Patent Description:
Manipulating devices for engaging tissue may require involved techniques for positioning and orienting the devices and associated medical instruments. For example, endoscopic submucosal dissection (ESD) is a procedure that enables tissue resection within the gastrointestinal tract. One aspect of ESD that may be difficult is the positioning and maneuvering (e.g., retraction) of the resected tissue flap during and after cutting.

It is with these considerations in mind that a variety of advantageous medical outcomes may be realized by the medical devices, systems, and methods of the present disclosure.

<CIT> relates to a lifting method for a lesion area including: a step of introducing an anchoring tool having a magnetic body and an anchor into a hollow organ having a lesion area, by using a working channel inserted from a natural opening into the hollow organ, a step of anchoring the anchoring tool, by sequentially placing the anchor in a predetermined position around the lesion area, so as to arrange a plurality of the magnetic bodies around the lesion area, and a step of lifting a tissue including the lesion area, by attracting the magnetic bodies using a magnetic field generation tool arranged on the outside of the hollow organ.

<CIT> relates to a surgical clip including a pair of jaws, pivoted together with a spring holding the jaws together. An applicator is also provided, particularly with a ball and socket connection to the surgical clip.

<CIT> discloses an endoscopic clip device including a clip that comprises a plurality of arms for gripping a living body tissue and a locking portion disposed on a proximal side of the arms, and a treatment instrument body that comprises an elongated sheath, and an operation wire which is inserted into the sheath so as to be movable forward and backward, and in which a chunky distal connection portion is disposed in a distal end. The locking portion of the clip comprises an accommodation portion which internally has a space for accommodating the distal connection portion, and a protruding portion which is formed to protrude inward on a proximal side of the accommodation portion.

All examples and embodiments not falling under the scope of the independent claim do not form part of the invention.

In various embodiments, the present disclosure relates to a tissue clipping device that may include an opening mechanism configured to be grasped from a plurality of angles relative to a longitudinal axis of the clip device. The opening mechanism may include first and second members configured to be displaced relative to one another along the longitudinal axis of the clip device into an opening configuration in response to an application of a compressive force. The opening mechanism may include a cam member extending from a first end to a second end, the first end may be fixedly coupled to the first member and may be slidably coupled to the second member. A plurality of clip arms may each extend from a first end to a second end, and the first end of each clip arm may be received within the opening mechanism. The clip arms may be movable between an open configuration, in which second ends of the clip arms are separated from one another, and a closed tissue clipping configuration, in which second ends of the clip arms are moved toward one another. Each of the clip arms may include a spring portion configured to form a spring space between the spring portions. The cam member may move into the spring space when the first and second members are moved to the opening configuration so that, as the cam member is moved into the spring space, the cam member may deflect the spring members away from one another to move the clip arms to the open configuration.

In the described and other embodiments, the first and second members may include angled surfaces configured to move the first and second members in opposite directions away from each other in response to an application of a compressive force to the angled surfaces. The cam member may include a U-bend at the second end and two legs extending from the U-bend to the first end. The legs may be configured to be slidably received through the second member and may be immovably coupled to the first member. The cam member may include a wedge centrally positioned on the U-bend. The wedge may extend from the U-bend toward the first end between the legs of the cam member. The wedge may be configured to be received in the space between the spring portions such that movement of the wedge toward the second member may cause the wedge to deflect the spring portions away from one another to move the clip arms to the open configuration. The wedge may taper from a first end at the first end of the cam member to a second end between the legs of the cam member. The clip arms may be formed of a single wire bent at a medial portion, the medial portion may form the first ends of the clip arms. The second member of the opening mechanism may include a channel configured to receive the first ends of the clip arms. The clip arms may be biased to the closed configuration.

In various embodiments, the present disclosure also relates to a clip device comprising an opening mechanism that may include a gripping member. A deformable fluid chamber may be configured to be grasped from a plurality of angles. The fluid chamber may define a cavity therein that may be configured to be filled with a fluid. A balloon chamber may define a cavity therein. The balloon chamber may be inflatable from a resting state when filled with the fluid. At least one connection channel may extend from a first end open to the cavity of the fluid chamber to a second end open to the cavity of the balloon chamber to provide fluid communication between the fluid chamber and the balloon chamber such that, as the fluid chamber is compressed, fluid may be dispelled from the fluid chamber to the balloon chamber via the connection channel to inflate the balloon chamber. The clip device may also include clip arms extending from a first end to a second end. The first end may be coupled to the gripping member. The clip arms may be movable between an open configuration, in which second ends of the clip arms may be separated from one another, and a closed tissue clipping configuration, in which second ends of the clip arms may be moved toward one another. Each of the clip arms may include a spring portion configured to form a spring space between the spring portions. The spring space may receive the balloon chamber such that, when the balloon chamber inflates, the spring members may be deflected away from one another to move the clip arms to the open configuration.

In the described and other embodiments, the gripping member may include an extension extending through a central closed lumen in the fluid chamber to couple to the first ends of the clip arms. The fluid chamber may be filled with one of saline, water, gel, or other suitable fluid. The spring portions may be formed as bends in the clip arms, a bend may extend toward a central axis of the clip device. The clip arms may be biased to the closed configuration. The gripping member may be configured to be gripped by a gripper tool. The clip arms may be formed of a wire bent at a medial portion to form the first end of the clip arms.

In various embodiments, the present disclosure also relates to a method of positioning a clip system on a target tissue from a plurality of angles. A clip system may be inserted to a target site via a working channel of an insertion device. The clip system may include a first clip device. The first clip device may include an opening mechanism that may be configured to be grasped from a plurality of angles relative to a longitudinal axis of the clip device. The opening mechanism may include a first and a second member that may be configured to be displaced relative to one another along the longitudinal axis of the clip device into an opening configuration in response to an application of a compressive force. The opening mechanism may include a cam member extending from a first end to a second end, and the first end may be fixedly coupled to the first member and slidably coupled to the second member. A plurality of clip arms may each extend from a first end to a second end, and the first end of each clip arm may be received within the opening mechanism. The clip arms may be movable between an open configuration, in which second ends of the clip arms may be separated from one another, and a closed tissue clipping configuration, in which second ends of the clip arms may be moved toward one another. Each of the clip arms may include a spring portion configured to form a spring space between the spring portions. The cam member may move into the spring space when the first and second members are moved to the opening configuration so that, as the cam member is moved into the spring space, the cam member may deflect the spring members away from one another to move the clip arms to the open configuration. The method may include inserting a gripper tool to the target site via the working channel. The method may include grasping the opening mechanism of the first clip device via the gripper tool to move the clip arms of the first clip device to the open configuration. The method may include positioning the clip arms of the first clip device so that a first portion of target tissue is received between the clip arms of the first clip device. The method may include releasing the gripper tool to move the clip arms of the first clip device from the open configuration to the closed configuration to clip the first portion of target tissue.

In the described and other embodiments, the method may further include coupling the first clip device to a second clip device via a tether. In the described and other embodiments, a method may further include grasping an opening mechanism of the second clip device from the gripper tool to move clip arms of the second clip device to an open configuration. The method may include positioning a second portion of target tissue between the clip arms of the second clip device. The method may include releasing the gripper tool to move the clip arms of the second clip device from the open configuration to the closed tissue clipping configuration to clip the second portion of target tissue, the location of the second target portion of tissue may be selected so that, when the first and second target portions of tissue are clipped by the first and second clip devices, respectively, a desired level of tension may be applied to the first target portion of tissue via the tether. The first and second members may include angled surfaces configured to move the first and second members in opposite directions away from the applied compressive force. The clip arms may be biased to the closed configuration.

In various embodiments, the present disclosure relates to a tissue clipping device that may include a first member. One or more arms, each extending from a first end to a second end, may each be received within the first member. Each of the arms may include a spring portion configured to form a spring space between the spring portions. The arms may be movable between an open configuration, in which the spring portions of the arms are biased toward one another, and a closed configuration, in which the spring portions of the arms are separated apart from one another. A second member may be slidably disposed about the plurality of arms. A grasper may have a first end engaged between the arms and a second end that may include jaws configured to engage tissue. The first member and the second member may be configured to be grasped from a plurality of angles relative to a longitudinal axis of the clipping device, and may be configured to be displaced relative to one another along the longitudinal axis of the clipping device in response to an application of a compressive force. A cam member may extend from a first end to a second end, the first end may be fixedly coupled to the second member and the second end may be configured to engage the spring space. The second end of the cam member may be moveable into and out of engagement with the spring space when the first and second members are displaced relative to one another, such that when the first and second members are displaced apart from one another the second end of the cam member may move out of engagement with the spring space and the arms may assume the open configuration, and when the first and second members are displaced toward one another the second end of the cam member may move into engagement with the spring space and the arms transition to the closed configuration.

In the described and other embodiments, the first and second members may include angled surfaces configured to displace the first and second members apart from one another in response to an application of a compressive force to the angled surfaces. The cam member may include a U-bend at the second end of the cam member and two legs may extend from the U-bend to the first end of the cam member. The cam member may include a wedge centrally positioned on the U-bend, and the wedge may taper to a smaller width transverse to the longitudinal axis as the wedge extends from the U-bend between the legs toward the first end of the cam member. The wedge may be configured to engage the spring space. The arms may be formed of a single wire bent at a medial portion, and the medial portion may form the first ends of the arms. The first member may include a channel configured to fixedly receive the first ends of the arms. The arms may be biased to the open configuration. The grasper may include first and second grasper arms in a crossing configuration. The second ends may move away from each other when the first ends move closer together.

In various embodiments, the present disclosure also relates to a tissue clipping device that may include a first member. The device may include a plurality of arms. Each of the arms may extend from a first end to a second end. The first end of each arm may be received within the first member. The arms may be movable between an open configuration and a closed configuration. A second member may be slidably disposed with respect to the first member. The first member and the second member may be configured to be grasped from a plurality of angles relative to a longitudinal axis of the clipping device. The first member and the second member may be configured to be displaced relative to one another along the longitudinal axis of the clipping device in response to an application of a compressive force. The first and second members may include angled surfaces configured to displace the first and second members apart from one another in response to an application of a compressive force to the angled surfaces such that when the first and second members are displaced with respect to each other the arms may transition between the open configuration and the closed configuration.

In various embodiments, the present disclosure relates to a tissue clipping device that may include a first member. One or more arms, each extending from a first end to a second end, may be received within the first member. The arms may be movable between an open configuration, in which the second ends of the arms may be separated apart from one another, and a closed configuration, in which the second ends of the arms may be biased toward one another. Each of the arms may include a spring portion configured to form a spring space between the spring portions. A second member may be slidably disposed about the plurality of arms. The second member may have one or more channels internal to the second member that may be engageable with opposing sloped surfaces of the arms. The first member and the second member may be configured to be grasped from a plurality of angles relative to a longitudinal axis of the clipping device, and may be configured to be displaced relative to one another along the longitudinal axis of the clipping device in response to an application of a compressive force. The one or more channels may be moveable into and out of engagement with the opposing sloped surfaces of the arms when the first and second members are displaced relative to one another to transition the arms between the closed configuration and open configuration.

In the described and other embodiments, the opposing sloped surfaces of the arms may slope toward each other and the longitudinal axis, such that when the first and second members are displaced apart from one another the one or more channels may be moved into engagement with the sloped surfaces separating the arms apart into the open configuration, and when the first and second members are displaced toward one another the one or more channels may be moved out of engagement with the sloped surfaces and the arms transition to the closed configuration. In other embodiments, the opposing sloped surfaces of the arms may slope away from each other and the longitudinal axis, such that when the first and second members are displaced apart from one another the one or more channels may be moved into engagement with the sloped surfaces space bringing the arms together into the open configuration, and when the first and second members are displaced toward one another the one or more channels may be moved out of engagement with the sloped surfaces and the arms transition to the closed configuration.

In the described and other embodiments, the arms may be biased to the closed configuration with the arms toward each other in the spring space. The first and second members may include angled surfaces configured to displace the first and second members apart from one another in response to an application of a compressive force to the angled surfaces. The arms may be formed of a single body bent at a medial portion. The medial portion may form the first ends of the arms. A grasper may be disposed between the second ends of the arms.

In various embodiments, the present disclosure relates to a tissue clipping device. The device may include a housing defining a cavity and may have a first end that is movable toward a second end of the housing within the cavity. A plurality of arms extending from a first end to a second end may be received within the cavity. The arms may be movable between an open configuration, in which the second ends of the arms may be separated apart from one another, and a closed configuration, in which the second ends of the arms may be displaced toward one another. An inner layer may be disposed about the piston housing and may extend proximally of the housing to define a chamber configured to contain a fluid. The chamber may be compressible from a plurality of angles relative to a longitudinal axis of the clipping device in response to an application of a compressive force. In response to an application of a compressive force to the chamber, the first end of the housing may be moved toward the second end of the housing extending the arms to the open configuration. When the compressive force is not applied to the chamber, the first end of the housing may be displaced away from the second end of the housing retracting the arms to the closed configuration.

In the described and other embodiments, an outer layer may be disposed about the inner layer, and the outer layer may be configured to be grasped from a plurality of angles relative to a longitudinal axis of the clipping device to apply the compressive force to the chamber. The inner layer may be configured to be grasped from a plurality of angles relative to a longitudinal axis of the clipping device to apply the compressive force to the chamber. The arms may be formed of a single wire bent at a medial portion. The medial portion may form the first ends of the arms. The arms may be biased to the open configuration.

The present disclosure is not limited to the particular embodiments described. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.

Although embodiments of the present disclosure are described with reference to particular body lumens and tissues, it should be appreciated that such devices, systems, and methods may be used with a variety of anatomies that include the gastrointestinal tract, the bronchi, mucosal tissue, epithelial tissue, connective tissue, muscle tissue, and the like.

The terms "comprises" and/or "comprising," or "includes" and/or "including" when used herein, specify the presence of stated features, regions, steps, elements and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and/or groups thereof.

As used herein, the term "distal" refers to the end farthest away from the medical professional along a medical device when introducing the device into a patient, while the term "proximal" refers to the end closest to the medical professional along the medical device when introducing the medical device into a patient.

As used herein, the conjunction "and" includes each of the structures, components, features, or the like, which are so conjoined, unless the context clearly indicates otherwise, and the conjunction "or" includes one or the others of the structures, components, features, or the like, which are so conjoined, singly and in any combination and number, unless the context clearly indicates otherwise.

As used herein, the terms "element" and "member" may be used interchangeably among and between the description of the figures, discussion of various embodiments, and in the claims.

The term "about", in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). Other uses of the term "about" (i.e., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified. The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g. <NUM> to <NUM> includes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>).

Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless clearly stated to the contrary.

The present disclosure may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present disclosure relates to a clip opening mechanism of an endoscopic tissue traction device for, in an example, endoscopic submucosal dissection (ESD) and/or endoscopic mucosal resection (EMR). Exemplary embodiments of the present disclosure describe a clip device including an opening mechanism that allows a physician to open and reposition the clip device from any angle. In these embodiments, the physician is able to grasp the opening mechanism of the clip device from any approach angle and open the clip for attaching to tissue. In exemplary embodiments of the present disclosure, two clip devices may be used in conjunction with a tether to form a tether traction clip device.

In various embodiments, the clip devices described herein may be used interchangeably in systems in a substantially similar manner. Various clip devices may have one or more gripping elements or members that may move with respect to each other such that the device and/or system transitions between an open configuration and a closed configuration. It will be understood that the gripping elements or members described with respect to a specific embodiment may be used additionally or interchangeably with that of another embodiment in a substantially similar manner.

Tether traction clip devices may be used to manipulate the flap of tissue during ESD. However, these clip devices may be difficult to open, close, and/or position, because the clip devices may require gripping along a specific angle or plane. Other tissue clipping devices, e.g., a tissue traction device for ESD, may include an opening mechanism to engage and manipulate tissue. Operating such devices may be difficult for a medical professional because of the viewing angle, devices or anatomies blocking the field of view, size of the operating tools, or strict angles of proper engagement with respect to the devices, as examples. For example, a clipping device may be engaged by another instrument controlled by a medical professional to orient the device and/or manipulate the arms of the device. The device may be controlled during a procedure as above by engaging the device substantially along the longitudinal axis of the device. Attempts to engage the device at angles that are not substantially along the longitudinal axis may fail to control the device properly, cause procedural errors or delay, or frustrate the medical professional. Thus, it is with these considerations in mind that the present improvements may be helpful to allow a physician to open, close and/or reposition a clip from numerous angles.

As shown in <FIG>, a clip device <NUM> according to an exemplary embodiment of the present disclosure extends from a coupling end <NUM>, which is configured to couple to a tether <NUM> (e.g., in a similar fashion as shown in <FIG> with respect to device <NUM> <FIG>), to a clipping end <NUM> opposite the coupling end <NUM>. The clip device <NUM> comprises a grasping portion <NUM> and a clipping portion <NUM> and is insertable through, for example, a working channel of a flexible endoscope to a target tissue to be treated. The grasping portion <NUM> comprises first and second conical gripping elements <NUM>, <NUM> and a cam member <NUM>. The clipping portion <NUM> includes clip arms <NUM>. The clip device <NUM> is sufficiently flexible to permit it to traverse a tortuous path through the body, e.g., passing through the working channel of an endoscope inserted through a natural body lumen accessed via a natural bodily orifice. The clipping portion <NUM> includes clip arms <NUM> which, in this embodiment, are formed from a single wire <NUM>. As can be seen in <FIG>, the wire <NUM> is bent at a medial portion to form a first end <NUM> of the clip arms <NUM>, the first end <NUM> being closest to the coupling end <NUM> of the clip device <NUM>. The first and second clip arms <NUM> each extend from the first end <NUM> to second ends <NUM> at the clipping end <NUM> of the clip device <NUM>. The clip arms <NUM> can be moved between an open configuration, in which the second ends <NUM> of the clip arms <NUM> are separated from one another to receive target tissue therebetween, and a closed configuration, in which the second ends <NUM> of the clip arms <NUM> are moved toward one another e.g., to grip the target tissue therebetween or to reduce an overall size of the device compared to when the clip arms <NUM> are moved apart from one another. The clipping portion <NUM> of the clip device <NUM> is coupled to the grasping portion <NUM> via the second conical gripping element <NUM>. The clip arms <NUM> are movable between the open and closed configuration via movement of the second conical gripping element <NUM> relative to the first conical gripping element <NUM>. The coupling end <NUM> of the clip device <NUM> of this embodiment is configured to be coupled to a tether <NUM> (depicted in <FIG>), as will be described in further detail below.

As further shown in <FIG>, the clip arms <NUM> are joined at the first end <NUM> and extend to second ends <NUM>. As those skilled in the art will understand, the clip arms <NUM> of this embodiment are biased toward the closed configuration. When the grasping portion <NUM> of the clip device <NUM> is activated as described below, the clip arms <NUM> are forced into the open configuration. Each of the clip arms <NUM> of this embodiment is contoured to include a spring portion <NUM> formed as a curve or bend in the clip arms <NUM> that extends toward a longitudinal axis of the clip device <NUM>. The spring portions <NUM> form a space therebetween that is sized and shaped to receive a first end of the cam member <NUM> of the gripping portion <NUM>. The cam member <NUM>, which includes, in this embodiment, a triangular wedge <NUM> at the first end thereof, deflects the clip arms <NUM> away from one another to the open configuration as it is advanced between the clip arms <NUM> toward the first end <NUM> of the clip arms <NUM>.

The gripping portion <NUM> includes the first gripping element <NUM> (i.e., closer to the coupling end <NUM> of the clip device <NUM>) and a second gripping element <NUM> (i.e., closer to the clipping end <NUM> of the clip device <NUM>) and the cam member <NUM> with the wedge <NUM>. In this embodiment, the first and second gripping elements <NUM>, <NUM> are substantially conical (e.g., frustroconical) with a diameter that increases as a distance from ends at which the first and second gripping elements <NUM>, <NUM>, respectively, abut one another, increases. As shown in <FIG>, each of the first and second gripping elements <NUM>, <NUM> tapers toward a minimum diameter at the ends positioned adjacent to one another forming an hourglass shape when the first and second gripping elements <NUM>, <NUM> abut one another. Specifically, the first gripping element <NUM> tapers from a first end thereof to a second end while the distal gripping element <NUM> tapers from a second end thereof to a first end (the first end being adjacent to the second end of the first gripping element <NUM>). This hourglass shape is used as a gripping cylinder which allows the user to grip the clip device <NUM> (e.g., using a gripper tool <NUM> (depicted in <FIG>) inserted via a working channel of a flexible endoscope) regardless of the clip orientation relative to the endoscope. As also illustrated in <FIG>, the second gripping element <NUM> includes a curved channel <NUM> therein that extends from a first end <NUM> to a second end <NUM>, the first and second ends <NUM>, <NUM> being open at the second end <NUM> of the distal gripping element <NUM>. The channel <NUM> is sized and shaped to receive a first portion <NUM> of the clip arms <NUM>, extending between the first end <NUM> and the spring portion <NUM>, therethrough. A surface or ledge <NUM> of the second end of the second gripping element <NUM> between the open first and second ends <NUM>, <NUM> of the curved channel <NUM> is positioned between the first portion <NUM> of the clip arms <NUM> to provide a stop controlling a maximum opening of the clip arms <NUM> and preventing the clip arms <NUM> from passing out of the second gripping element <NUM>. The second gripping element <NUM> also includes two through holes (not shown) extending from the first end to the second end of the distal gripping element <NUM>, each through hole being configured to receive a leg <NUM> of the cam member <NUM>.

The cam member <NUM> of this embodiment, as shown in <FIG>, is substantially U-shaped with two legs <NUM> extending toward the coupling end <NUM> from a distal U-bend <NUM>. Each of the legs <NUM> includes an enlarged stop member <NUM>. The wedge <NUM> is centrally positioned at the U-bend and is substantially triangular in shape. Specifically, the wedge <NUM> tapers from a second end <NUM> closest to the clipping end <NUM> to a first end <NUM> closest to the coupling end <NUM>. The wedge <NUM> extends toward the coupling end <NUM> from the U-bend <NUM> between the two legs <NUM>. The legs <NUM> of the cam member <NUM> are slidably received through the through holes (not shown) within the first gripping element <NUM>. The blind holes extend partially through the length of the first gripping element <NUM> a distance equal to a length of the stop members <NUM>. The blind holes have a diameter substantially equal to the stop members <NUM>. However, the openings of the blind holes at the second end of the first gripping element <NUM> have a smaller diameter (i.e., a diameter equal to a diameter of the clip arms <NUM>) such that the stop members <NUM> of the cam member <NUM> are prevented from passing out of the first gripping element <NUM>. Thus, the first gripping element <NUM> and the cam member <NUM> are immovable with respect to one another. It is noted that the first ends of the cam member <NUM> may be coupled to the first gripping element <NUM> in any other preferred method, such as adhesion, welding, etc., so long as the components do not move relative to each other.

In use, when the clip device <NUM> is in the closed configuration, the spring portions <NUM> of the clip arms <NUM> are spaced a distance smaller than a width (i.e., a dimension extending in a plane perpendicular to the longitudinal axis of the clip device <NUM> between the two clip arms <NUM>) of the wedge <NUM> of the cam member <NUM>. As a radially inwardly directed force (i.e., a gripping force) is applied by, for example, a gripper tool <NUM> (see e.g., <FIG>), at the tapered ends of the first and second gripping elements <NUM>, <NUM>, the first and second gripping elements <NUM>, <NUM> are displaced relative to one another (i.e., moved away from one another along the longitudinal axis of the clip device <NUM>), as shown in <FIG>. This linear motion actuates the cam member <NUM> such that the wedge <NUM> moves toward the first end <NUM> of the clip arms <NUM> into the space between the spring portions <NUM>, deflecting the spring portions <NUM> away from one another and moving the clip arms <NUM> to the open configuration, as shown in <FIG>. In turn, when the force from the gripper tool <NUM> is removed from the proximal and distal gripping elements <NUM>, <NUM>, due to the spring action of the clip arms <NUM> against the triangular surface of the wedge <NUM>, the cam member <NUM> is forced to its original location, drawing the clip arms <NUM> toward one another into the tissue gripping configuration gripping any tissue received between the second ends <NUM> of the clip arms <NUM>.

As shown in <FIG>, a clip device <NUM> according to an exemplary embodiment of the present disclosure is substantially similar to the clip device <NUM>, except as described herein. Specifically, the clip device <NUM> extends from a coupling end <NUM> to an opposing clipping end <NUM> and includes a grasping portion <NUM> and a clipping portion <NUM>. The clip device <NUM> is insertable through, for example, a working channel of an endoscope to target tissue to be treated. The clipping portion <NUM> includes clip arms <NUM> which, in this embodiment, are formed from a single wire <NUM>, as shown in <FIG>. As can be seen in <FIG>, the wire <NUM> is bent at a medial portion to form a first end <NUM> of the clip arms <NUM> closest to the coupling end <NUM>. The clip arms <NUM> extend from the first end <NUM> to second ends <NUM> located at the clipping end <NUM> of the clip device <NUM>. The clip arms <NUM> are biased to a closed configuration but each include curved portions forming spring portions <NUM>, similar to spring portions <NUM>.

The grasping portion <NUM> includes a conical gripping element <NUM>, a fluid chamber <NUM>, a distal balloon chamber <NUM> and two connection channels <NUM>. The conical gripping element <NUM> is substantially similar in shape to the first conical gripping element <NUM> except that it includes an extension <NUM> extending in the direction of the clipping end <NUM>, as can be seen in <FIG>. The extension <NUM> is configured to extend through a central lumen <NUM> of the fluid chamber <NUM>. A second end <NUM> (closest to the clipping end <NUM>) of the distal extension <NUM> extends past a second end (closest to the clipping end <NUM>) of the fluid chamber <NUM> to couple to the first end <NUM> of the clip arms <NUM>, as shown in <FIG>. In the present embodiment, the second end <NUM> of the distal extension <NUM> is a hook or loop <NUM> defining a central space sized and shaped to receive the first end <NUM> of the clip arms <NUM> therethrough.

The fluid chamber <NUM>, is substantially spherical in shape with the closed lumen <NUM> extending therethrough from a first end to a second end thereof. The fluid chamber <NUM> includes an internal cavity <NUM> configured to be filled with a fluid such as, for example, saline, sterile water, gel, or any other minimally compressible fluid appropriate for use in internal medicine. The fluid chamber <NUM> is formed of a deformable material such as, for example, nylons, PEBAX, polyethylene terephthalate (PET), rubber, or silicone, such that when and external pressure is applied thereto by, for example, a gripper tool <NUM>, the fluid chamber contracts inwardly, reducing and internal volume and dispelling fluid therefrom into the connection channels <NUM>. The connection channels <NUM> extend from the fluid chamber <NUM> to the balloon chamber <NUM> and provides fluid communication therebetween. That is, fluid that is forced out of the fluid chamber <NUM>, upon application of an external force, moves through the connection channels <NUM> and into the balloon chamber <NUM>. The balloon chamber <NUM> is inflatable from a normal deflated state, shown in <FIG>, as the balloon chamber <NUM> is filled with fluid. The balloon chamber <NUM> is positioned between the spring portions <NUM> of the clip arms <NUM> so that as fluid is forced thereinto, the balloon chamber <NUM> inflates, generating enough pressure to open the clip arms <NUM>, as shown in <FIG>. When the external force is removed from the fluid chamber <NUM>, the spring portions <NUM> apply an inward force on the balloon chamber <NUM>, reducing the internal volume of the balloon chamber <NUM> so that the fluid moves back through the connection channels <NUM> and into the fluid chamber <NUM>.

In the embodiment described above in <FIG> or otherwise within the scope of the present disclosure, various of the clip devices may have one or more chambers that may be engaged and disengaged, such that the one or more chambers may be compressed or inflated to transition the devices between a tissue receiving configuration and a tissue engaging configuration. It will be understood that the chambers described with respect to a specific embodiment may be used additionally or interchangeably with that of another embodiment in a substantially similar manner.

With reference to <FIG>, an embodiment of a tissue clipping device <NUM> is illustrated, which includes a first member <NUM> and second member <NUM> that are a substantially frustum shape. Two clip arms <NUM> extend from a first end 1110p to a second end 1110d. The first end 1110p of each arm <NUM> is received within the first member <NUM> via a channel <NUM> extending through the first member <NUM>. The clip arms <NUM> are formed of a single wire that is bent at a medial portion <NUM> that forms the first ends 1110p of the arms <NUM>. A grasper <NUM> for engaging tissue is engaged (e.g., held) between the second end 1110d of the arms <NUM>. The grasper <NUM> has a first end 1130p between the arms <NUM> and a second end 1130d comprising jaws for engaging tissue. The grasper <NUM> has first and second grasper arms that are in a crossing configuration. A spring force in a bend at the medial portion <NUM> of the clip arms <NUM> contained in the first member <NUM> creates a bias at the second end 1110d of the clip arms <NUM> urging the arms toward each other, such that the spring portion <NUM> of arms <NUM> are driven toward each other, e.g., to be in substantial contact with one another. The grasper <NUM> assumes an open configuration when first member and second member <NUM>, <NUM> are spread apart (e.g., <FIG>). The spring force could be applied by a torsion spring, a flat spring or the like. The clip arms <NUM> are movable such that the grasper <NUM> may transition between a closed configuration (e.g., for deployment and/or engaging tissue), as depicted in <FIG>, in which the spring portions <NUM> of the clip arms <NUM> are separated apart from one another, and an open configuration (e.g., for receiving tissue), as depicted in <FIG>, in which the spring portions <NUM> of the clip arms <NUM> are in contact with one another. The spring portion <NUM> of each of the arms <NUM> forms a spring space <NUM> between the spring portions <NUM>. The spring space <NUM> is open when the device <NUM> is in the closed configuration (<FIG>), and the spring space <NUM> is closed when the device <NUM> is in the open configuration (<FIG>). The second member <NUM> is slidably positioned about the plurality of arms <NUM>. The arms <NUM> extend through tapered channels <NUM> of the second member <NUM>. Each of the first member <NUM> and the second member <NUM> may be grasped either individually or together from a plurality of angles relative to a longitudinal axis ℓ of the clipping device <NUM>. The first and second members <NUM>, <NUM> may each be displaced apart relative to one another along the longitudinal axis ℓ of the clipping device <NUM> into the open configuration in response to an application of a compressive force <NUM>. A cam member <NUM> extends from a first end 1112p to a second end 1112d. The first end 1112p of the cam member <NUM> is fixedly coupled to the second member <NUM> and the second end 1112p extends into and engages the spring space <NUM> in the closed configuration. The cam member <NUM> is moved out of engagement with the spring space <NUM> when the first and second members <NUM>, <NUM> are displaced relative to each other to the open configuration, such that as the cam member <NUM> is moved out of engagement with the spring space <NUM> the spring portions <NUM> of the plurality of arms <NUM> move toward each other due to the spring force. As such, the arms <NUM> cause the grasper jaws <NUM> at the second end 1130d to move to the open configuration. When the cam member <NUM> is engaged between spring portions <NUM> in the spring space <NUM>, the device <NUM> is in the closed configuration and the clips arms <NUM> are prevented from transitioning the device <NUM> to the open configuration while the device <NUM> is in a rested state (i.e., without any substantial compressive force <NUM> applied). When there is no compressive force <NUM> applied, the first and second members <NUM>, <NUM> are displaced towards each other, into substantial contact with one another, e.g., by a linear spring <NUM> that extends between the members <NUM>, <NUM>. The linear spring <NUM> is in a rested state in the closed configuration (<FIG>) and is in an extended state (in tension) in the open configuration (<FIG>). The extended state of the linear spring <NUM> has a spring force that pulls the members <NUM>, <NUM> together, moving the second end 1112d of the cam member <NUM> into engagement with the spring space <NUM> and the spring portions <NUM> of the arms <NUM>. The cam member <NUM> includes a U-bend at the second end 1112d, two legs extending from the U-bend to the first end 1112p, and a wedge <NUM> that is centrally positioned on the U-bend at the second end 1112d. The wedge <NUM> tapers to a smaller width transverse to the longitudinal axis ℓ as the wedge <NUM> extends from the U-bend toward the first end 1112p between the legs of the cam member <NUM>. The wedge <NUM> is receivable within the spring space <NUM>. The first and second members <NUM>, <NUM> include angled surfaces <NUM> that allow the members <NUM>, <NUM> to move in opposite directions away from each other in response to an application of a compressive force <NUM> to the angled surfaces <NUM>. A loop <NUM> extends from the first member <NUM> for attachment with another device such as an elastomeric tether.

In an exemplary embodiment, the clip devices <NUM> may be coupled to a tether <NUM> to form a tether traction clip system <NUM>, as shown in <FIG> illustrates a device <NUM> as an example, but it will be understood that any embodiment of a clipping device of this disclosure could be used in a substantially similar manner. The tether traction system <NUM>, in this embodiment, comprises two clip devices <NUM> coupled together via the tether <NUM> extending therebetween. Specifically, opposing ends of the tether <NUM> are coupled to coupling ends <NUM> of the clip devices <NUM>. The tether <NUM> may be formed of an elastomeric material with high energy recovery properties such as, for example, natural rubber latex, thermoplastic elastomers and silicone rubbers. Alternatively or additionally, the tether <NUM> may be comprised of a metallic spring or shape memory material. As will be described in further detail below, the tether traction system <NUM>, in this embodiment, allows a physician to adjust a selected portion of tissue to provide the physician with a clearer line of sight to a desired target tissue. For example, a first clip device <NUM> may be coupled to a resected portion of tissue while a second clip device <NUM> may be coupled to nearby tissue such that the tether <NUM> provides tension sufficient hold the resected portion of tissue in a desired position.

With reference to <FIG>, an embodiment of a tissue clipping device <NUM> for engaging tissue is illustrated, which includes a first member <NUM> that is a substantially frustum shape. Two clip arms <NUM> extend from a first end 1210p to a second end 1210d. The first end 1210p of each arm <NUM> is received within the first member <NUM> via a channel <NUM> extending through the first member <NUM>. The clip arms <NUM> are formed of a single wire that is bent at a medial portion <NUM> that forms the first ends 1210p of the arms <NUM>. The clip arms <NUM> are movable between a closed configuration as depicted in <FIG>, in which second ends 1210d of the arms <NUM> are positioned toward one another, and an open configuration as depicted in <FIG>, in which second ends 1210d of the arms <NUM> are separated away from one another. Each of the clip arms <NUM> includes a spring portion <NUM> that extends radially toward a longitudinal axis ℓ of the clipping device <NUM> and is configured to form a spring space between the spring portions <NUM>. A spring force in a bend at the medial portion <NUM> of the clip arms <NUM> contained in the first member <NUM> creates a bias at the second end 1210d of the clip arms <NUM> toward the closed configuration. A second member <NUM> is slidably positioned about the plurality of arms <NUM>, with the arms <NUM> extending through tapered channels <NUM> of the second member <NUM>. The tapered channels <NUM> each taper (i.e., reduce in diameter) in the direction toward the first member <NUM>. The tapered channels <NUM> are internal to the second member <NUM> and are engageable with opposing sloped surfaces of the spring portions <NUM> of the arms <NUM>. The opposing sloped surfaces of the spring portions <NUM> of the arms <NUM> slope toward each other and the longitudinal axis ℓ, such that when the first and second members <NUM>, <NUM> are displaced apart from one another, the tapered channels <NUM> are moved into engagement with the sloped surfaces of the spring portions <NUM>, separating the arms <NUM> apart into the open configuration. When the first and second members <NUM>, <NUM> are displaced into substantial contact with one another, the tapered channels <NUM> are moved out of engagement with the sloped surfaces of the spring portions <NUM>, and the arms <NUM> transition to the closed configuration with the spring portion of the arms biased toward each other. Like the first member <NUM>, the second member <NUM> is also a substantially frustum shape. Each of the first member <NUM> and the second member <NUM> may be grasped either individually or together from a plurality of angles relative to the longitudinal axis ℓ of the clipping device <NUM>. The first and second members <NUM>, <NUM> may each be displaced relative to one another along the longitudinal axis ℓ of the clipping device <NUM> into the open configuration in response to application of a compressive force <NUM>. The first and second members <NUM>, <NUM> include angled outer surfaces that allow the members <NUM>, <NUM> to move in opposite directions longitudinally away from each other along the longitudinal axis ℓ in response to an application of a compressive force <NUM> to the angled outer surfaces. Although the first member <NUM> cannot move with respect to the arms <NUM> because the end 1210p extends through the first member <NUM>, the first member <NUM> may move away from the second member <NUM> together with the arms <NUM>. When the first and second members <NUM>, <NUM> are displaced relative to each other, the tapered channels <NUM> are moved into and out of engagement with the opposing sloped surfaces of the spring portions <NUM> of the arms <NUM>, transitioning the arms <NUM> between the closed configuration and open configuration. The second member <NUM> or the arms <NUM> may move longitudinally with respect to each other while one of the second member <NUM> or the arms <NUM> are fixed, or both the second member <NUM> and the arms <NUM> may move longitudinally with respect to each other. The clip arms <NUM> are biased to the closed configuration, while the device <NUM> is in a rested state (i.e., without any substantial compressive force <NUM> applied) with the spring force of the medial portion <NUM> biasing the arms <NUM> together and the first and second members <NUM>, <NUM> displaced toward each other. A loop <NUM> may extend from the first member <NUM> for another device to attach or grasp onto (e.g., using a tether therebetween).

With reference to <FIG>, an embodiment of a tissue clipping device <NUM> for engaging tissue is illustrated, which includes a first member <NUM> that is a substantially frustum shape. Two clip arms <NUM> extend from a first end 1310p to a second end 1310d. The first end 1310p of each arm <NUM> is received within the first member <NUM> via a channel <NUM> extending through the first member <NUM>. The clip arms <NUM> are formed of a single wire that is bent at a medial portion <NUM> that forms the first ends 1310p of the arms <NUM>. The clip arms <NUM> are movable between a closed configuration as depicted in <FIG>, in which second ends 1310d of the arms <NUM> are positioned toward one another, and an open configuration as depicted in <FIG>, in which second ends 1310d of the arms <NUM> are separated away from one another. Each of the clip arms <NUM> includes a spring portion <NUM> that extends radially away from a longitudinal axis ℓ of the clipping device <NUM> and is configured to form a spring space between the arms <NUM> at the spring portions <NUM>. A spring force in a bend at the medial portion <NUM> of the clip arms <NUM> contained in the first member <NUM> creates a bias at the second end 1310d of the clip arms <NUM> toward the closed configuration. A second member <NUM> is slidably positioned about the plurality of arms <NUM> and the arms <NUM> extend through tapered channels <NUM> of the second member <NUM>. The tapered channels <NUM> each taper (i.e., reduce in diameter) toward the first member <NUM>. The tapered channels <NUM> are internal to the second member <NUM> and are engageable with opposing sloped surfaces of the spring portions <NUM> of the arms <NUM>. The opposing sloped surfaces of the spring portions <NUM> of the arms <NUM> slope away from each other and the longitudinal axis ℓ, such that when the first and second members <NUM>, <NUM> are displaced apart from one another, the tapered channels <NUM> are moved into engagement with the sloped surfaces of the spring portions <NUM>, to transition the arms <NUM> apart into the open configuration. When the first and second members <NUM>, <NUM> are displaced into substantial contact with one another, the tapered channels <NUM> are moved out of engagement with the sloped surfaces of the spring portions <NUM>, and the arms <NUM> transition to the closed configuration. Like the first member <NUM>, the second member <NUM> is also a substantially frustum shape. Each of the first member <NUM> and the second member <NUM> may be grasped either individually or together from a plurality of angles relative to the longitudinal axis ℓ of the clipping device <NUM>. The first and second members <NUM>, <NUM> may each be displaced relative to one another along the longitudinal axis ℓ of the clipping device <NUM> into the open configuration in response to application of a compressive force <NUM>. The first and second members <NUM>, <NUM> include outer angled surfaces that allow the members <NUM>, <NUM> to be displaced in opposite directions away from each other in response to an application of a compressive force <NUM> to the outer angled surfaces. Although the first member <NUM> cannot move with respect to the arms <NUM> because the end 1310p extends through the first member <NUM>, the first member <NUM> may move away from the second member <NUM> together with the arms <NUM>. When the first and second members <NUM>, <NUM> are displaced relative to each other, the tapered channels <NUM> are moved into and out of engagement with the opposing sloped surfaces of the spring portions <NUM> of the arms <NUM> to transition the arms <NUM> between the closed configuration and open configuration. The second member <NUM> or the arms <NUM> may move longitudinally with respect to each other while one of the second member <NUM> or the arms <NUM> are fixed, or both the second member <NUM> and the arms <NUM> may move longitudinally with respect to each other. The clip arms <NUM> are biased to the closed configuration, while the device <NUM> is in a rested state (i.e., without any substantial compressive force <NUM> applied) with the spring force of the medial portion <NUM> biasing the arms <NUM> together and the first and second members <NUM>, <NUM> displaced toward each other. A loop <NUM> may be extended from the first member <NUM> for another device to attach or grasp onto (e.g., using a tether therebetween).

A clip device <NUM>, according to another exemplary embodiment of the present disclosure, is shown in <FIG>. In this embodiment, the clip device <NUM> includes a first chamber <NUM> closest to a coupling end <NUM> of the clip device <NUM> and a second chamber <NUM> closest to an opposing clipping end <NUM> of the device. The coupling end <NUM> may be attached to another device, e.g., a tether <NUM> of <FIG>, or <FIG>. The first and second chambers <NUM>, <NUM> are connected via a two-way valve such that material or fluid is exchanged therebetween to open and close the clip device <NUM>. In an exemplary embodiment, the material is a memory foam or similar material. In another embodiment, a viscous fluid or similar material may be used. Similar to clip devices <NUM>, <NUM>, the clip device <NUM> includes first and second clip arms <NUM> which, in this embodiment, are formed from a single wire <NUM>. As can be seen in <FIG>, the wire <NUM> is bent at a medial portion to form a first end <NUM> of the first and second clip arms <NUM> which extend therefrom to second ends <NUM> at the clipping end <NUM> of the clip device <NUM>. In this embodiment, however, the clip arms <NUM> are spring-biased to an open configuration. For example, in an embodiment, the clip arms <NUM> are bent outwardly (i.e., in a direction away from a central longitudinal axis of the clip device <NUM>) at a medial portion thereof. As shown in <FIG>, the clip arms <NUM> may be bent inwardly (i.e., in a direction toward the central longitudinal axis of the clip device <NUM>) at a spring portion <NUM> thereof such that the clip arms <NUM> cross over one another substantially at the central longitudinal axis of the clip device <NUM>. Thus, second portions <NUM> of the clip arms <NUM>, extending from the spring portion <NUM> to the second ends <NUM>, will extend away from the central longitudinal axis of the clip device <NUM> on a side of the central longitudinal axis that is opposite first portions <NUM> of the clip arms <NUM>, extending from the first end <NUM> to the spring portion <NUM>.

The clip arms <NUM> are disposed within the dual chambers with the first portions <NUM> disposed within the proximal chamber <NUM> and the second portions <NUM> partially disposed within the second chamber <NUM> and partially extending past a second end of the second chamber <NUM> closest the clipping end <NUM>, as can be seen in <FIG>. The first and second chambers <NUM>, <NUM> are substantially spherical in shape and include internal cavities <NUM>, <NUM>, respectively, configured to hold the memory foam material. The first and second chambers <NUM>, <NUM> are formed of a deformable material which allows the first and second chambers <NUM>, <NUM> to inflate and deflate as a result of material passing therebetween. As noted above, the first and second chambers <NUM>, <NUM> are coupled to one another via a two-way valve which allows free movement of the fluid between the two chambers <NUM>, <NUM>. Thus, for example, when an external pressure is applied to the first chamber <NUM> by, for example, a gripper tool <NUM>, the first chamber <NUM> contracts inwardly, reducing and internal volume and dispelling fluid therefrom into the second chamber <NUM>. Contrarily, when an external pressure is applied to the second chamber <NUM> by the gripper tool <NUM>, the second chamber <NUM> contracts inwardly, reducing the internal volume and dispelling fluid therefrom into the first chamber <NUM>. Alternatively, a contracting force applied by the material of the first chamber <NUM> may be greater than that provided by the material of the second chamber <NUM> so that, when the grasper is released from the second chamber <NUM>, the first chamber <NUM> contracts automatically forcing the material out of the first chamber <NUM> and into the second chamber <NUM>, automatically drawing the clip arms <NUM> together into the tissue gripping configuration.

In use, the clip arms <NUM> are moved to the closed configuration, depicted in <FIG>, for insertion by squeezing the first chamber <NUM> until the material therein is moved to the second chamber <NUM>, as shown in <FIG>. This movement of the material to the second chamber <NUM> forces the clip arms <NUM> to the closed configuration by inflating the second chamber <NUM> laterally of the second portions <NUM> clip arms <NUM>. This inflation of the second chamber <NUM> pushes the clip arms <NUM> towards one another and into the closed, tissue gripping configuration. Once the clip device <NUM> has been positioned at a target site adjacent target tissue, the gripper tool <NUM> is used to apply pressure to the second chamber <NUM>, as shown in <FIG>, forcing the material to move back into the first chamber <NUM>. With the pressure removed from the second portions <NUM> of the clip arms <NUM>, the clip arms <NUM> move under their pre-configured bias to the open configuration as shown in <FIG>. Clip ends <NUM> of the clip arms <NUM> are then positioned on either side of the target tissue and the clip arms <NUM> are again moved to the closed configuration by applying pressure to the first chamber <NUM> using the gripper tool <NUM>, clipping the target tissue.

With reference to <FIG>, an embodiment of a tissue clipping device <NUM> for engaging tissue is illustrated. <FIG> illustrate the device <NUM> in closed configuration, while <FIG> illustrate the device <NUM> in an open configuration. <FIG> and <FIG> are partial cross-sectional views of the device <NUM> with portions removed/revealed. The device <NUM> includes a housing <NUM> defining a cavity 1804c having a first end 1804p movable toward a second end 1804d within the cavity 1804c. Within the cavity 1804c are two clip arms <NUM> that extend from a first end 1810p to a second end 1810d. The first end 1810p of each arm <NUM> is received within the cavity 1804c. The clip arms <NUM> are movable between an open configuration (e.g., as illustrated in <FIG>), in which second ends 1810d of the arms <NUM> are separated apart from one another, and a closed configuration (e.g., as illustrated in <FIG>), in which second ends 1810d of the arms <NUM> are displaced toward one another. The arms <NUM> are biased in the open configuration or shaped in a fashion such that when they extend out of the cavity 1804c of the housing <NUM> and mostly past the second end 1804d, the arms <NUM> move into the open configuration. It is the second end 1804d of the housing <NUM> that restrains the arms <NUM> into the closed configuration. A spring element is contained in the cavity 1804c of the housing <NUM> that biases the ends 1804p, 1804d away from each other into the closed configuration when the spring element is in a relaxed configuration. The housing <NUM> is within an inner layer <NUM>. The inner layer <NUM> extends proximally of the housing <NUM> into a chamber <NUM> that contains a fluid. The inner layer <NUM> may be compressed by a force <NUM> from a plurality of angles relative to a longitudinal axis ℓ of the clipping device <NUM> into the open configuration. When compressed, the inner layer <NUM> forces the fluid <NUM> against the first end 1804p of the housing <NUM> such that the first end 1804p is moved toward the second end 1804d of the housing <NUM>. When the compressive force <NUM> is not applied to the layers <NUM>, <NUM> and the chamber <NUM>, the first end 1804p of the housing <NUM> is displaced away from the second end 1804d of the housing <NUM>, retracting the arms <NUM> to the closed configuration. As the ends 1804p, 1804d of the housing move toward each other, the second ends 1810d of the arms <NUM> move away from one another to the open configuration. An outer layer <NUM> is layered over the inner layer <NUM> and, like the inner layer <NUM>, may be grasped from a plurality of angles relative to a longitudinal axis ℓ. The inner layer <NUM> may comprise a flexible and compliant material while the outer layer <NUM> may comprise a more rigid and less compliant yet flexible material relative to the inner layer <NUM>. Examples of materials comprising the inner layer <NUM> include thermoplastic elastomers (TPE) with low durometer, polyisoprene, nitrile, polysiloxane. Examples of materials comprising the outer layer <NUM> include materials resistant to puncture such as polyurethane, thermoplastic urethane elastomers, and polyester amide elastomers, copolyether ester elastomers. The arms <NUM> may be formed from a single wire bent at a medial portion at the first end 1810p.

A clip device <NUM>, according to another exemplary embodiment of the present disclosure is shown in <FIG>. In this embodiment, the clip device <NUM> includes clip arms <NUM>, a slidable sheath <NUM> and a stop member <NUM>. The clip arms <NUM>, as with other embodiments, may be formed as wires. In this embodiment, the clip arms <NUM> extend between first ends <NUM> coupled to the stop member <NUM> and opposing second ends <NUM>. Each of the clip arms <NUM>, in this embodiment, is bent at a spring portion <NUM> radially outward away from a longitudinal axis of the clip device <NUM> biasing the clip arms <NUM> toward an open configuration, as shown in <FIG> (i.e., so that, when no external force is applied to the clip arms <NUM>, the clip arms move outward to the open, e.g., tissue receiving, configuration). The sheath <NUM> is, in this embodiment, substantially cylindrical and includes a lumen <NUM> extending therethrough from a first end closest to the stop member <NUM> of the clip device <NUM> to a second end closest to the clipping end <NUM> of the clip device <NUM>. The sheath <NUM> may be formed of any suitable material such as, for example, stainless steel or similar metals, polymers such as polycarbonate, Delrin or acrylonitrile butadiene styrene (ABS). The lumen <NUM> is sized and shaped to slidably receive the clip arms <NUM> therethrough. The stop member <NUM> is located at a side of the slidable sheath <NUM> closest to the stop member <NUM> and acts both as a stop for the slidable sheath <NUM> as well as a first grasping point for the gripper tool <NUM> as the sheath <NUM> is moved longitudinally along the clip arms <NUM>. Thus, the sheath <NUM> is slidable along the clip arms <NUM> from the stop member <NUM> to the second ends <NUM> of the clip arms <NUM>. The size of the clip arms <NUM> is configured so that when in their closed configuration, their combined width (i.e., dimension perpendicular to a longitudinal axis of the clip device <NUM>) is larger than the inner diameter of the sheath <NUM>. Additionally, the friction between the clip arms <NUM> and the sheath <NUM> will keep the sheath <NUM> from sliding longitudinally relative to the clip arms <NUM>. Although the stop member <NUM> is shown to be substantially spherical in the figures, one skilled in the art would understand that the stop member <NUM> may have any shape so long as it is capable of being held by the grasping member.

In use, the clip device <NUM> is inserted into the body in an insertion configuration with the sheath <NUM> positioned adjacent the second ends <NUM> of the clip arms <NUM> so that the clip arms <NUM> are in a closed configuration. When the clip device <NUM> is positioned at the target site adjacent the tissue, the stop member <NUM> is held by a first gripper tool <NUM> while the sheath <NUM> is held by a second gripper tool <NUM>. Holding the stop member <NUM> provides the leverage needed to move the sheath <NUM> toward the first ends <NUM> of the clip arms <NUM>, allowing the clip arms <NUM> to spring to the biased open configuration depicted in <FIG>. The second ends <NUM> of the clip arms <NUM> are then positioned on either side of the target tissue in the open configuration. With the second ends <NUM> in a desired position on the target tissue, the second gripper tool <NUM> is again used to move the sheath <NUM> toward the second ends <NUM> of the clip arms, moving the clip arms <NUM> toward one another to close the second ends <NUM> over the target tissue, as depicted in <FIG>.

A clip device <NUM>, according to another exemplary embodiment of the present disclosure, is shown in <FIG>. The clip device <NUM> uses a sliding ball actuator which acts as a fulcrum for a plurality of clip arms <NUM>. In this embodiment, the clip arms <NUM> are positioned radially about a central longitudinal axis of the clip device <NUM>, forming a substantially cylindrical clipping portion <NUM> of the clip device <NUM>. The clip arms <NUM> are formed with teeth <NUM> at second ends <NUM> (i.e., ends closest to a clipping end <NUM> of the clip device <NUM>) thereof, as shown in <FIG>. The teeth <NUM> enable the clip device <NUM> to capture tissue therein. Each of the clip arms <NUM> includes a grasping portion <NUM> extending from first ends <NUM> closest to the coupling end <NUM> of the clip device <NUM> to a first curved stop portion <NUM>. The grasping portions <NUM> are configured to be pinched by the gripper tool <NUM> to actuate the clip arms <NUM>. Each of the clip arms <NUM> also includes a pivoting portion <NUM> extending from the first curved stop portion <NUM> to a second curved stop portion <NUM>. The pivoting portions <NUM> are configured to move about the sliding ball actuator <NUM> held therein. The grasping portions <NUM> and the pivoting portions <NUM> are separated by the first curved stop portion <NUM> of each clip arm <NUM>. The first curved stop portions <NUM> and the second curved stop portions <NUM> prevent the sliding ball actuator <NUM> from moving out of the pivoting portion <NUM>. The clip arms <NUM> are spring-biased toward the closed position via an overtube <NUM> positioned over an outer surface of the clip arms <NUM>. That is, the elastomeric overtube <NUM> provides the force necessary to bias the clip arms <NUM> toward the closed position with the sliding ball actuator <NUM> at the first end of the pivoting portion <NUM> (i.e., at the first curved stop portion <NUM>) closest to the coupling end <NUM>. Although the teeth <NUM> and second ends <NUM> are described with respect to <FIG>, it will be understood that these features may be used in addition to or interchangeably with other embodiments in a substantially similar manner.

As noted above, when in the closed configuration, the sliding ball actuator <NUM> resides at a first end of the pivoting portion <NUM>, as depicted in <FIG>, with the elastomeric overtube <NUM> positioning the second ends <NUM> of the clip arms <NUM> toward one another into a closed, e.g., tissue gripping, configuration. When in use, the clip arms <NUM> are moved to the open, e.g., tissue receiving, configuration by pinching the grasping portion <NUM> of the clip arms <NUM> with the gripper tool <NUM>. Because the elastomeric overtube <NUM> is, in this embodiment, cylindrical, and the plurality of clip arms are arranged in a cylindrical layout, the elastic overtube provides a surface that can be gripped at any angle. Thus, when the gripper tool <NUM> pinches the grasping portion <NUM>, the sliding ball actuator <NUM> acts as a fulcrum about which the pivoting portion <NUM> moves, stretching the elastomeric overtube <NUM> to a larger diameter, as shown in <FIG>. Continued pinching of the clip device <NUM> drives the sliding ball actuator <NUM> toward the second curved stop portions <NUM>, further opening the clip arms <NUM> and further stretching the elastomeric overtube <NUM>. When the second ends <NUM> of the clip arms <NUM> are positioned about target tissue as desired, the pinching force from the gripper tool <NUM> is released and the elastomeric overtube <NUM> forces the clip arms <NUM> closed, forcing the sliding ball actuator <NUM> toward the first curved stop portions <NUM>. The closing of the elastomeric overtube <NUM> enables tissue captured within the teeth to be retained, allowing the tissue to be pulled in traction by the placement of a second clip device <NUM> attached to the opposite end of the tether traction clip device.

When reaching and grasping for tools (i.e., the clip devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and others described herein) at a distance in minimally invasive procedures, such as ESD and/or EMR procedures, one challenge may be contacting the grasping points on the clip devices with the gripper tool. In an exemplary embodiment, <FIG> depicts a tether traction clip system comprising magnets which may be used to provide simpler and faster interactions between the grasper and the grasping points on the clips, such as the clip devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and others described herein. <FIG> depicts a gripper tool <NUM> and clip devices <NUM> coupled together via a tether <NUM>. In this embodiment, each of the clip devices <NUM> include first magnets <NUM> of the same polarity positioned on grasping points <NUM> thereof. A second magnet <NUM> of reverse polarity is positioned on a grasping portion <NUM> of the gripper tool <NUM>. Thus, when the gripper tool <NUM> is brought into the general vicinity of one of the clip devices <NUM>, the magnets <NUM>, <NUM> of the clip device <NUM> and the gripper tool <NUM>, respectively, force the clip device <NUM> and the gripper tool <NUM> to self-orient to each other in a desired configuration. It is noted that the clip devices <NUM> of this embodiment are only exemplary and may take the form of any of clip devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. For example, the first magnets <NUM> may be positioned on the proximal grasping portion <NUM> of the clip device <NUM>, the proximal grasping portion <NUM> of the clip device <NUM>, the first chamber of the clip device <NUM>, the stop member <NUM> and/or sheath <NUM> of the clip device <NUM> or the grasping portion <NUM> of the clip device <NUM>. In various embodiments, magnets may be embedded within and/or on the surface of conical gripping elements, a first member, and/or a second member.

An exemplary method for use of embodiments of clip devices for endoscopic submucosal dissection in accordance with present disclosure is illustrated in <FIG>. For simplification, <FIG> depict clip device <NUM> of <FIG>. However, it will be understood that any of the embodiments of clip devices described herein or otherwise within the scope of the present disclosure may be used in a substantially similar manner. Prior to insertion into the body, two clip devices <NUM> are coupled to either end of an elongated elastomeric tether <NUM> to form the tether traction clip system <NUM>. The clip devices <NUM> and tether <NUM> are then inserted through a working channel of an endoscope <NUM> (or any other insertion device) using any known delivery device and inserted into the body (e.g., via a natural body lumen) to a site adjacent to a target portion of tissue, or a lesion, <NUM> to be resected. The clip devices <NUM> and tether <NUM> are extended, or pushed, out of the endoscope working channel via the gripper tool <NUM>, which is also positioned within the working channel proximal of the clip devices <NUM>. When extended out of the working channel, the clip devices <NUM> and tether <NUM> will lean against the adjacent tissue within the target body lumen. As would be understood by those skilled in the art, the lesion <NUM> (i.e., the target tissue) may have previously been marked and manipulated to make it more accessible (e.g., the tissue may have been pulled or pushed to alter folding of the tissue so that the lesion is exposed and not located deep within a fold of tissue). The target tissue may also have been injected with a bulking agent to lift the lesion <NUM> away from the underlying muscle layer.

The gripper tool <NUM> is then used to grasp the clipping device, e.g., members <NUM>, <NUM> of the clip device <NUM>, opening the clip device <NUM>. It is noted that a longitudinal length of the jaws of the gripper tool <NUM> may preferably be selected to be smaller than a diameter of members <NUM>, <NUM> of the clip devices <NUM> such that the gripper tool <NUM> does not inadvertently grasp the tissue against which the clip devices <NUM> may be adjacent (e.g., leaning against). The first clip device <NUM>, in the open configuration, is then positioned so that a first target portion of the lesion <NUM> (or adjacent tissue) is located between the separated arms of the grasper <NUM>. The gripper tool <NUM> then releases the one or more members <NUM>, <NUM> of the first clip device <NUM>, permitting the spring <NUM> attached to the members <NUM>, <NUM> to draw toward one another under the natural bias of the device <NUM> and also permitting the cam member <NUM> to move into the spring space <NUM> between the arms <NUM> to close the device <NUM>, so that the first target portion of tissue is gripped and clipped by the closing arms of the grasper <NUM>. When a clip device <NUM> has been clipped to the first target portion of tissue, another clip device <NUM> is then attached to a nearby second target portion of tissue <NUM>. The tether <NUM> applies tension between the two clip devices <NUM> and, consequently, applies tension to the first and second target portions of tissue <NUM> - in this example, the lesion <NUM> and the second target portion of tissue <NUM>. With the two clip devices <NUM> in place, the gripper tool <NUM> is removed from the endoscope <NUM> and a resection device <NUM> is inserted through the working channel of the endoscope <NUM>. The user then operates the resection device <NUM> in a known manner to make an initial incision in the lesion <NUM> permitting a resect a portion of the lesion (lesion flap <NUM>) to lift away from underlying muscle via the tension created applied by the clip devices <NUM> and tether <NUM>. This enables the physician to more clearly observe the resection, e.g., cutting plane of the lesion, as shown in <FIG>. As a greater surface area of the lesion is resected, the tension provided by the clip devices <NUM> and tether <NUM> may decrease. At this point, the resection device <NUM> may be removed from the working channel and the gripper tool <NUM> may be reinserted. The gripper tool <NUM> is then used to reposition the clip device <NUM> that was first placed into engagement with the tissue <NUM> on a different portion of tissue <NUM>, so that a desired level of tension is again provided to the lesion flap <NUM> and the process for resecting the desired tissue free from surrounding tissue is repeated. This is repeated until the entirety of the lesion <NUM> has been resected from the underlying tissue. At this point, the additional device <NUM> is detached from the tissue <NUM> via the gripper tool <NUM> and the tether traction clip system <NUM> along with the lesion tissue gripped by the clipping device <NUM> is removed from the patient's body.

In various embodiments, the arms of a device may be multiple shapes. Such shapes may include one or more bends, jogs, or curves. The arms may be continuous and/or extensions of each other. The arms may include recesses, ridges, frictional surfaces, or additional materials configured to engage a tissue or a grasper. A device may have any number of arms, e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, etc. that may be made up of one or more wires. One or more graspers may be integral to, removably engaged, or attached to the ends of the arms.

In various embodiments, a channel of a device may be multiple shapes. The channel may substantially match the shape or curve of an arm or the channel may be shaped to accept one or more arms with a volume of unoccupied space about at least portions of the arm. Various channels throughout this disclosure are tapered, but a channel may have a substantially uniform diameter throughout and still be able to manipulate one or more arms.

In various embodiments, the shape of the first and second members may vary. For example, the members may include one or more angles configured to be engaged by a tool such that one or more of the members is displaced to engage the one or more arms. The members may be symmetrical or asymmetrical with respect to each other. For example, the members may be substantially frustum-shaped such that an apex of each frustum is oriented toward the other member, so as to form an hourglass shape when they are in substantial contact with each other. The members may be configured such that the proximal and/or distal member is displaced while the other member is fixed or is also displaced.

In various embodiments, one or more arms of a device may be used to manipulate a grasper. The arms may open and close to receive or engage the grasper. The motion of a second end of the arms may create opposing movement at a second end of the jaws of the grasper (e.g., as illustrated in <FIG>). The arms of a device may be arranged to be closed in order to open the jaws of a grasper and vice versa.

In various embodiments, other methods of using a device described herein may include inserting a tissue clipping device into a patient. A member of the clipping device may be engaged by another medical device from a plurality of angles relative to a longitudinal axis of the clipping device. The member of the clipping device may be displaced apart from the other member such that it engages and manipulates one or more arms of the device into an open configuration. The device may be manipulated such that the arms receive a tissue. The member may be displaced into substantial contact with the other member such that it disengages from the one or more arms and the arms transition from the open configuration to a closed configuration. The device may be fixed to a tissue. The device may be moved while the device is engaged with a tissue such that the device and the tissue move together for removal from a patient (e.g., resection).

Claim 1:
A tissue clipping device (<NUM>, <NUM>), comprising:
a first member (<NUM>, <NUM>);
a plurality of arms (<NUM>, <NUM>), each of the arms extending from a first end (1210p, 1310p) to a second end (1210d, 1310d), the first end of each arm being received within the first member (<NUM>, <NUM>), the arms movable between an open configuration, in which the second ends (1210d, 1310d) of the arms are separated apart from one another, and a closed configuration, each of the arms (<NUM>, <NUM>) including a spring portion (<NUM>, <NUM>) configured to form a spring space between the spring portions (<NUM>, <NUM>);
a second member (<NUM>, <NUM>) slidably disposed about the plurality of arms (<NUM>, <NUM>), the second member having one or more channels (<NUM>, <NUM>) internal to the second member that are engageable with opposing sloped surfaces of the arms (<NUM>, <NUM>);
wherein the first member (<NUM>, <NUM>) and the second member (<NUM>, <NUM>) are configured to be grasped from a plurality of angles relative to a longitudinal axis (I) of the clipping device (<NUM>, <NUM>), and are configured to be displaced relative to one another along the longitudinal axis (I) of the clipping device (<NUM>, <NUM>) in response to an application of a radially inwardly directed compressive force (<NUM>, <NUM>); and
wherein the one or more channels (<NUM>, <NUM>) are moveable into and out of engagement with the opposing sloped surfaces of the arms (<NUM>, <NUM>) when the first and second members (<NUM>, <NUM>, <NUM>, <NUM>) are displaced relative to one another to transition the arms (<NUM>, <NUM>) between the closed configuration and open configuration,
wherein the first and second members (<NUM>, <NUM>, <NUM>, <NUM>) include angled surfaces configured to displace the first and second members (<NUM>, <NUM>, <NUM>, <NUM>) apart from one another when the compressive force (<NUM>, <NUM>) is applied to the angled surfaces.