Clip device

Abstract

This clip device comprises: a clip unit having arms that open and close in terms of the front direction; a wire connected to the clip unit; and a sheath through which the wire is inserted and that extends in the longitudinal axis direction. The clip unit is separably connected to a tip end part of the sheath. The clip unit can transition between a first mode in which the front direction of the arms is aligned with the longitudinal axis direction and a second mode in which the front direction of the arms is aligned with a direction intersecting the longitudinal axis direction.

Description

Clip Device

[0001] This application claims priority to U.S. Provisional Application No. 63 / 583,011, filed in the United States on September 15, 2023, the contents of which are incorporated herein by reference.

[0002] In endoscopic treatment, medical instruments such as clip devices for treating biological tissue are used. These medical instruments are introduced to the treatment site by an applicator (introduction device) that can be inserted through a channel of an endoscope.

[0003] Patent Document 1 describes a clipping device for treating biological tissue. In the clipping device described in Patent Document 1, a control wire that controls the clip has a bent portion. When the bent portion of the control wire bends, the clip connected to the control wire moves significantly and comes into contact with the tissue.

[0004] US Patent Application Publication No. 2021 / 030425

[0005] However, since medical instruments such as clip devices are used in narrow lumens, it is desirable that they not only contact tissue but also adequately grasp the tissue in a narrow space.

[0006] In view of the above circumstances, an object of the present invention is to provide a clip device that can suitably grasp tissue in a narrow space such as a lumen.

[0007] A clip device according to a first aspect of the present invention comprises a clip unit having an arm that opens and closes toward the front, a wire connected to the clip unit, and a sheath through which the wire passes and extends in the longitudinal axis direction, wherein the clip unit is detachably connected to the tip of the sheath, and the clip unit is capable of transitioning between a first form in which the front direction of the arm faces in the same direction as the longitudinal axis direction, and a second form in which the front direction of the arm faces in a direction intersecting the longitudinal axis direction.

[0008] The clip device of the present invention is capable of suitably gripping tissue in a narrow space such as a lumen.

[0009] 1A and 1B are views showing a clip device according to a first embodiment; FIG. 1C are a perspective view of a clip unit loaded in an applicator of the clip device; FIG. 1D are a perspective view of the clip unit loaded in the applicator; FIG. 1E are a cross-sectional view of a distal end of the clip device; FIG. 1F are a view of a clip locked in a closed form; FIG. 1G are views showing a change in shape of the clip unit; FIG. 1G are views of the clip unit for treating tissue by a tangential approach; FIG. 1H are views of the clip unit with a pair of arms swung; FIG. 1H are views showing a locking step by the clip unit; FIG. 1H are views showing a separation step by the clip unit; FIG. 1G are views showing a modified example of a coupler in the clip device; FIG. 1H are views showing another modified example of the coupler; FIG. 1H are views showing another modified example of the coupler; FIG. 1H are views showing a clip device according to a second embodiment; FIG. 1C are a cross-sectional view of a distal end of the clip device; FIG. 1G are views showing a change in shape of the clip unit of the clip device; FIG. 1G are views of the clip unit for treating tissue by a tangential approach; FIG. 1H are views of the clip unit with a pair of arms swung; FIG. 1H are views showing a locking step by the clip unit; FIG. 1H are views showing a separation step by the clip unit; FIG. 1H are views showing a modified example of a pressure tube of the clip unit; FIG. 1H are views showing a modified example of the pressure tube; FIG. 1H are views showing a procedure using an outer sheath; FIG. 10 is a diagram showing a procedure using the outer sheath. FIG. 11 is a diagram showing a procedure using the outer sheath. FIG. 12 is a diagram showing a clip device according to a third embodiment. FIG. 13 is a diagram showing the clip device. FIG. 14 is a diagram showing another aspect of the flexible member of the clip device. FIG. 15 is a diagram showing another aspect of the flexible member of the clip device. FIG. 16 is a diagram showing a modified example of the bending member of the clip device. FIG. 17 is a diagram showing another modified example of the bending member. FIG. 18 is a diagram showing another modified example of the bending member.

[0010] First Embodiment A first embodiment of the present invention will be described with reference to Fig. 1 to Fig. 10. Fig. 1 is a diagram showing a clip device 300 according to this embodiment. The clip device (clip system, endoscopic treatment tool) 300 includes a clip unit 100, a coupler (connecting member) 150, and an applicator 200. The clip unit 100 is loaded into the applicator 200, which can be inserted into a channel of an endoscope, and introduced to a treatment position.

[0011] The clip device 300 may be capable of reloading the clip unit 100 into the applicator 200. In this case, a user can remove a used clip unit 100 from the applicator 200 and reload an unused clip unit 100 into the applicator 200.

[0012] In the following description, the clip unit 100 side in the longitudinal direction A of the clip device 300 will be referred to as the tip side (distal side) A1 of the clip device 300, and the operating portion 240 side of the applicator 200 will be referred to as the base side (proximal side) A2 of the clip device 300.

[0013] [Applicator 200] Figure 2 is a perspective view of the clip unit 100 loaded into the applicator 200. The applicator (clip unit introduction device) 200 includes a sheath 220, an operating wire 230, and an operating section 240. The applicator 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.

[0014] 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 coil 222 and the proximal coil 224 may be integrated.

[0015] Figure 3 is a perspective view of the clip unit 100 loaded into the applicator 200. The coupler 150 is not shown in Figure 3. The distal tip (distal portion) 221 is formed in a cylindrical shape and is disposed at the distal end of the distal coil 222. An engaging portion 225 is formed at the distal end of the distal tip 221. The engaging portion 225 is a convex portion that protrudes outward in the radial direction R perpendicular to the longitudinal direction A. The engaging portion 225 is provided around the entire circumference of the distal tip 221 along the circumferential direction C.

[0016] The operation wire (power transmission member) 230 is inserted through the sheath 220 and attached to the clip unit 100 and the operation section 240. As shown in Fig. 3, the operation wire 230 can protrude toward the distal end from the distal tip (distal end portion) 221. The operation wire 230 advances and retreats through the distal tip (distal end portion) 221 along the longitudinal axis direction L of the sheath 220 to transmit power to the clip 2 of the clip unit 100.

[0017] 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, the slider 242, and the thumb ring 248 are 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 it 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 is attached to the proximal end of the operation wire 230. When the slider 242 moves forward and backward along the operation portion main body 241, the operation wire 230 moves forward and backward relative to the sheath 220.

[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] 4 is a cross-sectional view of the distal end of the clip device 300. The clip unit 100 is loaded onto the distal tip (distal end) 221 of the sheath 220 of the applicator 200 via a coupler (connecting member) 150. The clip unit 100 includes a clip 2, a pressing tube (tubular member) 3, and a bending member 4.

[0021] The clip (clip arm) 2 has a pair of arms 21 and a support portion 28 that supports the pair of arms 21. The support portion 28 is attached to the tip of the bending member 4.

[0022] The pair of arms 21 can be opened and closed in a forward direction F, and can transition between an open configuration (open state) and a closed configuration (closed state). The pair of arms 21 can swing in a swing direction Q. The forward direction F of the pair of arms 21 changes when they swing (see FIG. 6 ). As shown in FIGS. 2 and 3 , the position of the pair of arms 21 where the forward direction F substantially coincides with the longitudinal axis direction L of the sheath 220 is referred to as the “initial position” of the pair of arms 21.

[0023] The pair of arms 21 includes a first arm 211 and a second arm 212. As shown in Figures 2 and 3, when the clip 2 is in an "initial position" where the clip 2 is not swung, the first arm 211 and the second arm 212 are disposed on either side of a central axis O1 in the longitudinal direction A. The clip 2 may have three or more arms.

[0024] The first arm 211 and the second arm 212 have a claw 22, a gripping portion 23, a sliding portion 24, and an engaging portion 25 from the distal end side A1 to the proximal end side A2.

[0025] The claws 22 are formed by bending inward the tips of the first arm 211 and the second arm 212. The gripping portion 23 is formed in a flat plate shape and is the portion that grips tissue. The sliding portion 24 is the portion that elastically deforms when the pair of arms 21 are retracted into the pressing tube 3.

[0026] The engaging portion 25 is a portion that can engage with the inner peripheral surface of the pressing tube 3. The engaging portion 25 is a convex portion that protrudes from the sliding portion 24. Specifically, the engaging portion 25 protrudes on both sides in the vertical direction that is perpendicular to the longitudinal direction A and the opening / closing direction P of the pair of arms 21.

[0027] 5 is a diagram showing the clip 2 locked in the closed position. The engaging portion 25 and the inner peripheral surface of the presser tube 3 constitute a locking mechanism that locks the clip 2 in the closed position. Once the pair of arms 21 are locked in the closed position by the locking mechanism, the pair of arms 21 cannot return to the open position. Note that the locking mechanism is not limited to the combination of the engaging portion 25 of the clip 2 and the inner peripheral surface of the presser tube 3, and other configurations may be used.

[0028] The support portion 28 supports the pair of arms 21 (first arm 211 and second arm 212) so that they can be opened and closed in the opening and closing direction P. The pair of arms 21 supported by the support portion 28 are biased to be 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 P.

[0029] The support portion 28 has a separation portion 29 that is separably connected to the distal end member 41 of the bending member 4 on the base end side A2. For example, the separation portion 29 may be a breaking portion that breaks when a predetermined breaking force or more is applied by pulling. Alternatively, the separation portion 29 may be a deforming portion that is formed into a hook shape or the like and that separates from the distal end member 41 by plastic deformation.

[0030] The retaining tube (tubular member) 3 is a cylindrical member capable of storing at least a portion of the clip 2. The retaining tube 3 has an internal space 38 through which the clip 2 advances and retreats in the longitudinal direction A. The retaining tube 3 can fix the clip 2 retracted into the internal space 38 in a closed state.

[0031] An engagement portion 32 is formed at the base end of the pressing tube 3. The engagement portion 32 is a convex portion that protrudes outward in a radial direction R perpendicular to the longitudinal direction A. The engagement portion 32 is provided around the entire circumference of the pressing tube 3 along the circumferential direction C.

[0032] The curved member 4 supports the pair of arms 21 so that they can swing (rotate) around a rotation axis RO that is aligned in a direction substantially perpendicular to the longitudinal direction A. In this embodiment, the swing direction (rotation direction) Q of the pair of arms 21, with the rotation axis RO as the center of rotation, substantially coincides with the opening and closing direction P of the pair of arms 21. In other words, the plane along which the pair of arms 21 swing (the plane through which the pair of swinging arms 21 pass) and the plane along which the pair of arms 21 open and close (the plane through which the pair of opening and closing arms 21 pass) substantially coincide with each other.

[0033] The bending member 4 swings the pair of arms 21 when a force equal to or greater than a predetermined value is applied to at least one of the first arm 211 and the second arm 212, such as when at least one of the first arm 211 and the second arm 212 comes into contact with biological tissue or when an external force equal to or greater than a predetermined value is applied to at least one of the first arm 211 and the second arm 212. In other cases, the support portion 28 does not swing the pair of arms 21.

[0034] The bending member 4 has a distal end member 41, a proximal end member 42, and a hinge (rotating portion) 43 that rotatably connects the distal end member 41 and the proximal end member 42. The proximal end member 42 is attached to the operation wire 230 in an inseparable manner.

[0035] The hinge (rotating portion) 43 connects the distal end member 41 and the proximal end member 42 so that the proximal end member 42 rotates in a swing direction (rotating direction) Q relative to the proximal end member 42 .

[0036] [Coupler (connecting member) 150] The coupler (connecting member) 150 separably connects the pressing tube 3 and the sheath 220. The coupler 150 connects the pressing tube 3 and the sheath 220 so that a gap (play) G in the longitudinal axis direction L is formed between the pressing tube 3 and the sheath 220. The coupler 150 is formed in a cylindrical shape and has a tubular portion 151, a distal engaging portion 152, and a proximal engaging portion 153.

[0037] The tip engaging portion 152 is provided at the tip of the cylindrical portion 151 and is a convex portion that protrudes inward in a radial direction R that is perpendicular to the longitudinal direction A. The tip engaging portion 152 is provided around the entire circumference of the cylindrical portion 151 along the circumferential direction C. The tip engaging portion 152 engages with the engaging portion 32 of the pressing tube 3, thereby connecting the coupler 150 and the pressing tube 3.

[0038] The proximal end engaging portion 153 is provided at the proximal end of the cylindrical portion 151, and is a convex portion that protrudes inward in a radial direction R that is perpendicular to the longitudinal direction A. The proximal end engaging portion 153 is provided around the entire circumference of the cylindrical portion 151 along the circumferential direction C. The proximal end engaging portion 153 engages with the engaging portion 225 of the sheath 220, thereby connecting the coupler 150 and the sheath 220.

[0039] At least one of the distal end and the proximal end of the coupler 150 is deformable (elastically or plastically). By deforming the coupler 150, the pressing tube 3 and the sheath 220 can be separated.

[0040] 6 is a diagram showing the transition of the shape of the clip unit 100. The clip unit 100 can transition between a linear form (first form) shown in FIGS. 2 and 3 and a swing form (second form) shown in FIG. 6.

[0041] The linear configuration (first configuration) is a configuration of the clip unit 100 in which the front direction F of the pair of arms 21 faces the same direction as the longitudinal axis direction L of the sheath 220, as shown in FIGS.

[0042] As shown in FIG. 6 , the swing configuration (second configuration) is a configuration of the clip unit 100 in which the forward direction F of the pair of arms 21 faces a direction intersecting with the longitudinal axis direction L of the sheath 220. When a force equal to or greater than a predetermined value is applied to at least one of the first arm 211 and the second arm 212, the clip unit 100 swings in the swing direction Q to transition to the swing configuration (second configuration). Specifically, as the pair of arms 21 swing in the swing direction Q, the pressing tube 3 in contact with the pair of arms 21 moves relative to the sheath 220. When the clip unit 100 is in at least the linear configuration (first configuration), a gap (backlash) G in the longitudinal axis direction L is formed between the engaging portion 32 of the pressing tube 3 and the engaging portion 225 of the sheath 220, which are connected by the coupler 150. Therefore, the pressing tube 3 can tilt with respect to a direction intersecting with the longitudinal axis direction L of the sheath 220. When the clip unit 100 is in the second configuration, the engaging portion 32 of the pressing tube 3 and the engaging portion 225 of the sheath 220 connected by the coupler 150 may be in contact with each other.

[0043] As shown in Fig. 4, the gaps G arranged at positions sandwiching the operating wire 230 are referred to as a first gap G1 and a second gap G2. When the clip unit 100 is in the linear form (first form), a first distance D1 (the distance between the first gap G1) of the first gap G1 and a second distance D2 (the distance between the second gap G2) of the second gap G2 are substantially the same. As shown in Fig. 6, when the clip unit 100 is in the swing form (second form), the first distance D1 and the second distance D2 are different. Specifically, when the clip unit 100 transitions from the linear form (first form) to the swing form (second form), one of the first distance D1 and the second distance D2 increases, and the other of the first distance D1 and the second distance D2 decreases.

[0044] The clip unit 100 can also transition from the swing configuration (second configuration) to the straight configuration (first configuration).

[0045] [Operation and Function of Clip Device 300] Next, the operation and function of the clip device 300 will be described with reference to FIGS.

[0046] <Approach Step> The surgeon introduces the clip unit 100 loaded in the applicator 200 into the body via the channel of the endoscope. The surgeon moves the endoscope and the sheath 220 to bring the clip 2 of the clip unit 100 closer to the tissue T, which is the treatment area.

[0047] Methods for approaching the clip unit 100 to the treatment area include at least a frontal approach and a tangential approach. In the frontal approach, the surgeon operates the endoscope and sheath 220 to position the clip unit 100 so that the longitudinal direction A of the clip unit 100 is approximately perpendicular to the surface of the treatment area. In the tangential approach, the surgeon operates the endoscope and sheath 220 to position the clip unit 100 so that the longitudinal direction A of the clip unit 100 is along the surface of the treatment area.

[0048] <Tangential Approach> Figure 7 is a diagram showing the clip unit 100 treating tissue T by a tangential approach. The surgeon approaches the clip unit 100, which is in a linear form, to the tissue T, which is the treatment area, by a tangential approach. The surgeon hooks the claw 22 of the first arm 211 onto the mucosa (first mucosa M1 in Figure 7) that is on the endoscope side (near side) of the first mucosa M1 and second mucosa M2, which are located on either side of the center of the tissue T.

[0049] FIG. 8 is a diagram showing the clip unit 100 with the pair of arms 21 swung. The surgeon brings the clip unit 100, with the claws 22 hooked on the first mucosa M1, closer to the tissue T, which is the treatment area. Specifically, the surgeon advances the applicator 200 through the endoscope channel. Alternatively, the surgeon advances the endoscope to further press the clip unit 100 against the tissue T. As a result, as shown in FIG. 8 , the pair of arms 21 swing around the rotation axis RO, and the clip unit 100 assumes a swing form. When the second arm 212 contacts the second mucosa M2, the pair of arms 21 are positioned so that the front direction F faces the front of the tissue T, which is the treatment area. The first mucosa M1 and the second mucosa M2 are grasped by the pair of arms 21.

[0050] <Traction Step> The user retracts the operation wire 230 by retracting the slider 242 along the operation unit main body 241. The curved member 4 connected to the operation wire 230 retracts the clip 2. As the clip 2 is pulled toward the base end side A2, the pair of arms 21 are retracted into the pressing tube 3, and the pair of arms 21 engaged with the distal opening 3a gradually close. When the traction force of the operation wire 230 is released in this state, the self-expanding force of the pair of arms 21 causes the clip 2 to return to the open state while moving toward the distal end side A1. The user can return the pair of arms 21 to the open state to re-grasp the tissue T (reopening).

[0051] <Lock Step> Figure 9 is a diagram showing the lock step performed by the clip unit 100. The surgeon retracts the operating wire 230 by retracting the slider 242 along the operating unit body 241. When the clip 2 is pulled to a predetermined position in the pressing tube 3, the engaging portion 25, which is a locking mechanism, engages with the inner surface of the pressing tube 3, and the pair of arms 21 is locked in the closed state. Once the pair of arms 21 is locked in the closed state, the pair of arms 21 cannot return to the open state.

[0052] <Separation Step> Figure 10 is a diagram showing the separation step performed by the clip unit 100. The surgeon further pulls the clip 2. A breaking force is applied to the separation portion 29 of the clip 2 by pulling, causing the separation portion 29 to break. As a result, the clip 2 and the curved member 4 are separated. Furthermore, the coupler 150 is deformed, causing the pressure tube 3 and the sheath 220 to separate. The surgeon retracts the sheath 220, and leaves the clip 2 and the pressure tube 3 in the body, with the first mucosa M1 and the second mucosa M2 ligated.

[0053] The clip device 300 according to this embodiment can suitably grasp the tissue T in a lumen. Even when treating the tissue T using a tangential approach, the clip unit 100 can be swung relative to the sheath 220, and the pair of arms 21 can be positioned facing the front of the tissue T, which is the treatment area. Because the clip unit 100 swings relative to the sheath 220, it is easy to position the clip unit 100 facing the front of the tissue T, even in a narrow lumen.

[0054] 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 embodiment and modifications can be configured in any suitable combination.

[0055] (Variation 1-1) Figure 11 is a diagram showing a coupler 150A that is a variation of the coupler 150. The coupler 150A has a cylindrical portion 151, a tip engaging portion 152A, and a base end engaging portion 153. The tip engaging portion 152A is inseparably attached to the pressing tube 3. The pressing tube 3 and the coupler 150A may be formed integrally.

[0056] 12 is a diagram showing a coupler 150B that is a modification of the coupler 150. The coupler 150B has a tubular portion 151, a distal end engaging portion 152, and a proximal end engaging portion 153B. The proximal end engaging portion 153B is inseparably attached to the distal end coil 222 of the sheath 220. The distal end coil 222 of the sheath 220 and the coupler 150B may be formed integrally.

[0057] 13 is a diagram showing a coupler 150C that is a modification of the coupler 150. The coupler 150C has a cylindrical portion 151 and a proximal end engaging portion 153B. The coupler 150C does not have a distal end engaging portion 152. The distal end coil 222 of the sheath 220 and the coupler 150C may be formed integrally.

[0058] (Variation 1-4) Figure 14 is a diagram showing coupler 150D, which is a variation of coupler 150. The coupler 150 of the above embodiment is disposed on the outer side of the pressing tube 3 and the distal tip 221 in the radial direction R. On the other hand, coupler 150D is disposed on the inner side of the pressing tube 3 and the distal tip 221 in the radial direction R. Coupler 150D has a tubular portion 151, a distal engaging portion 152D, and a proximal engaging portion 153D.

[0059] The tip engaging portion 152D is provided at the tip of the cylindrical portion 151 and is a convex portion that protrudes outward in a radial direction R that is perpendicular to the longitudinal direction A. The tip engaging portion 152D engages with an engaging portion 32D that protrudes inward in the radial direction R at the base end of the pressing tube 3.

[0060] The proximal end engaging portion 153D is a convex portion that is provided at the proximal end of the cylindrical portion 151 and protrudes outward in a radial direction R that is perpendicular to the longitudinal direction A. The proximal end engaging portion 153D engages with an engaging portion 225D that protrudes inward in the radial direction R at the tip of the sheath 220.

[0061] Second Embodiment A second embodiment of the present invention will be described with reference to Fig. 15 to Fig. 21. In the following description, components common to those already described will be assigned the same reference numerals and redundant description will be omitted.

[0062] 15 is a diagram showing a clip device 300B according to this embodiment. The clip device (clip system, endoscopic treatment tool) 300B includes a clip unit 100 and an applicator 200B. The clip unit 100 is loaded into the applicator 200B, which can be inserted into a channel of an endoscope, and introduced to a treatment position.

[0063] The applicator (clip unit introduction device) 200B includes a sheath 220B, an operation wire 230, and an operation section 240. Like the applicator 200 of the first embodiment, the applicator 200B is inserted into, for example, a treatment tool insertion channel of an endoscope and used in combination with the endoscope.

[0064] The sheath 220B has a different distal end portion from the sheath 220 of the first embodiment. The sheath 220B includes a distal tapered portion 226, a distal coil 222, and a proximal coil 224, and is formed into an elongated tubular shape as a whole. The distal tapered portion 226 is disposed on the distal end side of the sheath 220.

[0065] 16 is a cross-sectional view of the distal end of the clip device 300B. The distal tapered portion 226 is inclined with respect to the longitudinal axis direction L of the sheath 220 and is formed in a tapered shape that reduces in diameter toward the distal side A1. The pressing tube 3 and the distal tapered portion 226 are fitted together. Specifically, the distal end of the distal tapered portion 226 is inserted into the internal space 38 of the pressing tube 3 from the proximal end opening 3b of the pressing tube 3.

[0066] Fig. 17 is a diagram showing the transition of the shape of the clip unit 100. The clip unit 100 can transition between a linear form (first form) shown in Fig. 16 and a swing form (second form) shown in Fig. 17.

[0067] When a force equal to or greater than a predetermined value is applied to at least one of the first arm 211 and the second arm 212, the clip unit 100 swings in the swing direction Q and transitions to a swing configuration (second configuration). Specifically, as the pair of arms 21 swing in the swing direction Q, the pressing tube 3 in contact with the pair of arms 21 moves relative to the sheath 220. When the clip unit 100 is in at least the linear configuration (first configuration), a gap (backlash) G in the radial direction R is formed between the inner circumferential surface 3 c of the pressing tube 3 and the distal tapered portion 226 of the sheath 220. Therefore, the pressing tube 3 can tilt with respect to a direction intersecting the longitudinal axis direction L of the sheath 220.

[0068] The clip unit 100 can also transition from the swing configuration (second configuration) to the straight configuration (first configuration).

[0069] [Operation and Function of Clip Device 300B] Next, the operation and function of the clip device 300B will be described with reference to FIGS.

[0070] <Approach Step> The surgeon introduces the clip unit 100 loaded in the applicator 200B into the body via the channel of the endoscope. The surgeon moves the endoscope and the sheath 220B to bring the clip 2 of the clip unit 100 closer to the tissue T, which is the treatment area.

[0071] <Tangential Approach> Figure 18 is a diagram showing the clip unit 100 treating tissue T by a tangential approach. The surgeon approaches the clip unit 100, which is in a linear form, to the tissue T, which is the treatment area, by a tangential approach. The surgeon hooks the claw 22 of the first arm 211 onto the mucosa (first mucosa M1 in Figure 18) that is on the endoscope side (near side) of the first mucosa M1 and second mucosa M2 that are on either side of the center of the tissue T.

[0072] FIG. 19 is a diagram showing the clip unit 100 with the pair of arms 21 swung. The surgeon brings the clip unit 100, with the claws 22 hooked on the first mucosa M1, closer to the tissue T, which is the treatment area. Specifically, the surgeon advances the applicator 200B through the endoscope channel. Alternatively, the surgeon advances the endoscope to further press the clip unit 100 against the tissue T. As a result, as shown in FIG. 19 , the pair of arms 21 swing around the rotation axis RO, and the clip unit 100 assumes a swing form. When the second arm 212 contacts the second mucosa M2, the pair of arms 21 are positioned so that the front direction F faces the front of the tissue T, which is the treatment area. The first mucosa M1 and the second mucosa M2 are grasped by the pair of arms 21.

[0073] <Traction Step> The user retracts the operation wire 230 by retracting the slider 242 along the operation unit main body 241. The curved member 4 connected to the operation wire 230 retracts the clip 2. As the clip 2 is pulled toward the base end side A2, the pair of arms 21 are retracted into the pressing tube 3, and the pair of arms 21 engaged with the distal opening 3a gradually close. When the traction force of the operation wire 230 is released in this state, the self-expanding force of the pair of arms 21 causes the clip 2 to return to the open state while moving toward the distal end side A1. The user can return the pair of arms 21 to the open state to re-grasp the tissue T (reopening).

[0074] <Lock Step> Figure 20 is a diagram showing the lock step performed by the clip unit 100. The surgeon retracts the operating wire 230 by retracting the slider 242 along the operating unit main body 241. When the clip 2 is pulled to a predetermined position in the pressing tube 3, the engaging portion 25, which is a locking mechanism, engages with the inner surface of the pressing tube 3, and the pair of arms 21 is locked in the closed state. Once the pair of arms 21 is locked in the closed state, the pair of arms 21 cannot return to the open state.

[0075] <Separation Step> Figure 21 is a diagram showing the separation step performed by the clip unit 100. The surgeon further pulls the clip 2. A breaking force is applied to the separation portion 29 of the clip 2 by pulling, causing the separation portion 29 to break. As a result, the clip 2 and the bending member 4 are separated. The surgeon retracts the sheath 220, and leaves the clip 2 and the presser tube 3 in the body, with the first mucosa M1 and the second mucosa M2 ligated together.

[0076] The clip device 300B according to this embodiment can suitably grasp the tissue T in a lumen. Even when treating the tissue T using a tangential approach, the clip unit 100 can be swung relative to the sheath 220B so that the pair of arms 21 can be positioned facing the front of the tissue T, which is the treatment area. Because the clip unit 100 swings relative to the sheath 220B, it is easy to position the clip unit 100 facing the front of the tissue T even in a narrow lumen.

[0077] 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 embodiment and modifications can be configured in any suitable combination.

[0078] (Variation 2-1) Figures 22 and 23 are views showing a holder tube 3C, which is a variation of the holder tube 3. The holder tube 3C has a proximal tapered portion 33 on the proximal end side. The proximal tapered portion 33 is formed in a tapered shape that reduces in diameter toward the proximal side A2. The proximal end of the proximal tapered portion 33 is inserted into the sheath 220. When the clip unit 100 is in at least the straight form (first form), a gap (backlash) G in the radial direction R is formed between the outer circumferential surface 3d of the holder tube 3C and the inner circumferential surface of the sheath 220. Therefore, the holder tube 3C can tilt with respect to a direction intersecting the longitudinal axis direction L of the sheath 220.

[0079] (Variation 2-2) FIGS. 24 to 27 are diagrams illustrating a procedure using an outer sheath 260. The applicator 200 may further include an outer sheath 260. As shown in FIG. 24 , by disposing the outer sheath 260 outside the sheath 220 and the pressure tube 3C, the outer sheath 260 can maintain the clip unit 100 in a straight configuration (first configuration). As shown in FIG. 25 , by protruding the pressure tube 3C from the outer sheath 260 toward the distal end side A1, the clip unit 100 can transition to a swing configuration (second configuration). As shown in FIGS. 26 and 27 , the locking step and separation step are performed with the pressure tube 3C protruding from the outer sheath 260 toward the distal end side A1.

[0080] Third Embodiment A third embodiment of the present invention will be described with reference to Fig. 28 to Fig. 31. In the following description, components common to those already described will be assigned the same reference numerals and redundant description will be omitted.

[0081] 28 and 29 are diagrams showing a clip device 300C according to this embodiment. The clip device (clip system, endoscopic treatment tool) 300C includes a clip unit 100, a flexible member 160, and an applicator 200.

[0082] The flexible member 160 detachably connects the pressure tube 3 and the sheath 220. The flexible member 160 is formed in a cylindrical shape and is flexible. The flexible member 160 is, for example, a bellows, a tube, or a pipe spiral-cut with a laser. Because the flexible member 160 is flexible, the pressure tube 3 can tilt with respect to a direction intersecting the longitudinal axis direction L of the sheath 220.

[0083] 30 and 31 are views showing a flexible member 160B, which is another embodiment of the flexible member 160. The flexible member 160B detachably connects the pressing tube 3 and the sheath 220. The flexible member 160 has, for example, a hinge structure. Because the flexible member 160B is flexible, the pressing tube 3 can tilt with respect to a direction intersecting the longitudinal axis direction L of the sheath 220.

[0084] The clip device 300C according to this embodiment can suitably grasp the tissue T in a lumen. Even when treating the tissue T using a tangential approach, the clip unit 100 can be swung relative to the sheath 220, and the pair of arms 21 can be positioned facing the front of the tissue T, which is the treatment area. Because the clip unit 100 swings relative to the sheath 220, it is easy to position the clip unit 100 facing the front of the tissue T, even in a narrow lumen.

[0085] 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 embodiment and modifications can be configured in any suitable combination.

[0086] (Variation 3-1) Figure 32 is a diagram showing a bending member 4B that is a variation of the bending member 4. The bending member 4B supports a pair of arms 21 so that they can swing (rotate) around a rotation axis RO that is aligned in a direction substantially perpendicular to the longitudinal direction A. The swing direction (rotation direction) Q of the pair of arms 21, with the rotation axis RO as the center of rotation, is substantially perpendicular to the opening and closing direction P of the pair of arms 21. In this case, the clip unit can transition between a linear configuration (first configuration) in which the front direction F of the pair of arms 21 faces the same direction as the longitudinal axis direction L, and a swing configuration (second configuration) in which the clip unit swings in a direction substantially perpendicular to the opening and closing direction P, so that the front direction F of the pair of arms 21 faces a direction intersecting the longitudinal axis direction L.

[0087] 33 is a diagram showing a bending member 4C, which is a modified example of the bending member 4. The bending member 4C is a ball joint and supports a pair of arms 21 so that they can swing (rotate) around a ball 43C. The swing direction (rotation direction) Q of the pair of arms 21 with the ball 43C as the center of rotation is omnidirectional. In this case, the clip unit can transition between a linear form (first form) in which the front direction F of the pair of arms 21 faces the same direction as the longitudinal axis direction L, and a swing form (second form) in which the arms swing in all directions and face a direction intersecting the front direction F of the pair of arms 21.

[0088] 34 is a diagram showing a bending member 4D, which is a modified example of the bending member 4. The bending member 4D is an elastic member such as rubber. The swing direction (rotation direction) Q of the pair of arms 21 with the bending member 4D as the center of rotation is omnidirectional. In this case, the clip unit can transition between a linear form (first form) in which the front direction F of the pair of arms 21 faces the same direction as the longitudinal axis direction L, and a swing form (second form) in which the arms swing in all directions and face a direction intersecting the front direction F of the pair of arms 21.

[0089] 35 is a diagram showing a bending member 4E, which is a modified example of the bending member 4. The bending member 4E is a hook provided at the tip of the operating wire 230. As in the first embodiment, the swing direction (rotation direction) Q of the clip 2 substantially coincides with the opening and closing direction P of the pair of arms 21. In this case, the clip unit can transition between a linear form (first form) in which the front direction F of the pair of arms 21 faces the same direction as the longitudinal axis direction L, and a swing form (second form) in which the clip unit swings in substantially the same direction as the opening and closing direction P and the front direction F of the pair of arms 21 faces a direction intersecting the longitudinal axis direction L.

[0090] 300, 300B, 300C Clip device (clip system, endoscopic treatment tool) 200, 200B Applicator (clip unit introduction device) 220, 220B Sheath 221 Distal tip (distal portion) 225 Engagement portion 226 Distal tapered portion 230 Operation wire (power transmission member) 240 Operation portion 100 Clip unit 2 Clip (clip arm) 21 Pair of arms 29 Separation portion 3, 3C Presser tube (tubular member) 32 Engagement portion 33 Base end tapered portion 4 Bending portion

Claims

1. A clip device comprising: a clip unit having an arm that opens and closes toward the front; a wire connected to the clip unit; and a sheath through which the wire passes and extends in a longitudinal axis direction, wherein the clip unit is detachably connected to a tip of the sheath, and the clip unit is transitionable between a first form in which the front direction of the arm faces in the same direction as the longitudinal axis direction, and a second form in which the front direction of the arm faces in a direction intersecting the longitudinal axis direction.

2. A clip device as described in claim 1, further comprising a connecting member that detachably connects the clip unit and the tip of the sheath, and when the clip unit is in the first form, a gap is formed in the longitudinal direction between the clip unit and the tip of the sheath connected by the connecting member.

3. A clip device as described in claim 2, wherein the gap has a first gap and a second gap, the first gap and the second gap are arranged at positions sandwiching the wire in the radial direction of the wire, when the clip unit is in the first form, a first distance of the first gap and a second distance of the second gap are approximately the same, and when the clip unit is in the second form, the first distance and the second distance are different.

4. The clip device of claim 3, wherein one of the first distance and the second distance increases when the clip unit transitions from the first configuration to the second configuration.

5. The clip device according to claim 4, wherein the other of the first distance and the second distance decreases when the clip unit transitions from the first configuration to the second configuration.

6. The clip device according to claim 2, wherein the connecting member is inseparably attached to the clip unit.

7. The clip device according to claim 2, wherein said connecting member is inseparably attached to said distal end of said sheath.

8. The clip device according to claim 2, wherein the clip unit has a tubular member in which at least a portion of the arm can be stored, and the connecting member detachably connects the tubular member and the tip portion of the sheath.

9. A clip device as described in claim 1, wherein the clip unit has a tubular member in which at least a portion of the arm can be stored, the tip of the sheath and the tubular member are fitted together, and when the clip unit is in the first form, a radial gap is formed between the tubular member and the tip of the sheath.

10. The clip device according to claim 9, wherein at least a portion of the tapered portion formed at the distal end of the sheath is inserted into the tubular member.

11. The clip device according to claim 9, wherein at least a portion of a tapered portion formed at a proximal end of said tubular member is inserted into said distal end of said sheath.

12. The clip device according to claim 1, further comprising a flexible member that detachably connects said clip unit and said tip portion of said sheath, said flexible member having flexibility.

13. The clip device according to claim 1, wherein the clip unit has a tubular member in which at least a portion of the arm can be stored, and further has an outer sheath disposed outside the tubular member and the distal end of the sheath.

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