Hemostatic Clip Short System

Abstract

A device includes a capsule body and first and second clamp arms, the proximal ends of the first and second clamp arms being received within a channel so that the first and second clamp arms are movable relative to each other between an open configuration and a closed configuration. A deployment mechanism includes a tension member connected to the proximal ends of the first and second arms, a yoke releasably coupled to the tension member and movable longitudinally relative to the capsule body to move the first and second arms between the open and closed configurations. The tension member and yoke are configured to separate from each other in response to a predetermined proximal force relative to the tension member. A locking mechanism is coupled to the deployment mechanism and is configured to engage the capsule body to lock a one-piece clamping element in the closed configuration when the yoke is separated from the tension member.

Description

[0001] Inventors: Esteban SOLANO MONTENEGRO, Daniel Eduardo MATA BARRANTES and JosePablo NUNEZ CORELLA

[0002] Priority declaration

[0003] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 863,016, filed on June 18, 2019; the disclosure of which is incorporated herein by reference. Technical Field

[0004] The present invention relates to endoscopic devices and, in particular, to endoscopic gripping devices for manipulating tissue along the gastrointestinal tract. Background Art

[0005] During endoscopic gastrointestinal (GI) surgery, the patient may be at risk for GI tract wall perforation or may require closure of the GI tract wall as part of the procedure. Hemostatic clips can be used, for example, to stop bleeding from mucosal / submucosal defects, bleeding ulcers, arteries, polyps, diverticula, and closure of luminal perforations. Depending on the size of the defect, multiple clips may be required. Summary of the invention

[0006] The present invention relates to a device for treating tissue, comprising a capsule body and first and second clamp arms, the capsule body extending longitudinally from a proximal end to a distal end and comprising a channel extending therethrough, the proximal ends of the first and second clamp arms being received within the channel so that the first and second clamp arms are movable relative to each other between an open configuration and a closed configuration. A deployment mechanism comprises a tension member connected to the proximal ends of the first and second clamp arms, a yoke releasably coupled to the tension member and movable longitudinally relative to the capsule body to move the first and second clamp arms between an open configuration and a closed configuration. The tension member and the yoke are configured to separate from each other in response to a predetermined proximal force relative to the tension member to release the device from a proximal portion thereof. A locking mechanism is coupled to the deployment mechanism and comprises a pair of locking fingers configured to engage corresponding locking features of the capsule body to lock the first and second clamp arms in a closed configuration when the yoke is separated from the tension member.

[0007] In one embodiment, the first and second clamp arms may be defined via a one-piece clamping element extending from a first end to a second end and including a bend along a portion thereof extending along a midpoint of the one-piece clamping element such that the lengths of the first and second clamp arms substantially correspond.

[0008] In one embodiment, the distal end of the tension member may be connected to the proximal end of the clamp arm via a pin extending diametrically across the distal end of the tension member and passing through a substantially circular space formed at the proximal end of the clamp arm via a bend along the one-piece clamping element.

[0009] In one embodiment, the locking mechanism may include a ring coupled to the distal end of the tension member via a pin, with a pair of locking fingers extending proximally from the ring.

[0010] In one embodiment, the locking fingers may be biased radially outward and include a locking structure extending from a proximal end thereof.

[0011] In one embodiment, the yoke may include a pair of cantilevered arms that constrain against the proximal ends of the locking fingers of the yoke and prevent the locking structure from engaging the locking features of the capsule until the yoke is separated from the tension member.

[0012] In one embodiment, the capsule body may have a length ranging between about 7.5 mm and 8.5 mm.

[0013] In one embodiment, the first and second clamp arms can be biased toward an open configuration such that when the first and second clamp arms are pulled proximally into the capsule body, the first and second clamp arms are constrained toward a closed configuration, and when the first and second clamp arms are moved distally out of the capsule body, the first and second clamp arms are allowed to return to their biased open configuration.

[0014] The present invention also relates to a clamping device, which includes a clamp, the clamp including a capsule body extending longitudinally from a proximal end to a distal end and including a channel extending therethrough. The proximal ends of the first and second clamp arms are slidably received in the channel of the capsule body so that the first and second clamp arms can move between an open configuration and a closed configuration relative to each other. The deployment mechanism includes a tension member connected to the proximal ends of the first and second clamp arms. The yoke is releasably coupled to the tension member and is coupled to a control member, which is movable relative to the capsule body to move the first and second clamp arms between an open configuration and a closed configuration. The tension member and the yoke are configured to separate in response to a predetermined proximal force relative to the tension member. The locking mechanism is coupled to the deployment mechanism and includes a pair of locking fingers, which are configured to engage corresponding locking features of the capsule body when the yoke is separated from the tension member to lock the first and second clamp arms in a closed configuration. The proximal portion is releasably coupled to the proximal end of the capsule body so that when the yoke is separated from the tension member, the clamp is released from the proximal portion and deployed on a target tissue in the body.

[0015] In one embodiment, the first and second clamp arms may be defined via a one-piece clamping element extending from a first end to a second end and including a bend along a portion thereof extending along a midpoint of the one-piece clamping element such that the lengths of the first and second clamp arms substantially correspond.

[0016] In one embodiment, the distal end of the tension member may be connected to the proximal end of the clamp arm via a pin extending diametrically across the distal end of the tension member and passing through a substantially circular space formed at the proximal end of the clamp arm via a bend along the one-piece clamping element.

[0017] In one embodiment, the locking mechanism may include a ring coupled to the distal end of the tension member via a pin, with a pair of locking fingers extending proximally from the ring.

[0018] In one embodiment, the locking fingers may be biased radially outward and include a locking structure extending from a proximal end thereof.

[0019] In one embodiment, the yoke may include a pair of cantilevered arms that constrain against the proximal ends of the locking fingers of the yoke and prevent the locking structure from engaging the locking features of the capsule until the yoke is separated from the tension member.

[0020] In one embodiment, the capsule body may have a length ranging between about 7.5 mm and 8.5 mm.

[0021] The present invention also relates to a method for treating a target tissue. A clamp device is inserted into a target site in a body through a working channel of an endoscope until the clamp of the clamp device extends distally beyond the distal end of the working channel. The clamp device includes a capsule body and a pair of clamp arms, the proximal ends of the clamp arms being slidably received in the capsule body. The clamp device moves between an open configuration and a closed configuration until a selected target tissue is clamped between first and second ends of a one-piece clamping element, the first and second clamp arms being moved between the open and closed configurations via a control line coupled to a yoke that is releasably coupled to a tension member that is coupled to the first and second clamp arms. Once the target tissue is clamped as desired, the clamp device is locked in the closed configuration by applying a predetermined proximal force along the control member to separate the yoke from the tension member, which allows a locking finger of the locking mechanism to engage a corresponding locking feature of the capsule body. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 shows a longitudinal side view of a device according to an exemplary embodiment of the present invention;

[0023] Figure 2 Shown according to Figure 1 a partially transparent longitudinal side view of a clamp of the device;

[0024] Figure 3 Shows the opening pattern Figure 2 Another partially transparent longitudinal side view of the clip;

[0025] Figure 4 The 3D-printed ... Figure 2 Another partially transparent longitudinal side view of the clip;

[0026] Figure 5 Shows Figure 2 A perspective view of a deployment mechanism, a locking mechanism and a clamp arm of the clamp;

[0027] Figure 6 Shows Figure 2 A perspective view of the deployment mechanism and locking mechanism of the clip; and

[0028] Figure 7 Shows Figure 2 A longitudinal side view of the clamp's deployment mechanism and clamp arms. DETAILED DESCRIPTION

[0029] The present invention may be further understood with reference to the following description and accompanying drawings, in which like elements are indicated by like reference numerals. The present invention relates to an endoscopic clamping device for treating internal tissue perforations, defects and / or bleeding. In some embodiments, a shorter deployment clip may be preferred to improve visualization of the target site and allow better maneuverability when placing multiple clips. An exemplary embodiment of the present invention describes a clip comprising a clamp arm defined by a one-piece element that can slide within a capsule body to move the clamp between an open form and a closed form as needed to clamp the target tissue. The one-piece element is connected to a separate deployment mechanism and a locking mechanism to reduce the length of the deployment clip relative to other conventional clip designs that include a capsule body. Those skilled in the art will understand that the terms proximal and distal as used herein are intended to refer to directions toward and away from a user of the device, respectively.

[0030] like Figures 1 to 7As shown, a clip device 100 according to an exemplary embodiment of the present invention includes a clip 101, which includes a one-piece element 102, which defines a pair of clamp arms 104 received in a capsule body 106 to move the clamp arms 104 between an open configuration and a closed configuration, in which the distal ends 108 of the clamp arms 104 are separated from each other, and in which the distal ends 108 are pulled toward each other to clamp tissue. In an embodiment, the one-piece element 102 extends from a first end 110 to a second end 112, and is bent, for example, at a joint or midpoint 114 to define the clamp arms 104. The midpoint 114 is connected to a deployment mechanism 116 including a tension member 118 and a yoke 120, which are slidably received in the capsule body 106 to move the clamp arms 104 between the open and closed configurations.

[0031] The locking mechanism 122 is coupled to the one-piece element 102 and the deployment mechanism 116 so that the clip 101 is locked in the closed configuration when the clip 101 is deployed over the target tissue in the body. Figure 1 As shown, the clip 101 is releasably coupled to an elongated proximal portion 160 of the device 100, the proximal portion 160 being sized to facilitate insertion of the clip 101 through a working channel of an endoscope to a target site in the body, while the proximal end remains outside the body accessible to a user. The proximal portion 160 may include, for example, a handle member 162, which includes an actuator 164 that enables a user to control movement and deployment of the clip 101 and a flexible shaft 166 extending distally from the handle member 162 to the clip 101, the distal end 168 of the flexible shaft 166 being releasably coupled to the clip 101 via, for example, a bushing 172. The user manipulates the actuator 164 to move a control member 170 extending from the handle member 162, which is connected to the clamp arm 104 through the flexible shaft 166 to control movement of the clamp arm 104 between the open and closed configurations.

[0032] The capsule body 106 extends from a proximal end 124 to a distal end 126 and includes a passage 128 extending therethrough. In one embodiment, the proximal end 124 is configured to be releasably coupled to a proximal portion of the device via a lug 130 at the proximal end 124 of the capsule body 106, which lug 130 can be radially crimped inward to engage a corresponding portion of the proximal portion. The capsule body 106 also includes a locking feature, such as, for example, a locking window 132 extending transversely through the capsule body wall to engage a portion of the locking mechanism 122, as will be described in further detail below.

[0033] In one embodiment, the capsule body 106 can have a length ranging between 7.5 mm and 8.55 mm. The capsule body 106 of this embodiment is significantly shorter than the capsule body length of some conventional clips, which can have a length ranging between 12.5 mm and 13.5 mm. It will be appreciated by those skilled in the art that the one-piece design of the clamp arm 104 and the separate locking mechanism 122 (described in further detail below) allow the capsule body 106 to have a shorter length relative to some existing clamps without sacrificing the opening width of the clamp arm 104.

[0034] As described above, the clamp arm 104 is formed from a one-piece element 102 that extends along a length from a first end 110 to a second end 112 and is bent at, for example, a midpoint 114 so that the clamp arm 104 extends along a portion of the length that extends from opposite sides of the midpoint 114, for example, proximal to the first and second ends 110, 112. Thus, the first and second ends 110, 112 of the one-piece element 102 correspond to the distal end 108 of the clamp arm 104. The midpoint 114 is connected to a deployment mechanism 116 that is slidably received within the channel 128 of the capsule body 106 so that the clamp arm 104 can move between an open and closed configuration.

[0035] In one embodiment, the clamp arms 104 are biased toward the open configuration so that when the capsule 106 is pushed out distally, the clamp arms 104 move apart from each other into the open configuration under their natural bias. When the arms 104 are pulled proximally into the capsule 106, the clamp arms 104 are constrained by the walls of the capsule 106 and pulled together into a closed position with the distal ends 108 adjacent to each other. Those skilled in the art will appreciate that any number of other mechanisms for opening and closing the clamp arms 104 may be employed. Those skilled in the art will also appreciate that while the exemplary embodiment shows and describes a one-piece element 102 that includes a bend to form the clamp arms 104, in alternative embodiments, the proximal ends of the clamp arms may be attached to each other such that the proximal ends may be connected to the tension member 118.

[0036] The clamp arm 104 of this embodiment also includes an engagement feature 134 extending from the clamp arm 104 and configured to engage a portion of the capsule body 106 such that when the engagement feature 134 engages the capsule body 106, the clamp arm 104 is prevented from further proximal movement into the capsule body 106. In one embodiment, the engagement feature 134 extends laterally outward from the portion of the clamp arm 104 such that the portion of the clamp arm 104 distal to the engagement feature 134 has a greater width than the portion of the clamp arm 104 proximal to the engagement feature 134. The portion of the clamp arm 104 extending proximally to the engagement feature 134 is sized to allow these portions of the clamp arm 104 to be pulled proximally into the capsule body 106.

[0037] When the proximal portion of the clamp arm 104 is pulled proximally into the capsule body 106, the engagement feature 134 abuts a portion of the distal end surface 127 of the capsule body 106, thereby preventing the clamp arm 104 from being pulled further proximally into the capsule body 106. The engagement feature 134 is positioned along the length of the clamp arm 104 so that at the point where the engagement feature 134 has engaged the capsule body 106, the clamp arm 104 has been pulled proximally into the capsule body 106 sufficiently to draw the clamp arm 104 together into the closed configuration. In one example, the engagement feature 134 is configured as a wing extending laterally from a longitudinal edge of the clamp arm 104.

[0038] The tension member 118 extends from a proximal end 136 configured to releasably couple to the yoke 120 to a distal end 138 attached to the midpoint 114 of the one-piece element 102 via, for example, a pin 140. In one embodiment, the distal end 138 extends above the midpoint 114 such that the pin 140 extending diametrically across the distal end 138 is received within a substantially circular space at the proximal end 158 of the clamp arm 104 defined by the bend of the one-piece element 102 at the midpoint 114. In other words, the pin 140 extends immediately distal to the midpoint 114 such that the pin 140 extends along the inner surface of the one-piece element 102 (along the bend at the midpoint 114) between the pair of arms 104. The tension member 118 and the pin 140 are connected to the one-piece element 102 such that longitudinal movement of the tension member 118 relative to the capsule body 106 correspondingly moves the clamp arm 104 relative to the capsule body 106. The proximal end 136 of the tension member 118 is sized and shaped to engage a correspondingly sized and shaped portion of the yoke 120. In one embodiment, the proximal end 136 includes a substantially C-shaped protrusion.

[0039] The yoke 120 extends from a proximal end 142 configured to be connected to a control member, such as, for example, a pull wire, to a distal end 144 configured to releasably engage the proximal end 136 of the tension member 118. In one embodiment, the distal end 144 includes a substantially C-shaped recess 146 that is sized and shaped to receive the C-shaped protrusion of the proximal end 136. The proximal end 136 of the tension member 118 and the distal end 144 of the yoke 120 are configured to disengage from each other when subjected to a predetermined force, as will be described in more detail below.

[0040] In one embodiment, the width along at least a portion of the yoke 120 substantially corresponds to the width (e.g., diameter) of the channel 128 of the capsule body 106, such that when the yoke 120 is positioned within the proximal end 124 of the capsule body 106, the yoke 120 engages the lugs 130 to move the lugs 130 radially outwardly out of engagement with the proximal portion of the device. The yoke 120 also includes a pair of cantilever arms 148 extending distally from a portion thereof. As will be described in further detail below, the cantilever arms 148 are configured to constrain the proximal ends 154 of the locking arms 152 of the locking mechanism 122, such that the locking arms 154 are prevented from engaging the locking features 134 of the capsule body 106 until the clip 101 has been deployed over the target tissue.

[0041] The locking mechanism 122 is attached to the tension member 118 and includes locking arms 152 as described above, which are constrained by the yoke 120 until the clip 101 is deployed. In one embodiment, the locking mechanism 122 includes a ring 150 and a pair of locking arms 152 extending proximally from the ring 150. The ring 150 is attached to the tension member 118 via the same pin 140 that connects the tension member 118 to the clamp arm 104. In particular, the pin 140 extends diametrically across the ring 150 so that the ring 150 extends around both the distal end 138 of the tension member 118 and the proximal end 158 of the clamp arm 104.

[0042] The locking arms 152 extend proximally from opposite sides of the ring 150 to the proximal ends 154 and, in one embodiment, are biased radially outward. The ring 150 is connected to the tension member 118 so that the locking arms 152 extend along opposite sides of the tension member 118 to be constrained via the cantilever arms 148 of the yoke 120. The proximal ends 154 of the locking arms 152 include a locking structure 156 extending therefrom so that when the proximal ends 154 are allowed to return to their biased configuration, the locking structure 156 engages the locking feature 132 of the capsule body 106. In one embodiment, the locking structure 156 is configured as a locking lug extending from the proximal end 154 to engage the locking window 132 of the capsule body 106 when the proximal end 154 is released from the cantilever arms 148. As will be described in further detail below, when a predetermined force is applied to the yoke 120 to separate the yoke 120 from the tension member 118, the proximal end 154 is released and allowed to return to its radially outward biased configuration.

[0043] According to an exemplary method, the clip 101 of the clip device 100 is inserted into a target site in the body via a working channel of, for example, an endoscope. The clip 101 is inserted through the working channel in a closed configuration so that the clip arms 104 are not damaged inside the working channel. Once the clip 101 has reached the target site, the clip arms 104 are moved distally relative to the capsule body 106, so that the distal portions of the clip arms 104 extend out of the capsule body 106 and the clip arms 104 are free to move apart under their natural bias toward the open configuration so that the target tissue can be received between the clip arms 104. The clip 101 can be repeatedly moved between the open and closed configurations until the target portion of the tissue is positioned between the clip arms 104 as desired. The user then pulls the clip arms 104 proximally into the capsule body 106 so that when the clip arms 104 are pulled into the capsule body 106, the clip arms 104 are pulled toward each other to clamp the target tissue between the distal ends 108 of the clip arms 104. As described above, the clip 101 can be moved between open and closed configurations via, for example, movement of a control member 170 coupled to the yoke 120 .

[0044] When the user is satisfied that the clip 101 is in the desired position to clamp the target tissue, the user applies an increasing proximally directed force to the control member 170 after the engagement feature 134 has engaged the capsule body 106, as described above, until the predetermined force pulls the yoke 120 proximally away from the tension member 118, disengaging them from each other. As the yoke 120 is separated from the tension member 118, the proximal end 154 of the locking mechanism 122 of the clip arm 104 is released from the cantilever 148 of the yoke 120, thereby allowing the proximal end 154 to freely rebound toward its radially outwardly biased configuration until the locking lug 156 engages the locking window 132 of the capsule body 106, thereby locking the clip 101 in the closed configuration.

[0045] The yoke 120 may then be further pulled proximally relative to the capsule body 106 (e.g., via a control member connected thereto) until a portion of the yoke 120 having a width corresponding to the passage 128 of the capsule body 106 is positioned within the proximal end 124 of the capsule body 106, thereby pushing the radially inwardly crimped lugs 130 radially outwardly, disengaging from, for example, the bushing 172 of the proximal portion 160 of the device 100, and separating the clip 101 from the proximal portion 160. Thus, the clip 101 remains clamped on the target tissue while the proximal portion 160 may be removed from the body. In one embodiment, upon separation of the clip 101 from the proximal portion 160, the lugs 130 return to their radially inwardly crimped configuration, such that the yoke 120 remains attached to the proximal end 124 of the capsule body 106 despite separation from the tension member 118.

[0046] In this embodiment, further proximal force applied to the control member 170 causes the control member to separate from the yoke 120, thereby leaving the clip 101 in the body and allowing the proximal portion 160 of the device 100 (including the control member 170) to be removed therefrom. According to another embodiment, when the capsule body 106 is separated from the proximal portion 160, the yoke 120 can be pulled proximally out of the capsule body 106, so that the clip 101 remains in the body, clamped on the target tissue, while the proximal portion 160 and the yoke 120 can be removed from the body.

[0047] It will be apparent to those skilled in the art that various modifications can be made in the present invention without departing from the scope of the invention.

Claims

1. A device for treating tissue, comprising: a clip comprising a capsule body and first and second clip arms, the capsule body extending longitudinally from a proximal end to a distal end and including a passage extending therethrough, proximal portions of the first and second clip arms being received within the passage so that the first and second clip arms are movable relative to each other between an open configuration and a closed configuration, wherein the first and second clip arms are formed as a single piece extending from a distal end of the first clip arm around a bend to a distal end of the second clip arm, and wherein the proximal portion of the first clip arm and the proximal portion of the second clip arm meet at the bend; a deployment mechanism comprising a tension member in the single piece connected at the bend to proximal portions of the first and second clamp arms, a yoke releasably coupled to the tension member and movable longitudinally relative to the capsule body to move the first and second clamp arms between the open and closed configurations, the tension member and yoke being configured to separate from one another in response to a predetermined proximal force applied to the tension member to release the clamp from the proximal portion of the device; and A locking mechanism is coupled to the deployment mechanism and the clamp arms and includes a pair of locking arms configured to engage corresponding locking features of the capsule body to lock the first and second clamp arms in the closed configuration when the yoke is separated from the tension member.

2. The device of claim 1, wherein the bends of the first and second clamp arms are formed at the midpoint of the single piece forming the first and second clamp arms, so that the length of the first clamp arm substantially corresponds to the length of the second clamp arm.

3. The device of claim 2, wherein the distal end of the tension member is connected to the proximal portions of the first and second clamp arms via a pin, the pin extending diametrically across the distal end of the tension member and passing through a substantially circular space at the proximal portions of the first and second clamp arms formed by the bend in the single piece forming the first and second clamp arms.

4. The device of claim 3, wherein the locking mechanism comprises a ring coupled to the distal end of the tension member via the pin, the pair of locking arms extending proximally from the ring.

5. The device of any one of claims 1 to 4, wherein the locking arm is biased radially outwardly and includes a locking structure extending from a proximal end thereof.

6. The device of claim 5, wherein the yoke includes a pair of cantilevered arms that constrain against proximal portions of the locking arms of the yoke and prevent the locking structure from engaging the locking features of the capsule until the yoke is separated from the tension member.

7. The device according to any one of claims 1 to 4, wherein the capsule body has a length of from 7.5 mm to 8.5 mm.

8. The device according to any one of claims 1 to 4, wherein the first and second clamp arms are biased toward the open form so that when the first and second clamp arms are pulled proximally into the capsule body, the first and second clamp arms are constrained toward the closed form, and when the first and second clamp arms are moved distally out of the capsule body, the first and second clamp arms are allowed to return to their biased open form.

9. A clamping device comprising: a clip comprising a capsule extending longitudinally from a proximal end to a distal end and comprising a passage extending therethrough, proximal portions of first and second clamp arms being slidably received within the passage of the capsule to move the first and second clamp arms relative to each other between an open configuration and a closed configuration, wherein the first and second clamp arms are formed as a single piece extending from a distal end of the first clamp arm around a bend to a distal end of the second clamp arm, and wherein the proximal portions of the first clamp arm and the proximal portions of the second clamp arm meet at the bend; a deployment mechanism comprising a tension member connected to proximal portions of the first and second clamp arms at a bend in the single piece, a yoke releasably coupled to the tension member and coupleable to a control member, the control member movable relative to the capsule body to move the first and second clamp arms between the open and closed configurations, the tension member and yoke configured to separate in response to a predetermined proximal force applied to the tension member; a locking mechanism coupled to the deployment mechanism and the clamp arms and comprising a pair of locking arms configured to engage corresponding locking features of the capsule to lock the first and second clamp arms in the closed configuration when the yoke is separated from the tension member; and A proximal member is releasably coupled to the proximal end of the capsule body such that when the yoke is separated from the tension member, the clip is released from the proximal member and deployed on a target tissue in the body.

10. The device of claim 9, wherein the bends of the first and second clamp arms are formed at a midpoint of the single piece forming the first and second clamp arms such that the length of the first clamp arm substantially corresponds to the length of the second clamp arm.

11. The device of claim 10, wherein the distal end of the tension member is connected to the proximal portions of the first and second clamp arms via a pin, the pin extending diametrically across the distal end of the tension member and passing through a substantially circular space at the proximal portions of the first and second clamp arms formed by the bend in the single piece forming the first and second clamp arms.

12. The device of claim 11, wherein the locking mechanism comprises a ring coupled to the distal end of the tension member via the pin, the pair of locking arms extending proximally from the ring.

13. The device of any one of claims 9 to 11, wherein the locking arm is biased radially outwardly and includes a locking structure extending from a proximal end thereof.

14. The device of claim 13, wherein the yoke includes a pair of cantilevered arms that constrain against proximal portions of the locking arms of the yoke and prevent the locking structure from engaging the locking features of the capsule until the yoke is separated from the tension member.

15. The device according to any one of claims 9 to 11, wherein the capsule body has a length of from 7.5 mm to 8.5 mm.

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