Repositionable over-the-scope clip

Abstract

The system includes a cap having first and second cap members, a clip, and first and second coupling members. The clip includes a first portion rotatably coupled to a second portion, a first member coupled to the first portion, and a corresponding second member coupled to the second portion. Each of the first members is coupled to a corresponding one of the second members to form a throttle mechanism that operates to change the size of a central opening of the clip when the portions are rotated relative to each other between an open and closed configuration. The first coupling member is coupled between the first cap member and the first portion, and the second coupling member is coupled between the second cap member and the second portion, such that rotation of the first cap member relative to the second cap member rotates the first portion relative to the second portion.

Description

[Technical Field]

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

[0002] Some endoscopic procedures (e.g., removal of larger lesions (e.g., cancerous), tunneling under the mucosal layer of the GI tract to treat submucosal lesions, full-thickness removal of tissue (e.g., cancerous), treatment of lesions in other organs by passing outside the GI tract (natural orifice transluminal endoscopic surgery, also known as NOTES®)), and endoscopic treatment / repair of post-operative problems (e.g., post-operative leaks, surgical staple line damage, and / or anastomotic leaks) may, in some cases, increase the risk of, for example, intra-abdominal hypertension and spread of cancer cells. In addition, these procedures generally result in tissue openings that must be sealed to achieve hemostasis. Summary of the Invention [Means for solving the problem]

[0003] The present disclosure relates to a clipping system for treating tissue. The system includes a cap, a clip, a first coupling member, and a second coupling member. The cap is configured to be mounted over the distal end of an insertion device. The cap extends from the proximal end to the distal end and includes a channel extending therethrough. The cap includes a first cap member and a second cap member. The first cap member is rotatable relative to the second cap member.

[0004] The clip includes a peripheral body having a first portion rotatably coupled to a second portion, a plurality of first flexible members coupled to the first portion, and a corresponding plurality of second flexible members coupled to the second portion, each of the first flexible members coupled to a corresponding one of the second flexible members, forming an iris mechanism that operates to change the size of a central opening of the clip when the first and second portions are rotated relative to one another from a fully open configuration in which the central opening is at a maximum size configured to receive target tissue therein to a fully closed configuration in which the central opening is at a minimum size configured to clip target tissue received therein.

[0005] A first coupling member is coupled between the first cap member and the first portion of the clip, and a second coupling member is coupled between the second cap member and the second portion of the clip such that upon rotation of the first cap member relative to the second cap member, the first portion of the clip rotates relative to the second portion of the clip.

[0006] In one embodiment, the first cap member includes a helical feature and the second cap member includes a coupling arrangement that engages the helical feature such that linear movement of the first cap member relative to the second cap member rotates the first cap member relative to the second cap member.

[0007] In one embodiment, the helical feature is a groove and the coupling arrangement includes a protrusion extending from the second cap member into the groove of the first cap member. In one embodiment, the system further includes a cap coupling arrangement configured to attach the cap to the insertion device, wherein the first cap member is coupled to the cap coupling arrangement such that the first cap member can move longitudinally relative to the cap coupling arrangement, and engagement between the helical feature of the first cap member and the coupling of the second cap member translates longitudinal movement of the first cap member relative to the cap coupling arrangement into rotation of the second cap member relative to the first cap member.

[0008] In one embodiment, the first and second flexible members are configured to bias the throttle mechanism toward a fully closed configuration. In one embodiment, each of the first and second flexible members extends substantially along an arc.

[0009] In one embodiment, the first portion of the clip is a first disk having a distal surface and the second portion of the clip is a second disk having a proximal surface adjacent the distal surface of the first portion.

[0010] In one embodiment, the first and second flexible members extend into the central spaces of the first and second discs, respectively. In one embodiment, the system further includes a pull wire coupled to the first cap member such that movement of the pull wire relative to the cap coupling arrangement causes the first cap member to move longitudinally relative to the cap coupling arrangement.

[0011] In one embodiment, the throttle mechanism is configured such that a central opening of the throttle mechanism is opened when the first portion of the clip is rotated relative to the second portion of the clip in a direction that decreases the distance between a connection point between each first flexible member and the first portion of the clip and a connection point between a corresponding one of the second flexible members and the second portion of the clip.

[0012] Additionally, the present disclosure relates to a method for clipping tissue, the method comprising coupling to an endoscope a device including a cap having a first cap member and a second cap member, and a clip coupled to the cap via first and second control members, the clip including a first portion rotatably coupled to a second portion and a plurality of first flexible members extending within the first portion, each of the first flexible members having a first end coupled to the first portion, the clip further including a corresponding plurality of second flexible members, each of the second flexible members including a first end coupled to the second portion, and the second end of each of the first flexible members being coupled to a corresponding one of the second flexible members. the first and second portions of the clip relative to one another in a first direction via the first and second control members to open a central opening of the clip to a fully open configuration in which the central opening is of a maximum size configured to receive target tissue therein; drawing tissue through the central opening of the clip and into the cap; and rotating the first and second portions of the clip relative to one another in a second direction opposite the first direction to close the clip and clip tissue extending through the central opening of the clip.

[0013] In one embodiment, the device further includes a first coupling member coupled between the first cap member and the first portion of the clip and a second coupling member coupled between the second cap member and the second portion of the clip, and further includes rotating the first cap member relative to the second cap member to rotate the first portion of the clip relative to the second portion of the clip.

[0014] In one embodiment, the method further includes rotating the first and second portions of the clip relative to one another in a second direction to close the clip and clip tissue extending through the central opening of the clip, and then retracting the endoscope and cap proximally relative to the clip to a review position where the clip and clipped tissue are more clearly visible.

[0015] In one embodiment, the method further includes the step of retracting the endoscope and cap to the probing position, then advancing the endoscope and cap distally toward the clip and either reopening and repositioning the clip or finally deploying the clip.

[0016] In one embodiment, the clip is finally deployed by severing the bond between the control wire and the clip. [Brief explanation of the drawings]

[0017] [Figure 1A] FIG. 1 is a perspective view of a system according to an exemplary embodiment. [Figure 1B] FIG. 10 is a perspective view of a system according to an exemplary embodiment having an alternative handle. [Figure 1C] FIG. 1C shows a perspective view of the handle of FIG. 1B. [Figure 2] 1 shows a perspective view of a distal portion of a clipping system according to an exemplary embodiment of the present disclosure in an insertion configuration. [Figure 3] 2 shows the distal end of the clipping system of FIG. 1 with the clip in an open configuration. [Figure 4] 2 shows a perspective view of a clip of the system of FIG. 1, showing the connection between the clip and the control wire. [Figure 5] 4 shows a perspective view of the clip of FIG. 3. [Figure 6] 4 shows a perspective view of the clip of FIG. 3 in its final deployed configuration, clipped over a portion of tissue that has been separated from the clipping system. [Figure 7A] 4 shows the clip of FIG. 3 in an open configuration. [Figure 7B] 4 shows the clip of FIG. 3 in an open configuration with tissue drawn into the clip. [Figure 7C] 4 shows the clip of FIG. 3 closed over tissue drawn through the clip. [Figure 7D] 4 shows the clip of FIG. 3 closed over target tissue and spaced away from the endoscope in a probing configuration. [Figure 7E] 4 shows the clip of FIG. 3 again opened and separated from the tissue to which it was previously clipped. [Figure 7F] 4 shows the clip of FIG. 3 separated from the clipping system and deployed to ultimately clip the target tissue. DETAILED DESCRIPTION OF THE INVENTION

[0018] The present disclosure can be further understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals. The present disclosure relates to clipping systems, and in particular to an over-the-scope endoscopic clipping system that may be used, for example, to close tissue openings created by full-thickness excision procedures in the GI tract while hygienically collecting tissue from the clipping site to minimize the possibility of disseminating cancerous or other undesirable tissue from the excision site to other areas of the body. An exemplary embodiment of the present disclosure includes a disk-shaped clip configured to be worn over the distal end of an endoscope via a cap coupled to the distal end of the endoscope. It should be noted that in this application, the terms proximal and distal refer to directions along the device toward (proximal) and away from (distal) the user.

[0019] The clip includes concentric disks, each including multiple arcuate inner members that interact to form a throttle mechanism that opens and closes a central opening in the clip as the disks are rotated relative to one another. That is, as the disks of the clip are rotated relative to one another, the clip moves from a closed configuration, in which the central opening formed between the points of the various arcuate members closest to the center of the disks is at its smallest size (to clip tissue), to a fully open configuration, in which the central opening is at its largest size (to allow target tissue to be drawn into the clip).

[0020] The system includes a cap configured to fit over the distal end of an insertion device (e.g., a flexible endoscope) and a plurality of control wires configured to enable a user to move the clip proximally and distally relative to the distal end of the cap and rotate the disks of the clip between fully open and closed configurations. The control wires of the disclosed embodiments also enable the user to separate the clip from the rest of the system when the user determines that the clip has been clipped to the target tissue as desired.

[0021] The system also allows the user to move the insertion device away from the clip clipped onto a portion of tissue to a probing configuration while maintaining a connection between the clip and the rest of the system. In the probing configuration, the endoscope is pulled away from the clip to increase the field of view of the endoscopic vision system so that the user can probe the position of the clip relative to the target tissue (e.g., the tissue to be clipped). If, in the probing configuration, it is determined that the clip is not clipped onto the target tissue as desired, the clip may be reopened so that the previously clipped tissue can be released, and the cap and clip may be repositioned relative to the target tissue to resume the clipping process. The clip is again clipped onto the tissue, and once it is observed (e.g., in the probing configuration) that the clip is clipped onto the target tissue as desired, the clip is finally deployed by separating the clip from the control member.

[0022] It will be understood by those skilled in the art that the exemplary embodiments of the present disclosure describe a clipping system that may be used to optimize various tissue treatment / resection procedures within the body, such as those performed using a flexible endoscope.

[0023] 1A-7F, a clipping system 100 according to an exemplary embodiment of the present disclosure includes a clip 102 configured to be inserted, for example, through a body lumen into a target area to clip target tissue 10 (shown in FIG. 6), e.g., a target portion of a lesion to be clipped, the edge of a wound or incision to be healed, etc. Clip 102 is insertable into the target area via an insertion device 104, as shown in FIG. 1, including, for example, an endoscope 106 and a cap 110 attached (e.g., via a friction fit) over a distal end 108 of endoscope 106. Cap 110 includes an outer body 112 and an inner body 114 rotatably mounted relative to one another. Clip 102 is configured to be positioned at the distal end of cap 110 for insertion into a target site in vivo (e.g., adjacent to the target tissue to be clipped) as the insertion device is navigated through a body lumen.

[0024] Those skilled in the art will appreciate that the cap 110, including the outer body 112 and the inner body 114, is formed from a transparent material in this embodiment to allow a user to view the widest possible field of view through the vision system of the endoscope (e.g., mounted on the distal end of the endoscope 106, facing into the interior space of the inner body 114 when the cap 110 is mounted over the distal end of the endoscope 106). The cap 110 in this embodiment is mounted over the endoscope 106, for example, such that the channel of the cap 110 is substantially longitudinally aligned with the longitudinal axis of the endoscope 106, allowing the target tissue to be observed through the channel of the cap 110 via the inspection system of the endoscope 106. In another embodiment, to improve visibility of the tissue and / or clip 102, the cap 110 is formed from a transparent material so that a user can view areas that would otherwise be blocked by the cap 110. Those skilled in the art will appreciate that these components do not need to be transparent to function as described herein. This is generally preferred, but not required, as it can enhance the user's ability to visualize the area surrounding the distal end of the endoscope.

[0025] According to the exemplary embodiment, clip 102 includes a distal disk 116 rotatably mounted to a proximal disk 118. Cap 110, including outer body 112 and inner body 114 in this embodiment, is cylindrical to match the cylindrical outer shape of endoscope 106. However, one skilled in the art will understand that the shape of these components may be altered in any manner that does not interfere with the function of the system in positioning and deploying clip 102 as described below.

[0026] In this embodiment, clip 102 is substantially circular (distal disk 116 and proximal disk 118 are each circular), so that clip 102 can be made as large as possible without increasing the maximum cross-sectional area of ​​system 100 beyond the cross-sectional area of ​​the circular distal end of cap 110. Thus, in this embodiment, the outer diameter of clip 102 is substantially the same as the outer diameter of outer body 112. However, as will be understood by those skilled in the art, clip 102 of other shapes may be used depending on the characteristics of the target tissue or tissue defect being treated.

[0027] The system 100 further includes at least one inner coil 120 slidably received within the outer coil 122. In each embodiment, there are two inner coils 120 and two outer coils 122, with each inner coil 120 received within a corresponding one of the outer coils 120. However, in the embodiment of FIG. 1A, the two outer coils 122 (and corresponding inner coils 120) merge near the proximal end into a single integrated outer coil 122' that houses the integrated inner coil 120'. The integrated inner coil 120 of FIG. 1A extends from a proximal end coupled to a spool 206 that is slidably mounted on the body 204 of the handle 200. The integrated inner coil 120' is coupled to each of the inner coils 120. A first of the inner coils 120 extends to a distal end 124 coupled to the outer body 112, and the other inner coil 120 extends from the integrated inner coil 120′ to a distal end coupled to the inner body 114. The integrated outer coil 122 is coupled to the handle body 204, which is coupled to the proximal end of the outer coil 122. Each of the outer coils 122 extends to a distal end 126 coupled to a flange 128 (e.g., along the outer surface of the insertion device 104) that is attached to a fixed position on the insertion device 104 during use. As described in more detail below, each of the inner coils 120 includes corresponding first and second control wires 140, 144 slidably received therein. In the embodiment of FIG. 1A, the first and second control wires 140, 144 from the inner coil 120 merge into the integrated control wire at a location near where the inner coil 120 merges into the integrated inner coil 120′. An integrated control wire extends through the integrated inner coil 120 ′ and couples to a push button 208 slidably mounted on the spool 206 .

[0028] In the present embodiment, the outer body 112 is coupled to the flange 128 such that the outer body 112 can move in the proximal and distal directions relative to the flange 128, but the outer body 112 is constrained to prevent relative rotation between the outer body 112 and the flange 128 (and as a result, relative to the insertion device 104). The inner body 114 of the present embodiment is attached to the flange 128 such that while the distance between the flange and the inner body 114 is fixed, the inner body 114 can rotate relative to the flange 128 and the outer body 112. Thus, when the user operates the spool 206 to move the inner coil 120 proximally and distally within the outer coil 122, the outer body 112 moves proximally and distally on the inner body 114.

[0029] In the embodiment of FIG. 1B, the components and operation of the handle 200 are identical to those of the handle 200 of FIG. 1A, except that the outer coil 122, the inner coil 120, and the first and second control wires 140, 144 are not incorporated into any integrated coil or control wire. In this embodiment, the proximal end of the outer coil 122 is coupled to the body 204 of the handle 200, the proximal end of the inner coil 120 is coupled to the spool 206, and the proximal ends of the first and second control wires 140, 144 are coupled to the push button 208. Each of the handles 200 of both FIGS. 1A and 1B also includes a liner lock 210 that can be operated to lock the spool 206 in place if it is desired to finally deploy the clip 102 (as described below).

[0030] The inner body 114 in this embodiment is coupled to the outer body 112 via a pin 130 that protrudes outward from the inner body to slidably ride within a helical groove 132 formed on the radially inner surface of the outer body 112 (i.e., the surface of the outer body 112 facing the inner body 114). Thus, when the spool 206 is operated to move the inner coil 120 proximally and distally into and out of the outer coil 122, the outer body 112 is moved proximally and distally relative to the inner body 114 as the pin 130 rides within the groove 132 and rotates the inner body 112 relative to the outer body 114. Those skilled in the art will appreciate that in alternative embodiments, the inner body 114 may be coupled to the flange 128 in a manner that allows proximal and distal movement of the inner body 114 relative to the flange 128 while preventing rotation of the inner body 114 relative to the flange 128.

[0031] In this configuration, the outer body 112 is attached to the flange 128 in a manner that prevents proximal and distal movement of the outer body 112 relative to the flange 128 while allowing rotation of the outer body 112 relative to the flange 128. Additionally, as will be understood by one skilled in the art, the same arrangement of the pins 130 and grooves 132 may be maintained, or the arrangement of these elements may be reversed, with the pins 130 extending radially inward from the outer body 112 to slidably reside in grooves 132 formed on the radially outer surface of the inner body 114.

[0032] Additionally, any other known mechanism may be employed to translate longitudinal movement of one of the inner and outer bodies (114, 112, respectively) into rotation of the other of the inner and outer bodies (114, 112, respectively) without departing from the teachings of the present application. Further, as one skilled in the art will appreciate, groove 132 may be replaced by a helical protrusion on one of the outer and inner bodies 112, 114, which may be engaged by a protrusion or protrusions extending from the other of the outer and inner bodies 112, 114.

[0033] Operation of system 100 will be described with reference to handle 200 in FIG. 1B . However, one skilled in the art will understand that user operation is substantially the same for both handles 200. As described above, first control wire 140 extends through a first one of inner coils 120 from a proximal end coupled to push button 208 to a distal end 142 coupled to distal disk 116 of clip 102. In this embodiment, inner coil 120 with first control wire 140 extending therethrough passes through flange 128 and then through lumen 113 that extends through outer body 112 from the proximal end to the distal end where it exits outer body 112. First control wire 140 extends distally from inner coil 120 and couples to distal disk 116. When the inner coil 120, through which the first control wire 140 extends, is received within the lumen 113 of the outer body 112, the inner coil 120 and the first control wire 140 are prevented from rotating relative to the outer body 112.

[0034] A second control wire 144 extends within the other inner coil 120 from a proximal end coupled to the push button 208, through a lumen within the inner body 114, and to a distal end 146 coupled to the proximal disk 118 of the clip 102. Thus, the inner coil 120 and second control wire 144 are prevented from rotating relative to the inner body 114. Because the first control wire 140 cannot rotate relative to the outer body 112 and the second control wire 144 cannot rotate relative to the inner body 114, rotation of the inner body 114 relative to the outer body 112 causes the first and second control wires 140, 144 to rotate relative to each other. This causes the proximal disk 118 and distal disk 116 of the clip 102 (to which the first and second control wires 140, 144 are coupled) to rotate relative to each other, opening and closing the clip 102.

[0035] As seen in FIG. 1 , the distal end 142 of the first control wire 140 is coupled to the distal disc 116 via a first protrusion 148 extending radially outward from the radially outermost edge of the distal disc 116. This allows the first control wire 140 to extend distally through the radially outer portion of the outer body 112 and engage the clip 102. The second control wire 144 is coupled to the proximal disc 118 via a second protrusion 150 extending radially inward from the radially inner surface of the proximal disc 118, with the first and second protrusions 148, 150 being separated from each other around the circumference of the clip 102. The separation angle between the first and second protrusions can be, for example, in the range of 10 to 180 degrees. Those skilled in the art will appreciate that the smaller this angle, the greater the rotational stroke provided to open the clip. In other words, if this angle is set to 10 degrees, the central opening of the clip 102 can be made larger because the protrusion can be moved by a 260 degree rotation (e.g., from an initial 10 degree position to a final position of 270 degrees), whereas if the initial separation angle is 180 degrees, only about a 90 degree rotation (e.g., from an initial 180 degree position to a final position 270 degrees apart) is possible.

[0036] Thus, when the inner body 114 rotates relative to the outer body 112 and flange 128, the second control wire 144 rotates with the inner body 114 relative to the outer body 112 and first control wire 140. This, in turn, rotates the proximal disc 118 relative to the distal disc 116, opening and closing the clip 102, as shown in FIG. 7A and described in more detail below. Those skilled in the art will understand that the first control wire 140 and the second control wire 144 must each have a sufficient degree of longitudinal stiffness to apply the desired rotational forces to the proximal disc 118 and distal disc 116 against the clip's natural bias (described in more detail below). The first and second control wires in this embodiment are formed from hardened stainless steel. However, those skilled in the art will understand that Nitinol or any other suitable material could be used.

[0037] The distal disc 116 of the clip 102 includes a plurality of flexible first arcuate members 154, each of which extends within a central opening 155 of the distal disc 116 from a first end 156 attached to the distal disc 116 to a second end 158. The second end 158 of each of the first arcuate members 154 is coupled to a second end 162 of a corresponding flexible second arcuate member 160. In addition, the second end 158 of each of the first arcuate members 154 rests against an adjacent one of the first arcuate members 154. Each of the second arcuate members 160 extends from its second end 162 to a first end 164 attached to the proximal disc 118. Similarly, the second end 162 of each of the second arcuate members 160 rests against an adjacent one of the second arcuate members 160.

[0038] In this embodiment, when the clip 102 is in the closed configuration (i.e., when the second ends 158, 162 of the first and second arcuate members 154, 160 are in their radially innermost positions), each of the first arcuate members 154 extends along an arc that is substantially circular, and the corresponding second arcuate member extends away from its corresponding first arcuate member second end 158 along an arc that is a continuation of the same circle. Those skilled in the art will understand that non-circular shapes may be employed as desired, with any arcuate member arc size depending on the diameter of the clip.

[0039] 5, the first end 156 of each of the first arcuate members 154 is moved toward the first end 164 of its corresponding second arcuate member 160. This pushes all of the second ends 158, 162 radially outward toward the radially inner surfaces of the proximal and distal disks 118, 116, respectively, and each of the second ends 158, 162 pushes the second end of an adjacent one of the first and second arcuate members 154, 160 radially outward, increasing the size of the central opening 155, as seen in FIG. As will be understood by one skilled in the art, the spool 206 and groove 132 are configured such that, when fully actuated, the amount of proximal-distal movement of the outer body 112 relative to the inner body 114 produces an amount of rotation of the proximal disc 118 relative to the distal disc 116 that will bring the clip 102 from a fully closed configuration (i.e., the central opening 155 is at its smallest diameter) to a fully open configuration (the central opening 155 is at its largest diameter).

[0040] 5 , the clip 102 is moved away from the fully open configuration and back toward the fully closed configuration. Furthermore, as will be appreciated by those skilled in the art, the first and second arcuate members 154, 160 are each biased to rotate the proximal disc 118 in the direction opposite to arrow A, such that the clip 102 naturally returns to the fully closed configuration when not acted upon by an external force. The clip 102 of this embodiment is formed from a biocompatible plastic, such as PEEK, polypropylene, PU, ​​PVC, or PC.

[0041] As explained in more detail below, the user may then open and close the clip 102 as frequently as desired by moving the spool 206 in a desired direction relative to the body 204 of the handle 200 and rotating the inner body 114 relative to the outer body 112 as desired (i.e., achieving rotation of the proximal disc 118 relative to the distal disc 116, corresponding to opening or closing the clip 102). In fact, the user can generally achieve closure of an open clip 102 by simply releasing the spool 206, such that the clip 102 returns to the fully closed configuration under its own natural biasing force. As seen in FIG. 4 , the first control wire 140 extends through the inner coil 120 and extends through the first protrusion 148.

[0042] An enlarged end 143 at the distal end of first control wire 140 prevents first control wire 140 from being pulled proximally through the opening in first protrusion 148. After the user has positioned clip 102 as desired (e.g., after visually confirming that the targeted portion of tissue has been clipped by clip 102 as desired), the user may finally deploy clip 102 by separating clip 102 from system 100 (see FIGS. 6 and 7F). To do so, the user holds the distal end of inner coil 120 against the proximal surface of first protrusion 148, preventing inner coil 120 from moving proximally.

[0043] Simultaneously, the user applies a proximal force to the first control wire 140 by sliding the push button 208 proximally relative to the spool 206 until a predetermined tension is applied to the first control wire 140 and the enlarged end 143 moves away from the proximal portion of the first control wire 140. If the user holds the distal end of the other inner coil 120 in place against the proximal surface of the second protrusion 150 while moving the push button 208 proximally relative to the spool 206 to apply a predetermined tension to the second control wire 144, actuation of the spool 206 and the push button 208 will simultaneously perform the same action on the second control wire 144 (which, in this embodiment, has substantially the same connections as the second protrusion 150). When the enlarged ends of both the first and second control wires 140, 144, respectively, are separated from their proximal portions, the clip 102 is completely separated from the system 100 and remains closed, clipping over the target tissue under its own natural deflection force.

[0044] Those skilled in the art will appreciate that once the user determines that the clip 102 is positioned as desired and the user wishes to finally deploy the clip 102, the user may choose to use the liner lock 210 on the handle 200 to lock the spool 206 in place with the distal end of the inner coil 120 abutting the proximal portion of the clip 102. This may facilitate operation of the push button 208 to fire the clip 102. In an alternative embodiment, the first and second control wires 140, 144 and the first and second protrusions 148, 150 may be configured such that the first and second protrusions 148, 150 cannot release the first and second control wires 140, 144 intact from the clip 102 once a predetermined tension is reached.

[0045] In use, the flange 128 and cap 110 (coupled to the inner coil 120, the first and second control wires 140, 144, and the clip 102) are fitted over the endoscope 106 (e.g., a flexible endoscope), e.g., via a friction fit, and the outer coil 122 (housing the inner coil 120 and the first and second control wires 140, 144) extends along the length of the insertion device 104 and, if desired, is secured thereto. The push button 208 is operated to move the first and second control wires 140, 144 proximally until the clip 102 is drawn proximally into contact with the cap 110, and the spool 206 is operated to move the inner coil 120 such that the outer body 112 moves relative to the inner body 114 to position the clip 102 in a closed position. The user then inserts the insertion device 104 equipped with the system 100 into the patient's body (e.g., through a natural body orifice) and manipulates the insertion device 104 within the body (e.g., through a natural body lumen) until the clip 102 is in the desired position relative to the portion of tissue to be clipped.

[0046] The user then manipulates the spool 206 to move the clip 102 to a fully open configuration ( FIG. 7A ) and draw the target tissue through the central opening 155 of the clip 102 and into the interior space of the cap 110 (e.g., within the interior space defined by the inner body 114) ( FIG. 7B ). As will be understood by one skilled in the art, tissue may be drawn through the central opening 155 of the clip 102 by, for example, a grasper advanced into the cap 110 through a working channel of an endoscope that opens into the open interior space of the inner body 114, or by applying suction to the interior of the cap 110 by application of negative pressure to the working channel of the endoscope 106.

[0047] The user then manipulates the spool 206 to move the clip 102 to the fully closed configuration, such that the natural biasing forces of the first and second arcuate members 154 and 160, respectively, clamp the central opening 155 around the target tissue (FIG. 7C). The user may then retract the endoscope 106 and cap 110 to the probing configuration, proximally away from the clip 102, which remains clipped in place over the target tissue (FIG. 7D). To do this, the user moves the push button 208 distally relative to the spool 206, advancing the first and second control wires 140, 144, respectively, as the cap 110 is moved proximally, such that the clip 102 remains coupled to the system 100 while the endoscope 106 and cap 110 are spaced apart therefrom. In this position, the user has a wider field of view and can better probe whether the clip 102 has clipped across the target tissue as desired. If the user determines that the clip 102 is not properly positioned, the user operates the push button 208 to retract the first and second control wires 140, 144 proximally while advancing the endoscope 106 distally so that the distal end of the cap 110 approaches the clip 102.

[0048] The user then manipulates spool 206 to return clip 102 to the fully open configuration and pulls endoscope 106 and cap 110 proximally to separate clip 102 from the previously clipped tissue (FIG. 7E). The user may then view the target site and reposition endoscope 106 and cap 110 so that clip 102 is positioned as desired relative to the target tissue to be clipped. The user then pulls a new portion of tissue through central opening 155 in the same manner as described above and actuates spool 206 to close clip 102 onto this new portion of target tissue.

[0049] The system may then be retracted to the probing configuration so that the user can determine whether the clip 102 has been clipped over the target tissue as desired. This procedure can be repeated as many times as necessary until the user is satisfied with the placement of the clip 102. Once the user determines that the clip 102 has been clipped onto the target tissue as desired, the user advances the endoscope 106 distally by moving the push button 208 proximally on the spool 206 and retracting the first and second control wires 140, 144 proximally into the inner coil 120 so that the distal end of the cap 110 approaches the clip 102. The user then advances the inner coil distally until the inner coil 120 abuts the proximal faces of the first and second protrusions 148, 150.

[0050] The user then pulls the push button 208 proximally relative to the spool 206 to apply a proximally directed force to the first and second control wires 140, 144 while maintaining the inner coil 120 in position relative to the first and second protrusions 148, 150 until a predetermined tension is reached at which the enlarged ends of the first and second control wires 140, 144 separate from their proximal portions. Once the enlarged ends of both the first and second control wires 140, 144, respectively, are separated from their proximal portions, the clip 102 is completely separated from the system 100 and remains closed, clipped over the target tissue under its own natural deflection force (FIGS. 6 and 7F).

[0051] As mentioned above, the clip 102 can be attached to an insertion device, which can include any standard endoscope 106. The clip 102 may be attached to the endoscope 106 via a cap 110 that is sized, shaped, and configured to fit over the distal end of the endoscope 106. As will be appreciated by those skilled in the art, the endoscope 106 is configured to be inserted through a body lumen to a target area within the lumen and, therefore, must be sufficiently flexible to navigate through even the tortuous paths of the body lumen.

[0052] Cap 110 extends from the proximal end to the distal end and includes a channel extending therethrough (i.e., the proximal end of cap 110 is open so that the vision system, working channel, and other features of the distal end of endoscope 106 open into the channel of cap 110). In one embodiment, cap 110 is substantially cylindrical. However, it will be understood by those skilled in the art that cap 110 may have any of a variety of shapes and configurations, so long as cap 110 is configured to fit over the distal end of endoscope 106 and includes a channel sized and shaped to receive the target portion of tissue to be clipped.

[0053] It will be apparent to those skilled in the art that various changes can be made in the present disclosure without departing from the scope of the disclosure. Furthermore, those skilled in the art will understand that the features of any of the various embodiments can be combined in any manner consistent with the description and / or functionality of the embodiments.

Claims

1. 1. A clipping system for treating tissue, the system comprising: a cap configured to fit over a distal end of an insertion device, the cap extending from a proximal end to a distal end and including a channel extending therethrough, the cap including a first cap member and a second cap member, the first cap member being rotatable relative to the second cap member; a clip including a peripheral body including a first portion rotatably coupled to a second portion, a plurality of first flexible members coupled to the first portion, and a corresponding plurality of second flexible members coupled to the second portion, each of the first flexible members coupled to a corresponding one of the second flexible members to form a throttling mechanism that operates to change the size of a central opening of the clip when the first and second portions are rotated relative to one another from a fully open configuration in which the central opening is of a maximum size configured to receive target tissue therein, to a fully closed configuration in which the central opening is of a minimum size configured to clip target tissue received therein; a first coupling member coupled between the first cap member and the first portion of the clip; a second coupling member coupled between the second cap member and the second portion of the clip such that when the first cap member is rotated relative to the second cap member, the first portion of the clip is rotated relative to the second portion of the clip; Including, the system.

2. 2. The system of claim 1, wherein the first cap member includes a helical feature and the second cap member includes a coupling arrangement that engages the helical feature such that linear movement of the first cap member relative to the second cap member rotates the first cap member relative to the second cap member.

3. The system of claim 2 , wherein the spiral feature is a groove and the coupling arrangement includes a protrusion extending from the second cap member into the groove of the first cap member.

4. 3. The system of claim 2, wherein: further comprising a cap coupling arrangement configured to attach the cap to the insertion device; the first cap member is coupled to a cap coupling arrangement such that the first cap member can move longitudinally relative to the cap coupling arrangement, and engagement between the helical feature of the first cap member and the coupling of the second cap member translates longitudinal movement of the first cap member relative to the cap coupling arrangement into rotation of the second cap member relative to the first cap member.

5. The system of any one of claims 1 to 4, wherein the first and second flexible members are configured to bias the throttle mechanism toward the fully closed configuration.

6. The system of claim 5 , wherein each of the first and second flexible members extends substantially along an arc.

7. 6. The system of claim 5, wherein the first portion of the clip is a first disk having a distal surface and the second portion of the clip is a second disk having a proximal surface adjacent the distal surface of the first portion.

8. The system of claim 7 , wherein the first and second flexible members extend into central spaces of the first and second disks, respectively.

9. 5. The system of claim 4, wherein: The system further includes a pull wire coupled to the first cap member, wherein movement of the pull wire relative to the cap coupling arrangement causes the first cap member to move longitudinally relative to the cap coupling arrangement.

10. The system of any one of claims 1 to 9, wherein the throttle mechanism is configured such that the central opening of the throttle mechanism is opened when the first portion of the clip is rotated relative to the second portion of the clip in a direction that reduces the distance between a connection point between each first flexible member and the first portion of the clip and a connection point between a corresponding one of the second flexible members and the second portion of the clip.

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