direction B of the pair of arms 21. However, the longitudinal direction A does not have to be perpendicular to the opening / closing direction B, as long as it is a direction that intersects with the opening / closing direction B.

[0028] The first claw 261 is a member provided at the tip of the first arm 211 and capable of puncturing the mucous membrane, extending inward (closed side) in the opening / closing direction B. The first claw 261 is formed by bending the tip of the first arm 211 inward in the opening / closing direction B. That is, a bent portion is formed by bending between the first arm 211 and the first claw 261. When the clip 2 is in the closed state, the first arm 211 extends along the longitudinal direction A, and the first claw 261 extends along the opening / closing direction B. The first claw 261 is formed in a tapered shape that tapers inward in the opening / closing direction B. In this embodiment, the first claw 261 is formed in the shape of a right triangle when viewed from the longitudinal direction A. Note that the first claw 261 does not have to be formed in the shape of a right triangle when viewed from the longitudinal direction A, and may be formed in, for example, a triangular shape.

[0029] The first claw 261 has a plurality of first anchors 271 on an outer surface (first outer surface) 261b on the outer side in the opposing direction C (opposite the second claw 262 side). The plurality of first anchors 271 extend from the first claw 261 toward the outer side in the opposing direction C and may be capable of puncturing a mucous membrane. Specifically, the plurality of first anchors 271 are formed in a tapered shape that tapers toward the outer side in the opposing direction C.

[0030] The outer surface 261b of the first claw 261 is inclined with respect to the opening / closing direction B, and approaches the opposing surface CS toward the inside in the opening / closing direction B (close side).

[0031] The multiple first anchors 271 are arranged on the outer surface 261b of the first claw 261 along the opening / closing direction B. The more the multiple first anchors 271 are arranged on the inner side (closed side) in the opening / closing direction B, the longer the protrusion length from the outer surface 261b.

[0032] 5 and 6 are diagrams showing modified examples of the first anchor 271. The protruding lengths of the multiple first anchors 271 from the outer surface 261b may be uniform. As shown in Fig. 5, the protruding lengths of the multiple first anchors 271 may extend to a length that fits within the inner cavity of the pressing member 3. As shown in Fig. 6, the protruding lengths of the multiple first anchors 271 may extend to the ends of the gripping portion 23 in the opposing direction C.

[0033] The second claw 262 is a member provided at the tip of the second arm 212 and capable of puncturing the mucous membrane, extending inward (closed side) in the opening / closing direction B. The second claw 262 is formed by bending the tip of the second arm 212 inward in the opening / closing direction B. That is, a bent portion is formed by bending between the second arm 212 and the second claw 262. In the closed state of the clip 2, the second arm 212 extends along the longitudinal direction A, and the second claw 262 extends along the opening / closing direction B. The second arm 212 is formed in a tapered shape that tapers inward in the opening / closing direction B. In this embodiment, the second claw 262 is formed in the shape of a right triangle when viewed from the longitudinal direction A. Note that the second claw 262 does not have to be formed in the shape of a right triangle when viewed from the longitudinal direction A, and may be formed in, for example, a triangular shape.

[0034] The first claw 261 of the first arm 211 and the second claw 262 of the second arm 212 are formed in shapes that are asymmetric with respect to the central axis O1. Therefore, when attaching the clip 2 to the connecting member 4, the user can easily grasp the orientation of the clip 2 to be attached to the connecting member 4. Note that the first claw 261 of the first arm 211 and the second claw 262 of the second arm 212 may be formed in shapes that are symmetric with respect to the central axis O1.

[0035] 7 is a view of the pair of arms 21 in the closed state as viewed from the opposing direction C. In the opening / closing direction B, the length L1 of the first claw 261 is greater than the length L3 between the first arm 211 and the second arm 212 when the pair of arms 21 are in the closed state. Also, in the opening / closing direction B, the length L2 of the second claw 262 is greater than the length L3 between the first arm 211 and the second arm 212 when the pair of arms 21 are in the closed state.

[0036] 8 is a view of the pair of arms 21 in the closed state as viewed from the opening / closing direction B. The first claw 261 and the second claw 262 are members that grasp biological tissue. When the pair of arms 21 are in the closed state, the first claw 261 and the second claw 262 do not come into contact with each other. When the pair of arms 21 are in the closed state, a gap G is present between the first claw 261 and the second claw 262 in the opposing direction C in which the first claw 261 and the second claw 262 face each other.

[0037] Specifically, when the pair of arms 21 are in the closed state, a first inner surface 261a on the inside of the first claw 261 in the opposing direction C and a second inner surface 262a on the inside of the second claw 262 in the opposing direction C are disposed opposite each other across an opposing surface CS that passes through the central axis O1 and is horizontal to the opening / closing direction B. When the pair of arms 21 are in the closed state, the first inner surface 261a of the first claw 261 and the second inner surface 262a of the second claw 262 are parallel to each other.

[0038] When the pair of arms 21 are in the closed state, the positions of the first claw 261 and the second claw 262 in the longitudinal direction A are the same.

[0039] In the following description, when there is no need to distinguish between the first claw 261 and the second claw 262, the first claw 261 and the second claw 262 will also be referred to as "claws 26".

[0040] The sliding portion 24 is a portion that elastically deforms when the pair of arms 21 are retracted into the pressing member 3 .

[0041] The engaging portion 25 is a member that can engage with the fastening member 32 of the pressing member 3. The tip side A1 of the engaging portion 25 is formed as a slope that forms an obtuse angle with respect to the longitudinal direction A, and the base side A2 is formed as a slope that forms an acute angle with respect to the longitudinal direction A.

[0042] The base end 28 connects the first arm 211 and the second arm 212. The first arm 211 and the second arm 212 connected by the base end 28 are provided so as to be able to open and close toward the tip side A1. The base end 28 is bent into a U-shape and is connected to a hook 41f of the connecting member 4. The base end 28 is biased so that the pair of arms 21 are in an open state. Therefore, the pair of arms 21 of the clip 2 have a self-expanding force in the opening and closing direction B.

[0043] As shown in FIG. 3, the base end portion 28 and the hook 41f of the connecting member 4 are connected by inserting the hook 41f of the connecting member 4 into the base end portion 28 which is formed in a U-shape.

[0044] 9 is a cross-sectional view of the holding member 3 in the longitudinal direction A. The holding member (tubular member) 3 is a cylindrical member capable of storing at least a portion of the clip 2. The holding member 3 has an internal space 38 through which the clip 2 advances and retreats in the longitudinal direction A. The holding member 3 can fix the clip 2 in a closed state after it has been retracted into the internal space 38. The holding member 3 has a holding tube 3A provided on the base end side A2 and a holding pipe 3B provided on the tip end side A1.

[0045] The pressure tube (second tubular member) 3A has a pressure tube main body 30 formed in a cylindrical shape, protruding and retracting wings 31 , and a fastening member 32 .

[0046] The holding tube body 30 is formed by injection molding a material softer than the clip 2, such as a thermoplastic resin having appropriate elasticity, such as PPA (polyphthalamide), PA (polyamide), PEEK (polyether ether ketone), or LCP (liquid crystal polymer). The holding tube body 30 may also be formed from a metal instead of a thermoplastic resin.

[0047] The protruding and retracting wings 31 are a pair of protruding and retracting projections relative to the outer peripheral surface 30a of the retaining tube main body 30. The protruding and retracting wings 31 are provided on both sides of the central axis O1. The protruding and retracting wings 31 have a basic position in which they protrude outward in the radial direction R relative to the outer peripheral surface 30a. When the protruding and retracting wings 31 receive a force from the outside toward the inside in the radial direction R, they enter a retracted state in which they retract into the outer peripheral surface 30a. When the force is released, the protruding and retracting wings 31 return from the retracted state to the protruding state.

[0048] The clamping member 32 is a ring-shaped member provided in the internal space 38 of the presser tube 3A. The clamping member 32 is made of metal. Note that the clamping member 32 only needs to be formed to be harder than the presser tube main body 30, and may be formed of, for example, a thermoplastic resin instead of metal.

[0049] The clamping member 32 is disposed so that its central axis coincides with the central axis O1. The clamping member 32 is disposed on the base end side A2 relative to the protruding / recessed wing 31. The clamping member 32 is incorporated into the holding tube main body 30 by, for example, insert molding. The clamping member 32 is disposed in a position that protrudes inward in the radial direction R from the inner circumferential surface of the holding tube main body 30.

[0050] The pressure pipe (first tubular member) 3B is a cylindrical member made of metal. The pressure pipe 3B is press-fitted into the tip of the pressure pipe 3A. The pressure pipe 3A and the pressure pipe 3B may be connected by heat welding, adhesive bonding, or screw fastening.

[0051] 10 is a perspective view of the connecting member 4. The connecting member 4 is detachably connected to the base end 28 of the clip 2. The connecting member 4 is also detachably connected to the arrowhead hook portion 231 that passes through the sheath 220. In other words, the connecting member 4 connects the clip 2 and the arrowhead hook portion 231. The connecting member 4 includes an insertion portion 41 that is inserted into the internal space 38 of the pressing member 3, and a connecting portion 42 that is provided at the base end of the insertion portion 41.

[0052] The insertion portion 41 has a hook 41f provided at the distal end and a breaking portion 41b provided on the proximal end side A2 of the hook 41f. The hook 41f is a hook extending in a direction perpendicular to the central axis O1 and is formed in a substantially cylindrical rod shape. The proximal end 28 of the clip 2 is hooked onto the hook 41f.

[0053] The breaking portion 41b breaks when the base end 28 is pulled toward the base end side A2, and a breaking force of, for example, 20 N to 90 N is applied to the hook 41f. Note that the breaking portion 41b may have a mechanism for releasing the connection between the base end 28 of the clip 2 and the hook 41f of the connecting member 4. For example, the breaking portion 41b may have a mechanism for releasing the connection between the base end 28 and the hook 41f by deforming (plastic deformation or elastic deformation) without breaking.

[0054] The connecting portion 42 is an engaging portion that is engaged (connected) with the arrowhead hook portion 231 of the clip introduction device 200. The connecting portion 42 has a connecting portion main body 43 and an elastic arm portion 44.

[0055] The elastic arm 44 is provided at the base end of the connecting body 43 and is bifurcated. The elastic arm 44 is elastically deformable with respect to the connecting body 43 and can open and close with respect to the connecting body 43. The elastic arm 44 is formed with a notch 44m that grips and stores the engaging portion 231a of the arrowhead hook 231. The notch 44m is formed in a shape that fits closely to the outer peripheral surface of the engaging portion 231a of the arrowhead hook 231.

[0056] [Operation and Function of Clip Unit 100] Next, the operation and function of the clip unit 100 will be described with reference to Figs. 11 to 21 .

[0057] 11 is a diagram showing the clip unit 100 loaded into the clip introducing device 200. The clip unit 100 is loaded into the clip introducing device 200 using a cartridge or the like. The connecting member 4 of the clip unit 100 loaded into the clip introducing device 200 is connected to the arrowhead hook portion 231 that passes through the inside of the sheath 220. The protruding and retracting wings 31 are pressed against the inner circumferential surface of the sheath 220 and are in a retracted state.

[0058] The pair of arms 21 of the loaded clip unit 100 are in a closed state, being pressed against the inner circumferential surface of the sheath 220. The engaging portion 25 is located on the distal side A1 of the fastening member 32, and the pair of arms 21 are not locked in the closed state.

[0059] 12 is a diagram showing the clip unit 100 introduced into the body. The surgeon introduces the clip unit 100 loaded into the sheath 220 into the body via the channel of the endoscope. Next, the surgeon advances the slider 242 along the operation unit main body 241 to advance the arrowhead hook portion 231. The surgeon advances the clip unit 100 until the protruding / retracting wings 31 emerge from the sheath 220. By emerging from the sheath 220, the protruding / retracting wings 31 return from the retracted state to the protruding state, which is the basic position.

[0060] When the distal ends of the pair of arms 21 come out of the sheath 220, the self-expanding force of the pair of arms 21 serves as a restoring force, and the clip 2 returns to the open state while moving toward the distal end relative to the pressing member 3. Even when the pair of arms 21 return to the open state and protrude most from the pressing member 3, the engaging portion 25 is disposed in the internal region of the pressing member 3.

[0061] The surgeon moves the endoscope and sheath 220 to bring the clip 2 of the clip unit 100 closer to the treatment area, which is the defect D. In the following description, the mucous membranes at the periphery surrounding the defect D and positioned opposite each other across the defect D will be referred to as the "first mucosa M1" and the "second mucosa M2."

[0062] 13 is a diagram showing the clip unit 100 gripping the first mucosa M1. The surgeon grips the first mucosa M1 with the pair of arms 21. The surgeon punctures the first mucosa M1 with the first claw 261 and the second claw 262.

[0063] 14 is a diagram showing a first mucosa M1 grasped by a pair of arms 21. When the first claw 261 and the second claw 262 puncture the first mucosa M1, mucosal tissue MZ is disposed in a gap G formed between the first claw 261 and the second claw 262. Therefore, a hole region R1 formed by the first claw puncturing the first mucosa M1 and a hole region R2 formed by the second claw puncturing the first mucosa M1 do not communicate with each other.

[0064] The surgeon pulls the first mucosa M1 grasped by the pair of arms 21 toward the second mucosa M2. Because the first mucosa M1 is firmly grasped by the first claws 261 and the second claws 262, the surgeon can easily pull the first mucosa M1 toward the second mucosa M2.

[0065] 15 is a diagram showing the clip unit 100 with the second claw 262 removed from the first mucosa M1. In order to grasp the second mucosa M2 with the second arm 212, the surgeon removes the second claw 262 from the first mucosa M1.

[0066] FIG. 16 is a diagram showing the first mucosa M1 after the second claw 262 has been removed. Because the second claw 262 does not have an anchor, the second claw 262 is easily removed from the first mucosa M1. On the other hand, because the first claw 261 has a first anchor 271, the first claw 261 is difficult to remove from the first mucosa M1. Furthermore, because the hole region R1 and the hole region R2 do not communicate with each other, even after the second claw 262 has been removed from the first mucosa M1, the hole region R1 does not connect to the hole region R2, and the hole region R1 does not expand. Therefore, the first claw 261 is difficult to remove from the first mucosa M1. As a result, the surgeon can easily remove the second claw 262 from the first mucosa M1 while the first claw 261 is punctured into the first mucosa M1.

[0067] 17 is a diagram showing the clip unit 100 gripping the second mucosa M2. The surgeon grips the first mucosa M1 with the second arm 212. The surgeon punctures the second mucosa M2 with the second claw 262. As a result, the first mucosa M1 is gripped by the first arm 211, and the second mucosa M2 is gripped by the second arm 212.

[0068] 18 is a diagram showing the clip unit 100 with the pair of arms 21 closed. The surgeon retracts the arrowhead hook portion 231 by retracting the slider 242 along the operation unit body 241. The connecting member 4 connected to the arrowhead hook portion 231 pulls the clip 2. The pair of arms 21, which have a self-expanding force, are pulled toward the base end side A2, thereby pushing the distal opening 3a of the holding member 3 toward the base end side A2. The protruding and retracting wings 31, which are in the protruding state, engage with the sheath 220 and are therefore not retracted into the sheath 220. Therefore, the clip 2 pulled by the connecting member 4 is retracted into the holding member 3.

[0069] When the connecting member 4 pulls the base end 28 of the clip 2 toward the base end side A2 of the pressing member 3, the pair of arms 21 are pulled into the pressing member 3 and gradually close. When the pulling force on the base end 28 is released in this state, the clip 2 returns to the open state while moving toward the tip end side A1, using the self-expanding force of the pair of arms 21 as a restoring force. The surgeon can return the pair of arms 21 to the open state and re-grasp the tissue.

[0070] 19 is a diagram showing the clip unit 100 in which the clip 2 is locked. When the proximal end 28 is further pulled toward the proximal side A2 of the presser member 3, the engaging portion 25 is retracted toward the proximal side A2 from the fastening member 32. Because the proximal side A2 of the engaging portion 25 is formed as an obtuse-angled slope, the engaging portion 25 is easily retracted toward the proximal side from the fastening member 32. On the other hand, because the distal side A1 of the engaging portion 25 is formed as an acute-angled slope, when the engaging portion 25 is retracted toward the proximal side A2 from the fastening member 32, the engaging portion 25 engages with the fastening member 32. As a result, movement of the clip 2 toward the distal side A1 relative to the presser member 3 is restricted, and the pair of arms 21 are locked in the closed state. Once the pair of arms 21 are locked in the closed state, they cannot return to the open state.

[0071] 20 is a diagram showing the clip unit 100 from which the clip 2 has been separated. The surgeon further pulls the clip 2. A breaking force of, for example, 20 to 90 Newtons (N) is applied to the hook 41f, causing the breaking portion 41b to break. The breaking strength of the breaking portion 41b is lower than the breaking strength of the connecting portion main body 43. Therefore, the breaking portion 41b, not the connecting portion main body 43, breaks.

[0072] 21 is a diagram showing the clip unit 100 after breaking. The surgeon retracts the sheath 220, and leaves the clip 2 in the state of ligating the tissue inside the body.

[0073] The surgeon reloads a new clip unit 100 into the clip introduction device 200 using a cartridge or the like.

[0074] According to the clip delivery device 300 of this embodiment, the procedure of suturing the defect D can be suitably performed.

[0075] Although the first embodiment of the present invention has been described above in detail with reference to the drawings, the specific configuration is not limited to this embodiment and includes design modifications within the scope of the present invention. Furthermore, the components shown in the above embodiment and the modified examples shown below can be configured by appropriately combining them.

[0076] 22 is a diagram showing second claw 262A, which is a modification of second claw 262. Second claw 262A has a plurality of second anchors 272 on second outer surface 262b on the outer side (opposite side from first claw 261) in facing direction C. Second claw 262A is less likely to come out of the mucous membrane than second claw 262.

[0077] (Variation 1-2) Figure 23 is a diagram showing first claw 261B and second claw 262B, which are variations of first claw 261 and second claw 262A. First claw 261B has a plurality of third anchors 273 on first inner surface 261a. The plurality of third anchors 273 extend inward from first claw 261B in the opposing direction C and are capable of puncturing a mucous membrane. Second claw 262B has a plurality of fourth anchors 274 on second inner surface 262a. The plurality of fourth anchors 274 extend inward from second claw 262B in the opposing direction C and are capable of puncturing a mucous membrane.

[0078] (Variation 1-3) FIGS. 24 and 25 show a presser member 3C, which is a variation of the presser member 3, and a pair of arms 21C, which is a variation of the pair of arms 21. The pair of arms 21C further have convex portions 2p that protrude outward in the opening / closing direction B at the sliding portion 24. The presser member 3C has slits 3s that engage with the convex portions 2p. The slits 3s are formed linearly along the longitudinal direction A. Therefore, the pair of arms 21C can move forward and backward without tilting relative to the longitudinal direction A. That is, the gap G between the first claw 261 and the second claw 262 can be maintained whether the clip 2 is in the open state or the closed state. In other words, the positions of the first claw 261 and the second claw 262 in the opposing direction C are different whether the clip 2 is in the open state or the closed state. The slits 3s may be formed in a curved shape as shown in FIG. 25. In this case, the pair of arms 21C have convex portions 2p that protrude outward in the opposing direction C at the sliding portion 24. The protrusion 2p has a first portion and a second portion. The first portion has a width smaller than the width of the slit 3s and slides inside the slit 3s. The second portion is disposed outside the pressing member 3C and has a width larger than the width of the slit 3s. The second portion of the protrusion 2p abuts against the pressing member 3C, thereby restricting the first claw 261 and the second claw 262 from moving toward each other in the opposing direction C. Therefore, the pair of arms 21C can move forward and backward without tilting relative to the longitudinal direction A. In other words, the clip 2 can maintain the gap G between the first claw 261 and the second claw 262 in both the open and closed states. In other words, the positions of the first claw 261 and the second claw 262 in the opposing direction C are different whether the clip 2 is in the open or closed state.

[0079] (Variation 1-4) FIGS. 26 and 27 show a presser member 3D, which is a variation of the presser member 3, and a pair of arms 21D, which is a variation of the pair of arms 21. The presser member 3D further has a protrusion 3p that protrudes inward at the distal end opening 3a. The pair of arms 21D have slits 2s that engage with the protrusion 3p. The slits 2s are linearly formed along the longitudinal direction A. Therefore, the pair of arms 21D can move forward and backward without tilting relative to the longitudinal direction A. That is, the gap G between the first claw 261 and the second claw 262 can be maintained whether the clip 2 is in the open state or the closed state. In other words, the positions of the first claw 261 and the second claw 262 in the opposing direction C are different whether the clip 2 is in the open state or the closed state. The protrusion 3p may be a pin that connects the opposing inner surfaces of the distal end opening 3a, as shown in FIG. 27.

[0080] Second Embodiment A second embodiment of the present invention will be described with reference to Figures 28 to 30. In the following description, components that are common to those already described will be assigned the same reference numerals, and duplicate descriptions will be omitted.

[0081] 28 to 30 are views showing a clip assembly 100E according to the second embodiment. The clip assembly 100E includes a clip 2E, a pressing member 3, and a connecting member 4. Note that the connecting member 4 is not shown in FIGS. 28 to 30.

[0082] The clip 2E is formed by bending a metal plate at its center. The clip 2E has a pair of arms 21E that can open and close toward a distal end A1, and a proximal end 28 that connects the pair of arms 21E. The proximal end A2 of the clip 2E is inserted into the internal space 38 of the pressing member 3.

[0083] The pair of arms 21E includes a first arm 211E and a second arm 212E. The first arm 211E and the second arm 212E are disposed on either side of a central axis O1 in the longitudinal direction A of the clip unit 100E. Note that the clip 21E may have three or more arms.

[0084] The first arm 211E has, from the distal end side A1 to the proximal end side A2, a first claw 21a, a flat plate-shaped gripping portion 23, a sliding portion 24, and an engaging portion 25.

[0085] The second arm 212E has, from the distal end side A1 to the proximal end side A2, a second claw 22a, a flat plate-shaped gripping portion 23, a sliding portion 24, and an engaging portion 25.

[0086] 29 , when the pair of arms 21E are in the closed state, the first claw 21a and the second claw 22a face each other in the opening / closing direction B. That is, in this embodiment, when the pair of arms 21E are in the closed state, the facing direction C in which the first claw 21a and the second claw 22a face each other coincides with the opening / closing direction B. Note that when the pair of arms 21E are in the closed state, the first claw 21a and the second claw 22a may come into contact with each other.

[0087] The first claw 21a has a right side surface and a left side surface in the left-right direction E perpendicular to the opening / closing direction B. Right side anchors 21b and 21c protruding in the left-right direction E are provided on the right side of the first claw 21a. Left side anchors 21d and 21e protruding in the left-right direction E are provided on the left side of the first claw 21a.

[0088] The second claw 22a has a right side surface and a left side surface in the left-right direction E perpendicular to the opening / closing direction B. Right side anchors 22b and 22c protruding in the left-right direction E are provided on the right side of the second claw 22a. Left side anchors 22d and 22e (not shown) protruding in the left-right direction E are provided on the left side of the second claw 22a.

[0089] When approaching defect D obliquely, right lateral anchors 21b, 21c of first arm 211E and right lateral anchors 22b, 22c of second arm 212E touch the tissue before first claw 21a and second claw 22a. Therefore, right lateral anchors 21b, 21c, 22b, 22c generate a large frictional force against the tissue, suppressing slippage from the tissue. The same is true for left lateral anchors 21d, 21e of first arm 211E and left lateral anchors 22d, 22e of second arm 212E.

[0090] According to the clip unit 100E of this embodiment, the procedure of suturing the defect D can be suitably carried out.

[0091] Although the second embodiment of the present invention has been described above in detail with reference to the drawings, the specific configuration is not limited to this embodiment and includes design modifications within the scope of the present invention. Furthermore, the components shown in the above embodiment and the modified examples shown below can be configured by appropriately combining them.

[0092] (Variation 2-1) Figure 31 shows clip 2F, a variation of clip 2E. In clip 2F, the right anchor 21c on the proximal side A2 is longer than the right anchor 21b on the distal side A1. Therefore, when approaching defect D at an angle, both right anchors 21b and 21c are likely to come into contact with tissue. Specifically, when clip 2F approaches defect D at an angle so that the right sides of the first claw 21a and the second claw 22a face defect D, the right anchors 21b, 21c, 22b, and 22c face toward defect D. At this time, because right anchor 21c is longer than right anchor 21b, both right anchors 21b and 21c are likely to come into contact with tissue at the same time. This generates a large frictional force between the right anchors 21b, 21c, 22b, and 22c and the tissue, preventing the first claw 21a and the second claw 22a from slipping from the tissue. The same applies to the left lateral anchors 21d, 21e, 22d, and 22e.

[0093] (Variation 2-2) Figure 32 is a diagram showing clip 2G, which is a variation of clip 2E. In the above embodiment, the number of anchors in one arm (e.g., right lateral anchors 21b, 21c and left lateral anchors 21d, 21e) is four. However, the number of anchors is not limited to this. For example, the number of anchors in one arm may be one as shown in Figure 32, or it may be two or three.

[0094] (Variation 2-3) Figures 33 and 34 are views showing clip 2H, which is a variation of clip 2E. In the above embodiment, the anchors (e.g., right lateral anchors 21b, 21c and left lateral anchors 21d, 21e) are provided on the claws (e.g., first claw 21a). However, the positions at which the anchors are arranged are not limited thereto. At least a portion of the anchors may be provided on the gripping portions 23 on the proximal side A2 of the claws, as shown in Figures 33 and 34.

[0095] Third Embodiment A third embodiment of the present invention will be described with reference to Figures 35 to 37. In the following description, components that are common to those already described will be assigned the same reference numerals, and duplicate descriptions will be omitted.

[0096] 35 to 37 are views showing a clip assembly 100I according to a third embodiment. The clip assembly 100I includes a clip 2I, a pressing member 3, and a connecting member 4. Note that the connecting member 4 is not shown in FIGS. 35 to 37.

[0097] The clip 2I is formed by bending a metal plate at its center. The clip 2I has a pair of arms 21I that can open and close toward a distal end A1, and a proximal end 28 that connects the pair of arms 21I. The proximal end A2 of the clip 2I is inserted into the internal space 38 of the pressing member 3.

[0098] The pair of arms 21I includes a first arm 211I and a second arm 212I. The first arm 211I and the second arm 212I are arranged on either side of a central axis O1 in the longitudinal direction A of the clip unit 100I. Note that the clip 2I may have three or more arms.

[0099] The first arm 211I has, from the distal end side A1 to the proximal end side A2, a first claw 21a, inner surface anchors 21f and 21g, a flat gripping portion 23, a sliding portion 24, and an engaging portion 25.

[0100] The second arm 212I has, from the distal end side A1 to the proximal end side A2, a second claw 22a, inner surface anchors 22f and 22g, a flat gripping portion 23, a sliding portion 24, and an engaging portion 25.

[0101] The inner surface anchors 21f, 21g are provided on the inner surfaces of the first claw 21a of the first arm 211I and the tip of the gripping portion 23, and protrude toward the closing side in the opening / closing direction B. The inner surface anchors 21f, 21g are arranged along the longitudinal direction A, and the inner surface anchor 21f is located on the tip side A1 of the inner surface anchor 21g.

[0102] The inner surface anchors 22f, 22g are provided on the inner surfaces of the second claw 22a of the second arm 212I and the tip of the gripping portion 23, and protrude toward the closing side in the opening / closing direction B. The inner surface anchors 22f, 22g are arranged along the longitudinal direction A, and the inner surface anchor 22f is located on the tip side A1 of the inner surface anchor 22g.

[0103] Even when the pair of arms 21I is in the open state, when the pair of arms 21I is pressed against living tissue, both of the inner surface anchors 21f and 21g (inner surface anchors 22f and 22g) come into contact with the tissue.

[0104] According to the clip unit 100I of this embodiment, the procedure of suturing the defect D can be suitably carried out.

[0105] Although the third embodiment of the present invention has been described above in detail with reference to the drawings, the specific configuration is not limited to this embodiment and includes design modifications within the scope of the present invention. Furthermore, the components shown in the above embodiment and the modified examples shown below can be configured by appropriately combining them.

[0106] (Variation 3-1) Figure 38 shows clip 2J, which is a variation of clip 2I. In clip 2J, inner surface anchor 21g on the base end side A2 is longer than inner surface anchor 21f on the tip end side A1. Therefore, when approaching defect D at an angle or when approaching defect D from the front, both inner surface anchors 21f, 21g are likely to come into contact with tissue. The same is true for inner surface anchors 22f, 22g.

[0107] (Fourth embodiment) A fourth embodiment of the present invention will be described with reference to Fig. 39 to Fig. 41. In the following description, components common to those already described will be assigned the same reference numerals and duplicated description will be omitted.

[0108] 39 to 41 are views showing a clip assembly 100K according to the fourth embodiment. The clip assembly 100I includes a clip 2K, a pressing member 3, and a connecting member 4. Note that the connecting member 4 is not shown in FIGS. 39 to 41.

[0109] The clip 2K is formed by bending a metal plate at its center. The clip 2K has a pair of arms 21K that can open and close toward a distal end side A1, and a proximal end 28 that connects the pair of arms 21K. The proximal end side A2 of the clip 2K is inserted into the internal space 38 of the pressing member 3.

[0110] The pair of arms 21K includes a first arm 211K and a second arm 212K. The first arm 211K and the second arm 212K are arranged on either side of a central axis O1 of the clip unit 100K in the longitudinal direction A. Note that the clip 21K may have three or more arms.

[0111] The first arm 211K has, from the distal end side A1 to the proximal end side A2, a first claw 21a, an inner surface anchor 21h, a flat plate-shaped gripping portion 23, a sliding portion 24, and an engaging portion 25.

[0112] The second arm 212K has, from the distal end side A1 to the proximal end side A2, a second claw 22a, an inner surface anchor 22h, a flat plate-shaped gripping portion 23, a sliding portion 24, and an engaging portion 25.

[0113] The inner surface anchor (needle) 21h is an anchor that is provided on the inner surface of the first claw 21a of the first arm 211K and protrudes toward the closing side in the opening / closing direction B. The inner surface anchor 21h is formed in a conical shape, and has a sharper tip than the inner surface anchor 21f of the third embodiment.

[0114] The inner surface anchor (needle) 22h is an anchor that is provided on the inner surface of the second claw 22a of the second arm 212K and protrudes toward the closing side in the opening / closing direction B. The inner surface anchor 22h is formed in a conical shape, and has a sharper tip than the inner surface anchor 22f of the third embodiment.

[0115] 40 , when the pair of arms 21K are in the closed state, the inner surface anchors 21 h and 22 h intersect. Specifically, when the pair of arms 21K are in the closed state, the position where the inner surface anchor 21 h of the first arm 211K is arranged and the position where the inner surface anchor 22 h of the second arm 212K are arranged are slightly misaligned in the left-right direction E perpendicular to the opening / closing direction B, and the inner surface anchors 21 h and 22 h intersect when viewed from the left-right direction E.

[0116] When the pair of arms 21K is pressed against biological tissue, the inner surface anchor 21h (inner surface anchor 22h) touches the tissue before the first claw 21a (second claw 22a). The inner surface anchor 21h (inner surface anchor 22h) pierces the tissue. This generates a large frictional force between the first claw 21a (second claw 22a) and the tissue, preventing the first claw 21a (second claw 22a) from slipping from the tissue.

[0117] According to the clip unit 100K of this embodiment, the procedure of suturing the defect D can be suitably carried out.

[0118] Although the fourth embodiment of the present invention has been described above in detail with reference to the drawings, the specific configuration is not limited to this embodiment and includes design modifications within the scope of the present invention. Furthermore, the components shown in the above embodiment and the modified examples shown below can be configured by appropriately combining them.

[0119] (Variation 4-1) Figure 42 is a diagram showing medial surface anchors 21i and 22i, which are variations of the medial surface anchors 21h and 22h. The medial surface anchor 21i has a hook 21Fi extending from the tip of the medial surface anchor body 21Bi toward the first arm 211K. The angle formed between the medial surface anchor body 21Bi and the hook 21Fi may be an acute angle. When the medial surface anchor 21i pierces tissue, the hook 21Fi catches on the tissue. This prevents the first claw 21a from slipping from the tissue.

[0120] The medial surface anchor 22i has a hook 22Fi extending from the tip of the medial surface anchor body 22Bi toward the second arm 212K. The angle formed between the medial surface anchor body 22Bi and the hook 22Fi may be an acute angle. When the medial surface anchor 22i pierces tissue, the hook 22Fi catches on the tissue. This prevents the second claw 22a from slipping from the tissue.

[0121] (Modification A) Figure 43 shows a clip 2L that is a modification of the clip 2. A first claw 261L and a second claw 262L provided at the tip of the clip 2L are formed in a curved shape that curves inward in the opening and closing direction B. In the clip 2L in the closed state, the first claw 261L and the second claw 262L are misaligned in the longitudinal direction A and do not interlock. In the clip 2L in the open state, the first claw 261L and the second claw 262L contact the tissue at approximately 90 degrees.

[0122] (Modification B) Figure 44 is a diagram showing a first claw 261M and a second claw 262M which are modifications of the first claw 261 and the second claw 262. The first claw 261M and the second claw 262M have a locking mechanism which locks them when they are engaged with each other.

[0123] 45 is a diagram showing first claws 261N and second claws 262N which are modifications of the first claws 261 and second claws 262. Two first claws 261N are provided along a direction perpendicular to the opening / closing direction B. Two second claws 262N are provided along a direction perpendicular to the opening / closing direction B.

[0124] 46 is a diagram showing first claws 261O and second claws 262O, which are a modification of first claws 261 and second claws 262. Three first claws 261O are provided along a direction perpendicular to opening / closing direction B. Three second claws 262O are provided along a direction perpendicular to opening / closing direction B.

[0125] The present invention can be applied to a clip unit or the like.

[0126] 300 Clip delivery device (clip system) 200 Clip introduction device (applicator) 100, 100E, 100I, 100K Clip unit 2, 2E, 2F, 2G, 2H, 2I, 2J, 2K, 2L Clip 21, 21C, 21D, 21E, 21I, 21K Arm 211, 211E, 211I, 211K First arm 212, 212E, 212I, 212K Second arm 21a First claw 21b Right side anchor 21c Right side anchor 21d Left side anchor 21e Left side anchor 21f Medial surface anchor 21g Medial surface anchor 21h Medial surface anchor (needle) 21h Medial surface anchor 21i Medial surface anchor 21Bi Medial surface anchor body 21Fi Hook 22a Second claw 22b Right side anchor 22c Right side anchor 22d Left side anchor 22e Left side anchor 22f Medial surface anchor 22g Medial surface anchor 22h Medial surface anchor (needle) 22h Medial surface anchor 22i Medial surface anchor 22Bi Medial surface anchor body 22Fi Hook 23 Gripping portion 24 Sliding portion 25 Engagement portion 26 Claw 261, 261B, 261L, 261M, 261N, 261O First claw 261a First inner surface 261b Outer surface (first outer surface) 262, 262A, 262B, 262L, 262M, 262N, 262O Second claw 262a Second inner surface 262b Second outer surface 271 First anchor 272 Second anchor 273 Third anchor 274 Fourth anchor 28 Base end portion 3, 3C, 3D Holding member (tubular member) 3A Holding tube (second tubular member) 3B Holding pipe (first tubular member) 30 Holding tube main body 30a Outer circumferential surface 31 Protruding and recessed wing 32 Fastening member 38 Internal space 4 Connecting member 41 Insertion portion 41b Breaking portion 41f Hook 42 Connecting portion 43 Connecting portion main body 44 Elastic arm portion 44m Cutout portion

Claims

1. A clip unit comprising: a clip having a first arm and a second arm that can be opened and closed toward a tip side; and a tubular member in which at least a portion of the clip can be stored, wherein the first arm has a first claw at its tip extending toward the closing side in the opening and closing direction, and the first claw has a first anchor.

2. A clip unit as described in claim 1, wherein the first claw is capable of puncturing a mucous membrane and is formed in a tapered shape that tapers toward the closing side in the opening and closing direction.

3. The clip unit according to claim 1, wherein the first anchor extends in a direction intersecting the opening and closing direction.

4. The clip unit according to claim 3, wherein the first anchor extends from the first claw in the longitudinal direction in which the first arm extends.

5. A clip unit as described in claim 3, wherein the second arm has a second claw at its tip extending toward the closing side in the opening and closing direction, the first claw and the second claw face each other in an opposing direction when the first arm and the second arm are in a closed state, and the first anchor extends from the first claw in the opposing direction.

6. The clip unit according to claim 5, wherein the first claw extends outward in the opposing direction.

7. A clip unit as described in claim 1, wherein the second arm has a second claw at its tip extending toward the closing side in the opening and closing direction, the first claw and the second claw face each other in the opposing direction when the first arm and the second arm are in a closed state, and the first claw and the second claw form a gap in the opposing direction.

8. A clip unit as described in claim 7, wherein when the first arm and the second arm are in a closed state, a first inner surface on the inside in the opposing direction of the first claw and a second inner surface on the inside in the opposing direction of the second claw are arranged opposite each other, and the first inner surface and the second inner surface are flat.

9. The clip unit according to claim 8, wherein when the first arm and the second arm are in a closed state, the first inner surface and the second inner surface are arranged parallel to each other.

10. The clip unit according to claim 8, wherein the second claw has a second anchor extending outward in the opposing direction.

11. A clip unit as described in claim 7, further comprising a slit extending along the longitudinal direction of said tubular member, and wherein movement of said first arm and said second arm in the opposing direction is restricted by said slit so as to form said gap between said first claw and said second claw.

12. A clip unit as described in claim 11, wherein the slit is provided in the tubular member, the first arm and the second arm have protrusions that can engage with the slit, and the protrusions extend radially outward of the tubular member.

13. A clip unit as described in claim 11, wherein the slit is provided in the first arm and the second arm, the tubular member has a protrusion that can engage with the slit, and the protrusion extends radially inward of the tubular member.

14. A clip unit as described in claim 1, wherein in the opening and closing direction, the length of the first claw is greater than the length between the first arm and the second arm when the first arm and the second arm are in a closed state.

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