Steerable Rotating Hemostatic Clip

Abstract

To provide a hemostasis clip device which has a rotatable and steerable distal end.SOLUTION: A device includes: a handle which includes a first actuator for an end effector; a shaft which extends from the handle and is sized and shaped to pass through a working channel of an endoscope; and a steering mechanism. A distal end of the shaft includes the end effector. A pull wire extends from the handle to the end effector for actuating the end effector. The mechanism includes a second actuator for bending the distal end relative to a longitudinal axis of the shaft. The mechanism includes a first steering wheel having a first steering wire extending therefrom to the distal end of the shaft. Rotating the second actuator rotates the first steering wheel and applies tension to the first steering wire to bend the shaft, and the pull wire for the end effector remains actuatable when the distal end is bent.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to hemostatic clips, and more particularly to hemostatic clip devices having rotatable and steerable distal ends. [Background technology]

[0002] During endoscopic gastrointestinal (GI) procedures, patients may risk perforation of the GI tract wall or may need to seal the GI tract wall as part of the procedure. Hemostatic clips may be used, for example, to seal luminal perforations as well as to provide hemostasis for mucosal / submucosal defects, bleeding ulcers, arteries, polyps, or diverticula. Some patient anatomical structures, such as the duodenum, are difficult to treat using a front-viewing scope due to their narrowness, and some hemostatic clip systems are not compatible with side-viewing scopes, such as duodenoscopes. Summary of the Invention

[0003] The present disclosure relates to a device including a handle, a shaft, and a steering mechanism. The handle includes a first actuator for an end effector. The shaft extends from the handle and is sized and shaped to pass through a working channel of an endoscope. The distal end of the shaft includes the end effector. A pull wire extends from the handle to the end effector to actuate the end effector. The mechanism includes a second actuator for bending the distal end relative to a longitudinal axis of the shaft. The mechanism includes a first steering wheel having a first steering wire extending to the distal end of the shaft. Rotating the second actuator applies tension to the first steering wire to rotate the first steering wheel and bend the shaft, and the pull wire for the end effector is in an actuable state when the distal end is bent.

[0004] In one embodiment, the first actuator is coupled to a pull wire to move the pull wire proximally and distally relative to the longitudinal axis of the shaft, and moving the pull wire actuates the end effector to move between the first and second configurations.

[0005] In one embodiment, the first actuator is a slidable spool. In some embodiments, the end effector is a clip. In one embodiment, the steering mechanism further includes a steering stopper secured to a bottom surface of the first steering wheel to limit tension on the first steering wire.

[0006] In some embodiments, the steering mechanism further includes a locking mechanism for holding the end effector in a desired position. In one embodiment, the locking mechanism further includes a locking knob, a threaded shaft extending from the locking knob toward the first steering wheel, and an annular brake plate at the end of the threaded shaft and connected to the first steering wheel.

[0007] In some embodiments, the device further includes a rotation knob rigidly secured to the shaft, the rotation knob and the shaft rotating together about the longitudinal axis of the shaft. In some embodiments, the rotatable knob further includes a first rotatable knob half and a second rotatable knob half, each having a first recess at a proximal end and a second recess at a distal end, the first recess sized and shaped to receive the distal end of the handle and the second recess sized and shaped to receive the proximal end of the shaft.

[0008] In some embodiments, the steering mechanism further includes a second steering wheel having a second steering wire extending to the distal end of the shaft, and rotating the second actuator applies tension to the second steering wire to rotate the second steering wheel and bend the shaft, with the pull wire for the end effector being actuated when the distal end is bent.

[0009] In one embodiment, actuation of a first steering wheel bends the shaft in a first direction and actuation of a second steering wheel bends the shaft in a second direction, the second direction being opposite to the first direction.

[0010] In one embodiment, the device further includes a lock knob, a threaded shaft extending from the lock knob toward the second steering wheel, and an annular brake plate at the end of the threaded shaft and connected to the second steering wheel.

[0011] In one embodiment, the annular brake plate fits closely onto a wheel ring that protrudes from the first face of the second steering wheel. In some embodiments, the device further includes a steering stop secured to the first surface of the second steering wheel to limit tension on the second steering wire. The present disclosure also relates to a device including a handle including a first actuator for a clip, a shaft extending from the handle, the distal end of the shaft including a clip, and a pull wire extending from the handle to the clip for actuating the clip, and a steering mechanism including a second actuator for bending the distal end relative to a longitudinal axis of the shaft, the steering mechanism including a steering wheel having a steering wire extending to the distal end of the shaft. Rotating the second actuator applies tension to the steering wire to rotate the steering wheel and bend the shaft, the pull wire for the clip being in an actuable state when the distal end is bent. Additionally, the present disclosure relates to a method. The method includes inserting a shaft extending from a handle of an apparatus through a working channel of an endoscope, the apparatus including a first actuator for an end effector at a distal end of the shaft; operating a first steering wheel of a steering mechanism to bend the distal end relative to a longitudinal axis of the shaft, thereby pulling a pull wire extending from the handle to the end effector proximally, the first steering wheel being coupled to a first steering wire extending therefrom to the distal end of the shaft; and actuating the pull wire to actuate the end effector.

[0012] In one embodiment, the end effector is actuated by sliding a first actuator proximally to move the end effector to a first configuration and sliding the first actuator distally to move the end effector to a second configuration.

[0013] In an embodiment, the method further includes rotating a rotation knob coupled to the shaft in a first direction to rotate the shaft in the first direction, and rotating the rotation knob in a second direction to rotate the shaft in the second direction opposite the first direction.

[0014] In some embodiments, the method further includes actuating a locking knob coupled to the steering mechanism to rotate a threaded shaft extending from the locking knob toward the first steering wheel in a first direction and positioning a brake plate on an end of the threaded shaft to contact the first steering wheel, thereby locking the distal end of the shaft in the desired configuration.

[0015] In an embodiment, the method further includes rotating the locking knob in a second direction opposite the first direction to move the brake plate out of contact with the first steering wheel and allow rotation of the steering mechanism. [Brief explanation of the drawings]

[0016] [Figure 1] 10A-10C show clipping devices with rotation and steering mechanisms for controlling the orientation of the distal end. [Figure 2] FIG. 2 is a side view of the clip device of FIG. 1. [Figure 3] FIG. 2 is a perspective view of the clip device of FIG. 1; [Figure 4] 2 is a diagram of the distal end of the coiled shaft of the clip device of FIG. 1 that couples to the clip. [Figure 5] FIG. 2 is an exploded view of the rotation knob of the clip device of FIG. 1. [Figure 6] 2 is a bottom perspective view of the upper steering wheel of the clipping device of FIG. 1; [Figure 7] 2 is a bottom view of the upper steering wheel of the clipping device of FIG. 1; [Figure 8] 2 is a top view of the lower steering wheel of the clipping device of FIG. 1; [Figure 9] 2 illustrates the distal end of the clip device of FIG. 1 in a bent state. [Figure 10] 2 illustrates the steering stop of the clipping device of FIG. 1 engaged with the upper steering wheel; [Figure 11] Exploded view of the RSM of the clip device of Figure 1. [Figure 12] 2 shows the assembled RSM of the clip device of FIG. 1, excluding the rotation knob. [Figure 13a]FIG. 6 shows an internal view of the upper rotary knob half of FIG. 5. [Figure 13b] FIG. 6 shows an internal view of the lower rotatable knob half of FIG. 5. [Figure 14] 2 is a perspective bottom view of the lower steering wheel of the clip device of FIG. 1; [Figure 15] 2 is a semi-perspective side view of the lower steering wheel of the clip device of FIG. 1; [Figure 16] 2 is a side view of the lower steering wheel together with the annular brake plate and lock knob of the device of FIG. 1; [Figure 17] FIG. 17 is a top perspective view of the lock knob of FIG. 16 . DETAILED DESCRIPTION OF THE INVENTION

[0017] The present disclosure may be further understood with reference to the following description and the accompanying drawings, in which like elements are designated by the same reference numerals. The present disclosure relates to a clip device having a rotatable and steerable distal end for deploying a clip. The distal end can be bent sufficiently to bring the clip into the field of view of a side-viewing endoscope. Additionally, full 360-degree rotatability provides access to difficult anatomical structures. The device handle includes a steering and rotation mechanism actuator (RSM) with a rotation knob and a steering knob, and the handle further includes an actuator for controlling movement of the clip arms. While the exemplary embodiment describes a hemostatic clip device, the principles of the present disclosure may be applied to other pull-wire-actuated end effector devices, as described in detail below. The steerability of the clip allows it to be used with duodenoscopes and side-viewing scopes. Additionally, even when used with a front-viewing endoscope, these clips may be maneuverable to reach tissue that is inaccessible with other clips or that is more easily reached by maneuvering the clip than by maneuvering the scope.

[0018] FIG. 1 illustrates a clip device 100 that includes a rotation and steering mechanism that allows a user to control the orientation of the device's 100 distal end 106 in multiple (e.g., six) degrees of freedom after it is extended from an insertion device, such as an endoscope. The handle 102 includes an actuator, including, for example, a rotation knob 132, a steering knob 150, and a slidable spool 112 for deploying the clip 120. A flexible coiled shaft 104 extends distally from the handle 102 to the steerable distal end 106, defining a lumen therein for housing steering and end effector pull wires. In this embodiment, the steering mechanism allows the distal end 106 to bend over a useful angular range, as described in detail below. In one embodiment, the useful angular range is 0 to 90 degrees, while in another embodiment, the useful angular range is 0 to 70 degrees.

[0019] The handle 102 includes a proximal thumb ring 108 configured to allow a user to insert their thumb to grasp the handle 102. A handle shaft 110 extends distally from the thumb ring 108 and passes through a slidable spool 112, which couples to the proximal end of the coiled shaft 104. In this embodiment, the slidable spool 112 serves as the actuator for the clip mechanism. The slidable spool 112 is coupled to the proximal end of a pull wire 118, which extends distally through a channel in the handle 102 and continues through the lumen of the coiled shaft 104. The pull wire 118 extends distally through a coupling 124 (e.g., a bushing) attached to the proximal end of a capsule 126 containing a clip 120, as shown in FIGS. 4 and 9, and couples to the clip 120. Thus, movement of the spool 112 relative to the handle shaft 110 moves the pull wire 118 proximally and distally through the coiled shaft 104 to actuate the clip 120, as described in detail below. An exemplary clipping device, including a bushing, capsule, and clip, for use in endoscopic procedures is described in U.S. Patent Application No. 15 / 589,620, which is incorporated herein by reference.

[0020] The pull wire 118 is coupled, directly or indirectly, to the clip 120. Thus, sliding the spool 112 proximally along the longitudinal axis of the handle 102 from an initial distal position pulls the pull wire 118 proximally, and contact between the capsule wall and the arms of the clip 120 draws the arms together into a closed, tissue-grasping configuration, drawing the clip 120 into the capsule 126. However, other pull wire-actuated mechanisms may be used to close the arms of the clip 120 without departing from the scope of the present disclosure. In this embodiment, the spool 112 is slidable within a longitudinal slot in the handle shaft 110.

[0021] Distal movement of the spool 112 along the handle shaft 110 moves the pull wire 118 distally, pushing the clip 120 distally from the capsule 126. In this embodiment, the arms of the clip 120 are biased to an open, tissue-receiving configuration, so that when the arms of the clip 120 are extended distally from the capsule 126, the clip arms are no longer constrained by the capsule 126 to a closed, tissue-grasping configuration and spread apart toward one another to the open, tissue-receiving configuration. As will be appreciated by those skilled in the art, other clip actuators may be used without departing from the scope of the present disclosure. Additionally, as noted above, other pull wire-actuated end effectors may be used with the rotation and steering mechanisms described below. For example, the end effector may be a scissors, a ligation band deployer, or the like.

[0022] The rotation and steering mechanism actuator (RSM) 130 extends from the distal end of the handle shaft 110 and includes a rotation knob 132 and a steering knob 150, as shown in Figures 2 and 3. The rotation knob 132 is comprised of a first (upper) half 132a and a second (lower) half 132b joined together, and a proximal portion 134 of the rotation knob 132 is joined over and over the distal end 114 of the handle shaft 110 to couple the rotation knob 132 thereto, as shown in Figure 5, which will be described further below. The assembled rotation knob 132 has a proximal portion 134 that can be grasped by a user and rotated about the longitudinal axis of the handle 102, a distal portion 138 that connects the rotation knob 132 to the coiled shaft 104 via a crimp box 122 (described below) so that the shaft 104 rotates with the rotation knob 132, and an intermediate portion 136 that connects the proximal portion 134 and the distal portion 138 and provides space for accommodating additional device components, as described below.

[0023] In this embodiment, each of the proximal portion halves 134a, 134b has a semicircular cross-section relative to the transverse plane of the handle 102, and the halves 134a, 134b clip together over the distal end 114 of the handle shaft 110. The distal end 114 of the handle shaft 110 is cylindrical with a cylindrical ridge 116 at its distal tip, the ridge 116 having a larger diameter than the remainder of the distal end 114. A recess 140 is formed from recess halves 140a, 140b on the inner surface of each of the proximal portions 134a, 134b of the rotation knobs 132a, 132b near the distal ends of each of the rotation knobs 132a, 132b. The recess 140 is sized and shaped to receive the cylindrical ridge 116 on the distal end 114 of the handle shaft 110. Each of the proximal portion halves 134a, 134b has a pin 142 that extends toward the other half 134a, 134b.

[0024] When the rotation knob halves 132a, 132b are mated together, as shown in Figures 13a-13b, each pin 142 is inserted into a corresponding pin hole 144 so that the rotation knob halves 132a, 132b snap together. When the proximal portion halves 134a, 134b are snapped together about the distal end 114 of the handle shaft 110, the distal ridges 116 are inserted into the recesses 140 to longitudinally secure the rotation knob 132 relative to the handle 102 while allowing the rotation knob 132 to rotate about the longitudinal axis of the handle 102. Although Figures 13a-13b show one pin 142 and one pin hole 144 on each of the rotatable knob halves 132a, 132b, those skilled in the art will understand that each of the rotatable knob halves 132a, 132b may have more pins 142 and correspondingly more pin holes 144.

[0025] In this embodiment, each of the distal section halves 138a, 138b of the rotation knob 132 has a substantially cylindrical outer surface, although any outer shape may be used. The inner surface of each of the distal section halves 138a, 138b has a rectangular cross-sectional recess 146a, 146b sized and shaped to receive the crimped box 122, with the box 122 being crimped toward the proximal end of the coiled shaft 104. When the rotation knob halves 132a, 132b are mated, the crimped box 122 is held in place relative to the rotation knob 132 such that rotation of the rotation knob 132 rotates the coiled shaft 104 therewith. It can therefore be seen that the RSM 130 and coiled shaft 104 have a full 360-degree rotatability relative to the handle shaft 110.

[0026] In essence, the RSM 130 is coupled to the handle shaft 110 via a cylindrical distal ridge 116 of the handle shaft 110 that is received in a cylindrical recess 140 in the proximal portion 134 of the rotation knob 132, allowing the RSM 130 to rotate freely relative to the handle shaft 110, while the coiled shaft 104 is rotationally fixed relative to the RSM 130 by a crimp box 122 that is received in a rectangular recess 146 in the distal portion 138 of the rotation knob 132. Thus, the coiled shaft 104 and distal end 106 of the device 100, including the clip 120, may be freely rotated together in unison with the rotation knob 132. As the distal end 106 is further steered, as will be appreciated by those skilled in the art, as described below, the rotatability of the distal end 106 facilitates access to hard-to-reach anatomical structures to be resected or otherwise treated that are difficult or impossible to reach with a non-steerable scope.

[0027] The intermediate portion 136 of the rotation knob 132 serves, in part, as a support structure for the steering knob 150, elements of which are visible on the interior and exterior of the intermediate portion 136. Each intermediate portion half 136a, 136b has a hollow cylindrical shape with a bore 148 extending through its outer surface and open inner surface so that, when mated, the intermediate portion 136 is generally a hollow cylinder with bore 148 extending through its top and bottom surfaces.

[0028] In this embodiment, the steering mechanism includes an upper steering wheel 152, as shown in Figures 6 and 7, and a lower steering wheel 154, as shown in Figure 8, each coupled to a respective steering pull wire 156a, 156b that extends from the RSM 130, through the coiled shaft 104, and to the proximal end of the coupling 124 that connects the coiled shaft 104 to the clip 120, as shown in Figure 4. When tension is applied to one of the steering wires 156a, 156b by the steering knob 150, the coiled shaft 104 bends in the direction of the tensioned wire, thereby directing the distal end 106 of the device 100 away from the longitudinal axis of the device 100, as shown in Figure 9, for example. The wires 156a, 156b are attached to and extend along opposite sides of the coiled shaft 104, allowing it to bend in either of two opposite directions.

[0029] However, in another embodiment, only a single steering wire may be included, including a bend in a single direction, so that when combined with the steering capability, the device can still be pointed and oriented in any desired direction. As shown in FIG. 4 , the pull wire 118 for the clip 120 is independent of and can move independently of the steering pull wires 156 a, 156 b. As described in detail below, the steering mechanism includes a steering stop 172 secured to the lower steering wheel 154, which limits the tension that can be applied to either of the steering wires 156 a, 156 b. The steering mechanism additionally includes a locking knob 180, which allows the physician to maintain a constant degree of tension in the wires, and therefore the bend in the distal end 106.

[0030] The upper steering wheel 152 is annular, having a thin, disk-shaped body with a hole extending through its center, and the inner surface 158 of the torus has a geared profile that mates with the geared section 170 of the steering knob 150, as described further below. The lower steering wheel 154 of this embodiment is similarly disk-shaped but does not have a through hole. The upper steering wheel 152 is disposed within the hollow interior of the upper half 136a of the middle portion 136 of the rotatable knob 132, while the lower steering wheel 154 is disposed within the hollow interior of the lower half 136b of the middle portion 136 of the rotatable knob 132.

[0031] Two pins 160 extending from the underside of the upper steering wheel 152 are sized to insert into corresponding pin holes 162 in the lower steering wheel 154 to attach the steering wheels 152, 154. The pin holes 162 extend through the lower steering wheel 154, and when the pins 160 are fully inserted therein, they extend beyond the underside of the lower steering wheel 154 and engage a steering stop 172. Each of the steering wheels 152, 154 has an internal channel 164 through which the steering wires 156 extend from the mounting connectors 166. The channel 164 extends around a portion of the steering wheels 152, 154 near the outer diameter of the disks.

[0032] 7 and 8, the upper steering wheel 152 is provided with an internal channel 164a that begins at a first side of the steering wheel 152 and extends through a generally circular path near the outer diameter of the steering wheel 152 to a second, opposite side of the steering wheel 152. When the upper steering wheel 152 is in the inoperative position, the first side of the steering wheel 152 is proximal, and the second side of the steering wheel 152 is distal. However, these relative proximal and distal orientations change when the steering wheel 152 is rotated. The internal channel 164a is open at the first side so that a steering wire 156a can be attached to the steering wheel 152 via a crimping portion 166a.

[0033] The internal channel 164a is similarly open on a second side so that the steering wire 156a can extend out of the channel 164a and into the coiled shaft 104. The remainder of the channel 164a is closed, constraining the steering wire 156a in its path while the steering wire 156a is tensioned or slackened, as described below. The lower steering wheel 154, like the upper steering wheel 152, is provided with an internal channel 164b that begins on a first side of the steering wheel 154 and extends through a substantially circular path near the outer diameter of the steering wheel 154 to a second, opposite side of the steering wheel 154. However, when the steering wheels 152, 154 are connected by the pin 160 and pin hole 162, the circular paths of the steering wheel channels 164a, 164b extend in opposite directions. For example, if the upper steering wheel 152 has a channel 164a that extends clockwise when the assembled, non-operating RSM 130 is viewed from the top, the lower steering wheel has a channel 164b that extends counterclockwise when viewed from the top.

[0034] When the lower steering wheel 154 is in the inactivated position, a first side of the steering wheel 154 is proximal, and a second side of the steering wheel 154 is distal. Similar to the upper steering wheel 152, the relative proximal and distal orientations for the lower steering wheel 154 change as the steering wheel is rotated. The lower steering wheel 154 is open on a first side, allowing the steering wire 156b to attach to the steering wheel 154 via a crimping portion 166b. The internal channel 164b is similarly open on a second side, allowing the steering wire 156b to extend out of the channel 164b and into the coiled shaft 104. The remainder of the channel 164b is closed, constraining the steering wire 156b in its path while tensioning or slackening the steering wire 156b.

[0035] Given the rigid attachment between the upper and lower steering wheels 152, 154 and the opposing paths for the steering wire channels 164a, 164b, it can be seen that rotation of the steering wheels 152, 154 applies tension to one of the wires 156 while slackening the other wire 156. Specifically, considering the example above in which the upper steering wire 156a extends clockwise from a proximal attachment point to a distal point and then extends through the coiled shaft 104, it can be seen that counterclockwise rotation of the upper steering wheel 152, by rotating the attachment point of the wire 156a, i.e., the crimping portion 166a, away from the path of the wire 156a, applies tension to the wire 156a, thus drawing the wire 156a proximally away from the coiled shaft 104. Conversely, because lower steering wire 156b extends counterclockwise from a proximal attachment point to a distal point and then extends through coiled shaft 104, rotating lower steering wheel 154 counterclockwise by rotating the attachment point of wire 156b, i.e., crimp portion 166b, toward the path of wire 156b, slackens, thus pushing wire 156b further distally into coiled shaft 104.

[0036] The opposing tension / slack of the two steering wires 156 causes the distal end 106 of the device 100 to bend in the direction of the tensioned steering wire 156, while the slack steering wire 156 is sufficiently slack to allow bending. Each of the steering wires 156 may be welded to the distal end 106 to control the bending of the distal end 106. In another embodiment, the steering wires 156 may extend through a sheath, which may then be attached (e.g., welded) to the coiled shaft 104. The degree of rotation of the upper and lower steering wheels 152, 154 directly correlates to the degree of bending of the distal end 106. Therefore, a physician who actuates the steering wheels 152, 154 by turning the steering knob 150 precisely controls the bending of the distal end 106 and, therefore, the position of the clip 120.

[0037] The steering knob 150 has a ridged handle portion 168 that extends across the disk-shaped body of the steering knob 150 and has ends that overhang the sides of the disk-shaped body. Either the ridge or the side of the handle portion 168 is grasped by the physician to rotate the steering knob 150. The steering knob 150 is coupled to the upper steering wheel 152 via a geared section 170 that is sized and shaped to fit within the geared inner surface 158 of the upper steering wheel 152. The steering knob 150, except for the geared section 170, remains external to the rotation knob 132, with the geared section 170 extending through a hole 148 in the middle of the upper rotation knob half 132a and engaging the upper steering wheel 152. The further engagement of the upper steering wheel 152 with the lower steering wheel 154 via pin 160 and pin hole 162 allows the physician to rotate both steering wheels 152, 154 in unison via the steering knob 150, effectively.

[0038] The degree of rotation of the steering wheels 152, 154 is limited by a steering stop 172 secured to the lower rotation knob 132b. The steering stop 172 may be secured to the lower rotation knob 132b by a securing mechanism (e.g., a snap fit, a pin / hole fit, etc.) that prevents the steering stop 172 from rotating relative to the lower rotation knob 132b. The steering stop 172 is annular, has an outer diameter substantially similar to the diameter of the steering wheels 152, 154, and includes a through hole 174 extending therethrough. The steering stop 172 additionally has two pin channels 176 sized to receive the pins 160 extending from the upper steering wheel 152 through pin holes 162 in the lower steering wheel 154.

[0039] Each of the pin channels 176 extends through a portion of a circle, e.g., approximately 90 degrees of a full circle, such that as the steering wheels 152, 154 are rotated, the ends of the channel 176 constrain further rotation of the pin 160 of the upper steering wheel 152. When the steering knob 150 is in an unactuated state, i.e., when no tension is applied to either of the steering wires 156, the pin 160 is located at or near the center of the pin channel 176. Rotating the steering knob 150 by approximately 45 degrees in either direction causes both of the pins 160 to contact one of the ends of the channel 176, thus limiting the range of motion of the steering wheels 152, 154 and the degree of bending of the distal end 106 of the device 100.

[0040] As shown in FIGS. 14-17 , the RSM 130 further includes a locking mechanism that holds the bend of the distal end 106 in a desired position. The locking mechanism includes an annular brake plate 182 that, when rotated via the lock knob 180, couples the lower steering wheel 154 to the fixed steering stop 172, preventing the steering wheels 152, 154 from rotating. The brake plate 182 fits tightly into the hole 174 in the steering stop 172. The brake plate 182 therefore fits tightly with the wheel ring 178 of the lower steering wheel 154, preventing movement of the lower steering wheel 154 from the resulting friction between the brake plate 182 and the wheel ring 178. The wheel ring 178 has an internal thread that corresponds to the threaded shaft 184 of the lock knob 180. The threaded shaft 184 extends from the center of the lock knob 180 toward the wheel ring 178. The threaded shaft 184 is rotationally fixed relative to the locking knob 180, in other words, the threaded shaft 184 rotates together and synchronously with the locking knob 180, as described below.

[0041] The lock knob 180 extends from a first surface 181 to a second surface 183. Additionally, the lock knob 180 has a first cavity 186 and a second cavity 188. The first cavity 186 is sized and shaped to receive the wheel ring 178 of the lower steering wheel 154. The second cavity 188 is sized and shaped to receive the brake plate 182. The first cavity 186 and the second cavity 188 extend radially from the center of the lock knob 180, and the diameter of the first cavity 186 is smaller than the diameter of the second cavity 188. The first cavity 186 and the second cavity 188 extend from the first surface 181 toward the second surface 183.

[0042] First cavity 186 extends a further distance toward second surface 183 than second cavity 188. In other words, the bottom of first cavity 186 is closer to second surface 183 than the bottom of second cavity 188. Lock knob 180 additionally includes a hole 187 that extends from first surface 181 toward second surface 183. Hole 187 is sized and shaped to receive pin 160, which extends from upper steering wheel 152 through lower steering wheel 154 and steering stop 172. Pin 160 terminates within hole 187 in lock knob 180, thereby locking pin 160 relative to lock knob 180.

[0043] Rotating the locking knob 180 in a first direction, e.g., clockwise, translates the brake plate 182 upward, engaging the lower steering wheel 154 with the steering stop 172, which, as described above, is secured to the rotation knob 132. The steering wheels 152, 154 are therefore fixed in their current rotational orientation, locking the distal end 106 of the device 100 at its current degree of bending. Rotating the locking knob 180 in the opposite direction, e.g., counterclockwise, releases the brake plate 182, allowing free, steerable rotation. If the physician is not engaging the steering knob 150 when the brake plate 182 is released, the distal end 106 will return to a substantially straight position due to the lack of tension on the steering wires 156, absent forces exerted by surrounding tissue.

[0044] Figure 11 shows an exploded view of the RSM 130 of the clip device 100, where the various layers of the RSM 130 are shown separated for clarity. Figure 12 shows the assembled RSM 130, excluding the rotation knob 132, so that the arrangement of the internal components can be seen.

[0045] Those skilled in the art will recognize that changes may be made to the above-described embodiments without departing from the inventive concept. It should further be appreciated that structural features and methods associated with any one of the embodiments may be incorporated into other embodiments. Therefore, it is understood that the present invention is not limited to the specific embodiments described, and that modifications are encompassed within the scope of the present invention as defined in the appended claims. The technical ideas included in the present disclosure are described below. (Appendix 1) 1. An apparatus comprising: The device comprises a handle including a first actuator for a hemostatic clip; the device comprises a flexible coiled shaft extending from the handle, the flexible coiled shaft sized and shaped to pass through a working channel of an endoscope, a distal end of the flexible coiled shaft containing the hemostatic clip, and a pull wire extending from the handle to the hemostatic clip for actuating the hemostatic clip; the device includes a steering mechanism including a second actuator for bending the distal end relative to a longitudinal axis of the flexible coiled shaft, the steering mechanism including a first steering wheel having a first steering wire extending to the distal end of the flexible coiled shaft; The device includes rotating the second actuator to apply tension to the first steering wire to rotate the first steering wheel and bend the flexible coiled shaft, and the pull wire for the hemostatic clip is in an actuable state when the distal end is bent. (Appendix 2) 2. The device of claim 1, wherein the first actuator is coupled to the pull wire to move the pull wire proximally and distally relative to the longitudinal axis of the flexible coiled shaft, and by moving the pull wire, actuates and moves the hemostatic clip between a first configuration and a second configuration. (Appendix 3) 3. The apparatus of claim 2, wherein the first actuator is a slidable spool. (Appendix 4) The steering mechanism includes: a steering stopper fixed to the bottom surface of the first steering wheel to limit tension applied to the first steering wire; 4. The device according to any one of claims 1 to 3, further comprising: (Appendix 5) The steering mechanism includes: A locking mechanism for holding the hemostatic clip in a desired position. 4. The device according to any one of claims 1 to 3, further comprising: (Appendix 6) The locking mechanism is Locking knob and a threaded shaft extending from the lock knob toward the first steering wheel; an annular brake plate at the end of the screw shaft and connected to the first steering wheel; 6. The apparatus of claim 5, further comprising: (Appendix 7) a rotating knob rigidly secured to said flexible coiled shaft; Furthermore, 7. The device of any one of claims 1 to 6, wherein the rotatable knob and the flexible coiled shaft rotate together about the longitudinal axis of the flexible coiled shaft. (Appendix 8) The rotary knob is a first rotatable knob half; a second rotary knob half; Furthermore, 8. The device of claim 7, wherein each of the first and second rotatable knob halves has a first recess at a proximal end and a second recess at a distal end, the first recess sized and shaped to receive the distal end of the handle and the second recess sized and shaped to receive the proximal end of the flexible coiled shaft. (Appendix 9) The steering mechanism includes: a second steering wheel having a second steering wire extending to the distal end of the flexible coiled shaft; 9. The device of any one of claims 1 to 8, wherein rotating the second actuator applies tension to the second steering wire to rotate the second steering wheel and bend the flexible coiled shaft, and the pull wire for the hemostatic clip is in an actuable state when the distal end is bent. (Appendix 10) 10. The apparatus of claim 9, wherein actuating the first steering wheel bends the flexible coiled shaft in a first direction and actuating the second steering wheel bends the flexible coiled shaft in a second direction, the second direction being opposite to the first direction. (Appendix 11) Locking knob and a threaded shaft extending from the lock knob toward the second steering wheel; an annular brake plate at the end of the screw shaft and connected to the second steering wheel; 10. The apparatus of claim 9, further comprising: (Appendix 12) 12. The apparatus of claim 11, wherein the annular brake plate fits closely onto a wheel ring protruding from a first face of the second steering wheel. (Appendix 13) a steering stopper fixed to a first surface of the second steering wheel to limit tension on the second steering wire; 10. The apparatus of claim 9, further comprising: (Appendix 14) 1. An apparatus comprising: The device comprises a handle including a first actuator for the clip; the device comprises a flexible coiled shaft extending from the handle, the distal end of the flexible coiled shaft containing the clip, and a pull wire extending from the handle to the clip for actuating the clip; the device includes a steering mechanism including a second actuator for bending the distal end relative to a longitudinal axis of the flexible coiled shaft, the steering mechanism including a steering wheel having steering wires extending to the distal end of the flexible coiled shaft; The device wherein rotating the second actuator applies tension to the steering wire to rotate the steering wheel and bend the flexible coiled shaft, and the pull wire for the clip is in an actuable state when the distal end is bent.

Claims

1. 1. An apparatus comprising: The device comprises a handle including a first actuator; the device comprises a flexible shaft extending from the handle, the flexible shaft sized and shaped to pass through a working channel of an endoscope, the distal end of the flexible shaft configured to be coupled to the hemostatic clip such that the hemostatic clip is deployable via actuation of the first actuator; the device comprises a steering mechanism comprising a second actuator for bending the distal end relative to a longitudinal axis of the flexible shaft, the steering mechanism comprising a first wire extending from the second actuator to the distal end of the flexible shaft, the second actuator configured to apply tension to the first wire to bend the flexible shaft by actuating the second actuator; The device includes a rotation knob coupled to the handle and the flexible shaft, and rotating the rotation knob relative to the handle rotates the flexible shaft about the longitudinal axis of the flexible shaft.

2. The device of claim 1, further comprising a pull wire coupled to the first actuator, wherein moving the first actuator moves the pull wire proximally and distally relative to the longitudinal axis of the flexible shaft, thereby moving the hemostatic clip between an open configuration and a closed configuration.

3. 3. The device of claim 2, wherein the first actuator is a spool slidable relative to the body of the handle.

4. The device according to any one of claims 1 to 3, wherein the steering mechanism further comprises a steering stopper fixed to a bottom surface of the second actuator to limit tension applied to the first wire.

5. The device of any one of claims 1 to 3, wherein the steering mechanism further comprises a locking mechanism for holding the hemostatic clip in a desired position.

6. The locking mechanism is Locking knob and a threaded shaft extending from the lock knob toward the second actuator; an annular brake plate at the end of the screw shaft and connected to the second actuator; The apparatus of claim 5 further comprising:

7. The device described in claim 1, wherein the rotatable knob is coupled to the handle such that the rotatable knob can rotate through 360 degrees relative to the handle.

8. The rotary knob is a first rotatable knob half; a second rotary knob half; Furthermore, 2. The device of claim 1, wherein each of the first and second rotatable knob halves has a first recess at a proximal end and a second recess at a distal end, the first recess sized and shaped to receive the distal end of the handle and the second recess sized and shaped to receive the proximal end of the flexible shaft.

9. The second actuator a first steering wheel coupled to the first wire; a second steering wheel coupled to a second wire extending from the second actuator to the distal end of the flexible shaft; and The apparatus of claim 1 , comprising:

10. 10. The device of claim 9, wherein actuating the first steering wheel causes the flexible shaft to bend in a first direction and actuating the second steering wheel causes the flexible shaft to bend in a second direction, the second direction being different from the first direction.

11. Locking knob and a threaded shaft extending from the lock knob toward the second steering wheel; an annular brake plate at the end of the screw shaft and connected to the second steering wheel; The apparatus of claim 9 further comprising:

12. 12. The apparatus of claim 11, wherein the annular brake plate fits closely within a wheel ring that projects from the second steering wheel.

13. 10. The apparatus of claim 9, further comprising a steering stop secured to a first surface of the second steering wheel to limit tension on the second wire.

14. 1. An apparatus comprising: The device comprises a handle including a first actuator; the device comprises a flexible shaft extending from the handle; the device includes a first wire extending from the handle, the first wire coupled to a clip and configured to actuate the clip; the device comprises a steering mechanism including a second actuator for bending the distal end of the flexible shaft relative to a longitudinal axis of the flexible shaft, the second actuator coupled to a second wire extending to the distal end of the flexible shaft, the second actuator coupled to the handle such that rotating the second actuator relative to the handle applies tension to the second wire to bend the flexible shaft, and the first wire remains actuable when the distal end is bent; The device includes a rotation knob coupled to the handle and the flexible shaft, and rotating the rotation knob relative to the handle rotates the flexible shaft about the longitudinal axis of the flexible shaft.

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