Large tissue defect capture device

Abstract

A tissue capture device for treating and closing a defect and a method of using the same. The tissue capture device includes a tissue capture assembly having two grippers and a shroud. An actuation assembly couples a control actuator to the grippers via an actuation element. The grippers can be operated to grip tissue from different positions by actuation of the control actuator. The grippers can be retracted into the shroud to substantially close the defect. The grippers and shroud can be decoupled from the remainder of the tissue capture assembly to maintain closure of the defect.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 344,063, filed May 20, 2022, the entire disclosure of which is incorporated herein by reference as if set forth in its entirety herein.

[0002] The present disclosure relates generally to surgical devices and, more particularly, to tissue capture devices that enable improved tissue capture. [Background technology]

[0003] Tissue grasping and ingesting devices are used in various parts of the body, including the gastrointestinal system, the urinary system, and the vascular system, to treat internal bleeding or defects. These devices are deployed with an endoscope, such as a flexible endoscope, and can come in a variety of configurations and be used in conjunction with hemostatic devices, including clamps, clips, staples, sutures, etc. One or more hemostatic devices may be deployed around tissue within the body to apply a contractile force to blood vessels and surrounding tissue to control and prevent bleeding.

[0004] In some cases, a hemostatic device may be deployed around a tissue growth, such as a polyp. The hemostatic device may be used to close the defect after the growth has been excised to prevent or reduce bleeding. In other cases, the hemostatic device may be used to close the defect after the target tissue has been entrapped, such as in a pseudopolyp, and the entrapped tissue has been cut or dissected to eliminate the defect. The target tissue may be dysplasia, a defect, or the like. However, in some cases, particularly larger defects and those involving fibrotic tissue, it may be difficult to successfully close the defect utilizing conventional hemostatic devices.

[0005] Most hemostatic devices rely on variations of conventional tissue capture techniques to capture tissue prior to deployment of the hemostatic device. Conventional tissue capture techniques often involve extending a tissue capture device through an endoscope to a desired location to capture the tissue. However, conventional tissue capture techniques may not adequately capture tissue before the hemostatic device is deployed. For example, conventional tissue capture techniques may not adequately grasp and capture multiple sides of a defect. Additionally, the need to deploy hemostatic clips to close the defect can be difficult, cumbersome, and expensive. Thus, there is an unmet need for improved capture devices that utilize separate, independently controlled graspers to improve tissue capture. 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, features included in the examples of this summary are not required by the claims unless the feature is expressly recited in the claims. Also, features, components, steps, concepts, etc. described in the examples of this summary and 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 to populate tissue, such as tissue defects. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized herein. Additionally, the treatment techniques, methods, operations, steps, etc. described or suggested herein can be performed on live animals or on non-living simulations, such as cadavers, simulators (e.g., where body parts, tissues, etc. are simulated).

[0007] In one exemplary embodiment, a tissue capture device is provided. The tissue capture device includes a catheter and a tissue capture assembly including first and second gripping devices and a shroud operably coupled to the catheter and configured to at least partially surround the gripping devices in a retracted position. The tissue capture device also includes an actuation assembly including a first control actuator coupled to a first actuation element and a second control actuator coupled to a second actuation element, the first actuation element operably coupled to the first gripping device and the second actuation element operably coupled to the second gripping device. The first control actuator is operable to manipulate the first gripping device to grip the tissue at the first position and the second control actuator is operable to manipulate the second gripping device to grip the tissue at the second position. When the gripping devices grip the tissue, the gripping devices can be decoupled from the actuation elements and the shroud can be decoupled from the catheter.

[0008] In one exemplary embodiment, a tissue capture assembly of a tissue capture device operable to extend through a catheter and grasp tissue is provided. The tissue capture assembly includes a first gripping device operably coupled to a first actuating element by a first coupler and a second gripping device operably coupled to a second actuating element by a second coupler. The tissue capture assembly also includes a shroud configured to surround the first and second gripping devices and a connector configured to operably connect the shroud to the catheter. The first gripping device can be controlled by the first actuating element to grasp the tissue at a first position and the second gripping device can be controlled by the second actuating element to grasp the tissue at a second position. When the gripping device grasps the tissue, it can be retracted into the shroud and locked in place. The gripping device is operably decoupled from the actuating element, and the shroud is operably decoupled from the catheter after the gripping device is retracted into the shroud.

[0009] In one exemplary embodiment, a method of treating a defect with a tissue capture device is provided, the method including grasping a first side of the defect with a first grasping device via a first working element, grasping a second side of the defect with a second grasping device via a second working element, retracting the first and second grasping devices into a shroud coupled to a catheter, decoupling the first grasping device from the first working element and the second grasping device from the second working element, and decoupling the shroud from the catheter.

[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.

[0011] In order to further clarify various aspects of the embodiments of the present disclosure, certain examples and embodiments will be described with more particularity with reference to various aspects of the accompanying drawings. These drawings show only exemplary embodiments of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Moreover, although the figures may be drawn to scale for some examples, the figures are not necessarily drawn to scale for all examples. The embodiments and other features and advantages of the present disclosure will be described with more particularity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a schematic diagram of a tissue capture device. [Diagram 2] FIG. 1 is a schematic diagram of another tissue capture device. [Diagram 3] FIG. 1 is a perspective view of a catheter sheath assembly according to one embodiment of the present disclosure. [Figure 4] FIG. 4 is a front view of the catheter-sheath assembly of FIG. 3. [Diagram 5] 3A-3D are schematic diagrams of a tissue capture assembly of the tissue capture device of FIGS. 1-2 capturing tissue. [Figure 6] 1 is a schematic diagram of an example of a grasping device that may be used with a tissue capture device. [Figure 7] 1A-1D show various views of a gripping device according to one embodiment. [Figure 8] 1A-1D show various views of a gripping device according to one embodiment. [Figure 9] 1A-1D show various views of a gripping device according to one embodiment. [Figure 10] 1A-1D show various views of a gripping device according to one embodiment. [Figure 11A] FIG. 11 is a top view of a tissue capturing device including two of the gripping devices shown in FIGS. [Figure 11B] FIG. 2 is a perspective view of an actuation element according to one embodiment. [Figure 11C] 11C is a perspective view of a distal end of a tissue capture device according to one embodiment having the working element of FIG. 11B. [Figure 11D] FIG. 1 is a perspective view of a catheter according to one embodiment. [Figure 11E] FIG. 1 is a perspective view of a catheter according to one embodiment. [Figure 11F] FIG. 11C is a front view of the catheter of FIGS. 11D-11E. [Figure 11G] FIG. 11C is a perspective view of a distal portion of the catheter of FIGS. 11D-11E according to one embodiment. [Figure 12] 11A through 11D are schematic diagrams showing an example of grasping and capturing tissue using the grasping device of FIGS. 7 through 10 with the tissue capturing device of FIG. 11A. [Figure 13A] 11A-11C show various views of a gripping device according to another embodiment. [Figure 13B] 11A-11C show various views of a gripping device according to another embodiment. [Figure 14A] FIG. 13 is a front perspective view of a gripping device according to another embodiment. [Figure 14B] FIG. 13 is a rear perspective view of a gripping device according to another embodiment. [Figure 15A] FIG. 13 is a front perspective view of a gripping device according to another embodiment. [Figure 15B] FIG. 13 is a rear perspective view of a gripping device according to another embodiment. [Figure 16A]FIG. 13 is a front perspective view of a gripping device according to another embodiment. [Figure 16B] FIG. 13 is a rear perspective view of a gripping device according to another embodiment. [Figure 17A] FIG. 13 is a front perspective view of a gripping device according to another embodiment. [Figure 17B] FIG. 13 is a rear perspective view of a gripping device according to another embodiment. [Figure 18A] 1 shows various views of a gripping device having two flutes. [Figure 18B] 1 shows various views of a gripping device having two flutes. [Figure 19] 1A and 1B are perspective views of a gripping device retracted into and extended from a shroud according to one embodiment. [Figure 20A] FIG. 13 is a perspective view of a gripping device extending from a shroud according to another embodiment. [Figure 20B] FIG. 20B is a perspective view of the shroud of FIG. 20A. [Figure 20C] FIG. 20B is a front view of the shroud of FIG. 20A according to one embodiment. [Figure 20D] FIG. 20C is a front view of the shroud of FIG. 20B according to another embodiment. [Figure 20E] FIG. 20C is a perspective view of a hood of the shroud of FIG. 20B according to one embodiment. [Figure 20F] FIG. 20F is a schematic side view of the hood of FIG. 20E. [Figure 21] 5A-D are schematic diagrams illustrating an example of entrapment of tissue within a shroud to close the defect and deployment of the grasper and shroud to maintain closure of the defect. [Figure 22] 1A and 1B are schematic diagrams illustrating actuation elements coupled to a gripping device according to one embodiment. [Figure 23] 1A and 1B are schematic diagrams illustrating actuation elements coupled to a gripping device via a coupler according to one embodiment. [Figure 24A] FIG. 1 is a schematic diagram illustrating an actuation element coupled to a gripping device via a coupler according to one embodiment. [Figure 24B]FIG. 13 is a perspective view showing an actuating element coupled to a connection part of a gripping device via a coupler according to another embodiment. [Diagram 25] 1A-C are schematic diagrams illustrating actuation elements coupled to and decoupled from a gripping device via a coupler according to another embodiment. [Figure 26] 1A and 1B are schematic diagrams illustrating an actuation element coupled to and decoupled from a gripping device via a coupler according to another embodiment. [Figure 27] 1A and 1B are schematic diagrams illustrating an actuation element coupled to and decoupled from a gripping device via a coupler according to another embodiment. [Figure 28A] FIG. 2 is a perspective view of a coupler according to one embodiment. [Figure 28B] FIG. 28B is a perspective view of a gripping device configured to operably couple with the coupler of FIG. 28A. [Figure 28C] 28B. FIG. 28C shows various views of the coupler of FIG. 28A interfacing with the gripping device of FIG. 28B. [Figure 28D] 28B. FIG. 28C shows various views of the coupler of FIG. 28A interfacing with the gripping device of FIG. 28B. [Figure 29A] FIG. 13 is a perspective view of a coupler according to another embodiment. [Figure 29B] 29B is a perspective view of the gripping device of FIG. 28B coupled with the coupler of FIG. 29A. [Figure 30A] FIG. 4 is a perspective view showing a shroud connected to a connector. [Figure 30B] FIG. 4 is a perspective view showing a shroud connected to a connector. [Figure 31A] FIG. 1 is a perspective view of a tissue capture assembly according to one embodiment coupled to a catheter. [Figure 31B] FIG. 31B is a perspective view of the tissue capture assembly of FIG. 31A with the connector removed. [Figure 31C] FIG. 31C is a perspective view of the tissue capture assembly of FIG. 31B with the shroud removed. [Figure 32A] 31B shows various views of the connector of the tissue capture assembly of FIG. 31A. [Figure 32B]31B shows various views of the connector of the tissue capture assembly of FIG. 31A. [Figure 32C] FIG. 32C is a front perspective view of a proximal connector portion of the connector of FIGS. 32A and 32B. [Fig. 32D] FIG. 32C is a rear perspective view of the proximal connector portion of the connector of FIGS. 32A and 32B. [Figure 32E] FIG. 32C is a front perspective view of a distal connector portion of the connector of FIGS. 32A and 32B. [Fig. 32F] FIG. 32C is a rear perspective view of a distal connector portion of the connector of FIGS. 32A and 32B. [Figure 33A] FIG. 13 is a front perspective view of a proximal connector portion according to another embodiment. [Figure 33B] FIG. 13 is a rear perspective view of a proximal connector portion according to another embodiment. [Figure 34A] FIG. 13 is a front perspective view of a proximal connector portion according to another embodiment. [Figure 34B] FIG. 13 is a rear perspective view of a proximal connector portion according to another embodiment. [Diagram 35] FIG. 31B is a front perspective view of a locking slider of the tissue capture assembly of FIG. 31A. [Diagram 36] FIG. 31B is a front perspective view of a release slider of the tissue capture assembly of FIG. 31A. [Figure 37A] FIG. 37 is a front perspective view of the release slider of FIG. 36 coupled with a shroud. [Figure 37B] FIG. 37B is a front view of the release slider and shroud of FIG. 37A. [Figure 38A] FIG. 37 is a perspective view of the gripping device with the release slider and lock slider of FIGS. 35 and 36 in a locked position. [Figure 38B] 38B is a perspective view of the gripping device of FIG. 38A separated from the coupler of FIG. 38A by the release and locking sliders of FIGS. 35 and 36. FIG. [Figure 39A]FIG. 31B is a side view showing operation of the tissue capture device of FIG. 31A to manipulate the grasping device to grasp tissue, retract the grasped tissue into the shroud, disengage the grasping device from the working element, and disengage the shroud from the catheter to maintain closure of the defect. [Figure 39B] FIG. 31B is a side view showing operation of the tissue capture device of FIG. 31A to manipulate the grasping device to grasp tissue, retract the grasped tissue into the shroud, disengage the grasping device from the working element, and disengage the shroud from the catheter to maintain closure of the defect. [Figure 39C] FIG. 31B is a side view showing operation of the tissue capture device of FIG. 31A to manipulate the grasping device to grasp tissue, retract the grasped tissue into the shroud, disengage the grasping device from the working element, and disengage the shroud from the catheter to maintain closure of the defect. [Figure 39D] FIG. 31B is a side view showing operation of the tissue capture device of FIG. 31A to manipulate the grasping device to grasp tissue, retract the grasped tissue into the shroud, disengage the grasping device from the working element, and disengage the shroud from the catheter to maintain closure of the defect. [Figure 39E] FIG. 31B is a side view showing operation of the tissue capture device of FIG. 31A to manipulate the grasping device to grasp tissue, retract the grasped tissue into the shroud, disengage the grasping device from the working element, and disengage the shroud from the catheter to maintain closure of the defect. [Figure 39F] FIG. 31B is a side view showing operation of the tissue capture device of FIG. 31A to manipulate the grasping device to grasp tissue, retract the grasped tissue into the shroud, disengage the grasping device from the working element, and disengage the shroud from the catheter to maintain closure of the defect. [Figure 39G] FIG. 31B is a side view showing operation of the tissue capture device of FIG. 31A to manipulate the grasping device to grasp tissue, retract the grasped tissue into the shroud, disengage the grasping device from the working element, and disengage the shroud from the catheter to maintain closure of the defect. [Fig. 39H]FIG. 31B is a side view showing operation of the tissue capture device of FIG. 31A to manipulate the grasping device to grasp tissue, retract the grasped tissue into the shroud, disengage the grasping device from the working element, and disengage the shroud from the catheter to maintain closure of the defect. [Diagram 40] FIG. 13 shows an example of a procedure for closing a defect via two grasping devices. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The following description, with reference to the accompanying drawings showing specific embodiments of the present disclosure, describes exemplary embodiments according to the general inventive concept, and is not intended to limit the invention or the claims in any way. Indeed, the invention as described by the claims is broader than the exemplary embodiments described herein, and is not limited thereby, and the terms used in the claims have their full ordinary meaning.

[0014] The general inventive concept will be more fully understood from the detailed description set forth below and 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 provided for illustration and understanding only. Exemplary embodiments of the present disclosure are directed to devices and methods for entrapment of tissue. Various embodiments of devices and systems for entrapment of tissue are disclosed herein, and any combination of these options may be made unless specifically excluded. In other words, individual components of the disclosed devices and systems may be combined unless they are mutually exclusive or otherwise physically impossible.

[0015] 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 only for 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.

[0016] As described herein, when one or more components are described as being connected, coupled, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct between the components or may be indirect through the use of one or more intermediate components. Also, as used herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but may include a collection of components, members, or elements.

[0017] Therefore, unless otherwise indicated, all numerical values ​​used in the specification and claims, such as numerical values ​​expressing measurements or physical properties, are 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 approximations that may vary depending on the preferred 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 approximations, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical value inherently contains some errors necessarily resulting from the error found in its respective measurement. Also, as described herein, the terms "substantially" and "about" are defined as at least close to (and including) the given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0018] In discussing the exemplary embodiments herein, the terms "proximal" and "distal" may often be used. These terms are used to describe a location or orientation relative to an operator of the instrument. For example, a proximal location or direction is a direction toward the user or operator of the instrument, and a distal location or direction is a direction away from the user or operator of the instrument, i.e., toward an object that the operator is attempting to grasp, hold, and / or view.

[0019] The present invention provides a tissue capture device for use through an endoscope. The tissue capture device may be configured to access tissue better than standard tissue capture devices. The tissue capture device may also be configured to capture tissue across larger defects than standard tissue capture devices. For example, the tissue capture device of the present disclosure may be configured to access tissue defects having a width or diameter between about 1 cm and about 10 cm. In some embodiments, the tissue capture device is configured to access tissue defects greater than 10 cm in width or diameter. The tissue capture device of the present disclosure may also be configured to access multiple sides of the defect simultaneously to achieve more consistent circumferential closure of the defect. The tissue capture device may be configured to achieve more consistent circumferential closure of the tissue defect, such as when a hemostatic device is deployed around the tissue captured by the tissue capture device. Although the device is described as usable to close defects, it may also be used to grasp intact tissue, such as hypoplastic tissue, T1A tissue, T1B tissue, etc. In some embodiments, the tissue capture device may be a sterile, disposable device to reduce costs.

[0020] A functional block diagram of tissue capture device 100 is shown in Figures 1-2. Tissue capture device 100 includes a tissue capture assembly 102 at a distal end, an actuation assembly 200 at a proximal end, and a catheter and sheath assembly 300 disposed between tissue capture assembly 102 and actuation assembly 200. Tissue capture assembly 102 may include one or more tissue graspers 104 configured to grasp. Grasping device 104 may be an end effector or device capable of grasping tissue. It will be understood that grasping by grasper 104 encompasses grabbing, pinching, hooking, or securing tissue with grasper 104.

[0021] A proximal end of each gripping device 104 may be coupled to an actuation element 208 of the actuation assembly 200. Each actuation element 208 is configured to control the position and rotation of the attached gripping device 104, for example, via manipulation of the actuation assembly 200. Each actuation element 208 may be configured to transmit both translational motion to position the gripping device 104 and torque or rotational motion to rotate the gripping device 104 to the gripping device 104. Each actuation element 208 may be a solid cable, hollow tube, or other suitable elongated object or combination of objects, such as a drive cable, torque cable, hypotube, spring sheath, or catheter, configured to control the gripping device 104.

[0022] In the illustrated embodiment, the tissue capture device 100 has two gripping devices 104, each coupled to an actuating element 208. However, the device 100 may have other assemblies and configurations. For example, the tissue capture assembly 102 may have one or more than two gripping devices 104, and the actuating element 208 may be coupled to two or more gripping devices 104.

[0023] The catheter and sheath assembly 300 includes one or more catheters 302 operably connected to a distal end of the actuation assembly 200. The tissue grasping devices 104 and the actuation elements 208 may extend through one or more lumens of the one or more catheters 302. In some embodiments, the proximal end of the actuation elements 208 may extend through the proximal end of the catheter 302 for operably coupling with other components of the actuation assembly 200, as described below. The one or more catheters 302 may be sized, shaped, and configured such that each grasping device 104 may extend distally beyond the distal end of the one or more catheters 302 via the actuation elements 208 extending therethrough. In some embodiments, the catheter and sheath assembly 300 is flexible to allow sufficient endoscopic maneuverability without compromising the handholds of the tissue capture assembly 102, such as the handholds that the tissue capture assembly 102 has at multiple edges of a tissue defect.

[0024] As shown in Figure 1, each pair of gripping devices 104 and actuating elements 208 is disposed through a separate catheter 302. However, the catheter and sheath assembly 300 may have other configurations and assemblies. For example, as shown in Figure 2, each pair of gripping devices 104 and actuating elements 208 may extend through a single catheter 302. The actuating elements 208 and gripping devices 104 may extend through separate lumens in the catheter 302, or all of the gripping devices 104 and actuating elements 208 may extend through a single lumen in the single catheter 302.

[0025] In some embodiments, one or more of the catheters 302 may be constructed from polyetheretherketone (PEEK), thermoplastics, nylon, pellethane, polytetrafluoroethylene (PTFE), polyimide, composite metal and polymer tubes, metal tubes, metal coils, or similar structures known in the art, or combinations thereof. In a preferred embodiment, the catheter 302 is a metal spring sheath configured to resist compressive and manipulation forces exerted on the catheter 302 by the actuation elements 208 and / or manipulation elements, as described below. In some embodiments, the catheter 302 includes a liner or coating, such as a PTFE liner and / or coating, disposed within one or more lumens to increase the resiliency of the catheter 302 and / or to reduce friction between the actuation elements 208 and the catheter 302.

[0026] In some embodiments, as shown in FIGS. 3-4, the catheter 302 is a dual lumen catheter having a generally figure-of-eight shaped cross section. The catheter and sheath assembly 300 also includes one or more support wires 310 that extend along the length of the catheter 302, for example in rounded grooves between the lumens, and above and / or below the exterior surface of the catheter 302. The support wires 310 may reinforce the catheter 302, providing it with strength to resist or reduce compressive forces experienced by the device 100 during operation. The support wires 310 may be constructed from a shape memory material such as stainless steel or nitinol. Additionally or alternatively, the support wires 310 may be constructed from PEEK, superelastic nitinol, liquid crystal polymer (LCP), or other metals or polymers having sufficient strength to resist compressive forces, or combinations thereof. The dual lumens of the catheter 302 may aid in tissue grasping operations, such as by preventing the working element 208 from becoming entangled within the catheter 302.

[0027] 3-4 is shown as including two support wires 310 at the top and bottom of the catheter 302, it will be understood that the catheter sheath assembly 300 may have other assemblies and configurations. For example, the catheter sheath assembly 300 may include one support wire 310 below the catheter 302, one support wire 310 above the catheter 302, or three or more support wires 310 positioned at various locations around the exterior of the catheter 302.

[0028] Returning to FIGS. 1-2, the grasping device 104 may be positioned through the distal end of the endoscope and the catheter sheath assembly 300. In some embodiments, the grasping device 104 may be manipulated by a user at the proximal end of the endoscope, for example, via the actuation assembly 200, via an actuation element 208 extending through a channel disposed within and extending through the endoscope. In other embodiments, the device 100 may be used during minimally invasive procedures using a suitable opening, either natural or artificially created within the body. The device 100 is configured and constructed such that it may be inserted into a subject through an opening or small incision and manipulated to capture target tissue, such as defective tissue. The device 100 may be configured to capture tissue across a large defect, such as a tissue defect greater than 1 cm or a tissue defect greater than 3 cm. In some embodiments, the device 100 is configured to capture tissue across a defect greater than 10 cm in diameter. Additionally, the device 100 may be configured to simultaneously capture multiple sides of a defect to achieve a more consistent circumferential closure of the defect.

[0029] The device 100 may be used with any suitable or conventional endoscopic or laparoscopic surgical device. For purposes of this disclosure, the device 100 will be described in the context of use with an endoscope / colonoscope / sigmoidoscopic type device of a conventional or suitable construction. However, the device may be used in other embodiments, for example, in any minimally invasive procedure using a suitable opening, natural or artificially created in the body. The scope comprises an elongated body having a controllably flexible protruding end region. Surgical instruments, such as the device 100, may be introduced through an instrument channel, such as an accessory channel extending through the scope body, for capturing targeted tissue by a surgeon operating the scope. The grasping devices 104 may be sized, shaped, and configured such that all grasping devices 104 may be positioned through the same instrument or accessory channel of the endoscope.

[0030] Each grasping device 104 is configured to grasp tissue, such as defective tissue, such that tissue capture device 100 can capture the grasped tissue. The grasping devices 104 may be any suitable device for grasping tissue. For example, the grasping devices 104 may be forceps, clamps, hooks, pins, claws, etc. Each of the tissue grasping devices 104 may be controlled by the actuation assembly 200, such as via an actuation element 208 to which the grasping devices 104 are attached. In some embodiments, the grasping devices 104 are independently controllable via the actuation assembly 200.

[0031] The actuation assembly 200 may be operatively connected to each of the gripping devices 104 via one or more actuation elements 208. The actuation elements 208 may be configured to control the translational and rotational motion of each of the gripping devices 104. For example, the actuation elements 208 may be configured to allow a user to deploy or otherwise manipulate the gripping devices 104 to position the gripping devices 104, such as on the side of a defect, and to grasp tissue, for example. The actuation elements 208 may be sufficiently rigid or stiff to impart rotational and linear forces to the gripping devices 104 to maintain the gripping devices 104 at various positions and angles during operation. The actuation elements 208 may also be sufficiently flexible to allow the deployed or actuated gripping devices 104 to continue to grasp tissue as the actuation elements 208 are positioned through a channel of the endoscope and / or catheter 302 to a desired location and the endoscope and / or catheter sheath assembly 300 is manipulated. The actuating element 208 may also be flexible enough to manipulate the first gripper 104 to grasp tissue at a first position and manipulate the second gripper 104 to grasp tissue at a second position with the first gripper 104 grasping tissue. In some embodiments, the actuating element 208 may be constructed from a polymer, such as ABS, PC, acrylic, plastic, or a metal, such as stainless steel or nitinol, or a combination thereof.

[0032] In the illustrated embodiment, the actuation assembly 200 is operably connected to each grasper 104 via a single actuation element 208. However, it will be understood that the tissue capture device 100 may have other suitable configurations. For example, the actuation assembly 200 may be operably connected to each grasper 104 via multiple actuation elements 208, such as an actuation element 208 configured to control the translation of the grasper 104 and an actuation element 208 configured to control the rotation of the grasper 104.

[0033] In some embodiments, as shown in FIG. 2, the actuating elements 208 are operably disposed through one or more sheaths 304 disposed between the actuating elements 208 and the catheter 302. Each actuating element 208 may extend through a separate sheath 304, or the actuating elements 208 may extend through a single sheath 304, such as a single sheath 304 having two lumens or a sheath 304 having a single lumen. The one or more sheaths 304 may cover the actuating elements 208, as well as any additional control or manipulation elements, as they extend through the endoscope and / or catheter 302. The sheaths 304 may be configured to reduce friction between the actuating elements 208 and / or between the actuating elements 208 and the catheter 302. The sheaths 304 may also be configured to prevent the actuating elements 208 from becoming entangled within the catheter 302. For example, the sheaths 304 may be implemented in an embodiment in which the actuating elements 208 are disposed through a single catheter 302. The one or more sheaths 304 may be spring sheaths, reinforced composite sheaths, and / or tubes, such as polymeric tubes and / or hypotubes. It will be further understood that the actuating element 208 may be disposed directly through one or more lumens of the catheter 302, for example, without a sheath 304.

[0034] A proximal end of each sheath 304 may be operatively connected or coupled to the actuation assembly 200. A distal end of each sheath 304 may extend toward a respective gripping device 104. In some embodiments, a distal end of each sheath 304 is connected or coupled to a respective gripping device 104. The sheaths 304 may be sized, shaped, or configured to accommodate the actuation elements 208 therein. For example, the sheaths 304 may be hollow to at least partially cover the actuation elements 208. In some embodiments, such as those in which one of the gripping devices 104 is operated via an operating element, the sheaths 304 may also be sized, shaped, or configured to accommodate the operating element therein.

[0035] In some embodiments, such as those in which one or more gripping devices 104 may be manipulated (e.g., opened and closed), the actuation element 208 may have a hollow shape, shape, or size to at least partially enclose a manipulation element 290 coupled with the gripping device 104 and configured to manipulate the gripping device 104. The manipulation element 290 may be a drive cable, torque cable, hypotube, spring sheath, catheter, or other suitable member configured to control the gripping device 104. For example, each manipulation element 290 may be configured to transmit translational and / or rotational forces to actuate the gripping device 104. Alternatively, the manipulation element 290 may be disposed in parallel with the actuation element 208 (e.g., FIG. 6).

[0036] The manipulating element 290 may be movable, such as linearly movable, rotationally movable, etc., relative to the actuation element 208 to control a function or operation (e.g., open or closed) of the gripping device 104 apart from the translation and / or rotation of the gripping device 104. A proximal end of the manipulating element 290 may be operatively coupled to the actuation assembly 200 such that a user may control the operation of the gripping device 104 via the actuation assembly 200. Each manipulating element 290 may be a metallic actuation wire or tether configured to impart a translational force that controls the operation of the gripping device 104. For example, the gripping device 104 may include distal jaws normally positioned in a closed position, such as by a spring or other biasing element, and distal movement of the manipulating element 290 relative to the gripping device 104 may open the jaws. When the manipulating element 290 is retracted relative to the gripping device 104, the jaws may return to a closed position to grasp tissue.

[0037] In the illustrated embodiment, the device 100 includes an operating element 290 disposed through one of the actuation elements 208. However, it will be understood that the device 100 may have other configurations and assemblies. For example, the device 100 may not include an operating element 290, or the operating element 290 may be disposed through or alongside each of the actuation elements 208.

[0038] The actuation assembly 200 includes a body 202 configured to be grasped by a user. The proximal ends of the actuation elements 208 and optional manipulating elements 290 may extend into or through the body 202. The actuation assembly 200 also includes a plurality of control actuators 230 operable to control the position, rotation, and movement of the gripping device 104 via the actuation elements 208. Each of the actuation elements 208 and each of the manipulating elements 290 may be coupled with one or more control actuators 230 such that a user may control the position, rotation, and movement of the gripping device via the control actuators 230. The control actuators 230 may be any suitable device that a user may actuate to control the position and / or rotation of one of the actuation elements 208 or one of the manipulating elements 290. For example, the control actuators 230 may be a push button, a toggle, a switch, a lever, a trigger, a slider, or the like.

[0039] In the illustrated embodiment, the actuation assembly 200 may include a first or translational control actuator 230a operable to control a linear or translational position of one of the actuation elements 208, a second or rotational control actuator 230b operable to control a rotational position of one of the actuation elements 208, and a manipulation control actuator 230c operable to control a linear or translational position of one of the manipulation elements 290. For example, an operator may use the translational and rotational control actuators 230a, 230b to control the translational and rotational positions of the grasper 104 via the actuation elements 208 to deploy the grasper 104 at a desired position. Optionally, an operator may also use the manipulation control actuator 230c to control the movement of the grasper 104 via the manipulation element 290, for example, to open and close the grasper 104 to grasp tissue.

[0040] In the illustrated embodiment, the actuation assembly 200 includes two translational control actuators 230a, two rotational control actuators 230b, and one steering control actuator 230c. However, the actuation assembly 200 may have other suitable configurations and assemblies. For example, the actuation assembly 200 may include any suitable number of translational control actuators 230a, rotational control actuators 230b, and steering control actuators 230c.

[0041] In the illustrated embodiment, each translation control actuator 230a is disposed near a proximal end of one of the actuating elements 208 proximal to the body 202, and each rotation control actuator 230b is disposed at a proximal end of one of the actuating elements 208 proximal to the translation control actuator 230a. Each translation control actuator 230a may be translatably fixed to a respective actuating element 208 such that translational motion of the translation control actuator 230a is translated into translational motion of the actuating element 208. The actuating element 208 may be rotationally decoupled from the translation control actuator 230a such that the actuating element 208 may rotate independently of the translation control actuator 230a. The translation control actuator 230a may be depressed or otherwise moved toward the body 202, such as by a user, to distally extend the actuating element 208 and thereby position the gripping device 104.

[0042] The rotation control actuator 230b may be rotatably coupled to a respective actuation element 208 such that rotational motion of the rotation control actuator 230b is translated into rotational motion of the actuation element 208. The rotation control actuator 230b may be rotated, such as by a user, to rotate the actuation element 208 and thereby rotate the grip device 104. The rotation control actuator 230b may be rotated independently of the first control actuator 230a.

[0043] The manipulation control actuator 230c may be disposed proximally of the body 202, for example more proximally than the translation and rotation control actuators 230a, 230b. The manipulation control actuator 230c may be directly or indirectly coupled to the manipulation element 290 to manipulate the manipulation element 290 to actuate the gripping device 104. The manipulation control actuator 230c may be coupled to the manipulation element 290 such that depression or actuation of the manipulation control actuator 230c translates the manipulation element 290 to actuate the respective gripping device 104, such as opening or closing the gripping device 104. The manipulation control actuator 230c may be coupled to the manipulation element 290 via a biasing element such that when the user releases the manipulation control actuator 230c, the manipulation control actuator 230c returns to a non-actuated position, thereby retracting the manipulation element 290.

[0044] However, it will be appreciated that the actuation assembly 200 may have other suitable shapes, assemblies, and configurations. For example, the manipulation control actuator 230c may be disposed on a different side of the body 202 than the other control actuators 230a, 230b, one or more of the control actuators 230 may be disposed along the body 202, the translation control actuator 230a may not be aligned with the rotation control actuator 230b, and / or the translation and rotation control actuators 230a, 230b may be coupled to their respective gripping devices 104 via separate actuation elements 208. Additionally, one or more of the translation control actuator 230a, the rotation control actuator 230b, and the manipulation control actuator 230c may be combined. For example, the translation control actuator 230a and the rotation control actuator 230b may be combined into a single control actuator 230 operable to control the translational and rotational positions of the gripping devices 104 via the actuation elements 208.

[0045] In operation, the actuation assembly 200 may be manipulated, such as by a user, to control the tissue capture assembly 102 to capture tissue with one or more graspers 104. The graspers 104 may be disposed at a distal end of an endoscope (not shown) and through a catheter sheath assembly 300. The actuation assembly 200 may be manipulated by a user at a proximal end of the endoscope via actuation elements 208 and / or manipulation elements 290 that are disposed within the endoscope and extend through a channel extending through the endoscope. The endoscope and / or graspers 104 may be inserted through a subject such that the graspers 104 are positioned at a desired location, such as above an identified defect. Each grasper 104 may be moved via a respective translation control actuator 230a, rotated via a respective rotation control actuator 230b, and / or actuated by a respective manipulation control actuator 230c to grasp tissue. For example, a user may control the position of the gripping device 104 by positioning the distal end of the endoscope and sliding or otherwise moving the translation control actuator 230a to extend and / or retract the actuation element 208. The user may control the rotation of the gripping device 104 by rotating the respective rotation control actuator 230b. Optionally, the user may also control the manipulation of the gripping device 104, such as opening and closing the gripping device 104, by engaging and disengaging the manipulation control actuator 230c. After the gripping device 104 has grasped tissue, the actuation assembly 200 may be used to capture the grasped tissue proximally, for example, to close the defect or to appose two sides of the defect so that a hemostatic device may be used to close the defect, for example, by retracting the translation control actuator 230a proximally.

[0046] Exemplary methods of manipulating the gripping device 104 of the tissue capture assembly 102 are illustrated generally in FIGS. 5A-5D. As shown in FIG. 5A, the tissue capture assembly 102 may be positioned over a defect, for example, via a catheter and sheath assembly 300 and an endoscope. The gripping device 104 may be extended from a distal end of the catheter 302 via an actuating element 208. In some embodiments, the defect is identified and visualized using one or more cameras (not shown) operably connected to the endoscope. In the illustrated embodiment, a first gripping device 104a is coupled to a first actuating element 208a and a second gripping device 104b is coupled to a second actuating element 208b.

[0047] As shown in FIG. 5B, one of the gripping devices 104 may be deployed to engage tissue on a first side of the defect. The endoscope, catheter 302, and / or actuation element 208 may be manipulated to orient the first gripping device 104a toward the first side of the identified defect. The actuation element 208 coupled with the first gripping device 104a may be translated and rotated, for example, via one of the translation control actuators 230a and one of the rotation control actuators 230b of the actuation assembly 200, such that the first gripping device 104a engages and grasps tissue on the first side of the defect. Although not shown, the first gripping device 104a may also be manipulated to grasp tissue via the manipulation element 290, such as via one of the manipulation control actuators 230c of the actuation assembly 200. The second gripping device 104b may remain stationary relative to the catheter 302 while the first gripping device 104a is deployed to grip tissue.

[0048] As shown in FIG. 5C, the second gripping device 104b may be deployed to engage tissue on the second side of the defect. The endoscope, catheter 302, and / or second actuating element 208b may be manipulated to orient the second gripping device 104b to the second side of the identified defect. The second gripping device 104b may be controlled or manipulated independently of the first gripping device 104a to grip tissue on the second side of the defect. The second actuating element 208b may be translated and rotated, for example, via one of the translation control actuators 230a and one of the rotation control actuators 230b of the actuating assembly 200, to engage and grip tissue on the second side of the defect. Independent operation of the second gripping device 104b may enable the tissue capture device 100 to extend beyond the limits of standard capture devices to treat and close larger defects. For example, the flexibility of device 100, such as actuation element 208, and independent movement of gripping device 104 may enable device 100 to treat and close larger defects than standard capture devices. Although not shown, second gripping device 104b may also be manipulated to grasp tissue via manipulation element 290, such as via one of the manipulation control actuators 230c of actuation assembly 200. First gripping device 104a may remain deployed to grasp tissue on a first side of the defect while second gripping device 104b is deployed to grasp tissue on a second side of the defect.

[0049] Although device 100 has been described as deploying two grasping devices 104a, 104b to grasp tissue, it will be understood that more than two grasping devices 104 may be deployed on multiple sides of a defect. For example, device 100 may include more than two grasping devices 104, or more grasping devices 104 may be mounted on device 100 for subsequent deployment after the first two grasping devices 104a, 104b are deployed to grasp tissue.

[0050] As shown in FIG. 5D, one or both of the gripping devices 104a, 104b may be retracted by retracting one or more respective actuating elements 208a, 208b proximally to capture the gripped tissue. For example, one or both of the translation control actuators 230a may be actuated to retract the actuating elements 208a, 208b proximally. The gripping devices 104a, 104b may continue to grip tissue as the gripping devices 104 are retracted. Retraction of one or both of the gripping devices 104a, 104b may substantially close the defect or appose the sides of the defect such that a hemostatic device may be deployed to close the defect. In some embodiments, the gripping devices 104a, 104b may be retracted to a locked position such that the gripping devices 104a, 104b are substantially fixed relative to the catheter 302.

[0051] Optionally, after the gripping devices 104a, 104b are retracted to capture the target tissue, a tissue closure mechanism, such as a through-the-scope clip (TTS) or an over-the-scope clip (OTS), may be positioned around the captured tissue to treat and / or substantially close the defect. The tissue closure mechanism may be deployed around the gripping devices 104a, 104b that grip the tissue. For example, the tissue capture assembly 102 may be used with an over-the-scope (OTS) clip or a through-the-scope (TTS) clip to close the defect. In embodiments that include an OTS clip, the gripping device 104 may retract into the OTS housing to capture the tissue. In embodiments that include a TTS clip, the gripping device 104 may capture the tissue at the distal end of the catheter 302. The OTS clip may be released (deployed) via the actuation assembly 200 or via a separate control device.

[0052] In some embodiments, after the captured tissue is clamped or closed with a tissue closure mechanism, such as an OTS or TTS clip, the gripping device 104 and / or actuation element 208 may be disengaged or disengaged from the tissue. For example, the manipulation element 290 may be actuated to open the gripping device 104 and release the tissue. The gripping device 104 and / or actuation element 208 may be withdrawn or retracted from the closed defect.

[0053] The gripping device 104 may be an end effector that may grip a target tissue, such as via one or more actuation elements 208 and / or one or more manipulation elements 290. As shown in FIG. 6, the tissue capture assembly 102 includes a first gripping device 104 having a plurality of helical coils 114 extending in a spiral or corkscrew shape, and a second gripping device 104b having at least one movable jaw 113. The helical coil 114 of the first gripping device 104a may be configured to grip tissue as the first gripping device 104a is spirally inserted or screwed into tissue. The movable jaw 113 of the second gripping device 104b may be opened and closed to grip tissue. The gripping devices 104a, 104b may be operated via an actuation assembly 200 of FIGS. 1-2.

[0054] The first gripping device 104a may be manipulated via a first actuating element 208a operable to translate and rotate the first gripping device 104a so that the first gripping device 104a grips tissue. For example, the first actuating element 208a, e.g., via the actuating assembly 200, may translate and rotate the first gripping device 104a so that the first gripping device 104a spirals into or shears through tissue so that the first gripping device 104a grips tissue.

[0055] The second gripping device 104b may be manipulated via the second actuation element 208b and the manipulation element 290. The second actuation element 208b may translate and rotate the second gripping device 104b, for example, via the actuation assembly 200, so that the second gripping device 104b is properly positioned above the target tissue. The manipulation element 290 may be extended distally, for example, by actuation of the manipulation control actuator 230c, so that the second gripping device 104b grips tissue, for example, tissue on the opposite side of the defect relative to the first gripping device 104a. The distal extension of the manipulation element 290 may rotate the movable jaw 113 about an axis so that the movable jaw 113 opens to grip tissue. After the tissue is positioned between the movable jaw 113 and the remainder of the second gripping device 104b, the manipulation element 290 may be retracted proximally (e.g., the manipulation control actuator 230c may be retracted) so that the movable jaw 113 rotates closed with the tissue grasped between the movable jaw 113 and the remainder of the second gripping device 104b. Additionally, the gripping device 104 may have more than one movable jaw 113, such as two movable jaws 113 that rotate about a central axis. In the illustrated schematic, the manipulation element 290 extends outside the actuation element 208. However, it will be understood that the manipulation element 290 may extend through the interior of the actuation element 208.

[0056] The illustrated embodiment includes a first gripping device 104a having a helical coil 114 operable by one actuation element 208a, and a second gripping device 104b having a movable jaw 113 operable by an actuation element 208b and an operating element 290, although it will be understood that the device 100 may have other assemblies and configurations.

[0057] 7-10, a gripping device 104 is shown according to one embodiment of the present disclosure. As shown, the gripping device 104 is generally cylindrical. The gripping device 104 includes a proximal end 106 and a distal end 108 opposite the proximal end 106. The proximal end 106 of the gripping device 104 may be coupled, directly or indirectly, to a distal end of one of the actuating elements 208. The gripping device 104 may be coupled to the actuating elements 208 such that translational and rotational motion of each actuating element 208 is substantially translated into translational and rotational motion of the gripping device 104.

[0058] The grasping device 104 includes a coupling portion 110 near the proximal end 106 and a gripping portion 112 near the distal end 108. The coupling portion 110 is configured to couple, directly or indirectly, with the distal end of the actuating element 208. The gripping portion 112 is configured to extend into and grasp tissue, for example, tissue on the sides of the defect and / or in the center of the defect.

[0059] As shown, the gripper 112 is generally helical (e.g., corkscrew-shaped) having a plurality of helical windings or coils 114 extending generally longitudinally along the length of the gripper 104. The gripper 104 may also include a tip 116 at or near the distal end 108 of the gripper 104. The tip 116 may be configured to penetrate, puncture, or be inserted into tissue. For example, the tip 116 may be pointed or sharpened to penetrate tissue. The helical coil 114 and tip 116 may enable the gripper 104 to penetrate and helically weave through tissue to secure the gripper 104 in grasping engagement with the tissue. The helical configuration of the gripper 112 of the gripper 104 may be more reliable than conventional graspers, such as graspers that have jaws or arms that can be opened and closed to grasp tissue. For example, the helical coil 114 of the grasper 112 may enable the grasper 104 to consistently capture deeper layers of tissue when performing a particular procedure, while minimizing scarring or tearing of tissue.

[0060] The gripping portion 112 of the gripping device 104 may be sized, shaped, and configured to penetrate, spiral, and grip tissue. The gripping portion 112 may have a length that extends generally longitudinally, such as parallel to the distal end of the actuation element 208. The length of the gripping portion 112 may be between about 1 mm and about 10 mm, such as between about 1.5 mm and about 7 mm, such as between about 2 mm and about 6 mm. However, it will be appreciated that the length of the gripping portion 112 may be selected based on the location of the target tissue. For example, the length of the gripping portion 112 may be between about 2.5 mm and about 4.0 mm, such as between about 3.0 mm and about 3.5 mm, when the gripping device 104 is used in a location such as the colon. The length of the gripping portion 112 may be between about 4.0 mm and about 7.5 mm, e.g., between about 5.0 mm and about 6.0 mm, when the gripping device 104 is used to reach tissue layers deeper than the submucosa, such as in a stomach location. Additionally, the length of the gripping portion 112 may be selected based on the application of the gripping device 104. For example, the length of the gripping portion 112 may be between about 4.0 mm and about 7.5 mm, e.g., between about 5.0 mm and about 6.0 mm, when the gripping device 104 is deployed in deeper tissue layers, such as tissue in the stomach, and may be between about 2.5 mm and about 4.0 mm, e.g., between about 3.0 mm and about 3.5 mm, when the gripping device 104 is used to capture tissue, e.g., tissue in the stomach.

[0061] In some embodiments, the helical coil 114 is laser cut into the distal end of the gripping device 104 to form the gripping portion 112. In other embodiments, the helical coil 114 is wound in a coil or spiral shape.

[0062] The gripping portion 112 can also be sized, shaped, and configured such that the gripping device 104 can be deployed through a catheter 302, such as the dual lumen catheter 302 of FIG. 3. The gripping portion 112 can have a width or diameter such that the gripping device 104 can be extended through the catheter 302, such as with a space between the inner surface of the catheter 302 and the gripping portion 112. In some embodiments, the gripping portion 112 has a width or diameter between about 0.025 inches (0.6 mm) and about 0.050 inches (1.3 mm), for example about 0.045 inches (1.1 mm).

[0063] In operation, the gripping device 104 is positioned over a target tissue, and the gripping device 104 may be translated distally and / or rotated such that the tip 116 penetrates the target tissue and the distal end 108 of the gripping device 104 is disposed within the tissue. Once the distal end 108 of the gripping device 104 is inserted into the tissue, the gripping device 104 may be manipulated, for example, via the actuation assembly 200, to further secure the gripping device 104 in a disposed position within the tissue. For example, the gripping device 104 may be translated distally into the tissue, such as via one of the first control actuators 230a, and / or the gripping device 104 may be rotated, such as via one of the second control actuators 230b, to place one or more helical coils 114 within the tissue. The translational and rotational movement of the gripping device 104 may cause the helical coils 114 to spiral into the target tissue. The helical coil 114 may be oriented approximately perpendicular to the longitudinal axis of the grasping device 104 to prevent or limit the grasping device 104 from being pulled out of the tissue by securing the tissue around the helical coil 114.

[0064] 9, the grasper 104 can include a barb 118 proximal to the tip 116. The barb 118 can be configured to prevent or limit the tip 116 from being pulled out or removed from tissue once the tip 116 is inserted into the tissue. For example, the barb 118 can be wider than the helical coil 114 to substantially prevent tissue disposed around the helical coil 114 from passing over the barb 118.

[0065] In some embodiments, the barb 118 includes an angled shoulder 120 configured to hold the tip 116 in tissue. The angled shoulder 120 may be located at a proximal end of the barb 118 and may be generally perpendicular or at a proximal angle to an adjacent portion of the helical coil 114. The angled shoulder 120 may be configured to abut tissue disposed about the helical coil 114 such that when the gripper 112 is at least partially inserted into tissue, the abutment between the angled shoulder 120 and tissue disposed about the helical coil 114 prevents or limits the gripper 104 from being pulled out of the tissue when the barb 118 is inserted into the tissue. In some embodiments, the barb 118, such as the angled shoulder 120, may include serrations. The serrations on the barb 118 may enhance the grip of the gripper 104 on the tissue.

[0066] The linkage 110 may be directly or indirectly coupled to a distal end of one of the actuating elements 208 such that translational and rotational motion of the actuating element 208 may be translated into translational and rotational motion of the gripping device 104. In some embodiments, the proximal end of the linkage 110 may be directly coupled to the distal end of the actuating element 208 by welding, adhesive, overmolding, crimping, swaging, etc. In other embodiments, the linkage 110 is indirectly coupled to the distal end of the actuating element 208, such as through one or more couplers, as described below.

[0067] In some embodiments, as shown in FIG. 10 , the coupling 110 includes a receiver 122 extending distally into the coupling 110 from the proximal end 106. In some embodiments, the receiver 122 is a generally cylindrical bore. In some embodiments, the receiver 122 is sized, shaped, and configured to receive a distal end of one of the actuating elements 208. The distal end of the actuating element 208 may be inserted into the receiver 122 to couple the actuating element 208 with the gripping device 104. The gripping device 104 and the actuating element 208 may be further secured to one another by welding or adhesive. In other embodiments, the receiver 122 is configured to receive a coupler configured to operably couple the gripping device 104 to the actuating element 208, as described below.

[0068] 7-8 and 10, the proximal end 106 of the gripping device 104, such as the proximal end of the link 110, may be tapered. The tapered end of the gripping device 104 may aid in the retraction of the gripping device 104 into the catheter 302. It will be understood that tapering the proximal end of the gripping device 104 may include chamfering, filing, rounding, or narrowing the proximal end of the gripping device 104 to aid in the retraction of the gripping device 104 into the catheter 302.

[0069] As shown in FIG. 11 , an actuation assembly 200 according to one embodiment may be operable with two gripping devices 104 having helical coils 114 configured to be spirally inserted into tissue to grip the tissue. In the illustrated embodiment, the actuation assembly 200 includes a first control actuator 230a coupled to a first actuation element 208a to control the operation of the first gripping device 104a. The actuation assembly 200 also includes a second control actuator 230b coupled to a second actuation element 208b to control the operation of the second gripping device 104b. The actuation elements 208a, 208b extend through the body 202 of the actuation assembly 200. The actuation assembly 200 is operable to independently control the deployment of the first and second gripping devices 104a, 104b. For example, the first control actuator 230a may be operable to translate and rotate the first actuation element 208a to control the first gripping device 104a, and the second control actuator 230b may be operable to translate and rotate the second actuation element 208b to control the second gripping device 104b. Although the actuation assembly 200 is illustrated as independently controlling two similar gripping devices 104, it will be understood that the actuation assembly 200 may be operable for different gripping devices 104, and the device 100 may include different first and second gripping devices 104a, 104b, such as any of the gripping devices 104 described below.

[0070] In some embodiments, as shown in FIGS. 11B-11C, one or more of the actuating elements 208 may have a non-circular cross-section to reduce friction between the catheter 302 and / or sheath 304 and the actuating element 208. For example, the actuating element 208 may have a cross-section that reduces a surface area of ​​the actuating element 208 that contacts the catheter 302 and / or sheath 304, such as during operation of the device 100. In the illustrated embodiment, the actuating element 208 has a generally rectangular cross-section that is twisted along the length of the actuating element. However, it will be understood that the actuating element 208 may have other shapes to reduce friction with the catheter 302 and / or sheath 304. For example, the actuating element 208 may be oval, oval, elliptical, triangular, hexagonal, D-shaped, crescent, pie-shaped, grooved, tapered, or other suitable shape.

[0071] As shown in FIGS. 11B-11C, the actuating elements 208 may be twisted to further reduce frictional contact between the actuating elements 208 and the catheter 302 and / or sheath 304. It will be understood that twisting of the actuating elements 208 also encompasses actuating elements 208 having a helical or spiraled profile. The twisting of the actuating elements 208 may help a user identify that the actuating elements 208 are rotating. Additionally, the twisting of one of the actuating elements 208 may help a user identify which actuating element 208 is being actuated. For example, as shown in FIG. 11C, a first actuating element 208a having a rectangular cross-section that is twisted along the length of the actuating element 208a is coupled to the first gripping device 104a, and a second actuating element 208b having a generally circular cross-section is coupled to the second actuating element 208b. The difference in shape between the first and second actuation elements 208a, 208b may aid a user in identifying which actuation element 208a, 208b and which gripping device 104a, 104b is being manipulated, for example, via the actuation assembly 200. In the illustrated embodiment, the first actuation element 208a has a rectangular cross-section that is twisted along the length of the actuation element 208, and the second actuation element 208b is generally circular. However, it will be understood that both actuation elements 208 may have a rectangular cross-section that is twisted along the length of the actuation element 208.

[0072] In some embodiments, the catheter 302 may be configured to increase the resistance to compression of the catheter 302 during operation. As shown in Figures 11D-11G, the catheter 302 may be a spring sheath wound into a helical coil having multiple compression sections 303 disposed along the length of the catheter 302. The compression sections 303 may be formed by winding the coil into a tighter spiral at predetermined intervals along the length of the catheter 302.

[0073] The catheter 302 may also include a number of struts 305 extending across the cross section of the catheter 302 at predetermined intervals. The struts 305 may be formed by bending coils across the cross section of the catheter 302 which may form constrictions 303. The struts 305 may radially support the catheter 302 against compressive forces acting on the catheter 302 during operation. The struts 305 may also be substantially aligned such that they separate the catheter 302 such that the actuating elements 208 do not tangle during operation. The struts 305 may define a pseudo lumen extending through the catheter 302. In some embodiments, only the distal coils of the catheter 302 are bent to form the struts 305 which separate the actuating elements 208 at the distal end of the device 100 and prevent the actuating elements 208 from tangling during operation.

[0074] As shown in FIGS. 12A-12D, two gripping devices 104 with helical coils 114 may be manipulated, for example, via the actuation assembly 200 of FIG. 11, to grasp and capture tissue. As shown in FIG. 12A, an endoscope and / or catheter 302 may be positioned above an identified defect such that a first gripping device 104a and a second gripping device 104b are positioned substantially above the defect. As shown in FIG. 12B, the first gripping device 104a may be manipulated, for example, via a first control actuator 230a of the actuation assembly 200, to grasp tissue on a first side of the defect. For example, the first actuation element 208a may be rotated and translated such that the first gripping device 104a penetrates and spirals into the tissue to securely grasp the tissue.

[0075] 12C, the second gripping device 104b may be manipulated to grasp tissue on a second side of the defect, for example, via the second control actuator 230b of the actuation assembly 200. The endoscope and / or catheter 302 may be manipulated so that the second gripping device 104b is positioned over the second side of the defect after the first gripping device 104a has been manipulated to grasp tissue. The second actuating element 208b may be rotated and translated to penetrate and spiral into the tissue on the opposite side of the defect to securely grasp the tissue.

[0076] 12D, the first and second actuating elements 208a, 208b may be retracted proximally toward the catheter 302. The actuating elements 208a, 208b may be retracted proximally, such as via the first and second control actuators 230a, 230b of the actuating assembly 200, to bring the gripping devices 104a, 104b and the gripped tissue toward the catheter 302. Optionally, a hemostatic clip may be deployed around the tissue captured by the first and second gripping devices 104a, 104b.

[0077] 13A-18B, the gripping device 104 may have a variety of shapes and configurations depending, for example, on the desired application and / or tissue of the gripping device 104. As shown in FIGS. 13A-14B, the gripping portion 112 of the gripping device 104 may include a proximal portion 124 at a proximal end of the gripping portion 112 and a distal portion 126 extending distally from the proximal portion 124. The distal portion 126 may be configured to be inserted and retained within the target tissue. The proximal portion 124 may be configured to increase the flexibility of the gripping device 104 as the gripping device 104 is retracted within the shroud, as described below. The proximal portion 124 may also be configured to provide a visual indication to the user regarding the desired depth to which the gripping device 104 should be inserted into the tissue. The proximal portion 124 may limit the depth to which the gripping portion may be inserted into the tissue. For example, proximal portion 124 may be configured to prevent grasper 104 from being inserted into tissue beyond distal portion 126. In some embodiments, proximal portion 124 may be configured to increase the flexibility of grasper 104. In some embodiments, distal portion 126 may also be configured to allow grasper 104 to flex or bend, such as when grasper 104 grasps tissue and subsequent grasper 104 is manipulated.

[0078] As shown in FIGS. 13A-13B, the pitch of the helical coils 114 of the proximal portion 124 may be smaller than the pitch of the helical coils 114 of the distal portion 126 such that the helical coils 114 of the proximal portion 124 are closer together or closer together than the helical coils 114 of the distal portion 126. For example, the helical coils 114 of the proximal portion 124 may have a pitch and configuration such that each helical coil 114 abuts an adjacent helical coil 114 without a gap. The helical coils 114 of the distal portion 126 may have a pitch and configuration such that each helical coil 114 is spaced apart from an adjacent helical coil 114 with a gap. The different pitches of the helical coils 114 of the proximal portion 124 and the distal portion 126 may improve the flexibility of the gripping portion 112 when the gripping device 104 is retracted, such as toward the shroud. The helical coils 114 of the proximal and distal portions 124, 126 may also reduce bending stresses when the grasper 104 is retracted, such as to prevent the grasper 112 from being pulled out of tissue. The difference in pitch of the helical coils 114 of the proximal and distal portions 124, 126 may also provide a visual indication and / or act as a physical stop to prevent tissue from continuing past the distal portion 126 as the grasper 112 is inserted into tissue.

[0079] As shown in FIGS. 14A-14B, the helical coil 114 of the proximal portion 124 may be narrower than the helical coil 114 of the distal portion 126. The wider helical coil 114 of the distal portion 126 may more securely grasp the target tissue. The narrower helical coil 114 of the proximal portion 124 may increase the flexibility of the grasping device 104 and / or reduce stress and strain on the device 100, such as when the grasping device 104 is retracted proximally via the actuation element 208 to capture the grasped tissue. In some embodiments, the helical coil 114 of the distal portion 126 may include one or more barbs 118 disposed proximally from the tip 116. The distal barbs 118 may further secure the tissue after the grasping device 104 is inserted into the tissue. For example, barbs 118 may be included on one or more distal sides of helical coil 114 to further anchor grasping device 104 within tissue when helical coil 114 of distal portion 126 is inserted into tissue. Barbs 118 may be located at various locations around the circumference of helical coil 114.

[0080] In some embodiments, the gripping device 104 may include a stop or other component at the transition between the distal portion 126 and the proximal portion 124 to prevent or limit tissue from engaging the proximal portion 124. For example, the gripping device 104 may include a flange or shoulder at the transition between the distal portion 126 and the proximal portion 124 that is generally perpendicular to the helical coil 114 and configured to abut tissue when the distal portion 126 is inserted into the tissue. Additionally or alternatively, the gripping device 104 may include a weld between the proximal portion 124 and the distal portion 126 that interrupts the winding path of the helical coil 114 to substantially prevent tissue from advancing into the proximal portion 124.

[0081] 15A-15B, in some embodiments, the gripping device 104 may include a flexible region or portion 128 configured to allow the gripping device 104 to flex or bend, such as when the gripping portion 112 of the gripping device 104 is secured within tissue or during subsequent actuation of the gripping device 104. The flexible portion 128 may be spaced a preset distance from the distal end of the gripping device 104, such as at a mid-portion of the gripping device 104. For example, the flexible portion 128 may be spaced from the distal end of the gripping device 104 such that when the gripping device 104 is deployed within tissue, the flexible portion 128 is disposed proximal to the tissue.

[0082] The flexible portion 128 may be sized, shaped, and configured to aid in the deployment of the gripping device 104 or another gripping device 104. The gripping device 104 may flex at the flexible portion 128 to aid in the insertion of the gripping portion 112 into tissue via rotation and translation of the actuation element 208, such as when the gripping portion 112 is inserted into tissue at an angle different from the longitudinal axis of the distal end of the actuation element 208. The flexible portion 128 may also be sufficiently stiff so that the gripping device 104 may be positioned and controlled to grip the target tissue. The flexible portion 128 may also be sized, shaped, and configured to aid in the deployment of the second gripping device 104 after the first gripping device 104 is anchored into tissue. For example, after the gripping portion 112 of the first gripping device 104 is secured within tissue, the flexible portion 128 may allow the linkage 110 of the first gripping device 104 to flex so that the device 100 can be manipulated to position and deploy the second gripping device 104.

[0083] In the illustrated embodiment, the flexible portion 128 includes a plurality of slots 129 extending laterally through the body of the gripping device 104. The slots 129 may allow the flexible portion 128 to bend or flex about the slots 129. Additionally or alternatively, the flexible portion 128 may be constructed with thinner helical coils 114, more space between the helical coils 114, a closed pitch between the helical coils 114, reduced material (e.g., including openings) and / or more pliable material, or combinations thereof, so that the flexible portion 128 may flex or flex. The flexible portion 128 of the gripping device 104 may improve tissue approximation. For example, the flexible portion 128 may facilitate manipulation of the gripping device 104, such as engaging additional gripping devices 104 with tissue after a distal end of the gripping device 104 is deployed within the tissue. The flexible portions 128 may also reduce the force applied to tissue when subsequent graspers 104 are deployed so as to reduce the likelihood that the first-inserted grasper 104 will be pulled out of the tissue.

[0084] The actuating element 208 may also be sufficiently flexible so that the actuating element 208 and tissue capture assembly 102 may be extended, for example, through an endoscope to a desired location within the body, and the endoscope may be manipulated with the actuating element 208 extending therethrough. The actuating element 208 may also be sufficiently rigid so that the actuating element 208 may be manipulated to grasp tissue, as described below. In some embodiments, the actuating element 208 is a solid core nitinol wire having a diameter between about 0.018 inches (0.46 mm) and about 0.030 inches (0.76 mm), for example, about 0.024 inches (0.61 mm). In some embodiments, the actuating element 208 provides a one-to-one torque response over the length of the endoscope such that the distal end of the actuating element 208 rotates equivalently to the rotation of the proximal end of the actuating element 208.

[0085] As shown in FIGS. 16A-17B, the coupling portion 110 and the gripping portion 112 can have various sizes, shapes, and configurations depending, for example, on the tissue to be gripped and other components of the device 100. As shown in FIGS. 16A-16B, the gripping portion 112 can be shorter and include two helical coils 114. As shown in FIGS. 17A-17B, the gripping portion 112 can be longer and include three helical coils 114. Also, the gripping portion 112 can include more than three helical coils 114. Additionally, as shown in FIGS. 16A-17B, the coupling portion 110 can include various configurations, such as including tabs, slots, teeth, or apertures. For example, the coupling portion 110 of the gripping device 104 can be sized, shaped, and configured based on the coupling of the gripping device 104 to the actuation element 208, as described below. As shown in FIG. 17B, the coupling portion 110 may include a number of serrations that may be operable to couple the gripping device 104 to a distal end of the actuation element 208, as described below.

[0086] As shown in FIGS. 18A-18B, the gripping device 104 may include two flutes 130 positioned opposite one another. Each flute 130 may include a helical coil 114 that extends toward the distal end of the gripping device 104 and extends to a tip 116. The tips 116 of the flutes 130 may be positioned equidistant from the gripping portion 112 of the gripping device 104 such that the tips 116 of each flute 130 may simultaneously engage tissue. In some embodiments, each flute 130 may include a barb 118 with an angled shoulder 120, as described above with reference to FIG. 9. The inclusion of two flutes 130 with helical coils 114 may enhance tissue engagement when the gripping device 104 is deployed within tissue. Additionally, any of the other gripping devices 104 having helical coils 114 described above, such as the gripping devices 104 of FIGS. 7-10 and 13A-17B, may be configured to include two flutes 130.

[0087] One or more graspers 104 may be operably coupled to a respective actuation element 208 such that the graspers 104 may be decoupled from the actuation element 208, such as after the graspers 104 are deployed to grasp a target tissue. For example, the graspers 104 may be operably coupled to the actuation element 208 such that the actuation element 208 translates and rotates the graspers 104 during operation, e.g., via the actuation assembly 200, and decouples the graspers 104 from the actuation element 208 after the graspers 104 are deployed into the target tissue, such as to close a defect. The actuation element 208 may be initially coupled to the graspers 104 to control the operation of the graspers 104 to grasp tissue. After the graspers 104 are deployed or actuated to grasp tissue, the graspers 104 may be decoupled from the actuation element 208, such as while the graspers 104 are grasping tissue. The actuation element 208 may then be retracted from the deployed or actuated grasper 104 .

[0088] 19A-20D, in some embodiments, the tissue capture assembly 102 includes one or more shrouds 170. The shrouds 170 may be configured to substantially cover the gripping devices 104 when the gripping devices 104 are in an undeployed or retracted state. The one or more shrouds 170 may be directly or indirectly coupled to a distal end (not shown) of the catheter 302. The one or more shrouds 170 may be configured to protect the endoscope and / or the gripping devices 104 during operation. The one or more shrouds 170 may be comprised of any suitable material for protecting the endoscope, the gripping devices 104, and / or retaining tissue captured therein. In some embodiments, the one or more shrouds 170 include a polymer. Additionally or alternatively, the shroud 170 may be constructed from metal, polymer, flexible metal, PEEK, polyimide, polyamide, thermoplastic, HDPE, PTFE, heat shrink, RNF, polyolefin, or compression springs, or combinations thereof, and may be an extension of the catheter 302. It will be further understood that the shroud 170 may be an oversheath and / or extend the entire length of the device 100, such as along the entire length of the catheter 302.

[0089] The one or more shrouds 170 may be generally hollow cylinders defining a tissue capture region 172 configured to receive the one or more gripping devices 104 and tissue captured by the gripping devices 104 to hold the tissue in a captured position for closing the defect after the gripping devices 104 are decoupled from the actuation element 208, as described below. The tissue capture region 172 may have a longitudinal length configured to substantially surround or encircle the gripping devices 104 when the gripping devices 104 are in an undeployed or retracted state, e.g., a fully retracted state, such that the gripping devices 104 are substantially disposed in the tissue capture region 172 (FIG. 19A). The gripping devices 104 may extend distally from the shroud 170 (FIGS. 19B and 20A) to grip tissue. In some embodiments, the distal end of each shroud 170 flares radially outward to facilitate deployment and retraction of the gripping devices 104. In other embodiments, the distal end of the shroud 170 is tapered or lanced.

[0090] The proximal end of each shroud 170 may be directly coupled to the distal end of one of the catheters 302, as described below, or may be indirectly coupled to the distal end of the catheter 302, such as via a connector. In the illustrated embodiment, the tissue capture assembly 102 includes one shroud 170 configured to encase both of the gripping devices 104. However, it will be understood that the tissue capture assembly 102 may have other configurations. For example, the catheter and sheath assembly 300 may include two catheters 302, and the tissue capture assembly 102 may include a separate shroud 170 for covering each of the gripping devices 104.

[0091] The tissue capture region 172 may have an inner diameter larger than an outer diameter of the one or more gripping devices 104 housed within the shroud 170 such that the one or more gripping devices 104 may move relatively freely within the tissue capture region 172, e.g., extend and retract the gripping devices 104 therefrom. For example, the tissue capture region 172 may have an inner diameter configured to allow for deployment of the second gripping device 104 after the first gripping device 104 has been manipulated to grip tissue. The tissue capture region 172 may also be sized, shaped, and configured to receive tissue grasped by the gripping device 104 when the gripping device 104 is retracted into the tissue capture region 172 to maintain closure of the defect.

[0092] The shroud 170 may be sized, shaped, and configured such that the gripping devices 104 may be retained within, extended from, and retracted into the shroud 170. The shroud 170 may substantially cover the gripping devices 104 when the gripping devices 104 are in a non-actuated position, e.g., when the tissue capture assembly 102 is inserted, such as through an endoscope, to a desired location within the body. The shroud 170 may allow the gripping devices 104 to be extended from the shroud 170 via the actuating elements 208 to grasp tissue at different locations. For example, the shroud 170 may be configured to allow the actuating elements 208 to flex or bend such that the gripping devices 104 may independently grasp tissue at spaced apart locations, such as on opposite sides of a defect. Additionally, the shroud 170 may be configured such that the grasping device 104 may be retracted to a retracted position within the shroud 170 such that the grasped tissue is received in the tissue capture area 172 .

[0093] In some embodiments, the shroud 170 is operable to hold the gripping device 104 in a locked position. The locked position may substantially correspond to the retracted position of the gripping device 104. The proximal end of the shroud 170 may be narrower than a distal portion of the shroud 170, e.g., a portion of the shroud 170 that defines the tissue capture area 172. The proximal end of the shroud 170 may be narrower such that the proximal end of the shroud 170 maintains the position of the gripping device 104 when the gripping device 104 is retracted to the retracted position to retain the gripped tissue in the tissue capture area 172. The proximal end of the shroud 170 may substantially hold the gripping device 104 in the retracted position via a compression fit, an interference fit, and / or frictional forces. For example, shroud 170 may be constructed from a polymer, metal, or a combination thereof, and / or may be constructed from a polymer liner such that shroud 170 substantially conforms to a proximal end of gripping device 104, such as coupling 110, when gripping device 104 is retracted to a retracted position so as to maintain the position of coupling 110 of gripping device 104. Grip device 104 may be substantially prevented from translating and / or rotating when gripping device 104 is in a locked position within shroud 170.

[0094] In some embodiments, as shown in FIGS. 20C-20D, the shroud 170 may include or incorporate one or more lumens 173 extending at least partially through the shroud 170. The lumen 173 may be a generally hollow tube configured to allow the grasping device 104 to extend therethrough. The lumen 173 may be flexible such that the grasping device 104 and the actuating element 208 may be manipulated such that the grasping device 104 may grasp tissue at different positions. The lumen 173 may keep the actuating element 208 from tangling as the actuating element 208 is extended, rotated, and retracted to control the movement of the grasping device 104. The lumen 173 may also aid in the retraction of the actuating element 208 and the grasping device 104 after the grasping device 104 has grasped tissue such that the tissue is properly captured in the tissue capture area 172. For example, lumen 173 may guide the extension and retraction of actuating element 208 and gripping device 104 so that actuating element 208 does not tangle and so that actuating element 208 is substantially aligned when retracted such that actuating element 208 is aligned at a central portion of shroud 170. In some embodiments, lumen 173 is configured to maintain the retracted position of gripping device 104, such as through a compression fit, an interference fit, and / or frictional forces with coupling 110 of gripping device 104. In some embodiments, the proximal end of shroud 170 may be substantially solid except for an opening defined by lumen 173.

[0095] As shown in FIGS. 20D-20F, the shroud 170 may include a hood 175 disposed in the tissue capture region 172. The hood 175 may be generally cylindrical and may have a substantially solid proximal end defining one or more lumens 173. A distal end of the hood 175 may be generally hollow and sized, shaped, and configured to receive the gripping device 104. The hood 175 may also be configured to control the operation of the gripping device 104, to prevent the actuating element 208 from entangling as the actuating element 208 is extended, rotated, and retracted, and to assist in retraction of the actuating element 208 and the gripping device 104 after the gripping device 104 has grasped tissue so that the tissue is properly captured in the tissue capture region 172. The hood 175 may be configured to retain the gripping device 104 in the retracted position, such as via a compression fit, an interference fit, and / or frictional forces with the coupling 110 of the gripping device 104. In some embodiments, the device 100 may not include the hood 175, and the catheter 302 may prevent entanglement of the actuating element 208 during operation. For example, the struts 305 of the catheter 302 of Figures 11D-11G may prevent the actuating element 208 from entangling during operation. The catheter 302 may also include individualized lumens formed from a polymer.

[0096] In some embodiments, one or more shrouds 170 are configured to collapse or retract or compress proximally relative to the tissue after the gripping devices 104 have secured the tissue and been retracted proximally, such as into the tissue capture region 172. For example, one or more shrouds 170 may include stress relief features that allow a distal end of the shroud 170 to collapse or retract proximally after the gripping devices 104 have been manipulated to grasp the tissue and have been retracted proximally into the tissue capture region 172 to capture the grasped tissue. The shroud 170 may also be configured to fan outwardly relative to the tissue as the gripping devices 104 are captured, to reduce the longitudinal length of the shroud.

[0097] As shown in FIGS. 20A-20B, the shroud 170 includes a number of slots 174 extending through the body of the shroud 170 from the distal end toward the proximal end. The slots 174 may define a number of protrusions 176 extending toward the distal end of the shroud 170. The protrusions 176 may substantially cover the gripping device 104 when the gripping device 104 is in an undeployed state. After the gripping device 104 has been manipulated to grip tissue, retraction of the gripping device 104 may cause the captured tissue to abut the distal end of the shroud 170. Further proximal retraction of the gripping device 104 into the tissue capture region 172 may cause the protrusions 176 to collapse or move toward the proximal end of the shroud 170 to shorten the length of the shroud 170. For example, the slots 174 allow the protrusions 176 to be compressed after the grasper 104 is manipulated to grasp tissue and captured in the tissue capture region 172 of the shroud 170, for example, to reduce the distance that the shroud 170 extends outwardly from the tissue when the grasper 104 is deployed to close a defect. The protrusions 176 may be resiliently compressed such that the protrusions 176 return to their original shape after being compressed. For example, the protrusions 176 may be compressed as tissue is captured toward the shroud 170 and the protrusions 176 may return to their original shape when the tissue is released.

[0098] Although shroud 170 has been described as including a plurality of slots 174 defining stress relief features, it will be understood that one or more of shrouds 170 may include other suitable stress relief features. For example, additionally or alternatively, one or more of shrouds 170 may be comprised of crumple zones, circumferential pleats that allow shroud 170 to fold proximally, helical coils that allow shroud 170 to compress as grasper 104 is engaged, and / or tissue engagement portions (FIG. 30) and openings extending around the periphery of material that allow shroud 170 to roll or fold proximally, or combinations thereof.

[0099] In some embodiments, the gripping apparatus 104 may be locked into position within the shroud 170 when the gripping apparatus 104 is sufficiently retracted within the shroud 170 such that the position of the gripping apparatus 104 is maintained relative to the shroud 170, as described below. In some embodiments, the shroud 170 is operable to maintain the position of the gripping apparatus 104 in the retracted position by a compression fit, an interference fit, and / or friction with the coupling 110 of the gripping apparatus 104, as described below. In some embodiments, the force required to lock the gripping apparatus 104 into the shroud 170 is between about 4 pounds and about 5 pounds.

[0100] As shown in Figures 21A-21B, the two gripping devices 104 may be manipulated to grip target tissue, such as on opposite sides of a defect, and capture the gripped tissue into the shroud 170 to move the gripped tissue toward or into a tissue capture region 172 of the shroud 170 to close the defect. The gripping devices 104 may be decoupled from the actuating element 208, and the shroud 170 may be decoupled from the catheter 302 to maintain closure of the defect via the gripping devices 104. In the illustrated embodiment, the first gripping device 104a is coupled to a first actuating element 208a, and the second gripping device 104b is coupled to a second actuating element 208b. A first coupler 140a is included for operably coupling the first gripping device 104a with the first actuation element 208a, and a second coupler 140b is included for operably coupling the second gripping device 104b with the second actuation element 208b. Although the gripping devices 104a, 104b are described as being operably coupled to the actuation elements 208a, 208b via the couplers 140a, 140b, it will be understood that the gripping devices 104a, 104b may be operably coupled directly to the actuation elements 208a, 208b.

[0101] The endoscope and / or catheter 302 may be positioned above the identified defect such that the gripping devices 104a, 104b are disposed substantially above the defect. As shown in FIG 21A, the first gripping device 104a may be manipulated, such as via the actuation assembly 200, to grasp tissue on a first side of the defect. For example, the first actuation element 208a may be rotated and translated such that the first gripping device 104a securely grasps tissue.

[0102] 21B, the second grasping device 104b may be manipulated, for example, via the actuation assembly 200, to grasp tissue on a second side of the defect. The endoscope and / or catheter 302 may be manipulated such that the second grasping device 104b is positioned above the second side of the defect when the second actuation element 208b is manipulated to control the second grasping device 104b. For example, the second actuation element 208b may be rotated and translated such that the second grasping device 104b securely grasps tissue.

[0103] 21C, the first and second actuating elements 208a, 208b may be retracted proximally toward the catheter 302. The actuating elements 208a, 208b may be retracted proximally, such as via the actuating assembly 200, such that the grippers 104a, 104b and the gripped tissue are brought toward the catheter 302, toward or into the tissue capture region 172 of the shroud 170. The grippers 104a, 104b may be retracted proximally via the actuating elements 208a, 208b and into the shroud 170 such that the shroud 170 locks the grippers 104a, 104b in a retracted position such that the shroud 170 maintains the translational and rotational positions of the grippers 104a, 104b.

[0104] As shown in FIG. 21D, the gripping devices 104a, 104b may be decoupled from their respective actuating elements 208a, 208b, and the shroud 170 may be decoupled from the catheter 302. The gripping devices 104a, 104b may be disposed within the shroud 170 such that tissue grasped from opposite sides of the defect is held together by the gripping devices 104a, 104b to maintain substantial closure of the defect. The gripping devices 104a, 104b may be decoupled from the actuating elements 208a, 208b by operatively decoupling the couplers 140a, 140b from the actuating elements 208a, 208b, as described below. The shroud 170 may be decoupled from the catheter 302, as described below. The tissue capture assembly 102 may be configured to lock the gripping device 104 within the shroud 170 after the gripping device 104 is decoupled from the actuating element 208 and the shroud 170 is decoupled from the catheter 302, as described below. Although the coupler 140 has been described as remaining with the gripping device 104 when the gripping device 104 is decoupled from the actuating element 208, it will be understood that the coupler 140 may be coupled to the actuating element 208.

[0105] The gripping device 104 may be operably coupled to the actuating element 208 in a variety of manners such that the gripping device 104 may be decoupled from the actuating element 208, such as after the gripping device 104 has grasped tissue and is captured toward or within the tissue capture region 172 of the shroud 170. In some embodiments, the coupling 110 of the gripping device 104 is operably coupled directly to a distal end of the actuating element 208. In other embodiments, the coupling 110 of the gripping device 104 is operably coupled to a distal end of the actuating element 208 via a coupler 140.

[0106] 22A-23B, the gripping device 104 may include one or more tabs 132 configured to operably couple the gripping device 104 with the actuating element 208. The tabs 132 extend from a proximal end of the link 110 and are flexible or pivotable to couple with the actuating element 208, as described below. In some embodiments, the tabs 132 are laser cut from a distal end of the gripping device 104. In other embodiments, the tabs 132 are laser cut from a distal end of the actuating element 208 and a detent 134 is disposed at a proximal end of the gripping device 104.

[0107] In some embodiments, as shown in FIGS. 22A-22B, the actuation element 208 includes one or more detents 134 configured to engage and operably retain the tabs 132 of the gripping device 104. The detents 134 may extend on the outer surface of the actuation element 208 near the distal end. The detents 134 may be recesses, openings, cutouts, or slots that extend radially inwardly into the outer surface of the actuation element 208. In the illustrated embodiment, the detents 134 extend entirely through the actuation element 208. In other embodiments, the detents 134 may be recesses, grooves, bores, or slots that extend partially into the outer surface of the actuation element 208. The actuation element 208 may have multiple detents 134 in a configuration about the outer surface of the actuation element 208 that corresponds to the number and location of the tabs 132 of the gripping device 104. In other embodiments, the tabs 132 may couple to the outer surface of the actuation element 208 via friction such that the detents 134 may be omitted.

[0108] The tabs 132 of the grasper 104 may be operable to couple the grasper 104 to the actuation element 208. The distal end of the actuation element 208 may be inserted into the receiver 122 of the grasper 104, and the tabs 132 of the grasper 104 may be inserted into or bent radially inward to engage the detents 134 of the actuation element 208. When the tabs 132 of the grasper 104 are inserted into or engaged with the detents 134, the grasper 104 may remain directly or indirectly coupled to the distal end of the actuation element 208. Translational and rotational motion of the actuation element 208 may be transferred to the grasper 104 when the tabs 132 of the grasper 104 couple with the detents 134 of the actuation element 208 to manipulate the grasper 104 to grasp tissue.

[0109] The tabs 132 are also operable to disengage the gripping device 104 from the actuation element 208, such as after the gripping device 104 has been manipulated to grip tissue. The actuation element 208 may be retracted proximally, such as via the actuation assembly 200, with sufficient force to, for example, push or pivot the tabs 132 radially outward from the detents 134 to disengage the tabs 132 from the detents 134. Once the tabs 132 are disengaged from the detents 134, the gripping device 104 may be disengaged from the actuation element 208. For example, the gripping device 104 may be graspably inserted into tissue, and the actuation element 208 may be retracted proximally, such as via the actuation assembly 200, to disengage the tabs 132 of the gripping device 104 from the detents 134 of the actuation element 208. The force required to disengage the gripping device 104 from the actuation element 208 may be greater than the force required to pull the gripping device 104 from the tissue. In some embodiments, the force required to disengage the gripping device 104 from the actuation element 208 is between about 3 and about 6 pounds. After the tabs 132 are disengaged from the detents 134, the actuation element 208 may be retracted proximally from the gripping device 104, such as with the gripping device 104 graspably inserted into tissue.

[0110] 23A-23B, tissue capture assembly 102 includes one or more couplers 140 operable to couple gripping device 104 to actuation element 208. Coupler 140 can be sized, shaped, and configured to couple gripping device 104 to actuation element 208 during an operation, such as manipulating gripping device 104 to grasp tissue on an opposite side of a defect, and to decouple gripping device 104 from actuation element 208, such as after gripping device 104 has been manipulated to grasp tissue.

[0111] As shown in FIGS. 23A-23B, the coupler 140 may be attached to a distal end of the actuation element 208 to operatively couple the actuation element 208 to the gripping device 104. The coupler 140 may be sized, shaped, and configured to be operably held by the tab 132 of the gripping device 104 to couple the actuation element 208 to the gripping device 104. In the illustrated embodiment, the coupler 140 has a generally spherical coupling portion at its distal end configured to couple with the tab 132 of the gripping device 104. In other embodiments, the coupler 140 is asymmetrical, rectangular, oval, triangular, etc. In some embodiments, the coupler 140 is welded to or from the distal end of the actuation element 208. In some embodiments, the coupler 140 includes a neck that is fixed to a distal end of the actuation element 208 relative to the grip device 104 such that the actuation element 208 can control the position and rotation of the grip device 104. The coupler 140 can also be sized, shaped, and configured to decouple from the grip device 104 after the grip device 104 is actuated or otherwise deployed.

[0112] The tab 132 of the gripping device 104 may be configured to operably hold the connection of the coupler 140. The tab 132 may be configured to flex or bend around the coupler 140, such as around a spherical connection of the coupler 140, to couple the actuation element 208 with the gripping device 104. In some embodiments, the tab 132 is laser cut from the proximal end of the gripping device 104.

[0113] The coupler 140 may be disposed near the coupling 110 of the gripping device 104, such as inserted into the receiver 122 of the gripping device 104, and the tab may be bent radially inward around the coupling of the coupler 140. The bent tab 132 may prevent or limit the coupler 140 from being retracted from the gripping device 104. For example, the tab 132 may be sized, shaped, and configured such that the coupler 140 remains partially disposed in the receiver 122 of the gripping device 104 during deployment of the gripping device 104. For example, the tab 132 may be sized and shaped to substantially cover the proximal side of the coupler 140. Additionally, the tab 132 may be configured such that the tab 132 remains in position around the coupler 140 during positioning and rotation of the gripping device 104.

[0114] The gripping device 104 may be disengaged from the coupler 140, such as after the gripping device 104 has been manipulated to grip tissue. The actuating element 208 may be retracted proximally, such as via the actuating assembly 200, with sufficient force to disengage the tabs 132 from holding the coupler 140 to the gripping device 104. The actuating element 208 may be retracted with sufficient force such that retraction of the coupler 140 causes the tabs 132 of the gripping device 104 to bend radially outward such that the tabs 132 no longer surround the coupling of the coupler 140. The force required to disengage the gripping device 104 from the actuating element 208 may be greater than the force required to pull the gripping device 104 from the tissue. The tabs 132 may be configured to deflect or release the coupler 140 when a force between about 1 pound and about 10 pounds, such as between about 3 pounds and about 6 pounds, is applied to the actuating element 208.

[0115] The coupler 140 may then be retracted from the grasper 104 to decouple the actuating element 208 and coupler 140 from the grasper 104. The coupler 140 may remain coupled to the actuating element 208. For example, the grasper 104 may be graspably inserted into tissue and the actuating element 208 may be retracted proximally such that the coupler 140 bends the tabs 132 radially outward. After the tabs 132 are bent radially outward, the actuating element 208 and coupler 140 may be retracted proximally from the grasper 104, such as with the grasper 104 graspably inserted into tissue and locked to the shroud 170.

[0116] In some embodiments, the coupler 140 has a size, shape, and configuration that allows the actuation element 208 to be operably coupled with the gripping device 104. The coupler 140 may have a size, shape, or configuration that allows the coupler 140 to be inserted into the receiver 122 of the gripping device 104 when the coupler 140 is in a certain orientation and / or when the coupler 140 is disposed in a certain orientation relative to the receiver 122. The coupler 140 may mate with the receiver 122 of the gripping device 104 after the coupler 140 is inserted into the receiver 122. For example, the coupler 140 may rotate within the receiver 122, the coupler 140 may expand within the receiver 122, and the receiver 122 may close around the coupler 140. The coupler 140 may remain mated with the linkage 110 of the gripping device 104 such that translation and rotation of the actuation element 208 are transmitted to the gripping device 104. The coupler 140 may be disengaged from the receiver 122 of the grasper 104, such as after the grasper 104 has been operated to grasp tissue and the grasper 104 has been locked in a retracted position, and the actuating element 208 may be retracted from the grasper 104.

[0117] As shown in FIG. 24A, the coupler 140 may have a generally spherical coupling portion at its distal end configured to couple with the gripping device 104. The coupler 140 may be substantially similar to the coupler 140 of FIGS. 23A-23B. The coupler 140 may be inserted into the receiver 122 of the gripping device 104 such that the coupling portion of the coupler 140 is disposed in the receiver 122. The receiver 122 may have a generally circular opening (FIG. 10) sized to receive the coupling portion of the coupler 140. After the coupling portion of the coupler 140 is inserted into the receiver 122, the coupling portion 110 of the gripping device 104 may be crimped proximally from the coupling portion (e.g., ball) of the coupler 140 to operably hold the coupler 140 in the receiver 122 of the gripping device 104. The actuating element 208 may remain coupled to the grasper 104 while the coupler 140 is disposed in the receiver 122 such that translation and rotation of the actuating element 208 may be transferred to the grasper 104 to grasp tissue with the grasper 104. In some embodiments, the coupling 110 of the grasper 104 may also be crimped, welded, crimped, or otherwise connected distally from the coupler 140 to further secure the coupler 140 within the receiver 122.

[0118] The coupler 140 may be operatively decoupled from the grasper 104, such as after the grasper 104 has been manipulated to grasp tissue. The actuating element 208 may be retracted proximally with sufficient force to break or destroy one or more connections, such as a crimp, in the grasper 104 so that the coupler 140 may be retracted from the receiver 122. The force required to decouple the grasper 104 from the actuating element 208 may be greater than the force required to withdraw the grasper 104 from the tissue. The actuating element 208 and coupler 140 may be retracted proximally from the grasper 104, such as with the grasper 104 deployed in tissue and locked within the shroud 170.

[0119] 24A has been described as being generally spherical, it will be appreciated that the coupler 140 and receiver 122 may have other suitable sizes, shapes, and configurations. For example, the coupler 140 may be rectangular, helical, screw-like, asymmetrical, or other shape suitable for imparting translation and rotation of the actuation element 208 to the gripping device 104 when the coupler 140 is received in the receiver 122 of the gripping device 104.

[0120] In some embodiments, the coupler 140 has a size, shape, and configuration that allows the coupler 140 to be inserted into the receiver 122 of the gripping device 104 and to mate with the gripping device 104 until the coupler 140 is moved to the unlocked position. As shown in FIG. 24B, the receiver 122 of the gripping device 104 may have a proximal opening that substantially corresponds to the shape of the coupler 140. The distal portion of the receiver 122 may have a width or diameter that is greater than the proximal opening of the receiver 122. The coupler 140 may be inserted into the receiver 122 at a position that corresponds to the shape of the proximal opening. After the coupler 140 is inserted into the holder through the proximal opening, the coupler 140 may be rotated to operably secure the coupler 140 to the receiver 122.

[0121] In some embodiments, the receiver 122 is configured such that the coupler 140 can be rotated a predetermined amount within the receiver 122 such that the coupler 140 is operably locked in place within the receiver 122. For example, rotating the coupler 140 can cause the cross-section of the coupler 140 to have a shape that prevents the coupler 140 from backing out of the proximal opening of the receiver 122. In some embodiments, the coupler 140 is operably locked in place in the receiver 122 when the coupler 140 is rotated 90 degrees after it is inserted through the opening of the receiver 122. The receiver 122 can include one or more locking elements that prevent or limit the coupler 140 from rotating or translating within the receiver 122 during deployment of the gripping device 104. For example, the receiver 122 may include one or more tabs that bend when the coupler 140 is properly positioned within the receiver 122, limiting opposing rotation of the coupler 140 to operably hold the coupler 140 in place within the receiver 122. In some embodiments, the coupler 140 may be magnetically locked within the receiver 122 until sufficient force is exerted on the actuating element 208 to overcome the magnetic attraction.

[0122] In operation, the actuating element 208 may be controlled, e.g., via the actuating assembly 200, to deploy the gripping device 104. For example, the actuating element 208 may be positioned and rotated such that the gripping device 104 is deployed within tissue. After the gripping device 104 is deployed, the actuating element 208 may be rotated, e.g., in a direction opposite to the rotation to lock the coupler 140 within the receiver 122, such that the shape of the coupler 140 matches the shape of the proximal opening of the receiver 122. The actuating element 208 may be retracted proximally to retract the coupler 140 from the receiver 122, thereby disengaging the actuating element 208 and the gripping device 104.

[0123] In the illustrated embodiment, coupler 140 is a generally rectangular block and the proximal opening of receiver 122 is similarly rectangular. However, it will be understood that coupler 140 and the proximal opening of receiver 122 may have any suitable shape and configuration. For example, coupler 140 may be oval, oval, elliptical, triangular, pentagonal, spiral, or any other suitable shape.

[0124] Additionally, the coupling 110 of the gripping device 104 may have additional features to operatively hold the coupler 140 in the receiver 122. The coupling 110 may have a number of cutouts or slots extending proximally from a distal end into the gripping device 104 (e.g., FIGS. 14A-17B), which may receive a portion of the coupler 140. The coupler 140 may be inserted into the receiver 122, and the slots may allow the proximal end of the coupling 110 to flex radially outward. The coupler 140 may be further inserted into the receiver 122 such that a side of the coupler 140 extends at least partially into a receiving area defined by the slots. For example, a radially outer portion of the coupler 140 may extend radially outward from the receiver 122 through the slots. The proximal end of link 110 may then move radially inward to surround the proximal end of the link of coupler 140 and retain coupler 140 in receiver 122 .

[0125] The configuration of the coupling 110, such as the receiving area and the inner diameter of the receiver 122, may hold the coupler 140 within the receiver 122 of the grasper 104 during actuation of the grasper 104. After the grasper 104 is inserted into tissue, the actuation element 208 may be retracted proximally with sufficient force to deflect the proximal end of the coupling 110 radially outward, such as through contact with the coupler 140, causing the coupler 140 to be retracted from the receiver 122. The force required to disengage the grasper 104 from the actuation element 208 may be greater than the force required to withdraw the grasper 104 from the tissue. The actuation element 208 and coupler 140 may be retracted proximally from the grasper 104, such as with the grasper 104 deployed within tissue and locked within the shroud 170.

[0126] Although the coupler 140 has been described as being generally spherical or rectangular for coupling with the receiver 122 of the gripping device 104, it will be understood that the coupler 140 may have other shapes and configurations for operably coupling with the gripping device 104. For example, in some embodiments, the coupler 140 may have one or more protrusions extending radially outward to be secured within the receiver 122 of the gripping device 104, e.g., a receiving area defined by a slot. The coupler 140 may be sized, shaped, and configured to operably mate with the receiver 122 of the gripping device 104 such that the actuation element 208 can control the deployment of the gripping device 104 and disengage the coupler 140 from the gripping device 104 after deployment of the gripping device 104, such as by rotating the coupler 140.

[0127] In some embodiments, the coupler 140 may be a tubular element disposed around the distal end of the actuating element 208 and the coupling portion 110 of the gripping device 104 to operably couple the actuating element 208 with the gripping device 104. In some embodiments, the coupler 140 is a hypotube. As shown in FIGS. 25A-25C, the coupler 140 may be disposed at least partially around the distal end of the actuating element 208 (FIG. 25A). The coupler 140 may be secured to the actuating element 208 via crimping, such as crimping an inner surface of the coupler 140 to the actuating element 208. The coupler 140 may also be crimped or welded to the actuating element 208. In other embodiments, the coupler 140 is a flexible wire, such as a helical wire or coil, such as stainless steel or nitinol wire. The coupling 110 of the gripping device 104 may be inserted into a distal end of the coupler 140, and the coupler 140 may be operably secured to the coupling 110 of the gripping device 104. The distal end of the coupler 140 may be distally connected, such as via a crimp, to a proximal end of the gripping device 104 ( FIG. 25B ) such that the gripping device 104 is coupled to an actuation element 208 via the coupler 140 to manipulate the gripping device 104 to grasp tissue.

[0128] The coupler 140 may operatively disconnect the gripping device 104 from the actuation element 208, such as after the gripping device 104 has been manipulated to grip tissue. The actuation element 208 may be retracted proximally with sufficient force to break or destroy a connection, such as a crimp, between the gripping device 104 and the coupler 140. Once the connection between the gripping device 104 and the coupler 140 has been broken or destroyed, the gripping device 104 may be disconnected from the actuation element 208 and the coupler 140 (FIG. 25C). The coupler 140 may remain coupled to the actuation element 208. For example, the gripping device 104 may be graspably inserted into tissue, and the actuation element 208 may be retracted proximally, such as via the actuation assembly 200, to break the connection between the gripping device 104 and the coupler 140. The force required to release the connection may be greater than the force required to withdraw the gripping device 104 from the tissue. After the connection is broken, the actuating element 208 and coupler 140 may be retracted proximally from the grasper 104, such as with the grasper 104 graspably inserted into tissue. For example, the grasper 104 may be locked in place within the shroud 170, and the connection between the actuating element 208 and the grasper 104 may be broken or otherwise destroyed such that the actuating element 208 is decoupled from the grasper 104, and the grasper 104 remains locked in the retracted position within the shroud 170.

[0129] As shown in FIGS. 26A-26B, the coupler 140 is generally cylindrical and is secured to a distal end of the actuating element 208. In some embodiments, the coupler 140 may be welded to the distal end of the actuating element 208. The coupler 140 includes a distal channel 142 extending proximally from a distal end of the coupler 140. A connecting link 144 extends into the distal channel 142 and is secured within the distal channel 142. A distal end of the connecting link 144 may extend into and be secured within the receiver 122 of the gripping device 104. When secured, the connecting link 144 may operably connect the actuating element 208 to the gripping device 104. In some embodiments, the connecting link 144 is laser welded into the distal channel 142 of the coupler 140 and into the receiver 122 of the gripping device 104.

[0130] The connecting link 144 may be sized, shaped, and configured to transfer the movement and rotation of the actuating element 208 to the gripping device 104 when the connecting link 144 couples the coupler 140 and the gripping device 104. The connecting link 144 may also be sized, shaped, and configured to break when subjected to a desired tensile load, such as a force applied to the connecting link 144 when the gripping device 104 is deployed in tissue and the actuating element 208 is retracted proximally. The force required to break the connecting link 144 may be greater than the force required to pull the gripping device 104 out of the tissue. In some embodiments, the connecting link 144 may have a width or diameter between about 0.003 inches and about 0.020 inches, such as between about 0.006 inches and about 0.010 inches. For example, after the grasper 104 has been manipulated to grasp tissue, the actuation element 208, e.g., via the actuation assembly 200, may be retracted with sufficient force to break the coupling link 144 (FIG. 26B) such that the coupling link 144 no longer couples the coupler 140 and the grasper 104, and the coupler 140 and actuation element 208 may be retracted from the grasper 104. In some embodiments, the coupling link 144 may be constructed from stainless steel or nitinol, or a combination thereof. In some embodiments, the coupling link 144 has a diameter between about 0.001 inches and about 0.006 inches. Additionally, the coupler 140 may include a sheath or coating on the coupling link 144 to reduce torsional loads on the coupling link 144 and prevent the coupling link 144 from prematurely fracturing.

[0131] As shown in FIGS. 27A-27B, coupler 140 may be substantially similar to coupler 140 of FIGS. 26A-26B (discussed above) with a proximal end of connecting link 144 secured within distal channel 142 of coupler 140. Receptacle 122 of gripping device 104 may have a proximal opening narrower than a distal portion of receiver 122. Connecting link 144 may be deformable such that connecting link 144 is inserted into and operably retained in receiver 122 of gripping device 104. For example, connecting link 144 may be bent or otherwise deformed within receiver 122 such that connecting link 144 is inserted into a proximal opening of receiver 122 such that connecting link 144 has a width greater than the proximal opening of receiver 122, thereby preventing connecting link 144 from backing out of receiver 122 during normal operation. The connecting links 144 may be a shape memory material, such as Nitinol, such that the connecting links 144 remain in a deformed state when inserted into the receivers 122 without breaking.

[0132] In operation, the actuating element 208 may be controlled, for example, via the actuation assembly 200, to deploy the gripping device 104. The connecting link 144 may be configured to transfer rotational and translational motion of the actuating element 208 to the gripping device 104. For example, the actuating element 208 may be positioned and rotated such that the gripping device 104 is deployed within tissue. After the gripping device 104 is deployed, the actuating element 208 may be retracted proximally with sufficient force to withdraw the connecting link 144 from the deformed state such that the connecting link 144 may be retracted from the receiver 122. The force required to remove the connecting link 144 from the receiver 122 may be greater than the force required to withdraw the gripping device 104 from the tissue. The actuating element 208 and coupler 140 may then be retracted proximally from the gripping device 104, such as with the gripping device 104 deployed within tissue and locked within the shroud 170.

[0133] In some embodiments, the coupler 140 may be configured to be operably inserted into the receiver 122 of the gripping device 104 and biased into coupling engagement with the gripping device 104 such that the actuating element 208 is operably coupled to the gripping device 104. As shown in FIGS. 28A-28D, the coupler 140 may include two or more prongs 146 extending distally from a remainder of the coupler 140, such as from a proximal portion of the coupler 140 that couples to the actuating element 208 (not shown). The prongs 146 are configured to be inserted into the receiver 122 ( FIG. 10 ) of the gripping device 104 to operably couple the coupler 140 to the gripping device 104. The prongs 146 may be shaped and configured such that in a normal condition they are biased radially outward and may be compressed radially inward to insert the prongs 146 into the receiver 122. In some embodiments, the coupler 140 is constructed from a shape memory material, such as Nitinol, that is laser cut to a desired shape. In some embodiments, the proximal end of the coupler 140 is welded to the distal end of the actuation element 208 .

[0134] The prongs 146 may be compressed together and inserted into the receiver 122 of the gripping device 104. After insertion, the compression force may be released so that the prongs 146 pivot radially outward. A radially outward bias of the prongs 146 may hold the prongs 146 in the receiver 122 to operatively couple the coupler 140 to the gripping device 112. The prongs 146 may be disposed within the receiver 122 of the gripping device 104 such that the position and rotation of the gripping device 104 may be controlled by the actuation element 208 via the coupler 140, for example, via the outward bias of the prongs 146 relative to the receiver 122.

[0135] The prongs 146 may also be operable to decouple the coupler 140 from the gripping device 104, such as after the gripping device 104 is manipulated to grip tissue. For example, the prongs 146 of the coupler 140 may be compressed to retract the prongs 146 from the receiver 122 of the gripping device 104. After the gripping device 104 is manipulated to grip tissue, the actuation element 208 may be retracted proximally with sufficient force to compress the prongs 146 of the coupler 140 against the proximal opening of the receiver 122 such that the prongs 146 may be withdrawn from the receiver 122. The compressed prongs 146 of the coupler 140 may be retracted from the receiver 122 to decouple the coupler 140 and the gripping device 104. The force required to retract the prongs 146 from the receiver 122 may be greater than the force required to withdraw the gripping device 104 from the tissue. After the coupler 140 is decoupled from the grasper 104, the actuation element 208 and coupler 140 may be retracted from the grasper 104, such as with the grasper 104 positioned within tissue and locked within the shroud 170.

[0136] In some embodiments, the coupler 140 includes one or more protrusions 148 extending radially outward from an outer side or edge (top or bottom) of one or more prongs 146. The protrusions 148 are each configured to be received in a detent 150 extending radially outward from an inner surface of the receiver 122 of the gripping device 104. The detents 150 may be recesses, slots, or openings configured to receive the protrusions 148 of the prongs 146. In the illustrated embodiment, the detents 150 extend through the body of the gripping device 104. When the prongs 146 are inserted into the receiver 122 of the gripping device 104, the protrusions 148 may be biased radially outward into the detents 150 of the receiver 122 to further lock the prongs 146 in place in the receiver 122. The projection 148 may be configured to prevent the prong 146 from translating or rotating out of its coupled position with the gripping device 104 when the projection 148 is disposed within the detent 150. For example, the detent 150 may have a shape or cross-section substantially similar to that of the projection 148 such that the projection 148 is prevented from translating or rotating within the detent 150 when the projection 148 is disposed within the detent 150. To disengage the coupler 140 from the gripping device 104, the actuation element 208 may be retracted proximally with sufficient force to compress the prong 146 such that the projection 148 is retracted from the detent 150 and the prong 146 may be withdrawn from the receiver 122.

[0137] As shown in FIGS. 29A-29B, the coupler 140 of FIGS. 28A-28D may include one or more guide arms 152 configured to further secure the coupler 140 to the receiver 122 of the gripping device 104. The guide arms 152 may be disposed to the sides of the prongs 146 and may operate similarly to the prongs 146. For example, the guide arms 152 may be configured to be biased radially outward to further couple the coupler 140 within the receiver 122 and / or to contact an inner surface of the receiver 122, e.g., perpendicular to the prongs 146. The guide arms 152 may be inserted into the receiver 122 and abut against an inner surface of the receiver 122 to hold the coupler 140 in the receiver 122. The guide arms 152 ensure a better coupling between the coupler 140 and the gripping device 104. The guide arm 152 may remain coupled to the gripping device 104 when the gripping device 104 and / or coupler 140 are subjected to a load or external force. For example, the guide arm 152 may prevent the connection between the coupler 140 and the gripping device 104 from snapping or breaking during operation. The guide arm 152 may also increase the stability of the connection between the gripping device 104 and the actuating element 208. The guide arm 152 may be retracted from the receiver 122 similar to the prong 146. For example, the guide arm 152 may be similarly compressed via proximal movement of the actuating element 208 to retract the coupler 140 from the receiver 122. In some embodiments, the guide arm 152 may also include a protrusion 148 that engages a detent 150 of the gripping device 104.

[0138] In some embodiments, the coupler 140 of FIGS. 28A-28D or the coupler 140 of FIGS. 29A-29B may include a flange 154 configured to guide the gripping device 104 during coupling and operation and prevent the gripping device 104 from sliding proximally past the coupler 140. The flange 154 may extend distally and radially outward from the remainder of the coupler 140. The flange 154 may be operable to abut a proximal end of the gripping device 104 to prevent the coupler 140 from extending further into the receiver 122 so as to prevent the coupler 140 from moving to a position where the protrusion 148 cannot move from the detent 150. The flange 154 may also stabilize the coupler 140 during operation, such as by preventing wobble in the connection between the gripping device 104 and the actuation element 208 and maintaining the gripping device 104 concentric with the actuation element 208. The flange 154 may also be configured to compress the prongs 146 and / or guide arms 152 so that the coupler 140 may be decoupled from the gripping device 104, as described below. The proximal and distal ends of the flange 154 may be rounded or tapered so that the flange 154 facilitates coupling and decoupling of the coupler 140 and the gripping device 104.

[0139] Although coupler 140 has been described as operably coupling actuating element 208 to gripping device 104 having helical coil 114, it will be understood that any of the couplers 140 or coupling methods described herein may be used with any of the gripping devices 104 described herein. For example, the couplers 140 and coupling methods described above may be used to operably couple actuating element 208 to gripping device 104 having movable jaw 113 of FIG.

[0140] In some embodiments, the shroud 170 may be operably coupled to the distal end of the catheter 302 such that the shroud 170 may be decoupled from the catheter 302. For example, the shroud 170 may be operably coupled to the distal end of the catheter 302 such that the shroud 170 may be decoupled from the catheter 302 and the catheter-sheath assembly 300 and the working element 208 may be retracted from the body, such as to hold the grasping device 104 in a position to close a defect after the grasping device 104 has been manipulated to grasp tissue and captured in the tissue capture region 172 of the shroud 170.

[0141] 30-34B, the tissue capture assembly 102 may include a connector 180 configured to operably couple the shroud 170 with the catheter 302. The connector 180 may couple the shroud 170 to the catheter 302 while the gripping devices 104 are manipulated to grip tissue and then retracted toward or into the tissue capture region 172. The connector 180 may also decouple the shroud 170 from the catheter 302 after the gripping devices 104 are captured toward or into the tissue capture region 172 such that the gripping devices 104 remain retracted within the shroud 170 to maintain closure of the defect.

[0142] As shown in FIGS. 30A-30B, the connector 180 includes one or more connecting protrusions 182 operable to couple the connector 180 to the shroud 170. The connecting protrusions 182 extend distally from the remainder of the connector 180 and are operably received in corresponding connecting slots 178 of the shroud 170 to couple the shroud 170 to the connector 180. The shroud 170 may translate and rotate with the catheter 302 when the connecting protrusions 182 are coupled to the connecting slots 178. In some embodiments, each connecting protrusion 182 includes a lateral flange 184 extending laterally from a distal end of the connecting protrusion 182 to retain the connecting protrusion 182 within the corresponding connecting slot 178 during operation. The proximal end of the connector 180 may be secured to a distal end (not shown) of the catheter 302. In some embodiments, the connector 180 is welded to the distal end of the catheter 302.

[0143] The connecting projections 182 may be disengaged from the connecting slots 178 to disengage the shroud 170 from the connector 180, such as after the grasping device 104 is manipulated to capture tissue toward or into the tissue capture region 172 of the shroud 170 and the grasping device 104 is locked within the shroud 170. The connecting projections 182 may be deflected radially outward from the connecting slots 178, for example, by deflecting the connecting projections 182 such that the lateral flanges 184 deflect radially outward from the connecting slots 178. For example, the connecting projections 182 may be deflected radially outward via sufficient proximal retraction of the actuating element 208, as described below. After the connecting projections 182 are deflected out of the connecting slots 178, the connector 180, the actuating element 208, and the catheter 302 may be retracted from the shroud 170 and the grasping device 104, for example, with the grasping device 104 capturing tissue to close the defect. Additionally, the tissue capture assembly 102 may include release and lock sliders disposed within the shroud 170 and connector 180 configured to decouple the grasper 104 from the actuation element 208 and to decouple the connector 180 from the shroud 170, as described below.

[0144] 31A-34B and 32A-34B, the connector 180 may include a proximal connector portion 181 and a distal connector portion 183. A proximal end of the proximal connector portion 181 may be secured to a distal end of the catheter 302. The proximal connector portion 181 may be coupled to the distal end of the catheter 302 via adhesive, welding, fasteners, or the like. In an exemplary embodiment, the proximal connector portion 181 is welded to the catheter 302. A distal end of the distal connector portion 183 is coupled to the shroud 170. For example, the distal end of the distal connector portion 183 may be coupled to an outer surface of the shroud 170 such that the gripping device 104 may be extended from and retracted into the shroud 170. The distal connector portion 183 may be coupled to the shroud 170 via adhesive, heat bonding, welding, fasteners, or the like. In the exemplary embodiment, distal connector portion 183 is heat bonded to shroud 170. Proximal connector portion 181 may be operably coupled to distal connector portion 183 to operably couple shroud 170 to catheter 302. The distal end of proximal connector portion 181 has a shape or configuration that allows it to be coupled to and decoupled from the proximal end of distal connector portion 183.

[0145] As shown in Figures 32A-32F, the proximal connector portion 181 and the distal connector portion 183 each include a connecting portion 186 having one or more connecting projections 182 and defining one or more receiving areas 188. The connecting portion 186 of the proximal connector portion 181 defines a distal end of the proximal connector portion 181 with the connecting projections 182 extending distally from the remainder of the proximal connector portion 181 and the receiving areas 188 plugged proximally beyond a portion of the connecting projections 182. The connecting portion 186 of the distal connector portion 183 defines a proximal end of the distal connector portion 183 with the connecting projections 182 extending proximally from the remainder of the distal connector portion 183 and the receiving areas 188 plugged distally beyond a portion of the connecting projections 182. The connecting projections 182 of the proximal connector portion 181 are configured to be received in receiving areas 188 of the distal connector portion 183, and the connecting projections 182 of the distal connector portion 183 are configured to be received in receiving areas 188 of the proximal connector portion 181. When the connecting projections of the proximal and distal connector portions 181, 183 are received in the receiving areas 188 of the other connector portion 181, 183, the proximal connector portion 181 may mate with the distal connector portion 183 such that the connector portions 181, 183 may rotate and translate together. The shroud 170 is operably coupled to the catheter 302 when the proximal connector portion 181 mates with the distal connector portion 183.

[0146] In some embodiments, the connecting protrusions 182 of the connector portions 181, 183 each include a lateral flange 184 extending laterally from a side of the connecting protrusion 182. The lateral flange 184 of the proximal connector portion 181 may extend laterally at a distal end of the connecting protrusion 182. The lateral flange 184 of the distal connector portion 183 may extend laterally at a proximal end of the connecting protrusion 182. The lateral flange 184 of the proximal connector portion 181 may interlockingly hook around the lateral flange 184 of the distal connector portion 183 to further secure the coupling of the proximal and distal connector portions 181, 183.

[0147] The lateral flanges 184 of the proximal connector portion 181 may be disposed distally rearward of the lateral flanges 184 of the distal connector portion 183 when the connecting projections 182 of the proximal connector portion 181 are disposed in the receiving area 188 of the distal connector portion 183. The lateral flanges 184 of the distal connector portion 183 may be disposed proximally rearward of the lateral flanges 184 of the proximal connector portion 181 when the connecting projections 182 of the distal connector portion 183 are disposed in the receiving area 188 of the proximal connector portion 181. The overlap of the lateral flanges 184 may further secure the connection between the proximal and distal connector portions 181, 183. In some embodiments, the lateral flanges 184 are arcuate such that when the proximal connector portion 181 is coupled with the distal connector portion 183, the proximal and distal connector portions 181, 183 are generally cylindrical.

[0148] The proximal connector portion 181 may be decoupled from the distal connector portion 183, e.g., to decouple the connection 186 of the proximal and distal connector portions 181, 183, to decouple the shroud 170 from the catheter 302. The connection protrusion 182 of the proximal connector portion 181 may be moved from the receiving area 188 of the distal connector portion 183, and / or the connection protrusion 182 of the distal connector portion 183 may be moved from the receiving area 188 of the proximal connector portion 181, e.g., via the actuation assembly 200, such that the proximal connector portion 181 is decoupled from the distal connector portion 183. Additionally or alternatively, the proximal connector portion 181 may be decoupled from the distal connector portion 183 by removing a component disposed within the proximal and distal connector portions 183 between the connection 186 of the proximal and distal connector portions 181, 183, as described below. In some embodiments, the proximal connector portion 181 and / or the distal connector portion 183 are configured to be decoupled via proximal retraction of one or more actuating elements 208, as described below. Once the proximal connector portion 181 is decoupled from the distal connector portion 183, the catheter 302, actuating elements 208, and proximal connector portion 181 may be withdrawn from the shroud 170 and the grasping device 104, e.g., with the grasping device 104 engaging tissue to close the defect.

[0149] In some embodiments, the proximal connector portion 181 is sized, shaped, and configured to further secure the proximal connector portion 181 to the distal end of the catheter 302. In some embodiments, the proximal end of the proximal connector portion 181 is coupled to the distal end of the catheter 302 by mating the proximal end of the proximal connector portion 181 with a polymeric dual lumen extrusion and flowing a molten polymer, such as a thermoplastic material, around the connection between the proximal connector portion 181 and the catheter 302.

[0150] In some embodiments, as shown in FIGS. 33A-33B, the proximal portion of the proximal connector portion 181 includes a coil 189 configured to further secure the proximal connector portion 181 to the catheter 302. The coil 189 extends proximally from the remainder of the proximal connector portion 181 (e.g., opposite the connection portion 186) in a generally helical or spiral manner. The coil 189 may provide strain relief at the connection between the catheter 302 and the proximal connector portion 181 to allow for slight bending of the connection between the catheter 302 and the proximal connector portion 181. The coil 189 may be laser cut to form a helix or corkscrew. The proximal connector portion 181 may be connected to the distal end of the catheter 302 with a molten polymer applied to the catheter 302. For example, the polymer may be applied to the proximal connector portion 181 and / or the catheter 302, melting the polymer into the gaps between the coils 189. In some embodiments, the proximal connector portion 181 includes one or more struts extending longitudinally to connect adjacent portions of the coil 189 in the gaps between the coils 189. The struts between the helices of the coil 189 may space the helices of the coil 189 so as to minimize or reduce the spring or biasing effect of the coil 189.

[0151] Alternatively, a helical spring may be placed around the distal portion of the catheter 302 and the proximal end of the proximal connector portion 181 may be secured to the spring, such as by welding. The spring may be fitted under a polymer applied to the catheter 302.

[0152] Additionally or alternatively, the proximal end of the proximal connector portion 181 may include other features or configurations to further secure the proximal connector portion 181 to the distal end of the catheter 302. As shown in FIGS. 34A-B, the proximal end of the proximal connector portion 181 may include one or more flared tabs 185 disposed about the periphery of the proximal connector portion 181. When a polymer is applied to the proximal connector portion 181 and / or the catheter 302, the polymer may melt into the gaps between and around the flared tabs 185 to further secure the proximal connector portion 181 to the catheter 302. The proximal end of the proximal connector portion 181 may also include a plurality of openings disposed about the periphery of the proximal connector portion 181 to similarly strengthen the connection between the proximal connector portion 181 and the catheter 302.

[0153] Although the proximal connector portion 181 has been described as being coupled to the catheter 302 via a polymer, it will be understood that the proximal connector portion 181 may be coupled to the catheter 302 in other ways. For example, in some embodiments, the proximal connector portion 181 may be welded to the distal end of the catheter 302. Additionally, features of the proximal connector portion 181 may be incorporated into the distal end of the catheter 302 and / or features of the distal connector portion 183 may be incorporated into the proximal end of the shroud 170.

[0154] The tissue capture assembly 102 may include one or more components configured to operably control the connection of the proximal and distal connector portions 181, 183 and / or to operably control the connection of the grasper 104 and the actuation element 208. For example, Figures 31B-31C show the tissue capture assembly 102 with the proximal and distal connector portions 181, 183 removed.

[0155] As shown in FIGS. 31B-31C and 35-37B, the tissue capture assembly 102 may include a release slider 190 slidably disposed along the actuation element 208 and a release member 192 circumferentially disposed along the actuation element 208 distally from the release slider 190. The release slider 190 may be disposed along the actuation element 208 proximally relative to the release member 192. The release slider 190 may be operable to maintain the coupling of the proximal and distal connector portions 181, 183 and operably decouple the proximal and distal connector portions 181, 183, such as after the gripping device 104 has grasped tissue and been retracted to the locked position. The release member 192 may be operable to decouple the gripping device 104 from the actuation element 208, such as, for example, decoupling the gripping device 104 from the coupler 140. The release member 192 may also be operable to maintain the position and rotation of the gripping device 104 in the locked position. The release slider 190 and release member 192 may be constructed from a polymer, PEEK, ABS, ceramic, polymer, metal, or other plastic or metal operable to withstand operating forces, or any combination thereof.

[0156] The position of release member 192 may be fixed relative to shroud 170 and / or distal connector portion 183. A distal end of release member 192 may be fixed to a proximal end of shroud 170 and / or an inner surface of distal connector portion 183 (FIGS. 37A-37B). For example, release member 192 may be welded to an inner surface of distal connector portion 183 (which couples with shroud 170) such that release member 192 is disposed at the proximal end of shroud 170.

[0157] The release slider 190 may slide relatively freely on the actuating element 208 such that the actuating element 208 may be extended through the release member 192 and such that the actuating element 208 may rotate and translate through the release member 192. During a tissue capture operation, the release slider 190 may be positioned along the actuating element 208 and within the proximal and distal connector portions 181, 183 such that the release slider 190 maintains a connection between the proximal and distal connector portions 181, 183. The release slider 190 is also slidable within the proximal and distal connector portions 181, 183 such that the release slider 190 no longer maintains a connection between the proximal and distal connector portions 181, 183, thereby decoupling the proximal connector portion 181 from the distal connector portion 183.

[0158] The release slider 190 and the release member 192 may both be generally cylindrical. The release slider 190 may include two actuation passages 194 extending therethrough, each configured to receive an actuation element 208 therein. The release member 192 may include two release passages 196 extending therethrough, each configured to receive an actuation element 208 therein. The actuation passages 194 of the release slider 190 may be sized, shaped, and configured to allow the actuation element 208 to translate and rotate when disposed therein. The actuation passages 194 of the release slider 190 may also be sized, shaped, and configured to prevent the coupler 140 from extending therethrough. The actuation passage 194 may have a diameter or cross-section that allows the actuation element 208 to translate and rotate therethrough, but prevents the coupler 140 from extending proximally therethrough, e.g., having a diameter greater than the diameter of the actuation element 208 and less than the diameter of the coupler 140. For example, the actuation passage 194 of the release slider 190 may be sized, shaped, and configured to lockably receive a proximal portion of the coupler 140 therein, but prevent a distal end of the coupler 140, e.g., the prongs 146 of the coupler 140, from being inserted therein. Additionally or alternatively, the actuation passage 194 may be undersized such that the coupler 140 bends or flexes to fit an inner diameter of the actuation passage 194 to secure at least a portion of the coupler 140 within the actuation passage 194.

[0159] The release passage 196 of the release member 192 may be sized, shaped, and configured to operatively decouple the gripping device 104 from the coupler 140. The release passage 196 may be sized, shaped, and configured to allow the coupler 140 to pass therethrough, but prevent the gripping device 104 from extending therethrough. For example, the release passage 196 may have a diameter or cross-section that is larger than the diameter of the coupler 140 and smaller than the diameter of the gripping device 104, e.g., a diameter smaller than the diameter of the coupling portion 110 of the gripping device 104.

[0160] The release slider 190 and the release member 192 may be disposed about the actuation element 208 and within the proximal and / or distal connector portions 181, 183. The actuation element 208 may rotate and translate via the release slider 190 and the release member 192 to manipulate the grasper 104 during a tissue grasping operation. The release slider 190 and the release member 192 may have an outer surface that is slightly smaller than the inner diameter of the proximal and distal connector portions 181, 183. The outer surface of the release slider 190 may be sized such that the release slider 190 may slide within the inner surfaces of the proximal and distal connector portions 181, 183. The outer surface of the release member 192 may be sized such that the release member 192 may be secured within the distal connector portion 183, such as by welding.

[0161] During a tissue grasping operation, the release slider 190 may be disposed in an operating position within the connector 180 such that the release slider 190 retains or prevents separation of the proximal and distal connector portions 181, 183. The release slider 190 may be disposed within the proximal and distal connector portions 181, 183 such that an outer surface of the release slider 190 abuts an inner surface of the proximal and distal connector portions 181, 183. An outer surface of the release member 192 may abut an inner surface of the connecting portion 186 of the proximal and distal connector portions 181, 183 to prevent separation of the proximal and distal connector portions 181, 183. For example, the outer surface of the release slider 190 may simultaneously abut against the connection portion 186 of the connector 180 to prevent the connection projection 182 of the proximal connector portion 181 from disengaging from the receiving area 188 of the distal connector portion 183 and to prevent the connection projection 182 of the distal connector portion 183 from disengaging from the receiving area 188 of the proximal connector portion 181.

[0162] Also, the release slider 190 may be slidable within the proximal and distal connector portions 181, 183 such that the release slider 190 may be moved from the operating position. The release slider 190 may be retracted proximally from the operating position, such as by proximal retraction of the actuation element 208, such that the release slider 190 no longer maintains a connection between the proximal and distal connector portions 181, 183. Once the release slider 190 is moved from the operating position, the proximal connector portion 181 may be decoupled from the distal connector portion 183.

[0163] In some embodiments, the proximal connector portion 181 includes a retention tab 187 configured to operably retain the release slider 190 in an operative position to maintain a connection between the shroud 170 and the catheter 302, e.g., to maintain a connection between the proximal and distal connector portions 181, 183. The retention tab 187 may be bent or deflected radially inward to abut a proximal end of the release slider 190 when the release slider 190 is in the operative position. The abutment between the retention tab 187 and the release slider 190 may prevent the release member 192 from retracting proximally during a tissue grasping operation. The retention tab 187 may bend or deflect radially outward when the release slider 190 is retracted proximally with sufficient force, e.g., via the actuation element 208, thereby allowing the release slider 190 to be retracted proximally.

[0164] The release member 192 is operable, e.g., via the actuation assembly 200, to disengage the gripping device 104 from the actuation element 208, e.g., to disengage the gripping device 104 from the coupler 140, once the actuation element 208 and the gripping device 104 have been retracted a sufficient distance. As shown in FIG. 38A, the actuation element 208 and the gripping device 104 may be retracted proximally to a locked position. The shroud 170, e.g., a proximal portion of the shroud 170, may be narrow such that the shroud 170 is operable to hold the position of the gripping device 104 in a fully retracted position, such as by applying a compression fit, an interference fit, and / or a frictional force with the gripping device 104, such as the coupling portion 110 of the gripping device 104. The translational and rotational positions of the gripping device 104 may be maintained such that the gripping device 104 maintains its grip on the target tissue when the gripping device 104 is locked within the shroud 170.

[0165] The gripping apparatus 104 may be retracted into the shroud 170, such as when the gripping apparatus 104 is retracted to the locked position, with the coupler 140 extending at least partially through the release passage 196 of the release member 192. The gripping apparatus 104 may be held in the locked position such that the gripping portion 112 of the gripping apparatus 104 is distal to the release member 192. In some embodiments, the coupling portion 110 of the gripping apparatus 104 is distal to the release member 192 when the gripping apparatus 104 is in the locked position. In other embodiments, the coupling portion 110 of the gripping apparatus 104 extends at least partially into the release passage 196 of the release member 192 when the gripping apparatus 104 is in the locked position such that the release member 192 is operable to further hold the gripping apparatus 104 in the locked position. The release passage 196 may be sized, shaped, and configured to retain the position of the gripping device 104 when the coupling 110 is at least partially disposed within the release passage 196. For example, the release passage 196 may be constructed from a polymer to conform to the coupling 110 of the gripping device 104 and retain the gripping device 104 in the locked position.

[0166] 38B, the coupler 140 may be disengaged from the gripping device 104 such that the gripping device 104 is disengaged from the actuation element 208, such as after the gripping device 104 is retracted to the locked position. The actuation element 208 may be retracted proximally, e.g., via the actuation assembly 200, and retract proximally through the release passage 196 of the release member 192. The proximal retraction of the actuation element 208 may pull the coupler 140 proximally through the release passage 196 of the release member 192. The release member 192, e.g., the release passage 196, may be sized, shaped, and configured to prevent the gripping device 104 from retracting through the release passage 196 along with the actuation element 208 and the coupler 140. For example, a distal end of the release member 192 may abut a portion of the gripping device 104 to prevent the gripping device 104 from retracting proximally through the release passage 196.

[0167] The actuating element 208 may be retracted proximally farther such that the coupler 140 is retracted proximally through the release passage 196 and disengaged from the gripping device 104 which is prevented from retracting proximally via abutment with the release member 192. The actuating element 208 may be retracted proximally with sufficient force to pull or disengage the coupler 140 from the receiver 122 of the gripping device 104. For example, the actuating element 208 may be retracted with sufficient force to proximally retract the prongs 146 of the coupler 140 from the receiver 122 of the gripping device 104, as described above.

[0168] After the coupler 140 is decoupled from the gripping device 104, the actuation element 208, release slider 190, and coupler 140 may be retracted from the gripping device 104 and release member 192 (and shroud 170), such as after the gripping device 104 has grasped tissue and is captured toward or within the tissue capture region 172 of the shroud 170, e.g., in a locked position. The force required to decouple the gripping device 104 from the actuation element 208 via the release member 192 may be greater than the force required to pull the gripping device 104 from the tissue. In some embodiments, the force required to lock the gripping device 104 into the shroud 170 is between about 4 and about 5 pounds, and the force required to decouple the gripping device 104 from the actuation element 208 is between about 3 and about 6 pounds. The force required to lock each of the gripping devices 104 may be less than the force required to decouple the shroud 170 from the catheter 302. For example, the force required to lock the gripping devices 104 may be distributed evenly among the gripping devices 104 such that each gripping device receives between about 2.0 and about 2.5 pounds of force.

[0169] The release slider 190 may be configured to decouple the shroud 170 from the catheter 302 via further proximal retraction of the actuating element 208, such as after the gripping device 104 has grasped tissue into the tissue capture region 172 of the shroud 170, locked in place, and decoupled from the actuating element 208. The actuating element 208 may be further retracted proximally such that a distal end of the actuating element 208 and / or the coupler 140 abuts a distal face of the release slider 190, preventing the distal end of the actuating element 208 and / or the coupler 140 from extending through the actuating passage 194. For example, the actuating element 208 may be retracted such that a prong 146 of the coupler 140 abuts a distal face of the release slider 190, preventing the prong 146 from extending through the actuating passage 194. Additionally or alternatively, at least a portion of the coupler 140 may bend or flex within the actuation path 194 to secure the coupler 140 in a portion of the actuation path 194 such that the position of the coupler 140 is fixed relative to the release slider 190 .

[0170] The actuating element 208 may then be retracted with sufficient proximal force to retract the release slider 190 proximally from the operating position due to abutment between the actuating element 208 and / or coupler 140 and the release member 192. The actuating element 208 may be retracted with sufficient force to deflect the retention tabs 187 radially outward such that the release slider 190 is retracted proximally with the actuating element 208. The release slider 190 may then be retracted proximally relative to the proximal and distal connector portions 181, 183. Once the release slider 190 is retracted proximally from the operating position, the release slider 190 may no longer maintain coupling between the proximal and distal connector portions 181, 183 such that the proximal and distal connector portions 181, 183 may be decoupled to disconnect the shroud 170 from the catheter 302. For example, the release slider 190 may be retracted proximally from beneath the connection 186 of the proximal and distal connector portions 181, 183 such that the connection between the proximal and distal connector portions 181, 183 is broken or destroyed. Additionally or alternatively, the catheter 302 may be manipulated to withdraw the connection protrusions 182 of the proximal connector portion 181 from the receiving area 188 of the distal connector portion 183 to decouple the shroud 170 from the catheter 302. After the shroud 170 has been decoupled from the catheter 302, the tissue capture assembly 102 may be deployed within the body, such as with the tissue grasping device 104 in the locked position and capturing tissue in the tissue capture area 172 of the shroud 170, and the actuating element 208 (and coupler 140), the proximal connector portion 181, the catheter 302, and the release slider 190 may be withdrawn from the body.

[0171] Although the release slider 190 has been described as releasably maintaining the connection between the proximal and distal connector portions 181, 183, it will be appreciated that the release slider 190 may be similarly operable in other configurations and assemblies of the tissue capture device 100. For example, the features of the connection 186 of the distal connector portion 182 may be incorporated into the proximal end of the shroud 170 and the features of the connection 186 of the proximal connector portion 181 may be incorporated into the distal end of the catheter 302. The release slider 190 may be positioned below the connection of the catheter 302 and the shroud 170 during operation to maintain the connection between the catheter 302 and the shroud 170, and the release slider 190 may be retracted proximally after the tissue capture operation to decouple the catheter 302 from the shroud 170.

[0172] As shown in FIGS. 31A-32F and 36-38B, the release member 192 may include a protrusion 198 extending radially outward from an outer surface of the release member 192. The protrusion 198 may be disposed near a proximal end of the release member 192. The protrusion 198 may extend radially outward and enter into a slot 191 in the distal connector portion 183 during operation (FIG. 31A). The protrusion 198 and / or the slot 191 may be sized, shaped, and configured to substantially prevent the protrusion 198 from rotating out of the slot 191. During operation, the protrusion 198 may be disposed within the slot 191 to maintain the position and / or orientation of the release member 192 to maintain the position and / or orientation of the release passage 196 relative to the shroud 170 and the distal connector portion 183. The release passage 196 may be oriented via the protrusion 198 to facilitate control of the actuation element 208 during a tissue grasping operation. In some embodiments, the protrusion 198 is secured within the slot 191 , such as via welding, to secure the release member 192 to the distal connector portion 183 .

[0173] 28A-28D, it will be appreciated that the release slider 190 and release member 192 may be operable in other manners to decouple the gripping device 104 from the actuation element 208 and to decouple the proximal and distal connector portions 181, 183. For example, the release slider 190 and release member 192 may be used with the connection between the gripping device 104 and the actuation element 208 described in FIGS. 22A-22B and the coupler 140 described in FIGS. 23A-27B, the coupler 140 of FIGS. 29A-29B, or any of the other couplers 140 described herein.

[0174] 39A-39H, two or more gripping devices 104 may be secured in tissue, such as on multiple sides of a defect, and brought together and secured in a locked position to close the defect. The gripping devices 104, shroud 170, and distal connector portion 183 may then be disconnected from the remainder of the tissue capture device 100 to maintain closure of the defect in the tissue capture region 172 of the shroud 170 via the gripping devices 104 and without the need for hemostatic clips. FIGS. 39B, 39D, 39F, and 39H show the tissue capture assembly 102 without the proximal and distal connector portions 181, 183, and FIGS. 39F and 39H show the tissue capture assembly 102 without the shroud 170 either.

[0175] As shown in FIGS. 39A-39B, the tissue capture assembly 102 may be extended, such as through an endoscope, through a catheter 302 to a desired location, such as above a defect. A proximal connector portion 181 may be connected to a distal end of the catheter 302, and a distal connector portion 183 may be coupled to the proximal connector portion 181 via a connecting portion 186. The distal connector portion 183 may be coupled to the shroud 170. A release slider 190 may be disposed within the proximal and distal connector portions 181, 183 in an operative position to maintain the connection of the connecting portion 186 of the proximal and distal connector portions 181, 183. For example, a retention tab 187 may be bent or deflected radially inward to maintain the release slider 190 in an operative position. A release member 192 may be disposed within the distal connector portion 183, such as at the proximal end of the shroud 170. The gripping devices 104 may be disposed partially or entirely within the shroud 170. An actuating element 208 may extend through the catheter 302, the release slider 190, and the release member 192 into the shroud 170 and couple with each of the gripping devices 104. Each actuating element 208 may be coupled to one of the gripping devices 104 via a coupler 140 (FIGS. 39C-39F). In the illustrated embodiment, the catheter 302 is a spring sheath constructed of coiled metal. However, it will be understood that the catheter 302 may have other configurations.

[0176] As shown in Figures 39C and 39D, the actuating element 208 can be extended through the catheter 302 to manipulate the grasping device 104 to grasp tissue. The actuating element 208 can be translated and rotated, for example, via the actuation assembly 200, such that the grasping device spirals through the tissue to insert the helical coil 114 into the tissue for grasping. The grasping device 104 can be independently actuated such that the grasping device 104 grasps tissue on the opposite side of the defect. The shroud 170 remains coupled to the catheter 302 via the proximal and distal connector portions 181, 183 of the connector 180, and the grasping device 104 remains coupled to the actuating element 208 via the coupler 140.

[0177] As shown in FIGS. 39E and 39F , the actuation element 208, e.g., via the actuation assembly 200, may be retracted proximally to move the gripping device 104 into a locked position within the shroud 170 and / or with the release member 192. For example, the gripping device 104 may be retracted proximally after gripping tissue on an opposite side of the defect such that the gripped tissue is captured toward or within the tissue capture region 172 of the shroud 170 to substantially close the defect. The actuation element 208 may be retracted to retract the gripping device 104 into a locked position within the shroud 170 and / or release member 192. The actuation element 208 may be retracted such that the coupler 140 extends at least partially through the release passage 196 of the release member 192. In some embodiments, the actuation element 208 may be retracted such that the coupler 140 extends partially into the actuation passage 194 of the release slider 190. In other embodiments, the actuation element 208 may be retracted such that the proximal end of the coupler 140 abuts the distal face of the release slider 190 .

[0178] The gripping device 104 may be disposed distal to the release member 192, such as with the gripping portion 112 disposed distal to the release member 192 to capture tissue, and remains in a locked position relative to the shroud 170 and distal connector portion 183. The shroud 170 remains operatively coupled to the catheter 302 via the proximal and distal connector portions 181, 183 of the connector 180, and the gripping device 104 remains operatively coupled to the actuation element 208 via the coupler 140 when the gripping device 104 is moved in the locked position.

[0179] As shown in FIGS. 39G and 39H, the actuation element 208 may be decoupled from the gripping device 104 and the catheter 302 may be decoupled from the shroud 170. The actuation element 208 may be retracted proximally such that the coupler 140 is pulled proximally through the release passage 196 of the release member 192 while the gripping device 104 remains distal to the release member 192. The release passage 196 may be sized, shaped, and configured to prevent the gripping device 104 from passing through the release passage 196, thereby allowing the coupler 140 to be released from the coupling 110 of the gripping device 104 and retracted proximally as the actuation element 208 is retracted proximally. Proximal retraction of the coupler 140 relative to the gripping device 104 may decouple the actuation element 208 from the gripping device 104. The coupler 140 may remain coupled to the distal end of the actuation element 208.

[0180] The actuating element 208 may also be retracted proximally to decouple the shroud 170 from the catheter 302. After or while the coupler 140 is retracted through the release passage 196 of the release member 192, a distal end of the actuating element 208 and / or a portion of the coupler 140 may abut or engage the release slider 190 such that the release slider 190 is retracted proximally with the actuating element 208. For example, the prongs 146 of the coupler 140 may abut a distal face of the release slider 190 such that the release slider 190 may be retracted proximally with the actuating element 208. The actuating element 208 may be retracted proximally such that the release slider 190 is retracted proximally from an operating position that maintains the connection between the proximal and distal connector portions 181, 183. For example, the actuation element 208 may be retracted proximally with sufficient force to deflect or bend the retention tabs 187 radially outward such that the release slider 190 is retracted proximally from the operating position. The release slider 190 may be retracted proximally into the proximal connector portion 181 such that the release slider 190 no longer supports the connection 186 of the proximal and distal connector portions 181, 183. The proximal retraction of the release slider 190 may allow the proximal connector portion 181 to be decoupled from the distal connector portion 183.

[0181] The gripping device 104, along with the gripped tissue, may remain retracted within the shroud 170. The gripping device 104 may remain locked in the retracted position by the shroud 170 and / or the release member 192. For example, the gripping device 104 may be locked in the retracted position via a friction / compression fit, locking tabs, and / or locking features in the proximal end of the shroud 170 and / or the proximal end of the release member 192 that cooperate with the gripping device 104 to maintain the translational and rotational positions of the gripping device 104.

[0182] Retraction of the gripping device 104 into the tissue capture region 172 of the shroud 170 may maintain substantial closure of the defect such that a hemostatic clip is not required to close the defect. The gripping device 104, shroud 170, distal connector portion 183, and release member 192 may be decoupled from the actuating element 208, coupler 140, release slider 190, and catheter 302. The gripping device 104 and shroud 170 may remain deployed within the tissue to maintain closure of the defect. After the actuating element 208, coupler 140, release slider 190, proximal connector portion 181, and catheter 302 are decoupled from the gripping device 104, shroud 170, distal connector portion 183, and release member 192, the actuating element 208, coupler 140, release slider 190, proximal connector portion 181, and catheter 302 may be withdrawn from the body. The grasper 104, shroud 170, distal connector portion 183, and release member 192 may remain deployed within the body to maintain tissue closure.

[0183] 40 illustrates an exemplary methodology 400 relating to deploying a grasper to close a defect. Although the methodology is illustrated as a series of acts performed in sequence, it should be understood and appreciated that the methodology is not limited by the order. For example, an act may be performed simultaneously with another act. Furthermore, in some cases, not all acts may be required to implement a methodology described herein.

[0184] At step 402, a grasping device is positioned over the identified defect. The grasping device may be incorporated into a tissue capturing assembly of a tissue capturing device. The grasping device may be coupled to an actuation assembly via an actuation element such that a user may control the position and rotation of the grasping device. As described above, the grasping device may include a helical coil configured to spiral through tissue to grasp the target tissue. The grasping device may be extended through a catheter that is inserted through an endoscope to a desired location.

[0185] In step 404, a first side of the defect is grasped with one of the graspers. The first grasper can be controlled via a first actuation element, e.g., via an actuation assembly, to translate and rotate such that the first grasper penetrates and grasps tissue on the first side of the defect.

[0186] In step 406, a second side of the defect is grasped with another grasping device. The grasping device may be positioned over the second side of the defect by manipulating the endoscope and / or catheter. The second grasping device may be independently controlled via a second actuating element, e.g., via an actuating assembly, to translate and rotate such that the second grasping device penetrates and grasps tissue on the second side of the defect. The first grasping device may continue to grasp tissue on the first side of the defect while the second grasping device is manipulated.

[0187] In steps 404 and 406, as the tissue is grasped, it may be pulled toward the distal end of the catheter. For example, the catheter may be retracted as the tissue is grasped. Pulling the tissue toward the catheter may pull the tissue away from adjacent organs (e.g., organs on the outer wall of the grasped tissue) to prevent the grasping device from contacting the organ.

[0188] Additionally, while a first gripping device has been described as gripping tissue at a first location and a second tissue has been described as gripping tissue at a second location, it will be understood that the first and second gripping devices may be used at the same location. For example, the first gripping device may initially grip tissue to pull it away from the organ toward the catheter, and the second gripping device may be operated to securely grip the tissue pulled by the first gripping device. The second gripping device may then be used to apply tension to the tissue, such as via an actuation element, such that the first gripping device is operated to securely grip the tissue.

[0189] At step 408, the grasped tissue is retracted into the shroud. As described above, an actuation element may be retracted proximally, e.g., via an actuation assembly, such that the grasper is retracted into the shroud. Additionally, a catheter may be advanced toward the defect to aid in maneuvering the grasper into the shroud. The grasper may capture the grasped tissue into a tissue capture region of the shroud. Capture of the grasped tissue from the opposite side of the defect may substantially close the defect.

[0190] The grasper is locked within the shroud at step 410. As described above, the grasper can be locked within the shroud in a retracted position such that the grasped tissue remains captured in a tissue capture area of ​​the shroud to substantially close the defect.

[0191] At step 412, the gripping device is decoupled from the actuation element. As described above, the actuation element may be retracted farther such that the gripping device is decoupled from the actuation element. In some embodiments, proximal retraction of the actuation element decouples the gripping device from a coupler coupled to a distal end of the actuation element. In some embodiments, the actuation element and coupler are withdrawn through a release member such that the coupler is withdrawn from the gripping device, as described above.

[0192] At step 414, the shroud is disconnected from the catheter. As described above, retraction of the actuating element may cause the shroud to decouple from the connector connected to the distal end of the catheter. In some embodiments, the shroud is connected to a distal connector portion that is decoupled from a proximal connector portion that is connected to the distal end of the catheter. The coupling between the proximal and distal connector portions may be maintained during the tissue grasping operation by a release slider disposed below the coupling between the proximal and distal connector portions. In some embodiments, retraction of the actuating element may cause the release slider to retract proximally such that the release slider no longer maintains the coupling between the proximal and distal connector portions, decoupling the proximal and distal connector portions. For example, the distal end of the actuating element and / or a portion of the coupler may contact the release slider such that the release slider is withdrawn from the operating position when the actuating element is retracted proximally. Decoupling between the proximal and distal connector portions may cause the catheter to decouple from the shroud.

[0193] At step 416, the catheter and working elements are retracted from the body. The gripping device and shroud may be separated from the working elements and catheter. The gripping device 104 may remain retracted within the shroud along with the gripped tissue, etc. By retracting the gripping device into the tissue capture area of ​​the shroud, substantial closure of the defect may be maintained such that hemostatic clips are not required to close the defect. After the catheter and working elements are retracted from the body, the gripping device and shroud may remain within the body to maintain closure of the defect.

[0194] It should be understood that the detailed description is intended to be illustrative and not limiting of the described embodiments. Other embodiments will be apparent to those skilled 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, the 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.

[0195] Moreover, the components and materials described below as making up various embodiments are intended to be illustrative 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. The tissue capture device comprises: A catheter; 1. A tissue capture assembly comprising: First and second gripping devices; a shroud operatively coupled to the catheter and configured to at least partially surround the grasper in a retracted position; and and an actuation assembly, the actuation assembly comprising: a first control actuator coupled to the first actuation element; a second control actuator coupled to a second actuation element, the first actuation element being operably coupled to the first gripping device, the second actuation element being operably coupled to the second gripping device; the first control actuator is operable to manipulate the first grasper to grasp tissue at a first position and the second control actuator is operable to manipulate the second grasper to grasp tissue at a second position; The tissue capture device, wherein when the grasper grasps tissue, the grasper can be decoupled from the actuation element and the shroud can be decoupled from the catheter.

2. The tissue capture device of claim 1 , wherein each grasper is operably coupled to the respective actuation element by a coupler.

3. The tissue capture device of claim 2 , wherein the coupler is secured to a distal end of the actuation element and includes outwardly biased prongs configured to be received in a receiver of the grasper.

4. The tissue capture device of claim 3 , wherein the prongs of the coupler include projections configured to be received in detents of coupling portions of the grasper to operably couple the coupler to the grasper.

5. The tissue capture device of claim 1 , wherein the shroud is operably coupled to the catheter by a connector.

6. 2. The tissue capture device of claim 1, wherein the actuation element is operable to capture the grasper within the shroud before the grasper is decoupled from the actuation element, and the shroud is decoupled from the catheter when the grasper grasps tissue.

7. The tissue capture device of claim 1 , further comprising a release member operable to decouple the grasper from the actuation element via proximal retraction of the actuation element.

8. 1. A tissue capture assembly of a tissue capture device operable to extend through a catheter and grasp tissue, the tissue capture assembly comprising: a first gripping device operably coupled to the first actuation element by a first coupler; a second gripping device operably coupled to the second actuation element by a second coupler; a shroud configured to surround the first and second gripping devices; a connector configured to operably connect the shroud to the catheter; The first grasper may be controlled by the first actuation element to grasp tissue at a first position, and the second grasper may be controlled by the second actuation element to grasp tissue at a second position; When the grasping device has grasped tissue, it may be retracted into the shroud and locked into place; The tissue capture assembly, wherein the gripper is operably decoupled from the actuation element, and the shroud is operably decoupled from the catheter after the gripper is retracted into the shroud.

9. The tissue capture assembly of claim 8 , wherein the connector includes a proximal connector portion secured to the catheter and a distal connector portion secured to the shroud.

10. The tissue capture assembly of claim 8 , wherein each coupler includes a connecting link operably connecting the actuation element to the grasper.

11. The tissue capture assembly of claim 8 , further comprising a release slider operatively arranged to decouple the grasper from the coupler upon proximal retraction of the actuation element.

12. The tissue capture assembly of claim 8 , wherein each of the grasping devices has a plurality of helical coils for grasping tissue.

13. The tissue capture assembly of claim 8 , wherein the grasper and the shroud are configured to maintain closure of a defect after the grasper is decoupled from the actuation element and the shroud is decoupled from the catheter.

14. The tissue capture assembly of claim 8 , wherein the shroud is configured to decrease in length when the grasper grasps tissue and is retracted into the shroud.

15. 1. A method of treating a defect with a tissue capture device, the method comprising: grasping a first side of the defect with a first grasping device via a first actuation element; grasping a second side of the defect with a second grasping device via a second actuation element; retracting the first and second gripping devices into a shroud coupled to a catheter; decoupling the first gripping device from the first actuation element and decoupling the second gripping device from the second actuation element; and separating the shroud from the catheter.

16. The method of claim 15 , wherein each gripping device is coupled to the respective actuation element by a coupler.

17. The method of claim 15 , wherein each grasper includes a helical coil, and the actuation element is operable to translate and rotate the graspers to grasp tissue.

18. The method of claim 15 , wherein the gripping device is disengaged from the actuation element by proximal retraction of the actuation element.

19. The method of claim 15 , further comprising the step of retracting the catheter and the working element from the grasping device and the shroud.

20. The method of claim 15 further comprising locking the gripping device within the shroud.

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