Repositionable out-of-range clip with compliant mechanism

Abstract

A system includes a clamp, a first control member, and an adapter including a channel extending from a proximal end to a distal end. The clip includes a base mounted on the periphery of the adapter and an arm extending distally from the base. The arms are movable relative to each other between inserted and initially deployed configurations. A first member is releasably coupled to the portion and movably connected to the adapter such that longitudinal movement of the first member relative to the adapter moves the clamp between an insertion configuration, an initial deployment configuration, and an inspection configuration. The first member is operable to retract the clip proximally on the adapter toward the insertion configuration such that the arms are forcibly opened when the clip is retracted on the adapter, releasing the clip from tissue that has been clamped thereon.

Description

[0001] This disclosure claims priority to U.S. Provisional Patent Application Serial No. 63 / 366,216, filed on June 10, 2022; the disclosure of that application is incorporated herein by reference. Technical Field

[0002] The present disclosure relates to endoscopic devices, and more particularly to endoscopic gripping devices for manipulating tissue along the gastrointestinal tract. Background Art

[0003] Physicians are increasingly willing to perform aggressive invasive and therapeutic endoscopic gastrointestinal (GI) procedures, which may increase the risk of perforating the wall of the GI tract or may require closure of the wall of the GI region as part of the procedure. Such procedures may include, for example, removal of large lesions, opening of submucosal openings in the GI tract to address problems below the mucosa, removal of full thickness tissue, addressing problems in other organs by accessing procedures outside the GI tract, and endoscopic treatment / repair of postoperative problems (e.g., postoperative leaks, damage to surgical staple lines, and anastomotic leaks).

[0004] Currently, tissue can be processed via endoscopic closure devices that include through-the scope clips or over-the-scope clips. Over-the-scope clips may be particularly useful for achieving closure of larger tissue defects. These endoscopic closure devices can save costs for hospitals and provide benefits to patients. However, in some cases, current endoscopic closure devices may be difficult to use, time-consuming to locate, or insufficient for certain perforations, conditions, and anatomical structures. For example, current over-the-scope clips typically require the clamp to be activated from a position where the operator cannot see the clamp itself. That is, before clamping, the operator may view the target tissue to be clamped, and based on the visualization of the target tissue, it can be determined that the distal end of the device and the clamp is in the desired position relative to the target tissue. Based on the observation of the target tissue, the operator then deploys the clamp without viewing the clamp itself until the clamp is deployed. Once deployed, such current over-the-scope clips cannot usually be repositioned. Summary of the invention

[0005] The present invention relates to a clamping system for treating tissue, which includes an adapter configured to be mounted on the distal end of an insertion device. The adapter extends from a proximal end to a distal end and includes a channel extending therethrough. The system also includes a clamp, which includes a base configured to be mounted on the periphery of the adapter and a plurality of arms extending distally from the base. The plurality of arms can be moved relative to each other between an insertion configuration and an initial deployment configuration, in which the plurality of arms extend along the outer surface of the adapter so that the distal ends of the plurality of arms are separated from each other in an open configuration to receive tissue therebetween, and in the initial deployment configuration, the clamp is moved distally away from the adapter so that the distal ends of the plurality of arms are restored toward a biased closed configuration in which their distal ends are pulled toward each other to grasp tissue therebetween. The system further comprises a first control member, the first control member being releasably coupled to the base of the clamp and movably connected to the adapter, such that longitudinal movement of the first control member relative to the adapter causes the clamp to move between an insertion configuration, an initial deployment configuration, and an inspection configuration, wherein the adapter is allowed to be withdrawn proximally away from the clamp while the first control member remains coupled to the clamp to enhance visual observation of the clamp, and the first control member is operable to retract the clamp proximally on the adapter toward the insertion configuration, such that the plurality of arms are forced to open when the clamp is retracted on the adapter, releasing the clamp from tissue clamped thereon.

[0006] In one embodiment, the first control member includes an enlarged distal end (the original text does not have the word "end", which should be a mistake), which is engaged with the distal side of the base, so that the remaining length of the first control member extends proximally through the opening of the base to a proximal end accessible to a user, and the enlarged distal end of the first control member is connected to the remaining length of the first control member via a joint, and the joint is configured to release when subjected to a force exceeding a predetermined threshold.

[0007] In one embodiment, the system further includes a first extension member, which is configured to slidably accommodate a first control member therein, so that the enlarged distal end of the first control member extends distally from the distal end of the first extension member to couple to the base of the clamp, and the proximal movement of the first control member relative to the first extension member is configured to pull the clamp against the distal end of the first extension member to release the joint and move the clamp toward a final deployment configuration.

[0008] In one embodiment, each of the multiple arms includes a proximal portion and a distal portion, which are movably connected to each other via a hinge, and the hinge biases each of the multiple arms toward a closed configuration, wherein the proximal portion and the distal portion of each arm are bent relative to each other so that the distal end extends toward the longitudinal axis of the adapter.

[0009] In one embodiment, the distal portion of each of the plurality of arms includes an engagement feature extending laterally therefrom to engage the distal end of the adapter when the clamp is pulled proximally on the adapter to prevent further proximal movement of the clamp relative to the adapter.

[0010] In one embodiment, when the engagement feature engages the distal end of the adapter, the distal portions of the respective plurality of arms engage the adapter to hold the plurality of arms toward the open configuration.

[0011] In one embodiment, the distal end of the adapter includes a lip projecting radially outwardly therefrom.

[0012] In one embodiment, the distal end of each arm extends laterally inward relative to each other and includes tissue grasping features.

[0013] In one embodiment, the base is annular.

[0014] In one embodiment, the system further includes: a second control member, which is releasably coupled to the base of the clamp and movably connected to the adapter, so that longitudinal movement of the second control member relative to the adapter causes the clamp to move between an insertion form, an initial deployment form and an inspection form; and a second extension member, which extends longitudinally from a user-accessible proximal end to a distal end of the system, and the second control member is slidably received in the second extension member, so that the distal end of the second control member extends distally from the distal end of the second extension member to couple to the clamp.

[0015] The clamping system for processing tissue comprises: an endoscope, which extends longitudinally from a proximal end to a distal end; an adapter, which can be mounted on the distal end of the endoscope so that the channel of the adapter is aligned with the longitudinal axis of the endoscope; a clamp, which includes: an annular base, which is configured to be mounted on the adapter; and a plurality of arms, which extend distally from the base, the plurality of arms being movable relative to each other between an insertion configuration and an initial deployment configuration, wherein the plurality of arms extend along an outer surface of the adapter in the insertion configuration so that the distal ends of the plurality of arms are separated from each other in the open configuration to receive tissue therebetween, and in the initial deployment configuration the clamp moves distally away from the adapter so that the distal ends of the plurality of arms return toward a biased closed configuration in which the distal ends are pulled toward each other to grasping tissue therebetween; and first and second control members releasably coupled to the base of the clamp and movably connected to the adapter, whereby longitudinal movement of the first and second control members relative to the adapter causes the clamp to move between an insertion configuration, an initial deployment configuration, and an inspection configuration, wherein the inspection configuration allows the endoscope to be withdrawn proximally away from the clamp while the first and second control members remain coupled to the clamp to enhance visual observation of the clamp through the endoscope, the first and second control members being operable to retract the clamp proximally on the adapter toward the insertion configuration, whereby the plurality of arms are forced to open as the clamp is retracted on the adapter, releasing the clamp from tissue clamped thereon.

[0016] In one embodiment, the first control member and the second control member each include an enlarged distal end that engages with the distal side of the base, and the remaining length of the first control member extends proximally through the opening of the base to a proximal end of the first control member accessible to a user, and the enlarged distal end of the first control member is connected to the remaining length of the first control member via a joint, and the joint is configured to release when subjected to a force exceeding a predetermined threshold.

[0017] In one embodiment, the system further comprises a first extension member and a second extension member, the first extension member and the second extension member extending longitudinally from a user-accessible proximal end to a distal end of the system, the first extension member and the second extension member each being configured to slidably accommodate a corresponding one of the first control member and the second control member therein, such that pulling the clamp proximally against the distal ends of the first extension member and the second extension member via the first control member and the second control member releases the clamp from the proximal portion of the first control member and the second control member.

[0018] In one embodiment, each arm includes a proximal portion and a distal portion, which are movably connected to each other via a hinge, and the hinge biases each arm toward a closed configuration, wherein the proximal portion and the distal portion of the first arm are bent relative to the distal portion of the second arm, so that the distal ends of the first arm and the second arm extend toward the longitudinal axis of the adapter.

[0019] In one embodiment, the adapter includes a lip that projects radially outward from a distal end of the adapter, such that when the distal portion of the arm engages the lip, the distal portion of the arm is lifted above the adapter.

[0020] The present disclosure also relates to a method for treating tissue, the method comprising: inserting a clamp into a target area in a body cavity via an endoscope, the clamp being mounted on the distal end of the endoscope via an adapter in an open insertion form, wherein in the open insertion form, the base of the clamp is mounted on the adapter so that arms extending distally from the base extend along the outer surface of the adapter and the distal ends of the arms of the clamp are separated from each other; pulling tissue into a channel of the adapter and between the arms of the clamp; moving the clamp from the open insertion form toward an initial deployment form by moving the clamp distally relative to the endoscope, the distal end of a control member being releasably coupled to the base of the clamp so that the control member pushes the clamp distally away from the adapter, releasing the arms to recover toward a biased closed form, in which the distal ends of the arms extend toward each other to grasp tissue therebetween; and pulling the endoscope proximally away from the clamp while the clamp remains coupled to the distal end of the control member toward an inspection form, in which visualization of the clamp is enhanced via the endoscope.

[0021] In one embodiment, when it is determined that the clamp needs to be repositioned, the control member is pulled proximally relative to the endoscope until the clamp is pulled proximally on the adapter toward the open insertion configuration and the clamp is repositioned over the target tissue.

[0022] In one embodiment, the method further includes moving the clamp from an inspection configuration toward a final deployment configuration by pulling a control member proximally relative to the endoscope, whereby the clamp is pulled proximally against a distal end of an extension member, and the control member is slidably received by the extension member until a force applied to the control member exceeds a predetermined threshold force, separating the enlarged distal end of each control member from its remaining length to release the clamp from the endoscope.

[0023] In one embodiment, the enlarged distal end of each control member is positioned to abut the distal surface of the base of the clamp, so that the remaining length of each control member extends proximally through the opening of the base, and the distal end of the extension member is positioned adjacent to the base of the clamp, so that the control member and the extension member move simultaneously relative to the endoscope to move the clamp between the open insertion form, the initial deployment form and the inspection form.

[0024] In one embodiment, moving the clamp toward the final deployed configuration includes moving the extension member distally relative to the endoscope until the distal end is positioned against a proximal surface of the base of the clamp such that the clamp can be pulled proximally thereagainst. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1showing a perspective view of a distal portion of a clamping system according to an exemplary embodiment of the present disclosure; Figure 2 Show according to Figure 1 A perspective view of a fixture of an exemplary system; Figure 3 Shown in open insertion configuration Figure 1 A longitudinal side view of a distal portion of the clamping system; Figure 4 Shown in closed form Figure 1 a perspective view of a distal portion of the clamping system; and Figure 5 Show according to Figure 1 An enlarged perspective view of an exemplary system of a control member and an extension member connected to a clamp. DETAILED DESCRIPTION

[0026] The present disclosure may be further understood with reference to the following description and accompanying drawings, wherein similar elements are indicated by the same reference numerals. The present disclosure relates to a clamping system, and more particularly to an over-the-range endoscope clamping system, wherein the initial placement of the clamp may be observed and adjusted prior to its final deployment. An exemplary embodiment of the present disclosure includes a clamp that may be mounted on the distal end of an endoscope via an adapter. The clamp is releasably coupled to the distal end of a control member, which is slidably received in an extension member. The clamp may be moved between an insertion configuration, an initial deployment configuration, and an inspection configuration via movement of the control member and / or the extension member relative to the endoscope. In this embodiment, the clamp includes a base designed to be mounted on an adapter in size and shape and a plurality of arms extending distally from the base. The arms may be moved between an open configuration and a closed configuration, wherein the distal ends of the arms are separated from each other to allow tissue to be received therebetween, and wherein the distal ends of the arms are moved toward each other to grasp tissue in a closed configuration.

[0027] In the insertion configuration, the clamp is mounted on the adapter with the base extending around the periphery of the adapter and the proximal portions of the arms extending distally from the base along the exterior of the adapter to hold the arms in the open configuration. The clamp is held in the insertion configuration to facilitate insertion of the endoscope into a target site near the tissue to be clamped, thereby minimizing the position of the clamp from obstructing the view of the endoscope's vision system. The arms are biased toward the closed configuration so that when the clamp is moved distally away from the adapter and the arms are extended distally beyond the distal end of the adapter, the arms are free to rebound radially inwardly to the closed configuration (e.g., clamped on tissue in the initial expanded configuration) under their natural bias.

[0028] The system allows the endoscope to be pulled proximally away from the clamp and the tissue it is clamped on, while the clamp remains coupled to the endoscope via a control member. As the endoscope is withdrawn proximally while the clamp remains in place over the target tissue, the field of view of the endoscope's visual system widens to display the clamp and the clamped tissue, so that the operator can determine whether the position of the clamp is as expected or needs to be adjusted. If the operator determines that the clamp is positioned as expected, the clamp is moved toward the final deployed configuration by releasing the clamp from the control member, so that the clamp is left in the appropriate position clamped on the target tissue, while the remainder of the device including the adapter and the endoscope is withdrawn from the body. If the operator determines that the position of the clamp needs to be adjusted, the endoscope and the adapter coupled thereto are moved distally to a position adjacent to the clamp. The clamp is then pulled proximally back onto the adapter (via proximal retraction of the control member) to reopen the clamp, and the arms of the clamp are forced open as the clamp is pulled proximally back onto the adapter, returning the clamp to the insertion configuration.

[0029] After removing the clamp from the tissue and returning it to the insertion configuration, the operator can reposition the endoscope and device as needed to pull a new portion of tissue into the adapter (e.g., under suction or by applying a grasper, such as through the working channel of the endoscope). The user can then deploy the clamp from the adapter again in this new position so that it closes on the new portion of tissue (i.e., returns to the initial deployment position). Then, while the clamp remains coupled to the device, the endoscope is withdrawn proximally again, so that the device moves to the inspection configuration again. The position of the clamp and the clamped tissue is observed again, and this process is repeated until the operator determines that the clamp has been positioned as expected. When the operator sees that the tissue above which the clamp is closed is the expected tissue portion, the clamp can be released from the control member and is in the final deployment configuration. It should be understood by those skilled in the art that the terms proximal and distal as used herein refer to the direction toward and away from the user of the device, respectively.

[0030] like Figures 1 to 5 As shown, a clamping system 100 for treating tissue defects and / or perforations according to an exemplary embodiment includes a clamp 102 configured to be inserted into a target area through, for example, a body cavity to clamp its target tissue. The clamp 102 can be inserted into the target area via an insertion device 104 including, for example, an endoscope 106. Figure 1As shown, the clamp 102 is coupled to the distal end 108 of the endoscope 106 via the adapter 110, and the adapter 110 is mounted on the distal end 108 of the endoscope 106. According to an exemplary embodiment, the clamp 102 includes a base 112 configured to be slidably mounted on the adapter 110 and a plurality of arms 114 extending distally from the base 112, and the arms 114 can be moved between an open configuration and a closed configuration, in which the distal ends 124 of the arms 114 are separated from each other, and in which the distal ends 124 are pulled toward each other. The clamp 102 can be releasably coupled to the control member 116, and the clamp 102 can be moved between an insertion form, an initial deployment form and an inspection form via the control member 116. In the insertion form, the clamp 102 is mounted on the adapter 110 in an open form, in the initial deployment form, the clamp 102 is pushed distally away from the adapter 110 toward a closed form, and in the inspection form, the clamp 102 moves away from the distal end 108 of the endoscope 106 to widen its field of view.

[0031] In an exemplary embodiment, each control member 116 includes a distal end 120 coupled to the clamp 102, and the distal end 120 is connected to the remaining length of the control member 116 via a releasable joint 160, so that when it is necessary to move the clamp 102 toward final deployment, the clamp 102 can be released from the control member 116 via the release and / or separation of the joint 160. Each control member 116 extends through a corresponding extension member 118, so that the distal end 120 of the control member 116 extends distally beyond the distal end 122 of the extension member 118 to couple to the clamp 102. As will be described in further detail below, the release of the joint 160 can be facilitated by pulling the control member 116 relative to the extension member 118.

[0032] In the insertion configuration, the clamp 102 is mounted on the adapter 110 such that a portion of the plurality of arms 114 extends along the exterior of the adapter 110, holding the arms 114 in an open configuration in which the distal ends 124 of the arms 114 are separated from one another so that tissue can be received therebetween. To move the clamp 102 from the insertion configuration toward the initial deployment configuration, the extension member 118 (and the control member 116) are moved distally relative to the adapter 110, pushing the clamp 102 away from the adapter 110, thereby moving the plurality of arms 114 toward a closed configuration in which the distal ends 124 move toward one another to clamp tissue therebetween. When clamping tissue in the initial deployment configuration, the clamp 102 can be moved toward the inspection configuration by pulling the endoscope 106 proximally away from the clamp 102 (or by moving the clamp 102 distally away from the distal end 108), while remaining constrained to the insertion device 104 via the control member 116 and the extension member 118. This widens the field of view of the endoscope's visual system relative to the clamp 102 and the target tissue. As described below, if the user determines that the position of the clamp 102 is incorrect or undesirable, the user can move the endoscope 106 distally to a position adjacent to the clamp 102.

[0033] The clamp 102 may then be retracted over the adapter 110 toward the open insertion configuration by pulling the control member 116 (and the extension member 118) proximally relative to the adapter 110. The user may then reposition the endoscope 106 and clamp 102 and repeat these steps, thereby adjusting the placement and / or position of the clamp 102 relative to the target tissue as desired prior to final deployment of the clamp 102. That is, if the operator determines in the review mode that the clamp 102 is not positioned as desired, the clamp 102 may be reopened and removed from the tissue, thereby repositioning the device until the clamp 102 is closed on the desired tissue portion. Once it is determined that the clamp 102 has been clamped on the target tissue as desired, the clamp 102 may be moved toward the final deployment configuration by releasing the clamp 102 from the control member 116.

[0034] As described above, the clamp 102 includes a base 112 and a plurality of arms 114 extending distally therefrom. The size and shape of the base 112 are designed to be mounted on the adapter 110 so that the base 112 extends around its periphery. In one embodiment, the base 112 can be generally annular. However, those skilled in the art will appreciate that the base 112 can have a variety of shapes and sizes as long as the size, shape and configuration of the base 112 are designed and configured to be slidably mounted on the adapter 110.

[0035] According to an exemplary embodiment, the base 112 includes a pair of openings 166 extending longitudinally therethrough from the proximal side 162 of the base 112 to the distal side 156. Each opening 166 is configured to receive a portion of a corresponding one of the control members 116 therethrough. In one embodiment, the openings 166 may extend through areas of the base 112 that are diametrically opposed to each other. Although two openings 166 are shown and described in the exemplary embodiment, it should be understood by those skilled in the art that the base 112 may include any number of openings 166 as long as the number of openings 166 corresponds to the number of control members 116 of the insertion device 104.

[0036] like Figures 2 to 4 As shown, a plurality of arms 114 extend distally from the base 112 to a distal end 124, each arm 114 including a proximal portion 126 and a distal portion 128 that are movable relative to each other between an open configuration and a closed configuration. According to an exemplary embodiment, the plurality of arms 114 are biased toward a closed configuration, wherein the distal ends 124 are pulled toward each other. In this embodiment, the proximal portion 126 and the distal portion 128 of each arm 114 are angled and / or curved relative to each other, such that, according to one embodiment, in the biased closed configuration, the proximal portion 126 extends substantially parallel to the longitudinal axis of the adapter 110, while the distal portion 128 extends at an angle relative to the longitudinal axis of the adapter 110. In this embodiment, the distal portion 128 is angled relative to the proximal portion 126, such that the distal end 124 tapers toward the longitudinal axis of the adapter 110.

[0037] The proximal portion 126 and the distal portion 128 of each arm 114 can be connected to each other via a hinge 130, which allows the clamp 102 to move between the closed configuration and the open configuration. In an exemplary embodiment, the hinge 130 is spring-biased, biasing the arms 114 toward the closed configuration. Specifically, when the clamp 102 is mounted on the adapter 110 in the inserted configuration, the arms 114 extend along a portion of the adapter 110 so that the outer surface 164 of the adapter 110 holds the clamp 102 toward the open configuration, and the distal ends 124 of the arms 114 are separated from each other.

[0038] In one example, in the open configuration, the proximal portion 126 and the distal portion 128 of the arm 114 can be substantially straight relative to each other, so that the tissue receiving space between the distal ends 124 is larger than that of conventional clamps. However, when the clamp 102 moves distally away from the adapter 110 toward the initial deployment configuration, the arms 114 are allowed to return to their biased closed configuration, and the distal portion 128 is bent relative to the proximal portion 126 via the hinge 130, so that tissue can be clamped between the distal ends 124. In one embodiment, the hinge 130 can be configured as a curved portion of the arm 114 connecting the proximal portion 126 and the distal portion 128. It should be understood by those skilled in the art that the hinge 130 and / or the plurality of arms 114 can each be formed of a variety of materials, as long as the hinge 130 biases each arm 114 toward the closed configuration, as described above, and the bias is thereby strong enough to maintain the clamp 102 in a clamped position above the target tissue after the clamp 102 is finally deployed. In one example, portions of the clamp 102 (eg, hinge 130 ) are formed from a shape memory alloy, such as Nitinol, to provide and / or increase the bias toward the closed configuration.

[0039] The distal portion 128 of the arm 114 includes an engagement feature 132 extending therefrom that is configured to engage a portion of the adapter 110 such that when the engagement feature 132 engages the adapter 110, the arm 114 is prevented from further proximal movement relative to the adapter 110. According to an exemplary embodiment, the engagement feature 132 extends along the distal portion 128 and extends laterally therefrom to engage a distal end 138 of the adapter 110, for example.

[0040] In one embodiment, the engagement features 132 can be configured as wings extending laterally from the longitudinal edges of the arms 114, such that the distal portion 128 of the arms 114 has a greater width than the proximal portion 126 of the arms 114. When the arms 114 are moved from the closed configuration toward the open configuration, the arms 114 are pulled proximally on the adapter 110 until the proximal portion 126 and the hinge 130 extend along the outer surface 164 of the adapter 110. Once the hinge 130 is moved proximally on the adapter 110, the engagement features 132 along the distal portion 128 can abut a portion of the distal end 138 of the adapter 110. Figure 3 As shown, the engagement features 132 are positioned along the arms 114 such that where the engagement features 132 have engaged the adapter 110, the arms 114 have been sufficiently pulled proximally on the adapter 110 such that the arms 114, and specifically the distal portions 128 of the arms 114, move toward the open configuration.

[0041] Each distal end 124 of the arms 114 may include a gripping feature 134 configured to grip tissue contained between the distal ends 124. The gripping feature 134 of each arm 114 may extend laterally inwardly, and in one embodiment may include a radially inwardly bent portion, which may be generally hook-shaped. The gripping feature 134 may include, for example, teeth. Those skilled in the art will appreciate that the gripping feature 134 may have any of a variety of configurations, as long as the gripping feature 134 is configured to facilitate gripping tissue between the distal ends 124 when the clamp 102 is in the closed configuration. For example, in the closed configuration, as shown in FIG. Figure 4 As shown, the grasping features 134 may contact each other and / or extend toward each other to grasp tissue received between the distal ends 124 of the arms 114 .

[0042] Although the exemplary embodiment is shown as including four arms 114, those skilled in the art will appreciate that the clamp 102 may include any number of arms 114, as long as the clamp 102 includes at least two arms 114. In one embodiment, the arms 114 may be equally spaced from one another around the base 112. However, those skilled in the art will appreciate that the arms 114 may extend distally from the base 112 in any number of configurations, as long as the arms 114 are configured to grasp tissue between the distal ends.

[0043] As described above, the clamp 102 may be mounted on an insertion device 104, which may include any standard endoscope 106. The clamp 102 may be mounted on the endoscope 106 via an adapter 110, which is sized, shaped, and configured to be mounted on the distal end 108 of the endoscope 106. Those skilled in the art will appreciate that the endoscope 106 is configured to be inserted through a body cavity to a target area within the cavity, and therefore must be flexible enough to travel an even more tortuous path through the body cavity.

[0044] The adapter 110 extends from a proximal end 136 to a distal end 138 and includes a passage 140 extending therethrough. In one embodiment, the adapter 110 may be generally cylindrical. However, it will be appreciated by those skilled in the art that the adapter 110 may have any of a variety of shapes and configurations, as long as the adapter 110 is configured to be mounted on the distal end 108 of the endoscope 106. The adapter 110 may be mounted to the endoscope 106 via, for example, a friction fit, such that the passage 140 of the adapter 110 is substantially longitudinally aligned with the passage of the endoscope 106. Thus, tissue may be viewed through the passage 140 via a viewing system of the endoscope 106. In another embodiment, the adapter 110 may be formed of a transparent material to enhance visibility of the tissue and / or the clamp 102.

[0045] According to an exemplary embodiment, the adapter 110 can include a proximal portion 142 having a larger outer cross-section (e.g., diameter) than a remaining distal portion 148 of the adapter 110. The proximal portion 142 can include a pair of apertures 144 extending longitudinally through a wall 146 thereof. As will be described in further detail below, the pair of apertures 144 are each configured to slidably receive a corresponding one of the extension members 118 therein. The distal ends 122 of the extension members 118 extend distally beyond the distal openings of the apertures 144. Each extension member 118 slidably receives a corresponding one of the control members 116 therein, such that the distal ends 120 of the control members 116 extend distally beyond the distal ends 122 of the extension members 118 to releasably couple to the clamp 102.

[0046] The outer diameter of the distal portion 148 of the adapter 110 is sized, shaped and configured to allow the base 112 to be slidably received thereon in the inserted configuration. In an exemplary embodiment, the distal end 138 of the adapter 110 may include a radially outwardly projecting lip 150. Although the lip 150 projects beyond the outer diameter of the distal portion 148, the base 112 is sized and shaped to be slidable proximally thereon along the distal portion 148.

[0047] As will be described in further detail below, the lip 150 is configured such that when the base 112 slides proximally along the distal portion 148, the arm 114 slides along the lip 150, such that the lip 150 lifts the distal portion 128 of the arm 114 away from the longitudinal axis of the adapter 110. Specifically, when the arm 114 is pulled proximally on the lip 150, the distal portion 128 of the arm 114 moves relative to the proximal portion 126 of the arm via the hinge 130, such that the angle between the distal portion 128 and the proximal portion 126 increases, thereby moving the distal ends 124 of the arms away from the longitudinal axis of the adapter 110 and away from each other. According to an exemplary embodiment, the arm 114 moves proximally on the distal portion 148 of the adapter 110 until the engagement feature 132 abuts the distal end 138 of the adapter 110, preventing the clamp 102 from moving further proximally relative to the adapter 110. At this point, the lip 150 engages the proximal end of the distal portion 128 of each arm 114 to lift the distal portion 128 away from the longitudinal axis.

[0048] The extension members 118 extend along the length of the endoscope 106 from a proximal end accessible to a user, for example, via a user interface at the proximal end of the insertion device 104, to a distal end 122. As described above, each extension member 118 is slidably received within a corresponding one of the holes 144 extending through the proximal portion 142 of the adapter 110. Each extension member 118 may be configured, for example, as a nickel titanium alloy hypotube, a plastic tube, or any of a variety of structures having a coiled and / or substantially tubular shape. The extension members 118 may have any of a variety of configurations, as long as the extension members 118 are configured to slidably receive the control member 116 therein.

[0049] According to one embodiment, each extension member 118 can extend through, for example, an outer shaft 152 that extends from a proximal end connected to, for example, a portion of a user interface to a distal end 154 connected to the adapter 110. Specifically, the distal end 154 of the outer shaft 152 can be connected to the proximal end 136 of the adapter 110, such that each outer shaft 152 is aligned with a corresponding one of the holes 144 of the adapter 110. Therefore, in this embodiment, each extension member 118 extends through a corresponding one of the outer shaft 152 and the hole 144, such that the extension member 118 can be longitudinally moved therein relative to the endoscope 106.

[0050] As described above, the control member 116 is housed within the extension member 118 and extends from a proximal end connected to, for example, a user interface at the proximal end of the insertion device 104 to a distal end 120 that extends distally beyond a distal end 122 of the extension member 118. Figure 5 As shown, the distal end 120 of the control member 116 can be enlarged and coupled to the clamp 102 via an opening 166 extending through the base. In one embodiment, the size and shape of the enlarged distal end 120 are designed so that the enlarged distal end 120 cannot pass through the opening 166. In this embodiment, the enlarged distal end 120 of the control member 116 engages the distal side 156 of the base 112, so that the remaining length of the control member 116 extends proximally through the opening 166 and through the extension member 118 to the proximal end of the insertion device 104.

[0051] In one embodiment, the enlarged distal end 120 can be fixed and / or otherwise attached to the distal surface 156 so that the enlarged distal end 120 does not cause any dislodged parts in the body during the final deployment of the clamp 102. As described above, the size, shape and configuration of the enlarged distal end 120 are designed to prevent the enlarged distal end 120 from proximally passing through the opening 166 of the base 112. Similarly, the size, shape and configuration of the opening 166 are designed to prevent the distal end 122 of the extension member 118 from passing distally therethrough. Therefore, the base 112 of the clamp 102 is retained between the enlarged distal end 120 of the control member 116 and the distal end 122 of the extension member 118.

[0052] According to an exemplary embodiment, the enlarged distal ends 120 of the control members 116 are configured to be released and / or separated from their remaining length 158 during the final deployment process. In one embodiment, as described above, each enlarged distal end 120 is connected to the remaining length 158 of the control member 116 via a joint 160, and the joint 160 is configured to break, fail, release, or otherwise separate when subjected to a predetermined threshold force. In one embodiment, the joint 160 can be configured as a reduced diameter portion of the control member 116.

[0053] In another embodiment, the joint may be configured as an adhesive that is configured to break or fail when subjected to a predetermined force. In another embodiment, the joint is configured as a releasable coupling or other mechanical connector that is configured to release when subjected to a predetermined force. However, it should be understood by those skilled in the art that the joint 160 may have any of a variety of configurations as long as the joint 160 is configured to separate the enlarged distal end 120 from the remaining length 158 when subjected to a predetermined threshold force. Therefore, when it is necessary to move the clamp 102 toward the final deployment configuration, the control member 116 may be pulled proximally relative to the extension member 118, thereby enlarging the distal end 120 and the clamp 102 being pulled proximally against the distal end 122 of the extension member 118. The clamp 102 is pulled proximally against the extension member 118 until the force applied to the joint 160 reaches or exceeds the predetermined threshold force required to cause the joint 160 to break, fail, or otherwise separate. As a result, the remaining length 158 of the distal end 120 is released from the control member 116 and the clamp 102 is deployed from the insertion device 104 .

[0054] According to an exemplary embodiment, the control member 116 and the extension member 118 are moved together simultaneously to move the clamp 102 between the insertion configuration, the initial deployment configuration, and the inspection configuration. In this embodiment, the distal end 120 of the control member 116 is fixed to and / or in contact with the distal side 156 of the base 112, and the distal end 122 of the extension member 118 is positioned adjacent to the proximal side 162 of the base 112. Therefore, the base 112 is held between the distal ends 120, 122 of the control member 116 and the extension member 118, respectively, so that the simultaneous movement of the control member 116 and the extension member 118 will correspondingly move the clamp 102.

[0055] According to an exemplary embodiment, the control member 116 and the extension member 118 can be locked relative to each other via a user interface so that movement of one of the control member 116 and the extension member 118 correspondingly moves the other. Only when it is necessary to move the clamp 102 toward the final deployment configuration, the control member 116 and the extension member 118 can be unlocked relative to each other so that the control member 116 can be pulled proximally relative to the extension member 118, pushing the base 112 proximally against the distal end 122 of the extension member 118 via the distal end 120 of the control member 116 until the force applied thereto reaches and / or exceeds a predetermined threshold. When the force reaches the predetermined threshold, the joint 160 will break, fail, or otherwise separate to release the clamp 102 from the remaining length 158 of the control member 116.

[0056] In another embodiment, the control member 116 and the extension member 118 can remain independently movable relative to each other. However, since the distal end 120 of the control member 116 is connected to and / or fixed to the base 112 of the clamp 102, when the extension member 118 moves distally relative to the endoscope 106 to push the clamp 102 away from the adapter 110 from the insertion configuration toward the initial deployment configuration, the control member 116 moves distally relative to the endoscope 106 accordingly. In order to move the clamp 102 from the initial deployment configuration toward the inspection configuration, the endoscope 106 can simply be withdrawn relative to the clamp 102, so that the endoscope 106 moves proximally relative to the control member 116 and / or the extension member 118.

[0057] To move the clamp 102 toward the final deployed configuration, the control member 116 may be pulled proximally relative to the extension member 118, e.g., to lock the position of the extension member 118, while the control member 116 is pulled proximally relative thereto until the joint 160 is released, separating the clamp 102 from the remaining length 158 of the control member 116 for final deployment of the clamp 102, as described above. However, if it is necessary to reposition the clamp 102, the clamp 102 may be moved back toward the inserted configuration by pulling the control member 116 proximally relative to the endoscope 106, allowing the extension member 118 to be pulled proximally accordingly until the clamp 102 is pulled proximally past the adapter 110 toward the open configuration. The clamp 102 may then be repositioned over the tissue as desired.

[0058] According to another exemplary embodiment, the clamp 102 can be moved between the insertion configuration, the initial deployment configuration, and the inspection configuration via the movement of the control member 116 relative to the endoscope 106. In this embodiment, the distal end 120 of the control member 116 is fixed to the base 112, so that the movement of the control member 116 relative to the endoscope 106 will correspondingly move the clamp 102. Only when it is necessary to move the clamp 102 toward the final deployment configuration, the extension member 118 will be moved distally toward the clamp 102 until the distal end 122 is positioned adjacent to and / or against the proximal side 162 of the base 112.

[0059] Then, similar to the above-described embodiment, the control member 116 can be pulled proximally relative to the extension member 118, thereby pulling the clamp 102 proximally against the distal end 122 of the extension member 118, thereby applying a force to the control member 116. When the force reaches / exceeds the predetermined threshold, the joint 160 fails, breaks, or otherwise separates to release the clamp 102 from the remaining length 158 of the control member 116, so that the clamp 102 is deployed to the final configuration and clamped on the target tissue. It should be understood by those skilled in the art that in this embodiment, the predetermined threshold force is greater than the force required to move the clamp 102 between the insertion configuration, the initial deployment configuration, and the inspection configuration.

[0060] According to an exemplary method of performing tissue closure using the clamp system 100, the clamp 102 may be inserted into a target area in a body cavity, such as the gastrointestinal tract, via an insertion device 104. In one embodiment, the insertion device 104 may include an endoscope 106. As described above, in the insertion configuration ( Figure 3 ), the clamp 102 is mounted to the distal end 108 of the endoscope 106 via the adapter 110, so that the distal ends 124 of the arms 114 of the clamp 102 are separated from each other toward the open configuration. In this insertion configuration, the clamp 102 is guided to the target area via the visualization system of the endoscope 106 and positioned above the target tissue.

[0061] Suction and / or tissue graspers may be applied through the working channel of the endoscope 106 so that the target tissue may be drawn into the channel 140 of the adapter 110. Thus, when the clamp 102 is moved toward the initial deployment configuration ( Figure 4 ), the clamp 102 can slide distally away from the adapter 110 toward the biased closed configuration. When the clamp 102 moves toward the biased closed configuration, tissue is grasped between the distal ends 124 of the arms 114 of the clamp 102 in the initial deployment configuration.

[0062] It will be appreciated by those skilled in the art that suctioning and / or grasping tissue in this initial deployment configuration may obstruct the imaging / optical lens of the endoscope 106, making it impossible for the user to observe and / or confirm whether the desired target tissue has been properly clamped. Therefore, the clamp 102 may be moved toward the inspection configuration ( Figure 1 ), while the clamp 102 remains engaged with the control member 116. The distance between the adapter 110 and the clamp 102 widens the field of view of the endoscope 106, so that the clamp 102 and the tissue clamped thereby can be observed via the optical / visualization system of the endoscope 106.

[0063] If the user determines after observation that the clamp 102 needs to be adjusted and / or repositioned relative to the target tissue, the control member 116 and / or the extension member 118 can be translated proximally relative to the endoscope 106 until the clamp 102 is moved proximally on the adapter 110 toward the open insertion configuration, as described above. Specifically, the endoscope 106 can be moved distally relative to the control member 116, so that the clamp 102 and the adapter 110 are pulled toward each other.

[0064] When the clamp 102 is moved toward the open configuration, the tissue grasped thereby is released, allowing the clamp 102 to be repositioned over the target tissue as desired. The clamp 102 can then be moved again toward the initial deployment configuration, and then again toward the inspection configuration. This process can be repeated as needed until the user can visually confirm that the clamp 102 is clamped on the target tissue as desired.

[0065] As described above, in one embodiment, the clamp 102 is moved between the insertion configuration, the initial deployment configuration, and the inspection configuration by moving both the control member 116 and the extension member 118 together relative to the endoscope 106. In another embodiment, the clamp 102 can be moved between the insertion configuration, the initial deployment configuration, and the inspection configuration solely via movement of the control member 116 relative to the endoscope 106. Only when it is determined during the inspection configuration that the clamp 102 has been clamped on the target tissue as intended, the extension member 118 can be moved distally relative to the endoscope 106 so that the distal end 122 is positioned proximate to the proximal side 162 of the base 112 of the clamp 102.

[0066] The clamp 102 can then be moved toward the final deployment configuration by pulling the clamp 102 proximally against the distal end 122 via the control member 116 until the force applied to the joint 160 reaches or exceeds a predetermined threshold, resulting in the clamp 102 being released from the remaining length 158 of the control member 116. As the clamp 102 moves toward the final deployment configuration, the insertion device 104, including the remaining length 158 of the control member 116 and the extension member 118, is removed from the body, leaving the clamp 102 clamped on the target tissue.

[0067] It will be clear to those skilled in the art that various modifications may be made to the present disclosure without departing from the scope of the present disclosure. In addition, it will be appreciated by those skilled in the art that any features in the various embodiments may be combined in any manner not inconsistent with the description and / or function of the embodiments.

Claims

1. A clamping system for processing tissue, comprising: an adapter configured to be mounted on the distal end of the insertion device, the adapter extending from the proximal end to the distal end and including a passage extending therethrough; A clamp comprising: a base configured to be mounted on a periphery of the adapter; and a plurality of arms extending distally from the base, the plurality of arms being movable relative to each other between an insertion configuration in which the plurality of arms extend along an outer surface of the adapter such that distal ends of the plurality of arms are separated from each other in an open configuration to receive tissue therebetween, and an initial deployment configuration in which the clamp is moved distally away from the adapter such that the distal ends of the plurality of arms are restored toward a biased closed configuration in which the distal ends of the plurality of arms are pulled toward each other to grasp tissue therebetween; and A first control member is releasably coupled to the base of the clamp and movably connected to the adapter, so that longitudinal movement of the first control member relative to the adapter causes the clamp to move between the insertion configuration, the initial deployment configuration and the inspection configuration, in which the adapter is allowed to be withdrawn proximally away from the clamp while the first control member remains coupled to the clamp to enhance visual observation of the clamp, and the first control member is operable to retract the clamp proximally on the adapter toward the insertion configuration, so that the multiple arms are forced to open when the clamp is retracted on the adapter, releasing the clamp from the tissue clamped thereon.

2. A system according to claim 1, wherein the first control member includes an enlarged distal end that engages with the distal surface of the base, so that the remaining length of the first control member extends proximally through the opening of the base to a user-accessible proximal end, and the enlarged distal end of the first control member is connected to the remaining length of the first control member via a joint, and the joint is configured to release when subjected to a force exceeding a predetermined threshold.

3. The system according to claim 2 further includes a first extension member, which is configured to slidably accommodate the first control member therein, so that the enlarged distal end of the first control member extends distally from the distal end of the first extension member to couple to the base of the clamp, and the proximal movement of the first control member relative to the first extension member is configured to pull the clamp against the distal end of the first extension member to release the joint and move the clamp toward a final deployment configuration.

4. A system according to any one of claims 1 to 3, wherein the plurality of arms each include a proximal portion and a distal portion, which are movably connected to each other via a hinge, and the hinge biases each of the plurality of arms toward the closed form, in which the proximal portion and the distal portion of each of the arms are bent relative to each other so that the distal end extends toward the longitudinal axis of the adapter.

5. A system according to claim 4, wherein the distal portion of each of the plurality of arms includes an engagement feature extending laterally therefrom to engage the distal end of the adapter when the clamp is pulled proximally on the adapter to prevent further proximal movement of the clamp relative to the adapter.

6. The system according to claim 5, wherein: When the engagement feature engages the distal end of the adapter, the distal portion of each of the plurality of arms engages the adapter to maintain the plurality of arms toward the open configuration.

7. The system of any one of claims 1 to 6, wherein the distal end of the adapter includes a lip projecting radially outwardly therefrom.

8. The system of any one of claims 1 to 7, wherein the distal ends of each of the arms extend laterally inwardly relative to each other and include tissue grasping features.

9. The system of any one of claims 1 to 8, wherein the base is annular.

10. The system according to any one of claims 1 to 9, further comprising: a second control member releasably coupled to the base of the clamp and movably connected to the adapter such that longitudinal movement of the second control member relative to the adapter causes the clamp to move between the insertion configuration, the initial deployment configuration, and the inspection configuration; and A second extension member extends longitudinally from a user-accessible proximal end of the system to a distal end, and the second control member is slidably received within the second extension member so that the distal end of the second control member extends distally from the distal end of the second control member to couple to the clamp.

11. A clamping system for processing tissue, comprising: an endoscope extending longitudinally from a proximal end to a distal end; an adapter mountable on the distal end of the endoscope so that a channel of the adapter is aligned with a longitudinal axis of the endoscope; A clamp comprising: an annular base configured to be mounted on the adapter; and a plurality of arms extending distally from the base, the plurality of arms being movable relative to each other between an insertion configuration in which the plurality of arms extend along an outer surface of the adapter such that distal ends of the plurality of arms are separated from each other in an open configuration to receive tissue therebetween, and an initial deployment configuration in which the clamp is moved distally away from the adapter such that the distal ends of the plurality of arms are restored toward a biased closed configuration in which the distal ends of the plurality of arms are pulled toward each other to grasp tissue therebetween; and and a first control member and a second control member which are releasably coupled to the base of the clamp and movably connected to the adapter, such that longitudinal movement of the first control member and the second control member relative to the adapter causes the clamp to move between the insertion configuration, the initial deployment configuration, and an inspection configuration, wherein the endoscope is allowed to be withdrawn proximally away from the clamp while the first control member and the second control member remain coupled to the clamp to enhance visual observation of the clamp through the endoscope, and the first control member and the second control member are operable to retract the clamp proximally on the adapter toward the insertion configuration, such that the multiple arms are forced to open when the clamp is retracted on the adapter, releasing the clamp from tissue clamped thereon.

12. The system of claim 11 , wherein the first control member and the second control member each include an enlarged distal end that engages with a distal surface of the base, and a remaining length of the first control member extends proximally through an opening in the base to a proximal end of the first control member accessible to a user, the enlarged distal end of the first control member being connected to the remaining length of the first control member via a joint, the joint being configured to release when subjected to a force exceeding a predetermined threshold.

13. The system according to claim 12 further includes a first extension member and a second extension member, wherein the first extension member and the second extension member extend longitudinally from a proximal end accessible to a user of the system to a distal end, and the first extension member and the second extension member are each configured to slidably accommodate a corresponding one of the first control member and the second control member therein, so that the first control member and the second control member pull the clamp proximally against the distal ends of the first extension member and the second extension member to release the clamp from the proximal portion of the first control member and the second control member.

14. A system according to any one of claims 11 to 13, wherein the arms each include a proximal portion and a distal portion, both of which are movably connected to each other via a hinge, and the hinge biases each of the arms toward a closed configuration, wherein the proximal portion and the distal portion of the first of the arms are bent relative to the distal portion of the second of the arms, so that the distal ends of the first arm and the second arm extend toward the longitudinal axis of the adapter.

15. The system of claim 14, wherein the adapter comprises a The distal end of the arm has a lip that projects radially outwardly, so that when the distal portion of the arm engages the lip, The distal portion of the arm is raised above the adapter.

Images