Clip device and clip unit

Abstract

This clip device comprises a clip unit having arms that open and close towards a front direction, a wire connected to the clip unit, and a sheath through which the wire is inserted and that extends in a longitudinal axis direction. The clip unit is separably connected to the tip part of the sheath. The clip unit can transition to a first form in which the front direction of the arms is oriented in the same direction as the longitudinal axis direction, and a second form in which the front direction of the arms is oriented in a direction intersecting the longitudinal axis direction.

Description

Clip Devices and Clip Units

[0001] This application claims priority to U.S. Provisional Application No. 63 / 508,598, filed June 16, 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 and a clip unit 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] A clip device according to a second aspect of the present invention is a reloadable 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 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.

[0009] A clip unit according to a third aspect of the present invention is a clip unit that is loaded into the sheath of an applicator, and comprises an arm that opens and closes toward the front, and a tubular member in which at least a portion of the arm can be stored, and 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 of the sheath, and a second form in which the front direction of the arm faces in a direction intersecting the longitudinal axis direction.

[0010] The clip device and clip unit of the present invention can suitably grasp tissue in a narrow space such as a lumen.

[0011] 1 is a diagram showing a clip device according to a first embodiment; FIG. 1 is a perspective view of a clip unit loaded into an applicator; FIG. 2 is a perspective view of the clip unit loaded into the applicator; FIG. 2 is a cross-sectional view of the clip unit; FIG. 3 is a cross-sectional view of the clip unit; FIG. 4 is a diagram showing the transition of the shape of the clip unit; FIG. 5 is a diagram showing the transition of the shape of the clip unit; FIG. 6 is a diagram showing the clip unit treating tissue by a tangential approach; FIG. 7 is a diagram showing the clip unit with a pair of arms swinging; FIG. 8 is a diagram showing a separation step by the clip unit; FIG. 9 is a diagram showing a modified example of a pressure tube of the clip unit; FIG. 10 is a diagram showing another modified example of the pressure tube; FIG. 11 is a diagram showing a clip unit according to a second embodiment; FIG. 12 is a diagram showing a tangential approach by the clip unit; FIG. 13 is a diagram showing a tangential approach by the clip unit; FIG. 14 is a diagram showing a clip unit according to a third embodiment; FIG. 15 is a diagram showing a modified example of a curved member of the clip unit; FIG. 16 is a diagram showing a clip unit according to a fourth embodiment.

[0012] 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 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.

[0013] 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.

[0014] 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.

[0015] 2 and 3 are perspective views 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.

[0016] 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 (distal portion) 221 is formed in a cylindrical shape and is disposed at the distal end of the distal coil 222.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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 .

[0021] [Clip unit 100] The clip unit 100 is loaded onto the distal tip (distal end) 221 of the sheath 220 of the applicator 200. The clip unit 100 includes a clip 2, a pressing tube (tubular member) 3, and a curved member (connecting member) 4.

[0022] 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.

[0023] The pair of arms 21 can be opened and closed in the 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 pair of arms 21 change their forward direction F by swinging (see FIGS. 6 and 7). 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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, as will be described later. 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] The holding tube (tubular member) 3 has a distal tube portion 31 , a proximal tube portion 32 , and a flexible tube portion 33 connecting the distal tube portion 31 and the proximal tube portion 32 .

[0033] The distal tube portion 31 is a hard member made of metal or the like, and is formed in a circular ring shape. The distal tube portion 31 is provided at the distal end of the flexible tube portion 33. A distal opening 3a is formed on the distal side A1 of the distal tube portion 31.

[0034] The proximal tube portion 32 is a hard member made of metal or the like, and is formed in a circular ring shape. The proximal tube portion 32 is provided at the proximal end of the flexible tube portion 33.

[0035] The flexible tube section 33 is bendable and has higher flexibility than the distal tube section 31 and the proximal tube section 32. In this embodiment, the flexible tube section 33 is a coil sheath. The flexible tube section 33 has elasticity that allows it to return to a straight shape in its natural state when not subjected to external force.

[0036] The flexible tube section 33 may be a cylindrically formed flexible tubular member such as a spring, a laser-cut pipe, a flexible tube, etc. These tubular members also have elasticity that allows them to return to a straight shape in a natural state when not subjected to external force.

[0037] The flexible tube section 33 may be a tubular member to which cylindrical bending pieces made of a hard material such as metal are connected. The bending pieces do not need to be flexible individually, as long as the tubular member to which multiple bending pieces are connected has flexibility. Note that the number of connected bending pieces may be two.

[0038] When the distal tube portion 31, the proximal tube portion 32, and the flexible tube portion 33 are made of different materials, one of the materials may be made of a material with lower magnetic properties than the other material, thereby reducing the influence of the clip unit 100 on MRI.

[0039] The proximal tube portion 32 of the pressing tube 3 is detachably connected to the distal tip 221 of the applicator 200. The proximal tube portion 32 may be detachably connected to the distal tip 221 by, for example, an adhesive. Alternatively, the proximal tube portion 32 may be detachably connected to the distal tip 221 by, for example, fitting. Alternatively, the proximal tube portion 32 may simply be in contact with the distal tip 221.

[0040] 4 and 5 are cross-sectional views of the clip unit 100. The curved member (connecting 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 about the rotation axis RO 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.

[0041] The curved member (connecting member) 4 causes the pair of arms 21 to swing 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 cause the pair of arms 21 to swing.

[0042] The bending member (connecting 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 together.

[0043] 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 .

[0044] The position to which the bending member 4 can be arranged on the distal end side A1 is restricted to a distal end position PD (see FIG. 4). For example, the enlarged diameter portion 231 provided on the operating wire 230 engages with the reduced diameter portion 225 provided in the internal space of the distal tip 221, etc., so that the bending member 4 cannot move further toward the distal end side A1 than the distal end position PD.

[0045] When the pair of arms 21 are not locked in the closed position by the locking mechanism, the position at which the bending member 4 can be placed on the base end side A2 is restricted to a base end position PP (see FIG. 5 ). The pair of arms 21 have a self-opening force in the opening and closing direction. Therefore, even if the bending member 4 is pulled toward the base end side A2 beyond the base end position PP, if the pulling force is released while the pair of arms 21 are not locked, the self-opening force of the pair of arms 21 causes the pair of arms 21 to return to the open state while moving toward the distal end side A1. As a result, the bending member 4 advances to the base end position PP and is placed at the base end position PP.

[0046] When the bending member 4 moves within a range from the distal position PD to the proximal position PP, it is desirable that the hinge 43 of the bending member 4 be disposed in the internal space 38 of the flexible tube section 33 of the holding tube 3. In this case, as shown in Figures 4 and 5 , the movement range Z1 of the hinge 43 when the bending member 4 moves within a range from the distal position PD to the proximal position PP is included in the internal space 38 of the flexible tube section 33. When the pair of arms 21 swing relative to the bending member 4, the flexible tube section 33 bends in conjunction with the arms 21, so that the swinging motion of the bending member 4 is not hindered by the holding tube 3.

[0047] 6 and 7 are diagrams 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. 6 and a swing form (second form) shown in Fig. 7.

[0048] The linear configuration (first configuration) is a configuration of the clip unit 100 in which the forward 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 Figures 2 and 3. That is, as shown in Figure 4, the linear configuration is a configuration in which the central axis O3 of the distal end tube section 31 extends in the longitudinal axis direction L of the sheath 220. The linear configuration is also a configuration in which an imaginary line segment V intersects with the central axis O2 of the sheath 220 in the longitudinal axis direction L. Here, the imaginary line segment V is a line segment connecting the distal ends of the pair of arms 21 in the open configuration. The linear configuration is also a configuration in which the distal end of the first arm 211 and the distal end of the second arm 212 are disposed with the central axis O2 of the sheath 220 sandwiched therebetween. In addition, the linear form is a form in which, in a pair of arms 21 in the open form, the distance between the tip of the first arm 211 and the central axis O2 of the sheath 220 is approximately equal to the distance between the tip of the second arm 212 and the central axis O2 of the sheath 220.

[0049] The swing configuration (second configuration) is a configuration of the clip unit 100 in which, as shown in FIGS. 6 and 7 , the forward direction F of the pair of arms 21 faces a direction intersecting the longitudinal axis direction L of the sheath 220. That is, as shown in FIG. 7 , the swing configuration is a configuration in which the central axis O3 of the distal end tube section 31 faces a direction intersecting the longitudinal axis direction L of the sheath 220. The swing configuration is also a configuration in which the imaginary line V does not intersect with the central axis O2 of the sheath 220. The swing configuration is also a configuration in which the distal end of the first arm 211 and the distal end of the second arm 212 are arranged without sandwiching the central axis O2 of the sheath 220 therebetween. The swing configuration is also a configuration in which, in the pair of arms 21 in the open configuration, the distance between the distal end of the first arm 211 and the central axis O2 of the sheath 220 is smaller or larger than the distance between the distal end of the second arm 212 and the central axis O2 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 and transitions to the swing form (second form). Specifically, the pair of arms 21 swing in the swing direction Q, and the pressing tube 3 in contact with the pair of arms 21 bends.

[0050] The clip unit 100 can also transition from the swing form (second form) to the straight form (first form). If the flexible tube portion 33 has sufficient elasticity, the clip unit 100 in the swing form returns to the straight form in its natural state when not subjected to external force.

[0051] [Operation and Function of Clip Unit 100] Next, the operation and function of the clip unit 100 will be described with reference to FIGS. 8 to 10. FIG.

[0052] <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.

[0053] 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.

[0054] <Tangential Approach> Figure 8 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 the tangential approach. The surgeon hooks the claw 22 of the first arm 211 onto the mucosa (first mucosa M1 in Figure 8) 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.

[0055] FIG. 9 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. 9 , 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.

[0056] <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).

[0057] The pressing tube 3 has a hard distal tube portion 31 on the distal side A1. Therefore, the distal tube portion 31 and the pair of arms 21 have high sliding properties, allowing the pair of arms 21 to move forward and backward smoothly. In addition, the pressing tube 3 has a hard proximal tube portion 32 on the proximal side A2. Because the proximal tube portion 32 firmly contacts the distal tip 221 of the sheath 220, the power of the operating wire 230 is easily transmitted to the clip unit 100.

[0058] <Lock Step> 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 peripheral surface of the pressing tube 3, and the pair of arms 21 is locked in the closed state. Once the pair of arms 21 are locked in the closed state, the pair of arms 21 cannot return to the open state.

[0059] <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 by pulling to the separation portion 29 of the clip 2, causing the breaking portion 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.

[0060] The clip unit 100 according to this embodiment can suitably grasp tissue T in a lumen. Even when treating tissue T using a tangential approach, the entire clip unit 100 can be swung, allowing the pair of arms 21 to be positioned facing the front of the tissue T, which is the treatment area. Because the entire clip unit 100 swings, it is easy to position the clip unit 100 facing the front of the tissue T, even in a narrow lumen.

[0061] 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.

[0062] 11 is a diagram showing a holder tube 3A, which is a modification of the holder tube 3. The holder tube 3A has a flexible tube portion 33, and does not have a distal tube portion 31 or a proximal tube portion 32. The holder tube 3A is composed only of the flexible tube portion 33, and has lower manufacturing costs than the holder tube 3.

[0063] 12 is a diagram showing a pressing tube 3B, which is a modification of the pressing tube 3. The pressing tube 3B has a proximal tube portion 32 and a flexible tube portion 33, but does not have a distal tube portion 31. In the pressing tube 3B, the proximal tube portion 32 firmly contacts the distal tip 221 of the sheath 220, so that the power of the operating wire 230 is easily transmitted to the clip unit 100. The pressing tube 3B is composed only of the proximal tube portion 32 and the flexible tube portion 33, and has lower manufacturing costs than the pressing tube 3.

[0064] (Variation 3) Figure 13 is a diagram showing a holder tube 3C, which is a variation of the holder tube 3. The holder tube 3C has a distal tube portion 31 and a flexible tube portion 33, but does not have a proximal tube portion 32. The distal tube portion 31 and the pair of arms 21 have high slidability, allowing the pair of arms 21 to move forward and backward smoothly. The holder tube 3C is composed only of the distal tube portion 31 and the flexible tube portion 33, and has lower manufacturing costs than the holder tube 3.

[0065] Second Embodiment A second embodiment of the present invention will be described with reference to Figures 14 to 16. In the following description, components common to those already described will be assigned the same reference numerals and redundant description will be omitted.

[0066] 14 is a diagram showing a clip unit 100B according to this embodiment. The clip unit 100B is loaded onto the distal tip (distal end) 221 of the sheath 220 of the applicator 200, similar to the clip unit 100 of the first embodiment.

[0067] The clip unit 100B includes a clip 2, a holding tube (tubular member) 3, and a curved member (connecting member) 4B.

[0068] The curved member (connecting member) 4B 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 about the rotation axis RO is substantially perpendicular to the opening and closing direction P of the pair of arms 21.

[0069] 15 and 16 are diagrams showing a tangential approach using the clip unit 100B. The surgeon brings the clip unit 100B, with its two claws 22 hooked onto the mucosa, closer to the tissue T. Specifically, the surgeon advances the applicator 200 relative to the endoscope channel. Alternatively, the surgeon advances the endoscope to further press the clip unit 100B against the tissue T. As a result, as shown in FIG. 16 , the pair of arms 21 swing about the rotation axis RO, and the clip unit 100B assumes a swing configuration. The pair of arms 21 are positioned such that the forward direction F faces the front of the tissue T, which is the treatment area.

[0070] The clip unit 100B according to this embodiment can suitably grasp tissue T in a lumen. Even when treating tissue T using a tangential approach, the entire clip unit 100B can be swung so that the pair of arms 21 are positioned facing the front of the tissue T, which is the treatment area. Because the entire clip unit 100B swings, the clip unit 100B can be easily positioned facing the front of the tissue T, even in a narrow lumen.

[0071] 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.

[0072] Third Embodiment A second embodiment of the present invention will be described with reference to Fig. 17. In the following description, components common to those already described will be assigned the same reference numerals and redundant description will be omitted.

[0073] 17 is a diagram showing a clip unit 100C according to this embodiment. The clip unit 100C is loaded onto the distal tip (distal end) 221 of the sheath 220 of the applicator 200, similar to the clip unit 100 of the first embodiment.

[0074] The clip unit 100C includes a clip 2, a holding tube (tubular member) 3, and a curved member (connecting member) 4C.

[0075] The curved member (connecting member) 4C is a ball joint, and supports the pair of arms 21 so that they can swing (rotate) around a ball 43C. In this embodiment, the swing direction (rotation direction) Q of the pair of arms 21 around the ball 43C as the rotation center is omnidirectional.

[0076] The clip unit 100C can perform both the operations of the clip unit 100 of the first embodiment and the operations of the clip unit 100 of the second embodiment.

[0077] The clip unit 100C according to this embodiment can suitably grasp tissue T in a lumen. Even when treating tissue T using a tangential approach, the entire clip unit 100C can be swung so that the pair of arms 21 are positioned facing the front of the tissue T, which is the treatment area. Because the entire clip unit 100C swings, it is easy to position the clip unit 100C facing the front of the tissue T, even in a narrow lumen.

[0078] 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.

[0079] 18 is a diagram showing a bending member 4D, which is a modification of the bending member 4C. The bending member 4D is an elastic member such as rubber. The swing direction (rotation direction) Q of the pair of arms 21 around the bending member 4D as the center of rotation is omnidirectional.

[0080] Fourth Embodiment A fourth embodiment of the present invention will be described with reference to Fig. 19. In the following description, components common to those already described will be assigned the same reference numerals and redundant description will be omitted.

[0081] 19 is a diagram showing a clip unit 100D according to this embodiment. The clip unit 100D is loaded onto the distal tip (distal end) 221 of the sheath 220 of the applicator 200, similar to the clip unit 100 of the first embodiment.

[0082] The clip unit 100D includes a clip 2 and a retaining tube (tubular member) 3. The clip unit 100D does not have a curved member (connecting member) 4. The clip 2 is hooked onto a hook 239 provided at the tip of the sheath. 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, as in the first embodiment.

[0083] The clip 2 may be connected to a ball joint provided at the tip of the sheath. In this case, the swing direction (rotation direction) Q of the clip 2 is omnidirectional, as in the third embodiment.

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

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

[0086] 300 Clip device (clip system, endoscopic treatment tool) 200 Applicator (clip unit introduction device) 220 Sheath 221 Distal tip (distal portion) 230 Operation wire (power transmission member) 240 Operation portion 100, 100B, 100C, 100D Clip unit 2 Clip (clip arm) 21 Pair of arms 22 Claws 28 Support portion 29 Separation portion 3, 3A, 3B, 3C Presser tube (tubular member) 31 Distal tube portion 32 Base end tube portion 33 Flexible tube portion 38 Internal space 4, 4B, 4C, 4D Curved member (connecting member) 41 Distal member 42 Base end member 43 Hinge (rotating portion) 43C Ball

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. The clip device according to claim 1, wherein the clip unit is in the first configuration when separated from the sheath and deployed.

3. The clip device according to claim 1, wherein the swing direction of said clip unit in transition between said first form and said second form is the same as the opening and closing direction of said arms.

4. The clip device according to claim 1, wherein the swing direction of said clip unit in transitioning between said first form and said second form is a direction substantially perpendicular to the opening and closing direction of said arms.

5. The clip device according to claim 1, wherein the clip unit has a tubular member capable of storing at least a portion of the arm, and the tubular member has a flexible tube portion that is deformable in accordance with the transition of the clip unit between the first form and the second form.

6. The clip device according to claim 5, wherein the flexible tube portion has elasticity that returns the clip unit to the first configuration.

7. The clip device according to claim 5, wherein said clip unit has a curved member that connects said arm and said wire and transitions said arm between said first configuration and said second configuration.

8. The clip device according to claim 7, wherein the tubular member has a locking mechanism that locks the arms in a closed configuration when at least a portion of the arms is retracted, and when the arms are not locked in the closed configuration by the locking mechanism, the pivoting portion of the curved member is positioned in the internal space of the flexible tubular portion.

9. A reloadable 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.

10. A clip device as described in claim 9, wherein the clip unit has a tubular member in which at least a portion of the arm can be stored, and the tubular member has a flexible tube portion that can deform in accordance with the transition of the clip unit between the first form and the second form.

11. The clip device according to claim 10, wherein the clip unit includes a curved member connecting the arm and the wire and transitioning the arm between the first configuration and the second configuration.

12. The clip device according to claim 11, wherein the tubular member has a locking mechanism that locks the arms in a closed configuration when at least a portion of the arms is retracted, and when the arms are not locked in the closed configuration by the locking mechanism, the pivoting portion of the curved member is positioned in the internal space of the flexible tubular portion.

13. A clip unit to be loaded into a sheath of an applicator, comprising: an arm that opens and closes toward the front; and a tubular member in which at least a portion of the arm can be stored, the clip unit being capable of transitioning between a first configuration in which the front direction of the arm faces in the same direction as a longitudinal axis direction of the sheath; and a second configuration in which the front direction of the arm faces in a direction intersecting the longitudinal axis direction.

14. The clip unit according to claim 13, which is in said first configuration when separated from said sheath and deployed.

15. The clip unit according to claim 13, wherein a swing direction in which the clip unit transitions between the first form and the second form is the same as a direction in which the arms are opened and closed.

16. The clip unit according to claim 13, wherein a swing direction in which the clip unit transitions between the first configuration and the second configuration is substantially perpendicular to a direction in which the arms are opened and closed.

17. The clip unit according to claim 13, wherein the tubular member has a flexible tube portion that is deformable in accordance with the transition of the clip unit between the first configuration and the second configuration.

18. The clip unit according to claim 17, wherein the flexible tube portion has elasticity that returns the clip unit to the first configuration.

19. The clip unit according to claim 17, further comprising a curved member that connects said arm to a wire passing through said sheath and transitions said arm between said first configuration and said second configuration.

20. A clip unit as described in claim 19, wherein the tubular member has a locking mechanism that locks the arm in a closed configuration when at least a portion of the arm is retracted, and when the arm is not locked in the closed configuration by the locking mechanism, the rotating portion of the curved member is positioned in the internal space of the flexible tubular portion.

Images