LOCKING FEATURE FOR HEMOSTASIS CLIP

A clipping system includes a clip, a core member and a control member. The clip includes a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, and clip arms. Proximal ends of the arms are slidably received within the channel to move the arms between open and closed configurations. The core member is received between and connected to the proximal ends of the arms to couple the arms to one another. The core member includes a locking feature movable between unlocked and locked configurations. The control member extends through a proximal portion of the system from a proximal end to an enlarged distal end housed within a proximal portion of the core member so that a longitudinal movement of the control member relative to the capsule moves the clip between the open and closed configurations.

FIELD

The present disclosure relates to endoscopic devices and, in particular, relates to endoscopic clipping devices for treating tissue along the gastrointestinal tract.

BACKGROUND

Physicians have become more willing to perform aggressive interventional and therapeutic endoscopic gastrointestinal (GI) procedures, which may increase the risk of perforating the wall of the GI tract or may require closure of the GI tract wall as part of the procedure. Such procedures may include, for example, the removal of large lesions, tunneling under the mucosal layer of the GI tract to treat issues below the mucosa, full thickness removal of tissue, treatment of issues on other organs by passing outside of the GI tract, and endoscopic treatment/repair of post-surgical issues (e.g., post-surgical leaks, breakdown of surgical staple lines, and anastomotic leaks). Currently, tissue openings may be closed via endoscope closure devices such as, for example, hemostasis clips inserted through an endoscope. In some cases, however, current endoscopic closure devices may be difficult to use, time consuming to position, or insufficient for certain perforations, conditions, and anatomies.

SUMMARY

The present disclosure relates to embodiments a clipping system for treating tissue. The system includes a clip including a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, and a pair of clip arms, proximal ends of which are slidably received within the channel to move the clip arms between an open configuration, in which distal ends of the clip arms are separated from one another to receive a tissue therebetween, and a closed configuration, in which distal ends of the clip arms are drawn toward one another to grip a tissue therebetween; a core member received between and connected to the proximal ends of the clip arms to couple the clip arms to one another, the core member including a locking feature movable between an unlocked configuration, in which the core member is slidable within the channel of the capsule, and a locked configuration, in which the locking feature engages a corresponding portion of the capsule to lock the clip arms in the closed configuration; and a control member extending through a proximal portion of the clipping system from a proximal end to an enlarged distal end housed within a proximal portion of the core member so that a longitudinal movement of the control member relative to the capsule moves the clip between the open and the closed configurations.

In an embodiment, the core member is connected to the clip arms via a connector received within holes extending through the proximal ends of the clip arms and through an elongated opening extending through the core member.

In an embodiment, the connector is slidable from a proximal end of the elongated opening to a distal end of the elongated opening to move the locking feature from the unlocked configuration to the locked configuration, the connector configured to interface with a portion of the locking feature as the connector is moved distally through the elongated opening.

In an embodiment, the core member is formed of a stamped sheet of metal sized and shaped to bent into a configuration including a proximal portion defining a cavity therewithin for housing the enlarged distal end of the control member therein and a distal portion including the locking feature.

In an embodiment, the locking feature is configured as a portion of the stamped sheet of metal bent to overlap a portion of the elongated opening of the core member to form a first and second wings which, when engaged with the connector as the connector moves distally along the elongated opening, each of which is moved radially outward to engage a corresponding locking feature of the capsule.

In an embodiment, the locking features of the capsule include a pair of windows extending through a wall thereof, the windows sized, shaped, and configured to receive therein a corresponding one of the first and second wings.

In an embodiment, the distal ends of the clip arms are biased toward the open configuration so that, when the clip arms are drawn into the capsule, the clip arms are constrained toward the closed configuration via an interior surface of the capsule and, when the clip arms are moved distally out of the capsule, the clip arms are permitted to revert to their biased open configuration.

In an embodiment, the distal end of the control member is configured to separate from a remaining length of the control member when the control member is subject to a force exceeding a predetermined threshold value to release the clip from the proximal portion of the clipping system in a clipped configuration.

In an embodiment, the core member includes a proximal opening extending through the core member in communication with the cavity so that a length of the control member extends proximally from the enlarged distal end proximally through the proximal opening, the proximal opening configured to deform to permit a proximal passage of the distal end therethrough when the control member is subject to a force exceeding a predetermined threshold value.

In addition, the present disclosure relates to a clipping system for treating tissue, which includes an insertion device extending longitudinally from a proximal end to a distal end and including a channel extending therethrough; a clip including a capsule releasably coupled to the insertion device and a pair of clip arms, the capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, proximal ends of the clip arms slidably received within the channel to move the clip arms between an open configuration, in which distal ends of the clip arms are separated from one another to receive a tissue therebetween, and a closed configuration, in which distal ends of the clip arms are drawn toward one another to grip a tissue therebetween; a core member received between and connected to the proximal ends of the clip arms to couple the clip arms to one another, the core member including a locking feature movable between an unlocked configuration, in which the core member is slidable within the channel of the capsule, and a locked configuration, in which the locking feature engages a corresponding portion of the capsule to lock the clip arms in the closed configuration; and a control member extending through the insertion device from a proximal end accessible to a user of the clipping system to an enlarged distal end received a proximal portion of the core member so that a longitudinal movement of the control member relative to the capsule moves the clip between the open and the closed configurations.

In an embodiment, the core member is connected to the clip arms via a connector received within holes extending through the proximal ends of the clip arms and through an elongated opening extending through the core member.

In an embodiment, the connector is slidable from a proximal end of the elongated opening to a distal end of the elongated opening to move the locking feature from the unlocked configuration to the locked configuration, the connector configured to interface with a portion of the locking feature as a pin is moved distally along the elongated opening.

In an embodiment, the core member is formed of a stamped sheet of metal sized and shaped to bent into a configuration including a proximal portion defining a cavity therewithin for housing the enlarged distal end of the control member therein and a distal portion including the locking feature.

In an embodiment, the locking feature is configured as a portion of the stamped sheet of metal bent to overlap a portion of the elongated opening of the core member to form a pair of wings which, when engaged with the connector as the connector moves distally along the elongated opening, is moved radially outward to engage the corresponding portion of the capsule.

In an embodiment, the proximal end of the capsule includes a pair of tabs crimped radially inwardly to engage a corresponding portion of a bushing at the distal end of the insertion device to releasably couple the clip to the insertion device, the core member including a pair of flaps along the proximal portion thereof which, when the core member is in the locked configuration relative to the capsule, engages the tabs of capsule to deform the tabs radially outward, out of engagement with the bushing.

Furthermore, the present disclosure relates to a method for treating target tissue, which includes inserting a clip through a working channel of an endoscope to a target site within a body via a catheter, the clip including a capsule and a pair of clip arms, proximal ends of the clip arms coupled to one another via a core member that is slidably received within the capsule; moving the clip between an open configuration and a closed configuration until a target tissue is received between distal ends of the clip arms as desired, the clip moved between the open and closed configurations via a control member coupled to the clip arms via the core member, an enlarged distal end of the core member received within a cavity defined via a proximal portion of the core member; moving the clip toward the closed configuration to grip the target tissue between the distal ends of the clip arms by drawing the control member proximally relative to the catheter; locking the clip in the closed configuration by moving a locking feature of the core member from an unlocked configuration toward a locked configuration in which the locking feature engages a corresponding portion of the capsule; and deploying the clip from the catheter by drawing the control member proximally until a force exerted on the control member exceeds a predetermined threshold value so that the enlarged distal end of the control member is separated from a remaining length thereof to release the clip from the insertion device.

In an embodiment, the core member is connected to the clip arms via a connector received within holes extending through the proximal ends of the clip arms and through an elongated opening extending through the core member.

In an embodiment, locking the clip in the closed configuration includes drawing clip arms proximally until a portion of the clip arms engage a portion of the capsule to prevent any further proximal movement of the clip arms relative to the capsule so that a further proximal movement of the control member relative to the insertion device causes the connector to slide from a proximal end of the elongated opening to a distal end of the elongated opening to move the locking feature from the unlocked configuration to the locked configuration, the connector configured to interface with a portion of the locking feature as a pin is moved distally along the elongated opening.

In an embodiment, the locking feature includes a pair of wings which overlap a portion of the elongated opening of the core member so that, when engaged with the connector as the connector moves distally along the elongated opening, the wings are moved radially outward to engage the corresponding portion of the capsule.

In an embodiment, when the locking feature is locked relative to the capsule, a pair of flaps along the proximal portion of the core member engage tabs at a proximal end of the capsule to move the tabs out of engagement with a corresponding portion of a bushing at a distal end of the catheter to release the capsule from the insertion device.

DETAILED DESCRIPTION

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 is directed to an endoscopic clipping system for treating internal tissue perforations, defects and/or bleeds. Exemplary embodiments of the present disclosure describe a clipping system comprising a clip releasably coupled to a proximal portion of the system, the clip including a pair of clip arms, proximal ends of which are slidable within a capsule to move the clip arms between an open configuration, in which distal ends of the clip arms are separated from one another to receive target tissue therebetween, and a closed configuration, in which the clip arms are drawn into the capsule so that the distal ends of the clip arms are moved toward one another to grip the target tissue therebetween.

The exemplary clipping system further comprises a core member which couples the proximal ends of the clip arms to one another and to a distal end of a control member moved by an operator of the clipping system (e.g., a surgeon) to move the clip between the open and closed configurations and, upon clipping of the clip over a target tissue as desired, toward a deployment of the clip. The exemplary core member includes a locking feature or structure which, when the deployment is initiated, locks the clip arms relative to the capsule in the closed configuration. The exemplary locking feature allows the use of a capsule that is shorter reducing an overall length of a deployed clip as compared to current hemostasis clips including capsules in which a clip is locked via locking structures on the clip arms themselves.

As will be understood by those of skill in the art, shorter deployed clips may improve visualization of the target site and allow for better maneuverability when, for example, placing multiple clips. Some current clip designs also create shed parts during the deployment process of separating the clip from the catheter which shed parts may be left in the body to pass through the GI tract naturally. As the treatment of larger defect cases such as Peroral Endoscopic Myotomy (POEM) and Endoscopic Submucosal Dissection (ESD) become more prevalent, physicians may prefer clips that do not generate shed parts to eliminate the possibility of shed parts causing harm, e.g., by becoming embedded in the defects, etc.

A core member according to an exemplary embodiment is shaped or otherwise configured to eliminate shed parts by, for example, encapsulating a distal end of a control wire which separates from a remaining length of the control wire during deployment of the clip. The severed distal end of the control member remains trapped within the core member, which remains housed within the capsule of the deployed clip to contain these parts and prevent them from being shed. It will be understood by those of skill in the art that the terms proximal and distal as used herein, are intended to refer to a direction toward and away from, respectively, a user of the system.

FIGS.1-17show a clipping system100for treating tissue defects comprising a clip102releasably coupled to an insertion device such as, for example, a catheter104. The clip102includes a pair of clip arms106, proximal ends108of which are coupled to one another via a core member110which is slidably received within a capsule112to move the clip102between an open configuration, in which distal ends114of the clip arms106are separated from one another to receive tissue therebetween, and a closed configuration, in which the distal ends114of the clip arms106are drawn toward one another to grip tissue therebetween.

The clip arms106are moved between the open and closed configurations via a control member116, a distal end118of which is received within a cavity120of the core member110while a reduced dimension portion122of the control member116extends proximally therefrom to pass out of the core member110. The remaining portion of the control member116extends through the catheter104, to a proximal end that is accessible to a user of the system100for actuation via an actuator (not shown). In this embodiment, the distal end118of the control member is enlarged (i.e., of increased diameter) relative to at least a portion of the control member116that passes through an opening in the core member110so that, when the control member116is drawn proximally, the distal end118pulls the core member110and the clip arms proximally relative to the capsule. Thus, the user may move the control member116longitudinally relative to the catheter104to move the clip102between the open and the closed configurations. In particular, the control member116may be moved distally relative to the capsule112to move the clip arms106distally out of the capsule112toward the open configuration and to withdraw the clip arms106proximally into the capsule112to move the clip102toward the closed configuration.

According to the exemplary embodiment, the core member110includes a locking feature124so that, when the clip102has been clipped over the target tissue as desired, deployment of the clip102may be initiated by drawing the control member116further proximally relative to the capsule112. As will be described in further detail below, the further proximal motion of the control member116moves the locking feature124radially outward so that the locking feature124engages corresponding locking structures126of the capsule112. Locking of the clip102facilitates deployment of the clip102. In one embodiment, the control member116may be drawn even further proximally until a force exerted thereon until a widened portion of one or both of the clip arms106contacts the distal end of the capsule112preventing the clip arms106from being moved further proximally. Continued application of proximal force to the control member116after this point increases a tension on the control member116. When this tension exceeds a predetermined threshold force, the distal end118of the control member116is separated from the reduced dimension portion122of the control member116releasing the clip102from the catheter104. After the distal end118is separated from the rest of the control member116. the distal end118remains trapped within the core member110, which remains housed within the capsule112of the deployed clip102. Thus, deployment of the clip102does not result in any shed parts.

As described above, according to an exemplary embodiment, the clipping system100includes the catheter104for inserting the clip102to a target area within a body. The system100of this embodiment includes a bushing128fixed to a distal end of the catheter104and the bushing128is releasably coupled to the capsule112. The control member116extends through the catheter104and the bushing128so that the distal end118extends distally therefrom to be connected to the clip102. It will be understood by those of skill in the art that the distal end118has a width in at least one dimension larger than that of the opening in the core member110through which the control member116passes through to extend proximally from the core member110. This prevents the distal end118of this embodiment from passing proximally out of the opening in the core member110. In addition, as would be understood by those skilled in the art, the separation of the distal end118from the rest of the control member116and the release of the busing128from the capsule112separates the clip102from the rest of the system100so that the clip102can remain in the body clipped over target tissue after the rest of the system including the catheter104, the bushing128and the proximal portion of the control member116are withdrawn from the body.

In an exemplary embodiment, the distal end118is connected to the remaining length of the control member116(proximal portion of the control member116) via a thinned portion, a joint or connection that is configured to release, break, or otherwise separate the distal end118from the reduced dimension portion122when subject to a force that exceeds a predetermined threshold value during the deployment process. In one example, the connection between the distal end118and the remaining length includes a reduced diameter portion configured to fail when subject to a force exceeding the predetermined threshold force (i.e., to fail at a force lower than a force required to break any other part of the control member116or to pull the distal end118out of the core member110).

It will be understood by those of skill in the art, however, that the connection between the distal end118and the reduced dimension portion122of the control member116may have any of a variety of configurations. Additionally, although the exemplary embodiment describes the insertion device as the catheter104, it will be understood by those of skill in the art that the insertion device may include any flexible elongate member that is insertable through, for example, tortuous paths of a body lumen to reach a target site.

The capsule112of the clip102extends from a proximal end130to a distal end132and includes a channel134extending therethrough. In one embodiment, the proximal end130is releasably coupled to the bushing128via, for example, one or more tabs136each of which is crimped radially inward to engage a corresponding engaging portion142of the bushing128. The corresponding engaging portion142of the bushing128may include, for example, a groove or recess formed within the bushing128, the groove or recess sized, shaped, or otherwise configured to engage the radially inwardly crimped tabs136. In one embodiment, the capsule112includes a pair of tabs136diametrically opposing one another. The capsule112also includes locking structures126configured to engage the locking features124of the core member110. The locking structures126may be formed in a capsule wall and, in one embodiment, includes windows extending laterally through the capsule wall.

Each of the clip arms106extends from the proximal end108to the distal end114. As described above, the proximal ends108are slidably received within the channel134so that the clip arms106may be moved relative to the capsule112between the open and the closed configurations via manipulation of the control member116. In one embodiment, the clip arms106are biased toward the open configuration so that, when advanced distally out of the capsule112, the clip arms106move apart from one another into the open configuration under their natural bias. When the clip arms106are drawn proximally into the capsule112, the clip arms106are constrained by the wall of the capsule112and drawn together toward the closed configuration, with the distal ends114adjacent to one another. Those skilled in the art will understand that a number of other mechanisms for opening and closing the clip arms106may be employed.

Each of the clip arms106of this embodiment also includes engaging features138extending therefrom configured to engage a portion of the capsule112so that when the engaging features138engage the capsule112, the clip arms106are prevented from being moved further proximally into the capsule112. In one embodiment, the engaging features138extend laterally outward from distal portions of the clip arms106, so that the distal portions of the clip arms106have a width greater than proximal portions of the clip arms106and greater than a diameter of a distal opening of the capsule112. Thus, the proximal portions of the clip arms106are sized to permit them to be drawn proximally into the capsule112while the portions of the clip arms106extending from the engagement features138distally, are too wide to be drawn into the capsule112. Thus, as the clip arms106are drawn proximally into the capsule112, the engaging features138abut a portion of a distal face140of the capsule112preventing further proximal movement of the clip arms106relative to the capsule112. The engaging features138are positioned along the clip arms106so that, at the point where the engaging features138have engaged the capsule112, the clip arms106have been drawn sufficiently proximally into the capsule112to draw the clip arms106together, into the closed configuration. In one example, the engaging features138may be configured as wings extending laterally from longitudinal edges of the clip arms106.

Each of the proximal ends108of the clip arms106, in this embodiment, includes a hole152extending therethrough. The hole152is configured to facilitate a coupling of the proximal ends108of the clip arms106with the core member110. According to an exemplary embodiment, when the clip arms106are diametrically opposed relative to one another, the holes152of the clip arms106are aligned with one another so that a connector such as, for example, a rivet154may be passed through the holes152at the proximal ends108of the clip arms106and through a corresponding opening156of the core member110to couple the clip arms106to the core member110.

As described above, the core member110is sized and configured to be longitudinally slidable within the channel134of the capsule112. In an exemplary embodiment, the core member110is a one-piece mechanism configured to connect the control member116to the clip arms106and, according to an exemplary embodiment, is formed of a stamped sheet of material117(e.g., metal) sized and shaped so that, when bent as will described in further detail below, the material117includes a proximal portion158defining the cavity120, configured to receive the distal end118of the control member116, and a distal portion160, which defines the locking feature124configured to lock the clip arms106relative to the capsule112in the closed configuration.

The core member110, in the bent configuration, extends from a proximal end162to a distal end164. According to an exemplary embodiment, the material117is bent over the proximal end162to include a first surface166and a second surface168. A portion of the first and second surfaces166,168extending along the proximal portion158defines the cavity120therebetween. A portion of the first and second surfaces166,168extending along the distal portion160of the core member110may be substantially planar, extending parallel to one another and to a longitudinal axis of the capsule112within which the core member110is received in an operative configuration.

Along the distal portion160, each of the first and second surfaces166,168include an elongated opening170extending therethrough along a central axis. Each elongated opening170is elongated along a longitudinal axis of the core member110and are aligned relative to one another along the central axis, which extends substantially perpendicular to the first and second surfaces166,168. As will be described in further detail below, the elongated opening170of each of the first and second surfaces166,168is configured to receive the rivet154or other connector which connects the clip arms106to the core member110.

In addition to the first and second surfaces166,168, the core member110also includes a first flap172and a second flap174extending from the proximal end162and bent relative to the longitudinal axis of the core member110toward the distal end164to further define the cavity120. In particular, each of the first and second flaps172,174extends along the proximal portion158of the core member110so that the cavity120is defined between the first and second surfaces166,168and the first and second flaps172,174. The proximal end162includes an opening180extending therethrough along a central axis that is substantially aligned with a longitudinal axis of the core member110. The proximal opening180is sized and shaped so that, when the distal end118is received within the cavity120, the reduced dimension portion122of the control member116passes through the proximal opening180to extend proximally from the enlarged distal end118.

It will be understood by those of skill in the art that the defined cavity120is sized, shaped, and configured to house the enlarged distal end118of the control member116therein while the proximal opening180is sized and shaped to prevent the passage of the enlarged distal end118therethrough. No space extending between adjacent ones of the first and second flaps172,174and the first and second surfaces166,168is sufficient to permit the passage of the enlarged distal end118therethrough so that, upon deployment of the clip102, the enlarged distal end118is retained housed within the cavity120, eliminating the potential for the severed enlarged distal end118to escape the core member110thereby eliminating the risk of shed parts.

The first and second flaps172,174are angled with respect to the longitudinal axis of the core member110so that a width of the core member110at the distal ends176(e.g., a distance between the distal ends176) of the first and second flaps172,174is greater than a width of the core member110at the proximal end162(e.g., a distance between proximal ends of the first and second flaps172,174). The first and second flaps172,174are angled so that, when the core member110is drawn proximally relative to the capsule112during a deployment of the clip102, the first and second flaps172,174come into contact with and engage the tabs136, which are crimped radially inwardly relative to the longitudinal capsule to112engage the capsule112with the bushing128. As the angled surfaces of the first and second flaps172,174slide proximally along the tabs136, engagement between the first and second flaps172,174and the radially inwardly crimped tabs136causes the tabs136to move radially outward relative to the longitudinal axis of the capsule112disengaging the tabs136from the corresponding engaging portion of the bushing128.

Portions of the material117extending from exterior longitudinal edges182of one of the first surface166and the second surface168are also bent inward to extend between the first and second surfaces166,168to define the locking feature124. In an exemplary embodiment, the locking feature124is configured as a pair of wings144extending between the first and second surfaces166,168and movable between an unlocked configuration and a locked configuration. In the unlocked configuration, exterior longitudinal edges146of the wings144are substantially aligned with the longitudinal edges182of the first surface166(and longitudinal edges of the second surface168) so that the core member110is free to slide longitudinally within the channel134of the capsule112to move the clip arms106between the open and closed configurations. In the locked configuration, a portion of each of the pair of wings144is moved radially outward to engage the locking structures126of the capsule112.

According to an exemplary embodiment, each of the wings144is connected to either the first surface166or the second surface168via a bent portion184of the material117extending along a proximal length of the exterior longitudinal edges182,146of the one of the first and second surfaces166,168and the wings144. This bent portion184is deformed as the core member110is moved from the unlocked configuration toward the locked configuration such that a distal portion of each of the wings144is moved radially outward. Interior longitudinal edges148include a proximal portion186and a distal portion188which are angled relative to one another and relative to the longitudinal axis of the core member110.

Each of the proximal and distal portions186,188of the interior longitudinal edges148of the wings144is angled such that a width (e.g., a distance between the exterior longitudinal edge146and the interior longitudinal edge148) of each of the wings144increases toward the distal end162of the core member110. The interior longitudinal edges148are angled so that a portion of each of the wings144overlaps with the elongated openings156. In particular, a portion of each of the wings144overlaps the elongated openings156so as not to interfere with the rivet154, which is received within the proximal portion of the elongated openings156in the unlocked configuration. In one embodiment, the proximal portion186of the interior longitudinal edges148defines a portion of a space within the elongated openings156through which the rivet154is received in the unlocked configuration.

As the core member110is moved toward the locked configuration, the rivet154is moved toward the distal portion of the elongated openings156, pressing distally against a point150along the interior longitudinal edges148at which the proximal and distal portions186,188of the interior longitudinal edges148meet. Once the rivet154moves past the point150, the rivet154is slid distally along and between the angled distal portions188of the interior longitudinal edges148, moving the wings144away from one another and in a radially outward away from the longitudinal axis of the core member110, toward the locking configuration.

A force required for facilitating a deployment of the clip102may be adjusted, as desired, by adjusting the magnitude of the angle at which the proximal and distal portions186,188of each of the interior longitudinal edges148of the wings144meet. In one example, as shown inFIG.10, a point150aat which proximal and distal portions186a,188aof an interior longitudinal edge148aof each wing144aincludes a smooth curved edge decreasing a force required to deploy the clip102. In another example, as shown inFIG.11, an angle150bat which proximal and distal portions186b,188bof an interior longitudinal edge148bof each wing144bmeet is sharpened to increase the force required to deploy the clip102. It will be understood by those of skill in the art that the force required to deploy the clip102may also be adjusted by adjusting a length of the bent portions184extending along and between the wings144and of the one of the first and second surfaces166,168from which the wings144extend.

The clip102is assembled so that the core member110is received between the proximal ends108of the clip arms106, the elongated openings156of the core member aligned with the holes152extending through the proximal ends108of the clip arms106. The rivet154extends through the holes152of the clip arms106and through the proximal portion of the elongated openings156. The core member110assembled with the clip arms106is slidably received within the channel134of the capsule112. As described above, the enlarged distal end118of the control member116is housed within the cavity120within the proximal portion158of the core member110with the reduced dimension portion122extending proximally therefrom through the opening180at the proximal end162of the core member110and through the bushing128and catheter104to a proximal end accessible via the user or operator of the system100.

According to an exemplary method utilizing the clipping system100, as shown inFIGS.12-17, the clip102is inserted through, for example, a working channel of an endoscope to a target site within a body. The clip102is inserted to the target site, in the closed configuration, via an insertion device such as the catheter104to which the clip102is releasably coupled via the bushing128. Once the clip102has reached the target site, the user advances the control member116distally relative to the catheter104to move the clip arms106distally relative to the capsule112toward the open configuration.

As the clip arms106are extended distally from the capsule112, the clip arms106move toward the open configuration, as shown inFIG.12, under their natural bias (as they are freed from the constraints of the capsule112) so that tissue may be received between the distal ends114thereof. The user may then draw the control member116proximally (or advance the catheter104distally over the control member116) so that, as the clip arms106are drawn into the capsule112, the clip arms106are drawn toward one another to grip the tissue received between the distal ends114of the clip arms106. The clip102may be moved between the open and closed configurations, as desired, until a target portion of the tissue is positioned between the clip arms106as desired.

When the user is satisfied that the clip102is in a desired position gripping the target tissue, the user may deploy the clip102to lock the clip102in the closed configuration and release the clip102from the catheter104. According to an exemplary embodiment, the user draws the control member116proximally so that the engaging features138of the clip arms106engage the distal face140of the capsule112, preventing a further proximal motion of the clip arms106relative to the capsule112. After this point, continued proximal motion of the control member116, draws the core member110proximally relative to the clip arms106, the rivet154received within the openings156of the clip arms106, and the capsule112. This causes the core member110to slide proximally over the rivet154which moves from its position in the proximal portions of the elongated openings156of the core member110toward the distal portions of the elongated openings156.

As the rivet154slides toward the distal portion of the elongated openings156, the rivet154engages portions of the wings144overlapping the elongated openings156. The rivet154slides distally along the angled interior longitudinal edges148of the wings144pushing the wings144from the unlocked configuration radially outward toward the locked configuration. In the locked configuration, the wings144are moved radially outward relative to the longitudinal axis of the core member110to engage the locking structures126(e.g., the wings144extend into and/or through the windows) extending along the capsule wall.

The core member110is configured so that when the wings144of the locking feature124of the core member110are in the locked configuration, the proximal portion158of the core member110is received within the proximal end130of the capsule112so that the first and second flaps172,174engage the radially inwardly crimped tabs136of the capsule112, forcing the tabs136radially outward, out of engagement with the bushing128. Thus, once the core member110is locked with respect to the capsule112, to finally deploy the clip102, the user my continue to draw the control member116proximally until the force exerted therealong exceeds the predetermined threshold value, causing the enlarged distal end118to separate from the remaining length of the control member116. The catheter104and the reduced dimension portion122of the control member116may then be withdrawn from the body, leaving the clip102deployed within the body, gripped over the target tissue.

As shown inFIG.18, a core member210according to another exemplary embodiment of the present disclosure may be substantially similar to the core member110, as described above with respect to the clipping system100, comprising a proximal portion258defining a cavity220, within which the enlarged distal end118of the control member116may be received, and a distal portion260including a locking feature224such as, for example, wings244received between a first surface266and a second surface268of the core member110. The distal portion260may be substantially similar to the distal portion160of the core member110, including substantially similar features and functioning substantially similarly to the core member110.

The proximal portion258may also be substantially similar to the proximal portion158of the core member110, the cavity220being defined via proximal portions of the first and second surfaces266,268and via first and second flaps272,274. One of the first and second flaps272,274in the embodiment, however, includes a slot290extending therealong so that a proximal opening280extending through a proximal end262of the core member210is open to an edge292of the one of the first and second flaps272,274. The slot290is sized, shaped, and configured to facilitate an assembly of the control member116with the core member210. In particular, a portion of the control member116immediately proximal the enlarged distal end118may be slid along the slot290so that the enlarged distal end118may be passed into the cavity220, with the reduced dimension portion122of the control member116extends proximally therefrom through the proximal opening280.

In one embodiment, during deployment, the enlarged distal end118may separate from the reduced dimension portion122when a force exerted thereon exceeds a predetermined threshold force so that the enlarged distal end118remains housed within the cavity220. In another embodiment, during deployment, when a force exerted on the proximal end262exceeds the predetermined threshold value, the portions of the one of the first and second flaps272,274defined via the slot290are deformed away from one another, increasing a size of the proximal opening280so that the enlarged distal end118may pass proximally therethrough.

According to yet another exemplary embodiment, as shown inFIG.19, clip arms306are integrally formed with a core member310so that the clip arms306and the core member310form a single component301. The clip arms306and the core member310may be substantially similar to the clip arms106and core member110described above with respect to the clipping system100. In this embodiment, however, proximal ends308of the clip arms306are directly connected to the core member310(e.g., at a distal end364of the core member310). Since a rivet is not required to connect the proximal ends308of the clip arms306with the core member310, in this embodiment, a pin or rivet may be received with a distal portion of the elongated openings356of the core member310in the unlocked configuration and slid toward a proximal portion of the elongated openings356in the locked configuration. The pin or rivet may be attached to a distal end of a control member, which extends through a proximal opening of the core member310, substantially as described above with respect to the system100.

During deployment of a clip according to this embodiment, the control member (and the pin or rivet received within the elongated openings356) is drawn proximally relative to the clip arms306to move the core member310from the unlocked to the locked configuration. It will be understood by those of skill in the art that the locking feature324of the core member310may simply be inverted relative to the locking feature124described above with respect to the system100. For example, portions of wings of the locking feature324may overlap with a proximal portion of the elongated openings356.

As shown inFIGS.20-22, a system400according to another exemplary embodiment of the present disclosure may be substantially similar to the system100described above, comprising a clip402releasably coupled to an insertion device such as, for example, a catheter (not shown), via a bushing428. Similarly to the clip102, the clip402, as shown inFIG.20, includes a pair of clip arms406, proximal ends408of which are coupled to one another via a core member410, which is slidably received within a capsule412to move the clip402between an open configuration, in which distal ends414of the clip arms406are separated from one another to receive a tissue therebetween, and a closed configuration, in which the distal ends414of the clip arms406are drawn toward one another to grip tissue therebetween. The clip402is moved between the open and the closed configurations via a control member416, an enlarged distal end418of which is received within a cavity420of the core member410. The clip402, the control member416, and the core member410, in this embodiment, may be substantially similar to the clip102, the control member116, and the core member110(or core members210,310), as described above, and may be utilized in a manner substantially similar to the system100. As will be described in further detail below, however, the enlarged distal end418, in this embodiment, does not separate from a remaining portion of the control member416during a deployment process. Rather, during deployment, the enlarged distal end418of the control member416is draw proximally against a proximal opening480of the core member410until the proximal opening480deforms to permit a proximal passage of the enlarged distal end418therethrough, thereby separating the control member416from the clip402.

Similarly to the clip102, the clip402is moved between the open and the closed configurations until a target tissue is clipped, as desired. In particular, the control member416is moved distally relative to the capsule412to move the clip arms406toward the open configuration and proximally relative to the capsule412to move the clip arms406toward the closed configuration. Upon clipping of the target tissue, the clip402may be locked in the closed configuration by drawing the control member416further proximally relative to the capsule412until locking features424(e.g., wings) of the core member410engage corresponding locking structures426(e.g., windows) of the capsule412. As described above with respect to the system100, this further proximal motion of the control member416relative to the capsule410causes the locking features424to move in a radially outward direction so that the locking features424engage the corresponding locking structures426of the capsule412(shown inFIGS.20-21). According to an embodiment, when the locking features424engage the corresponding locking structures426, first and second flaps472,474along a proximal portion458of the core member410engage radially inwardly crimped tabs436of the capsule412, forcing the tabs436out of engagement with the bushing428, which connects the clip402to the insertion device. Thus, once the core member410is locked with respect to the capsule412, to finally deploy the clip402, the user may continue to draw the control member416proximally relative to the capsule412until the force exerted therealong exceeds a predetermined threshold value, causing the control member416to separate from the clip402, as shown inFIG.20. The user may then withdraw the insertion device and control member416from the body, as shown inFIG.21, leaving the deployed clip402.

In this embodiment, however, the proximal opening480of the core member410, through which a remaining length422of the control member416extends when the enlarged distal end418is received within the cavity420, is configured to deform when subject to a force exceeding the predetermined threshold value. In particular, the proximal opening480is deformed to permit the proximal passage of the enlarged distal end418therethrough so that the control member416remains intact during deployment. According to an exemplary embodiment, a thickness of a portion of a material417surrounding the proximal opening480may be selected to facilitate a deformation thereof, as the enlarged distal end418is drawn proximally thereagainst. As shown in the sequence of images inFIGS.22a-22d, the control member416is drawn proximally relative to the control member410so that the enlarged distal end418continues to apply a force exceeding the predetermined threshold force on the proximal opening480and, in particular, along a portion of the material417surrounding the proximal opening480, until the proximal opening480is sufficiently deformed to permit passage of the entire enlarged distal end418therethrough. Thus, once the enlarged distal end418passes through the deformed proximal opening480, the insertion device and the control member416may be separated from the clip402and removed from the body, leaving the deployed clip402clipped over the target tissue in the body. As there are no broken and/or separated pieces during deployment, it will be understood by those of skill in the art that this embodiment also does not create any shed parts and thus eliminates the risks thereof.

Although the exemplary embodiment shows and describes the core member410as including first and second flaps472,474configured to engage a portion of the capsule412to release the bushing428therefrom, in another embodiment, the first and second flaps472,474may be eliminated. As discussed above with respect to the system100, the first and second flaps472,474facilitate housing of the enlarged distal end418within the cavity420. Since the enlarged distal end418of the system400, however, is not separated from the remaining length422of the control member416during deployment, the flaps472,474may be eliminated as they are not required to prevent escape of the enlarged distal end418after deployment. In this embodiment, bent portions484of the core member410, which connect the locking features424to a surface of the core member410, may be configured to engage the crimped tabs436of the capsule412during a deployment process. Similarly to the core member110, as described above with respect to the system100, these bent portions484deform as the locking features424are moved toward the locking configuration. In this embodiment, the bent portions484are configured so that, as they are deformed when the core member410moves from the unlocked configuration to the locked configuration, the bent portions484engage the radially inwardly crimped tabs436of the capsule412, forcing the tabs436radially outward, out of engagement with the bushing428.