Linear Tissue Clipping Device

Abstract

A tissue clipping device for clipping tissue and a method of using the same. The device includes a tissue clipping assembly for clipping tissue and a drive assembly operable to control operation of the tissue clipping assembly. The tissue clipping assembly includes a distal arm that is linearly extendable and retractable to clip tissue. The tissue clipping assembly can be decoupled from the drive assembly after the tissue has been clipped. Additional clipping assemblies can be deployed with the drive assembly to close larger defects.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 344,354, filed May 20, 2022, the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure relates generally to surgical devices and, more particularly, to a linear tissue clipping device that allows for improved tissue mobilization. [Background technology]

[0003] Tissue mobilization devices are used in various parts of the body, including the gastrointestinal system, urinary system, and vascular system, to mobilize tissue, such as tissue from a lumen wall. Tissue mobilization devices can be deployed using an endoscope to mobilize tissue so that it can be treated. Tissue mobilization devices can be used in conjunction with hemostatic devices to treat internal bleeding or defects. Conventional hemostatic devices, such as clamps, clips, staples, and sutures, can be applied around the mobilized tissue to apply a contractile force to the tissue, such as applying a contractile force to prevent bleeding.

[0004] Conventional tissue mobilization and hemostatic devices are operated from a position substantially above and perpendicular to the target tissue. However, such tissue mobilization and hemostatic devices can be difficult to properly position or manipulate to mobilize and close tissue. For example, the target tissue can be located in a location that is difficult or impossible to access using a conventional perpendicular approach. This can increase the length of the procedure and limit the efficiency of tissue mobilization and target tissue closure, e.g., the mobilization device does not properly mobilize the target tissue and / or the hemostatic device does not properly close the target tissue.

[0005] Thus, there is an unmet need for improved mobilization devices and improved hemostatic devices that facilitate their use in non-vertical approaches. Summary of the Invention

[0006] This Summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples of the Summary is not required by the claims unless the claims explicitly recite the feature. Also, features, components, steps, concepts, etc. described in the Summary and in the examples elsewhere in this disclosure can be combined in various ways. The description herein relates to systems, assemblies, methods, devices, apparatus, combinations, etc. that can be utilized for hemostasis of bodily defects, perforations, ulcers, and other conditions requiring hemostasis. Various features and steps described elsewhere in this disclosure can be included in the examples summarized here. Additionally, the treatment techniques, methods, operations, steps, etc. described or suggested herein can be performed in live animals or in non-living simulations such as cadavers, simulators (e.g., where body parts, tissues, etc. are simulated), etc.

[0007] In one exemplary embodiment, a medical device for clipping tissue is provided. The medical instrument includes a catheter and a collar having a proximal arm extending distally. The proximal end of the collar is coupled to a distal end of the catheter. The medical device also includes a distal arm having an extension portion and a gripping portion, and a drive element extending through the catheter and coupled to the distal arm. The drive element is operable to linearly translate the distal arm through the collar. The medical device is operable to clip tissue between the proximal and distal arms by linearly retracting the distal arm towards the proximal arm.

[0008] In one exemplary embodiment, a medical device for clipping tissue is provided. The medical device includes a tissue clipping assembly operable to clip tissue and including a distal arm, a collar, and a proximal arm. The medical device also includes a drive assembly operable to actuate the tissue clipping assembly and including a handle, a catheter, and a drive element. A proximal end of the drive element is fixed to the handle and a distal end of the drive element is operably coupled to a proximal end of the distal arm. The drive element is operable to linearly translate the distal arm to clip tissue between the distal arm and the proximal arm. The tissue clipping assembly is operably decoupled from the drive assembly after the tissue clipping assembly clips tissue.

[0009] In one exemplary embodiment, a method for treating a defect with a tissue mobilization device is provided, the method includes positioning a tissue clipping assembly over the defect, linearly extending a distal arm of the tissue clipping assembly to grasp a first side of the defect via a drive assembly, grasping a second side of the defect with a proximal arm of the tissue clipping assembly, retracting the distal arm toward the proximal arm, clipping tissue between the distal and proximal arms, and decoupling the tissue clipping assembly from the drive assembly.

[0010] These and other objects, features and advantages of the present disclosure will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a schematic diagram of a tissue clipping device. [Diagram 2] 1A and 1B are schematic diagrams illustrating the operation of a tissue clipping assembly according to one embodiment. [Figure 3A]1 is a schematic diagram of a tissue clipping assembly for use with a tissue clipping device, according to one embodiment. [Figure 3B] 1 is a schematic diagram of a tissue clipping assembly for use with a tissue clipping device, according to one embodiment. [Figure 3C] 1 is a schematic diagram of a tissue clipping assembly for use with a tissue clipping device, according to one embodiment. [Figure 4A] 1 is a schematic diagram of a distal end of a tissue clipping device, according to one embodiment. [Figure 4B] 1 is a schematic diagram of a distal end of a tissue clipping device, according to one embodiment. [Diagram 5] 1A and 1B are schematic diagrams illustrating the operation of a tissue clipping assembly according to another embodiment. [Figure 6] 5A to 5D are schematic diagrams illustrating a tissue clipping operation using the tissue clipping device. [Figure 7] 1 is a side view of a tissue clipping device, according to one embodiment. [Figure 8A] FIG. 13 is a side view of a distal arm according to one embodiment. [Figure 8B] FIG. 8B is a side view of the distal arm of FIG. 8A. [Figure 9A] FIG. 13 is a perspective view of a distal arm according to another embodiment. [Figure 9B] FIG. 13 is a perspective view of a distal arm according to another embodiment. [Figure 9C] FIG. 13 is a perspective view of a distal arm according to another embodiment. [Figure 10A] FIG. 1 illustrates a perspective view of a collar with a proximal arm according to one embodiment. [Figure 10B] FIG. 10B is a bottom view of the proximal arm of FIG. 10A. [Figure 11A] FIG. 13 is a perspective view of a distal arm according to one embodiment. [Figure 11B] FIG. 11B is a perspective view of a collar according to one embodiment for use with the distal arm of FIG. 11A. [Figure 11C]FIG. 11C is a perspective view of the distal arm of FIG. 11A in a locked position within the collar of FIG. 11B. [Figure 12A] FIG. 13 is a perspective view of a distal arm according to another embodiment. [Figure 12B] FIG. 12B is a perspective view of a collar according to one embodiment for use with the distal arm of FIG. 12A. [Figure 12C] FIG. 12C is a perspective view of the distal arm of FIG. 12A retracted into a guide slot in the collar of FIG. 12B. [Figure 13] FIG. 13 is a perspective view of a collar according to another embodiment. [Figure 14A] FIG. 13 is a perspective view of a distal end of a drive element according to one embodiment. [Figure 14B] FIG. 14B is a perspective view of a distal arm for use with the drive element of FIG. 14A. [Figure 14C] FIG. 14B is a side view of a distal arm for use with the drive element of FIG. 14A. [Figure 14D] FIG. 14B is a perspective view of the drive element of FIG. 14A coupled with the distal arm of FIGS. 14A-14B. [Figure 15] 1A and 1B are schematic diagrams illustrating a distal arm coupled to a drive element via a coupler according to one embodiment. [Figure 16] 13A and 13B are schematic diagrams illustrating a distal arm coupled to a drive element via a coupler according to another embodiment. [Figure 17] 1A-C are schematic diagrams illustrating a distal arm coupled to a drive element via a coupler according to another embodiment. [Figure 18] FIG. 13 is a schematic diagram of a drive element coupled to a distal arm via a coupler according to another embodiment. [Figure 19A] FIG. 13 is a top perspective view of a distal arm having a housing, according to one embodiment. [Figure 19B] FIG. 13 is a bottom perspective view of a distal arm having a housing, according to one embodiment. [Figure 19C] FIG. 19C is a cross-sectional perspective view of the distal arm of FIGS. 19A-19B. [Figure 19D] FIG. 19C is a side cross-sectional view of the distal arm of FIGS. 19A-19B. [Figure 19] 19A-19H are various views of the housing of the distal arm of FIGS. 19A-19B. [Figure 19] IJ show various views of the distal prongs of the distal arm of Figures 19A-B. [Figure 19K] FIG. 19C is a perspective view of a distal portion of a drive element for use with the housing of FIGS. 19E-19H and the distal prongs of FIGS. 19I-19J. [Figure 19L] FIG. 19K is a perspective view of the drive element of FIG. 19K coupled with the distal prongs of FIGS. 19I-19J. [Figure 19M] FIG. 19C is a top view of a coupler for use with the distal arm of FIGS. 19A-19B. [Figure 19N] FIG. 19C is a bottom view of a coupler for use with the distal arm of FIGS. 19A-19B. [Figure 19O] FIG. 19C is a top perspective view of the distal arm of FIGS. 19A-19B in a locked position with the coupler of FIGS. 19M and 19N. [Figure 19P] FIG. 19C is a bottom perspective view of the distal arm of FIGS. 19A-19B in a locked position with the coupler of FIGS. 19M and 19N. [Figure 20A] FIG. 13 is a perspective view of a distal arm with a housing according to another embodiment. [Figure 20B] FIG. 20B is a perspective view of a distal portion of a drive element for use with the housing of FIG. 20A. [Figure 20C] FIG. 20B is a perspective view of a housing coupler for use with the housing of FIG. 20A. [Figure 20D] FIG. 20B is a perspective view of a distal prong for use with the housing of FIG. 20A. [Figure 20E] FIG. 20B is a cross-sectional view of the housing of FIG. 20A. [Figure 21A] FIG. 13 is a side view of a distal tine for use with a housing, according to one embodiment. [Figure 21B] FIG. 21B is a side cross-sectional view of the distal tine of FIG. 21A coupled with a housing. [Figure 22A] FIG. 13 is a perspective view of a distal arm according to another embodiment. [Figure 22B] FIG. 22B is a cross-sectional view of the distal arm of FIG. 22A. [Figure 23] FIG. 1 is a perspective view of a tissue clipping assembly coupled with a catheter, according to one embodiment. [Figure 24A] FIG. 24 is a top view of the catheter of FIG. 23 coupled with a connector. [Figure 24B] FIG. 24 is a bottom view of the catheter of FIG. 23 coupled with a connector. [Figure 25A] FIG. 24 is a top view of the collar of the catheter of FIG. 23. [Figure 25B] FIG. 24 is a bottom view of the collar of the catheter of FIG. 23. [Figure 26] 24 is a bottom perspective view of the tissue clipping assembly of FIG. 23 with the collar and connector removed. [Figure 27A] 24 is a front perspective view of an alignment spacer for use with the tissue clipping assembly of FIG. 23. [Figure 27B] 24 is a rear perspective view of an alignment spacer for use with the tissue clipping assembly of FIG. 23. [Figure 27C] 27B taken along line BB of FIG. 27B. FIG. [Figure 27D] 27A is a cross-sectional view of the alignment spacer of FIGS. 27A-27B taken along line AA of FIG. 27A. [Figure 28A] FIG. 2 is a perspective view of a drive element according to one embodiment. [Figure 28B] FIG. 13 is a perspective view of a drive element according to another embodiment. [Figure 29A] FIG. 24 is a side view of the tissue clipping assembly of FIG. 23 in a set position. [Figure 29B] 29B is a side view of the tissue clipping assembly of FIG. 29A with the collar and connector removed. [Figure 30A] 24 is a side view of the tissue clipping assembly of FIG. 23 in an extended position. [Figure 30B]FIG. 30B is a side view of the tissue clipping assembly of FIG. 30A with the collar and connector removed. [Figure 31A] 24 is a side view of the tissue clipping assembly of FIG. 23 in a closed and locked position. [Figure 31B] FIG. 31B is a side view of the tissue clipping assembly of FIG. 31A with the collar and connector removed. [Diagram 32] 24 is a side view of the tissue clipping assembly of FIG. 23 in a deployed position. [Figure 33A] 1 is a perspective view of a tissue clipping assembly according to another embodiment; [Figure 33B] FIG. 33B is a side view of the tissue clipping assembly of FIG. 33A with the collar removed. [Figure 33C] FIG. 33C is a perspective view of the tissue clipping assembly of FIG. 33B with the distal arm removed. [Diagram 34] 1A-D are schematic diagrams illustrating a method of clipping tissue with a tissue clipping device using multiple tissue clipping assemblies. [Diagram 35] 1 is an illustrative example showing a method for clipping tissue with a tissue clipping device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The following description refers to the accompanying drawings which show certain embodiments of the present disclosure, describes exemplary embodiments in accordance with general inventive concepts, and is not intended to limit the scope of the invention or the claims in any manner. Indeed, the invention as described by the claims is broader than and is not limited by the exemplary embodiments set forth herein, and the terms used in the claims have all of their ordinary meanings.

[0013] The general inventive concept will be more fully understood from the detailed description given below and from the accompanying drawings of various exemplary aspects and embodiments of the present disclosure. This should not be construed as limiting the general inventive concept to specific aspects or embodiments that are provided for illustration and understanding only. Exemplary embodiments of the present disclosure are directed to devices and methods for clipping tissue. Various embodiments of devices and systems for clipping tissue are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless they are mutually exclusive or otherwise physically impossible.

[0014] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art encompassing the general inventive concept. The terms described in this detailed description are for the purpose of describing specific embodiments and are not intended to limit the general inventive concept. As used in this detailed description and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise.

[0015] As described herein, when one or more components are described as connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct between the components or may be indirect, such as through the use of one or more intermediate components. Also, as described herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but may include an assembly of components, members, or elements.

[0016] Unless otherwise indicated, all numbers used in the specification and claims, such as numbers expressing measurements or physical properties, should be understood to be modified in all cases by the term "about". Thus, unless otherwise indicated, the numerical properties described in the specification and claims are approximate and may vary depending on the appropriate properties sought to be obtained in the embodiments of the invention. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the general inventive concept are approximate, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical value inherently contains certain errors found in their respective measurements. Also, as described herein, the terms "substantially" and "about" are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0017] In describing the exemplary embodiments herein, the terms "proximal" and "distal" may be used frequently. These terms are used to describe a location or orientation of an instrument relative to an operator. For example, a proximal location or orientation is toward a user or operator of the instrument, and a distal location or orientation is away from the user or operator of the instrument, i.e., toward an object the operator is attempting to grasp, hold, and / or view. Additionally, relative location terms such as "up" or "down" and "above" or "below" refer to the location of a component in the context of a drawing. Such relative location terms are used for ease of description only and are not intended to be limiting.

[0018] The present invention provides a tissue clipping device that can be used in a linear procedural approach parallel to the target tissue, such as parallel to the luminal wall. The tissue clipping device can be used acutely for injury closure and / or hemostasis, such as endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), full thickness perforation, or upper / lower GI bleeding. The tissue clipping device can be configured to better approximate tissue than standard tissue mobilization devices, such as tissue in the GI tract, such as the colon, small intestine, and esophagus. The tissue clipping device can also be configured to mobilize tissue over larger defects than standard tissue mobilization devices and hemostatic clips. For example, the tissue clipping device of the present disclosure can be configured to approximate tissue defects having a width or diameter greater than 10 mm. In some embodiments, the tissue clipping device is configured to approximate tissue defects between 20 mm and 30 mm in width or diameter. The tissue clipping device can be configured to effectively grip tissue across defects greater than 30 mm in width or diameter. The tissue clipping device can reduce the number of hemostatic devices required to close the defect. The tissue clipping device may be usable in locations and positions less suitable for traditional tissue mobilization devices, such as the splenic or hepatic flexure, or other articular locations, hi some embodiments, the tissue clipping device may be a sterile, single-use device.

[0019] A functional block diagram of tissue clipping device 100 is shown in Figure 1. Tissue clipping device 100 includes a tissue clipping assembly 102 at a distal end and a drive assembly 200 at a proximal end that is coupled to the proximal end of tissue clipping assembly 102. Tissue clipping device 100 is operable to clip tissue linearly, such as in a direction parallel to the tissue. It is understood that linear motion and movement of tissue clipping device 100 refers to a direction substantially parallel to the angle of insertion and movement of device 100, such as a direction substantially parallel to the distal end of an endoscope, the distal end of a catheter, and / or the surface of the tissue.

[0020] The tissue clipping assembly 102 is operable to clip tissue in a linear direction. The tissue clipping assembly 102 includes a distal arm 104 and a proximal arm 110. The distal arm 104 is extendable in a distal direction and retractable in a proximal direction relative to the proximal arm 110 to clip tissue between the distal arm 104 and the proximal arm 110. The distal arm 104 includes an extension portion 106 extending generally linearly in a distal direction and a gripping portion 108 extending from the extension portion 106. The gripping portion 108 is operable to grip target tissue such that the target tissue may be clipped between the distal arm 104 and the proximal arm 110. The proximal arm 110 is disposed proximal to the distal arm 104 such that it is proximal from the gripping portion 108 of the distal arm 104. It will be understood that clipping with the tissue clipping assembly 102 encompasses grasping, gripping, pinching, hooking, or otherwise securing tissue.

[0021] In the illustrated embodiment, the extension portion 106 of the distal arm 104 extends substantially straight, the gripping portion 108 extends substantially downward (e.g., in a direction substantially perpendicular to the linear motion of the tissue clipping assembly 102), and the proximal arm 110 extends distally and downward. However, it will be understood that the distal arm 104 and the proximal arm 110 may have other shapes and configurations. For example, the gripping portion 108 of the distal arm 104 may extend proximally toward the proximal arm 110, and the proximal arm 110 may extend substantially distally.

[0022] The drive assembly 200 includes a handle 202 that is manipulable by a user to control the tissue clipping assembly 102. The drive assembly 200 also includes one or more drive elements 204 that couple the tissue clipping assembly 102 and the handle 202 such that a user can control the tissue clipping assembly 102, such as to clip tissue, via the handle 202. Each drive element 204 can be configured to transmit translational motion to the tissue clipping assembly 102. In some embodiments, the drive element 204 is configured to transmit rotational motion to the tissue clipping assembly 102. Each drive element 204 can be a solid cable, a hollow tube, a drive cable, a torque cable / shaft, a hypotube, a spring sheath, a catheter, or other device configured to control a component of the tissue clipping assembly 102, or any combination thereof. In some embodiments, a distal end of the drive element 204 is fixed to the tissue clipping assembly 102. In other embodiments, the distal end of the drive element 204 may be operatively detached from the tissue clipping assembly 102, as described below.

[0023] In the illustrated embodiment, the tissue clipping device 100 includes one drive element 204 having a distal end coupled to a proximal end of the distal arm 104, such as the proximal end of the extension portion 106 of the distal arm 104, and operable to transmit linear and rotational motion to the distal arm 104. However, it will be understood that the tissue clipping device 100 may include multiple drive elements 204. For example, the tissue clipping device 100 may include a second drive element 204 coupled to the proximal arm 110 to control the linear and / or rotational position of the proximal arm 110 (see FIGS. 3A-3B).

[0024] The handle 202 may include a control actuator 210 coupled to a proximal end of each drive element 204. Each control actuator 210 may be operable to control the position and rotation of the coupled drive element 204, such as to control the position and rotation of the tissue clipping assembly 102. For example, a user may linearly translate and rotate the control actuator 210 to linearly translate and rotate a portion of the tissue clipping assembly 102 via one of the drive elements 204. In the illustrated embodiment, the control actuator 210 is a rotating wheel that is linearly slidable within a portion of the handle 202 to control the rotation and translation of the drive elements 204. The control actuator 210 may be any suitable device that a user can actuate to control the position and / or rotation of one of the drive elements 204. For example, the control actuator 210 may be a push button, a wheel, a toggle, a switch, a lever, a trigger, a slider, or the like, or any combination thereof.

[0025] The drive assembly 200 also includes a catheter 212 extending distally from the handle 202. The catheter 212 may include one or more lumens extending the length of the catheter 212. The catheter 212 can be sized, shaped, and configured to cover one or more components of the tissue clipping device 100, such as when the device 100 is positioned through an endoscope. The tissue clipping assembly 102 and the drive element 204 can be extended through the catheter 212 to a desired location within the body, such as through an endoscope. In some embodiments, the proximal arm 110 is coupled to a distal end of the catheter 212. It will be appreciated that the catheter 212 may be a tube, such as a polymer tube, a sheath, a coil, such as a stainless steel coil, or a composite shaft, such as a braided or coiled polymer, or any combination thereof.

[0026] In some embodiments, the catheter 302 includes polyetheretherketone (PEEK), thermoplastic, nylon, pellethane, polytetrafluoroethylene (PTFE), polyimide, composite metal, and / or a polymer tube, a metal tube, a metal coil, or a reinforced composite sheath containing coils and / or braids, or combinations thereof. In a preferred embodiment, the catheter 212 is a metal spring sheath configured to resist compressive and actuating forces applied to the catheter 212 by one or more actuating elements 204 as described below. In some embodiments, the catheter 212 is configured to translate and / or rotate the tissue clipping assembly 102, allowing an operator to control the position and / or orientation of the tissue clipping assembly 102. In some embodiments, the catheter 212 includes a liner or coating, such as a PTFE liner and / or coating, polyimide, HDPE, or other lubricious polymer, or any combination thereof, disposed within one or more lumens to increase the resiliency of the catheter 212 and / or to reduce friction between the one or more actuating elements 204 and the catheter 212. In some embodiments, the liner is a separate component from the catheter 212 and is disposed between the outer surface of the drive element 204 and the inner surface of the catheter 212.

[0027] In some embodiments, the tissue clipping assembly 102 includes a collar 120 operably coupled to a distal end of the catheter 212. The collar 120 may be a substantially tubular ring through which the distal arm 104 and drive element 204 may be extended and retracted. In some embodiments, the proximal arm 110 is coupled to a distal end of the collar 120. The proximal arm 110 and the collar 120 may be integrated into a single component. In some embodiments, the collar 120 may be operably decoupled from the catheter 212, such as after the tissue clipping assembly 102 has clipped tissue, allowing the tissue clipping assembly 102 to continue to clip the tissue closed.

[0028] The tissue clipping device 100 may be used with any suitable or conventional endoscopic or laparoscopic surgical instrument. For purposes of this disclosure, the tissue clipping device 100 is described in the context of use with an endoscope, such as a colonoscope, gastroscope, duodenoscope, enteroscope, or sigmoidoscopic type device of a conventional or suitable construction. However, the tissue clipping device 100 may also be used in other ways, such as in any minimally invasive procedure using a suitable natural or artificially formed orifice in the body. The scope is provided with an elongated body having a controllably bendable protruding end region. A surgical instrument, such as the device 100, may be introduced through an instrument channel, such as an accessory channel extending through the scope body, for mobilizing targeted tissue by a surgeon operating the scope. The tissue clipping assembly 102 may be sized, shaped, and configured to be positioned through a single instrument or accessory channel of an endoscope.

[0029] The tissue clipping assembly 102 may be operated by a user, such as via a drive assembly 200 at the proximal end of the endoscope, via one or more drive elements 204 located within the endoscope and extending through a channel extending therethrough. However, the device 100 may be used without an endoscope, for example, in minimally invasive procedures using a suitable natural or artificially formed orifice in the body. The tissue clipping device 100 is also constructed and arranged such that it may be inserted into a treatment subject through an orifice or small incision and operated to clip tissue into a tissue defect or the like.

[0030] 2A-2B, the distal arm 104 can be actuated by one of the drive elements 204 to extend from and retract into the catheter 212, such as to clip tissue. A drive element 204 coupled with the distal arm 104, such as the proximal end of the extension portion 106 of the distal arm 104, can be extended distally, for example, via the handle 202, to distally extend the distal arm 104. In some embodiments, the distal arm 104 and the proximal arm 110 comprise a wire, such as a flat wire.

[0031] The distal arm 104 may be linearly extended such that the gripping portion 108 of the distal arm 104 is spaced from the proximal arm 110, the collar 120, and the catheter 212. The tissue clipping assembly 102 may be in an extended or open position when the distal arm 104 is spaced from the proximal arm 110 (FIG. 2A). In some embodiments, the distal arm 104 may be distally extended about 1 cm to about 3 cm from the catheter 212. In some embodiments, the drive element 204 may also be rotated, such as via the handle 202, to rotate the distal arm 104, such as to position the gripping portion 108 of the distal arm 104 to clip the target tissue.

[0032] When the tissue clipping assembly 102 is in the open position, the distal arm 104 and the proximal arm 110 can be appropriately positioned relative to the target tissue. The gripping portion 108 of the distal arm 104 can be extended and positioned such that it is disposed on a first side of the defect. The proximal arm 110 can be positioned on a second side of the defect substantially opposite the first side. In some embodiments, the gripping portion 108 of the distal arm 104 is at least partially inserted into tissue on the first side of the defect and the proximal arm 110 is at least partially inserted into tissue on the second side of the defect such that the distal arm 104 and the proximal arm 110 are anchored in the tissue, respectively. In some embodiments, the gripping portion 108 of the distal arm 104 and / or the proximal arm 110 include barbs, tines, or other protrusions configured to further secure the tissue to the gripping portion 108 of the distal arm 104 and / or the proximal arm 110.

[0033] The actuation element 204 can also be retracted, such as via the handle 202, to retract the distal arm 104 toward the proximal arm 110, the collar 120, and / or the distal end of the catheter 212. As shown in FIG. 2B, the distal arm 104 can be retracted such that the tissue clipping assembly 102 is in a closed or clipping position where the gripping portion 108 of the distal arm 104 substantially contacts or abuts the distal end of the proximal arm 110, e.g., to clip tissue. Retraction of the distal arm 104 toward the proximal arm 110 can pull secured tissue from a first side of the defect to secured tissue on a second side of the defect, such as to close the defect. In some embodiments, the distal arm 104 and / or the proximal arm 110 can be locked in the closed position, as described below. In some embodiments, the distal arm 104 and the proximal arm 110 may be decoupled from the drive assembly 200 when the tissue clipping assembly 102 is in the closed position, for example, to hold the defect closed. In other embodiments, a hemostatic closure device can be deployed around the clipped tissue to apply a radial force around the tissue to maintain the tissue closure.

[0034] 3A-3C, the distal arm 104 may have various configurations to, for example, enhance the ability of the distal arm 104 to clip or otherwise grasp tissue. As shown in FIG. 3A, the gripping portion 108 of the distal arm 104 may be elongated in a radial direction (e.g., may extend further downward). The gripping portion 108 of the distal arm 104 may have a length such that the gripping portion 108 extends below the catheter 212 and / or the proximal arm 110. The distal arm 104 may include a flexible, superelastic, and / or shape-memory material, such as stainless steel or Nitinol, such that the gripping portion 108 may bend or flex toward the extension portion 106 as the distal arm 104 extends through the catheter 212, and such that the distal arm 104 may regain its shape as the gripping portion 108 extends through the distal end of the catheter 212.

[0035] 3B, the extension portion 106 of the distal arm 104 may be bent upward or otherwise curved. The upward extension of the extension portion 106 may provide additional space for grasping tissue, such as when the distal arm 104 and the proximal arm 110 are positioned on opposite sides of a defect. The distal arm 104 may include a flexible or shape memory material, such as Nitinol, such that the extension portion 106 may be bent downward or curved as the distal arm 104 extends through the catheter 212, and such that the extension portion 106 may regain its shape as the extension portion 106 extends through the distal end of the catheter 212.

[0036] 3C, the gripping portion 108 of the distal arm 104 may be curved or bent proximally toward the proximal arm 110. Orienting the gripping portion 108 toward the proximal arm 110 can improve the ability of the distal arm 104 to grip tissue, such as tissue on a first side of a defect, as described below. In some embodiments, the end of the gripping portion 108 may be pointed to enhance the ability of the gripping portion 108 of the distal arm 104 to pierce and / or grip tissue during a clipping operation.

[0037] Although the distal arm 104 has been described as being retractable relative to the proximal arm 110 to clip tissue, it will be understood that the device 100 may have other configurations and assemblies. For example, as shown in Figures 4A and 4B, the distal end of the catheter 212 (Figure 4A) or the distal end of the collar 120 (Figure 4B) may be angled so that the bottom of the catheter 212 or collar 120 protrudes distally. The catheter 212 or collar 120 may be angled so that the bottom of the distal end extends approximately 3 cm from the top of the distal end.

[0038] The distal protrusion of the catheter 212 or collar 120 can operate substantially similarly to the proximal arm 110 described in FIGS. 1-3B. For example, the distal arm 104 can be extended, such as via the drive element 204, and anchored in tissue on a first side of the defect, and the protrusion of the catheter 212 or collar 120 can be anchored in tissue on a second side of the defect. The distal arm 104 can then be retracted, such as via the drive element 204, toward the protrusion of the catheter 212 or collar 120, such that the anchored tissue from the first side of the defect is brought toward the anchored tissue on the second side of the defect, such as to close the defect. In embodiments in which the distal end of the collar 120 is angled to anchor tissue on one side of the defect, the distal arm 104 and collar 120 can be anchored together and decoupled from the drive assembly 200, such as to hold the defect closed.

[0039] In some embodiments, the proximal arm 110 can be extendable and retractable, similar to the distal arm 104. As shown in FIGS. 5A and 5B, a proximal end of the distal arm 104, such as the proximal end of the extension portion 106, is coupled to a first drive element 204a, and a proximal end of the proximal arm 110 is coupled to a second drive element 204b. The proximal arm 110 can be linearly translated and rotated via the second drive element 204b, such as via a second control actuator 210 of the handle 202, to position the proximal arm 110 to clip tissue. For example, the distal arm 104 can be translated and / or rotated to secure tissue on a first side of a defect, and the proximal arm 110 can be translated and / or rotated to secure tissue on a second side of the defect. To close the defect, the distal arm 104 can then be retracted towards the catheter 212 and / or the proximal arm 110 can be extended from the catheter 212. In some embodiments, the distal arm 104 and the proximal arm 110 rotate together via the same drive element 204. In other embodiments, the proximal arm 110 opens upon extension of the distal arm 104. In some embodiments, the distal arm 104 and the proximal arm 110 can be manipulated such that the distance between the distal end of the proximal arm 110 and the gripping portion 108 of the distal arm 104 is between about 0.5 cm and about 3 cm.

[0040] Any of the proximal arms 110 of the other tissue clipping devices 100 may be actuable by the drive element 204. For example, the proximal arms 110 of FIGS. 1-3B may be actuable by the drive element 204. In embodiments with two drive elements 204, the catheter 212 may include two lumens with one drive element 204 disposed through each lumen. In embodiments with one drive element 204, the catheter 212 may include a single lumen through which the tissue clipping assembly 102 extends.

[0041] 6A-6D, the tissue clipping assembly 102 may be manipulated via the drive assembly 200 to grasp tissue at two locations, such as on opposing sides of a defect, and clip the tissue together. To maintain tissue closure via the tissue clipping assembly 102, the tissue clipping assembly 102 may be disengaged from the drive assembly 200. Before the tissue clipping assembly 102 is disengaged from the drive assembly 200, the tissue clipping assembly 102 may be moved to a locked position.

[0042] As shown in FIG. 6A, the tissue clipping assembly 102 can be oriented substantially above a target tissue, such as an identified defect. For example, the endoscope and / or catheter 212 can be manipulated such that the tissue clipping assembly 102 is in a desired position substantially above the tissue. The gripping portion 108 of the distal arm 104 can be positioned near the distal end of the catheter 212. The drive assembly 200 can include a coupler 214 that operably couples a distal end of the drive element 204 to a proximal end of the extension portion 106 of the distal arm 104. The drive assembly 200 can also include a connector 216 that operably couples a distal end of the catheter 212 to a proximal end of the collar 120. The connector 216 can be fixed to the distal end of the catheter 212 or can be included as a component of the catheter 212.

[0043] As shown in FIG 6B, the distal arm 104 can be extended, such as via the drive element 204, such that a gripping portion 108 of the distal arm 104 secures tissue in a first location, such as on a first side of the defect. The coupler 214 can be configured to transfer translational and rotational motion of the drive element 204 to the distal arm 104 so that the distal arm 104 can be appropriately positioned. The proximal arm 110 can be steered, for example, via the catheter 212 and / or endoscope, such that the proximal arm 110 secures tissue in a second location, such as on a second side of the defect.

[0044] As shown in FIG. 6C, the tissue clipping assembly 102 can appose tissue from two locations, such as to close a defect. The distal arm 104 can be retracted, for example, via the drive element 204, to a closed position such that the tissue from the first location is brought toward the tissue at the second location. The position and rotation of the distal arm 104 can be locked or otherwise maintained in the closed position such that the tissue remains clipped. For example, the collar 120 can provide a frictional, interference, or compressive force against the distal arm 104 that maintains the distal arm 104 in the closed position.

[0045] As shown in FIG. 6D, the tissue clipping assembly 102 can be decoupled from the drive assembly 200. The distal arm 104 can be decoupled from the drive element 204 and the collar 120 can be decoupled from the catheter 212. The coupler 214 can decouple the drive element 204 from the distal arm 104 so that the drive element 204 and the coupler 214 can be retracted from the distal arm 104. The connector 216 can decouple the collar 120 from the catheter 212 so that the catheter 212 can be retracted from the collar 120 as described below. The drive assembly 200 can be withdrawn from the body and the tissue clipping assembly 102 can remain in position to continue clipping tissue. Optionally, the drive assembly 200 of the device 100 can be equipped with a second tissue clipping assembly 102 such that the second tissue clipping assembly 102 can be deployed to clip tissue at a different location to close a larger defect.

[0046] 7, a tissue clipping device 100 is shown according to one embodiment. The handle 202 includes a control actuator 210 operable to control movement of the distal arm 104 via a drive element 204. The distal arm 104 may be extended from and retracted into a collar 120 to clip tissue against the proximal arm 110 of the tissue clipping assembly 102. The collar 120 may be coupled to a distal end of a catheter 212. In some embodiments, the collar 120 is releasably coupled to the catheter 212, as described below.

[0047] A user can grasp the handle 202 and manipulate the control actuator 210 to steer the distal arm 104 via the drive element 204. The distal arm 104 can be extended from the collar 120 across the target tissue. The proximal arm 110 can be positioned to grasp tissue on a first side of the target tissue and the distal arm 104 can be positioned to grasp tissue on a second side of the tissue, such as opposite the first side. The distal arm 104 can be retracted to a closed position to clip tissue between the distal arm 104 and the proximal arm 110. In some embodiments, as the tissue clipping assembly 102 clips tissue, the distal arm 104 can be retracted to mobilize tissue into the collar 120. In some embodiments, the collar 120 can be decoupled from the catheter 212 such that the tissue clipping assembly 102 continues to clip tissue after the drive assembly 200 is withdrawn from the body.

[0048] In the illustrated embodiment, the handle 202 includes one control actuator 210 coupled to the distal arm 104 via the drive element 204. However, it will be understood that the device 100 may have other configurations and assemblies. For example, the handle 202 may include a second control actuator 210 coupled to a second drive element 204 to operably control the position of the proximal arm 110.

[0049] The proximal arm 110 and / or the distal arm 104 can be sized, shaped and configured to more securely grip tissue so as to better grip the tissue when the tissue clipping assembly 102 is moved to a closed position, and / or can be sized, shaped and configured to more securely hold the distal arm 104 and the proximal arm 110 within the tissue when the tissue clipping assembly 102 clips the tissue, such as when the tissue clipping assembly 102 then clips both sides of a defect together.

[0050] In some embodiments, as shown in FIGS. 8A and 8B, the distal arm 104 is configured to enhance gripping and fixation of the distal arm 104 on tissue. The gripping portion 108 of the distal arm 104 includes one or more distal tines 112 configured to enhance gripping of the distal arm 104 on a target tissue. The distal tines 112 may extend substantially proximally toward the proximal arm 110, such as for gripping and mobilizing tissue as the distal arm 104 is retracted proximally during a tissue clipping operation. Each distal tine 112 may include a tip 114 at a proximal end that is operable to pierce tissue. The tip 114 may be sized, shaped, and configured to push the distal tine 112 into the tissue. The distal tine(s) 112 may be integral with the distal arm 104 or may be an additional component attached to the distal arm 104. In some embodiments, the distal tines 112 comprise stainless steel, nitinol, ceramic, polymer, or other suitable composite material, or any combination thereof. In some embodiments, the gripping portion 108 of the distal arm 104 has a length of about 1 mm to about 7 mm, such as about 3 mm to about 6 mm, such as about 5 mm.

[0051] In some embodiments, at least a portion of the distal arm 104, such as the distal tine(s) 112, is flexible such that the distal arm 104 can bend when the distal arm 104 is manipulated to grasp tissue. The distal arm 104 may be flexible to allow the distal tine(s) 112 to be positioned against tissue during a tissue clipping operation. For example, the distal arm 104 may be flexible such that the distal tine 112 can be oriented downward, e.g., at an angle, toward the target tissue such that the distal arm 104 can grasp tissue on a second side of the target tissue. The distal arm 104 may also be sufficiently rigid such that the distal arm 104 can hold the grasped tissue and clip the tissue against the proximal arm 110, such as during a tissue clipping operation.

[0052] In some embodiments, the distal end of one or more of the distal tines 112 can be sized, shaped, or configured to reduce trauma to tissue as the distal arms 104 extend from the catheter 212 and / or prevent damage to the catheter 212 and / or endoscope, such as when the tissue clipping assembly 102 is extended through the catheter 212 and / or endoscope. For example, the distal ends of the distal tines 112 can each include a rounded portion 116 configured to deflect tissue and reduce damage to the catheter 212 and / or endoscope as the tissue clipping assembly 102 extends through the catheter 212 and / or endoscope. In some embodiments, the rounded portion 116 of the distal tines 112 also extends below the tip 114 to elevate the distal tines 112 against the surface of the tissue as the distal arms 104 are retracted from the clipped tissue. The rounded portion 116 can also cover the proximal arm 110 when the distal arm 104 is disposed near the proximal arm 110 to protect the proximal arm 110 as the tissue clipping assembly 102 extends through the catheter 212 and / or endoscope, and to protect the user from the proximal arm 110 during handling. The rounded portion 116 can be configured such that the tissue clipping assembly 102 is atraumatic, such as to protect the operator, endoscope, catheter 212, and / or patient, when the distal arm 104 is disposed near the proximal arm 110, such as when the tissue clipping assembly 102 is in a closed position.

[0053] The distal tines 112 may also include one or more curves 118 along the length of the distal tines 112. The curves 118 may be configured such that the tips 114 of the distal tines 112 are inserted into tissue when the distal arms 104 are retracted during a tissue clipping operation. The curves 118 may also be configured such that the tips 114 and the distal tines 112 are pulled away from the living tissue as the distal arms 104 are retracted proximally during a tissue clipping operation. The curves 118 may further be sized, shaped, or configured to increase the flexibility of the distal arms 104 as they grasp tissue and to stiffen the distal arms 104 as they grasp and mobilize tissue. For example, the curves 118 may be configured and positioned to prevent the distal tines 112 from pivoting radially outward about the rounded portions 116 during a tissue clipping operation. The curved portions 118 and / or tips 114 of the distal tines 112 can also be sized, shaped, and configured to guide the distal tines 112 into tissue. For example, one or more sides (e.g., the top and / or bottom) of the distal tines 112 may be chamfered or tapered toward the tip 114 such that the distal tines 112 are guided into tissue as the tip 114 is inserted into tissue and the distal arms 104 are retracted proximally (see FIG. 19D).

[0054] In the illustrated embodiment, the distal arm 104 is substantially linear. However, it will be understood that the distal arm 104 may have other suitable shapes and configurations. For example, the gripping portion 108 may include one or more radial curves 118 (e.g., left and right), for example, to enhance the ability of the distal arm 104 to be inserted into tissue and / or to enhance the ability of the distal arm 104 to grip tissue during a tissue clipping operation. Additionally, the distal arm 104 may include a hypotube having shorter tines on either side of the distal tines 112.

[0055] In some embodiments, the distal tines 112 are further configured to better grip tissue. For example, one or more of the distal tines 112 may include one or more barbs 119. The barbs 119 may extend substantially laterally from one or both sides of each distal tine 112. The barbs 119 may be positioned and configured to help anchor the distal tine(s) 112, such as within tissue during a clipping procedure. The barbs 119 can be inserted into tissue and sized, shaped, and configured to sufficiently prevent the distal tines 112 from retracting from the tissue, such as after the tissue clipping assembly 102 is deployed in the closed position.

[0126] In the illustrated embodiment, the barb 119 extends from the top of the distal tine 112. However, it will be understood that the distal arm 104 can have other configurations and assemblies. For example, the distal arm 104 can also include a barb 119 extending downward from the distal tine(s) 112 and / or the distal arm 104 can include a barb 119 extending from one or more sides of the distal tine(s) 112.

[0056] The distal arm 104 may include a plurality of distal tines 112 for gripping and mobilizing tissue during a tissue clipping operation. As shown in FIGS. 9A-9C, the distal arm 104 includes two distal tines 112, each having a tip 114. The distal tines 112 may have shapes, sizes, and configurations other than the distal tines 112 of FIGS. 8A and 8B, for example, based on the location of the target tissue to be clipped. For example, the distal tines 112 may be oriented substantially downward (FIG. 9A). The distal tines 112 may also be rounded and shortened such that the gripping portion 108 of the distal arm 104 forms a semicircle (FIG. 9B).

[0057] The distal tines 112 may also include rounded portions 116 extending distally and downwardly from the remainder of the distal tines 112 to reduce trauma to tissue as the distal arms 104 extend from the collar 120 and / or prevent damage to the catheter 212 and / or endoscope, such as when the tissue clipping assembly 102 is extended through the catheter 212 and / or endoscope (FIG. 9C). The rounded portions 116 may also extend below the remainder of the distal tines 112, such as to elevate the distal tines 112 against the surface of tissue as the distal arms 104 are retracted to clip tissue. The rounded portion(s) 116 may also cover the proximal arm 110 when the distal arm 104 is disposed near the proximal arm 110 to protect the proximal arm 110 as the tissue clipping assembly 102 extends through the catheter 212 and / or endoscope, and to protect the user from the proximal arm 110 during handling. The rounded portion 116 may be configured to allow the tissue clipping assembly 102 to be atraumatic, such as to protect the operator, endoscope, catheter 212, and / or patient, when the distal arm 104 is disposed near the proximal arm 110, such as when the tissue clipping assembly 102 is in a closed position. Additionally, the distal arm 104 may include three or more distal tines 112.

[0058] The distal tines 112 may be separated by a distal gap 122. The distal gap(s) 122 may separate the distal tines 112 such that each distal tine 112 can grasp tissue separately. The distal gap(s) 122 may also be sized, shaped, and configured to receive a portion of the proximal arm 110 when the tissue clipping assembly 102 is in a closed position such that the distal arm 104 and the proximal arm 110 overlap in the closed position. For example, the tissue clipping assembly 102 may be steered, such as via the drive assembly 200, to grasp tissue on opposite sides of a target tissue with the distal arm 104 and the proximal arm 110, and the proximal arm 110 may then extend distally into the distal gap 122 as the tissue clipping assembly 102 moves to the closed position.

[0059] 10A and 10B, the proximal arm 110 includes one or more proximal tines 124 configured to increase the grip of the proximal arm 110 on a target tissue, such as a first side of the target tissue. The proximal tines 124 may be attached to the proximal arm 110 or may be integrally formed with the proximal arm 110. The proximal tines 124 may extend distally from the collar 120 and may be operable to further increase the grip of the proximal arm 110 on tissue. In embodiments where the proximal arm 110 is integral with the collar 120, the proximal tines 124 may be integral with the collar 120. In some embodiments, the proximal tines 124 include stainless steel, nitinol, ceramic, polymer, or composite material, or any combination thereof.

[0060] The proximal tines 124 may each include a tip 126 at a distal end of the proximal tines 124 operable to pierce tissue. The tips 126 of the proximal tines 124 may be inserted into tissue on a first side of the target tissue to grasp the tissue during a tissue clipping operation. In some embodiments, the proximal tines 124 may be substantially arcuate. For example, the proximal tines 124 may extend from the distal end of the collar 120 such that the top surfaces of the proximal tines 124 substantially correspond to the shape of the inner surface of the collar 120.

[0061] In some embodiments, the proximal tines 124 are further configured to better grip tissue. The more proximal tines 124 may also include one or more barbs 119. The barbs 119 may extend substantially laterally from one or more sides of each proximal tine 124. The barbs 119 may be positioned and configured to aid in anchoring the proximal tine(s) 124 within tissue, such as during a clipping procedure. For example, the barbs 119 may be inserted into tissue and positioned and configured to prevent or otherwise limit retraction of the proximal arms 110 from the tissue.

[0062] In the illustrated embodiment, the proximal arm 110 includes two proximal tines 124. However, it will be understood that the proximal arm 110 can have other configurations and assemblies. For example, the proximal arm 110 can include one or three or more proximal tines 124.

[0063] In some embodiments, the proximal tines 124 of the proximal arm 110 define one or more proximal gaps 128 between the proximal tines 124. The proximal gaps 128 may enhance the ability of the proximal arm 110 to grasp tissue. For example, the proximal gaps 128 between the proximal tines 124 may allow each proximal tine 124 to grasp tissue separately. The proximal gaps 128 can also be sized, shaped, and configured to receive a portion of the distal arm 104, such as the distal tines 112, when the tissue clipping assembly 102 is in the closed position. For example, the tissue clipping assembly 102 can be steered, such as via the drive assembly 200, to grasp tissue on opposite sides of a target tissue with the distal arm 104 and the proximal arm 110, which can then have the distal tines 112 extend proximally into the proximal gap 128 as the tissue clipping assembly 102 moves to a closed position. In some embodiments, the proximal tines 124 are shaped and configured such that the proximal gap 128 is narrower near the distal end of the proximal arm 110 to enhance the ability of the proximal arm 110 to be inserted into tissue such that the proximal tines 124 are inserted into tissue substantially simultaneously. The distal tines 112 can also be configured such that the distal gap 122 is narrower near the proximal end of the distal arm 104 to enhance the ability of the distal arm 104 to be inserted into tissue such that the distal tines 112 are inserted into tissue substantially simultaneously. In other embodiments, the proximal gap 128 is wider near the distal end of the proximal arm 110 and / or the distal gap 122 is wider near the proximal end of the distal arm 104, allowing each of the proximal tines 124 and / or distal tines 112 to grasp tissue separately.

[0064] Although the proximal gaps 128 have been described as being formed between the proximal tines 124, it will be understood that the proximal arm 110 may include additional proximal gaps 128 and / or the proximal gaps 128 may be formed in other manners. For example, the proximal arm 110 may include one or more proximal gaps 128 extending along the proximal arm 110, such as within the proximal tines 124. Additionally, the collar 120 may also be configured to include one or more proximal gaps 128 that extend within the collar 120.

[0065] In some embodiments, at least a portion of the proximal arm 110, such as a portion of the proximal tines 124, may be flexible to allow the proximal arm 110 to bend when the proximal arm 110 is manipulated to grasp tissue. The proximal arm 110 may be flexible to allow the proximal tine(s) 124 to be positioned against tissue during a tissue clipping operation. For example, the proximal arm 110 may be flexible such that the proximal tines 124 may be oriented downward, e.g., at an angle, toward the target tissue such that the proximal arm 110 may grasp tissue on a first side of the target tissue and the distal arm 104 may be manipulated to grasp tissue on a second side of the target tissue. The proximal arm 110 may also be sufficiently rigid such that the proximal arm 110 can hold the grasped tissue and clip the tissue against the distal arm 104, such as during a tissue clipping operation.

[0066] 11A-13, the tissue clipping device 100 is configured such that the collar 120 is operable to lock the position of the distal arm 104 when the distal arm 104 is fully retracted toward the catheter 212, such as when the distal arm 104 is moved to a closed position. The collar 120 can maintain the position of the distal arm 104 when it is in the locked position, such as to allow the distal arm 104 to continue clipping tissue against the proximal arm 110. In some embodiments, the distal arm 104 can be disengaged from the drive element 204 after the position of the distal arm 104 is retracted to the locked position and fixed relative to the collar 120. In some embodiments, the force required to lock the distal arm 104 with the collar 120 is between about 0.1 pounds and about 6 pounds, such as between about 2 pounds and about 4 pounds. In some embodiments, the force required to lock the distal arm 104 with the collar is about 2 pounds or more, such as to prevent unintentional locking of the distal arm 104.

[0067] 11A-13, the extension portion 106 of the distal arm 104 includes one or more locking protrusions 130 extending outwardly from an outer surface of the extension portion 106. The locking protrusions 130 may be sized, shaped, and configured to couple the distal arm 104 with the collar 120 when the distal arm 104 is moved to a locked position, such as when the tissue clipping assembly 102 is moved to a closed position. The locking protrusions 130 may be positioned and configured to be spaced from the distal end of the distal arm 104 and / or extend a distance from the outer surface of the distal arm 104, such as to prevent scratching or other damage to tissue during a tissue clipping operation. In some embodiments, the locking protrusions 130 are initially bent radially inward to avoid damage to tissue when the distal arms 104 extend, and when the distal arms 104 are in a locked position within the collar 120, the locking protrusions 130 extend radially outward.

[0068] The collar 120 includes or defines one or more receiving portions 136 configured to operably receive the locking protrusions 130 of the distal arm 104 when the distal arm 104 is moved to the locked position. The receiving portion(s) 136 may be disposed along a length of the collar 120 corresponding to a position of the locking protrusions 130 when the distal arm 104 is moved to the closed position. When the distal arm 104 is moved to the locked position, the locking protrusions 130 may extend into the receiving portion 136 of the collar 120 to maintain a position of the distal arm 104 relative to the collar 120. The receiving portion 136 and the locking protrusions 130 may be sized, shaped, and configured to prevent the locking protrusions 130 from being removed from the receiving portion 136, such as to maintain the distal arm 104 in the closed position after the tissue clipping assembly 102 is decoupled from the drive assembly 200. The locking protrusion 130 may remain within the receiving portion 136 of the collar 120 after the tissue clipping assembly 102 is deployed from the drive assembly 200, such as to maintain the tissue clipping assembly 102 in a closed position for clipping tissue.

[0069] In some embodiments, the locking projection 130 includes a ramp portion 132 at a proximal end and a shoulder portion 134 at a distal end. The ramp portion 132 can be configured to allow the locking projection 130 to move into a receiving portion 136 of the collar 120. For example, the ramp portion 132 may be angled or sloped to allow the locking projection 130 to slide under an inner surface of the collar 120 when the distal arm 104 is retracted into the collar 120 to position the locking projection 130 within the receiving portion 136. The shoulder portion 134 can be configured to retain the locking projection 130 within the receiving portion 136 of the collar 120 and prevent the distal arm 104 from moving distally relative to the collar 120 (e.g., to lock the distal arm 104 with the collar 120 prior to releasing the tissue clipping assembly 102). For example, the shoulder portion 134 can abut a side of the receiving portion 136 to prevent the locking projection 130 from being withdrawn from the receiving portion 136 .

[0070] In some embodiments, the collar 120 includes one or more locking tabs 138 that extend into the receiving portion 136 to retain the locking projections 130 within the receiving portion 136 of the collar 120. The locking tabs 138 may be bent or curved radially inward to retain the locking projections 130 within the receiving portion 136. In the illustrated embodiment, the collar 120 includes one locking tab 138 that extends proximally into the receiving portion 136. However, it will be understood that the collar 120 may have other configurations and assemblies. For example, the collar 120 may include two or more locking tabs 138, and the locking tabs 138 may extend proximally, distally, or outwardly into the receiving portion 136.

[0071] In some embodiments, as shown in FIGS. 12A-12C, the collar 120 may include one or more guide slots 140 extending from a distal end of the collar 120. The guide slots 140 may be operable to align the distal arm 104 when the distal arm 104 is retracted into the collar 120, such as when the distal arm 104 is retracted into a locked position. In some embodiments, the guide slots 140 extend distally into a receiver portion 136 (not shown). In some embodiments, the guide slots 140 act as the receiver portion 136 to lock the distal arm 104 in a closed position. In some embodiments, the guide slots are separate from the receiver portion 136 and align the other locking projections 130 with the receiver portion(s) 136 of the collar 120.

[0072] During a tissue clipping operation, one of the locking protrusions 130 of the distal arm 104 may be received within the guide slot 140 of the collar 120 when the distal arm 104 is retracted. One of the locking protrusions 130 or another portion of the distal arm 104 may extend into the guide slot 140 of the collar 120, such as when the distal arm 104 is oriented in a desired position. In some embodiments, the distal end of the guide slot 140 is flared or rounded to guide the locking protrusion 130 into the guide slot 140 and orient the distal arm 104 in a desired position when the distal arm 104 is retracted proximally. The placement of the locking protrusion 130 within the guide slot 140 may also orient the distal arm 104 during a tissue clipping operation, such as to prevent the distal arm 104 from unintentionally rotating during operation.

[0073] In some embodiments, the guide slot 140 can be configured to guide one of the locking projections 130 into the receiving portion 136 of the collar 120 to couple the distal arm 104 and the collar 120. For example, the receiving portion 136 may be connected with a proximal end of the guide slot, or the guide slot 140 can orient the distal arm 104 during retraction such that one of the other locking projections 130 extends into the receiving portion 136. In other embodiments, the guide slot 140 can be configured to retain the locking projection 130 to maintain the distal arm 104 in the locked position. For example, the proximal portion of the guide slot 140 can be narrower to provide a compression fit over the locking projection 130 to maintain the distal arm 104 in the locked position.

[0074] In some embodiments, as shown in FIG. 13 , the collar 120 may include a setting recess 141 aligned with the receiving portion 136 at the distal end of the collar 120. Each setting recess 141 may be configured to allow the tissue clipping assembly 102 to be moved closer to the closed position and to allow an operator to observe tissue clipping with the tissue clipping assembly 102 before the distal arm 104 is locked with the collar 120. The setting recess 141 may be a distally opening channel or groove at the distal end of the collar 120. The collar 120 may be narrower between the setting recess 141 and the receiving portion 136 to prevent accidental locking of the distal arm 104 and to maintain the distal arm 104 in the locked position when one of the locking projections 130 is disposed within the receiving portion 136. In some embodiments, the device 100 may be extended through a catheter 212 and / or endoscope having locking protrusion(s) 130 disposed within setting recess(es) 141 .

[0075] In operation, the distal arm 104 can be retracted, such as via the drive element 204, such that the locking protrusion 130 of the distal arm 104 is disposed within the setting recess 141. An operator can observe the clipping of tissue with the tissue clipping assembly 102 to determine whether the tissue clipping assembly 102 is properly clipping the tissue. If it is determined that the tissue clipping assembly 102 is not properly gripping the tissue, the operator can re-grasp the tissue with the distal arm 104 and the proximal arm 110. Alternatively, if it is determined that the tissue clipping assembly 102 is properly gripping the tissue, the distal arm 104 can be retracted, such as via the drive element 204, such that the locking protrusion 130 of the distal arm 104 is moved into the receiving portion 136. The distal arm 104 can remain locked with the collar 120 when the locking protrusion(s) 130 are moved from the setting recess(es) 141 into the receiving portion(s) 136 of the collar 120 .

[0076] In the illustrated embodiment, the collar 120 includes a setting recess 141 and a receiving portion 136 on either side of the collar 120, and a guide slot 140 on the top of the collar 120. The collar 120 also includes a stress relief 142 on one side of each setting recess 141 and receiving portion 136 pair. The stress relief 142 may allow the collar 120 to bend, curve, or compress so that the locking projection 130 may be moved from the setting recess 141 to the receiving portion 136. The collar 120 may regain its shape after the locking projection 130 is placed in the receiving portion 136 to maintain the distal arm 104 in the locked position. The stress relief 142 may be a groove or notch that allows the collar 120 to bend, curve, or compress. Additionally, it will be understood that any of the features of the collar 120 of FIG. 13 may be incorporated into any of the collars 120 described herein.

[0077] 14A-18, the one or more drive elements 204 may be operably coupled to the tissue clipping assembly 102, such as the distal arm 104, in a variety of ways such that the drive element 204 may be decoupled from the tissue clipping assembly 102, such as after the tissue clipping assembly 102 has clipped tissue. In some embodiments, the drive element 204 is operably coupled directly to the proximal end of the distal arm 104. In other embodiments, the drive element 204 is operably coupled to the proximal end of the distal arm 104 via one or more couplers 214. The one or more couplers 214 may be secured to the distal end of the drive element 204 by welding, crimping, swaging, soldering, adhesives, fasteners, or the like. The couplers 214 may also be integral with the drive element 204.

[0078] In some embodiments, the drive element 204 may be disengaged from the distal arm 104 by retracting the drive element 204 proximally with sufficient force, such as after the tissue clipping assembly 102 has been moved to the closed and locked position. In some embodiments, the proximal force applied to the drive element 204, such as the force applied by an operator via the handle 202 to disengage the drive element 204 from the distal arm 104, is between about 10 pounds and about 25 pounds, such that the force applied to the connection between the drive element 204 and the distal arm 104 is between about 5 pounds and about 10 pounds.

[0079] In some embodiments, the distal end of the drive element 204 is sized, shaped, and configured to operably couple with the distal arm 104 during movement of the distal arm 104 and operably separate from the distal arm 104 after the tissue clipping assembly 102 is moved to the closed position. As shown in FIGS. 14A-14D , the distal end of the drive element 204 includes two prongs 222 that extend distally from the remainder of the drive element 204. The prongs 222 may be shaped and configured to define a bond region 224 between the prongs 222. The prongs 222 may be closer together at the distal end such that the distal opening to the bond region 224 is narrower than the proximal portion of the bond region 224.

[0080] A distal arm 104, such as the extension portion 106, includes one or more coupling protrusions 144 configured to be operably received within a coupling region 224 defined by the prongs 222 of the drive element 204. The coupling protrusions 144 can extend from the extension portion 106 of the distal arm 104 to increase tissue mobilization by increasing the space below the grasping portion 108 of the distal arm 104 where tissue can be grasped, such as during a clipping operation. For example, the coupling protrusions 144 can extend a distance below the extension portion 106 to increase the space beneath and / or proximal to the distal tines 112 such that the distal tines 112 can grasp tissue.

[0081] The coupling protrusion(s) 144 and the prongs 222 may be sized, shaped, and configured such that the coupling protrusion 144 may be operably received within the coupling area 224 defined between the prongs 222 during operation and operably released from the coupling area 224, such as after the tissue clipping assembly 102 has been moved to the closed and locked positions. The coupling protrusion 144 may be inserted through a distal opening between the prongs 222 and positioned within the coupling area 224 defined by the prongs 222. A distal end of the prongs 222 may extend around a distal portion of the coupling protrusion 144 to operably retain the coupling protrusion 144 within the coupling area 224. In some embodiments, the prongs 222 snap-fit ​​around the coupling protrusion 144 to retain the coupling protrusion 144 within the coupling area 224. When the coupling protrusion 144 is disposed in the coupling region 224 and the prongs 222 extend distally around the coupling protrusion 144, the coupling protrusion 144 may be retained in the coupling region 224 and the distal arm 104 may be coupled to the drive element 204 such that linear and / or rotational motion of the drive element 204 is transferred to the distal arm 104. The prongs 222 may be sized, shaped, and configured to retain the coupling protrusion 144 within the coupling region 224 and maintain the coupling between the drive element 204 and the distal arm 104 during a tissue clipping operation. In some embodiments, the prongs 222 are configured to be biased radially inward around the coupling protrusion 144 such that the prongs 222 retain the coupling protrusion 144 within the coupling region 224 during operation.

[0082] The coupling protrusions 144 can also be removed from the coupling region 224 to decouple the distal arm 104 from the drive element 204, such as after the tissue clipping assembly 102 has been moved to the closed and locked position. The drive element 204 can be retracted proximally, such as via the handle 202, with sufficient force such that the prongs 222 are retracted proximally from the coupling protrusions 144 and the coupling protrusions 144 are pulled out of the coupling region 224 and through the distal openings between the prongs 222. The prongs 222 can flex or bend radially outward, such as by contacting a wider proximal portion of the coupling protrusions 144, as the drive element 204 is retracted such that the prongs 222 release the coupling protrusions 144 from the coupling region 224. The force required to pull the tissue clipping assembly 102 out of the binding area 224 defined by the prongs 222 can be greater than the force required to mobilize tissue with the distal arm 104, such that the distal arm 104 is not prematurely separated from the drive element 204. After the prongs 222 are retracted proximally from the binding projections 144, the distal arm 104 can be disengaged from the drive element 204, and the drive element 204 can be withdrawn from the distal arm 104 after clipping tissue with the tissue clipping assembly 102 in the closed and locked position.

[0083] In some embodiments, the coupling protrusion 144 includes a shoulder 146 extending outwardly from the remainder of the coupling protrusion 144. The shoulder 146 of the coupling protrusion 144 may be spaced from the remainder of the distal arm 104 and sized, shaped, and configured to receive the drive element 204 between the shoulder 146 and the outer surface of the distal arm 104 from which the coupling protrusion 144 extends. The shoulder 146 may abut a top or bottom of the drive element 204, such as the top and bottom of the prong 222, such that the distal end of the drive element 204 is substantially prevented from sliding off the top or bottom of the coupling protrusion 144. For example, in the illustrated embodiment, shoulder 146 can be disposed at the bottom of coupling protrusion 144 and prong 222 can be disposed around the remainder of coupling protrusion 144 such that shoulder 146 abuts the bottom of drive element 204, thereby preventing prong 222 from sliding off the bottom of coupling protrusion 144.

[0084] In the illustrated embodiment, the coupling protrusion 144 is oriented substantially downward from the extension portion 106 and is substantially triangular with a proximal end wider than the proximal end and pointing distally. The narrower distal end of the coupling protrusion 144 allows the coupling protrusion 144 to be withdrawn from the coupling region 224 defined by the prongs 222 of the drive element 204 to separate the arm 104 from the drive element 204, such as after the tissue clipping assembly 102 has clipped tissue. For example, the narrower distal end of the coupling protrusion 144 may be angled such that the prongs 222 radially separate when the drive element 204 is retracted relative to the coupling protrusion 144. However, it will be understood that the coupling protrusion 144 may have other shapes and configurations. For example, the coupling protrusion 144 may have a circular, elliptical, oval, rectangular, or other suitable shape, and the coupling protrusion 144 may be oriented substantially upward from the extension portion 106.

[0085] Although the prongs 222 have been described as forming part of the distal end of the drive element 204, it will be understood that the drive assembly 200 may have other assemblies and configurations. For example, the prongs 222 may be formed on a coupler 214 secured to the distal end of the drive element 204 such that the distal end of the drive element 204 may be releasably coupled to the distal arm 104 via the coupler 214.

[0086] 15A and 15B , a proximal end of the distal arm 104, such as the proximal end of the extension portion 106, includes one or more tabs 148 configured to operably couple the distal arm 104 with the drive element 204. The tabs 148 extend from the proximal end of the distal arm 104 and are flexible or pivotable to operably couple the distal arm 104 with the drive element 204. The drive element 204 may include or be coupled to a coupler 214. The coupler 214 can be sized, shaped, and configured to be operably held by the tab 148 of the distal arm 104 to couple the distal arm 104 to the drive element 204.

[0087] In the illustrated embodiment, the coupler 214 has a substantially spherical coupling portion at a distal end configured to couple with the tab 148 of the distal arm 104. In some embodiments, the coupler 214 is welded to the distal end of the drive element 204. In some embodiments, the coupler 214 includes a neck portion secured to the distal end of the drive element 204 such that the drive element 204 can control the position and / or rotation of the distal arm 104. In some embodiments, the coupler 214 is rectangular, spiral, elliptical, asymmetric, or other shape to impart a translational and / or rotational force to the distal arm 104 when coupled between the drive element 204 and the distal arm 104.

[0088] The tab 148 of the distal arm 104 may be configured to flex or bend around the coupler 214, such as a spherical coupling portion of the coupler 214 for coupling the drive element 204 to the distal arm 104. The curved tab 148 may prevent or otherwise limit the coupler 214 from being retracted from the distal arm 104 during a tissue clipping operation. For example, the tab 148 may be sized and shaped to substantially cover the proximal side of the coupler 214. Additionally, the tab 148 may remain disposed about the coupler 214 during operation such that linear and / or rotational motion of the drive element 204 may be transferred to the distal arm 104.

[0089] The tabs 148 can be deflected outwardly to disengage the drive element 204 from the distal arm 104, such as after the tissue clipping assembly 102 has been moved to a closed position. The drive element 204 can be retracted proximally, such as via the handle 202, with sufficient force to disengage the tabs 148 from holding the coupler 214 to the distal arm 104. The drive element 204 can be retracted with sufficient force to retract the coupler 214 such that the tabs 148 bend radially outward and no longer surround the mating portion of the coupler 214. The force required to release the tabs 148 can be greater than the force required to mobilize the tissue at the distal arm 104. After the tabs 148 bend radially outward, the drive element 204 and coupler 214 can be retracted proximally from the distal arm 104, such as with the tissue clipping assembly 102 clipping the tissue.

[0090] Additionally or alternatively, the distal end of the drive element 204 may include one or more detents extending radially into an outer surface of the drive element 204, each configured to receive a tab 148 extending from a proximal end of the extension portion 106 of the distal arm 104. The tabs 148 of the distal arm 104 may be pivoted or bent such that the tabs extend into the detents to operably couple the drive element 204 and the distal arm 104. The tabs 148 may be separated by retracting the drive element 204 proximally relative to the distal arm 104 and bending the tabs 148 out of the detents, thereby decoupling the drive element 204 from the distal arm 104.

[0091] In some embodiments, the proximal end of the distal arm 104 may include a bore or recess configured to receive a coupler 214, such as a spherical coupler. The coupler 214 may be inserted into the bore of the distal arm 104, and the distal arm 104 may be connected to the coupler 214, such as by crimping, swaging, or welding the distal arm 104 around the coupler 214, coupling the drive element 204 and the distal arm 104. The drive element 204 may be disconnected from the distal arm 104 by retracting the drive element 204 towards the distal arm 104 and releasing or otherwise breaking one or more connections, such as crimps, such that the coupler 214 may be retracted from the distal arm 104.

[0092] In some embodiments, the distal arm 104 may be coupled to the drive element 204 by a frangible connection. The distal arm 104 may be coupled to the drive element 204 until a sufficient proximal force is applied to the drive element 204, such as via the handle 202, to release or otherwise decouple the connection between the drive element 204 and the distal arm 104, such as after the tissue clipping assembly 102 is moved to a closed position to clip tissue.

[0093] 16A and 16B, the coupler 214 may be substantially cylindrical and include a first portion 214a secured about a distal end of the drive element 204 and a second portion 214b secured about a proximal portion of the distal arm 104, such as secured about a proximal portion of the extension portion 106 of the distal arm 104. The coupler 214 includes a channel 218 extending within the coupler 214 such that the first channel portion 218a extends proximally from a distal end of the first portion 214a into the first portion 214a and a second channel portion 218b extends distally from a proximal end of the second portion 214b into the second portion 214b. The coupling link 220 extends into the channel 218 and is secured within the channel 218 such that a proximal portion of the coupling link 220 is secured to the first channel portion 218a and a distal portion of the coupling link 220 is secured to the second channel portion 218b. When secured, the coupling link 220 can operably couple the drive element 204 to the distal arm 104. In some embodiments, the coupling link 220 is laser welded into the first channel portion 218a and the second channel portion 218b of the channel 218.

[0094] The coupling link 220 may be sized, shaped, and configured such that when the coupling link 220 couples the drive element 204 and the distal arm 104, the translation and / or rotation of the drive element 204 is transferred to the distal arm 104. The coupling link 220 may also be sized, shaped, and configured to break when subjected to a desired tensile load, such as a force applied to the coupling link 220 when the tissue clipping assembly 102 is in the closed position and the drive element 204 is retracted proximally. When the coupling link 220 is released, the distal arm 104 may be decoupled from the drive element 204 such that the drive element 204 may be retracted from the distal arm 104. In some embodiments, the coupling link 220 comprises stainless steel or nitinol, or a combination thereof.

[0095] 16A and 16B is described as including a first portion 214a disposed about the drive element 204, a second portion 214b disposed about the distal arm 104, and a channel 218, it will be understood that the coupler 214 may have other configurations and assemblies. For example, the coupler 214 may form a coupling link 220 by directly coupling a distal end of the drive element 204 to a proximal end of the distal arm 104. The coupling link 220 may be operable to transfer movement and / or rotation of the drive element 204 to the distal arm 104 when the coupling link 220 couples the drive element 204 and the distal arm 104. The coupling link 220 may also be configured to disengage, thereby decoupling, the drive element 204 from the distal arm 104 when the coupling link 220 is subjected to a desired tensile load, as described above. Additionally or alternatively, a portion of the distal arm 104 and / or a portion of the drive element 204 may be frangible such that the drive element 204 is coupled to the distal arm 104 during operation and disengages under a predetermined load to separate the distal arm 104 from the drive element 204.

[0096] As shown in FIGS. 17A-17C, the drive assembly 200 may be substantially tubular and may include a coupler 214 disposed about a distal end of the drive element 204. The coupler 214 may be a hypotube. The coupler 214 may be disposed about a distal end of the drive element 204 such that a portion of the coupler 214 extends distally beyond the distal end of the drive element 204 (FIG. 17A). The coupler 214 may be secured to the drive element 204 via swaging, such as by swaging an inner surface of the coupler 214 to the drive element 204. The coupler 214 may also be crimped or welded to the drive element 204. A proximal end of the distal arm 104, such as a proximal end of the extension portion 106, may be inserted into the distal end of the coupler 214, and the coupler 214 may be operably secured by the distal arm 104. The distal end of the coupler 214 can be distally connected, such as via crimping, to the proximal end of the distal arm 104 (FIG. 17B), such that the distal arm 104 can be coupled, via the coupler 214, to the drive element 204, such as for steering the distal arm 104 to grasp tissue.

[0097] The coupler 214 can operatively disconnect the distal arm 104 from the drive element 204, such as after the tissue clipping assembly 102 is moved to a closed and locked position to clip tissue. The drive element 204 can be retracted proximally with sufficient force to disconnect or otherwise sever a connection, such as a crimp, between the coupler 214 and the distal arm 104. Once the connection (e.g., crimp) of the coupler 214 to the distal arm 104 is disconnected or severed, the distal arm 104 can be decoupled from the drive element 204 (FIG. 17C). The force required to disconnect or sever the connection may be less than the force required to pull the tissue clipping assembly 102 from the tissue. After the connection is disconnected, the drive element 204 and coupler 214 can be retracted from the distal arm 104, for example, with the tissue clipping assembly 102 clipping the tissue. Although the coupler 214 is described as being connected to the distal arm 104 by crimping, it will be understood that the coupler 214 may be connected to the distal arm 104 in other ways, such as by swaging, soldering, and welding.

[0098] It will further be appreciated that the proximal end of the distal arm 104 may be further coupled to the distal end of the drive element 204 within the coupler 214. For example, the proximal end of the distal arm 104, such as the proximal end of the extension portion 106, may be configured to operatively interlock with the distal end of the drive element 204 (see FIG. 9A).

[0099] In some embodiments, the coupler 214 has a size, shape, and configuration that allows the coupler 214 to be inserted into and interlocked with a portion of the distal arm 104 until the coupler 214 is moved to an unlocked position. As shown in FIG. 18 , a proximal end of the distal arm 104, such as the proximal end of the extension portion 106, includes a mating bore 150 that extends distally into the distal arm 104. The mating bore 150 can be a bore having a proximal opening that substantially corresponds to the shape of the coupler 214. The distal portion of the mating bore 150 can have a width or diameter greater than the proximal opening of the mating bore 150. The coupler 214 can be inserted into the mating bore 150 at a position that corresponds to the shape of the proximal opening. After the coupler 214 is inserted into the mating bore 150 through the proximal opening, the coupler 214 can be rotated to operably secure the coupler 214 within the mating bore 150.

[0100] In some embodiments, the coupling bore 150 is configured such that the coupler 214 can be rotated a predetermined amount within the coupling bore 150 such that the coupler 214 operably locks in place within the coupling bore 150. For example, as the coupler 214 is rotated, a cross-section of the coupler 214 may have a shape that prevents the coupler 214 from being retracted from the proximal opening of the coupling bore 150. The coupling bore 150 may include one or more locking elements that prevent or otherwise limit the coupler 214 from rotating or translating within the coupling bore 150 during movement of the distal arm 104. For example, the coupling bore 150 may include one or more tabs that bend when the coupler 214 is properly positioned within the coupling bore 150 and limit the opposite rotation of the coupler 214 to operably hold the coupler 214 in place within the coupling bore 150. In some embodiments, the coupler 214 can be magnetically locked within the coupling bore 150 until a force sufficient to overcome the magnetic attraction is applied to the drive element 204 .

[0101] The coupler 214 can be interlocked with the mating bore 150 of the distal arm 104 such that the distal arm 104 can be translated and / or rotated via the drive element 204 during operation. The coupler 214 can be rotated within the mating bore 150, such as via the drive element 204, such that the coupler 214 can be retracted from the mating bore 150 to decouple the drive element 204 from the distal arm 104, such as after the clipping assembly 102 clips tissue. For example, the coupler 214 can be rotated in a direction opposite to the direction in which the coupler 214 is rotated to lock the coupler 214 within the mating bore 150, such that a cross-section of the coupler 214 is aligned with a proximal opening of the mating bore 150.

[0102] In the illustrated embodiment, coupler 214 is a substantially rectangular block, and the proximal opening of mating bore 150 is similarly rectangular. However, it will be understood that coupler 214 and the proximal opening of mating bore 150 may have any suitable shape and configuration. For example, coupler 214 may be oval, elliptical, triangular, pentagonal, hook-shaped, or any other suitable shape. Additionally, although coupler 214 is described as extending from a distal end of drive element 204, it will be understood that the distal end of drive element 204 may be sized, shaped, and configured to function similarly to coupler 214 of FIG. 18.

[0103] In other embodiments, the coupler 214 may be substantially spherical and the mating bore 150 may be sized, shaped, and configured to operably receive the coupler 214 in a ball-and-socket connection. The coupler 214 may be inserted into the mating bore 150 of the distal arm 104, such as via a snap-fit ​​or press-fit, to retain the coupler 214 within the mating bore 150 during operation. The mating bore 150 may be sized, shaped, and configured to retain the coupler 214, such as by having a narrower opening, such that the distal arm 104 may be controlled via the drive element 204 during operation. The coupler 214 may be retracted with sufficient force, such as sufficient force to overcome the snap-fit, to release the coupler 214 from the mating bore 150, thereby decoupling the drive element 204 from the distal arm 104.

[0104] Although the coupler 214 in FIG. 18 is described as having a shape that may correspond to the shape of the proximal opening of the coupling bore 150 of the distal arm 104, it will be understood that the coupler 214 may have other configurations such that the coupler 214 may be retained within the coupling bore 150. For example, the coupler 214 may form or include a deformable coupling link 220 such that the coupling link 220 may couple the distal arm 104 to couple the drive element 204. The opening of the receiving portion 136 may be narrower than the distal portion of the coupling bore 150. The coupling link 220 may be inserted into the coupling bore 150 and bend or deform within the coupling bore 150 such that the coupling link 220 has a width greater than the proximal opening of the coupling bore 150, thereby coupling the drive element 204 and the distal arm 104 and preventing the coupling link 220 from retracting from the coupling bore 150 during operation. The drive element 204 can be retracted proximally with sufficient force to pull the coupling link 220 from the deformed state such that the coupling link 220 can be retracted from the coupling bore 150 and decouple the drive element 204 from the distal arm 104. The coupling link 220 may comprise a shape memory material, such as Nitinol, and / or a superelastic material.

[0105] Additionally, the distal end of the drive element 204 can be sized, shaped, and configured to operably couple with the proximal end of the distal arm 104. For example, the distal end of the drive element 204 can be bent into a shape, such as an L-shape, that is received through a portion of the distal arm 104. When the drive element 204 is disposed through a portion of the distal arm 104, the distal arm 104 can be linearly extendable and retractable. After the tissue clipping assembly 102 is moved to the closed position, the shape of the distal end of the drive element 204 can be withdrawn from the distal arm 104 such that the drive element 204 is decoupled from the distal arm 104, such as by lifting the L-shaped bend from the receiving portion of the distal arm 104. Additionally, it will be appreciated that the distal arm 104 can be operably coupled to the drive element 204 in other manners as described below.

[0106] In embodiments in which the distal arm 104 is releasably coupled to the drive element 204, the drive assembly 200 can include one or more components configured to further maintain the coupling of the distal arm 104 and the drive element 204 during operation. For example, the drive assembly 200 can include a sheath or tube disposed about the drive element 204 and substantially covering the coupling of the drive element 204 to the distal arm 104. The sheath or tube can extend to a proximal end of the distal arm 104 to prevent or otherwise limit disengagement of the distal arm 104 from the drive element 204 during a tissue clipping operation. In some embodiments, the sheath or tube has a distal portion that is operably interlocked with a proximal portion. When the distal arm 104 is decoupled from the drive element 204, the distal portion can be decoupled from the proximal portion, such as by proximal retraction of the drive element 204.

[0107] Although coupler 214 has been described as being part of drive assembly 200 and attached to a distal end of drive element 204, it will be understood that coupler 214 may be part of tissue clipping assembly 102 and attached to a proximal end of distal arm 104. Additionally, it will be understood that any of the coupling methods described above may be switched such that the coupling component(s) of drive element 204 are disposed on tissue clipping assembly 102 and vice versa. Additionally, it will be understood that in embodiments in which proximal arm 110 is translatable by drive element 204, the proximal end of proximal arm 110 may be coupled similarly to drive element 204 such that proximal arm 110 may be decoupled from drive element 204.

[0108] 19A-21B, the distal arm 104 includes a housing 154 toward a distal end of the distal arm 104. The housing 154 can be configured to reduce trauma to tissue as the distal arm 104 extends from the catheter 212 and / or prevent damage to the catheter 212 and / or endoscope, such as when the tissue clipping assembly 102 is extended through the catheter 212 and / or endoscope. The housing 154 can deflect tissue as the distal arm 104 extends from the collar 120 such that the extension of the distal arm 104 is substantially atraumatic. The housing 154 can cover the proximal arm 110, such as to protect an operator, endoscope, catheter 212, and / or patient, such as when the tissue clipping assembly 102 is in a closed position. The housing 154 can also be configured to operably lock with the collar 120 to secure the distal arm 104 in a closed and locked position. In some embodiments, the housing 154 and / or the distal tines 112 of the distal arm 104 are releasably coupled to a distal end of the drive element 204 .

[0109] As shown in FIGS. 19A-19P, the housing 154 of the distal arm 104 includes a tine channel 156 operable to receive the distal tines 112 therein. The tine channel 156 may be substantially linear and may extend around the top, front, and bottom of the housing 154 and substantially corresponds to the shape of the distal tines 112. The tine channel 156 may be sized, shaped, and configured to receive at least a portion of the distal tines 112 therein. In some embodiments, the distal tines 112 are snap-fit ​​or press-fit within the tine channel 156 to secure the distal tines 112 to the tine channel 156. Additionally or alternatively, the distal tines 112 may be secured within the tine channel 156 by welding, crimping, swaging, soldering, adhesives, fasteners, or the like.

[0110] The housing 154 may include one or more housing extensions 158 extending radially outward from and at least partially laterally across the tine channel 156. The housing extensions 158 may be sized, shaped, and configured to prevent the distal tines 112 from being retracted from the tine channel 156. For example, the housing extensions may be operable to abut an outer surface of the distal tines 112 disposed in the tine channel 156 to prevent the distal tines 112 from moving radially out of the tine channel 156. The housing extensions 158 may be crimped, swaged, pressed, or otherwise mechanically deformed, such as to hold the distal tines 112 in place relative to the housing 154 and within the tine channel 156.

[0111] The distal tines 112 may include one or more retention tabs 162 extending radially outward from the remainder of the distal tines 112. The retention tabs 162 may be located at positions along the distal tines 112 and may extend outward from the remainder of the distal tines 112 to retain the distal tines 112 within the tine channel 156. The retention tabs 162 may extend radially outward above a bottom surface of the housing extension 158. The retention tabs 162 may be sized, shaped, positioned, and configured to abut proximal and distal sides of the housing extension 158. The retention tabs 162 may be located on either side of the housing extension 158 to prevent or otherwise limit linear translation of the distal tines 112 within the tine channel 156 relative to the housing 154.

[0112] The distal tines 112 and / or the housing 154 may be configured to releasably couple with a distal end of the drive element 204. As shown in FIG. 19K, the distal end of the drive element 204 may include a coupling region 224 inset proximally from the prongs 222. The coupling region 224 may be sized, shaped, and configured to receive a portion of the distal tines 112 and / or the housing 154 to releasably couple the distal arm 104 to the drive element 204 such that the position of the distal arm 104 can be controlled by the drive element 204.

[0113] 19I and 19J, the coupling protrusions 144 of the distal tines 112 extend downwardly from the tops of the distal tines near the proximal ends of the distal tines 112. The proximal and / or distal sides of the coupling protrusions 144 may be angled or rounded, such as to allow the coupling protrusions 144 to be withdrawn from the coupling regions 224 defined by the drive elements 204, as described below.

[0114] 19C and 19D , the coupling protrusion 144 can extend into a coupling region 224 defined by the drive element 204 to couple the distal arm 104 to the drive element 204. The coupling protrusion 144 can extend substantially from a proximal end of the coupling region 224 to a distal end of the coupling region 224 such that movement of the drive element 204 is translated to the distal arm 104.

[0115] The distal arm 104 may be disengaged from the drive element 204 by applying a sufficient proximal force to the drive element 204 to pull the coupling protrusion 144 back from the coupling region 224, such as after the tissue clipping assembly 102 has been moved to the closed and locked position. The drive element 204 may be retracted proximally such that a distal end of the coupling protrusion 144 contacts a distal side of the coupling region 224. The sides of the coupling protrusion 144 may be sized, shaped, and configured such that when the drive element 204 is retracted proximally, contact between the distal end of the coupling protrusion 144 and the distal side of the coupling region 224 causes the distal tines 112 to move upward. In the illustrated embodiment, the sides of the coupling protrusion 144 are angled or sloped. However, it will be understood that the coupling protrusion 144 may have other shapes and configurations. For example, the sides of the coupling protrusion 144 may be rounded. The drive element 204 may be retracted proximally such that the coupling protrusion 144 is lifted from the coupling region 224. The drive element 204 can be decoupled from the distal arm 104 once the coupling protrusion 144 is removed from the coupling region 224 and the drive element 204 is retracted proximally.

[0116] Although the distal tines 112 are described as releasably coupling with the distal end of the drive element 204, it will be understood that the distal arm 104 may have other configurations and assemblies. For example, the coupling protrusions 144 may be disposed on the housing 154 such that they are operably received within a coupling region 224 defined by the drive element 204.

[0117] In some embodiments, the housing 154 also includes a lateral passage 160 near the proximal end of the housing 154. The lateral passage 160 can be sized, shaped, and configured to at least partially receive one of the barbs 119 of the distal tines 112 therethrough. The placement of the barb 119 within the lateral passage 160 can allow the distal tines 112 to substantially close within the tine channels 156 of the housing 154.

[0118] As shown in FIGS. 19A-19C and 19E-19H, the locking protrusion 130 of the distal arm 104 can be disposed on an exterior surface of the housing 154, such as at a proximal end of the housing 154. As shown in FIGS. 19M-19O, the housing 154 can be retracted into and locked with the collar 120, such as when the tissue clipping assembly 102 is moved to a closed and locked position. The collar 120 includes a setting recess 141 at a distal end of the collar 120 and extending into the receiving portion 136. The setting recess 141 and the receiving portion 136 can be disposed to correspond to the location of the locking protrusion 130 of the housing 154. The distal arm 104 can be retracted such that the locking protrusion 130 is disposed in the setting recess 141, such as to orient the distal arm 104 and ensure that the tissue clipping assembly 102 properly clips tissue. To move the distal arm 104 to the closed and locked positions, the distal arm 104 can be retracted proximally, such as via the drive element 204, to move the locking projection 130 into the receiving portion 136 of the collar. The collar 120 can also include stress reliefs 142 disposed at the distal end of the receiving portion 136, on either side of the setting recess 141 and the receiving portion 136, to allow the locking projection 130 to move from the setting recess 141 of the collar 120 into the receiving portion 136. In some embodiments, as shown in FIG. 19P, when the distal arm 104 is retracted, the distal tines 112 can be disposed between the proximal tines 124 of the proximal arm 110 such that the proximal tines 124 act as guide slots 140.

[0119] 19O and 19P, the housing 154 can substantially surround the proximal tines 124 of the proximal arm 110 when the tissue clipping assembly 102 is in the closed and locked position. The housing 154 can be sized, shaped, and configured to maintain the tissue clipping between the distal arm 104 and the proximal arm 110 and reduce trauma to the surrounding tissue when the tissue clipping assembly 102 is in the closed and locked position.

[0120] As shown in FIGS. 20A-20E, the housing 154 may include a drive coupler 164 configured to further couple the distal arm 104 and the drive element 204. As shown in FIG. 20B, the drive element 204 may define one or more coupling regions 224 along a distal end of the drive element 204. As shown in FIG. 20C, the drive coupler 164 may be substantially triangular with a wider proximal end and may include one or more projection apertures 165 extending from a top of the drive coupler 164 to a bottom of the drive coupler 164. The projection apertures 165 may substantially correspond to the location of the coupling region 224 of the drive element 204. As shown in FIG. 20D, the distal tines 112 include one or more coupling protrusions 144 extending substantially downward. The coupling protrusions 144 may be sized and positioned to correspond to the coupling region 224 of the drive element 204 and the projection apertures 165 of the drive coupler 164. Coupling protrusion 144 may be substantially L-shaped with a proximally extending elongated portion.

[0121] As shown in FIG. 20E , when the distal tines 112 are coupled with the housing 154, the coupling protrusions 144 can extend through the coupling region 224 of the drive element 204 and the protrusion apertures 165 of the drive coupler 164 to couple the distal arm 104 to the drive element 204. The elongated portion of the coupling protrusions 144 can extend partially along a bottom surface of the drive coupler 164, such as to prevent the drive coupler 164 from slipping off the coupling protrusions 144. The drive coupler 164 can maintain the coupling of the drive element 204 to the distal arm 104 by preventing the drive element 204 from prematurely slipping off the coupling protrusions 144. When the tissue clipping assembly 102 is moved to the closed and locked positions, the drive element 204 can be manipulated such that the coupling protrusions 144 are retracted through the drive coupler 164 and the drive element 204, allowing the drive element 204 to be decoupled from the distal arm 104.

[0122] It will further be appreciated that the distal tines 112 may have a variety of configurations to maintain the distal tines 112 within the tine channel 156. For example, as shown in FIGS. 20D-20E, the tops of the distal tines 112 may include a notch for receiving the housing extension 158 therein. Placement of the housing extension 158 within the notch can maintain the translational position of the distal tines 112 relative to the tine channel 156 and can prevent the distal tines 112 from moving radially out of the tine channel 156.

[0123] In some embodiments, the distal arm 104, such as the housing 154, can be sized, shaped, or configured to limit bending or rotation of one or more of the distal tines 112, for example, to limit bending or rotation of the distal tines 112 about the rounded portion 116 of the distal tines 112. As shown in FIGS. 21A and 21B, the distal tines 112 can include a flange 166 extending radially outward (e.g., proximally) from the rounded portion 116. The housing 154 can include a stop 167 radially outward (e.g., proximally) from the tine channel 156. When the bottom of the distal tine 112, such as the tip 114, bends downward, such as into tissue, the flange 166 can abut the stop 167. The abutment between the flange 166 and the stop 167 can prevent the bottom of the distal tine 112, such as the tip 114, from bending further downward. For example, the abutment between the flange 166 and the stop 167 can prevent the distal tines 112 from opening beyond a point where they cannot return to a closed position to clip tissue. Additionally or alternatively, the rounded portion 116 of the distal tines 112 can be thicker and / or comprise a harder material to prevent the distal tines 112 from opening too far. Further, the housing 154 can include one or more housing extensions 158 that extend across the tine channels 156 on the bottom side of the housing 154, also preventing the distal tines 112 from opening too far during a tissue clipping operation.

[0124] In some embodiments, the distal arm 104 and / or the drive element 204 may be configured to simplify the device 100 and / or reduce the overall cost of the device 100. As shown in FIGS. 22A and 22B, the distal arm 104 may include a single curved distal tine 112. In some embodiments, the distal tine 112 may be a curved cut tube or a Nitinol wire. The distal tine 112 may have a bulbous end secured within a housing 154. The housing 154 may be coupled to the distal end of the drive element 204 via a frangible bond or the like. The distal end of the drive element 204 may include two or more wires, such as stainless steel wires or Nitinol wires, instead of a single element having a substantially rectangular cross-section, as described in more detail below.

[0125] Although the housing 154 is described as housing one distal tine 112, it will be understood that the housing 154 may have other configurations. For example, the housing 154 may include two or more tine channels 156 such that the housing 154 may be used with two or more distal tines 112. Additionally, any of the housings 154 may be used with any of the other distal tines 112 described herein, such as the distal tines of Figures 8A-8B.

[0126] 23-32, the collar 120 of the tissue clipping assembly 102 may be operatively coupled to the catheter 212 such that the collar 120 may be decoupled from the catheter 212, such as after the tissue clipping assembly 102 has clipped tissue. The distal end of the catheter 212 may be directly or indirectly coupled to the proximal end of the collar 120 during operation. The catheter 212 may be decoupled from the collar 120 after the tissue clipping assembly 102 has been moved to a closed position, such as by continued proximal retraction of the drive element 204.

[0127] 23-24, the drive assembly 200 may include a connector 216 configured to operably couple a distal end of the catheter 212 with a proximal end of the collar 120. The connector 216 may couple the catheter 212 with the collar 120 while the tissue clipping assembly 102 is being manipulated to clip tissue. The connector 216 may also decouple the catheter 212 from the collar 120 after the tissue clipping assembly 102 has been moved to the closed and locked positions, such as for deploying the tissue clipping assembly 102 within the body to maintain clipping of tissue. The connector 216 may be a substantially hollow cylinder operable to slidably receive the drive element 204 therethrough.

[0128] In some embodiments, the proximal end of the connector 216 is secured to the distal end of the catheter 212 such that the connector 216 remains coupled to the catheter 212 after the drive assembly 200 is decoupled from the tissue clipping assembly 102. The proximal end of the connector 216 may be coupled to the distal end of the catheter 212 via adhesives, welding, fasteners, thermal bonding, or the like. In an exemplary embodiment, the proximal end of the connector 216 is welded to the distal end of the catheter 212. In other embodiments, the connector 216 is included as an integral part of the distal portion of the catheter 212.

[0129] A distal end of the connector 216 is operable to mate with a proximal end of the collar 120. As shown in FIGS. 23-25B, the connector 216 includes a connecting portion 226 at a distal end of the connector 216 that is operable to mate with the collar 120. The connecting portion 226 of the connector 216 includes one or more connecting protrusions 228 and defines one or more receiving areas 230. The connecting protrusions 228 of the collar 120 may extend distally from the remainder of the connector 216 and may be substantially arcuate.

[0130] The collar 120 may also include a connecting portion 168 at a proximal end of the collar 120 operable to mate with a connecting portion 226 of the connector 216. The connecting portion 168 of the collar 120 may also include one or more connecting protrusions 170 and may define one or more receiving areas 172. The connecting protrusions 170 of the collar 120 may extend proximally from the remainder of the collar 120 and may be substantially arcuate.

[0131] The connection protrusions 170 of the collar 120 and the receiving area 230 defined by the connector 216 may be sized, shaped, and configured such that the connection protrusions 170 of the collar 120 may be received in the receiving area 230 of the connector 216 to couple the collar 120 to the connector 216. The connection protrusions 228 of the connector 216 and the receiving area 172 defined by the collar 120 may be sized, shaped, and configured such that the connection protrusions 228 of the connector 216 may be received in the receiving area 172 of the collar 120 to couple the collar 120 to the connector 216. The connection protrusions 170 of the collar 120 may be received in the receiving area 230 of the connector 216 and the connection protrusions 228 of the connector 216 may be received in the receiving area 172 of the collar 120 to operably couple the collar 120 to the connector 216. The connecting projection 170 and the receiving area 172 of the collar 120, and the connecting projection 228 and the receiving area 230 of the collar 120, can operably interlock together to operably couple the collar 120 with the connector 216. The connecting portion 168 of the collar 120 can linearly overlap the connecting portion 226 of the connector 216 when the connector 216 is coupled with the collar 120. For example, the connecting projection 170 of the collar 120 can extend proximally beyond a portion of the connecting projection 228 of the connector 216, and the connecting projection 228 of the connector 216 can extend distally beyond a portion of the connecting projection 170 of the collar 120 when the connector 216 is coupled with the collar 120. When the collar 120 is coupled with the connector 216, the collar 120 can translate and / or rotate with the catheter 212.

[0132] Each of the connection projections 170 of the collar 120 may include a lateral flange 174 extending laterally (e.g., radially) from a proximal end of the connection projection 170. The lateral flanges 174 of the collar 120 may be operable to retain the connection projections 170 within a corresponding receiving area 230 of the connector 216 during operation. The lateral flanges 174 of the connection projections 170 of the collar 120 may be sized, shaped, and configured to be received within the receiving area 230 of the connector 216 and extend laterally (e.g., radially) behind a portion of the connector 216. The extension of the lateral flanges 174 of the connection projections 170 of the collar 120 proximally behind a portion of the connector 216 may operably interlock the collar 120 with the connector 216 and may prevent the collar 120 from moving distally relative to the connector 216.

[0133] The connecting projections 228 of the connectors 216 may also include lateral flanges 232 extending laterally from the distal ends of the connecting projections 228. The lateral flanges 232 of the connectors 216 may be operable to retain the respective connecting projections 228 in the corresponding receiving areas 172 of the collars 120 during operation. The lateral flanges 232 of the connecting projections 228 of the connectors 216 may be sized, shaped, and configured to be received in the receiving areas 172 of the collars 120 and extend laterally (e.g., radially) distally rearward of a portion of the collar 120. The lateral flanges 232 of the connecting projections 228 of the connectors 216 extending distally rearward of a portion of the collar 120 may operably interlock the connector 216 with the collar 120 and may prevent the connector 216 from moving proximally relative to the collar 120.

[0134] In some embodiments, the lateral flange 174 of the connection projection 170 of the collar 120 is disposed proximally posterior to the lateral flange 232 of the connection projection 228 of the connector 216 when the connection projection 170 of the collar 120 is disposed in the receiving area 230 of the connector 216. The lateral flange 232 of the connection projection 228 of the connector 216 is disposed distally posterior to the lateral flange 174 of the connection projection 170 of the collar 120 when the connection projection 228 of the connector 216 is disposed in the receiving area 172 of the collar 120. The linear overlap of the lateral flange 174 of the collar 120 and the lateral flange 232 of the connector 216 may further secure the coupling between the connector 216 and the collar 120.

[0135] In the illustrated embodiment, the collar 120 and connector 216 have one connecting protrusion 170, 228 and two receiving areas 172, 230. However, it will be understood that the collar 120 and connector 216 may have any suitable number of connecting protrusions 170, 228 and receiving areas 172, 230 for operably interlocking the collar 120 to the connector 216.

[0136] The connecting projections 170 of the collar 120 may be disengaged from the receiving area 230 of the connector 216, and the connecting projections 228 of the connector 216 may be disengaged from the receiving area 172 of the collar 120, disengaging the connector 216 from the collar 120. The connecting projections 170 of the collar 120 may be moved laterally and / or bent radially outward from the receiving area 230 of the connector 216, and the connecting projections 228 of the connector 216 may be moved laterally and / or bent radially outward from the receiving area 172 of the collar 120. For example, the connecting projections 228 of the connector 216 and / or the connecting projections 170 of the collar 120 may be moved radially outward or bent by sufficient proximal retraction of the drive element 204, as described below. After the connecting projections 170 of the collar 120 are disconnected from the receiving area 230 of the connector 216 and the connecting projections 228 of the connector 216 are disconnected from the receiving area 172 of the collar 120, the connector 216 may be disconnected from the collar 120. After the connector 216 is disconnected from the collar 120, the connector 216 and the catheter 212 may be withdrawn from the collar 120.

[0137] Although the catheter 212 has been described as being releasably coupled to the collar 120 via the connector 216, it will be understood that the catheter 212 may be coupled to the collar 120 in other manners. For example, the connector 216 may be incorporated into a distal end of the catheter 212, and the catheter 212 may include a coupling portion operable to connect with the connecting portion 168 of the collar 120.

[0138] As shown in Figures 26-27D, the drive assembly 200 may include an alignment adapter or spacer 236 configured to substantially maintain the orientation of the distal arm 104 during operation and to operably decouple the collar 120 from the connector 216, such as after the tissue clipping assembly 102 has been moved to the closed and locked positions.

[0139] Alignment spacer 236 may be substantially cylindrical and sized, shaped, and configured to slide linearly within the inner surfaces of collar 120 and connector 216. Alignment spacer 236 may define a drive passage 238 extending through a length of alignment spacer 236. Drive passage 238 may be sized, shaped, and configured to receive a portion of drive element 204 therethrough such that drive element 204 is translatable therethrough.

[0140] The alignment spacer 236 may be disposed in an operative position within and between the collar 120 and the connector 216 when the collar 120 and the connector 216 are coupled to maintain the coupling of the collar 120 and the connector 216. The alignment spacer 236 may be disposed within the collar 120 and the connector 216 such that an outer surface of the alignment spacer 236 abuts an inner surface of the collar 120 and the connector 216. The outer surface of the alignment spacer 236 may abut an inner surface of the connecting portions 168, 226 of the collar 120 and the connector 216 to prevent the collar 120 and the connector 216 from separating. For example, the outer surface of the alignment spacer 236 can simultaneously abut the connecting protrusion 170 of the collar 120 and the connecting protrusion 228 of the connector 216 to prevent the connecting protrusion 170 of the collar 120 from moving out of the receiving area 230 of the connector 216 and the connecting protrusion 228 of the connector 216 from moving out of the receiving area 172 of the collar 120. The distal end of the alignment spacer 236 can be disposed near the proximal end of the distal arm 104 when the alignment spacer 236 is in the operating position and the distal arm 104 is in the set position. During operation, the positioning of the alignment spacer 236 near the collar 120 can help guide the distal arm 104 to mobilize tissue.

[0141] The alignment spacer 236 may also be linearly translatable within the collar 120 and connector 216 to decouple the connector 216 from the collar 120. The alignment spacer 236 may be linearly translated, such as from beneath the connecting portions 168, 226 of the collar 120 and connector 216, such that the alignment spacer 236 no longer supports the coupling between the collar 120 and connector 216. For example, the alignment spacer 236 may be fully retracted proximally within the connector 216. Without the support of the alignment spacer 236, the connector 216 may be moved, such as through the catheter 212, such that the connecting protrusions 228 of the connector 216 are moved out of the receiving areas 172 of the collar 120, and vice versa, thereby decoupling the collar 120 from the connector 216 and catheter 212.

[0142] 28A and 28B, the drive element 204 may include a proximal portion 206 that may be coupled to the handle 202, such as a control actuator 210, and a distal portion 208 that may be operably coupled to the tissue clipping assembly 102, such as via a coupler 214. The proximal portion 206 may be sized, shaped, and configured to extend through the catheter 212 and transfer translational and rotational motion from the handle 202 to the tissue clipping assembly 102. In some embodiments, the proximal portion 206 of the drive element 204 may be sized, shaped, and configured to reduce friction applied to the catheter 212 when the tissue clipping device 100 is manipulated. In an exemplary embodiment, the proximal portion 206 of the drive element 204 is configured to allow the distal arm 104 to flexibly mobilize tissue, and the distal portion 208 is configured to linearly guide the distal arm 104 out of and into the collar 120. The proximal portion 206 of the drive element 204 may be a torque shaft that may be translated and rotated by an operator, such as via the handle 202 .

[0143] A distal end of the distal portion 208 of the drive element 204 may be coupled to the tissue clipping assembly 102, such as at the proximal end of the distal arm 104. The distal portion 208 may be sized, shaped, and configured to enhance control of the distal arm 104 when the distal arm 104 is manipulated to clip tissue. The distal portion 208 of the drive element 204 may have a different cross-section than the proximal portion 206 of the drive element 204. In some embodiments, the distal portion 208 of the drive element 204 has a wider cross-section than the proximal portion 206 of the drive element 204, such as for decoupling the drive assembly 200 from the tissue clipping assembly 102, as described below. In some embodiments, the distal portion 208 of the drive element 204 has a substantially rectangular cross-section and comprises stainless steel or nitinol. In other embodiments, the distal portion 208 of the drive element 204 includes multiple laterally spaced wires extending in parallel toward the tissue clipping assembly 102 .

[0144] Although the proximal portion 206 of the drive element 204 is described as having a circular cross-section and the distal portion 208 of the drive element 204 is described as having a rectangular cross-section, it will be understood that the drive element 204 may have other shapes and configurations. For example, both the proximal portion 206 and the distal portion 208 of the drive element 204 may have a substantially circular cross-section, or both the proximal portion 206 and the distal portion 208 may have a substantially rectangular cross-section. The distal portion 208 may also be wider to guide the linear extension and retraction of the distal arm 104 relative to the proximal arm 110. For example, a wider distal portion 208 may make the distal portion 208 more rigid and keep the distal portion 208 substantially aligned with the distal opening of the alignment spacer 236 when the distal arm 104 is linearly extended and retracted, such as during a tissue clipping operation. The distal portion 208 can remain relatively wired when the proximal portion 206 is manipulated by an operator. For example, the distal portion 208 can be stiffer than the proximal portion 206.

[0145] A distal end of the proximal portion 206 of the drive element 204 may be secured to a proximal end of the distal portion 208 of the drive element 204. In an exemplary embodiment, the distal end of the proximal portion 206 is welded to the proximal end of the distal portion 208. In other embodiments, the distal end of the proximal portion 206 is coupled to the proximal end of the distal portion 208 via adhesive, soldering, fasteners, or other suitable means known in the art to couple the proximal portion 206 to the distal portion 208. In an exemplary embodiment, the proximal portion 206 and the distal portion 208 are unitary.

[0146] In some embodiments, the proximal portion 206 of the drive element 204 has a length that corresponds approximately to the distance that the distal arm 104 extends from the catheter 212. For example, the drive assembly 200 may be configured to limit the distal extension of the proximal portion 206 of the drive element 204 such that the extension length of the distal arm 104 is substantially equal to the length of the distal portion 208 of the drive element 204. In embodiments, if the distal arm 104 is configured to extend approximately 3 cm from the catheter 212, the distal portion 208 of the drive element 204 may have a length of approximately 3 cm, or slightly longer. The distal portion 208 may have a length similar to or longer than the length of the distal tines 112 such that the distal arm 104 may be effectively guided relative to the collar 120.

[0147] 27C-D, the drive passage 238 of the alignment spacer 236 may be sized, shaped, and configured to allow a proximal portion of the distal portion 208 of the drive element 204 to extend distally therethrough, such that the alignment spacer 236 may be retracted proximally when the drive element 204 is retracted proximally, such as after the tissue clipping assembly 102 is moved to the closed and locked positions. The drive passage 238 may include a proximal portion 238a at a proximal end and a distal portion 238b at a distal end. The proximal portion 238a of the drive passage 238 may be sized, shaped, and configured to receive the distal end of the proximal portion 206 of the drive element 204 therein and allow the distal portion 208 of the drive element 204 to translate therethrough. Distal portion 238b of drive passage 238 may be sized, shaped, and configured to allow distal portion 208 of drive element 204 to translate therethrough. Distal portion 238b of drive passage 238 may also be sized, shaped, and configured to prevent proximal portion 206 of drive element 204 from extending therethrough. Distal portion 238b of drive passage 238 may also be sized, shaped, and configured to prevent distal portions of drive element 204, such as prongs 222, from extending therethrough.

[0148] In some embodiments, a cross-section of the proximal portion 238a of the drive passage 238 is wider than a distal portion 238b of the drive passage 238. In some embodiments, a cross-section of the proximal portion 238a of the drive passage 238 corresponds to a cross-section (e.g., circular) of the proximal portion 206 of the drive element 204. In some embodiments, a cross-section of the distal portion 238b of the drive passage 238 corresponds to a cross-section (e.g., rectangular) of the distal portion 208 of the drive element 204.

[0149] In some embodiments, alignment spacer 236 includes a shoulder 240 disposed at a distal end of proximal portion 238a of drive passage 238. Shoulder 240 may be configured to abut a distal end of proximal portion 206 of drive element 204. Shoulder 240 may be configured to prevent proximal portion 206 of drive element 204 from extending into distal portion 238b of drive passage 238 while allowing distal portion 208 of drive element 204 to extend into distal portion 238b of drive passage 238. Drive element 204 may also include a stop feature that abuts shoulder 240 to prevent proximal portion 206 of drive element 204 from extending into distal portion 238b of drive passage 238.

[0150] An alignment spacer 236 may be disposed between the connecting portion 168, 226 of the collar 120 and the connector 216 when the device 100 is extended into the body and when the tissue clipping assembly 102 is manipulated (e.g., in an operating position) to clip tissue, such as to maintain coupling of the collar 120 and the connector 216. The alignment spacer 236 may allow the distal portion 208 of the drive element 204 to extend through the drive passage 238 such that the distal arm 104 may be operated to grasp tissue as described above. The alignment spacer 236 may also prevent the proximal portion 206 of the drive element 204 from extending through the drive passage 238, such as to control the extension length of the distal arm 104. A cross-section of distal portion 238b of drive passage 238 may substantially correspond to a cross-section of distal portion 208 of drive element 204, and an orientation of distal portion 208 of drive element 204 substantially corresponds to an orientation of alignment spacer 236 to prevent distal portion 208 of drive element 204 and distal arm 104 from rotating or twisting as distal portion 208 extends distally. In some embodiments, a distal end of alignment spacer 236 is narrower around distal portion 238b of drive passage 238 to increase the stiffness of alignment spacer 236.

[0151] In some embodiments, the alignment spacer 236 includes one or more ridges 242 extending radially outward from an outer surface of the alignment spacer 236. The ridges 242 may extend radially outward from a proximal portion of the alignment spacer 236. The ridges 242 may extend into slots 244 extending along the length of the connector 216 (see FIGS. 23-24B). The ridges 242 may be retained within the slots 244 of the connector 216 to maintain the orientation of the alignment spacer 236 during operation, such as maintaining the orientation of the distal portion 208 and distal arm 104 of the drive element 204 during a tissue clipping operation. For example, the slots 244 may allow linear translation of the alignment spacer 236 but prevent rotation of the alignment spacer 236 when the ridges 242 are disposed within the slots 244.

[0152] The slot 244 of the connector 216 may also control the linear translational movement of the alignment spacer 236. For example, the alignment spacer 236 may be prevented from translating distally through the connector 216 when the ridge 242 abuts the distal end of the slot 244. In some embodiments, the distal end of the slot 244 may be positioned such that the alignment spacer 236 is in an operating position between the connecting portion 168, 226 of the collar 120 and the connector 216 when the ridge 242 abuts the distal end of the slot 244 (e.g., the alignment spacer 236 may only translate proximally). In another embodiment, the slot 244 has a narrower portion that abuts the ridge 242, thereby preventing the alignment spacer 236 from moving proximally until a sufficient force is delivered to the alignment spacer 236 via the drive element 204. The force required to retract the alignment spacer 236 proximally can be between about 1 lbs and about 10 lbs, such as between about 2 lbs and about 4 lbs.

[0153] In some embodiments, as shown in FIG. 24B, the connector 216 includes a retention tab 234 configured to operably retain the alignment spacer 236 in an operative position to maintain the coupling between the collar 120 and the connector 216. The retention tab 234 may be curved or bent radially inward to abut a proximal end of the alignment spacer 236 when the alignment spacer 236 is in an operative position. The abutment between the retention tab 234 and the alignment spacer 236 may prevent the alignment spacer 236 from retracting in a proximal direction during a tissue clipping operation. When the alignment spacer 236 is retracted with sufficient force, such as via the drive element 204, the retention tab 234 may bend or bend such that the retention tab 234 no longer abuts the alignment spacer 236, thereby causing the alignment spacer 236 to be retracted proximally. In some embodiments, the connector 216 includes datums 246 extending between the slots 244 that aid in assembly and provide the operator with a visual indication that the connector 216 is properly positioned on the catheter 212. The datums 246 may also be flexible to allow the connector 216 to bend or curve, such as to position the proximal end of the connector 216 around the distal end of the catheter 212.

[0154] The alignment spacer 236 may be retracted proximally from between the connecting portions 168, 226 of the collar 120 and the connector 216 by retracting the drive element 204 proximally, such as after the tissue clipping assembly 102 has been moved to the closed and locked positions. After the distal end of the drive element 204 is disengaged from the tissue clipping assembly 102, the drive element 204 may be retracted proximally through the drive passage 238 of the alignment spacer 236. The drive element 204 may be retracted until a distal portion of the drive element 204, such as the prongs 222, abuts the distal end of the alignment spacer 236. The drive element 204 may then be retracted, such as via the handle 202, with sufficient proximal force that the abutment between the drive element 204 and the alignment spacer 236 retracts the alignment spacer 236 proximally. For example, the drive element 204 may be retracted with sufficient force to bend the retention tabs 234 radially outward such that the alignment spacer 236 may be retracted proximally along with the drive element 204. After the alignment spacer 236 has been retracted proximally from the operating position, the collar 120 may be disengaged from the connector 216 and the catheter 212 such that the tissue clipping assembly 102 is disengaged from the drive assembly 200.

[0155] Although the drive element 204 has been described with a distal portion 208 having a flat rectangular cross-section to control the orientation and deflection of the distal arm 104 during operation, it will be understood that the distal portion 208 may have other configurations and assemblies. For example, the distal portion 208 of the drive element 204 may include two or more wires, such as stainless steel wires or nitinol wires, that run parallel to the distal arm 104, as shown in FIG. 22A.

[0156] 29A-32, the tissue clipping device 100 may be operated to clip tissue with the tissue clipping assembly 102, which may be decoupled from the drive assembly 200, such as for deploying the tissue clipping assembly 102 within the body to maintain closure of the tissue. The tissue clipping assembly 102 may be inserted substantially parallel at a location above a target tissue, such as an identified defect. The tissue clipping assembly 102 may be manipulated via the drive assembly 200 to clip tissue in a linear fashion, such as clipping both sides of the defect together. The tissue clipping assembly 102 may be moved to a closed position and a locked position to continue clipping tissue. The tissue clipping assembly 102 may be decoupled from the drive assembly 200, such as for maintaining closure of the defect with the tissue clipping assembly 102. 29B, 30B, and 31B show the tissue clipping device 100 without the collar 120 and connector 216, illustrating the internal components of the tissue clipping assembly 102 and the drive assembly 200. FIG.

[0157] As shown in FIGS. 29A-29B, the tissue clipping assembly 102 may be extended, such as through an endoscope, through a catheter 212 to a desired location, such as above a defect. The distal arm 104 of the tissue clipping assembly 102 may be coupled to a distal end of a drive element 204. The distal arm 104 and the drive element 204 may extend through a collar 120, and the proximal arm 110 may also extend from a distal end of the collar 120. The locking protrusion 130 of the distal arm 104 may be disposed in a setting recess 141 of the collar 120 such that the tissue clipping assembly 102 is in a set position. The distal arm 104 may include a housing 154 that substantially surrounds the proximal arm 110. The collar 120 is operably coupled to a distal end of the catheter 212 via a connector 216. The connecting portion 168 of the collar 120 can be operably coupled to the connecting portion 226 of the connector 216, and an alignment spacer 236 can be disposed between the connecting portions 168, 226 to maintain the coupling between the collar 120 and the connector 216. The drive element 204 extends through the alignment spacer 236 and is operably coupled to the distal arm 104.

[0158] As shown in FIGS. 30A-B, the distal arms 104 can be extended linearly (e.g., parallel to a surface of the tissue) from the collar 120 to an extended configuration such that the tissue clipping assembly 102 can be positioned on opposing sides of a target tissue. The drive element 204 can be extended distally, such as via the handle 202, to linearly extend the distal arms 104. The tissue clipping device 100 can be manipulated such that the proximal arms 110, such as the proximal tines 124, grasp tissue at a first tissue location, and the distal arms 104, such as the distal tines 112, grasp tissue at a second tissue location. The second tissue location can be substantially opposite the first location. In some embodiments, the distal tines 112 of the distal arms 104 can be bent radially outward (e.g., downward) a distance such that the distal tines 112 can grasp tissue.

[0159] As shown in FIGS. 31A-31B, the distal arm 104 may be retracted proximally to clip tissue between the distal arm 104 and the proximal arm 110, and the tissue clipping assembly 102 may be moved to a closed and locked position such that the position of the distal arm 104 is maintained relative to the collar 120. The distal arm 104 may be retracted proximally by retracting the drive element 204 proximally, such as via the handle 202. Retraction of the distal arm 104 may clip tissue between the distal arm 104 and the proximal arm 110. In some embodiments, before the tissue clipping assembly 102 is moved to the locked position, the tissue clipping assembly 102 may be retracted proximally to a set position shown in FIGS. 29A-29B to allow an operator to verify that the tissue clipping assembly 102 is properly clipping tissue. The tissue clipping assembly 102 may be moved to the closed and locked positions by retracting the distal arm 104 proximally via the drive element 204 such that the locking projection 130 is moved into the receiving portion 136. The placement of the locking projection 130 on the receiving portion 136 may fix the position of the distal arm 104 relative to the collar 120 in the closed position. In some embodiments, the distal arm 104, such as the housing 154, may cover the proximal arm 110 to prevent trauma to the tissue. The distal tines 112 may be closed relative to the proximal arm 110. In some embodiments, the distal arm 104 linearly overlaps the proximal arm 110 to clip tissue in the closed position. In some embodiments, the distal arm 104 is operable to mobilize tissue into the collar 120 when the tissue clipping assembly 102 is moved to the closed position.

[0160] 32, the tissue clipping assembly 102 may be decoupled from the drive assembly 200, such as to deploy the tissue clipping assembly 102 in a closed clipping position within tissue. After the tissue clipping assembly 102 has been moved to the closed and locked position, the drive element 204 may be retracted proximally with sufficient force to decouple the distal arm 104 from the drive element 204. The drive element 204 may be further retracted such that the drive element 204 abuts the distal end of the alignment spacer 236. The drive element 204 may be retracted proximally with sufficient force such that the alignment spacer 236 is pulled proximally from its position and the coupling between the collar 120 and the connector 216 is maintained. The connector 216 may then be decoupled from the collar 120, such as via manipulation of the catheter 212. With the tissue clipping assembly 102 decoupled from the drive assembly 200, the tissue clipping assembly 102 may be deployed within the body such that the tissue clipping assembly 102 continues to clip tissue. The drive assembly 200 may then be withdrawn from the body. In some embodiments, the tissue clipping assembly 102 deployed within the body to clip tissue has a length of between about 5.0 mm and about 30.0 mm, such as between about 10.0 mm and about 20.0 mm, such as about 14 mm. For example, the tissue clipping assembly 102 may have a length that reduces abrasion of the surrounding tissue and premature dislodging of the tissue clipping assembly 102 as the tissue clipping assembly 102 is deployed.

[0161] Although the alignment spacer 236 has been described as being a single component with a drive channel 238 having a proximal portion 238a and a distal portion 238b, it will be understood that the tissue clipping device 100 may have other assemblies and configurations. For example, as shown in FIG. 33, the tissue clipping assembly 102 may include a first alignment spacer operable to limit the linear extension of the proximal portion 206 of the drive element 204 and a second alignment spacer operable to control the orientation of the distal portion 208 of the drive element 204 and abut the distal end of the drive element 204 when the drive element is retracted. However, the inclusion of a single alignment spacer 236 as described above may enable the tissue clipping device 100, the tissue clipping assembly 102, and / or the drive assembly 200 to have a smaller profile.

[0162] 33A-33C, the proximal arm 110 can be pivotable about a distal end of the collar 120. The proximal end of the proximal arm 110 can be coupled to a drive element 204 such that linear extension and retraction of the drive element 204 can open and close the proximal arm 110. For example, when the tissue clipping assembly 102 is placed in position relative to a target tissue, the proximal arm 110 can be opened and the proximal arm 110 can be approximated to grasp tissue on one side of the target tissue.

[0163] The proximal arm 110 may be decoupled from the drive element 204, such as after the tissue clipping assembly 102 is moved to the closed position. For example, the proximal arm 110 may be pivotally coupled to a distal end of the drive element 204 via a pin or link such that the proximal arm 110 may pivot about the link and disengage under a predetermined force to decouple the proximal arm 110 from the drive element 204. In other embodiments, the drive element 204 coupled to the proximal arm 110 may be decoupled from the drive element 204 in any of the manners described above. The position of the proximal arm 110 may be fixed relative to the collar 120, as described above.

[0164] In some embodiments, the tissue clipping device 100, such as the tissue clipping assembly 102 and / or the drive assembly 200, may include marks or other indicia to assist an operator in positioning and manipulating the tissue clipping device 100. For example, the collar 120 may include one or more indicia to indicate an orientation of the tissue clipping device 100. Additionally, the connector 216 may also include one or more indicia to indicate an orientation of the tissue clipping device 100. For example, one or more of the indicia on the collar 120 and the connector 216 may be an arrow indicating the direction of extension of the distal arm 104, and one or more indicia on the collar 120 may be an arrow indicating an orientation of the device 100 such that the tissue clipping assembly 102 is properly oriented to clip tissue. In some embodiments, the collar 120 also includes indicia or other markings to aid in the assembly and / or manufacture of the tissue clipping device 100.

[0165] The tissue clipping device 100 may be operable with multiple tissue clipping assemblies 102, such as for clipping multiple tissue locations. After the first tissue clipping assembly 102 is deployed to clip tissue, the second tissue clipping assembly 102 may be coupled to the drive assembly 200 such that the drive assembly 200 can deploy the second tissue clipping assembly 102 to clip tissue. The second tissue clipping assembly 102 may be substantially similar to the first tissue clipping assembly 102 or may have a different size, shape, or configuration, such as based on different tissue deployment locations. The deployment of multiple tissue clipping assemblies 102 allows the tissue clipping device 100 to close larger defects or lesions than conventional mobilization devices and hemostatic clips. For example, the device 100 may be used to clip elongated sections of tissue, such as elongated or oval lesions, using multiple tissue clipping assemblies 102.

[0166] 34A-34D, the tissue clipping device 100 can be operable to deploy multiple tissue clipping assemblies 102 to clip targeted tissue, such as to close an elongated defect.

[0167] As shown in FIG. 34A, after a target tissue, such as a defect, is identified within the body, an endoscope and / or tissue clipping device 100 may be positioned above and toward the tissue. The device 100 may be positioned on a first side of and at one end of the target tissue. The tissue clipping device 100 includes a first tissue clipping assembly 102a coupled to a drive assembly 200. The first tissue clipping assembly 102a includes a first distal arm 104a and a first proximal arm 110a. The first distal arm 104a may be linearly extended across the width of the tissue beyond a second side of the target tissue opposite the first side. The device 100 may be manipulated to grasp tissue on the second side of the tissue with the first distal arm 104a and grasp tissue on the first side of the tissue with the first proximal arm 110a. The device 100 can then be manipulated to clip the sides of the tissue with the distal arm 104a and the proximal arm 110a as described above.

[0168] Although the tissue clipping device 100 has been described as clipping two opposing sides of a defect together, it will be understood that the device 100 may be used in other ways. For example, the distal arms 104 can be extended to mobilize tissue from the center of the defect to the proximal arms 110 positioned on the sides of the defect. The device 100 can then clip half of the defect, such as to form two more manageable defects. The device 100 can be used to further close the defect, such as with additional tissue clipping assemblies 102, or a hemostatic closure mechanism can be deployed to close the defect.

[0169] 34B, the drive assembly 200 may be decoupled from the first tissue clipping assembly 102a, the drive assembly 200 may be withdrawn from the body, and the tissue clipping device 100 may be reloaded with the second tissue clipping assembly 102b. The collar 120 of the second tissue clipping assembly 102b may be coupled to the distal end of the connector 216, and the distal arm 104b of the second tissue clipping assembly 102b may be coupled to the drive element 204, as described above. For example, an operator may reach through the slot 244 of the connector 216 and reset the alignment spacer 236 to the operating position, maintaining the coupling between the connector 216 and the collar 120 of the second tissue clipping assembly 102.

[0170] The tissue clipping device 100 may be reinserted into the body, such as through an endoscope, and positioned above and facing the target tissue, spaced from the first tissue clipping assembly 102a. The device 100 may then be manipulated to clip the sides of the tissue with the distal arm 104b and the proximal arm 110b of the second tissue clipping assembly 102b. The second tissue clipping assembly 102b may be positioned such that the target tissue is substantially clipped or otherwise closed between the first tissue clipping assembly 102a and the second tissue clipping assembly 102b.

[0171] As shown in FIG. 34C, the drive assembly 200 can be decoupled from the second tissue clipping assembly 102b, the drive assembly 200 can be withdrawn from the body, and the tissue clipping device 100 can be reloaded with the third tissue clipping assembly 102c. The tissue clipping device 100 can be reinserted into the body, such as through an endoscope, and positioned over and toward the target tissue, such as at the other end of the target tissue, opposite the first tissue clipping assembly 102a, at a position spaced from the second tissue clipping assembly 102b. The device 100 can then be manipulated to clip the side of the tissue with the distal arm 104c and the proximal arm 110c of the third tissue clipping assembly 102c. The third tissue clipping assembly 102c can be positioned such that the target tissue is substantially clipped or otherwise closed between the second tissue clipping assembly 102b and the third tissue clipping assembly 102c.

[0172] As shown in FIG 34D, the drive assembly 200 can be decoupled from the third tissue clipping assembly 102c and withdrawn from the body. The tissue clipping assemblies 102a, 102b, 102c can be deployed to clip a first side and a second side of the target tissue along a length of the target tissue. The tissue clipping assembly 102 can be deployed to substantially close a length of the target tissue, such as to close a defect that would previously have required more clips to close.

[0173] In the illustrated embodiment, the tissue clipping device 100 is operated to deploy three tissue clipping assemblies 102a, 102b, 102c to clip together a strip of tissue. However, it will be understood that the tissue clipping method illustrated in Figures 34A-34D is merely exemplary. For example, the tissue clipping device 100 may be used with one, two, or four or more tissue clipping assemblies 102 to clip a section of tissue.

[0174] 35 illustrates an exemplary method 400 for clipping tissue, such as to close a defect. Although the method is shown as a series of acts performed in sequence, it is understood and appreciated that the method is not limited by the order of the sequence. For example, some acts can be performed simultaneously with other acts. Furthermore, in some instances, not all acts may be required to implement a method described herein.

[0175] In step 402, a clipping device is positioned over a target tissue, such as a defect. The tissue may be identified using one or more cameras operably connected to the endoscope. The clipping device may include a tissue clipping assembly positioned over the target tissue. The tissue clipping assembly may be coupled to a drive assembly such that a user may control the position and rotation of the tissue clipping assembly. Portions of the tissue clipping assembly and the drive assembly may be extended through the endoscope to a desired location.

[0176] The distal arm extends beyond the first tissue location, such as beyond a first side of the implanted defect. The distal arm may extend from a distal end of the endoscope and a distal end of the catheter of the drive assembly. The distal arm may be extended via a drive element, such as via a handle, to linearly translate and rotate the distal arm beyond the first tissue location. The distal arm may be extended such that a gripping portion of the distal arm is positioned linearly beyond (e.g., distally of) the tissue at the first location. The distal arm, such as a gripping portion of the distal arm, may be inserted into tissue at the first location to grasp and secure the tissue at the first location.

[0177] In some embodiments, one or more tines of the distal arm are oriented to face and grasp the tissue at a first location. Orientation of the tines may be achieved using one or more indicia, such as an arrow on the clip, to indicate the top of the tissue clipping device.

[0178] In some embodiments, tissue at a first location may be pulled or dragged proximally toward a second tissue location by proximally retracting the endoscope and / or catheter of the drive assembly without actuating the tissue clipping device, which may allow the tissue clipping device to close a defect larger than the actual opening of the tissue clipping device.

[0179] In step 406, a proximal arm of the tissue clipping device is placed on the tissue at a second location. The second location can be substantially proximal to the first location, such as a second side of the defect that is opposite the first side of the defect. The proximal arm can be positioned at the second location via a catheter. The proximal arm can be inserted into the tissue at the second location to grasp and secure the tissue at the second location. In some embodiments, one or more prongs of the proximal arm are oriented to face and grasp the tissue at the second location. In some embodiments, the proximal arm is fixedly attached to a collar of the tissue clipping assembly.

[0180] At step 408, the distal arm is retracted toward the proximal arm. The distal arm may be linearly retracted toward the proximal arm such that tissue grasped by the distal arm at a first location is pulled toward tissue grasped by the proximal arm at a second location. In some embodiments, the proximal arm remains fixed in position at the second location. Optionally, if it is determined that the tissue is not properly grasped, the distal arm and / or the proximal arm may be manipulated to release the tissue so that it may be re-grasped.

[0181] At step 410, tissue is clipped between the proximal and distal arms. The distal arm may be retracted toward the proximal arm such that tissue grasped at a first location is substantially adjacent to tissue grasped at a second location. The distal arm may be retracted such that the distal arm substantially abuts the proximal arm to clip tissue between the distal and proximal arms. For example, the distal arm that grasps tissue on a first side of the defect may be retracted toward the proximal arm that grasps tissue on a second side of the defect to substantially close the defect. As described above, the distal arm may be retracted toward the proximal arm such that the tissue clipping assembly moves to a closed position. In some embodiments, tissue mobilized by the distal arm is disposed within a collar when tissue is clipped between the proximal and distal arms.

[0182] At step 412, the distal arm is secured relative to other components of the tissue clipping assembly. The distal arm may be secured in a position that maintains the tissue clipping assembly in a closed position such that the tissue clipping assembly continues to clip tissue. In some embodiments, the distal arm includes one or more tabs that are lockingly received in a collar of the tissue clipping assembly and secure the position of the distal arm within the collar. The proximal arm may be integral with the collar.

[0183] At step 414, the tissue clipping assembly may be decoupled from the drive assembly, such as to deploy the tissue clipping assembly within the body, such as to maintain the clipping of tissue. The distal arm may be decoupled from the drive element, and the collar may be decoupled from the catheter, decoupling the tissue clipping assembly from the drive assembly. The distal arm may be decoupled from the drive element by continued proximal retraction of the drive element. For example, as described above, the distal arm may be operably coupled to the distal end of the drive element via a coupler or coupling protrusion that decouples the distal arm from the drive element when the distal arm is in a closed position and the drive element is retracted proximally. The collar may also be decoupled from the catheter via continued proximal retraction of the drive element, as described above. After the tissue clipping assembly is decoupled from the drive assembly, the tissue clipping assembly may remain within the body to continue clipping tissue, and the drive assembly may be withdrawn from the body. The endoscope may also be withdrawn from the body.

[0184] In some embodiments, the distal end of the catheter is coupled to a connector that operably couples the catheter to a proximal end of the collar. In operation, an alignment spacer can be disposed within the coupling between the collar and the connector, for example, in abutment with a connecting portion of the collar and the connector, such that the alignment spacer maintains the coupling between the collar and the connector, as described above. When the distal arm is in a closed position, further retraction of the drive element proximally can move the alignment spacer such that the alignment member no longer maintains the coupling between the collar and the connector and the collar is decoupled from the catheter.

[0185] As described above, the drive element can have a proximal portion that is narrower in cross section than the distal portion of the drive element. The proximal portion can be operatively coupled to the distal arm during operation to linearly translate the distal arm. After the tissue clipping assembly is moved to a closed position, such as to clip tissue, the drive element can be retracted proximally such that the distal end of the drive element is decoupled from the distal arm and the proximal portion of the drive wire is retracted from the alignment spacer. Further proximal retraction of the drive element can cause the distal end of the drive element to abut or otherwise contact the alignment spacer. Proximal retraction of the drive element can retract the alignment spacer proximally such that the alignment spacer no longer maintains coupling between the collar and connector and the collar can be decoupled from the connector.

[0186] In step 416, a second tissue clipping assembly may be optionally attached to the drive assembly. The second tissue clipping assembly may be substantially similar to the first tissue clipping assembly. A drive element of the drive assembly may be coupled to a distal arm of the second tissue clipping assembly, and the catheter may be coupled to a collar of the tissue clipping assembly such that the tissue clipping assembly may be steered by the drive assembly, as described above.

[0187] In step 418, a second tissue clipping assembly can be deployed via the drive assembly to clip tissue at a second location. Steps 402-414 can be repeated with the second tissue clipping assembly to deploy the second tissue clipping assembly. In some embodiments, the second tissue clipping assembly can be deployed substantially parallel to the first tissue clipping assembly to clip tissue adjacent and / or parallel to the tissue clipped by the first tissue clipping assembly. For example, the second tissue clipping assembly can clip tissue across the width of the identified defect at a location spaced from the first tissue clipping assembly to clip tissue along the length of the larger defect.

[0188] Steps 416 and 418 may be repeated with additional tissue clipping assemblies, as desired. For example, an additional tissue clipping assembly or multiple tissue clipping assemblies may be deployed in alignment with and spaced apart from the first and second tissue clipping assemblies, such as to close a larger defect. The additional tissue clipping assemblies may be deployed to clip tissue across the width of the identified defect and along the length of the larger defect at locations spaced apart from the first and second tissue clipping assemblies.

[0189] It should be understood that the detailed description is intended to be illustrative and not limiting to the described embodiments. Other embodiments will be apparent to those of ordinary skill in the art upon reading and understanding the above description. Moreover, in some cases, elements described in one embodiment may be readily adapted for use in other embodiments. Thus, any products, methods, and / or systems described herein are not limited to the specific details, representative embodiments, and / or illustrative examples shown and described. Thus, departures may be made from such details without departing from the spirit or scope of the general aspects of the disclosure.

[0190] Moreover, the components and materials described below as making up various embodiments are intended to be exemplary and not limiting, and it will be understood that many suitable components and materials that perform the same or similar functions as the materials described herein are intended to be encompassed within the scope of the embodiments of the present disclosure.

Claims

1. 1. A medical device for clipping tissue, comprising: A catheter; a collar having a distally extending proximal arm, the proximal end of the collar being coupled to the distal end of the catheter; a distal arm having an extension portion and a gripping portion; a drive element extending through the catheter and coupled to the distal arm; Including, the drive element is operable to linearly translate the distal arm through the collar; The medical device is operable to clip tissue between the proximal arm and the distal arm by linearly retracting the arm towards the proximal arm.

2. The medical device of claim 1 , wherein the distal arms have distal tines with tips and barbs configured to grasp tissue.

3. The medical device of claim 1 , wherein the proximal arm has proximal tines with tips and barbs configured to grasp tissue.

4. The medical device of claim 1 , wherein the proximal arm is fixed to the collar.

5. The medical device of claim 1 , wherein the distal arms include a locking protrusion configured to be received in a receiving portion of the collar to lock the distal arms in a closed position.

6. The medical device of claim 1 , wherein a distal arm includes a housing configured to cover the proximal arm when the tissue clipping device is in a closed position.

7. The medical device of claim 1 , wherein the proximal arm is pivotable about the collar.

8. 1. A medical device for clipping tissue, comprising:

1. A tissue clipping assembly operable to clip tissue, comprising: A distal arm; and Color and a proximal arm; the tissue clipping assembly; a drive assembly operable to actuate the tissue clipping assembly, A handle and A catheter; a drive element having a proximal end fixed to the handle and a distal end operably coupled to the proximal end of the distal arm; Including, the drive assembly; Including, the drive element is operable to linearly translate the distal arm to clip tissue between the distal arm and the proximal arm; The medical device, wherein the tissue clipping assembly is operatively decoupled from the drive assembly after the tissue clipping assembly clips tissue.

9. The medical device of claim 8 , wherein the drive element has a proximal portion extending through the catheter and a distal portion coupled to the distal arm, the distal portion having a rectangular cross-section.

10. The medical device of claim 8 , wherein the distal arm includes a coupling protrusion configured to releasably couple the distal arm with the drive element.

11. The medical device of claim 8 , wherein the drive assembly further comprises a coupler operable to couple the drive element with the distal arm.

12. The medical device of claim 8 , wherein the drive assembly further comprises a connector operable to couple the catheter with the collar.

13. The medical device of claim 12 , wherein the drive assembly further comprises an alignment spacer operable to maintain the coupling of the connector and the collar.

14. The medical device of claim 8 , wherein the distal arm is disengaged from the drive element and the collar is disengaged from the catheter by retracting the drive element proximally.

15. 1. A method for treating a defect with a tissue mobilization device, comprising: Positioning a tissue clipping assembly over the defect; linearly extending a distal arm of the tissue clipping assembly to grasp a first side of the defect via a drive assembly; grasping a second side of the defect with a proximal arm of the tissue clipping assembly; retracting the distal arm towards the proximal arm; clipping tissue between the distal arm and the proximal arm; decoupling the tissue clipping assembly from the drive assembly; The method comprising:

16. The method of claim 15 , further comprising the step of locking the distal arm within a collar of the tissue clipping assembly.

17. The method of claim 15 , wherein the distal arm is coupled to a handle of the drive assembly by a drive element.

18. The method of claim 17 , wherein the distal arm is coupled to the drive element via a coupler.

19. The method of claim 15 , wherein the collar is operatively coupled to a catheter, and the collar is decoupled from the catheter by proximally retracting the drive element.

20. The method of claim 15 , further comprising the step of attaching a second tissue clipping assembly to the drive assembly.

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