Device for capturing extensive tissue defects

Abstract

An actuating assembly for a tissue capture device for capturing tissue and closing a defect. The actuating assembly includes one or more control actuators operable to control the position and rotation of an actuating element coupled to a grasping device. The grasping device is configured to grasp tissue. The actuating assembly is operable by a user to deploy the grasping device via the actuating element to grasp tissue. The actuating assembly can independently deploy a plurality of grasping devices, such as on opposing sides of a defect. The actuating assembly can also deploy a closure mechanism configured to circumferentially surround the deployed grasping devices to close the defect.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 344,063, filed on May 20, 2022, the entire disclosure of which is incorporated herein by reference as if fully set forth herein.

[0002] This disclosure generally relates to surgical devices, and more specifically to an actuation assembly for a tissue - engagement device that enables improved tissue engagement to facilitate closure of extensive defects.

Background Art

[0003] Tissue - engagement and grasping devices are used in various parts of the body, including the gastrointestinal, urinary, and vascular systems, to treat internal bleeding or defects. These devices are deployed using an endoscope, such as a flexible endoscope, are provided in various forms, and can be used with hemostatic devices including clamps, clips, staples, sutures, etc. One or more hemostatic devices may be deployed around the tissue in the body to apply a constricting force to the blood vessels and surrounding tissue to control and prevent bleeding.

[0004] In some cases, a hemostatic device may also be deployed around a tissue growth, such as a polyp. The hemostatic device can be used to close the defect after resection of the growth to prevent or reduce bleeding. In other cases, the target tissue can be grasped and incorporated, such as within a pseudo - polyp, and then a hemostatic device can be used to close the defect after cutting or separating the incorporated tissue, for example, to remove the defect. The target tissue can be dysplasia, a defect, etc. However, in some cases, especially when larger defects and fibrotic tissue are involved, it can be difficult to successfully close the defect using conventional hemostatic devices.

[0005] Most hemostatic devices rely on variations of conventional tissue capture techniques for capturing tissue before deploying the hemostatic device. Conventional tissue capture techniques often involve extending a tissue capture device through an endoscope to a desired location for capturing tissue. However, with conventional tissue capture techniques, it may not be possible to properly capture tissue before the hemostatic device is deployed. For example, with conventional tissue capture techniques, it may not be possible to properly grasp and capture multiple sides of a defect. Thus, there is a need unmet for improving tissue capture by improving capture devices that utilize separate independently controlled grippers.

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 such features are explicitly 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. This specification relates to systems, assemblies, methods, instruments, devices, combinations, etc. that can be utilized for capturing tissue such as tissue defects. Various features and steps as described elsewhere in this disclosure may be included in the embodiments summarized herein. Further, treatment techniques, methods, operations, steps, etc. described or suggested herein can be performed on living animals or on non-living simulations such as cadavers, simulators (e.g., where body parts, tissues, etc. are simulated).

[0007] In an exemplary embodiment, an actuation assembly of a tissue capture device is provided that is operable to independently control first and second grasping devices to grasp tissue. The actuation assembly includes a body that defines a first channel and a second channel, a first actuation element that extends through the first channel and is coupled to the first grasping device, and a second actuation element that extends through the second channel and is coupled to the second grasping device. The actuation assembly includes at least one first control actuator operable to control the translation and rotation of the first grasping device to grasp tissue via the first actuation element, and at least one second control actuator operable to control the translation and rotation of the second grasping device to grasp tissue via the second actuation element. The at least one first control actuator is operable to control the translation and rotation of the first grasping device independently of the second grasping device.

[0008] In an exemplary embodiment, a tissue capture device is provided. The tissue capture device includes a first grasping device and a second grasping device, each grasping device being operable to grasp tissue. The tissue capture device also includes a first actuation element that extends through a first channel of the body, a proximal end of the first actuation element being coupled to a first control actuator and a distal end of the first actuation element being coupled to the first grasping device. The tissue capture device also includes a second actuation element that extends through a second channel of the body, a proximal end of the second actuation element being coupled to a second control actuator and a distal end of the second actuation element being coupled to the second grasping device. The first control actuator is independently operable to translate and rotate the first grasping device to grasp tissue via the first actuation element. The second control actuator is independently operable to translate and rotate the second grasping device to grasp tissue via the second actuation element.

[0009] In an exemplary embodiment, a method of treating a defect with a tissue capture device is provided. The method includes positioning a first grasping device above a first side of the defect, moving a first control actuator to control translation and rotation of the first grasping device via a first actuating element, grasping the first side of the defect with the first grasping device, positioning a second grasping device above a second side of the defect, moving a second control actuator to control translation and rotation of the second grasping device via a second actuating element, grasping the second side of the defect with the second grasping device, and retracting the actuating element to capture the grasped tissue.

[0010] These and other objects, features, and advantages of the present disclosure will become apparent from the following detailed description of its exemplary embodiments, read in conjunction with the accompanying drawings.

[0011] To further clarify various aspects of the embodiments of the present disclosure, specific examples and embodiments will be described more specifically with reference to various aspects of the accompanying drawings. These drawings show only exemplary embodiments of the present disclosure and are therefore not considered to limit the scope of the present disclosure. Further, although the figures may be drawn to scale for some examples, the figures are not necessarily drawn to scale for all examples. The examples of the present disclosure as well as other features and advantages are described more specifically and in detail through the use of the accompanying drawings.

Brief Description of the Drawings

[0012]

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DETAILED DESCRIPTION OF THE INVENTION

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

[0014] The general inventive concept will be more fully understood from the following detailed description 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 the specific aspects or embodiments provided for purposes of explanation and understanding only. The exemplary embodiments of the present disclosure are directed to devices and methods for capturing tissue. Various embodiments of devices and systems for capturing tissue are disclosed herein, and any combination of these options may be made, unless specifically excluded. In other words, the individual components of the disclosed devices and systems can be combined, provided they are not mutually exclusive or physically impossible.

[0015] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art, which includes the general inventive concept. The terms described in this detailed description are for the purpose of describing specific embodiments only and are not intended to limit the general inventive concept. When used in this detailed description and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0016] As described herein, when one or more components are described as being connected, coupled, attached, linked, mounted, or interconnected in some other way, such interconnection can be either direct between the components or 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 can include assemblies of components, members, or elements.

[0017] Accordingly, unless otherwise specified, all numerical values, such as those representing measurements or physical characteristics, used in this specification and the claims are to be understood as being modified in all instances by the term "about". Accordingly, unless otherwise specified, the numerical properties set forth in this specification and the claims are approximate values that can vary depending upon the desired properties sought to be obtained in embodiments of the present invention. Although numerical ranges and parameters representing the broad scope of the general inventive concept are approximate values, the numerical values reported in the specific examples are reported as precisely as possible. However, any numerical value inherently contains some error necessarily resulting from the standard deviation found in their respective measurements. Also, as described herein, the terms "substantially" and "about" are defined as being at least nearly (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

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

[0019] The present invention provides a tissue capture device for use through an endoscope. The tissue capture device is controllable by an actuation assembly. The tissue capture device can be configured to approach tissue better than standard tissue capture devices. The tissue capture device can also be configured to capture tissue over larger defects than standard tissue capture devices. For example, the tissue capture device of the present disclosure can be configured to approach 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 approach tissue defects having a width or diameter greater than 10 cm. The tissue capture device of the present disclosure can also be configured to simultaneously approach multiple sides of a defect to achieve a more consistent circumferential closure of the defect. The tissue capture device can be configured to achieve a 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. On the other hand, the tissue capture device can be used to grasp intact tissue, such as dysplastic or cancerous tissue. In some embodiments, the tissue capture device can be a sterile disposable device to reduce costs.

[0020] Functional block diagrams of the tissue capture device 100 are shown in FIGS. 1-2. The tissue capture device 100 includes a tissue capture assembly 102 at the distal end, an actuation assembly 200 at the proximal end, and a catheter-sheath assembly 300 disposed between the tissue capture assembly 102 and the actuation assembly 200. The tissue capture assembly 102 can include one or more tissue grasping devices 104 configured to grasp. The grasping device 104 may be an end effector or device capable of grasping tissue. It will be understood that grasping by the grasping device 104 includes picking up, pinching, hooking, or fixing the tissue with the grasping device 104.

[0021] The proximal end of each grasping device 104 can be coupled to an actuating element 208 of the actuation assembly 200. Each actuating element 208 is configured to control the position and rotation of the attached grasping device 104, for example, via operation of the actuation assembly 200. Each actuating element 208 can be configured to transmit both translational movement for positioning the grasping device 104 and torque or rotational movement for rotating the grasping device 104. Each actuating element 208 can be a solid cable, a hollow tube, or other suitable elongate object or combination of objects, such as a drive cable, a torque cable, a hypodermic tube, a spring sheath, or a catheter, configured to control the grasping device 104.

[0022] In the illustrated embodiment, the tissue capture device 100 has two grasping 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 three grasping devices 104, and the actuating elements 208 may be coupled to two or more grasping devices 104.

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

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

[0025] In some embodiments, one or more catheters 302 include polyetheretherketone (PEEK), thermoplastic materials, nylon, pelthane, polytetrafluoroethylene (PTFE), polyimide, composite metals 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 the compressive and operating forces exerted on the catheter 302 by the actuating element 208 and / or the operating element, 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 elasticity of the catheter 302 and / or to reduce the friction between the actuating element 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-eight cross-section. The catheter-sheath assembly 300 also includes one or more support wires 310 that extend between the lumens and above and / or below the outer surface of the catheter 302, for example, within a rounded groove between the lumens, along the length of the catheter 302. The support wires 310 reinforce the catheter 302 to provide strength to the catheter and may counteract or reduce the compressive forces that the device 100 experiences during operation. The support wires 310 may be constructed of a shape memory material such as stainless steel or nitinol. Additionally or alternatively, the support wires 310 may include PEEK, superelastic nitinol, liquid crystal polymer (LCP), or other metals or polymers having sufficient strength to resist compressive forces, or combinations thereof.

[0027] The catheter-sheath assembly 300 of FIGS. 3-4 is shown as including two support wires 310 at the upper and lower portions of the catheter 302, but 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 disposed at various positions around the outer surface of the catheter 302.

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

[0029] The device 100 can be used with any suitable or conventional endoscope or laparoscopic surgical device. For purposes of this disclosure, the device 100 is described in the context of use with a conventional or suitable structured endoscope / colonoscope / sigmoidoscope type device. However, the device can be used in other contexts, such as any minimally invasive procedure that utilizes a suitable natural or artificially created opening within the body. The scope comprises an elongate body having a controllably flexible distal end region. A surgical instrument such as the device 100 can be introduced through an instrument channel such as an accessory channel that extends through the scope body for a surgeon operating the scope to capture the targeted tissue. The grasping device 104 can be sized, shaped, and configured such that all grasping devices 104 can be disposed through the same instrument channel or accessory channel of the endoscope.

[0030] Each grasping device 104 is configured to grasp tissue such as defective tissue so that the tissue capture device 100 can capture the grasped tissue. The grasping device 104 may be any suitable device for grasping tissue. For example, the grasping device 104 may be forceps, a clamp, a hook, a pin, a claw, or the like. Each of the tissue grasping devices 104 can be controlled by the actuation assembly 200, such as via an actuation element 208 to which the grasping device 104 is attached. In some embodiments, the grasping device 104 is independently controllable via the actuation assembly 200.

[0031] The actuation assembly 200 may be operably connected to each grasping device 104 via one or more actuation elements 208. The actuation elements 208 may be configured to control the translational and rotational movements of the respective grasping devices 104. For example, the actuation elements 208 may be configured such that a user can position the grasping device 104, such as at the side of a defect, and deploy or operate the grasping device 104, for example, to grasp tissue. The actuation elements 208 may have sufficient rigidity or stiffness during operation to transmit rotational and linear forces to the grasping device 104 to maintain the grasping device 104 at various positions and angles. The actuation elements 208 may also have sufficient flexibility such that when the actuation elements 208 are positioned through the channels of the endoscope and / or catheter 302 to a desired position and the endoscope and / or catheter - sheath assembly 300 is operated, the deployed or actuated grasping device 104 can continue to grasp the tissue. In some embodiments, the actuation elements 208 include polymers, plastics such as ABS, PC, acrylic, or metals such as stainless steel or nitinol, or combinations thereof.

[0032] The actuating element 208 can also be sufficiently flexible such that the actuating element 208 and the tissue-engaging assembly 102 can extend to a desired location within the body, for example, through an endoscope, and the endoscope can be moved with the actuating element 208 extending therethrough. The actuating element 208 can also be sufficiently rigid such that the actuating element 208 can be manipulated to grip 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, a diameter of about 0.024 inches (0.61 mm). In some embodiments, the actuating element 208 provides a 1:1 torque response over the length of the endoscope such that rotation of the proximal end of the actuating element 208 is equivalent to rotation of the distal end of the actuating element 208.

[0033] In the illustrated embodiment, the actuation assembly 200 is operably connected to each grasping device 104 via a single actuating element 208. However, it will be understood that the tissue-engaging device 100 may have other suitable configurations. For example, the actuation assembly 200 may be operably connected to each grasping device 104 via a plurality of actuating elements 208, such as an actuating element 208 configured to control the translation of the grasping device 104 or an actuating element 208 configured to control the rotation of the grasping device 104.

[0034] In some embodiments, as shown in FIG. 2, the actuating element 208 is operably disposed through one or more sheaths 304 disposed between the actuating element 208 and the catheter 302. Each actuating element 208 may extend through a separate sheath 304, or the actuating element 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 element 208, as well as any additional control or operating elements, so as to extend through the endoscope and / or the catheter 302. The sheath 304 may be configured to reduce friction between the actuating elements 208 and / or between the actuating element 208 and the catheter 302. The sheath 304 may also be configured to prevent the actuating element 208 from becoming entangled within the catheter 302. For example, the sheath 304 may be implemented in embodiments where the actuating element 208 is disposed through a single catheter 302. The one or more sheaths 304 may be a spring sheath, a reinforced composite sheath, and / or a tube such as a polymer tube and / or a hypo tube. The sheath 304 may include a lubricating coating or liner disposed within the lumen of the sheath 304. Alternatively, as shown in FIG. 1, the actuating element 208 may float relatively freely within one or more lumens of the catheter 302, such as where the sheath 304 does not extend therethrough.

[0035] The proximal end of each sheath 304 may be operably connected or coupled to the actuation assembly 200. The distal end of each sheath 304 may extend toward the respective grasping device 104. The sheath 304 may be sized, shaped, or configured to accommodate the actuating element 208 therein. For example, the sheath 304 may be hollow so as to at least partially cover the actuating element 208. In some embodiments, such as embodiments where one of the grasping devices 104 is operated via an operating element, the sheath 304 may also be sized, shaped, or configured to accommodate the operating element therein.

[0036] In some embodiments, such as embodiments in which one or more gripping devices 104 can be operated (e.g., opened and closed), the actuating element 208 can have a hollow shape, shape, or size that at least partially encompasses an operating element 290 that is coupled to the gripping device 104 and configured to operate the gripping device 104. The operating element 290 can be a drive cable, torque cable, hypodermic tube, spring sheath, catheter, or other suitable member configured to control the gripping device 104. For example, each operating element 290 can be configured to transmit a translational force and / or a rotational force for actuating the gripping device 104.

[0037] Separate from the translation and / or rotation of the gripping device 104, the operating element 290 can be movable, such as linearly movable, rotationally movable, etc., relative to the actuating element 208 to control the function or operation (e.g., opening and closing) of the gripping device 104. The proximal end of the operating element 290 can be operably coupled to the actuating assembly 200 such that a user can control the operation of the gripping device 104 via the actuating assembly 200. Each operating element 290 can be a metallic actuating wire or tether configured to impart a translational force for controlling the operation of the gripping device 104. For example, the gripping device 104 can include a distal jaw that is normally disposed in a closed position by a spring or other biasing element, and the distal movement of the operating element 290 relative to the gripping device 104 can open the jaw. When the operating element 290 is retracted relative to the gripping device 104, the jaw can return to the closed position to grip tissue.

[0038] In the illustrated embodiment, the device 100 includes an operating element 290 disposed through one of the actuating elements 208. However, it will be understood that the device 100 can have other configurations and assemblies. For example, the device 100 can not include the operating element 290, or the operating element 290 can be disposed through each of the actuating elements 208 or alongside the actuating elements 208.

[0039] The actuation assembly 200 includes a body 202 configured to be grasped by a user. The proximal ends of the actuation element 208 and any operating element 290 may extend within or through the body 202. The actuation assembly 200 also includes a plurality of control actuators 230 operable to control the position, rotation, and operation of the grasping device 104 via the actuation element 208. Each of the actuation elements 208 and each of the operating elements 290 may be coupled to one or more of the control actuators 230 such that a user can control the position, rotation, and operation of the grasping device via the control actuators 230. The control actuator 230 may be any suitable device that a user can operate to control the position and / or rotation of one of the actuation elements 208 or one of the operating elements 290. For example, the control actuator 230 may be a push button, toggle, switch, lever, trigger, slider, etc.

[0040] 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 an operating control actuator 230c operable to control a linear or translational position of one of the operating 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 grasping device 104 via the actuation element 208 to deploy the grasping device 104 to a desired position. Optionally, the operator may also use the operating control actuator 230c to control the operation of the grasping device 104 via the operating element 290, for example, to open and close the grasping device 104 to grasp tissue.

[0041] In the illustrated embodiment, the actuation assembly 200 includes two translational control actuators 230a, two rotational control actuators 230b, and one operation 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 operation control actuators 230c.

[0042] In the illustrated embodiment, each translational control actuator 230a is disposed near the proximal end of one of the actuating elements 208 that is proximal to the body 202, and each rotational control actuator 230b is disposed at the proximal end of one of the actuating elements 208 that is proximal to the translational control actuator 230a. Each translational control actuator 230a may be translationally fixed to its respective actuating element 208 such that the translational movement of the translational control actuator 230a is converted into the translational movement of the actuating element 208. The actuating element 208 may be rotationally disengaged from the translational control actuator 230a such that the actuating element 208 can rotate independently of the translational control actuator 230a. The translational control actuator 230a can be pushed down or moved toward the body 202 by a user or the like to extend the actuating element 208 distally, thereby positioning the gripping device 104.

[0043] The rotational control actuator 230b may be rotatably coupled to its respective actuating element 208 such that the rotational movement of the rotational control actuator 230b is converted into the rotational movement of the actuating element 208. The rotational control actuator 230b can be rotated by a user or the like to rotate the actuating element 208, thereby rotating the gripping device 104. The rotational control actuator 230b can be rotated independently of the translational control actuator 230a.

[0044] The operation control actuator 230c can be arranged on the proximal side of the main body 202, such as, for example, on the proximal side of the translational control actuator and the rotational control actuators 230a, 230b. The operation control actuator 230c may be directly or indirectly connected to the operation element 290 in order to operate the operation element 290 to activate the gripping device 104. The operation control actuator 230c may be connected to the operation element 290 such that by depressing or activating the operation control actuator 230c, the operation element 290 is translated to activate the respective gripping devices 104, such as opening or closing the gripping device 104. The operation control actuator 230c may be connected to the operation element 290 via a biasing element such that when the user releases the operation control actuator 230c, the operation control actuator 230c returns to the inoperative position, thereby retracting the operation element 290.

[0045] However, it will be understood that the actuation assembly 200 may have other suitable shapes, assemblies, and configurations. For example, the operation control actuator 230c may be arranged on a different side of the main body 202 than the other control actuators 230a, 230b of the main body 202, one or more of the control actuators 230 may be arranged along the main body 202, the translational control actuator 230a may not be aligned with the rotational control actuator 230b, and / or the translational and rotational control actuators 230a, 230b may be connected to the respective gripping devices 104 via separate actuation elements 208. Further, one or more of the translational control actuator 230a, the rotational control actuator 230b, and the operation control actuator 230c may be combined. For example, the translational control actuator 230a and the rotational control actuator 230b may be combined into a single control actuator 230 operable to control the translational and rotational positions of the gripping device 104 via the actuation element 208.

[0046] In an operation, the actuation assembly 200 can be operated by a user or the like to control the tissue capture assembly 102 to capture tissue with one or more grasping devices 104. The grasping device 104 may be disposed through the distal end of an endoscope (not shown) and the catheter sheath assembly 300. The actuation assembly 200 can be operated by a user at the proximal end of the endoscope via an actuation element 208 and / or an operating element 290 that are disposed within the endoscope and extend through a channel extending through the endoscope. The endoscope and / or the grasping device 104 may be inserted through the subject such that the grasping device 104 is disposed at a desired location such as above the identified defect. Each grasping device 104 can be moved via its respective translational control actuator 230a, rotated via its respective rotational control actuator 230b, and / or actuated by its respective operating control actuator 230c to grasp tissue. For example, the user can control the position of the grasping device 104 by positioning the distal end of the endoscope and sliding or moving the translational control actuator 230a to extend and / or retract the actuation element 208. The user can control the rotation of the grasping device 104 by rotating its respective rotational control actuator 230b. Optionally, the user can also control the operation of the grasping device 104, such as opening and closing of the grasping device 104, by engaging and disengaging the operating control actuator 230c. After the grasping device 104 has grasped the tissue, the actuated tissue can be captured proximally using the actuation assembly 200, such as by retracting the translational control actuator 230a proximally to close the defect or juxtapose the two sides of the defect to enable use of a hemostasis device.

[0047] An exemplary method of operating the grasping device 104 of the tissue capture assembly 102 is schematically illustrated in FIGS. 5A-5D. As shown in FIG. 5A, the tissue capture assembly 102 may be positioned above the defect, for example, via a catheter-sheath assembly 300 and an endoscope. The grasping device 104 may extend from the distal end of the catheter 302 via the 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, the first grasping device 104a is coupled to the first actuating element 208a and the second grasping device 104b is coupled to the second actuating element 208b.

[0048] As shown in FIG. 5B, one of the grasping devices 104 may be deployed to engage the tissue on the first side of the defect. The endoscope, catheter 302, and / or actuating element 208 may be manipulated so that the first grasping device 104a faces the identified first side of the defect. The actuating element 208a coupled to the first grasping device 104a may be translated and rotated so that the first grasping device 104a engages and grasps the tissue on the first side of the defect, for example, via one of the translational control actuators 230a of the actuating assembly 200 and one of the rotational control actuators 230b. Although not shown, the first grasping device 104a may also be manipulated to grasp the tissue via the operating element 290, such as via one of the operating control actuators 230c of the actuating assembly 200. The second grasping device 104b may remain relatively stationary with respect to the catheter 302 when the first grasping device 104a is deployed to grasp the tissue.

[0049] As shown in FIG. 5C, the second grasping device 104b can be deployed to engage tissue on the second side of the defect. The endoscope, catheter 302, and / or the second actuation element 208b can be manipulated so that the second grasping device 104b faces the second side of the identified defect. The second grasping device 104b may be controlled or manipulated independently of the first grasping device 104a to grasp tissue on the second side of the defect. The second actuation element 208b may be translated and rotated so that the second grasping device 104b engages and grasps tissue on the second side of the defect, for example, via one of the translational control actuators 230a and one of the rotational control actuators 230b of the actuation assembly 200. By the independent operation of the second grasping device 104b, the tissue capture device 100 can extend beyond the limits of a standard capture device and may be able to treat and close a wider range of defects. For example, due to the flexibility of the tissue capture assembly 102 such as the actuation element 208 and the independent operation of the grasping devices 104, the device 100 may be able to treat and close a wider range of defects than a standard capture device. Although not shown, the second grasping device 104b may also be manipulated to grasp tissue via an operating element 290, such as via one of the operating control actuators 230c of the actuation assembly 200. The first grasping device 104a may remain deployed to grasp tissue on the first side of the defect while the second grasping device 104b is deployed to grasp tissue on the second side of the defect.

[0050] Although the 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 the defect. For example, the device 100 may include more than two grasping devices 104, or additional grasping devices 104 may be attached to the device 100 such that they are deployed subsequent to the initial two grasping devices 104a, 104b being deployed to grasp tissue.

[0051] As shown in FIG. 5D, one or both of the grasping devices 104a, 104b may be retracted by retracting each of the one or more actuating elements 208a, 208b proximally to capture the grasped tissue. For example, one or both of the translational control actuators 230a may be actuated to retract the actuating elements 208a, 208b proximally. The grasping devices 104a, 104b may continue to grasp the tissue while the grasping devices 104 are being retracted. When one or both of the grasping devices 104a, 104b are retracted, the defect may be substantially closed or the sides of the defect may be juxtaposed so that the hemostatic device can be deployed. In some embodiments, the grasping devices 104a, 104b may be retracted to a locked position such that the grasping devices 104a, 104b are substantially fixed relative to the catheter 302.

[0052] After retracting the grasping devices 104a, 104b to capture the target tissue, a tissue closure mechanism, such as a suture or clip, may be placed around the captured tissue to treat and / or substantially close the defect. The tissue closure mechanism may be deployed around the grasping devices 104a, 104n that grasp 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 including an OTS clip, the grasping device 104 may retract into the OTS housing to capture the tissue. In embodiments including a TTS clip, the grasping 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, alternatively, via a separate control device.

[0053] In some embodiments, after securing the captured tissue with a tissue closure mechanism, such as an OTS clip or a TTS clip, the grasping device 104 and / or the actuating element 208 may be detached from or disengaged from the tissue. For example, the operating element 290 may be actuated to open the grasping device 104 to release the tissue. The grasping device 104 and / or the actuating element 208 may be withdrawn or retracted from the closed defect.

[0054] The grasping device 104 may be an end effector that can grasp the target tissue, such as via one or more actuating elements 208 and / or one or more operating elements 290. As shown in FIG. 6, the tissue capture assembly 102 includes a first grasping device 104a having a plurality of helical coils 114 that extend in a spiral or corkscrew shape, and a second grasping device 104b having at least one movable jaw 113. The helical coils 114 of the first grasping device 104a may be configured to grasp the tissue when the first grasping device 104a is spirally inserted into or screwed into the tissue. The movable jaw 113 of the second grasping device 104b may be opened and closed to grasp the tissue. The grasping devices 104a, 104b may be operated via the actuation assembly 200 of FIGS. 1-2.

[0055] The first grasping device 104a may be operated via a first actuating element 208a that is operable to translate and rotate the first grasping device 104a such that the first grasping device 104a grasps the tissue. For example, the first actuating element 208a may translate and rotate the first grasping device 104a via, for example, the actuation assembly 200 such that the first grasping device 104a spirally enters or screws into the tissue to grasp the tissue.

[0056] The second grasping device 104b can be operated via a second actuating element 208b and an operating element 290. The second actuating element 208b can translate and rotate the second grasping device 104b via, for example, an actuation assembly 200 so that the second grasping device 104b is properly positioned above the target tissue. The operating element 290 can be extended distally so that the second grasping device 104b grasps tissue, for example, tissue on the opposite side of the defect relative to the first grasping device 104a, for example, by actuation of an operating control actuator 230c. The distal extension of the operating element 290 can rotate the movable jaw 113 about an axis so that the movable jaw 113 opens to grasp the tissue. After the tissue is positioned between the movable jaw 113 and the remainder of the second grasping device 104b, the operating element 290 can be retracted proximally so that the movable jaw 113 pivots and closes with the tissue grasped between the movable jaw 113 and the remainder of the second grasping device 104b (for example, the operating control actuator 230c may be released). Further, the grasping device 104 may have more than one movable jaw 113, such as two movable jaws 114 that rotate about a central axis. In the schematic illustration shown, the operating element 290 extends outside the actuating element 208. However, it will be understood that the operating element 290 may extend through the interior of the actuating element 208.

[0057] The illustrated embodiment includes a first grasping device 104a having a helical coil 114 operable by one actuating element 208a and a second grasping device 104b having a movable jaw 113 operable by an actuating element 208b and an operating element 290, but it will be understood that the device 100 may have other assemblies and configurations.

[0058] Referring now to FIGS. 7-19C, tissue capture device 100 includes an actuation assembly 200 according to one embodiment configured to independently move and operate one or more gripping devices 104. In some embodiments, actuation assembly 200 is operable to control the position and rotation of gripping devices 104, such as to grip tissue with gripping devices 104. Actuation assembly 200 may also be configured to actuate or otherwise control the operation of each gripping device 104, such as to open and close gripping devices 104 to grip tissue.

[0059] Actuation assembly 200 may be operable to independently control two gripping devices 104, such as gripping devices 104 having helical coils 114 (e.g., FIG. 18), to independently grip tissue at different locations, such as at opposing sides of a defect. Actuation assembly 200 includes a body 202 that extends from a proximal end 204 to a distal end 206. Body 202 may be sized, shaped, and configured such that a user's hand can comfortably grip body 202. In the illustrated embodiment, body 202 of actuation assembly 200 is substantially cylindrical with a narrowed distal portion. However, it will be understood that body 202 may be other shapes and configurations suitable for a user to grip during operation. Although device 100 has been described as gripping opposing sides of a defect, it will be understood that tissue may be gripped at other locations. For example, device 100 may be used to grip tissue at the center of a defect.

[0060] In some embodiments, as shown in FIGS. 8-9, body 202 includes a first half 202a and a second half 202b that are connected to each other to form body 202. In some embodiments, first half and second half 202a, 202b may be connected to each other by fasteners, welding, adhesives, press fitting, or snap fitting, among other things. Body 202 may be separable into first and second halves 202a, 202b such that body 202 can be assembled around actuation element 208.

[0061] Optionally, as shown in FIGS. 10-11, the actuating assembly may also include a cover 228 configured to be at least partially disposed around the body 202. The cover 228 may be sized, shaped, and configured such that a user's hand can comfortably grip the cover 228. In some embodiments, the cover 228 is configured to hold the first and second halves 202a, 202b of the body 202 together when the cover 228 is disposed around the body 202. The proximal end of the cover 228 may be substantially open or hollow such that the cover 228 can slide over the body 202 and, as described below, operate the actuating element 208.

[0062] FIGS. 12-14 show the body 202 with the second half 202b removed. The body 202 includes a first channel 210 that extends the length of the body 202 from the proximal end 204 to the distal end 206. The body 202 also includes a second channel 214 that extends the length of the body 202 from the proximal end 204 to the distal end 206. The first and second channels 210, 214 are each configured to receive one of the actuating elements 208. In some embodiments, the first and second channels 210, 214 are disposed substantially equidistant from the center of the body 202 and the first channel 210 closely resembles the second channel 214.

[0063] The first channel 210 defines a first proximal opening 212 (e.g., FIG. 9) within the proximal end 204 of the body 202, and the second channel 214 defines a second proximal opening 216 within the proximal end 204 of the body 202. The first and second proximal openings 212, 216 are sized, shaped, and configured such that the actuating elements 208 can extend proximally from within their respective channels 210, 214. In some embodiments, the first and second proximal openings 212, 216 are larger than the actuating elements 208, such as to receive an actuating sheath therethrough, as described below. The first and second proximal openings 212, 216 may be spaced apart from each other and / or angled, such as to enable independent control of each actuating element 208, as described below.

[0064] The first and second channels 210, 214 may each include a first portion 218 that extends distally from their respective proximal openings 212, 216. The first portions 218 of the first and second channels 210, 214 may extend substantially straight from their respective proximal openings 212, 216. The first and second channels 210, 214 may each include a second portion 220 that extends distally from the first portion 218. The second portions 220 of the first and second channels 210, 214 may be curved such that the distal ends of the first and second channels 210, 214 are disposed adjacent to each other at the distal end 206 of the body 202, or otherwise may be angled. The first portions 218 of the first and second channels 210, 214 may have a greater width than the width of the second portion 220. For example, the second portions 220 of the channels 210, 214 may be sized to receive one of the actuating elements 208 therethrough, and the first portions 218 may be sized to receive one of the actuating elements 208 and additional components, such as an actuating sheath, therethrough.

[0065] The second portions 220 of the first and second channels 210, 214 may terminate at distal openings 222. The distal openings 222 may be sized, shaped, and configured such that the actuating elements 208 may extend through the distal openings 222 from each of the first and second channels 210, 214. The body 202 has been described as including a single distal opening 222, but it will be understood that the body 202 may include a distal opening 222 for each of the channels 210, 214.

[0066] The actuation assembly 200 may also include a control actuator 230 coupled to the proximal end of each actuating element 208. Each control actuator 230 may be operable to control the position and rotation of one of the actuating elements 208 of the grasping device 104 as described below. Each control actuator 230 may be operable to independently control the position and rotation of its respective actuating element 208. Each control actuator 230 may be fixed to the proximal end of its respective actuating element 208. In some embodiments, each control actuator 230 is welded to the proximal end of its respective actuating element 208. In other embodiments, the control actuator 230 is coupled to the proximal end of the actuating element 208 via an adhesive, a fastener, an overmold, a press fit, a snap fit, or other similar method.

[0067] Each control actuator 230 can be sized, shaped, and configured to be twistable by a user, such as between the user's thumb and index finger, to control the rotation of the gripping device 104. The control actuator 230 can be ergonomic for the user, sized, shaped, and configured to facilitate rotation and translation of the control actuator 230 and the actuating element 208 and to facilitate the user in completing rotation without putting a strain on the user's finger or hand. Each control actuator 230 can also have a width greater than the proximal openings 212, 216 so as to prevent the proximal end of each actuating element 208 from extending distally into the body 202 by abutment between the control actuator 230 and the proximal end 204 of the body 202. As shown in FIG. 15, the control actuator 230 is substantially an elongated hexagon. The elongated hexagonal shape of the control actuator 230 can enable the user to not only grip and rotate the control actuator 230, such as between a finger and a thumb, but also feel comfortable and rounded. However, it will be understood that the control actuator 230 can have any suitable shape. For example, the control actuator 230 can be circular, oval, elliptical, triangular, rectangular, oblong, or other suitable shape.

[0068] The actuating assembly 200 has been described as having two channels 210, 214 and two control actuators 230, but it will be understood that the actuating assembly 200 can have other suitable configurations. For example, the actuating assembly 200 can have one or more than three channels and one or more than three control actuators 230, such as corresponding to the number of gripping devices 104.

[0069] As shown in FIG. 16, the actuation assembly 200 may also include an actuation sheath 224 disposed around the proximal end of each actuation element 208 and coupled to a respective control actuator 230. The actuation sheath 224 may be configured to assist in controlling the grasping device 104 during operation. For example, the actuation sheath 224 may limit the translational travel distance of the grasping device 104 and / or assist in transmitting torque from the control actuator 230 to the actuation element 208. The actuation sheath 224 may have an outer diameter sized to allow the actuation sheath 224 to translate and rotate within the first portion 218 of the channels 210, 214. The actuation sheath 224 may also have an outer diameter that prevents the actuation sheath 224 from translating into the second portion 220 of the channels 210, 214, thereby providing a limit to the actuation distance of the actuation element 208. The first portion 218 of the channels 210, 214 and / or the actuation sheath 224 may have a length corresponding to the desired translational travel distance of the actuation element 208 and the grasping device 104.

[0070] In some embodiments, the proximal openings 212, 216 have a diameter that is narrower than the first portion 218 of the channels 210, 214. The proximal openings 212, 216 may be sized such that the actuation sheath 224 (or the actuation element 208 in embodiments without an actuation sheath) can translate and rotate within the channels 210, 214. The smaller size of the proximal openings 212, 216 allows the actuation sheath 224 and / or the actuation element 208 to be centered within the channels 210, 214 such that the actuation element 208 and / or the actuation sheath 224 are spaced from the walls of the channels 210, 214. Reducing contact with the walls of the channels 210, 214 may reduce friction between the channels 210, 214, the actuation sheath 224, and / or the actuation element 208. Also, the smaller proximal openings 212, 216 may help ensure that the actuation element 208 and / or the actuation sheath 224 remain within the channels 210, 214.

[0071] The actuating sheaths 224 may each be substantially hollow tubes configured such that the proximal end of the actuating element 208 can extend therethrough. Each actuating sheath 224 may include stainless steel. Additionally or alternatively, the actuating sheath 224 may include polyetheretherketone (PEEK), high density polyethylene (HDPE), low density polyethylene (LDPE), or ultra-high molecular weight polyethylene (UHMW), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), acrylic, composite structures of these materials, composite structures of these materials, or other suitable metals that allow for adequate rigidity for actuation, or combinations thereof. The proximal ends of the actuating element 208 and the actuating sheaths 224 may be fixed to the control actuator 230 such that the actuating element 208 and the actuating sheaths 224 translate and rotate with the translation and rotation of the control actuator 230, respectively. In some embodiments, the proximal end of the actuating element 208 is molded within each actuating sheath 224.

[0072] In some embodiments, as shown in FIG. 15, each control actuator 230 includes a bore 232 that extends proximally within the distal end of the control actuator 230. The bore 232 may be configured to receive the proximal ends of the actuating element 208 and the actuating sheaths 224. The bore 232 may have a shape and diameter that substantially corresponds to the outer surface of the actuating sheath 224. The proximal ends of the actuating sheath 224 and the actuating element 208 may be fixed to the inner surface and / or the proximal end of the bore 232 to couple the control actuator 230 to the actuating sheath 224 and the actuating element 208. Although the control actuator 230 and the actuating sheath 224 have been described as separate components, it will be understood that the control actuator 230 and the actuating sheath 224 may be integrated into a single component (e.g., FIGS. 38A-38B).

[0073] In some embodiments, as shown in FIG. 17A, the actuating element 208 extends through the actuating sheath 224 in a non-linear manner. For example, the actuating element 208 may meander up, down, left, and right within the actuating sheath 224 such that the actuating element 208 is prevented from retracting from the actuating sheath 224 or, alternatively, is restricted. By extending non-linearly through the actuating sheath 224, the actuating element 208 can be further secured within the actuating sheath 224. The actuating sheath 224 may include one or more abutting portions 226 disposed inside the actuating sheath 224, by which the actuating element 208 forms a non-linear position when inserted into the actuating sheath 224 and / or the abutment 226 prevents or, alternatively, restricts the actuating element 208 from linearly retracting from the actuating sheath 224. In other embodiments, the actuating sheath 224 may not include the abutting portion 226, and the actuating element 208 may be formed non-linearly within the actuating sheath 224, such as using a core pin that is removed after the forming process.

[0074] In some embodiments, as shown in FIGS. 17B-17C, one or more actuating elements 208 may have a non-circular cross-section, such as to reduce friction between the actuating element 208 and the catheter 302 and / or sheath 304. For example, the actuating element 208 may have a cross-section that reduces the 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 twisted, generally rectangular cross-section. However, it will be appreciated 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, elliptical, triangular, hexagonal, D-shaped, crescent-shaped, pie-shaped, grooved, or other suitable shape.

[0075] As shown in FIGS. 17B - 17C, the actuating element 208 can be twisted to further reduce frictional contact between the actuating element 208 and the catheter 302 and / or the sheath 304. It will be appreciated that the twist of the actuating element 208 also encompasses an actuating element 208 having a helical or spiral outer profile. The twist of the actuating element 208 can also make it easier for the user to identify that the actuating element 208 is rotating. Further, one twist of the actuating element 208 can help the user identify which actuating element 208 is being operated. For example, as shown in FIG. 17C, a first actuating element 208a having a rectangular cross - section that is twisted along the length of the actuating element 208 is coupled to the first gripping device 104a, and a second actuating element 208b having a substantially circular cross - section is coupled to the second actuating element 104a. The difference in shape between the first and second actuating elements 208a, 208b can assist the user in identifying which actuating elements 208a, 208b and which gripping devices 104a, 104b are being operated, for example, via the actuation assembly 200. In the illustrated embodiment, the first actuating element 208a has a rectangular cross - section that is twisted along the length of the actuating element 208, and the second actuating element 208b is substantially circular. However, it will be appreciated that both actuating elements 208 could have a rectangular cross - section that is twisted along the length of the actuating element 208.

[0076] In some embodiments, the catheter 302 can be configured to increase the compression resistance of the catheter 302 during operation. As shown in FIGS. 17D - 17G, the catheter 302 can be a spring sheath wound around a helical coil having a plurality of compression portions 303 disposed along the length of the catheter 302. The compression portions 303 can be formed by winding the coil in a more narrow helix at a predetermined interval along the length of the catheter 302.

[0077] The catheter 302 may also include a plurality of struts 305 extending across the cross-section of the catheter 302 at predetermined intervals. The struts 305 may be formed by bending a coil across the cross-section of the catheter 302 that may create the compression portion 303. The struts 305 may be substantially aligned such that the struts 305 separate the catheter 302 within the lumen, etc., and prevent the operating element 208 from becoming entangled during operation. The struts 305 may define a pseudo-lumen extending through the catheter 302. In some embodiments, only the distal coil of the catheter 302 is bent to form the struts 305, such as to separate the operating element 208 at the distal end of the device 100 and prevent the operating element 208 from becoming entangled during operation.

[0078] As shown in FIG. 18, the operating assembly 200 may be operable with two grasping devices 104 having helical coils 114 configured to be spirally inserted into tissue to grasp the tissue. In the illustrated embodiment, the operating assembly 200 includes a first control actuator 230a coupled to a first operating sheath 224a and a first operating element 208a to control the operation of the first grasping device 104a. The operating assembly 200 also includes a second control actuator 230b coupled to a second operating sheath 224b to control the operation of the second operating element 208b. The first operating element 208a and the first operating sheath 224a may extend through the first channel 210, and the second operating element 208b and the second operating sheath 224b may extend through the second channel 214. The operating assembly 200 is operable to independently control the deployment of the first and second grasping devices 104a, 104b. Although the operating assembly 200 is shown as being operable to independently control two grasping devices 104 having helical coils 114, it will be understood that the operating assembly 200 may be operable to control other types of grasping devices 104.

[0079] Referring now to FIGS. 19A-19C, the actuation assembly 200 can be moved from a non-actuated configuration to an actuated configuration. The control actuator 230 of the actuation assembly 200 can be operated, such as by a user, to control the translation and rotation of the actuating element 208 when the actuation assembly 200 moves from the non-actuated position to the actuated position. The control actuator 230 can be independently operated to independently control the grasping device 104, such as to grasp the target tissue. For example, the control actuator 230 can independently operate to translate and rotate the first and second actuating elements 208a, 208b such that the helical coils 114 of the first and second grasping devices 104a, 104b (FIG. 18) spiral into the tissue to securely grasp the tissue.

[0080] As shown in FIG. 19A, in the non-actuated position, the control actuators 230a, 230b are disposed from the body 202 at a distance, such as a distance where the grasping device 104 is disposed near the distal end of the catheter 302. The actuating elements 208a, 208b extend through the channels 210, 214 of the body 202, and the proximal ends of the actuating elements 208a, 208b are disposed at a distance from the proximal end 204 of the body 202.

[0081] As shown in FIG. 19B, the actuation assembly 200 can move from the non-actuated position to a partially actuated position, such as to fix one of the grasping devices 104 to the first side of the defect. The first control actuator 230a can be actuated to move the first grasping device 104a to grasp the target tissue at the first position. The first control actuator 230a can be depressed and / or rotated, such as by a user, to translate and rotate the first actuating element 208a. For example, the first control actuator 230a can be depressed and / or rotated to translate and rotate the first actuating element 208a such that the first grasping device 104a (FIG. 18) spirals into the tissue and grasps the tissue on the first side of the defect.

[0082] The first actuating sheath 224a can control the translational distance of the first actuating element 208a and the grasping device 104. The first actuating sheath 224a can be sized, shaped, or configured such that the actuating sheath 224 can translate and rotate within the first portion 218 of the first channel 210 and the first actuating sheath 224a is prevented from translating into the second portion 220 of the first channel 210. For example, the first actuating sheath 224a may have an outer diameter that is larger than the diameter of the second portion 220 of the first channel 210. The smaller diameter of the second portion 220 can prevent the second actuating sheath 224a from extending distally beyond the first channel 218 of the first channel 210. Contact between the distal end of the first actuating sheath 224 and the proximal end of the second portion 220 of the first channel 210 prevents further movement of the first actuating sheath 224 and the first actuating element 208a, thereby controlling the linear actuation distance of the first control actuator 230a and thereby controlling the translational movement of the grasping element 104a.

[0083] As shown in FIG. 19C, the actuation assembly 200 can move from a partial actuation position to a full actuation position. While the actuation assembly 200 is in the partial actuation position, the sheath assembly 300 of the endoscope and / or catheter can be manipulated such that the second grasping device 104b is substantially aligned with a second position, such as the second side of the defect. The first grasping device 104a may remain in grasping engagement at the first position (e.g., the first side of the defect). The second control actuator 230b can be actuated to move the second grasping device 104b to grasp the target tissue at the second position. The second control actuator 230b can be depressed and / or rotated, such as by a user, to translate and rotate the second actuation element 208b. For example, the second control actuator 230b can be depressed and / or rotated to translate and rotate the actuation element 208b such that the second grasping device 104b (FIG. 18) spirals into the tissue and grasps the tissue over the second side of the defect. The second actuation sheath 224b can also be sized, shaped, and configured to control the linear actuation distance of the second control actuator 230b via abutment with the proximal end of the second portion 220 of the second channel 214, similar to the first actuation sheath 224a.

[0084] The actuation assembly 200 has been described as deploying the first grasping device 104a via the first control actuator 230a and then deploying the second grasping device 104b via the second control actuator 230b, but it will be understood that the actuation assembly 200 can operate in other ways. For example, the second control actuator 230b can be actuated to deploy the second grasping device 104b before the first grasping device 104a is deployed, and the first and second control actuators 230a, 230b may be operated substantially simultaneously, or one or both of the control actuators 230a, 230b may be operated in reverse to disengage the grasping devices 104a, 104b, such as if the grasping devices 104a, 10b are not properly deployed, in which case the control actuators 230a, 230b can be actuated substantially to move the grasping devices 104a, 104b to grasp or otherwise reacquire the tissue.

[0085] In some embodiments, the actuation assembly 200 may be operable to release the grip of one or both of the grasping devices 104 from the tissue, such as when one or both of the grasping devices 104a, 104b are improperly positioned or located within the tissue. If it is determined that one or both of the grasping devices 104a, 104b are improperly positioned within the tissue, the control actuators 230a, 230b may be operated by the user to release the grip of one or more of the grasping devices 104a, 104b on the tissue. To release each grasping device 104, each control actuator 230 may be retracted proximally from the body 202, such that the grasping device 104 is retracted from the tissue, and / or the control actuator 230 may be rotated such that the grasping device 104 is released from the tissue. For example, the control actuator 230 may be rotated in a direction opposite to the direction in which the control actuator 230 is rotated to engage the tissue.

[0086] In some embodiments, after the actuation assembly 200 has moved the grasping device 104 to the fully actuated position such that the grasping device 104 grasps the tissue at multiple sides of the defect, the actuation assembly 200 may be operable to capture the grasped tissue, such as to deploy a closure mechanism. After the grasping device 104 has been properly deployed within the tissue, the control actuator 230 is translated proximally, such that the actuation element 208 and the grasping device 104 are retracted toward the actuation assembly 200. The control actuator 230 may retract to the non-actuated position (FIG. 19A). By the retraction of the actuation element 208 and the grasping device 104, the grasped tissue may be captured toward the catheter 302. After the tissue has been captured, a closure mechanism, such as a clip, may be positioned around the captured tissue, such as to close the defect.

[0087] Referring now to FIGS. 20-30B and FIGS. 36A-38G, the actuation assembly 200 may also include one or more biasing elements 234 configured to maintain the linear and translational positions of the actuating element 208 within respective channels 210, 214, such as without user operation or user control. In some embodiments, the biasing element 234 extends within the first and second channels 210, 214, such that the biasing element 234 contacts the actuating element 208 and / or the actuating sheath 224 extending through the respective channels 210, 214. The biasing element 234 may exert a biasing force on each of the actuating elements 208 to prevent or otherwise limit the actuating element 208 from translating and rotating within the respective channels 210, 214. In other embodiments, the biasing element 234 is configured to maintain the control actuator 230 in a desired position. The biasing element 234 may be an additional element or may form part of the body 202.

[0088] As shown in FIGS. 20-26, the biasing element 234 may be a leaf spring. The biasing element 234 may be spherical or elliptical and may be disposed within the proximal portion of the body 202 such that the sides of the biasing element 234 extend into each of the channels 210, 214. The biasing element 234 may be bent or crimped such that the sides of the biasing element 234 exert a biasing force on the actuating element 208 and / or the actuating sheath 224 extending through the channels 210, 214 to prevent or otherwise limit the actuating element 208 and / or the actuating sheath 224 from translating and rotating within the channels 210, 214 without user operation. The biasing element 234 may include stainless steel, or plastic, or a combination thereof.

[0089] In some embodiments, the body 202 includes a biasing element receiving portion 236 configured to receive a biasing element 234. The biasing element receiving portion 236 can be disposed substantially between channels 210, 214 near the proximal end 204 of the body 202. The biasing element receiving portion 236 can be a recess extending in the adjacent faces of the first and second halves 202a, 202b of the body 202. The biasing element receiving portion 236 can be sized, shaped, and configured to receive the biasing element 234 in a normal or unbiased position, such that the outer surface of the biasing element 234 extends into each of the channels 210, 214. The biasing element receiving portion 236 can also be sized, shaped, and configured to allow the biasing element 234 to press against or otherwise conform to the actuating element 208 and / or the actuating sheath 224 as they extend through the channels 210, 214, such that the biasing element 234 can exert a biasing force on the actuating element 208 and / or the actuating sheath 224. The biasing element receiving portion 236 can also hold the biasing element 234 such that the biasing element 234 is retained in place at the proximal portion of the body 202 and is prevented from rotating within the body 202.

[0090] In some embodiments, the actuating assembly 200 also includes a cap 238 configured to be inserted into or otherwise disposed within the proximal end 204 of the body 202. The cap 238 can be configured to connect the first and second halves 202a, 202b of the body 202 to each other. The cap 238 can also leave a space in the body 202 for the biasing element 234 to be inserted after the halves 202a, 202b are locked to each other, such as to facilitate manufacture. As shown in FIGS. 27A - 27B, the cap 238 can include a prong 240 extending distally using a flange or protrusion that engages a detent at the proximal ends of the first and second halves 202a, 202b. When the cap 238 is inserted into the proximal end 204 of the body 202, the prong 240 can connect with the detents of the first and second halves 202a, 202b to connect the first and second halves 202a, 202b to each other.

[0091] The cap 238 may also assist in closing the proximal end 204 of the body 202 and aligning the actuating element 208. In some embodiments, the cap 238 includes notches 242 on both sides of the cap 238. Each notch 242 may define an edge or side of one of the proximal openings 212, 216. In some embodiments, the cap 238 may abut or otherwise contact the biasing element 234 such that the biasing element 234 remains in a desired position within the body 202, such as within the biasing element receiving portion 236. For example, the cap 238 may abut the biasing element 234 such that the biasing element 234 remains in place within the body 202 as the biasing element 234 moves between a relaxed position and a biased position. The cap 238 may include a ledge 244 that extends between the prongs 240 and defines a space, such as a slot, between the ledge 244 and the proximal end of the cap 238. The proximal end of the biasing element 234 may extend radially inwardly toward the center of the body 202 and include protrusions separated by a gap. When the biasing element 234 is disposed within the biasing element receiving portion 236 and the cap 238 is coupled to the proximal end 204 of the body 202, the radially inner protrusions of the biasing element 234 may extend around the ledge 244 and into the gap between the ledge 244 and the proximal portion of the cap 238. By disposing the biasing element 234 within the gap of the cap 238, the biasing element 234 is maintained within the biasing element receiving portion 236 as the biasing element 234 moves between a relaxed position and a biased position, and the radially inner protrusions of the biasing element 234 are ensured to be in a bent position and maintain the shape of the biasing element 234.

[0092] In some embodiments, as shown in FIG. 28, the actuating sheath 224 may include a groove or constriction 246 near the distal end of the actuating sheath 224. The constriction 246 may be a rounded or grooved channel that extends circumferentially around the distal portion of the actuating sheath 224 and extends radially inwardly from the remainder of the outer surface of the actuating sheath 224. When the actuation assembly 200 is in the non-actuated configuration, the actuating sheath 224 may be inserted into the first and second channels 210, 214, and the constriction 246 of each actuating sheath 224 is disposed adjacent to the biasing element 234. By disposing the constriction 246 adjacent to the biasing element 234, the biasing element 234 may be able to move to its relaxed state, such as when the device 100 is being packaged. The constriction 246 may also be disposed at a predetermined distance from the control actuator 230, such as the distance from the control actuator 230 corresponding to the starting or non-deployed position of the grasping device 104. In embodiments without the actuating sheath 224, the actuating element 208 may include a similar constriction 246.

[0093] The actuation assembly 200 has been described as including a single leaf spring biasing element 234 disposed within the biasing element receiving portion 236, but it will be understood that the actuation assembly 200 may have other suitable configurations and assemblies to maintain the translational and / or rotational positions of the actuating element 208 and / or the actuating sheath 224 extending through the channels 210, 214. For example, the biasing element 234 may be a helical spring, a coil spring, a worm spring, or an assembly thereof, or other device configured to exert a biasing force on one or more of the actuating elements 208 and / or the actuating sheath 224, or may be part of the body 202, as described below. Further, although the actuation assembly 200 has been described as including a single biasing element 234 configured to exert a biasing force on each of the actuating elements 208, it will be understood that the actuation assembly 200 may have one or more biasing elements 234 configured to exert a biasing force on one or more of the actuating elements 208.

[0094] The actuation assembly 200 may also include one or more biasing elements 234 configured to return the control actuator 230 to the starting position to prevent accidental operation of the actuation assembly 200 and / or to capture tissue grasped toward the catheter 302. As shown in FIG. 29, the actuation assembly 200 includes biasing elements 234 disposed around each actuation element 208 between the proximal end 204 of the body 202 and the distal end of each control actuator 230. The biasing element 234 may be a coil spring disposed around the actuation element 208 such that the actuation element 208 can rotate within the biasing element 234. In the relaxed or unbiased position, the biasing element 234 may space the body 202 from the control actuator 230 such that the grasping device 104 is substantially disposed in the undeployed position. Since the control actuator 230 is operated to control the position and rotation of the actuation element 208 and the grasping device 104, the biasing element 234 may compress such that the grasping device 104 deploys to grasp tissue.

[0095] The actuation assembly 200 has been described as including an additional biasing element 234 operable to apply a biasing force to the actuation element 208 that can maintain the position and rotation of the actuation element 208, but the actuation assembly 200 can include other configurations and assemblies for maintaining the position and rotation of the actuation element 208, such as when the user releases the control actuator 230. Additionally or alternatively, as shown in FIGS. 30A - 30, the biasing element 234 can be one or more biasing protrusions 248 of the body 202 that extend laterally within or across one of the channels 210, 214. Each biasing protrusion 248 can extend laterally at least partially across one of the channels 210, 214 from an outer portion of the body 202. The biasing protrusion 248 can be molded or cut into the body 202, such as within halves 202a, 202b. The biasing protrusions 248 can be connected to the body 202 across their respective channels 210, 214 and can extend inwardly (e.g., laterally inwardly) into their respective channels 210, 214. Each biasing protrusion 248 can be pivotable from a flexed position where the biasing protrusion 248 pivots downwardly to a normal or relaxed position where the biasing element 248 pivots upwardly within the channels 210, 214 and a position where the biasing protrusion 248 is disposed below the remainder of the channels 210, 214.

[0096] The biasing protrusion 248 can be biased or otherwise configured to normally project radially inwardly within the channels 210, 214 to engage the actuating element 208 and / or the actuating sheath 224 disposed through the respective channels 210, 214. In some embodiments, the upper surface of the biasing protrusion 248 includes an engaging portion configured to engage the outer surface of the actuating element 208 and / or the actuating sheath 224 disposed within the channels 210, 214. When the biasing protrusion 248 engages the actuating element 208 and / or the actuating sheath 224, the biasing protrusion 248 can exert a compressive force and / or a frictional force on the actuating element 208, thereby preventing the actuating element 208 and / or the actuating sheath 224 from translating and / or rotating. In some embodiments, the biasing protrusion 248 has a surface sized, shaped, or configured to correspond to the size and shape of the actuating element 208 or the actuating sheath 224 such that the biasing protrusion 248 prevents or otherwise limits the actuating element 208 and / or the actuating sheath 224 from translating and / or rotating when the biasing protrusion 248 engages the actuating element 208 and / or the actuating sheath 224. The biasing protrusion 248 is configured to bend or otherwise flex radially outwardly from the channels 210, 214 when the actuating element 208 is operated by a user. When the biasing protrusion 248 bends away from or otherwise disengages from the actuating element 208, the actuating element 208 can translate and rotate within the channels 210, 214.

[0097] Additionally or alternatively, the actuating element 208, the actuating sheath 224, and / or the channels 210, 214 of the body may be sized, shaped, and configured to maintain the position and rotation of the actuating element 208, such as when the user releases the control actuator 230. For example, each actuating element 208 and / or actuating sheath 224 may include one or more radially outwardly extending protrusions and / or one or more radially extending depressions disposed about the outer surface of the proximal portion of the actuating element 208 along its length. The protrusions and depressions may be formed by creating grooves or channels within the actuating element 208 and / or actuating sheath 224. The body 202 may correspondingly include one or more radially inwardly extending depressions and one or more radially outwardly extending protrusions disposed about the inner surface of the channels 210, 214 along its length. The protrusions and / or depressions of the actuating element 208 may correspond to the depressions and / or protrusions of the body 202 at various positions and rotations of the actuating element 208 relative to the body 202. Interaction between the protrusions and / or depressions of the working element 208 and the depressions and / or protrusions of the body 202 may prevent or otherwise limit the linear and rotational movement of the actuating element 208 from such positions. The interaction may also provide detectable feedback to the user regarding the movement of the actuating element 208 and / or actuating sheath 224, as described below.

[0098] Referring now to FIGS. 31-34B, the actuation assembly 200 may include one or more clamps 250 configured to prevent or otherwise limit the translational and rotational movement of the actuation element 208, such as through frictional engagement with the actuation element 208 and / or the actuation sheath 224. As shown in FIG. 31, the clamp 250 may be disposed within the body 202 between the channels 210, 214. The clamp 250 extends at least partially into each of the channels 210, 214 such that the clamp 250 may contact each actuation element 208 and / or actuation sheath 224 disposed through the channels 210, 214. The clamp 250 may be sized, shaped, and configured to impart a frictional force to the actuation element 208 and / or actuation sheath 224 disposed through the channels 210, 214. The frictional force may be large enough such that the engagement between the clamp 250 and the actuation element 208 and / or actuation sheath 224 maintains the linear and rotational position of the actuation element 208 within the channels 210, 214, such as when the operator releases the control actuator 230. The frictional force may also be small enough such that the actuation element 208 may be easily moved and rotated within the channels 210, 214, such as by the operator through the control actuator 230. The illustrated embodiment includes a single clamp 250 disposed within the body 202 to maintain the respective position and rotation of the actuation element 208, but it will be understood that the actuation assembly 200 may have other configurations and assemblies. For example, the actuation assembly 200 may include separate clamps 250 configured to extend into each of the channels 210, 214, and / or the actuation assembly 200 may include clamps 250 disposed at two or more positions along the length of the channels 210, 214. In some embodiments, the clamp 250 is biased, such as by a spring, to control the translation and rotation of the actuation element 208.

[0099] As shown in FIGS. 32A-32B, the clamp 250 can be operably coupled to the proximal end of each of the actuating element 208 and / or the actuating sheath 224 (not shown), such as a portion of each actuating element 208 between the body 202 and the control actuator 230, to maintain the translational and rotational positions of the actuating element 208. The clamp 250 can have two or more engagement portions, each engagement portion being configured to be disposed substantially around a proximal portion of one of the actuating element 208 and / or the actuating sheath 224. The engagement portion can be substantially circular having a slit configured such that the engagement portion can be disposed around an outer surface of one of the actuating element 208 and / or the actuating sheath 224. The inner surface of the engagement portion can have a liner, such as an elastomeric liner, configured to impart frictional force to the respective actuating element 208 and / or the actuating sheath 224. The clamp 250 can maintain the rotational and translational positions of the actuating element 208 when each engagement portion of the clamp 250 is disposed around the actuating element 208. The engagement portion can be disposed around the actuating element 208, such as after the actuating element 208 has been linearly and rotationally positioned, and the clamp 250 can impart sufficient frictional force to the actuating element 208 to maintain the translational and rotational positions of the actuating element 208.

[0100] Additionally or alternatively, the actuating assembly 200 may include a clamp 250 configured to be disposed around the control actuator 230 to maintain the translational and / or rotational position of the actuating element 208. The clamp 250 may include one or more bores configured to receive the control actuator 230. Each bore may be sized, shaped, and configured to be disposed over one of the control actuators 230 and impart a frictional force to the control actuator 230 to prevent or otherwise limit rotation of the control actuator 230. The inner surface of each bore may have a liner, such as an elastomeric liner, configured to impart a frictional force to the respective control actuator 230. Additionally or alternatively, the inner surface of each bore may include teeth or gripping members that engage the control actuator 230. The clamp 250 may be disposed around the control actuator 230, such as after the actuating element 208 has been rotationally positioned, and the clamp 250 may impart a frictional force to the control actuator 230 sufficient to maintain the rotational position of the actuating element 208.

[0101] As shown in FIG. 33, the actuation assembly 200 may include a clamp 250 (not shown) disposed about each actuation element 208 and / or the actuation sheath 224. Each clamp may be substantially tubular and operable to slide along the length of the actuation element 208 and / or the actuation sheath 224. During operation, the clamp 250 may be disposed between the body 202 and each respective control actuator 230 such that the control actuator 230 may be operated to control the translation and rotation of the actuation element 208. After one of the control actuators 230 is operated to translate and / or rotate each respective actuation element 208, such as to deploy one of the grasping devices 104 to grasp tissue, each clamp 250 may be radially slid along the actuation element 208 such that the clamp 250 is partially disposed in each respective proximal opening 212, 216. The clamp 250 may be disposed between the proximal openings 212, 216 and the actuation element 208 and / or the actuation sheath 224 such that the translational and rotational positions of the actuation element 208 are maintained. For example, the clamp 250 may be sandwiched between the edges of the proximal openings 212, 216 and the actuation element 208 or the actuation sheath 224 to prevent or otherwise limit rotation or translation of the actuation element 208 and / or the actuation sheath 224.

[0102] After one of the control actuators 230 is operated and the respective clamps 250 are moved to maintain the position of the respective actuating elements 208, the process can be repeated with the other control actuators 230 and the other clamps 250. Further, one or both of the clamps 250 can be retracted proximally from the respective proximal openings 212, 216 so that the actuating element 208 can be translated and / or rotated via the respective control actuator 230. In some embodiments, the inner and / or outer surfaces of the clamp 250 include protrusions and slots corresponding to the protrusions and slots of the channels 210, 214, proximal openings 212, 216, actuating element 208, and / or actuating sheath 224 so that the clamp 250 operably interlocks with the body 202, actuating element 208, and / or working sheath 224 to prevent or, in other cases, limit the translation and rotation of the actuating element 208.

[0103] Referring to FIGS. 34A-34B, the body 202 can include two clamps 250 disposed on the proximal end 204 of the body 202 on either side of the actuating element 208, such as near the proximal openings 212, 216. The clamp 250 can be slidable along the proximal end 204 of the body 202 between a first position (FIG. 34A) where the clamp 250 is spaced from the actuating element 208 and a second position (FIG. 34B) where the clamp 250 contacts the actuating element 208. When the clamp 250 is in the first position, the actuating element 208 is relatively unconstrained and can translate and rotate freely. When the clamp 250 is in the second position, the clamp 250 can at least partially surround the actuating element 208 such that the rotational and translational positions of the actuating element 208 are maintained without user intervention. In such embodiments, the actuating element 208 can have an oval cross-section so that the clamp 250 maintains better retention of the actuating element 208.

[0104] Each clamp 250 may be movable independently, such as to independently lock any of the actuating elements 208. In some embodiments, the clamp 250 is slidable by a user. In other embodiments, the clamp 250 is biased toward the actuating element 208, such as by a spring, such that the clamp 250 engages the actuating element 208 without user operation. Additionally, any of the clamps 250 of FIGS. 31-33 may be biased, such as via a spring, to contact and / or apply a force to the actuating element 208 to prevent or otherwise limit movement or rotation of the actuating element 208.

[0105] Additionally or alternatively, the actuation assembly 200 may include other configurations or assemblies configured to hold the position and / or rotation of the actuating element 208. In some embodiments, the actuation assembly 200 includes a fastener disposed distally of the body 202 around the actuating element 208 and operable to engage the body 202. The fastener may be operably engaged with the actuating element 208 to prevent or otherwise limit movement and / or rotation of the actuating element 208, such as by friction or interference fit with the actuating element 208. The actuation assembly 200 may also include an engagement element, such as a slider, button, etc., disposed on the outer surface of the body 202 or cover 228 and operable to engage one of the one or more clamps 250 with the actuating element 208 and / or the actuation sheath 224. For example, the actuation assembly 200 includes an engagement element on the proximal end 204 of the body 202 operable to laterally engage and disengage the clamp 250 around the outer surface of each respective actuating element 208 and / or actuation sheath 224, and may maintain the position and rotation of the actuating element 208.

[0106] Additionally or alternatively, channels 210, 214 of body 202 can be sized, shaped, and configured to impart frictional force to actuating element 208 to maintain the linear and / or rotational position of actuating element 208 without input from the user. For example, the inner surfaces of channels 210, 214, or liners disposed on the inner surfaces of channels 210, 214 can include a plurality of protrusions or teeth that impart frictional force to actuating element 208 and / or actuating sheath 224. The liner can be a wire mesh disposed through channels 210, 214. The protrusions or teeth can be disposed on opposite sides of channels 210, 214 such that the protrusions or teeth impart compressive or frictional force to the opposite sides of actuating element 208 and / or actuating sheath 224. The frictional and / or compressive force can be large enough such that the linear and rotational positions of actuating element 208 are maintained without input from the user. The frictional and / or compressive force can also be small enough such that, for example, an operator can easily move and rotate actuating element 208 within channels 210, 214 via control actuator 230.

[0107] Further, actuating element 208 or actuating sheath 224 can include a plurality of radially outwardly extending fins that control the position and rotation of actuating element 208 and / or actuating sheath 224. The fins can engage the surfaces of channels 210, 214 and can be configured to allow actuating element 208 and / or actuating sheath 224 to rotate easily in one direction (e.g., the deployment direction) and to prevent or limit rotation in the opposite direction (e.g., the release direction). The fins can be configured to maintain the position and rotation of actuating element 208 and / or actuating sheath 224 until sufficient force is provided by the user, such as to rotate and / or translate actuating element 208 and / or actuating sheath 224. The fins can also be configured to reverse or change direction when sufficient force is applied such that actuating element 208 can rotate smoothly in the opposite direction.

[0108] As shown in FIG. 35, the actuation assembly 200 may include a lock 292 configured to operably maintain rotation and translation of a distal actuation element 208 from a body 202. The actuation element 208 may extend from channels 210, 214 through the lock 292. The lock 292 may be coupled to the body 202 and / or a cover 228. The lock 292 may be movable between an unlocked position in which the actuation element 208 may translate and rotate through the lock 292, and a locked position in which the rotational and translational position of the actuation element 208 is maintained. The lock 292 may have a constricted opening that is operable by rotation of the lock 292. For example, the lock may be rotated from the unlocked position such that the constricted opening closes around the actuation element 208 in the locked position, preventing or otherwise restricting the actuation element 208 from rotating or translating through the lock 292. In other embodiments, the lock 292 may be squeezable or compressible to move from the unlocked position to the locked position.

[0109] Now referring to FIGS. 36A - 38G, the actuation assembly 200, such as the actuation element 208 and / or the actuation sheath 224, may be configured to provide detectable feedback, such as tactile feedback and / or audible feedback, regarding movement of the actuation element 208. The feedback may notify an operator at intervals of the amount by which the actuation element 208 has rotated and / or the amount by which the actuation element 208 has translated linearly. For example, a biasing element 234 may abut an outer surface of the actuation sheath 224 or the actuation element 208 during operation to create audible feedback and / or tactile feedback as the actuation element 208 is translated and / or rotated. The illustrated embodiment describes the feedback as being generated by the biasing element 234, but the feedback may similarly be generated by a clamp 250 (e.g., FIG. 31).

[0110] As shown in FIGS. 36A - 36B, the actuating element 208 may have a non - circular cross - section such that feedback, such as a click sound, occurs at the rotational interval of the operation of the actuating element 208 and / or the actuating sheath 224, for example, each time the actuating element 208 rotates by a given amount, due to the abutment between the actuating element 208 and the biasing element 234. The actuating element 208 may have a width with respect to the biasing element 234 that changes as the actuating element 208 rotates within the channels 210, 214. For example, the actuating element 208 may be oval, triangular, rectangular, or otherwise, oblong, such that the width of the actuating element 208 changes with respect to the biasing element 234 as the actuating element 208 rotates. The actuating element 208 may have a first width or diameter at a first rotational position and a different second width or diameter at a second rotational position, and as a result, feedback is generated to notify the operator of the rotation of the actuating element 208 and the gripping device 104 based on the relationship between the first width or diameter and the second width or diameter.

[0111] It will be understood that any actuating element 208 of other embodiments may similarly be oval, triangular, rectangular, or otherwise, oblong in some cases. The actuating element 208 may have a cross - sectional shape different from the cross - sectional shape of the channels 210, 214, or the lumen of the catheter 302. For example, the lumen of the channels 210, 214 or the catheter 302 may be circular, while the actuating element 208 may be oblong. The difference in the shape of the actuating element 208 from the lumen of the channels 210, 214 or the catheter 302 may reduce the friction between the actuating element 208 and the channels 210 and / or the catheter 302, such as when the actuating element 208 is translated and / or rotated.

[0112] As shown in FIG. 36A, the actuating element 208 may have a first width or diameter in a first rotational position such that the actuating element 208 does not contact the biasing element 234. As shown in FIG. 36B, the actuating element 208 may have a second width or diameter in a second rotational position such that the actuating element 208 contacts the biasing element 234. When one of the actuating elements 208 rotates from the first rotational position to the second rotational position, an audible click sound and / or tactile feedback may be created by the contact between the actuating element 208 and the biasing element 234. The feedback may notify the operator of the amount by which the actuating element 208 has rotated.

[0113] Additionally or alternatively, the actuating element 208 and / or the biasing element 234 may include one or more protrusions that cause similar feedback when the actuating element 208 rotates a given amount. The feedback may correspond to the tissue engagement depth based on the rotational speed of the grasping device 104. For example, the actuating element 208 and the biasing element 234 may be sized, shaped, and configured such that contact between one of the biasing element 234 and the actuating element 208 causes audible feedback and / or tactile feedback every 90 degrees, every 180 degrees, or every 360 degrees that the actuating element 208 rotates.

[0114] Although detectable feedback has been described as being created by contact between one of the biasing element 234 and the actuating element 208, it will be understood that the feedback may be created in other ways. For example, the actuating sheath 224 may have a similarly varying width or diameter that contacts the biasing element 234 to cause feedback regarding rotation of the actuating element 208. Additionally, the body 202 of the actuating assembly 200 may be configured to engage similarly to the actuating element 208 and / or the actuating sheath 224 to cause feedback as the actuating element 208 rotates.

[0115] As shown in FIGS. 37A - 37B, each time the actuating element 208 translates by a given interval or distance, the actuating element 208 may include one or more protrusions 252 that extend radially outward from the remainder of the actuating element 208 and / or one or more recesses 254 that extend radially inward from the remainder of the actuating element 208, such that the biasing element 234 produces detectable feedback such as a clicking sound. The protrusions 252 and recesses 254 may extend circumferentially around the actuating element 208. The protrusion 252 may have a width that contacts the biasing element 234 when the protrusion 252 is laterally aligned with the biasing element 234, and the recess may have a width that does not contact the biasing element 234 when the recess 254 is laterally aligned with the biasing element 234. Variations in the width along the longitudinal axis of the actuating element 208 may produce feedback that notifies the operator of the translation of the actuating element 208 and the gripping device 104.

[0116] As shown in FIG. 37A, the actuating element 208 may be disposed within the channels 210, 214 in a stationary position where the protrusions 252 and recesses 254 are proximal to the biasing element 234. As shown in FIG. 37B, the actuating element 208 extends distally through the channels 210, 214 such that one of the protrusions 252 contacts the biasing element 234. Contact between the protrusion 252 and the biasing element 234 may produce feedback that notifies the operator that the actuating element 208 has extended a given distance. As the actuating element 208 subsequently extends through the channels 210, 214, the biasing element 234 may alternately contact subsequent protrusions 252 without contacting the recesses 254. The number of times feedback such as the number of clicking sounds occurs may notify the operator of the distance the actuating element 208 has extended.

[0117] Further, the protrusions 252 and the recesses 254 can be configured to control the movement of the actuating element 208 during operation. The protrusions 252 can be configured to contact the biasing element 234 such that when the biasing element 234 abuts or otherwise contacts the protrusions 252, the translational position and / or rotational position of the actuating element 208 is maintained. For example, the protrusions 252 can be disposed at various positions along the length of the actuating element 208 such that the translational position and rotational position of the actuating element 208 can be locked or otherwise maintained at various positions. The actuating element 208 can translate and rotate relatively freely when the recesses 254 are aligned with the biasing element 234.

[0118] As shown in FIGS. 38A-38G, the actuation assembly 200 can include a biasing element 234 extending within each of the channels 210, 214 to control the position and rotation of the actuation sheath 224 and / or the actuating element 208 as described above. The biasing element 234 and / or the actuation sheath 224 can also be sized, shaped, and configured to produce detectable feedback when the actuation sheath 224 rotates at a given interval. In the illustrated embodiment, the biasing element 234 is a rounded flexible portion of the body 202 that extends partially within and contacts the actuation sheath 224 extending therethrough. The biasing element 234 can be an internally molded polymer spring molded within the body 202. The actuation sheath 224 is integral with the actuating element 208. The actuation sheath 224 can be a polymer overmolded on the actuating element 208. The actuation sheath 224 can include a polymer, stainless steel, or a polymer and stainless steel composite assembly.

[0119] Each biasing element 234 extends into adjacent channels 210, 214 and includes a tab or projection 235 (FIG. 38G) that can contact the actuating sheath 224 when the actuating sheath 224 is rotated within the channels. Each actuating sheath 224 can include a longitudinal channel 245 extending along the length of the actuating sheath 224 (FIG. 38F). The longitudinal channel 245 may be substantially flat. The longitudinal channel 245 and the biasing element 234 are configured such that when the actuating element 208 rotates to a position where the longitudinal channel 245 is aligned with the biasing element 234, the biasing element 234 can bend outwardly and the projection 235 can contact the longitudinal channel 245. The longitudinal channel 245 and the biasing element 234 are also configured such that when the longitudinal channel 245 rotates out of alignment with the biasing element 234, the biasing element 234 can bend inwardly or disengage from the longitudinal channel 245 and the projection 235 can contact other portions of the outer surface of the actuating sheath 224.

[0120] As the actuating sheath 224 rotates within the channels 210, 214, contact between the biasing element 234 and the actuating sheath 224 causes feedback detectable by the user at intervals of rotation of the actuating element 208 and / or the actuating sheath 224, such as each time the biasing element 234 engages and / or disengages from the longitudinal channel 245. For example, contact between the biasing element 234 and the actuating sheath 224 can generate a click sound and / or tactile feedback each time the biasing element 234 engages and / or disengages from the longitudinal channel 245, such as every 360 degrees of rotation of the control actuator 230 and the actuating sheath 224. In the illustrated embodiment, the actuating sheath 224 includes one longitudinal channel 245 each. However, it will be understood that the actuating sheath 224 can include other numbers of longitudinal channels 245. For example, the actuating sheath 224 can include two longitudinal channels 245 on both sides of the actuating sheath 224 such that feedback is generated each time the control actuator 230 and the actuating sheath 224 rotate 180 degrees, or the actuating sheath 224 can include three longitudinally spaced-apart longitudinal channels 245 around the actuating sheath 224 such that feedback is generated each time the control actuator 230 and the actuating sheath 224 rotate 120 degrees, or the actuating sheath 224 can include four longitudinally spaced-apart longitudinal channels 245 around the actuating sheath 224 such that feedback is generated each time the control actuator 230 and the actuating sheath 224 rotate 90 degrees.

[0121] In some embodiments, as shown in FIG. 38F, each control actuator 230 includes an extrusion portion 247 that extends laterally from one side of the control actuator 230. The extrusion portion 247 can indicate the relative rotational positions of the respective actuating sheaths 224, actuating elements 208, and gripping device 104 with respect to the user, such as with respect to the finger of the user during operation. The extrusion portion 247 can be disposed on the control actuator 230 such that the extrusion portion 247 extends vertically when the control actuator 230, actuating sheath 224, actuating element 208, and / or gripping device 104 are in a non-deployed and non-rotated position, such as when the device 100 is packaged. As the control actuator 230, actuating sheath 224, and actuating element 208 rotate, the extrusion portion 247 can rotate around the actuating sheath 224 to indicate the relative orientation of the gripping device 104. Although the extrusion portion 247 has been described as extending from the control actuator 230, it will be understood that the extrusion portion 247 can similarly extend from the side of the actuating sheath 224.

[0122] In some embodiments, as shown in FIG. 38E, the cover 228 includes a window 249 disposed at the distal end of the cover 228. The window 249 can make it easier to injection mold the cover 228. Also, the window 249 can make it easier for the user to grip the cover 228 during operation. Also, the window 249 can reduce the overall cost of the device 100 and the materials required to assemble the device 100 can be reduced.

[0123] Feedback has been described as being created by contact between the biasing element 234 and one of the protrusions 252, but it will be understood that feedback can be created in other ways. For example, the actuating sheath 224 can have a similarly varying width or diameter that contacts the biasing element 234 to create feedback regarding the translation of the actuating element 208. Further, the body 202 of the actuating assembly 200 can be configured to engage the actuating element 208 and / or actuating sheath 224 in a similar manner to create feedback as the actuating element 208 translates.

[0124] The actuation assembly 200 of FIGS. 38A-38G has been described as causing feedback regarding either rotation of the actuation element 208 or translation of the actuation element 208, but it will be understood that the actuation assembly 200 can be configured and assembled to cause feedback regarding both rotation and translation of the actuation element 208. For example, the actuation element 208 can have various widths or diameters at different rotational positions to cause feedback regarding rotation of the actuation element 208, and can also include protrusions 252 and / or recesses 254 to cause feedback regarding translation of the actuation element 208. Further, any of the actuation assemblies 200 described herein can include a biasing element 234, a protrusion 235, a longitudinal channel 245, and an extrusion 247 as described with respect to FIGS. 38A-38G.

[0125] As shown in FIG. 39, the actuation assembly 200 can include a strain relief tube 260 and a distal coupler 262. The strain relief tube 260 can be disposed around one or more catheters 302 and the actuation element 208. The strain relief tube 260 can have an inner diameter larger than that of the catheter 302 such that the strain relief tube 260 can be disposed around at least the proximal portion of the catheter 302. The strain relief tube 260 can be operable to reduce stress and / or tension on the catheter 302 and / or the actuation element 208 during operation, such as to prevent the catheter 302 and / or the actuation element 208 from buckling during operation. The strain relief tube 260 can include HDPE, PTFE, LDPE, PE, or other similar polymers, shape memory metals such as nitinol, stainless steel, heat shrink, overmolded polymer tubes, flexible metals, etc., or combinations. In a preferred embodiment, the strain relief tube 260 includes HDPE. In some embodiments, the strain relief tube 260 extends from the proximal end of the catheter 302 to the distal end of the catheter 302. In other embodiments, the strain relief tube 260 extends along the proximal portion of the catheter 302.

[0126] The distal coupler 262 is configured to couple the body 202 or the cover 228 to the catheter 302 and / or the tension relief tube 260. The distal coupler 262 can be coupled to the body 202, the cover 228, the catheter 302, and / or the tension relief tube 260 via an adhesive, welding, fasteners, overmolding, heat stake ing, etc., or a combination thereof. In a preferred embodiment, the distal coupler 262 is overmolded onto the catheter 302 and / or the tension relief tube 260 and press-fit or snap-fitted into the distal end of the cover 228. In some embodiments, the distal coupler 262 includes one or more ribs 264. The proximal end of the distal coupler 262 can include ribs 264 configured to maintain the rotational coupling and the positional coupling of the cover 228 and the distal coupler 262. For example, the rib 264 can fit into the slot of the cover 228 to prevent rotation of the catheter 302 relative to the body 202 and the cover 228. The distal end of the distal coupler 262 can also include one or more ribs 264 configured to increase the rigidity of the distal coupler 262 during operation.

[0127] In some embodiments, a tissue capture device 100, such as the actuation assembly 200, may include a mark or other indicia to assist an operator in identifying and manipulating the gripping devices 104a, 104b, such as during a procedure. In some embodiments, one of the first and second gripping devices 104a, 104b (FIG. 18) includes a mark or other indicia to assist an operator in identifying the first and second gripping devices 104a, 104b. In other embodiments, the first gripping device 104a includes a first mark or indicia, and the second gripping device 104b includes a second mark or indicia different from the first mark or indicia to assist an operator in identifying the first and second gripping devices 104a, 104b. For example, the first gripping device 104a may have a color different from the second gripping device 104b. In some embodiments, the corresponding catheter 302 (or the lumen of the catheter 302) and / or the corresponding actuation element 208 may also include a mark or other indicia corresponding to the gripping devices 104a, 104b to assist an operator in identifying the first and second gripping devices 104a, 104b.

[0128] In some embodiments, the actuation assembly 200 may also include a mark or other indicia to assist an operator in identifying the components of the actuation assembly 200 in order to control the respective gripping devices 104a, 104b, such as during operation. For example, one or more of the cover 170, the corresponding translational control actuator 230a, the rotational control actuator 230b, and the optional operation control actuator 230c may include a mark or other indicia corresponding to the corresponding gripping devices 104a, 104b.

[0129] Referring now to FIGS. 40 - 50, the actuation assembly 200 may have other configurations and assemblies for independently controlling the gripping devices 104. For example, the actuation assembly 200 may have different numbers of control actuators 230, different configurations or combinations of control actuators 230, different numbers of bodies 202, and different ways of independently translating, rotating, and optionally operating the gripping devices 104 via the actuation element 208 and the operation element 290.

[0130] As shown in FIG. 40, the actuating assembly may include a translational control actuator 230a for independently controlling the translation of the actuating element 208 and a separate rotational control actuator 230b for independently controlling the rotation of the actuating element 208. The translational control actuator 230a may be a slider that is translationally coupled to the distal end of the actuating element 208 such that the translational position of the actuating element 208 can be controlled via the translation of the respective control actuator 230a. The rotational control actuator 230b may be a rotational wheel that is rotationally coupled to the actuating element 208 such that the rotational position of the actuating element 208 can be controlled via the rotation of the respective control actuator 230b.

[0131] The body 202 includes two longitudinal slots 280 extending toward the proximal end of the body 202. The longitudinal slots 280 may extend through the body 202. Each longitudinal slot 280 is configured to receive one of the translational control actuators 230a such that the translational control actuator 230a can slide within the longitudinal slot 280. In some embodiments, the longitudinal slots 280 have a longitudinal length that is substantially equal to the desired translational operating distance of the actuating element 208 and the gripping device 104.

[0132] The body 202 also includes a transverse slot 282 distal to the longitudinal slots 280. The transverse slot 282 is configured to receive the rotational control actuators 230b in a transverse arrangement such that each rotational control actuator 230b can rotate independently within the transverse slot 282. The body 202 has been described as including a single transverse slot 282 for receiving both control actuators 230b, but it will be understood that the body 202 may include a transverse slot 282 for each control actuator 230b, or that the transverse slot 282 may be proximal to the longitudinal slots 280. Further, the body 202 may include a biasing element, such as a spring, disposed within the transverse slot 282 and operable to bias the rotational control actuator 230b, such as to provide linear control and rotational control.

[0133] The channels of the body 202 can be configured such that each actuating element 208 extends through one of the rotational control actuators 230b in the lateral slot 282 and is coupled to a translational control actuator 230a disposed within the corresponding longitudinal slot 280. Each actuating element 208 extends through its respective rotational control actuator 230b such that the actuating element 208 can translate proximally and distally through the rotational control actuator 230b. Each actuating element 208 is coupled to the rotational control actuator 230b such that rotation of the rotational control actuator 230b translates into rotation of the actuating element 208 and the gripping device 104. For example, the rotational control actuator 230b can have an internal channel sized, shaped, or configured to operate on the size, shape, and configuration of the actuating element 208 to rotate the actuating element 208 while allowing the actuating element 208 to freely translate through the rotational control actuator 230b.

[0134] The proximal end of each actuating element 208 is coupled to its respective translational control actuator 230a such that translation of the respective translational control actuator 230a within the longitudinal slot 280 translates into translation of the actuating element 208 and the corresponding gripping device 104. The actuating element 208 can be coupled to the translational control actuator 230a such that the actuating element 208 can rotate independently within the translational control actuator 230a. For example, the proximal end of the actuating element 208 can be coupled to the translational control actuator 230a via a ball joint, bearing, rotary coupling, slip ring, or other rotation-permissive coupling.

[0135] The body 202 can be reflected, for example, to enable better alignment of the gripping device 104 during operation. In some embodiments, the control actuators 230a, 230b extend through the body 202 such that the control actuators 230a, 230b are accessible from either side of the body 202.

[0136] In some embodiments, as shown in FIGS. 41A-41B, the actuation assembly 200 may include a control actuator 230 linearly arranged along the length of the body 202, and each control actuator 230 is operable to control one translation and rotation of the gripping device 104. For example, the control actuators 230 may be linearly aligned so that the body 202 is thinner and easier to hold.

[0137] The body 202 may include two longitudinal slots 280 longitudinally aligned between the proximal end and the distal end of the body 202. Each longitudinal slot 280 includes a control actuator 230 slidably disposed therein. Each control actuator 230 is independently slidable within its respective longitudinal slot 280 to operably control one translation of the actuating element 208. In the illustrated embodiment, the actuation assembly 200 includes a first actuating element 208a and a second actuating element 208b. As shown in FIG. 41B, the actuating elements 208a, 208b may be offset perpendicular to each other.

[0138] Each longitudinal slot 280 may include a guide rail 278 extending along the length of the longitudinal slot 280. Each control actuator 230 may be slidably disposed on one of the guide rails 278, and the control actuator 230 may rotate on the guide rail 278 to operably rotate the actuating element 208. Each longitudinal slot 280 may have a longitudinal length substantially equivalent to the desired translational operating distance of the actuating element 208 and the gripping device 104.

[0139] The first actuating element 208a extends proximally through the body 202 and is coupled to the distal control actuator 230. The proximal end of the first actuating element 208a may be translationally and rotationally coupled to the distal control actuator 230. For example, the first actuating element 208a may be coupled to the distal control actuator 230 such that as the distal control actuator 230 slides along the guide rail 278 and rotates with the rotation of the distal control actuator 230, the first actuating element 208a translates.

[0140] As shown in FIG. 41B, the second actuating element 208b can extend proximally through the body 202 below the control actuator 230. The second actuating element 208b can extend into a channel or slot in the body 202. The proximal end of the second actuating element 208b can be coupled to the proximal control actuator 230 via one or more gears 274 (such as having a gear box 276, FIGS. 41B, 46A - 47B). The gear 274 can translate with the translation of the proximal control actuator 230 and can be configured to rotate with the rotation of the proximal control actuator 230. The second actuating element 208b can be translationally and rotationally coupled to the proximal control actuator 230 via the gear 274. For example, the second actuating element 208b can be coupled to the proximal control actuator 230 such that as the proximal control actuator 230 slides along the guide rail 278 and rotates with the rotation of the proximal control actuator 230, the second actuating element 208b translates. In the illustrated embodiment, the proximal end of the second actuating element 208b is coupled to the proximal control actuator 230 using two or more gears 274 arranged in series, so that the second actuating element 208b rotates in the same direction as the proximal control actuator 230.

[0141] Referring now to FIGS. 42 - 44, the actuating assembly 200 can include two or more bodies 202, and each body 202 is configured to independently control one of the gripping devices 104.

[0142] As shown in FIG. 42, the actuation assembly 200 includes two bodies 202, each having a translational control actuator 230a operable to control the translation of one of the actuation elements 208 and a rotational control actuator 230b operable to control the rotation of the other control element 208. Each body 202 may include a longitudinal slot 280 configured to receive one of the translational control actuators 230a such that the translational control actuator 230a can slide within the longitudinal slot 280. In some embodiments, the longitudinal slot 280 has a longitudinal length that is substantially equal to the desired translational actuation distance of the actuation element 208 and the gripping device 104. The translational control actuator 230a may be coupled to one of the actuation elements 208 such that the translation of the actuation element 208 is transmitted to the actuation element 208 and the gripping device 104. In some embodiments, the translational control actuator 230a may be configured to rotate within the longitudinal slot 280 along with the rotation of the actuation element 208.

[0143] The longitudinal slot 280 extends through an opening at the proximal end of the body 202. Each rotational control actuator 230b includes a stem 286 that extends proximally into the longitudinal slot 280 and is coupled to the proximal end of the actuation element 208. The stem 286 may be coupled to the proximal end of one of the actuation elements 208 such that the rotation of the rotational control actuator 230b is transmitted to the actuation element 208 and the gripping device 104. The stem 286 may be sized, shaped, and configured such that the rotational control actuator 230b remains coupled to the actuation element 208 when the control element 208 is translated. In some embodiments, the translational control actuator 230b may be omitted, and the rotational control actuator 230a may be operable to control the translation and rotation of the actuation element 208.

[0144] As shown in FIG. 43, one or more of the bodies 202 of the actuation assembly 200 of FIG. 43 may be operable to independently control the translation and rotation of the gripping device 104 and the operation (e.g., opening and closing) of the gripping device 104. Each body 202 may include an operation control actuator 230c disposed at the proximal end of the body 202 and including a stem 286 that extends into the longitudinal slot 280 and is connected to the proximal end of each operation element 290. Each operation control actuator 230c may be connected to the operation element 290 such that movement of the operation control actuator 230c can control the operation of the gripping device 104 connected to the operation element 290.

[0145] Each actuating element 208 may be connected to one of the control actuators 230 disposed within the longitudinal slot 280. The control actuator 230 may be slidable and rotatable within the longitudinal slot 280 such that rotation and translation of the control actuator 230 are transmitted to the actuating element 208 and the gripping device 104. In some embodiments, the operation element 290 extends through the control actuator 230 such that the actuating element 208 can pivot and translate independently of the operation control actuator 230c and the operation element 290 can be moved independently of the control actuator 230.

[0146] In some embodiments, one or more of the bodies 202 may include a biasing element 234 configured to hold the control actuator 230 in a non-operating position when the biasing element 234 is in a relaxed or normal state. For example, the biasing element 234 may be a helical coil configured to bias the control actuator 230 to a non-operating position and may be compressed when the control actuator 230 is translated distally to operate the gripping device 104. The actuating element 208 and the operation element 290 may extend through the biasing element 234 such that the operation element 290 can be translationally connected to the operation control actuator 230c and the actuating element 208 can be translationally and rotationally connected to the control actuator 230. The operation control actuator 230c may be biased in the same manner as the biasing element 234 disposed between the body 202 and the operation control actuator 230c.

[0147] In some embodiments, as shown in FIG. 43, the actuation assembly 200 includes one or more locks 292 operable to lock or otherwise prevent rotation and / or translation of the actuation element 208 and / or the manipulation element 290. The lock 292 can be disposed along the actuation element 208 and the manipulation element 290 between one of the body 202 and the catheter 302. The lock 292 can be movable between an open configuration that allows the actuation element 208 and the manipulation element 290 to translate and rotate therethrough and a closed configuration that substantially maintains the translational and rotational positions of the actuation element 208 and / or the manipulation element 290 disposed therethrough. For example, the lock 292 can be a constricted orifice or valve that can rotate to close the orifice such that the lock 292 moves from the open configuration to the closed configuration. In some embodiments, the lock 292 can maintain the translation and rotation of the actuation element 208 when the lock is in the closed position and at the same time allow the manipulation element 290 to be manipulated, such as when the manipulation element 290 extends through the interior of the actuation element 208.

[0148] In schematic views, each lock 292 is disposed between the body 202 and the catheter 302. However, it will be understood that the lock 292 can be disposed in other ways. For example, the lock 292 can be coupled to the distal end of the body 202 or the proximal end of the catheter 302. Additionally, any of the other actuation assemblies 200 can include one or more locks 292 operable to maintain the translational and / or rotational movement of the actuation element 208 and / or the manipulation element 290.

[0149] As shown in FIG. 44, the actuation assembly 200 includes two bodies 202, each having a translational control actuator 230 operable to control the translation and rotation of the actuation element 208. Each control actuator 230 includes a stem 286 that extends distally into a channel 210 that extends through the body 202. The channel 210 may have a distal opening sized and shaped to receive the actuation element 208 therethrough and prevent the stem 286 from extending distally out of the channel 210. The channel 210 also has a proximal opening sized and shaped to receive the stem 286 of the control actuator 230 therethrough. The stem 286 is operable to translate and rotate within the proximal portion of the channel 210. The actuation element 208 may extend into the catheter 302 from the distal end of the channel 210, respectively.

[0150] The actuation element 208 may be coupled to the control actuator 230 such that the control actuator 230 is operable to control the translation and rotation of the actuation element 208. The control actuator 230 is coupled to the actuation element 208 such that rotation of the control actuator 230 is transmitted to the actuation element 208. The stem 286 is linearly translatable within the proximal portion of the channel 210 to control the translation of the actuation element 208. The stem 286 and / or the channel 210 may be sized, shaped, and configured such that the stem 286 is longitudinally movable within the channel 210 a distance substantially equal to the desired translational operating distance of the actuation element 208 and the grasping device 104. The two control actuators 230 of the two bodies 202 may operate independently to independently control the translation and rotation of their respective actuation elements 208 and grasping devices 104.

[0151] Each body 202 may include one or more rings 288 configured for an operator to grasp during operation, such as while the operator operates the respective control actuator 230. For example, the operator may insert a finger into each of the rings 288 to control the body 202 and use a thumb or other hand to translate and / or rotate the control actuator 230.

[0152] The actuating assembly 200 of FIGS. 42-44 has been described as including two substantially similar bodies 202 for deploying the grasping device 104, but it will be understood that the actuating assembly 200 can have other configurations and assemblies. For example, the actuating assembly 200 can have a first body 202 having one or more control actuators 230 operable to control the translation and rotation of a first grasping device 104, such as a grasping device 104 having a helical coil 114, and a second body 202 having one or more control actuators 230 operable to control the translation, rotation, and operation of a second grasping device 104, such as a grasping device 104 having a movable jaw 113 that can open and close to grasp tissue.

[0153] Referring now to FIGS. 45-47A, the actuating assembly 200 can include a single translational control actuator 230a operable to control the linear position of the actuating element 208 and a single rotational control actuator 230b operable to control the rotation of the actuating element 208. The actuating assembly 200 can also include a single operation control actuator 230c operable to control the operation of the grasping device 104, such as opening and closing the grasping device 104.

[0154] As shown in FIG. 45, the actuating assembly 200 includes a first actuating element 208a and a first operating element 290a extending within the body 202 on a first side, and a second actuating element 208b and a second operating element 290b extending within the body 202 on a second side. The first actuating element 208a and the first operating element 290a can be operable to control the operation of the first grasping device 104a and the second actuating element 208b, and the second operating element 290b can be operable to control the operation of the second grasping device 104b.

[0155] The translational control actuator 230a is slidable on the guide rail 278 within the longitudinal slot 280 and controls the translational position of either the actuating elements 208a, 208b. The motion control actuator 230c is slidable on another guide rail 278 within another longitudinal slot 280 and controls the translational position of either the operating elements 290a, 290b. The rotational control actuator 230b is a rotary wheel disposed at the proximal end of the body 202 and configured to control the rotation of either the actuating elements 208a, 208b.

[0156] The actuation assembly 200 also includes a selector 272 slidably disposed within the lateral slot 282. The selector 272 may be slidable between a first position (e.g., left), a second position (e.g., center), and a third position (e.g., right). When the selector 272 is in the first position, the control actuators 230a, 230b, 230c may be coupled to the first actuating element 208a and the first operating element 290a so as to operate the first gripping device 104a. When the selector 272 is in the third position, the control actuators 230a, 230b, 230c may be coupled to the second actuating element 208b and the second operating element 290b so as to operate the second gripping device 104b. When the selector 272 is in the second position, the control actuators 230a, 230b, 230c may be disengaged from the actuating elements 208a, 208b and the operating elements 290a, 290b, such as to reset the positions of the control actuators 230a, 230b, 230c.

[0157] As shown in FIGS. 46A to 46C, selector 272 can operably connect translational control actuator 230a to the first actuating element 208a (FIG. 46A), or the second actuating element 208b (FIG. 46C), or may not be connected to any of the actuating elements 208 (FIG. 46B). Selector 272 can be connected to translational control actuator 230a, and translational control actuator 230a may be slidable on guide rail 278. As selector 272 moves within the lateral elongated hole 282, translational control actuator 230a can be connected to the first actuating element 208a (FIG. 46A), the second actuating element 208b (FIG. 46C), or may not be connected to any of the actuating elements 208 (FIG. 46B). When translational control actuator 230a is connected to any of the actuating elements 208a, 208b, actuating elements 208a, 208b can move translationally in cooperation with translational control actuator 230a. Operation control actuator 230c is similarly controlled by selector 272 and can selectively connect to the first operation element 290a, the second operation element 290b, or may not be connected to any of the operation elements 290.

[0158] As shown in FIGS. 47A to 47B, selector 272 can operably connect rotational control actuator 230b to the first actuating element 208a (FIG. 47A), the second actuating element 208b (FIG. 47B), or may not be connected to any of the actuating elements 208 (for example, the position between FIGS. 47A and 47B). Selector 272 can be connected to one or more gears 274 that slide or rotate with the selector. As selector 272 moves within the lateral elongated hole 282, gear 274 can rotate or slide such that rotational control actuator 230b is rotationally connected to the first actuating element 208a, the second actuating element 208b, or is not connected to any of the actuating elements 208.

[0159] In some embodiments, selector 272 may also be operable to control the directional coupling between control actuators 230a, 230b, 230c, actuating element 208, and operating element 290, such as between a forward direction and a reverse direction. In the illustrated embodiment, selector 272 is a slider. However, selector 272 may have other shapes, assemblies, and configurations. For example, selector 272 may be a lever or arm, a rotatable dial, etc.

[0160] Although control actuator 230a, which is operable to control the linear position of actuating element 208, has been described as a slider, control actuator 230a may have other configurations and assemblies. For example, control actuator 230a may be a linear pull trigger coupled to a handle that can be actuated by a user by pushing a trigger into a handle and extending an arm tangentially around a portion of body 202 to pivot the arm.

[0161] In some embodiments, actuation assembly 200 is configured to deploy one of gripping devices 104 in a single movement. Referring back to FIG. 29, actuation assembly 200 may include a control actuator 230 configured to be pushed by a user to move gripping device 104 from a retracted position to a deployed position. For example, actuation assembly 200 may be configured such that when control actuator 230 is pushed downward or clicked, gripping device 104 deploys.

[0162] The control actuator 230 can be biased to a non-operating position by a biasing element 234 such as a coil spring. The user can depress the control actuator 230 by applying a downward force sufficient to overcome the biasing element 234, such as to deploy the grasping device 104. The actuating element 208 (or the actuating sheath 224) and the channels 210, 214 can include slots or protrusions that, when the control actuator 230 is depressed, rotate the actuating element 208 sufficiently. For example, the channels 210, 214 can each have a helical groove extending therethrough, and the actuating element 208 (or the actuating sheath 224) can include a protrusion that slides within the helical groove. When the control actuator 230 is depressed and the actuating element 208 moves distally through the channel 210, the protrusion of the actuating element 208 can advance into the helical groove of the channel 210 such that the actuating element 208 rotates sufficiently for the grasping device 104 to be deployed into tissue.

[0163] Referring now to FIGS. 48-50, each actuating element 208 can be translationally and / or rotationally controlled in other ways. The illustrated methods of translational and / or rotational control can be incorporated for any of the actuating assemblies 200 described herein. Each body 202 can include one or more guide rails 278 extending along the length of the body 202. The actuating assembly 200 includes a translational control actuator 230a slidably disposed along the length of the guide rail 278. The translational control actuator 230a is coupled to the actuating element 208 such that translation of the control actuator 230a along the guide rail 278 is operable to control translation of the actuating element 208 and the grasping device 104. In some embodiments, the guide rail 278 can include a gear track.

[0164] The actuating element 208 can be coupled to a mechanism operable to rotate the actuating element 208 independently of the translational control actuator 230a. As shown in FIG. 48, the distal end of the actuating element 208 is coupled to a rotational control actuator 230b operable to rotate the actuating element 208. The control actuator 230b may be a rotating wheel arranged in alignment with the actuating element 208.

[0165] As shown in FIG. 49, the rotational control actuator 230b can be arranged perpendicular to the actuating element 208. The rotational control actuator 230b can be rotationally coupled to the actuating element 208 via a gearbox 276. The gearbox 276 can be coupled to the translational control actuator 230a such that the gearbox 276 and the rotational control actuator 230b slide in cooperation with the translational control actuator 230a. The gearbox 276 can include one or more gears 274 configured to transmit rotational motion or torque from the rotational control actuator 230b to the actuating element 208 such that the actuating element 208 rotates about an axis extending along the length of the actuating element 208. In the illustrated embodiment, the gearbox 276 includes a rotating wheel shaft gear 274a rotationally coupled to the rotational control actuator 230b, such as via a shaft, and a helical shaft gear 274b coupled to the rotating wheel shaft gear 274a and the actuating element 208. Rotation of the rotational control actuator 230b causes the rotating wheel shaft gear 274a to rotate in the same plane as the rotational control actuator 230b, and the helical shaft gear 274b is configured and oriented to change the plane of rotation such that the actuating element 208 and the gripping device 104 rotate about the longitudinal axis of the actuating element 208.

[0166] As shown in FIG. 50, the actuation assembly 200 includes a linear translation motor 294 for operably controlling the translational movement of the actuation element 208, and a rotary motor 296 operable to control the rotation of the actuation element 208. The linear translation motor 294 may be coupled to the translational control actuator 230a such that the linear translation motor 294 is operable to drive the translational position of the translational control actuator 230a along the guide rail 278. The translational control actuator 230a may be a wheel or gear drivable along the length of the guide rail 278, such as on the gear track of the guide rail 278. The rotary motor 296 may be coupled to the gear box 276, such as to the rotary wheel shaft gear 274a, such that the rotary motor 296 is operable to drive the rotational position of the actuation element 208.

[0167] The actuation assembly 200 may also include a controller 298 in communication with the linear translation motor 294 and the rotary motor 296, such that the controller 298 is operable to control the linear translation motor 294 and / or the rotary motor 296. The controller 298 may include a user input mechanism such as a button, joystick, toggle, mouse, etc., such that the user may input commands to control the operation of the linear translation motor 294 and the rotary motor 296 to control the position and rotation of the actuation element 208. For example, an operator may input commands to the controller 298 to activate the linear translation motor 294 and / or the rotary motor 296 to translate and / or rotate the actuation element 208 and the grasping device 104.

[0168] In some embodiments, the tissue capture device 100 may be used with a snare or cutting device configured to cut tissue captured by the grasping device 104. In some embodiments, the tissue capture device 100 may be used with a closure mechanism such as an OTS clip or a TTS clip configured to secure tissue captured by the grasping device 104. For example, the closure mechanism may be deployed through the endoscope after the grasping device 104 is deployed to close the defect circumferentially.

[0169] As shown in FIG. 51, the actuating assembly 200 may incorporate or be coupled to a clip deployment system 400 operable to actuate and deploy a closure mechanism or clip 402, such as an OTS clip (FIGS. 52A-52E). In the illustrated embodiment, the clip deployment system 400 is incorporated into the body 202 of the actuating assembly 200. However, it will be understood that the clip deployment system 400 may have other configurations and assemblies. For example, the clip deployment system 400 may be actuated by a separate body, handle, controller, etc.

[0170] The clip deployment system 400 may be operable to deploy the clip 402, such as independently of the operation of the gripping device 104. In some embodiments,

[0171] The clip deployment system 400 may include a clip deployment wire 404 configured to deploy the clip 402. The clip deployment wire 404 may be configured to transmit a translational motion or force to deploy the clip deployment wire 404. The clip deployment wire 404 may be a solid cable, a hollow tube, or other suitable elongated object or combination of objects, such as a drive cable, torque cable, hypodermic tube, spring sheath, or catheter, configured to deploy the clip 402.

[0172] The proximal end of the clip deployment wire 404 can be coupled to the clip actuator 406. The clip actuator 406 can be coupled to the clip deployment wire 404 to control the linear translation of the clip deployment wire 404. In some embodiments, the clip actuator 406 is disposed within the longitudinal slot 280 in the body 202 such that the clip actuator 406 can linearly translate within the longitudinal slot 280. The clip actuator 406 can be linearly translated toward the distal end of the body 202, such as by a user, to extend the distal end of the clip deployment wire 404 distally so that the clip 402 is deployed. The clip 402 can be secured around the distal end of the catheter 302, or a housing or cover coupled to the distal end of the catheter 302. Movement of the clip deployment wire 404 in the distal direction can cause the clip 402 to be pushed from its secured position so that the clip 402 is deployed, such as around tissue that has been captured as described below.

[0173] Referring now to FIGS. 52A-52D, the tissue capture device 100 may be operable to capture a target tissue, such that as a result, the clip 402 may be deployed to secure the captured tissue. The tissue capture device 100 may include at least a first grasping device 104a coupled to a first actuating element 208a and a second grasping device 104b coupled to a second actuating element 208b that extends distally through the catheter 302. The grasping devices 104a, 104b may be any of the grasping devices 104 described herein. The clip 402 may be coupled to the distal end of the catheter 302 and secured around a clip deployment housing 408 that extends distally from the distal end of the catheter 302. The distal end of the clip deployment wire 404 may contact the proximal end of the clip 402 when the clip 402 is in the undeployed position. The clip 402 has been described as being disposed around the clip deployment housing 408 in the undeployed position, but it will be understood that the clip 402 may have other suitable positions in the undeployed position. For example, the clip 402 may be disposed around a cover or sheath of the grasping device 104, or may be secured around the distal end of a separate catheter 302.

[0174] After the defect has been identified, the endoscope and / or device 100 may be oriented above the defect, and the clip 402 is secured around the clip deployment housing 408. The grasping device 104 may be used to approach two or more sides of the defect and may be inserted or drawn into the clip deployment housing 408. The clip 402 may then be deployed around the sides of the defect to circumferentially close the defect.

[0175] As shown in FIG. 52A, the first grasping device 104a may be operated, such as via the actuation assembly 200, to grasp the tissue on the first side of the defect. For example, the first actuating element 208a may be rotated and translated such that the first grasping device 104a securely grasps the tissue.

[0176] As shown in FIG. 52B, the second grasping device 104b can be operated to grasp the tissue of the second side portion of the defect, such as via the actuation assembly 200. The endoscope and / or catheter 302 can be operated such that the second grasping device 104b is positioned above the second side portion of the defect when the second actuation element 208b is operated to control the second grasping device 104b. For example, the second actuation element 208b can be rotated and translated such that the second grasping device 104b securely grasps the tissue.

[0177] As shown in FIG. 52C, the first and second actuation elements 208a, 208b can be retracted proximally toward the catheter 302. Since the actuation elements 208a, 208b can be retracted proximally, such as via the actuation assembly 200, the grasping devices 104a, 104b and the grasped tissue are brought toward the catheter 302. The grasping devices 104a, 104b can be retracted such that a portion of the grasped tissue is captured within the clip deployment housing 408.

[0178] As shown in FIG. 52D, the clip deployment wire 404 can be actuated to deploy the clip 402 from the clip deployment housing 408, such as via the clip actuator 406, around the captured tissue. The clip deployment wire 404 can be translated distally to push the clip 402 distally from the clip deployment housing 408. The clip 402 is configured to secure or otherwise constrict around the captured tissue after the clip 402 is deployed from the clip deployment housing 408. For example, the clip 402 can be biased to move to a closed position after the clip 402 is deployed from the clip deployment housing 408. The clip 402 can close around the captured tissue to further close the defect. In some embodiments, the grasping device 104a / b and / or the actuation elements 208a, 208b can be retracted proximally and withdrawn from the tissue after the clip 402 is deployed.

[0179] FIG. 53 illustrates an exemplary method 500 for controlling a tissue capture device via an actuation assembly to capture tissue. The method is shown as a series of acts to be performed in order, but it should be understood and recognized that the method is not limited by the order. For example, one act may be performed concurrently with another act. Further, in some instances, not all acts may be required to implement the methods described herein.

[0180] In step 502, a grasping device is positioned above the identified defect. The grasping device may be incorporated into a tissue capture assembly of the tissue capture device. The grasping device may be coupled to the actuation assembly via an actuation element such that a user can control the position and rotation of the grasping device. The grasping device may extend through a catheter inserted through an endoscope to a desired location. In some embodiments, the grasping device includes a helical coil configured to penetrate the tissue and enter helically to grasp the target tissue.

[0181] In step 504, a control actuator is moved to translate a first grasping device. As described above, the control actuator of the actuation assembly is coupled to the first grasping device via a first actuation element. The control actuator is operable to control the translational movement of the first grasping device via the first actuation element. The control actuator may be controlled by a user such that the first grasping device is disposed substantially above a first side of the defect. In some embodiments, the control actuator is a translational control actuator operable to control the linear position of the first grasping device.

[0182] In step 506, the control actuator is moved to rotate the first grasping device. As described above, the control actuator of the actuating assembly is coupled to the first grasping device via the first actuating element. The control actuator is operable to control the rotation of the first grasping device via the first actuating element. The control actuator can be controlled by the user such that the first grasping device is rotated into place to grasp tissue at the first side of the defect. In some embodiments, the control actuator is a rotation control actuator operable to control the rotation of the first grasping device. In other embodiments, since the control actuator is the same control actuator used in step 504, a single control actuator is operable to control the translation and rotation of the first grasping device via the first actuating element.

[0183] In step 508, the first side of the defect is grasped by the first grasping device. In some embodiments, an operation control actuator is coupled to the first grasping device via the first operating element. The operation control actuator can be actuated to operate the first grasping device to grasp tissue, such as by opening and closing the movable jaws to grasp the tissue via the first operating element. In other embodiments, one or more control actuators are operated via the first actuating element to translate and rotate the first grasping device such that the first grasping device firmly grasps through the tissue at the first side of the defect.

[0184] In step 510, the control actuator is moved to translate the second grasping device. The endoscope and / or catheter can be moved such that the second grasping device is disposed substantially above the second side of the defect. As described above, the control actuator of the actuation assembly is coupled to the second grasping device via a second actuation element. The control actuator is operable to control the translation of the second grasping device via the second actuation element, independently of the first grasping device. The control actuator can be controlled by the user such that the first grasping device is disposed substantially above the second side of the defect. The first grasping device can continue to grasp tissue at the second side of the defect when the second grasping device translates via the second actuation element. In some embodiments, the control actuator is a translation control actuator operable to control the linear position of the second grasping device. In some embodiments, the control actuator is different from the control actuator used to translate the first grasping device in step 504.

[0185] In step 512, the control actuator is moved to rotate the second grasping device. As described above, the control actuator of the actuating assembly is connected to the second grasping device via the second actuating element. The control actuator is operable to control the rotation of the second grasping device via the second actuating element, independently of the first grasping device. The control actuator can be controlled by the user so that the second grasping device is rotated into place to grasp tissue on the second side of the defect. The first grasping device can continue to grasp the tissue on the second side of the defect when the second grasping device rotates via the second actuating element. In some embodiments, the control actuator is a rotation control actuator operable to control the rotation of the second grasping device. In other embodiments, the control actuator is the same control actuator used in step 510, so that a single control actuator is operable to control the translation and rotation of the second grasping device via the second actuating element. In some embodiments, the control actuator is different from the control actuator used to rotate the first grasping device in step 506.

[0186] In step 514, the second side of the defect is grasped by the other grasping device. In some embodiments, the motion control actuator is connected to the second grasping device via the second operating element. The operation control actuator can be actuated to operate the second grasping device to grasp the tissue, such as by opening and closing the movable jaws to grasp the tissue via the second operating element. The motion control actuator may be different from the motion control actuator in step 512. In other embodiments, one or more control actuators can be operated to translate and rotate the second grasping device via the second actuating element so that the second grasping device penetrates and firmly grasps the tissue on the second side of the defect.

[0187] In step 516, the actuating element is retracted to capture the tissue grasped by the first and second grasping devices. As described above, one or more control actuators can be controlled to retract the actuating element proximally so that the grasping device retracts toward the catheter. Further, before the actuating element retracts to capture the tissue, one or more of the grasping devices are released from the tissue, and the above steps can be repeated so that the grasping device grasps the tissue at a desired position. The catheter can also be advanced distally from the endoscope to close the defect away from the endoscope, such as to prevent the endoscope from restricting the movement of the actuating element.

[0188] Optionally, in step 518, the clip is deployed around the captured tissue to substantially close the defect. The clip may be a hemostatic clip that is deployed circumferentially around the captured tissue to substantially close the tissue. As described above, the clip actuator can be actuated to deploy the clip via the clip deployment wire. The clip actuator can translate the clip hand vicinity so that the clip is pushed out of the clip deployment housing to secure or close the captured tissue.

[0189] It should be understood that the embodiments for carrying out the invention are 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. Further, in some cases, elements described in one embodiment can be readily adapted for use in other embodiments. Accordingly, the products, methods, and / or systems described herein are not limited to the specific details, representative embodiments, and / or exemplary examples illustrated and described. Therefore, departures from such details can be made without departing from the spirit or scope of the general aspects of the present disclosure.

[0190] Furthermore, the components and materials described below as constituting various embodiments are intended to be illustrative and not limiting. It should be understood that many suitable components and materials that perform the same or similar functions to the materials described herein are intended to be encompassed within the scope of the embodiments of the present disclosure.

Claims

1. An operating assembly for a tissue acquisition device that is operable to independently control a first gripping device and a second gripping device for grasping tissue, wherein the operating assembly is A main body that defines the first channel and the second channel, A first actuation element extending through the first channel, wherein the first actuation element is connected to the first gripping device, A second actuation element extending through the second channel, wherein the second actuation element is connected to the second gripping device, A first control actuator, which is operable to control the translation and rotation of the first gripping device in order to grasp tissue via the first operating element, A second control actuator, which is operable to control the translation and rotation of the second gripping device in order to grasp tissue via the second operating element, Equipped with, An operating assembly in which the first control actuator is operable to control the translation and rotation of the first gripping device independently of the second gripping device.

2. The actuation assembly according to claim 1, further comprising actuation sheaths disposed around the proximal ends of the first actuation element and the second actuation element, respectively.

3. The actuation assembly according to claim 1, further comprising a biasing element configured to maintain the translation and rotation of the first actuation element and the second actuation element.

4. The actuation assembly according to claim 3, wherein the biasing element is configured to generate a feedback detectable at the rotational interval between the first actuation element and the second actuation element.

5. The actuation assembly according to claim 3, wherein the second actuation element is operable to control the translation and rotation of the second gripping device when the first control actuator controls the translation and rotation of the first gripping device.

6. The first channel and the second channel each have a first portion extending distally from the proximal end of the main body and a second portion extending from each of the first portions of the distal end of the main body, The operating assembly according to claim 1, wherein the first portion has a first width, the second portion has a second width, and the first width is greater than the second width.

7. The actuation assembly according to claim 3, wherein the biasing element is positioned between the first channel and the second channel near the proximal end of the body, and the biasing element extends laterally into the first channel and the second channel when the biasing element is in its normal position.

8. The main body further comprises a first biasing projection extending laterally into the first channel and a second biasing projection extending laterally into the second channel, The actuation assembly according to claim 1, wherein the first biasing projection is configured to engage a first actuation element extending through the first channel in order to operably maintain the rotational and translational positions of the first control actuator, and the second biasing projection is configured to engage a second actuation element extending through the second channel in order to operably maintain the rotational and translational positions of the second control actuator.

9. A tissue intake device, A first gripping device capable of operating to grasp tissue, A second grasping device capable of operating to grasp tissue, A first actuation element extending through a first channel of the main body, wherein the proximal end of the first actuation element is connected to a first control actuator and the distal end of the first actuation element is connected to a first gripping device, A second actuation element extending through a second channel of the main body, wherein the proximal end of the second actuation element is connected to a second control actuator and the distal end of the second actuation element is connected to a second gripping device, It is a tissue take-up device equipped with, The first control actuator is capable of independently operating to translate and rotate the first gripping device to grip tissue via the first operating element. A tissue acquisition device in which the second control actuator is independently operable to translate and rotate the second gripping device to grip tissue via the second actuation element.

10. The tissue acquisition device according to claim 9, wherein the first gripping device can grip tissue at a first position, and the second gripping device can be moved to grip tissue at a second position different from the first position.

11. The tissue acquisition device according to claim 9, wherein each gripping device includes a plurality of helical coils configured to grip tissue.

12. The tissue acquisition device according to claim 9, wherein the first control actuator and the second control actuator are operable to retract the first gripping device and the second gripping device when the first gripping device and the second gripping device grip tissue.

13. The tissue take-up device according to claim 9, wherein the first gripping device and the second gripping device and the first and second operating elements extend through a catheter.

14. The tissue acquisition device according to claim 9, wherein the first control actuator and the second control actuator are elongated hexagons.

15. The tissue acquisition device according to claim 9, further comprising a clamp configured to maintain the translation and rotation of the first actuating element and the second control element by friction.

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