Interface mechanism for repositioning and deployment of over the scope clip

Abstract

To provide an improved endoscope clipping device for treating a tissue along the gastrointestinal tract.SOLUTION: A device for clipping tissue includes: a cap mounted over a distal end of an endoscope; and a clip mountable over the cap and including first and second jaws. Therein the first and second jaws are movably connected to each other among: an insertion configuration in which the first and second jaws extend over the cap to receive a target tissue therebetween; a review configuration in which at least a portion of the clip extends into a field of view of an optical system of the endoscope; and a deployed configuration in which the clip is moved distally off of the cap so that the first and second jaws are drawn toward one another. A control element is configured so that movement proximally through the cap via a first distance moves the clip from the insertion configuration to the review configuration and a second distance moves the clip from the review configuration to the deployed configuration.SELECTED DRAWING: Figure 21

Description

Technical Field

[0001] The present disclosure relates to an endoscopic device, and more particularly to an endoscopic clipping device for treating tissue along the gastrointestinal tract.

Background Art

[0002] Physicians have increasingly performed advanced, invasive, and therapeutic endoscopic gastrointestinal (GI) procedures, which can increase the risk of perforating the wall of the GI tract or may require closure of the GI tract wall as part of the procedure. Such procedures can include, for example, removal of large lesions, tunneling under the mucosal layer of the GI tract to treat submucosal tissue, removal of the entire tissue layer, entering the body through the GI tract, penetrating tissue and exiting the GI tract to operate on tissue outside the GI tract, and endoscopic treatment / repair of postoperative problems (e.g., postoperative leakage, failure of the surgical staple line, and anastomotic leakage).

[0003] Currently, tissue can be treated via an endoscopic closure device that includes through-the-scope clips or over-the-scope clips. Over-the-scope clips can be particularly useful for achieving closure of larger tissue defects. These endoscopic closure devices can save hospital costs and provide benefits to patients. However, in some cases, current endoscopic closure devices can be difficult to use, time-consuming to position, or inadequate for certain perforations, conditions, and anatomical shapes. For example, current over-the-scope clips generally require the clip itself to be delivered from a position that is not visible to the operator. That is, prior to clipping, the operator can visualize the target tissue to be clipped and, based on this visualization of the target tissue, determine that the distal end of the device and the clip are in the desired position relative to the target tissue. Then, based on the observation of the target tissue, the operator deploys the clip in a state where the clip itself cannot be confirmed until the clip is deployed.

SUMMARY OF THE INVENTION

[0004] The present embodiment relates to a clipping system for treating tissue, including a cap. The cap is configured to be attached onto the distal end of an endoscope. The cap extends longitudinally from its proximal end to its distal end and includes a channel extending therethrough such that it can be disposed adjacent to a target tissue in vivo. The clip is configured to be attached onto the cap. The clip includes a first jaw portion and a second jaw portion. The first jaw portion and the second jaw portion are movably connected to each other via a hinge biased to draw the first jaw portion and the second jaw portion towards each other. The clip is movable relative to the cap among: (a) an insertion configuration in which the first jaw portion and the second jaw portion extend onto the cap, the first jaw portion and the second jaw portion are spaced apart from each other to receive a target tissue therebetween, and obstacles to the optical system of the endoscope to which the cap is attached are minimized; (b) an inspection configuration in which the clip is moved distally relative to the cap and a part of the clip extends distally until at least a part of the clip extends within the field of view of the optical system of the endoscope to which the cap is attached; and (c) a deployment configuration in which the clip is moved distally away from the cap and the first jaw portion and the second jaw portion are drawn towards each other under the bias of the hinge to close and clip the tissue received between the first jaw portion and the second jaw portion. The control element extends from a distal end releasably connected to the clip, through the channel of the cap and the endoscope to which it is connected, to a proximal end. During use, the control element remains outside the body while the cap is adjacent to the target tissue. The control element is configured to move the clip distally relative to the cap by proximal movement of the control element through the cap. The control element is configured to move the clip from the insertion configuration to the inspection configuration by proximal movement of the control element through the cap by a first distance, and to move the clip from the inspection configuration to the deployment configuration by proximal movement of the control element through the cap by a second distance.

[0005] In one embodiment, the system may further comprise an actuation assembly coupled to the proximal end of the control element, the actuation assembly including a first actuator configured to move the control element proximally through the endoscope by a first distance during actuation to move the clip from the insertion configuration to the inspection configuration.

[0006] In one embodiment, the first actuator may include a first elongate member and a second elongate member pivotally coupled to each other, such that when the proximal portions of the first elongate member and the second elongate member are drawn towards each other, the distal portions of the first elongate member and the second elongate member are correspondingly drawn towards each other.

[0007] In one embodiment, the actuation assembly may further include a second actuator configured to move the control element proximally through the endoscope by a second distance during actuation to move the clip from the inspection configuration to the deployment configuration.

[0008] In one embodiment, the actuation assembly may further include a movement element and a pulley mechanism, the control element being routed through the pulley mechanism to be coupled to the movement element, such that when the first elongate member and the second elongate member are drawn towards each other, the movement element moves from a proximal position to a distal position relative to the housing of the actuation assembly, pulling the control element proximally through the endoscope, whereby the clip moves from the insertion configuration towards the inspection configuration.

[0009] In one embodiment, the second actuator may include a push button including a tab extending within the housing of the actuation assembly, the tab engaging a portion of the control element such that when the clip is in the inspection configuration, pressing the push button applies additional tension along the control element to move the clip from the inspection configuration towards the deployment configuration.

[0010] In one embodiment, the actuation assembly may further include a biasing element that biases the first actuator toward the inserted configuration. In one embodiment, the actuation assembly may include a locking mechanism for locking the clip toward the inspection configuration.

[0011] In one embodiment, the first actuator may include a handle portion configured to be grasped by an operator of the system and a lever movably coupled to the handle portion, and a proximal end of the control element is coupled to the lever, and when the lever is pushed against the handle portion, the control element moves proximally by a first distance through the endoscope to move the clip from the inserted configuration toward the inspection configuration.

[0012] In one embodiment, the first actuator may include a housing and a rotary handle rotatably coupled to the housing, and a proximal end of the control element is connected to a moving element threadedly coupled to a part of the rotary handle, and rotation of the rotary handle relative to the housing causes the control element to move proximally through the endoscope.

[0013] The present embodiment also relates to a clipping system for treating tissue, comprising an endoscope including a shaft extending longitudinally from a proximal end to a distal end. A cap extending longitudinally from a proximal end to a distal end includes a channel extending through the cap such that the cap is slidably mounted on a distal portion of the endoscope shaft. The clip includes a first jaw portion and a second jaw portion movably connected to each other via a plurality of hinges, at least one of the plurality of hinges being biased to draw the first jaw portion and the second jaw portion towards each other, and the clip is attachable to the cap such that the first jaw portion and the second jaw portion extend over opposite sides of the cap so that the first jaw portion and the second jaw portion are spaced apart from each other to receive a target tissue therebetween. Distal movement of the cap relative to the endoscope from a proximal position along the endoscope to a distal position along the endoscope causes the clip to move from an insertion configuration towards an inspection configuration, in which the clip extends distally until at least a portion of the clip extends within the field of view of the endoscope's optical system. Distal movement of the clip relative to the cap causes the clip to move from the inspection configuration towards a deployment configuration, in which the clip moves distally away from the clip and the first jaw portion and the second jaw portion are drawn towards each other under the bias of at least one hinge and close on the tissue received therebetween. A repositioning element extends from a distal end connected to the cap through the channel of the cap and through the endoscope to a proximal end, and remains outside the body during use. The repositioning element is configured such that proximal movement of the repositioning element through the endoscope causes the cap to move distally along the endoscope from the insertion configuration towards the inspection configuration. A deployment element extends from a distal end releasably connected to the clip through the channel of the cap and through the endoscope to a proximal end, and remains outside the body during use. The deployment element is configured such that proximal movement of the deployment element through the endoscope causes the clip to move distally relative to the cap towards the deployment configuration.The actuation assembly includes a first actuator configured to control the movement of the repositioning element and a second actuator configured to control the movement of the deployment element.

[0014] In one embodiment, the actuation assembly further includes a housing extending such that the proximal ends of the repositioning element and the deployment element are coupled to the first actuator and the second actuator.

[0015] In one embodiment, the first actuator may include a lever pivotally coupled to a handle, and the proximal end of the repositioning element is coupled to a portion of the handle such that when the lever moves towards the housing, the repositioning element moves proximally through the endoscope and the cap and clip move from the inserted configuration towards the inspection configuration.

[0016] In one embodiment, the second actuator may include a push button extending within the housing and coupled to the proximal end of the deployment element such that when the push button is further pushed into the housing, the deployment element moves proximally through the endoscope and the clip moves distally relative to the cap from the inspection configuration towards the deployed configuration.

[0017] In one embodiment, the system may further include a biasing element extending between the distal end of the cap and a stop at the most distal end of the endoscope to which the cap is attached, the biasing element biasing the cap towards the inserted configuration and the entire clip attached to the cap being proximal to the most distal end of the endoscope such that when the lever is released, the cap and clip return towards the inserted configuration.

[0018] This embodiment also relates to a method for treating tissue. In the insertion configuration, a clip is inserted into a target region within a body lumen via an endoscope, and in the insertion configuration, the clip is attached onto the distal end of the endoscope via a transparent cap, with the proximal end of the cap extending onto the distal end of the endoscope, the distal portion of the cap extending distally from the distal end of the endoscope, and the jaw portions of the clip being attached onto the proximal portion of the cap such that the jaw portions are spaced apart from each other. A suction force is applied through the working channel of the endoscope, whereby tissue is drawn into the channel of the cap and between the jaw portions of the clip. A first actuator is actuated to move proximally a control element releasably coupled to the clip through the endoscope by a first distance, moving the clip towards the inspection configuration. In the inspection configuration, the clip is moved distally along the cap such that the clip extends onto the distal portion of the cap so that the clip is within the field of view of the endoscope in the inspection configuration. When the clip is in the inspection configuration, it is determined whether the clip is in a desired position relative to the target tissue. While the clip is in the inspection configuration, a second actuator is actuated to apply additional tension to the control element, whereby the control element moves further proximally relative to the endoscope by a second distance and the clip moves distally away from the cap towards the deployment configuration. In the deployment configuration, the clip returns towards the biased closed configuration, and in the biased closed configuration, the jaw portions are drawn towards each other to grip tissue between the jaw portions.

Brief Description of the Drawings

[0019]

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[0020] The present disclosure can be further understood with reference to the following description and the accompanying drawings, where like components are referred to by the same reference numerals. The present disclosure relates to a clipping system, and more particularly to an over-scope endoscope clipping system in which the initial placement of the clip can be visually inspected and adjusted via an actuation assembly prior to its deployment. Exemplary embodiments of the present disclosure include a clip attachable to the distal end of an endoscope via a cap and an actuation assembly that controls the movement of the clip relative to the endoscope among an insertion configuration, an inspection configuration, and a deployment configuration. In the insertion configuration, the clip is attached to the distal end of the endoscope such that the jaws of the clip are spaced apart from each other toward an open configuration in which tissue can be received therebetween.

[0021] In the inspection configuration, the clip is moved distally relative to the endoscope such that at least a portion of the clip extends within the field of view of the endoscope. In this inspection configuration, the clip remains attached to the cap in an open configuration with the jaws spaced apart from each other such that a target tissue can be received therebetween, during which the operator of the system can visually inspect via the endoscope to determine whether the clip is in a desired position relative to the target tissue. If it is determined that the clip is in a desired position relative to the target tissue, the clip can be moved toward the deployment configuration.

[0022] In the deployed configuration, the clip is moved distally away from the cap, whereby the clip returns toward its biased closed configuration and grasps target tissue between its jaws. The actuation assembly is releasably coupled to the clip via a control element to enable movement of the clip relative to the endoscope among an insertion configuration, an inspection configuration, and a deployed configuration. As the clip moves toward the deployed configuration, it will be understood by those skilled in the art that the clip becomes fully separated from the endoscope and is permanently released within the body. As used herein, it will be understood by those skilled in the art that the terms proximal and distal are intended to refer to the direction toward and away from the user of the device, respectively.

[0023] As shown in FIGS. 1-6, a tissue clipping system 100 for treating tissue defects and / or perforations according to an exemplary embodiment of the present disclosure includes a clip 102 configured to be mounted on a distal end 106 of an endoscope 104 via a transparent cap 108. The clip 102 is releasably coupled to a control element 110 such that tension in the control element 110 causes the clip 102 to move distally relative to the endoscope 104 (and the cap 108 mounted thereon) from the insertion configuration as shown in FIG. 1 toward the inspection configuration as shown in FIG. 2. When it is determined by an operator (e.g., a surgeon) of the system 100 that the clip 102 is in a desired position relative to the target tissue, further tension in the control element 110 causes the clip 102 to move from the inspection configuration toward the deployed configuration, in which the clip 102 is released from the cap 108 and closes on the target tissue as shown in FIG. 3. In the insertion configuration, as shown in FIG. 1, the clip 102 is mounted on the cap 108, and the cap 108 holds the clip 102 in an open position in which the jaws 114 of the clip 102 are spread apart around the cap 108 such that tissue to be clipped can be drawn through a channel 116 of the cap 108 between the jaws 114.

[0024] In this inserted configuration, the entire clip 102 of this embodiment (including the jaw-like portion 114) is attached onto the proximal portion 138 of the cap 108. Thus, obstacles in the field of view of the optical system of the endoscope 104 are minimized, and as a result, the user can fully observe the tissue adjacent to the cap 108 through the open end of the cap 108 and through the wall of the cap 108. To move the clip 102 from the inserted configuration towards the inspection configuration, as shown in FIG. 2, tension is applied to the control element 110, and the clip 102 is pushed distally along the cap 108 until a part of the clip 102 abuts against the protrusion 120 formed on the cap 108. This provides the operator with a tangible feedback indicating that the clip 102 is in the inspection configuration. In the inspection configuration, the jaw-like portion 114 maintains a spread state on the distal portion 140 of the cap 108 and extends distally beyond the distal end 106 of the endoscope 104. The jaw-like portion 114 is maintained in an open state near the cap 108 and is spaced apart from each other. Since the cap 108 is transparent, when the clip 102 is attached onto the distal portion 140 of the cap 108, the clip 102 is within the field of view of the optical system of the endoscope 104.

[0025] In the inspection configuration, the operator can visually determine whether the clip 102 is in the desired position with respect to the target tissue (e.g., a part of the tissue drawn into the cap 108). If the operator determines that the clip 102 is not in the desired position with respect to the target tissue, the tissue can be released from the cap 108, and the distal end 106 of the endoscope 104 is repositioned until the target tissue is drawn into the cap 108 as desired between the jaw-like portions 114 of the clip 102. When it is determined that the clip 102 is in the desired position, the target tissue is drawn into the cap 108 (e.g., by applying a suction force through the working channel of the endoscope 104 or by applying a gripper).

[0026] Next, tension is applied to the control element 110 until the force applied to the control element 110 exceeds a predetermined force that pushes the clip 102 beyond the protrusion 120 and disengages it from the cap 108, as shown in FIG. 3. When the clip 102 is pushed out from the cap 108, the jaw portions 114 of the clip 102 close due to their natural bias to grip the tissue drawn into the cap 108. As will be described in more detail below, an actuation assembly 124 at the proximal end of the endoscope 104 is coupled to the control element 110 to control the application of tension to the control element 110 and the movement of the clip 102 relative to the endoscope 104 between the insertion configuration, inspection configuration, and deployment configuration.

[0027] The clip 102 of this embodiment can be attached to any standard endoscope 104 via a cap 108 sized, shaped, and configured to be mounted (e.g., slid over and held thereon via a friction fit) on the distal end 106 of the endoscope 104. As will be appreciated by those skilled in the art, the endoscope 104 is configured to be inserted through a body lumen into a target region within the lumen and thus must be flexible enough to travel through even the tortuous paths of the body lumen, although the devices described herein can be configured to operate with any other type of endoscope or insertion device.

[0028] According to an exemplary embodiment, the proximal end of the endoscope 104 includes a handle member that is located outside the body accessible to a physician or other user and enables the user to guide the endoscope 104 through a body lumen (e.g., the gastrointestinal tract) to a target site. In one embodiment, the actuation assembly 124 is coupled to the handle member of the endoscope 104. In another embodiment, the actuation assembly 124 can be used independently of the handle member of the endoscope 104. The exemplary embodiment describes the use of the clip 102 with the endoscope 104, but it will be understood by those skilled in the art that the cap 108 may be sized and shaped to be mounted on the distal end of any (flexible or rigid) insertion device suitable for accessing a target site within the body where the tissue to be clipped is located.

[0029] The cap 108 extends longitudinally from a proximal end 136 to a distal end 118 and includes a channel 116 that extends longitudinally therethrough. The cap 108 is configured to be mounted on the distal end 106 of the endoscope 104, and the channel 116 of the cap 108 is substantially aligned with the longitudinal axis of the endoscope 104 and in communication with the channel of the endoscope 104. The channel 116 extends away from the distal end 106 of the endoscope 104, thereby minimizing obstruction of the field of view of the endoscope 104. The cap 108 is sized and shaped to correspond to the cross-sectional shape of the endoscope 104, and thus the cap 108 fits thereon via a friction fit.

[0030] When the cap 108 is attached onto the distal end 106 of the endoscope, the proximal portion 138 of the cap 108 extends onto the endoscope shaft, and at the same time, the distal portion 140 of the cap 108 extends distally beyond the distal end 106 of the endoscope 104. The cap 108 is formed from a transparent material, and thus, a part of the clip 102 that extends on or beyond the distal portion 140 of the cap 108 will be within the field of view of the endoscope 104. According to one exemplary embodiment, the length of the distal portion 140 of the cap 108 is selected such that a part of the clip 102 remains visible even when tissue is aspirated into the cap 108. In one example, the distal portion 140 may have a length of about 10 mm.

[0031] The cap 108 includes one or more protrusions 120 extending from its outer surface 142. The protrusions 120 are configured to engage a part of the clip 102. In one embodiment, the cap 108 includes a pair of protrusions 120 that are diametrically opposite to each other and positioned along the cap 108. Thus, when the clip 102 engages the protrusions 120, the clip 102 extends beyond the cap 108 in the inspection configuration. The protrusions 120 are sized, shaped, and configured such that when a distal force exceeding a predetermined threshold is applied to the clip 102, the clip 102 moves distally beyond the protrusions towards the deployment configuration.

[0032] Clip 102 includes a pair of jaw-like portions 114 connected to each other via a hinge 126, which enables movement of the jaw-like portions 114 relative to each other between an open configuration in which the jaw-like portions 114 are spaced apart from each other and a closed configuration in which the jaw-like portions 114 are moved towards each other to grip tissue. Each of the jaw-like portions 114 of this embodiment extends along a curve from a first end 128 to a second end 130, with a first hinge of the hinge 126 connecting the first ends 128 of the jaw-like portions 114 to each other and a second hinge of the hinge 126 connecting the second ends 130 of the jaw-like portions 114 to each other. According to an exemplary embodiment, each of the hinges 126 is a living hinge including a groove 132 sized and shaped to engage a protrusion 120 of the cap 108. The hinge 126 in this embodiment is a biasing spring that biases the jaw-like portions 114 towards the closed configuration. In an exemplary embodiment, each of the jaw-like portions 114 includes a gripping formation, such as a toothed portion 122, such that when the jaw-like portions 114 are moved towards each other into the closed configuration, tissue is gripped between the jaw-like portions 114 via the toothed portion 122.

[0033] When clip 102 is attached onto cap 108, the jaw-like portions 114 are spread open in an open state over portions on both sides of the cap 108 so as to cover the outer surface 142 of the cap 108. The cap 108 holds the clip 102 in the open state with the jaw-like portions 114 spaced apart from each other in the open configuration such that tissue drawn into the channel 116 of the cap 108 passes between the jaw-like portions 114. As will be understood by those skilled in the art, tissue can be drawn into the channel 116 via, for example, a suction force applied through the endoscope 104 or a gripping device inserted through the working channel of the endoscope 104.

[0034] In the insertion configuration, clip 102 is positioned on proximal portion 138 of cap 108. However, in the inspection configuration, clip 102 is moved distally relative to cap 108 until groove 132 of clip 102 engages projection 120 and clip 102 extends beyond distal portion 140 of cap 108. In one embodiment, tooth portions 122 of clip 102 extend distally beyond distal end 118 of cap 108 in the inspection configuration. Accordingly, clip 102 and the position of tooth portions 122 relative to the target tissue are visible to the operator via the optical system of endoscope 104.

[0035] When clip 102 is moved distally away from cap 108, clip 102 returns to its biased closed configuration to grip any tissue drawn into channel 116 between jaws 114. Hinge 126 and / or jaws 114 of clip 102 can be formed from any of a variety of materials, as will be understood by those skilled in the art, so long as hinge 126 biases jaws 114 toward the closed configuration with sufficient force to apply a desired clipping force to the tissue, as described above. In one example, a portion of clip 102 (e.g., hinge 126) can be formed from a shape memory alloy such as nitinol.

[0036] As described above, clip 102 is moved relative to cap 108 from the insertion configuration toward the inspection configuration and from the inspection configuration toward the deployment configuration via control element 110. Control element 110 can be formed as a thread, wire, strand, filament, or other similar flexible longitudinal element that extends from a distal end 144 that is releasably coupled to clip 102 to a proximal end 145 that is connected to actuation assembly 124.

[0037] According to an exemplary embodiment, the distal end 144 includes an enlarged end configured as a knot or enlarged end in one example. The distal portion 148 of the control element 110 is wrapped around a part of the clip 102. Thus, a part of the control element 110 is crimped between the clip 102 and the outer surface 142 of the cap 108, and the knot engages a part of the clip 102. The remaining length portion of the control element 110 extends distally from the clip 102, proximally through the distal opening of the channel 116 of the cap 108, through the channel 116 and the working channel of the endoscope 104 to the actuating assembly 124.

[0038] In one embodiment, the distal portion 148 of the control element 110 is wrapped around the first jaw-like portion of the jaw-like portions 114, and the knot engages the clip 102 between two adjacent tooth portions 122. More specifically, the knot at the distal end 144 of the control element 110 is engaged between the adjacent tooth portions 122 and wrapped around the first jaw-like portion of the jaw-like portions 114. Thus, a part of the control element 110 immediately proximal to the knot is crimped between the clip 102 and the outer surface 142 of the cap 108. The distal portion 148 is wrapped around the first jaw-like portion of the jaw-like portions 114. Thus, the remaining length portion of the control element 110 extends distally from the clip 102, proximally through the distal opening of the channel 116 of the cap 108, through the channel 116 and the working channel of the endoscope 104. Therefore, when the control element 110 is retracted proximally relative to the endoscope 104 and tension is applied thereto, the clip 102 moves distally relative to the cap 108.

[0039] When the clip 102 is attached over the cap 108 in the insertion configuration, the control element 110 can be retracted proximally relative to the endoscope 104 over a first distance such that the groove 132 of the clip 102 abuts the protrusion 120, thereby pulling the clip 102 into the inspection configuration. From the inspection configuration, the control element 110 may be further retracted proximally relative to the endoscope 104 over a second distance, applying a force that exceeds a predetermined threshold, such that the clip 102 moves distally beyond the protrusion 120 toward the deployment configuration. As the clip 102 moves distally away from the cap 108 toward the deployment configuration, the distal portion 148 of the control element 110 disengages, releasing the engagement of the clip 102 and thereby freeing the clip 102 from the remainder of the device to remain on the target tissue as the endoscope and cap 108 are withdrawn from the body. Thus, one of ordinary skill in the art will understand that the control element 110 must be able to withstand a force that exceeds a predetermined threshold.

[0040] In the inspection configuration, the clip 102 maintains its attachment over the cap 108 with the jaws 114 of the clip 102 in the open configuration, such that if the clip 102 is determined to not be in the desired position relative to the target tissue, the operator can simply release the tissue from the channel 116 and reposition the distal end 106 of the endoscope 104 as desired. In particular, the distal end 106 can be repositioned until the operator visually confirms that the target tissue has been drawn into the channel 116 between the jaws 114 of the clip 102 as desired. As described above, in the inspection configuration, the clip 102 extends over the distal portion 148 of the cap 108, distal to the distal end 106 of the endoscope 104 such that the clip 102 is within the field of view of the endoscope 104.

[0041] As shown in FIGS. 4-6, the actuation assembly 124 can be used to actuate the control element 110 to move the clip 102 from the inserted configuration to the inspection configuration by applying tension along the control element 110, and then to move from the inspection configuration towards the deployed configuration when the desired positioning of the clip 102 relative to the target tissue is visually confirmed. In one embodiment, the actuation assembly 124 can be coupled to a handle member at the proximal end of the endoscope 104 and connected to the proximal end 145 of the control element 110 that extends through the channel of the endoscope 104. In another embodiment, the actuation assembly 124 can be utilized independently of the endoscope 104. In other words, the actuation assembly 124 can be utilized without being directly coupled to any portion of the handle member of the endoscope 104 or any portion of the shaft of the endoscope 104. In particular, the proximal end 145 of the control element 110 can extend from the proximal end of the endoscope 104 so as to be connected to the actuation assembly 124.

[0042] According to an exemplary embodiment, as shown in FIGS. 4-6, the actuation assembly 124 includes a first actuator 161 for actuating the movement of the clip 102 from the inserted configuration towards the inspection configuration, and a second actuator 185 for actuating the movement of the clip 102 from the inspection configuration towards the deployed configuration. In one embodiment, the first actuator 161 includes first and second elongate members 162, 164 that are pivotably coupled to each other and are movable relative to each other to move the clip 102 from the inserted configuration towards the inspection configuration. The first and second elongate members 162, 164 are pivotably coupled to each other in a substantially scissor-like manner, for example via a connection pin 165, such that when the proximal portions 166, 168 of the first and second elongate members 162, 164 are drawn towards each other, the distal portions 170, 172 are also drawn towards each other. The distal portions 170, 172 are received within the housing 125 and are movably coupled to a movement element 174, which is connected to the proximal end 145 of the control element 110.

[0043] In an exemplary embodiment, the distal portions 170, 172 are coupled to the housing 125 via connection pins 165 such that the housing 125 is longitudinally fixed relative to the elongate members 162, 164. The distal portions 170, 172 can be moved toward and away from each other within the housing 125 and are connected to a movement element 174 such that when the distal portions 170, 172 are drawn toward each other, the movement element 174 moves from a proximal position relative to the elongate members 162, 164 to a distal position relative to the elongate members 162, 164.

[0044] In one exemplary embodiment, the movement element 174 is coupled to the distal portions 170, 172 via a sliding pin 176 that extends from the movement element 174 and is received within a longitudinal slot 178 along the distal portion 170 of the first elongate member 162. The pin 176 of the movement element 174 is slidably received within the slot 178 such that when the proximal portions 166, 168 of the first and second elongate members 162, 164 are drawn toward each other and correspondingly move the distal portions 170, 172 toward each other, the pin 176 slides distally along the slot 178 to move the movement element 174 from a proximal position to a distal position. However, those skilled in the art will understand that the movement element 174 can be coupled to the first elongate member 162 and the second elongate member 164 in any of several ways, as long as the movement element 174 is coupled such that it can slide longitudinally relative to the first elongate member 162 and the second elongate member 164 between a proximal position and a distal position.

[0045] In one exemplary embodiment, the proximal portions 166, 168 are biased to be spaced apart from each other, for example, via a compression spring 182. The compression spring 182 prevents the proximal portions 166, 168 from being inadvertently drawn together and moving the clip 102 toward the inspection configuration. In this embodiment, the proximal portions 166, 168 include a ratchet mechanism 184 extending therebetween, so that when the proximal portions 166, 168 are drawn toward each other, the proximal portions 166, 168 are prevented from returning to their biased configuration. Thus, when the proximal portions 166, 168 are drawn toward each other, the movement element 174 is locked in the distal position, and thus the clip 102 is locked in the inspection configuration. When the proximal portions 166, 168 are locked in the inspection configuration, the clip 102 can be visualized and readjusted as needed without the need to continuously hold the proximal portions 166, 168 toward each other to keep the clip 102 in the inspection configuration.

[0046] As shown in FIGS. 5-6, the control element 110 is routed to be coupled to the movement element 174 through a pulley mechanism 180 within the housing 125. In particular, the control element 110 extends from the distal end 144 connected to the clip 102, through the endoscope 104, and through the housing 125 and through the pulley mechanism 180 such that the proximal end 145 is coupled to the movement element 174. The pulley mechanism 180 is configured such that when the movement element 174 is moved from the proximal position to the distal position, the proximal end 145 of the control element 110 is moved proximally, moving the control element 110 along the pulley mechanism 180 such that tension is applied to the control element 110. The first and second elongate members 162, 164 are configured such that when the proximal portions 166, 168 are drawn toward each other, the tension applied to the control element 110 is sufficient to move the clip 102 from the insertion configuration to the inspection configuration such that a portion of the clip 102 engages the protrusion 120.

[0047] In one embodiment, when the moving element 174 is in the proximal position (see FIG. 5), the pulley mechanism 180 is disposed within a portion of the housing 125 that is substantially longitudinally aligned with the proximal end 145 of the control element 110. As the proximal portions 166, 168 are drawn towards each other and the moving element 174 is moved towards the distal position, the proximal end 145 of the control element 110 is also moved distally such that a portion of the control element 110 extends from the pulley mechanism 180 along a portion of the housing 125 that communicates with a second actuator 185 (see FIG. 6).

[0048] The second actuator 185 for actuating the movement of the clip 102 from the inspection configuration to the deployment configuration includes a push button 186 in an exemplary embodiment. The push button 186 includes a push portion 188 accessible to the user along the exterior of the housing 125 and a tab 190 extending into the housing 125. As shown in FIG. 6, as the moving element 174 moves from the proximal position towards the distal position, a portion of the control element 110 moves to engage the tab 190 of the push button 186 while tension is being applied along the control element 110. Thus, if it is desired to move the clip 102 from the inspection configuration towards the deployment configuration, the operator of the system 100 presses the push portion 188 such that the tab 190 moves further into the housing 125 and presses a portion of the control element 110 that engages the tab 190. Thus, when the push portion 188 is pressed, the tab 190 further presses the control element 110, applying additional tension along the control element 110 such that the length portion of the control element 110 extending through the endoscope is moved proximally relative to the endoscope 104 with sufficient force to move the clip 102 distally over the protrusion 120 along the cap 108 from the inspection configuration towards the deployment configuration. When the clip 102 is pushed distally from the cap 108, the clip 102 returns to its biased configuration to be clipped onto the target tissue.

[0049] According to an exemplary method for tissue closure using system 100, as shown in FIGS. 1-6, endoscope 104 with cap 108 and clip 102 attached is inserted into a body orifice and passed through a body lumen, such as the gastrointestinal tract, to reach a target region within the lumen. As described above, in the insertion configuration, as shown in FIG. 1, clip 102 is attached to the proximal portion 138 of cap 108 attached to the distal end 106 of endoscope 104. For this reason, the jaw portions 114 are spaced apart from each other towards the open configuration. Clip 102 is guided to the target region via endoscope 104 and positioned over the target tissue. Then, the target tissue is drawn into cap 108, for example, by a suction force applied through the working channel of endoscope 104.

[0050] Clip 102 then moves towards the inspection configuration by using a first actuator 161 to move clip 102 distally relative to cap 108. In particular, the proximal portions 166, 168 of the first and second elongate members 162, 164 move towards each other so that the moving element 174 to which the proximal end 145 of the control element 110 is attached moves from the proximal position towards the distal position as described above. Then, the first and second elongate members 162, 164 can be locked relative to each other via a ratchet mechanism 184 so that clip 102 is locked in the inspection configuration. In the inspection configuration, clip 102 extends over the distal portion 140 of cap 108 so that the position of clip 102 relative to the target tissue is within the field of view of endoscope 104. Thus, in the inspection configuration, the user determines whether clip 102 is in the desired gripping position relative to the target tissue.

[0051] As described above, the actuating assembly 124 can be locked in the inspection configuration. Thus, during the inspection configuration, if it is determined that the clip 102 is not in the desired position relative to the target tissue, the tissue drawn into the cap 108 is released therefrom, and the distal end 106 of the endoscope 104, and thus the clip 102, is repositioned over the target tissue. The clip 102 can be repeatedly repositioned relative to the target tissue as needed during the inspection configuration until the user can visually confirm that the clip 102 is positioned over the target tissue as desired.

[0052] Once the user confirms that the target tissue has been drawn into the channel 116 between the jaws 114 as desired, the clip 102 can be moved from the inspection configuration to the deployment configuration via a second actuator 185 for moving the clip 102. Specifically, the operator presses the push button 186 such that the tab 190 extends further into and engages a portion of the control element 110. The force exerted on the control element 110 via the tab 190 exceeds a predetermined threshold level, which enables the clip 102 to move distally beyond the projection 120 of the cap 108 towards the deployment configuration. The clip 102 is moved distally relative to the cap 108 until the clip 102 is moved distally away from the cap 108 and returns to its biased closed configuration in which the clip 102 grips the target tissue. As described above, when the clip 102 is moved to the deployment configuration, the control element 110 disengages the clip 102, releasing the clip 102 within the body, and the clip 102 clips the target tissue when the endoscope 104 and the cap 108 are withdrawn from the body.

[0053] As shown in FIGS. 7-10, an exemplary actuation assembly 224 according to another exemplary embodiment is substantially similar to actuation assembly 124 and is utilized in a similar manner with clip 102 and endoscope 104 as described above with respect to system 100. Similar to actuation assembly 124, actuation assembly 224 includes a first actuator 261 for moving clip 102 from an insertion configuration to an inspection configuration, and a second actuator 285 for moving clip 102 from the inspection configuration to a deployment configuration. Similar to actuation assembly 124, actuation assembly 224 may be coupled to the handle of endoscope 104 in one embodiment. In another embodiment, actuation assembly 224 may be utilized independently (i.e., without being directly coupled to the handle of endoscope 104) to control the movement of control element 110 and clip 102.

[0054] However, rather than having pivotally engaged components, first actuator 261 may include a lever 264 movable relative to handle portion 262 for moving control element 110. The proximal end 145 of control element 110 is coupled to the end of lever 264, and when lever 264 is pushed, control element 110 is moved proximally relative to endoscope 104, thereby moving clip 102 distally along cap 108 from the insertion configuration to the inspection configuration. Lever 264 needs to be held in the pushed state to maintain tension along control element 110 toward the inspection configuration. In one embodiment, similar to first actuator 161, lever 264 may be biased to move away from handle portion 262, for example, via a compression spring 282 extending therebetween. Accordingly, actuation assembly 224 may further include a lock 284 for locking lever 264 relative to handle portion 262 in the inspection configuration.

[0055] Similar to the actuation assembly 124, the actuation assembly 224 includes a pulley mechanism 280 within a housing 225, and the proximal portion of the control element 110 is routed to be connected to a lever 264 through the pulley mechanism 280. The pulley mechanism 280 routes the control element 110 through the housing 225 such that the control element 110 interacts with a second actuator 285. Thus, if it is desired to move the clip 102 from the inspection configuration towards the deployment configuration, additional tension sufficient to distally move the clip 102 beyond the protrusion 120 of the cap 108 is applied to the clip 102 using the second actuator 285. Similar to the second actuator 185, the second actuator 285 includes a push button 286. The push button 286 includes a push portion 288 accessible to the user along the exterior of the housing 225 and a tab 290 extending into the housing 225.

[0056] As shown in FIGS. 9-10, if it is desired to move the clip 102 from the inspection configuration towards the deployment configuration, the push portion 288 is pushed to further move the tab 290 into the housing 225 and push against the control element 110. Thus, when the push portion 288 is pushed, the tab 290 further pushes the control element 210, and additional tension is applied along the movement of the control element 110, causing the length portion of the control element 110 extending through the endoscope to move proximally relative to the endoscope 104 with sufficient force to distally move the clip 102 past the protrusion 120 on the cap 108 from the inspection configuration towards the deployment configuration. When the clip 102 is pushed distally out of the cap 108, the clip 102 returns to the biased configuration for clipping the tissue drawn into the cap 108.

[0057] As shown in FIGS. 11-16, an exemplary actuation assembly 324 according to another exemplary embodiment is substantially similar to actuation assemblies 124, 224 and is utilized with clip 102 and endoscope 104 as described above with respect to system 100 for actuating movement of clip 102 between an insertion configuration, an inspection configuration, and a deployment configuration. Similar to actuation assemblies 124, 224, actuation assembly 334 includes a first actuator 361 configured to move clip 102 from the insertion configuration to the inspection configuration and a second actuator 385 configured to move clip 102 from the inspection configuration to the deployment configuration. Actuation assembly 324 may be coupled to endoscope 104 as shown in FIG. 11 or utilized independently of the endoscope as shown in FIG. 12.

[0058] The handle portion 362 in this embodiment is, for example, an ergonomic substantially T-shaped handle configured to be gripped by an operator of system 100. In particular, in one embodiment, the handle portion 362 extends substantially perpendicular to the housing portion 325 and the control element 110 extends from the endoscope 104 through the housing portion. Further, rather than a long lever or handle as described above with respect to actuation assemblies 124, 224, the first actuator 361 in this embodiment includes a lever 364 extending along the handle portion 362, and the lever 364 may be gripped via a power grip. The proximal end 145 of the control element 110 is connected to the lever 364, and when the lever 364 is pushed against the handle portion 362, a length portion of the control element 110 passing through the endoscope 104 moves proximally with respect to the endoscope 104 and the clip 102 moves distally along the cap 108 from the insertion configuration towards the inspection configuration.

[0059] Similar to the aforementioned actuation assembly, the lever 364 is biased to be spaced apart from the handle portion 362, for example, via a compression spring 382 extending between the handle portion 362 and the lever 364. To maintain the tension along the control element 110 and lock the clip 102 in the inspection configuration, the actuation assembly 324 further includes a lock 384. The lock 384 includes, in this embodiment, a button disposed on the handle portion 362. When the button is pushed into the handle portion 362, a part of the button engages with a part of the lever 364 received within the handle portion 362, engages with the lever 364, and holds the lever 364 in a position corresponding to the inspection configuration with respect to the handle portion 362 (see FIG. 14). In particular, as shown in FIG. 16, a part of the button of the lock 384 extends into and engages with a slot 392 within the lever 364 to lock the lever 364 with respect to the handle portion 362.

[0060] When the control element 110 is retracted proximally from the insertion configuration towards the inspection configuration with respect to the endoscope 104, the proximal portion of the control element is retracted proximally through a part of the housing 325 that interacts with the second actuator 385. Similar to the aforementioned actuation assembly, the second actuator 385 in this embodiment includes a push button 386 including a push portion 388 and a tab 390 extending within the housing 325. If it is desired to move the clip 102 from the inspection configuration towards the deployment configuration, the operator presses the push portion 388 to further move the tab 390 into the housing 325 such that the tab 390 presses against the control element 110 to apply additional tension to the control element 110. Due to this tension, the length portion of the control element 110 extending through the endoscope 104 is moved proximally with respect to the endoscope 104 with a force sufficient to move the clip 102 distally beyond the protrusion 120 from the inspection configuration towards the deployment configuration. When the clip 102 is pushed distally out of the cap 108, the clip 102 returns to its biased configuration to clip onto the target tissue.

[0061] The exemplary embodiments illustrate and describe a target tissue drawn into channel 116 of cap 108 via suction applied through the working channel of endoscope 104, for example, although one of ordinary skill in the art will understand that the tissue may also be drawn into channel 116 using other methods. For example, in other embodiments, by using a device such as a tissue grasper passed through endoscope 104 to its distal end 106, the tissue may be drawn between the jaws 114 of clip 102 and within the channel when clip 102 is in, for example, the inspection configuration. Actuation assembly 324 further includes a port 396 extending through proximal end 397 of housing 325, which port 396 is configured to receive a device such as a tissue grasper. As substantially described above with respect to system 100, by inserting a tissue grasper through port 396 and the working channel of endoscope 104, tissue adjacent to distal end 106 can be drawn into channel 116 of cap 108. In one embodiment, a tissue grasper (or other similar device) is inserted into port 396 and passes through a corresponding channel extending through housing 325 and lever 364.

[0062] As shown in FIGS. 17-20, actuation assembly 424 according to another exemplary embodiment is substantially similar to the actuation assembly described above. Actuation assembly 424 can be utilized to control the movement of clip 102 relative to endoscope 104 as described above with respect to system 100. Actuation assembly 424 includes a single actuator 461 capable of controlling both the movement of clip 102 from the insertion configuration to the inspection configuration and the movement of clip 102 from the inspection configuration toward the deployment configuration.

[0063] According to an exemplary embodiment, the actuation assembly 424 includes a rotary handle 464 that is rotatable about a housing 425 in which a control element 110 from the endoscope 104 is received. The rotary handle 464 extends from a first end 490 coupled to the housing 425 to a second end 492 that maintains accessibility to the operator of the system so that the rotary handle 464 can be rotated about the housing 425. In one embodiment, the first end 490 includes a coupling member 491 that is rotatably received within the housing 425 and configured to receive a movement element 474. The movement element 474 in this embodiment is threadedly received within the coupling member 491 of the rotary handle 464 such that when the rotary handle 464 rotates about the housing 425, the movement element 474 moves longitudinally relative to the housing 425 as the rotary handle 464 rotates.

[0064] In one embodiment, when the rotary handle 464 is rotated in a first direction relative to the housing 425, the movement element 474 moves proximally relative to the housing. The proximal end 145 of the control element 110 is connected to the movement element 474. Thus, when the rotary handle 464 is rotated in the first direction, the control element 110 moves proximally relative to the housing 425 and thus the endoscope 104 to move the clip 102 distally along the cap 108.

[0065] Similar to the operating assembly described above, the operating assembly 424 includes, for example, a compression spring or other biasing element that biases the rotary handle toward the insertion configuration. To move the clip 102 toward the inspection configuration, the operator actively rotates the rotary handle. In an exemplary embodiment, the housing 425 includes a pin 494 or other protrusion along a portion of the housing 425. The pin 494 interacts with the rotary handle 464 as the rotary handle 464 rotates about the housing 425. The pin 494 is disposed along the housing 425, and the rotary handle 464 engages the pin 494 when the control element 110 is moved a proximal distance sufficient to move the clip 102 from the insertion configuration toward the inspection configuration as the rotary handle 464 rotates about the housing 425.

[0066] The engagement between the pin 494 and the rotary handle 464 provides the operator with a tangible feedback indicating that the clip 102 is engaged with the protrusion 120 along the cap 108 and is in the inspection configuration. If it is desired to move the clip 102 from the inspection configuration toward the deployment configuration, the operator further rotates the rotary handle 464 in a first direction about the housing 425, pushing the rotary handle 464 beyond the pin 494. As the rotary handle 464 is rotated beyond the pin 494, the clip 102 is pushed distally from the cap 108 and is pushed distally beyond the protrusion 120 accordingly until the clip 102 can return to the biased closed configuration for gripping the target tissue.

[0067] Similar to the actuation assembly 324, the actuation assembly 424 further includes a port 496 that extends through the proximal end 497 of the housing 425, and the port 496 is configured to receive a device such as a tissue grasper. As substantially described above with respect to the system 100, by inserting a tissue grasper through the port 496 and the working channel of the endoscope 104, the tissue adjacent to the distal end 106 can be drawn into the channel 116 of the cap 108. In one embodiment, a tissue grasper (or other similar device) is inserted into the port 496 and passes through a corresponding channel that extends across the moving element 474 so as to be received within the endoscope 104.

[0068] As shown in FIGS. 21 - 25, a tissue clipping system 500 according to another exemplary embodiment is substantially similar to the system 100 and includes a clip 502 that is attachable onto the distal end 506 of an endoscope 504 via a cap 508 such that the clip 502 is movable between an insertion configuration, an inspection configuration, and a deployment configuration with respect to the endoscope 504. Similar to the system 100, the clip 502 can be moved from the insertion configuration as shown in FIG. 21 to the inspection configuration as shown in FIG. 22, and then, upon confirmation that the target tissue has been received between the jaws 514 of the clip 502 as desired, the clip 502 is moved from the inspection configuration towards the deployment configuration as shown in FIG. 23. The system 500 is configured such that, during the inspection configuration, if the operator of the system 500 determines that the clip 502 is not in the desired position with respect to the target tissue, the clip 502 is moved back from the inspection configuration to the insertion configuration so that the distal end 506 and the clip 502 can be repositioned with respect to the target tissue when the clip 502 is in the insertion configuration.

[0069] Accordingly, system 500 further includes a repositioning element 512 configured to enable movement of clip 502 between the insertion configuration and the inspection configuration, and a deployment element 510 configured to enable movement from the inspection configuration to the deployment configuration when clip 502 is determined to be in a desired position relative to the target tissue. As described above, deployment element 510 and repositioning element 512 are connected to an actuation assembly 524 that is substantially similar to actuation assemblies 124-324 described above with respect to system 100. The actuation assembly includes a first actuator 561 for moving clip 502 between the insertion configuration and the inspection configuration, and a second actuator 585 for moving clip 502 from the inspection configuration towards the deployment configuration.

[0070] Similar to system 100, in the insertion configuration, clip 502 is mounted on cap 508 in the open configuration, and its jaw-like portions 514 are spaced apart from each other to receive tissue therebetween. Clip 502 is preferably inserted into the target site within the body in this insertion configuration. To improve the field of view of endoscope 504, clip 502 is moved distally relative to endoscope 504, causing clip 502 to move from the insertion configuration to the inspection configuration, so that the position of clip 502 relative to the target tissue becomes visible to the operator of system 500 (e.g., a surgeon or other user).

[0071] However, instead of moving clip 502 relative to cap 508, cap 508 to which clip 502 is attached is moved distally relative to endoscope 504 to move clip 502 from the insertion configuration towards the inspection configuration. Clip 502 is attached to cap 508 such that while clip 502 is maintained in the open position, a portion of clip 502 extends distally beyond distal end 518 of cap 508. Thus, when cap 508 is moved distally towards the inspection configuration relative to endoscope 504, a portion of clip 502 extends distally beyond distal end 506 of endoscope 504, and thus, a portion of clip 502 that extends distally beyond distal end 506 is within the field of view of endoscope 504.

[0072] If the operator determines that the clip 502 is in the desired position relative to the target tissue, the clip 502 can be moved from the inspection configuration towards the deployment configuration. However, if the operator determines that the clip 502 is not in the desired position relative to the target tissue, the clip 502 is moved back from the inspection configuration to the insertion configuration, thereby releasing any tissue drawn into the cap 508 and allowing the clip 502 to be repositioned as desired relative to the target tissue.

[0073] To enable movement between the insertion configuration and the inspection configuration of the cap 508 and the clip 502 relative to the endoscope 504, the system 500 further includes a biasing element 520 that extends between the cap 508 and the distal most end 507 of the endoscope 504 and biases the cap 508 and the clip 502 mounted thereon towards the insertion configuration. The repositioning element 512, whose distal end 550 is connected to the cap 508, can be used to move the cap 508 and the clip 502 between the insertion configuration and the inspection configuration as needed until the operator determines that the clip 502 is in the desired configuration relative to the target tissue.

[0074] When the operator determines that the clip 502 is in the desired position relative to the target tissue, the deployment element 510, whose distal end 544 is releasably coupled to the clip 502, can be used to move the clip 502 distally away from the cap 508 towards the deployment configuration. In the deployment configuration, the clip 502 returns towards the closed configuration under its own bias and grips the target tissue received between the jaws 514. The operation of the deployment element 510 and / or the repositioning element 512 to move the clip 502 between the insertion configuration, the inspection configuration, and the deployment configuration can be controlled via an actuation assembly 524 at the proximal end of the endoscope 504.

[0075] One of ordinary skill in the art will understand that the endoscope 504 can be substantially similar to the endoscope 104 and extends longitudinally from a proximal end including the handle member 534 to a distal end 506 to which the cap 508 is attached. The endoscope 504 includes a channel 505 that extends therethrough. In this embodiment, the endoscope 504 further includes a stopper 570, shoulder, or other protrusion that extends from the outer surface 542 of the cap 508 at the most distal end 507, engages with the distal end 572 of the biasing element 520, and stops the distal end 572 of the biasing element 520 from extending distally beyond the stopper 570.

[0076] The cap 508 can also be substantially similar to the cap 108, extends longitudinally from a proximal end 536 to a distal end 518, and forms a channel 516 therein. The channel 516 corresponds to the size of the endoscope 504 such that the cap 508 can be movably attached thereon. In one embodiment, as will be described in more detail below, the cap 508 also includes an opening that extends through its wall, and the opening is configured to receive a repositioning element 512 therein.

[0077] The biasing element 520 of this embodiment extends between the distal end 518 of the cap 508 and the stopper 570 of the endoscope 504 and biases the cap 508 toward the insertion configuration. According to one exemplary embodiment, the biasing element 520 can be configured as a spring that extends around the distal end 518 of the endoscope 504 between the distal end 506 of the cap 508 and the stopper 570 at the most distal end 507 of the endoscope 504. In the insertion configuration, a clip 502 that is substantially similar to the clip 102 is attached to the cap 508, and for this reason, the jaw-like portions 514 of the clip 502 are spread open on the cap 508.

[0078] The outer surface 542 of the cap 508 holds the jaw-like portions 514 in an open state, such that the jaw-like portions 514 are spaced apart from each other and can receive tissue therebetween. The clip 502 is attached onto the cap 508, and for example, the tooth portion 522 may extend distally beyond the distal end 518 of the cap 508. However, in the insertion configuration, the distal end 518 of the cap 508 is spaced from the most distal end 507 of the endoscope 504 by a selected distance, such that the tooth portion 522 does not extend distally beyond the most distal end 507 of the endoscope 504.

[0079] To move the clip 502 towards the inspection configuration, the cap 508 is moved distally relative to the endoscope 504, compressing the biasing element 520 until the tooth portion 522 extends distally beyond the most distal end 507 of the endoscope 504 and the tooth portion 522 is within the field of view of the endoscope 504. Accordingly, in the inspection configuration, the operator or user can determine whether the clip 502 is in the desired position relative to the target tissue. If the clip 502 is in the desired position, the clip 502 may be moved towards the deployment configuration by pushing it distally away from the cap 508.

[0080] However, if it is determined that the clip 502 is not in the desired position relative to the target tissue, the compressive force on the biasing element 520 is released, such that the biasing element 520 returns to its biased configuration and the cap 508 is pushed proximally along the endoscope 504 towards the insertion configuration, releasing any tissue previously drawn into the cap 508 and allowing the clip 502 to be repositioned. As will be described in more detail below, the movement of the clip 502 between the insertion and inspection configurations is controlled via the repositioning element 512, and the movement of the clip 502 from the inspection configuration towards the deployment configuration is controlled via the deployment element 510.

[0081] The deployment element 510 of this embodiment is substantially similar to the control element 110 and includes, for example, a thread, wire, strand, filament, or other similar flexible longitudinal element extending from a distal end 544 releasably coupled to a clip 502 to a proximal end connected to an actuation assembly 524. The deployment element 510 of this embodiment is releasably coupled to the clip 502 in substantially the same manner as the connection between the clip 102 and the control element 110. In an exemplary embodiment, a distal portion 548 of the deployment element 510 is wrapped around a portion of a first one of the jaws 514 such that a portion of the deployment element 510 is crimped between the clip 502 and an outer surface 542 of the cap 508, while a knot or other enlargement, for example at the distal end 544, is engaged between adjacent teeth 522 of the first one of the jaws 514.

[0082] The remaining length portion of the deployment element 510 extends distally from the clip 502, passes through the distal opening of the channel of the endoscope 504, and extends proximally through the endoscope 504. Thus, by pulling the deployment element 510 proximally relative to the endoscope 504, the clip 502 moves distally relative to the cap 508 and the clip 502 moves towards the deployed configuration. As described above, when the clip 502 is pushed distally towards the deployed configuration so as to move away from the cap 508, the distal portion 548 of the deployment element 510 is wound back from the clip 502, the knot is disengaged from the clip 502, and the clip 502 is released to clip the target tissue.

[0083] The repositioning element 512 can include, for example, a thread, a strand, a wire filament, or other similar flexible longitudinal element. However, the distal end 550 of the repositioning element 512 can be non - releasably secured to a part of the cap 508 rather than being releasably connected to the clip 502. According to one exemplary embodiment, the distal end 550 includes an enlarged end such as a knot, for example, so that when the repositioning element 512 passes through an opening extending through the wall of the cap 508, the knot 552 prevents the distal end 550 from passing therethrough. Thus, the knot of the repositioning element 512 engages the cap 508 along the outer surface 542 of the cap 508, whereby the remaining length portion of the repositioning element 512 extends distally between the inner surface of the cap 508 and the outer surface of the endoscope 504 through the opening, and distally between the biasing element 520 and the outer surface of the endoscope 504. As a result, the repositioning element 512 is received within the distal opening of the channel of the endoscope 504 and extends proximally through the endoscope 504.

[0084] Accordingly, when the repositioning element 512 moves proximally relative to the endoscope 504, the cap 508 moves distally relative to the endoscope 504 from the insertion configuration towards the inspection configuration. In this inspection configuration, the biasing element 520 is maintained in the compressed configuration via the tension along the repositioning element 512. However, during the inspection configuration, if it is determined that the clip 502 is not in the desired position relative to the target tissue, the tension along the repositioning element 512 can be released to allow the biasing element 520 to return to its biased configuration, whereby the cap 508 moves proximally relative to the endoscope 504 from the inspection configuration towards the insertion configuration.

[0085] In this embodiment, the proximal end of each of the deployment element 510 and the repositioning element 512 is connected to the actuation assembly 524 and is also connected to the handle member of the endoscope 504. The actuation assembly 524 is substantially similar to the actuation assembly described above, and includes a first actuator 561 for moving the clip 502 from the insertion configuration towards the inspection configuration, and a second actuator 585 for moving the clip 502 from the inspection configuration towards the deployment configuration. The actuation assembly 524 may also include a housing 525, and the proximal ends of the repositioning element 512 and the deployment element 510 extend through the housing 525 and are connected to the first and second actuators 561, 585.

[0086] According to an exemplary embodiment, as shown in FIGS. 24-25, the actuation assembly 524, the first actuator 561 may include a lever 564 configured to control the movement of the repositioning element 512 relative to the endoscope 504, and the second actuator 585 may include a push button 586 for controlling the movement of the deployment element 510 relative to the endoscope 504. The lever 564 is pivotally connected to the housing 525, and when the lever 564 is pushed towards the housing 525, the repositioning element 512 is retracted proximally through the endoscope 504. In particular, the proximal end of the repositioning element 512 is connected to the lever 564, and when the lever 564 is pushed, the repositioning element 512 is moved proximally relative to the endoscope 504, thereby moving the cap 508 distally relative to the endoscope from the insertion configuration towards the inspection configuration. The lever 564 needs to be maintained in the pushed state in order to maintain tension along the repositioning element 512 towards the inspection configuration and to maintain the biasing element 520 in a compressed state.

[0087] During this inspection mode, if the operator determines that the clip 502 is in the desired position relative to the target tissue, the operator presses the push button 586, for example, using the thumb. The push button 586 extends into the housing 525 and is connected to the proximal end of the deployment element 510. Thus, when pressed, the deployment element 510 is retracted proximally relative to the endoscope 504, moving the clip 502 distally relative to the cap 508 until the clip 502 moves away from the cap 508 and distally. However, if during the inspection mode the operator determines that the clip 502 is not in the desired position relative to the target tissue, the operator releases the lever 564, thereby releasing the tension along it and allowing the biasing element 520 to return to its biased configuration. When the biasing element 520 returns towards its biased configuration, the biasing element 520 presses the cap 508 proximally along the endoscope 504 towards the insertion configuration after releasing any tissue drawn into the cap 508, so that the clip 502 can be repositioned as needed.

[0088] An exemplary method of using the clipping system 500 to clip tissue can be substantially similar to the method of using the system 100 to clip tissue. Similar to the system 100, as shown in FIG. 21, the clip 502 attached on the distal end 506 of the endoscope 504 via the cap 508 in the insertion configuration is inserted through a body lumen (e.g., the gastrointestinal tract) into a target site within the body. As described above, the cap 508 is biased towards the insertion configuration via the biasing element 520.

[0089] Once the clip 502 is positioned on the target tissue, the tissue is drawn into the cap 508 (e.g., via a suction force that can be applied through the working channel of the endoscope 504) so as to extend between the jaws 514 of the clip 502. Then, as shown in FIG. 22, by moving the repositioning element 512 proximally relative to the endoscope 504, the clip 502 is moved from the insertion configuration towards the inspection configuration, whereby the cap 508 moves distally and the biasing element 520 is compressed. In the inspection configuration, the tooth portion 522 of the present embodiment extends distally beyond the most distal end 507 of the endoscope 504, so that the position of the tooth portion 522 relative to the target tissue is visible through the endoscope 504.

[0090] When the clip 502 is in the inspection configuration, the operator can determine whether the clip 502 is in the desired position relative to the target tissue. If the clip 502 is not in the desired position, the tension along the repositioning element 512 can be released, whereby the biasing element 520 returns to its biased configuration, moving the cap 508 back from the inspection configuration to the insertion configuration. Any tissue drawn into the cap 508 can then be released, and since the clip 502 is currently in the insertion configuration, the endoscope 504 and the cap 508 can be repositioned relative to the target tissue until the cap 508 and the clip 502 are in the desired position relative to the target tissue. The clip 502 can then be moved again towards the inspection configuration, and this procedure can be repeated as necessary until it is determined that the clip 502 is in the desired position relative to the target tissue.

[0091] Once it is determined that the clip 502 is in the desired position, as shown in FIG. 23, the clip 502 can be moved towards the deployed configuration by moving the deployment element 510 proximally relative to the endoscope 504 until the clip 502 is pushed distally away from the cap 508. As described above, when the clip 502 is pushed distally away from the cap 508, the clip 502 becomes free and returns to its biased closed configuration, whereby the target tissue is gripped between the jaws 514.

[0092] In addition, since the deployment element 510 is no longer crimped between the clip 502 and the cap 508, the distal portion 548 of the deployment element 510 becomes disengaged from the clip 502. As a result, the knot 546 is disengaged from the clip 502, releasing the clip, and the clip maintains its clipped state on the target tissue when the endoscope 504 is withdrawn from the body together with the cap 508. Since the repositioning element 512 is connected to the cap 508 and is never connected to the clip 502, those skilled in the art will understand that the repositioning element 512 need not be released or disengaged from the cap 508.

[0093] It will be apparent to those skilled in the art that various modifications can be made to the present disclosure without departing from the scope of the present disclosure. Further, those skilled in the art will understand that the features of any of the various embodiments can be combined in any manner that is not inconsistent with the description and / or function of the embodiments. The technical idea that can be grasped from the above embodiments is described below as an appended note. [Appended Note 1] A clipping system for treating tissue, A cap configured to be attached to the distal end of an endoscope, the cap including a channel that extends longitudinally from a proximal end to a distal end and that extends through the interior thereof so as to be disposed adjacent to a target tissue in a living body, the cap and A clip configured to be attached onto the cap, the clip including a first jaw portion and a second jaw portion movably connected to each other via a hinge, the hinge being biased to draw the first jaw portion and the second jaw portion towards each other, the clip being in: (a) an insertion configuration in which the first jaw portion and the second jaw portion extend onto the cap, the first jaw portion and the second jaw portion are spaced apart from each other to receive the target tissue therebetween, and obstacles to the optical system of the endoscope to which the cap is attached are minimized; (b) an inspection configuration in which a part of the clip extends distally until the clip is moved distally relative to the cap and at least a part of the clip extends into the field of view of the optical system to which the cap is attached; and (c) a deployment configuration in which the clip is moved distally away from the cap and the first jaw portion and the second jaw portion are drawn towards each other under the bias of the hinge to close and clip the tissue received between the first jaw portion and the second jaw portion, the clip being movable relative to the cap among the above configurations, A control element extending from a distal end releasably coupled to the clip to a proximal end through the channel of the cap and the endoscope to which the cap is coupled, remaining outside the body during use while the cap is adjacent to the target tissue, the control element being configured to move the clip distally relative to the cap by proximal movement of the control element through the cap, the control element being configured to move the clip from the insertion configuration to the inspection configuration by proximal movement of the control element through the cap by a first distance, and to move the clip from the inspection configuration to the deployment configuration by proximal movement of the control element through the cap by a second distance, the system comprising the control element. [Appendix 2] The system according to appended claim 1, further comprising an actuating assembly connected to the proximal end of the control element, wherein the actuating assembly includes a first actuator configured such that, upon actuation, the control element is moved proximally by the first distance through the endoscope to move the clip from the insertion configuration to the inspection configuration. [Appended claim 3] The system according to appended claim 2, wherein the first actuator includes a first elongate member and a second elongate member pivotally connected to each other, and when proximal portions of the first elongate member and the second elongate member are drawn towards each other, distal portions of the first elongate member and the second elongate member are correspondingly drawn towards each other. [Appended claim 4] The system according to appended claim 3, wherein the actuating assembly further includes a second actuator configured such that, upon actuation, the control element is moved proximally by the second distance through the endoscope to move the clip from the inspection configuration to the deployment configuration. [Appended claim 5] The system according to appended claim 4, wherein the actuating assembly further includes a moving element and a pulley mechanism, the control element is routed through the pulley mechanism to be connected to the moving element, and when the first elongate member and the second elongate member are drawn towards each other, the moving element moves from a proximal position to a distal position relative to the housing of the actuating assembly, pulling the control element proximally through the endoscope, whereby the clip moves from the insertion configuration towards the inspection configuration. [Appended claim 6] The system according to appended claim 4, wherein the second actuator includes a push button including a tab extending into the housing of the actuating assembly, and when the clip is in the inspection configuration, pressing the push button applies additional tension along the control element, and the tab engages a portion of the control element such that the clip moves from the inspection configuration towards the deployment configuration. [Appended claim 7] The system according to any one of appendices 2 to 6, wherein the actuating assembly further comprises a biasing element that biases the first actuator toward the inserted configuration. [Appendix 8] The system according to any one of appendices 2 to 6, wherein the actuating assembly includes a locking mechanism for locking the clip toward the inspection configuration. [Appendix 9] The first actuator includes a handle portion configured to be gripped by an operator of the system and a lever movably coupled to the handle portion, the proximal end of the control element being coupled to the lever, and when the lever is pushed against the handle portion, the control element moves proximally by the first distance through the endoscope to move the clip from the inserted configuration toward the inspection configuration. The system according to any one of appendices 2 to 6. [Appendix 10] The first actuator includes a housing and a rotary handle rotatably coupled to the housing, the proximal end of the control element being connected to a moving element screw-coupled to a part of the rotary handle, and the control element moves proximally through the endoscope by rotation of the rotary handle relative to the housing. The system according to any one of appendices 2 to 6. [Appendix 11] A clipping system for treating tissue, An endoscope including a shaft extending longitudinally from a proximal end to a distal end, A cap extending longitudinally from a proximal end to a distal end, the cap including a channel extending therethrough such that the cap is slidably mounted on a distal portion of the shaft of the endoscope, the cap and A clip including a first jaw portion and a second jaw portion movably connected to each other via a plurality of hinges, at least one of the plurality of hinges being biased to draw the first jaw portion and the second jaw portion towards each other, the clip being attachable to a cap such that the first jaw portion and the second jaw portion extend over opposite sides of the cap so that the first jaw portion and the second jaw portion are spaced apart from each other to receive a target tissue therebetween, distal movement of the cap relative to the endoscope from a proximal position along the endoscope to a distal position along the endoscope causes the clip to move from an insertion configuration towards an inspection configuration, in which the clip extends distally until at least a portion of the clip extends within the field of view of the optical system of the endoscope, and distal movement of the clip relative to the cap causes the clip to move from the inspection configuration towards a deployment configuration, in which the clip moves distally away from the clip and the first jaw portion and the second jaw portion are drawn towards each other under the bias of the at least one hinge and close on tissue received therebetween, the clip and, A repositioning element extending from a distal end connected to the cap to a proximal end through the channel of the cap and the endoscope, during use, the repositioning element remains outside the body, and by moving the repositioning element proximally through the endoscope, the cap is configured to move distally along the endoscope from the insertion configuration towards the inspection configuration, the repositioning element and, A deployment element extending from a distal end releasably connected to the clip to a proximal end through the channel of the cap and the endoscope, during use, the deployment element remains outside the body, and the deployment element is configured such that proximal movement of the deployment element through the endoscope causes the clip to move distally relative to the cap towards the deployment configuration, the deployment element and, An operating assembly including a first actuator configured to control movement of the repositioning element and a second actuator configured to control movement of the deployment element, and a system comprising the same. [Appendix 12] The system according to Appendix 11, wherein the operating assembly further comprises a housing extending such that proximal ends of the repositioning element and the deployment element are connected to the first actuator and the second actuator. [Appendix 13] The system according to Appendix 12, wherein the first actuator includes a lever pivotally connected to a handle, and the proximal end of the repositioning element is connected to a part of the handle, such that when the lever moves towards the housing, the repositioning element moves proximally through the endoscope, and the cap and the clip move from the insertion form towards the inspection form. [Appendix 14] The system according to Appendix 12, wherein the second actuator includes a push button extending into the housing and connected to the proximal end of the deployment element, and when the push button is further pushed into the housing, the deployment element moves proximally through the endoscope, and the clip moves distally relative to the cap from the inspection form towards the deployment form. [Appendix 15] The system according to Appendix 13, further comprising a biasing element extending between a distal end of the cap and a stopper at a most distal end of the endoscope to which the cap is attached, the biasing element biasing the cap towards the insertion form, and the entire clip attached to the cap is proximal to the most distal end of the endoscope, such that when the lever is released, the cap and the clip return towards the insertion form.

Claims

Claim 1 A device for clipping tissue, comprising a cap extending longitudinally from a proximal end to a distal end, the cap including a channel extending therethrough and configured to be attached onto a distal portion of an endoscope; a clip including a first jaw portion and a second jaw portion movably connected to each other via a plurality of hinges, at least one of the plurality of hinges being biased to draw the first jaw portion and the second jaw portion towards each other, the clip being attachable onto the cap such that the first jaw portion and the second jaw portion extend over opposite sides of the cap so as to be spaced apart from each other to receive a target tissue therebetween, the cap being configured to move the clip from an insertion configuration to an inspection configuration in which at least a part of the clip extends within a field of view of an optical system of the endoscope by distal movement of the cap relative to the endoscope, and the clip being configured to move from the inspection configuration to a deployment configuration in which the clip moves distally away from the cap and the first jaw portion and the second jaw portion are drawn towards each other under the bias of the at least one hinge and close on the tissue received therebetween by distal movement of the clip relative to the cap; a repositioning element extending from a distal end connected to the cap through the channel of the cap to a proximal end and remaining outside the body during use, the repositioning element being configured to move the cap distally from the insertion configuration to the inspection configuration along the endoscope by moving the repositioning element proximally; a deployment element extending from a distal end releasably connected to the clip through the channel of the cap to a proximal end and remaining outside the body during use, the deployment element being configured to move the clip distally relative to the cap towards the deployment configuration by moving the deployment element proximally; An operating assembly including a first actuator configured to control movement of the repositioning element and a second actuator configured to control movement of the deployment element; and a device comprising the same. **Claim 2** The operating assembly further includes a housing, and proximal ends of the repositioning element and the deployment element extend through the housing to be connected to the first actuator and the second actuator. The device according to claim 1. **Claim 3** The first actuator includes a lever pivotally connected to a handle, and a proximal end of the repositioning element is connected to a part of the handle. When the lever moves relative to the housing, the repositioning element is pulled proximally, and the cap and the clip move distally from the insertion form towards the inspection form. The device according to claim 2. **Claim 4** The second actuator includes a push button extending into the housing and connected to a proximal end of the deployment element. When the push button is further pushed into the housing, the deployment element moves proximally, and the clip moves distally from the inspection form towards the deployment form relative to the cap. The device according to claim 2. **Claim 5** The device further includes a biasing element extending between a distal end of the cap and a stopper configured to be disposed at a most distal end of the endoscope to which the cap is attached. When no distal force is applied through the repositioning element, the biasing element biases the cap towards the insertion form so that the cap and the clip return to the insertion form. The device according to claim 1. **Claim 6** The device further includes a biasing element extending between a distal end of the cap and a stopper configured to be disposed at a most distal end of the endoscope to which the cap is attached. When the lever is released, the biasing element biases the cap towards the insertion form so that the cap and the clip return to the insertion form. The device according to claim 3. **Claim 7** In the insertion form, the entire clip is proximal to the stopper. The device according to claim 5. **Claim 8** The device according to claim 1, wherein in the insertion configuration and the inspection configuration, the distal portion of the clip extends distally beyond the distal end of the cap.

9. The device according to claim 6, wherein the repositioning element is configured to move the cap distally relative to the endoscope against the biasing force of the biasing element by applying a distally directed force to the cap.

10. The device according to claim 1, wherein the repositioning element and the deployment element are configured to be fed through the working channel of the endoscope.

11. A device for clipping tissue, a cap extending longitudinally from a proximal end to a distal end, the cap including a channel extending therethrough and configured to be attached onto a distal portion of an endoscope, a clip including a first jaw and a second jaw biased towards adjacent tissue clipping positions, the clip being attachable onto the cap in an insertion configuration with the first jaw and the second jaw spaced apart from each other on an outer surface of the cap and tissue drawn into the distal end of the cap disposed between the first jaw and the second jaw, and the cap being movable relative to the endoscope to which the cap is attached to move the clip from the insertion configuration to an inspection configuration in which at least a portion of the clip extends distally into the field of view of the optical system of the endoscope beyond the distal end of the endoscope. a repositioning element extending from a distal end connected to the cap through the channel of the cap to a proximal end and remaining outside the body during use, the repositioning element being configured to move the cap distally along the endoscope from the insertion configuration to the inspection configuration. A deployment element that extends from a distal end releasably coupled to the clip, through the channel of the cap to a proximal end, and remains outside the body during use. Movement of the deployment element causes the clip to move distally away from the cap, and under the biasing of the first jaw-like portion and the second jaw-like portion, the first jaw-like portion and the second jaw-like portion are drawn towards each other and close in a deployed configuration on the tissue received therebetween. The device comprises the deployment element.

12. The device according to claim 11, further comprising an actuating assembly including a first actuator configured to control movement of the repositioning element and a second actuator configured to control movement of the deployment element.

13. The device according to claim 11, further comprising an actuating assembly including a first actuator configured to control movement of the repositioning element and a second actuator configured to control movement of the deployment element.

14. The actuating assembly further includes a housing. The first actuator includes a lever pivotally coupled to a handle. The proximal end of the repositioning element is coupled to a part of the handle. Movement of the lever relative to the housing draws the repositioning element proximally, causing the cap to move distally from the insertion configuration to the inspection configuration along the endoscope. The device according to claim 13.

15. The second actuator includes a push button that extends into the housing and is coupled to the proximal end of the deployment element. When the push button is further pushed into the housing, the deployment element moves proximally, causing the clip to move distally from the inspection configuration to the deployment configuration relative to the cap. The device according to claim 14.

16. The device according to claim 11, further comprising a biasing element extending between a distal end of the cap and a stopper configured to be disposed at a most distal end of the endoscope to which the cap is attached, the biasing element biasing the cap toward the insertion configuration such that the cap returns to the insertion configuration when no distal force is applied through the repositioning element.

17. The device according to claim 14, further comprising a biasing element extending between a distal end of the cap and a stopper configured to be disposed at a most distal end of the endoscope to which the cap is attached, the biasing element biasing the cap toward the insertion configuration such that the cap and the clip return to the insertion configuration when the lever is released.

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