Gripping cap for supermirror applications

Abstract

A device for facilitating super-mirror application of a tissue treatment element includes an end cap and a control member. The end cap includes a proximal portion mounted on a distal end of the endoscopic device and a distal portion including a flap. The proximal portion extends along a longitudinal axis from a proximal end to a distal end and includes a proximal channel therethrough. The proximal end of each flap is pivotally connected to the distal end of the proximal portion such that the flaps are movable between a closed configuration and an expanded configuration. The distal end of each control member is connected to a respective flap such that longitudinal movement of the member relative to the proximal portion of the end cap moves the flaps relative to the proximal portion between a closed configuration and an expanded configuration.

Description

Cross Reference to Related Applications

[0001] This disclosure claims priority to U.S. Provisional Patent Application No. 63 / 498,396, filed April 26, 2023, the disclosure of which is incorporated herein by reference. TECHNICAL FIELD

[0002] The present disclosure relates to endoscopic devices, and in particular to an end cap for over-the-scope applications, treating gastrointestinal tissue. BACKGROUND

[0003] Physicians are increasingly willing to perform aggressive interventional and therapeutic endoscopic gastrointestinal (GI) procedures, which can increase the risk of perforation of the GI wall or can require closure of one or more openings in the GI wall as part of the procedure. Such procedures can include, for example, resection of large lesions, creation of a tunnel under the mucosal layer of the GI tract to treat a problem under the mucosa, full-thickness tissue resection, treatment of organs outside the GI tract by inserting a device through the GI tract to a location adjacent to the organ to be treated and passing the device through the GI wall to the target organ. Subsequent endoscopic treatment / repair of post-procedural issues (e.g., post-procedural leaks, staple line breakdown, anastomotic leaks, or openings in the GI wall resulting from any procedure) can be required.

[0004] Currently, tissue can be treated by endoscopic closure devices, including through-the scope clips and / or over-the-scope clips. Over-the-scope clips (OTSCs) can be particularly useful in closing larger tissue defects. A typical OTSC can be placed on a plastic applicator cap mounted on the distal end of an endoscope (e.g., a gastroscope, a colonoscope, etc.). As the endoscope is navigated through the GI tract, the OTSC remains on the cap until the clip is positioned at the desired location and released from the endoscope to clamp the target tissue. These applicator caps are typically translucent so that something can be seen through them and are hollow so that the target tissue can be suctioned into them. The tissue is suctioned into the cap by, for example, suction, to a sufficient extent that when the user releases the clip from the cap, the clip will close on enough layers of the GI tract to ensure secure closure of the tissue opening.

[0005] However, some current cap designs can hinder long-term effectiveness. In some cases, the depth and inner diameter of the cap can limit the amount of tissue that can be aspirated, preventing the clip from achieving adequate and / or full-thickness tissue clipping, depending on the surface area of the tissue defect to be treated. Additionally, in some cases, the amount of tissue that the clip can contact can be limited by the suction of the endoscope or the force that can be applied to the tissue by any other mechanism that pulls tissue into the cap, such as a grasper. This is more likely to occur, for example, in the case of chronic or fibrotic tissue, which can result in superficial placement of the clip or low bite quality. Furthermore, because the cap extends out from the distal tip of the endoscope, the clinician’s view of the gastrointestinal tract can be limited. Although such caps are typically translucent, they are often not clear enough to allow unobstructed vision through, and can obstruct the user’s peripheral vision and limit the visible range to the inner diameter of the cap. SUMMARY

[0006] The present disclosure relates to a device for facilitating the application of a tissue treatment element over a scope. The device includes an end cap and a plurality of control members. The end cap includes a proximal portion configured to mount over a distal end of an endoscopic device and a distal portion extending distally from the proximal portion. The proximal portion extends along a longitudinal axis from a proximal end to a distal end and includes a proximal channel therethrough. The distal portion includes a plurality of petals. A proximal end of each petal is pivotably connected to a distal end of the proximal portion such that the petals are movable between a closed configuration in which the petals define a distal channel aligned with the proximal channel and an expanded configuration in which distal ends of the petals are moved away from one another to enlarge a distal opening of the end cap. A distal end of each control member is connected to a respective one of the petals such that longitudinal movement of the control members relative to the proximal portion of the end cap moves the petals relative to the proximal portion between the closed configuration and the expanded configuration.

[0007] In one embodiment, the inner surfaces of the plurality of petals include a plurality of grasping features configured to anchor the petals to a target tissue.

[0008] In one embodiment, the plurality of grasping features include teeth protruding from the inner surfaces of the plurality of petals.

[0009] In one embodiment, the outer surface of each petal of the plurality of petals is curved to facilitate sliding of a tissue clipping device therealong.

[0010] In one embodiment, in the closed configuration, each petal extends substantially parallel relative to the longitudinal axis and a longitudinal edge of each petal is in contact with a longitudinal edge of an adjacent petal to define the distal channel therebetween.

[0011] In one embodiment, the distal end of each control member is connected to an outer surface of a respective one of the petals such that the control members extend along an exterior of the end cap.

[0012] In one embodiment, the distal end of each control member is connected to an inner surface of a respective petal such that the control member extends proximally therefrom through the proximal passage of the end cap.

[0013] In one embodiment, the distal end of each control member comprises an enlarged ball that is received in a correspondingly shaped socket of a yoke member connected to a respective one of the plurality of petals, the ball being rotatable within the socket as the end cap is moved between the closed configuration and the expanded configuration.

[0014] In one embodiment, each petal of the plurality of petals comprises a longitudinal groove extending therealong, and the proximal portion comprises a respective groove extending therealong and longitudinally aligned with the longitudinal groove, the longitudinal groove and the respective groove being configured to receive a control member therein.

[0015] In one embodiment, the end cap further comprises a flexible membrane extending between adjacent petals of the plurality of petals such that, in the expanded configuration, the flexible membrane is stretched to increase a cross-sectional area of the distal passage.

[0016] In one embodiment, the flexible membrane is formed of a material comprising one of silicone and PET thermoplastic.

[0017] The present disclosure is also directed to an end cap configured to be mounted on a distal end of an endoscope to facilitate a superlens application of a tissue grasping device. The end cap comprises a proximal portion extending along a longitudinal axis from a proximal end to a distal end and including a proximal passage therethrough. The end cap further comprises a distal portion having a plurality of petals. A proximal end of each petal is pivotably connected to a distal end of the proximal portion such that the petals are movable between a closed configuration in which the petals define a distal passage aligned with the proximal passage and an expanded configuration in which distal ends of the petals are moved away from one another.

[0018] In one embodiment, inner surfaces of the plurality of petals comprise a plurality of grasping features configured to anchor the petals to a target tissue.

[0019] In one embodiment, in the closed configuration, each petal extends substantially parallel with respect to the longitudinal axis, and a longitudinal edge of each petal is in contact with a longitudinal edge of an adjacent petal to define the distal passage therebetween.

[0020] In one embodiment, the end cap further comprises a flexible membrane extending between adjacent petals of the plurality of petals such that, in the expanded configuration, the flexible membrane is stretched to increase a cross-sectional area of the distal passage.

[0021] Further, the present disclosure is directed to a method of treating tissue. The method includes mounting an end cap on a distal end of an endoscopic device, and inserting the distal end of the endoscopic device (with the end cap in a closed configuration) into a body lumen to a target region to be treated, the end cap including a proximal portion defining a proximal passage therein and a distal portion including a plurality of petals, a proximal end of each petal being pivotably coupled to the proximal portion, in the closed configuration the plurality of petals being in contact with one another to define a distal passage therebetween; moving the end cap from the closed configuration to an expanded configuration by pivoting the petals relative to the proximal portion such that distal ends of the petals move away from one another to enlarge a distal opening of the proximal passage; applying suction through the end cap to draw target tissue into the end cap; moving the end cap from the expanded configuration to the closed configuration to draw the drawn-in tissue further into the end cap; and sliding an overscope clip distally off the end cap to clamp onto the target tissue.

[0022] In one embodiment, the claim further includes pressing the tissue-grabbing feature along the inner surfaces of the plurality of petals against the target tissue to anchor the petals to the target tissue such that movement of the end cap from the expanded configuration to the closed configuration draws the target tissue into the distal passage formed by the plurality of petals.

[0023] In one embodiment, the petals are moved between the closed configuration and the expanded configuration by a plurality of control members, a distal end of each control member being connected to a respective one of the petals such that longitudinal movement of the control members relative to the proximal portion of the end cap and the endoscopic device correspondingly moves the petals between the closed configuration and the expanded configuration.

[0024] In one embodiment, in the closed configuration, each petal extends substantially parallel relative to the longitudinal axis such that the end cap extends along a substantially cylindrical shape.

[0025] In one embodiment, the distal ends of the control members are connected to the petals of the end cap by a ball and yoke mechanism. BRIEF DESCRIPTION OF DRAWINGS

[0026] Figure 1 a perspective view of a device according to an example embodiment of the present disclosure in a closed configuration is shown;

[0027] Figure 2 a perspective view of a device according to Figure 1 in a partially expanded configuration is shown;

[0028] Figure 3 a side view of a device according to Figure 1 in a closed configuration is shown;

[0029] Figure 4 a side view of a device according to Figure 1 in an expanded configuration is shown;

[0030] Figure 5 a perspective view of a proximal portion of an end cap of a device according to Figure 1

[0031] Figure 6 a perspective view of a distal portion of an end cap of a device according to Figure 1

[0032] Figure 7 a perspective view of a ball and yoke mechanism of a device according to Figure 1

[0033] Figure 8 a perspective view of a control member of a device according to Figure 1

[0034] Figure 9 a yoke component of a device according to Figure 1

[0035] Figure 10 a perspective view of a device according to another example embodiment of the present disclosure; and

[0036] Figure 11 a perspective view of a portion of a device according to Figure 8

[0037] Figure 12 a perspective view of a device according to another example embodiment of the present disclosure; and

[0038] Figure 13 a perspective view of a device according to another example embodiment of the present disclosure; and DETAILED DESCRIPTION

[0039] The present disclosure can be further understood with reference to the following description and appended claims with cognizant persons in the art to which this disclosure pertains, and the appended drawings wherein like reference numbers refer to like items. The present disclosure relates to endoscopic systems, and in particular to end caps for over-the-scope applications, such as over-the-scope clips and bands. Exemplary embodiments of the present disclosure describe an expandable end cap that includes a plurality of petals extending from a distal portion thereof, the petals being pivotably connected to a proximal portion of the cap such that the petals are movable between a closed configuration in which portions of the distal portion of the cap are drawn together to extend distally in a generally tubular configuration to minimize navigation issues and trauma to tissue through which the endoscope is advanced, and an expanded configuration in which distal ends of the petals are pivoted away from one another to open a distal end of the cap to allow a greater surface area of tissue to be drawn into the cap.

[0040] ​​​​​​In an exemplary embodiment, the flap may also include grasping features, such as protruding teeth, to grasp target tissue aspirated into the cap, thereby anchoring the target tissue within the cap. Grasping features can be particularly useful for defects involving fibrotic or chronic tissue that is difficult to aspirate. By combining suction with grasping features on the flap, two methods of pulling tissue into the cap, it is more likely to achieve high-quality, full-thickness occlusion of the target tissue via endoscopic devices such as clips or straps. In the expanded configuration, the cap also increases the peripheral field of view of the endoscopic visual system (i.e., by removing the flap from the visual system's field of view), thereby improving the confidence in clip or strap placement.

[0041] According to an exemplary embodiment, the over-the-scope clip is placed immediately adjacent to the end of the flap, such that, in the expansion configuration, tissue can be pulled into the cap, and then the cap moves from the expansion configuration to the closure configuration, allowing the clip to move distally along the flap until the clip moves distally away from the cap and is released to clamp onto the target tissue. Those skilled in the art will understand that, although the exemplary embodiment shows and describes the over-the-scope clip, other over-the-scope tissue closure devices (e.g., straps) can also be used in conjunction with any of the exemplary caps described herein. It should be noted that the terms "proximal" and "distal" as used herein refer to the direction toward the device user (proximal) and the direction away from the device user (distal), respectively.

[0042] like Figures 1-9 As shown, the apparatus 100 according to an exemplary embodiment of the present disclosure includes an end cap 102 configured to be mounted on the distal end of an endoscopic device (e.g., a gastroscope or colonoscope) to facilitate ultrascopic applications, such as placing an ultrascopic clip or other tissue closure device on target tissue within the gastrointestinal tract (e.g., to close an opening in the gastrointestinal wall). Figures 1-4 As shown, the end cap 102 includes a plurality of lobes 104 forming the distal portion 106 of the cap 102. Each lobe 104 is pivotally connected to the proximal portion 108 of the cap 102 such that the lobe 104 can be in a closed configuration (e.g., ...) relative to the proximal portion 108. Figure 1 and Figure 3 (as shown) and extended configurations (such as) Figure 2 and Figure 4 The end cap 102 (including the proximal portion 108 and the distal portion 106) moves between the two sides. In the closed configuration, the end cap 102 (including the proximal portion 108 and the distal portion 106) forms a generally continuous tubular shape. In the expanded configuration, the distal ends of the flaps 104 pivot away from each other (around the hinge formed between the flaps 104 and the proximal portion 108) to radially expand the distal portion 106 of the end cap 102 and remove the flaps 104 from a position that might obstruct a portion of the visual system of the endoscope (or minimize any such visual obstruction).

[0043] In the closed configuration, the end cap 102 is sized and shaped to fit snugly onto the distal end of the endoscope, allowing the endoscope to navigate through, for example, a body cavity to the target area to be treated with minimal disturbance to the cap 102. Once the endoscope reaches the target area, the cap 102 can be moved from the closed configuration to the expanded configuration as described above. Suction (or a gripper or any other suitable tissue manipulation device) is then applied through the working channel of the endoscope to pull the target tissue into the end cap 102, as the suction is applied through the cap 102 to pull the tissue into the cap 102 due to the distal opening of the cap 102 surrounding the working channel.

[0044] The flap 104 can then be moved from the expanded configuration back to the closed configuration, allowing tissue to be engaged by the gripping features 112 on the inner surface 130 of the flap 104 to help retain the tissue within the cap 102 and pull the tissue further into the end cap 102. One or more ultrascope clips or other ultrascope gripping / clamping elements located around the proximal portion 108 of the end cap 102 can be moved distally along the flap 104 to move distally away from the end cap 102 and clamp the target tissue. As will be described in more detail below, the end cap 102 can be moved between the open and closed configurations by a plurality of control members 132.

[0045] like Figure 5 As shown and as described above, the end cap 102 includes a proximal portion 108 and a distal portion 106. The proximal portion 108 extends along a longitudinal axis L from the proximal end 116 to the distal end 118 and defines a channel 120 therethrough, such that, in an exemplary embodiment, the proximal portion 108 has a tubular configuration, its size and shape generally designed to accommodate the distal end of an endoscope to be mounted thereon. The channel 120 of the proximal portion 108 is sized, shaped, and configured to mount on the distal end of the endoscope device, and those skilled in the art will understand that it can take any size and shape required to obtain the desired fit (e.g., interference fit) on the endoscope.

[0046] In an exemplary embodiment, the channel 120 of the proximal portion 108 is substantially cylindrical, and the size, shape, and configuration of the outer surface of the cap 102 enable it to accommodate a superscope clip or other superscope gripping / clamping element to be mounted externally thereon. Those skilled in the art will understand that the size and shape of the channel 120 and the outer surface of the cap 102 are designed such that when clips, ligatures, etc., mounted on the cap 102 are installed thereon, they will be stretched open to allow a desired amount of tissue to be drawn into them.

[0047] In the example embodiment, the proximal portion 108 can include a plurality of protrusions 150 extending from the distal end 118. Each protrusion 150 includes an opening 152 extending therein. The openings 152 of adjacent protrusions 150 are aligned with one another and are configured to receive, for example, a pin (not shown) configured to pivotably connect a respective one of the petals 104 therebetween. According to the example embodiment, each protrusion 150 can include two openings 152 such that each protrusion 150 facilitates connecting two of the plurality of petals 104 to the proximal portion 108. In the example embodiment, the proximal portion 108 also includes, at its distal end 118, along its outer edge, a groove 154 extending between each of the protrusions 150. Each groove 154 is sized, shaped, and configured to receive a portion of a respective one of the petals 104 therein as the petals move from the closed configuration to the expanded configuration, as shown in Figure 2 and Figure 4

[0048] As described above, the distal portion 106 of the end cap 102 includes petals 104, each of which extends from a proximal end 122 pivotably connected to the distal end 118 of the proximal portion 108 to a distal end 126. According to the example embodiment, as shown in Figure 6

[0049] Although the example embodiment illustrates and describes a pivotable connection including, for example, a pin, those skilled in the art will appreciate that the petals 104 can be coupled to the proximal portion 108 by any of a variety of pivotable connections, including, for example, through a living hinge or a spring.

[0050] ​​In example embodiments, the petals 104 are sized and shaped such that, in the closed configuration, the longitudinal edges 114 of each petal 104 are in contact with the longitudinal edges 114 of an adjacent petal 104, such that the petals 104 together form a generally continuous tube that forms the distal portion 106 and defines a passageway 124. The passageway 124 extends along the longitudinal axis L to align with the passageway 120, such that, in the closed configuration, the entire cap 102 (i.e., including the distal portion 106 and the proximal portion 108) forms a generally continuous tube. In example embodiments, each petal 104 extends generally parallel to the longitudinal axis L. According to example embodiments, the outer surface 138 of each petal 104 is curved such that, in the closed configuration, the distal portion 106 is generally cylindrical. Those skilled in the art will appreciate that such a cylindrical shape can facilitate the sliding of a clip along the distal portion 106.

[0051] As described above, the proximal end 122 of each of the plurality of petals 104 is pivotably coupled to the distal end 118 of the proximal portion 108, such that the petals 104 are movable between the closed configuration described above and an expanded configuration in which each petal 104 is pivoted relative to the proximal portion 108 such that the distal ends 126 of the petals 104 are distal from one another and from the longitudinal axis L. In example embodiments, the petals 104 can be pivoted relative to the proximal portion 108 between an angle of about 0 degrees (closed configuration) and about 90 degrees (expanded configuration).

[0052] In one embodiment, in the expanded configuration, the petals 104 can extend in a radially outward configuration, perpendicular relative to the longitudinal axis L. However, those skilled in the art will appreciate that the petals 104 can extend at any of a variety of angles relative to the longitudinal axis L in the expanded configuration. When the petals 104 are pivoted from the closed configuration to the expanded configuration, the distal opening 128 is enlarged through which tissue can be drawn into the passageways 120, 124 of the cap 102. In particular, as will be described in greater detail below, when the cap 102 is moved from the expanded configuration to the closed configuration, tissue received between the petals 104 will be drawn into the passageway 124 formed thereby and / or the passageway 120 of the proximal portion 108.

[0053] In example embodiments, the inner surface 130 of each petal 104 (i.e., the surface of the petal 104 that faces the longitudinal axis L when the cap 102 is in the closed configuration) can be generally planar and include a plurality of grasping features 112 configured to grasp tissue. Those skilled in the art will appreciate that the petals 104 need not be planar and can be formed in any other desired shape so long as they combine to form a tissue-receiving space of the desired dimensions. The grasping features 112 can include, for example, teeth or other protrusions extending from the inner surface 130 to anchor the petals 104 to tissue and / or to grasp tissue on which the petals 104 are placed. Thus, as the cap 102 is moved from the expanded configuration to the closed configuration, tissue grasped by the grasping features 112 will be pulled into the channels 124, 120. The grasping features 112 can be particularly useful for treating tissue defects that involve fibrotic or chronic tissue that is difficult to suction.

[0054] In example embodiments, the device 100 includes a respective control member 132 coupled to each petal 104 to move the petals 104 between the closed configuration and the expanded configuration. The control member 132 of this embodiment includes, for example, a control wire, with each control wire extending between a distal end 134 connected to a respective one of the petals 104 and a proximal end accessible to a user (e.g., a physician) at a proximal end of an endoscope device to which the cap is coupled (e.g., an actuator coupled to the proximal end of the control member 132 at or near a handle of the endoscope device). Those skilled in the art will appreciate that the control members 132 can be combined into or coupled to a single control member at any point between the distal end 134 and the proximal end thereof, such that the control members can be operated in unison (to operate the petals 104 in unison between the expanded configuration and the closed configuration) by moving the single control member proximally and distally (e.g., by operating an actuator to which the single control member is coupled).

[0055] The control members 132 can be moved longitudinally relative to the proximal portion 108 of the cap 102 (and the endoscope device) to move the petals 104 accordingly. Specifically, pulling the control members 132 proximally relative to the endoscope device (and the proximal portion 108 of the cap 102) moves the petals 104 from the closed configuration to the expanded configuration, while moving the control members 132 distally relative to the endoscope device (and the proximal portion 108 of the cap 102) moves the petals 104 from the expanded configuration to the closed configuration. Those skilled in the art will appreciate that the control members 132 are preferably formed with sufficient column strength to move the petals 104 from the expanded configuration to the closed configuration to compress the target tissue between the petals 104. For example, the control members 132 can be formed of a relatively rigid material, such as a PEEK tube or any other suitable rigid biocompatible plastic tube.

[0056] In an example embodiment, the control members 132 can be connected to the petals 104 by a ball and yoke mechanism, as shown in Figure 7 In this embodiment, as shown in Figure 8 the distal end 134 of each control member 132 includes an enlarged ball sized, shaped, and configured to be movably received in a corresponding yoke member 136 attached to a surface of the corresponding petal 104. In an example embodiment, as shown in Figure 9 the yoke member 136 includes a socket 140 sized and shaped to correspond to the enlarged distal end 134 of the control member 132, such that as the control member 132 is moved longitudinally relative to the endoscope device, the distal end 134 rotates within the socket 140 of the yoke member 136 as the petal 104 pivots between the open and expanded configurations relative to the proximal portion 108.

[0057] In an example embodiment, each petal 104 includes a yoke member 136 on its outer surface 138 (i.e., the surface of the petal 104 facing away from the longitudinal axis L) such that each control member 132 extends along the exterior of the end cap 102 and the endoscope device to the proximal end of the endoscope device. Those skilled in the art will appreciate that any desired portion of the control member 132 can be housed in one or more tubes that can be clamped or otherwise removably fastened to the exterior of the endoscope device in any conventional manner to maintain control over the positioning of the control member 132 and / or to prevent movement of the control member 132 from being stimulated or disturbed by contact with surrounding tissue.

[0058] According to an example method of utilizing the device 100, the end cap 102 is mounted on the distal end of an endoscope device oriented such that the control members 132 extend proximally along the endoscope device to the proximal end of the endoscope device. Prior to or after the cap 102 is mounted to the endoscope device, the super scope clip is positioned on the proximal portion 108 of the end cap 102, and the endoscope device is then inserted into a target site within a patient’s body through a body lumen accessed, for example, via a naturally occurring body orifice. The endoscope device is passed through the body lumen with the end cap 102 in the closed configuration such that the proximal portion 108 and the distal portion 106 together form a generally tubular configuration to minimize any navigation issues and to minimize trauma to tissue along the endoscope device path.

[0059] Once at the target site, the end cap 102 is positioned adjacent to the target tissue to be treated and moved from the closed configuration to the expanded configuration by moving the control member 132 proximally relative to the endoscope device (e.g., by operating an actuator coupled to the control member 312). Pulling the control member 132 proximally relative to the endoscope device causes the flaps 104 to pivot relative to the proximal portion 108 of the cap 102 such that the distal ends 126 of the flaps 104 move away from each other and away from the longitudinal axis L of the cap 102, expanding the distal opening 128 of the end cap 102 as described above.

[0060] Once the end cap 102 has been moved to the expanded configuration, negative pressure is applied through the working channel of the endoscope device to pass through the end cap 102. This draws tissue in the vicinity of the distal opening of the cap 102 into the channel 120 of the cap 102. In addition, as tissue in the vicinity of the tissue that has been drawn into the channel 120 is pulled proximally in contact with the open flaps 104, the grasping features 112 on the inner surfaces 130 of the flaps 104 penetrate and grasp this surrounding tissue such that when the end cap 102 is moved from the expanded configuration to the closed configuration, this grasped tissue is pulled into the channel 124 defined by the grasping features 112 and the flaps 104 of the end cap 102.

[0061] As described above, the grasping features 112, in combination with the suction force (or grasper or other tissue grasping device) applied through the end cap 102, can be particularly useful for treating fibrotic and / or chronic tissue that is difficult to be drawn in, as well as to increase the amount of tissue pulled into the cap 102 to increase the likelihood that full layer portions of tissue or the entire lateral extent of the target tissue portion is pinched. Those skilled in the art will appreciate that in the expanded configuration, the enlarged distal opening 128 formed by the flaps 104 allows a greater surface area of the target tissue to ultimately be pulled into the channels 120, 124 such that a greater portion of the tissue is pinched when the clip is deployed from the distal end of the cap 102.

[0062] After the end cap 102 has been moved to the closed configuration and the desired portion of the target tissue is received in the channels 120, 124, the control member 132 is moved distally to move the superlens clip distally along the end cap 102 until the clip moves off the distal end of the cap 102 and snaps shut (e.g., under the inherent spring bias of the clip as will be appreciated by those skilled in the art) to pinch the target tissue. As will be appreciated by those skilled in the art, the clip can be moved distally by any of a variety of control mechanisms to exit the end cap 102 toward the pinching configuration. In one embodiment as described above, the spring-biased hinges connecting the jaws of the clip bias the clip toward the pinching configuration in which the jaws are closed on each other.

[0063] When loaded onto cap 102, the jaws of the clamp open against the bias, so that once the clamp moves distally away from cap 102, the jaws are ready to close. By operating any known mechanism to move the clamp distally away from cap 102, a user can clamp the clamp onto tissue received in cap 102. For example, in one embodiment, the clamp may be releasably coupled to one or more control elements that pull cap 102 proximally and prevent the clamp from moving distally away from cap 102. Then, when the user determines that the desired portion of tissue has been pulled into cap 102, the user can release the tension of these control elements, allowing the jaws of the clamp to begin closing on the tapered surface of cap 102, such that the bias of the hinge and the closing of the jaws pull the clamp distally away from cap 102 to clamp the target tissue.

[0064] Once the clamp has gripped the target tissue, it can be finally deployed by releasing the clamp from the control element. Although the clamp is described as allowing it to slide distally away from the end cap 102, in another embodiment, the control element releasably coupled to the clamp can be moved distally relative to the end cap 102 to push the clamp away from the end cap 102. Those skilled in the art will understand that although the exemplary embodiments show and describe the device 100 used with a endoscopic clamp, the end cap 102 of the device 100 can be used in a similar manner with any of a variety of endoscopic devices (e.g., straps) to treat tissue defects.

[0065] like Figures 10-11 As shown, a device 200 according to another exemplary embodiment of the present disclosure is substantially similar to device 100, including an end cap 202 configured to be mounted on the distal end of an endoscope device for, for example, applying an endoscope clip 210 to target tissue. Similar to end cap 102, the end cap 202 of device 200 includes: a proximal portion 208 configured to receive the clip 210 thereon; and a distal portion 206 including a plurality of flaps 204 pivotally coupled to the proximal portion 208. The flaps 204 are pivotable relative to the proximal portion 208 between a closed configuration and an expanded configuration, in which the flaps 204 are positioned relative to each other such that the end cap 202 (including the distal portion 206) forms a generally tubular shape, and in the expanded configuration, the distal ends 226 of the flaps 204 move away from each other to enlarge the distal opening 228 of the end cap 202.

[0066] Similar to device 100, device 200 includes control members 232 operable to move the lobes 204 between a closed configuration and an expanded configuration, wherein each control member 232 is connected to a corresponding lobe 204 by, for example, a ball and yoke mechanism. However, the end cap 202 also includes a longitudinal groove 242 extending along the outer surface 238 of each lobe 204 (e.g., the surface of the lobe 204 opposite to the longitudinal axis along which the end cap 202 extends when the end cap 202 is in the closed configuration), and a corresponding longitudinal groove 244 aligned with the longitudinal groove 242 along a portion of the proximal portion 208.

[0067] Longitudinal grooves 242 and 244 extend along the lobes 204 and proximal portions 208, respectively, to receive a yoke member 236 attached to the outer surface 238 of a corresponding lobe 204 and a control member 232 extending proximally therefrom. Therefore, the yoke member 236 and the control member 232 are located within the longitudinal grooves 242 and 244 such that they do not protrude beyond the outer surface 238 of the peripheral portion of the lobe 204 and the outer surface of the proximal portion 208. Thus, the longitudinal grooves 242 and 244 reduce the likelihood of interference between the control member 232 and the clip 210 when the clip 210 slides along the end cap 202.

[0068] like Figure 12 As shown, the device 300 according to another exemplary embodiment of the present disclosure is substantially similar to the devices 100 and 200 described above, including an end cap 302 and a plurality of control members 332 for moving the end cap 302 between a closed configuration and an expanded configuration. Specifically, the end cap 302 includes a proximal portion 308 defining a channel 320 therethrough, and a plurality of lobes 304 pivotally attached to the proximal portion 308 to define a distal portion 306. The lobes 304 are pivotable relative to the proximal portion 308 to move between a closed configuration and an expanded configuration, in which the lobes 304 are positioned such that the end cap 302 forms a generally tubular shape, and in the expanded configuration, the distal ends 326 of the lobes 304 move away from each other.

[0069] However, the end cap 302 also includes a plurality of flexible membranes 346, each extending and connecting adjacent lobes among the plurality of lobes 304. When the end cap 302 is in a closed configuration, the flexible membranes 346 can fold themselves, allowing the lobes 304 to be pulled toward each other. However, when the end cap 302 is in an expanded configuration, the flexible membranes 346 can unfold and / or stretch to form a mesh structure between adjacent lobes 304. The flexible membranes 346 can be formed of any of a variety of materials, such as silicone, PET thermoplastic, or any material with stiffness that allows bending and / or stretching. Those skilled in the art will understand that the flexible membranes 346 can be configured to bias the lobes 304 toward the closed configuration to help overcome the resistance exerted by tissue pulled into the end cap 302 to move the lobes 304 into the closed configuration. Alternatively, if it is desired to achieve this bias toward the closed configuration without sealing the space between the lobes 304, an annulus of flexible material can be used instead of the flexible membranes 346.

[0070] In this embodiment, the flexible membrane 346 connects adjacent flaps of the plurality of flaps 304 such that the flaps 304 and the flexible membrane 346 together define a channel 324 extending through the distal portion 306 of the end cap 302, and the space between the flaps 304 is substantially sealed to prevent tissue from becoming trapped between the flaps 304 and to facilitate movement of the flaps 304 toward a closed configuration. In the expanded configuration, the cross-sectional area of ​​the channel 324 extending through the distal portion 306 increases to allow a larger surface area of ​​target tissue to be accommodated therein.

[0071] like Figure 13 As shown, the device 400 according to another exemplary embodiment of the present disclosure is substantially similar to device 100, including an end cap 402 comprising a proximal portion 408 and a plurality of lobes 404 pivotally connected to the proximal portion 408 to define a distal portion 406 movable between a closed configuration and an expanded configuration, in which the lobes 404 contact each other to form a substantially tubular shape, and in the expanded configuration, the distal ends 426 move away from each other to increase the distal opening 428 of the channel 420 of the end cap 402. Similar to end cap 102, the lobes 404 of end cap 402 are movable between the closed and expanded configurations by control members 432 connected to the lobes 404. However, the distal end 434 of each control member 432 is not connected to the outer surface 438 of the lobe 404, but rather to the inner surface 430 of the corresponding lobe 404.

[0072] Similar to the device 100, the distal end 434 of the control member 432 of this embodiment comprises, for example, an enlarged ball that is movably received in a yoke member 436 having a correspondingly shaped socket 440 that is connected to the inner surface 430 of the petal 404. However, as the control member 432 is connected to the inner surface 430 of the petal 404, it will be appreciated by those skilled in the art that the control member 432 will extend proximally from the yoke member 436, through the channel 420 of the end cap 402 and the channel of the endoscope device to its proximal end, thereby eliminating any contact between the control member 432 and the yoke member 436 and the surrounding tissue during insertion and withdrawal of the endoscope device from the target site in the body.

[0073] It will be apparent to those skilled in the art that various modifications can be made to the disclosed embodiments without departing from the scope of the disclosure. Furthermore, it will be apparent that features of any of the embodiments can be combined in any way with features of other embodiments without departing from the disclosure.

Claims

1. An apparatus for facilitating the application of a tissue treatment element through a scope, comprising: an end cap including a proximal portion configured to be mounted on a distal end of a scope device and a distal portion extending distally from the proximal portion, the proximal portion extending along a longitudinal axis from a proximal end to a distal end and including a proximal passage therethrough, the distal portion including a plurality of petals, a proximal end of each of the petals being pivotably connected to a distal end of the proximal portion such that the petals are movable between a closed configuration in which the petals define a distal passage aligned with the proximal passage and an expanded configuration in which distal ends of the petals are moved away from one another to enlarge a distal opening of the end cap; and a plurality of control members, a distal end of each of the control members being connected to a respective one of the petals such that longitudinal movement of the control members relative to the proximal portion of the end cap moves the petals relative to the proximal portion between the closed configuration and the expanded configuration.

2. The apparatus of claim 1, wherein, inner surfaces of the plurality of petals include a plurality of grasping features configured to anchor the petals to a target tissue.

3. The apparatus of claim 2, wherein, the plurality of grasping features include teeth protruding from the inner surfaces of the plurality of petals.

4. The apparatus of any one of claims 1-3, wherein, outer surfaces of each of the plurality of petals are curved to facilitate sliding of a tissue clamping device therealong.

5. The apparatus of any one of claims 1-4, wherein, in the closed configuration, each of the petals extends substantially parallel relative to the longitudinal axis and longitudinal edges of each of the petals are in contact with longitudinal edges of adjacent ones of the petals to define the distal passage therebetween.

6. The apparatus of any one of claims 1-5, wherein, the distal end of each of the control members is connected to an outer surface of a respective one of the petals such that the control members extend along an exterior of the end cap.

7. The apparatus of any one of claims 1-6, wherein, the distal end of each of the control members is connected to an inner surface of a respective one of the petals such that the control members extend proximally therefrom through the proximal passage of the end cap.

8. The apparatus of any one of claims 1-7, wherein, the distal end of each of the control members includes an enlarged ball that is received in a correspondingly shaped socket of a yoke member connected to a respective one of the plurality of petals, the ball being rotatable within the socket as the end cap is moved between the closed configuration and the expanded configuration.

9. The apparatus of any one of claims 1-8, wherein, each of the plurality of petals includes a longitudinal groove extending therealong and the proximal portion includes a corresponding groove extending therealong and longitudinally aligned with the longitudinal groove, the longitudinal groove and the corresponding groove being configured to receive the control member therein.

10. The apparatus of any one of claims 1-9, wherein, the end cap further includes a flexible membrane extending between adjacent ones of the plurality of petals such that in the expanded configuration, the flexible membrane is stretched to increase a cross-sectional area of the distal passage.

11. The apparatus of claim 10, wherein, the flexible membrane is formed of a material including one of silicone and PET thermoplastic.

12. An end cap configured to be mounted on a distal end of a scope to facilitate the application of a tissue grasping device through the scope, comprising: a proximal portion extending along a longitudinal axis from a proximal end to a distal end and including a proximal passage therethrough; and a distal portion comprising a plurality of petals, a proximal end of each of the petals being pivotably connected to the distal end of the proximal portion such that the petals are movable between a closed configuration in which the petals define a distal passage aligned with the proximal passage and an expanded configuration in which distal ends of the petals are moved away from one another.

13. The end cap of claim 12, wherein, inner surfaces of the plurality of petals comprise a plurality of grasping features configured to anchor the petals to target tissue.

14. The end cap of any one of claims 12-13, wherein, In the closed configuration, each of the petals extends substantially parallel with respect to the longitudinal axis, and a longitudinal edge of each of the petals is in contact with a longitudinal edge of an adjacent one of the petals to define the distal passage therebetween.

15. The end cap of any of claims 12-14, further comprising a flexible membrane extending between adjacent ones of the plurality of petals such that, in the expanded configuration, the flexible membrane is stretched to increase a cross-sectional area of the distal passage.

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