Hemostatic reloadable clamping device with cannula engagement

Abstract

The present invention relates to a system for treating tissue, the system comprising a clamping assembly having a pair of clamping arms, the proximal end of each clamping arm being slidably received within a channel of a package body and being movable between a tissue receiving configuration and a tissue clamping configuration. The system also comprises an applicator, which is releasably connected to the clamping assembly, the applicator comprising a control member connectable to the proximal end of each clamping arm, and a locking sleeve connectable to the proximal end of the package body via a deflectable tab, the deflectable tab comprising an engagement structure configured to engage with a corresponding engagement structure at the proximal end of the package body, and a release structure proximal to the engagement structure, the release structure being engageable with a portion of the control member to deflect the deflectable member and to disengage the engagement structure of the sleeve from the corresponding engagement structure of the package body.

Description

[0001] (Division of 201780051400.7)

[0002] Priority declaration

[0003] This disclosure claims priority to U.S. Provisional Patent Application Serial No. 62 / 378,100, filed on August 22, 2016, the disclosure of which is incorporated herein by reference. Background Art

[0004] Lesions of the gastrointestinal (GI) system, biliary system, vascular system, and other body cavities and hollow organs are often treated through endoscopic surgery, and many endoscopic surgeries require hemostasis to control internal bleeding. Hemostatic clips grasp the tissue around the wound and temporarily bring the edges of the wound together to allow the natural healing process to permanently close the wound. A dedicated endoscopic clamping device is used to deliver the clamp to the desired location inside the body, and the clamp delivery device is then removed, leaving the clamp inside the body. Summary of the invention

[0005] The present disclosure relates to a system for treating tissue, the system comprising a clamp assembly and an applicator. The clamp assembly comprises a pair of clamp arms, each clamp arm extending from a proximal end to a distal end, the proximal end of each clamp arm being slidably received within a channel of an enclosure so as to move between a tissue receiving configuration (wherein the distal ends of the clamp arms are separated from each other) and a tissue clamping configuration (wherein the distal ends of the clamp arms move toward each other). The applicator is releasably coupled to the clamp assembly so as to move the clamp assembly between the tissue receiving configuration and the tissue clamping configuration. The applicator comprises: a control member connectable to the proximal end of each clamp arm, and a locking sleeve connectable to the proximal end of the enclosure via a deflectable tab defined along the length of the locking sleeve from the free distal end to the proximal end, the proximal end being connected to the remainder of the locking sleeve so that the deflectable tab can be deflected relative to the remainder. The deflectable tab includes an engagement structure configured to engage with a corresponding engagement structure at the proximal end of the package body, and a release structure proximal to the engagement structure, which can engage with a portion of the control member to deflect the deflectable member and separate the engagement structure of the locking sleeve from the corresponding engagement structure of the package body.

[0006] In one embodiment, the engagement structure of the locking sleeve may be a first bend along the distal end of the deflectable tab and the corresponding engagement structure of the package may be a window extending laterally therethrough sized and shaped to receive the first bend.

[0007] In one embodiment, the first bend may extend inwardly into the longitudinal passage of the locking sleeve so that the locking sleeve may be mounted over the proximal end of the enclosure and the deflectable tab may be deflected from the longitudinal axis of the passage of the locking sleeve.

[0008] In one embodiment, the release structure may be a second bend extending into the channel of the locking sleeve.

[0009] In one embodiment, the control member may include a body extending longitudinally from an enlarged distal end to a proximal end.

[0010] In one embodiment, the proximal ends of the clamp arms may be connected via a yoke that includes an interface sized and shaped to releasably receive the enlarged distal end of the body of the control member.

[0011] In one embodiment, the yoke may be configured to deform when a force applied to the yoke by the enlarged distal end exceeds a predetermined threshold.

[0012] In one embodiment, the control member may further include a stop pad slidably mounted over a portion of the body, the stop pad including a surface for interacting with the release structure to deflect the deflectable member.

[0013] In one embodiment, the engagement structure of the locking sleeve can be a window extending laterally through the deflectable tab, and the corresponding engagement structure of the package body can be a bend extending outward from the longitudinal axis of the package body so that the locking sleeve can be received within the channel of the package body and the deflectable tab can be deflected toward the longitudinal axis of the locking sleeve.

[0014] In one embodiment, the release structure may be a protrusion that extends inwardly into the longitudinal passage of the locking sleeve such that when a portion of the control tab engages the protrusion, the deflectable tab is deflected toward the longitudinal axis of the locking sleeve.

[0015] In one embodiment, the release structure can be an element that extends from an inner surface of the deflectable tab through the passage of the locking sleeve such that when a portion of the control member engages the release structure, the deflectable tab is deflected toward the longitudinal axis of the locking sleeve.

[0016] In one embodiment, the applicator may further include an outer sleeve extending around a portion of the deflectable tab proximal to the engagement structure, the outer sleeve being deformable over the deflectable tab to release the locking sleeve from the enclosure.

[0017] In one embodiment, the clamp arms are biased in the tissue receiving configuration.

[0018] In one embodiment, the enclosure may include a locking window extending through a wall thereof for engaging a locking tab at a proximal end of at least one of the clamp arms to lock the clamp arm in the tissue clamping configuration.

[0019] The present disclosure also relates to a reloadable clamping device, which includes a clamping assembly, a box and an applicator. The clamping assembly includes a pair of clamping arms, each of which extends from a proximal end to a distal end, and the proximal ends of each clamping arm are interconnected via a yoke, and the yoke is slidably received in the passage interior of the package body to move the clamping arms between a tissue receiving configuration (wherein the distal ends of the clamping arms are separated from each other) and a tissue clamping configuration (wherein the distal ends of the clamping arms move toward each other). The box includes a groove therein, the size and shape of the groove being designed to accommodate the clamping assembly, and the box includes a proximal opening, which opens to the outside of the box communicating with the groove. The applicator has a distal end that can be inserted through the opening of the box so as to be releasably connected to the clamping assembly. The applicator includes: a control member having an enlarged distal end sized and shaped to be releasably received within an interface of a yoke; and a locking sleeve coupled to the proximal end of the enclosure via a deflectable tab defined along the length of the locking sleeve from a free distal end to a proximal end, the proximal end being connected to the remainder of the locking sleeve so that the deflectable tab is deflectable from the longitudinal axis of the locking sleeve, the deflectable tab including a distal bend extending into a channel of the locking sleeve to engage with a window extending laterally through the proximal end of the enclosure, and a proximal bend proximal to the distal bend extending into the channel of the locking sleeve so that when the proximal bend engages with a portion of the control member, the deflectable member is deflected from the longitudinal axis of the locking sleeve to separate the applicator from the clamping assembly.

[0020] The present disclosure also relates to a method for treating tissue, the method comprising: loading a first clamping assembly onto an applicator by connecting a control member of the applicator to a yoke; connecting the proximal end of a clamping arm of the first clamping assembly by pushing an enlarged distal end of the control member into an interface of the yoke; and connecting a locking sleeve of the applicator to a package body of the first clamping assembly by pushing the locking sleeve distally along the proximal end of the package body; a deflectable tab of the locking sleeve is deflected so that an engagement structure of the deflectable tab travels along a surface of the package body until the engagement structure engages with a corresponding engagement structure of the package body; inserting the loaded clamping assembly into a target site inside a living body through a working channel of an endoscope; and as needed The first clamping assembly is preferably moved between a tissue receiving configuration (in which the distal ends of the clamping arms are separated from each other) and a tissue clamping configuration (in which the distal ends of the clamping arms are moved toward each other) by moving the control member longitudinally relative to the locking sleeve until the target tissue is clamped therebetween; and the first clamping assembly is released from the applicator by pulling the control member proximally relative to the yoke beyond a predetermined threshold value so that the control member is separated from the yoke and a portion of the control member engages with a release structure located proximal to the engagement structure on the deflectable tab (engagement of this portion of the control member with the release structure causes the deflectable tab to deflect and separate the engagement structure of the locking sleeve from the corresponding engagement feature of the package body). BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 shows a perspective view of a system according to an exemplary embodiment of the present disclosure in an unassembled configuration;

[0022] Figure 2 The unassembled configuration is shown. Figure 1 A longitudinal side view of the system;

[0023] Figure 3 The assembled configuration is shown. Figure 1 A longitudinal cross-sectional view of the system;

[0024] Figure 4 Shows Figure 1 An exploded perspective view of a box and a clamping assembly of the system;

[0025] Figure 5 The tissue clamping configuration is shown. Figure 1 A longitudinal cross-sectional view of the system;

[0026] Figure 6 Shown according to Figure 1 A longitudinal side view of a yoke of the system;

[0027] Figure 7 Shown according to Figure 1a longitudinal side view of a distal portion of a control member of the system;

[0028] Figure 8 Shown according to Figure 1 A perspective view of a stop pad of the system;

[0029] Fig. 9 Shown according to Figure 1 A perspective view of a locking sleeve of the system;

[0030] Fig.10 Shown according to Figure 1 A longitudinal cross-sectional view of a system of interconnected clamping assemblies and applicators;

[0031] Fig.11 Shown according to Figure 1 A longitudinal cross-sectional view of a system of interconnected clamping assemblies and applicators;

[0032] Fig.12 Shown according to Figure 1 A longitudinal cross-sectional view of a clamping assembly of a system released from an applicator;

[0033] Fig.13 A perspective view showing a clamp assembly and an applicator of a system according to another exemplary embodiment of the present disclosure in an uncoupled configuration;

[0034] Fig.14 shows the uncoupled configuration, Fig.13 A longitudinal cross-sectional view of a clamping assembly and an applicator of the system;

[0035] Fig.15 shows the connected configuration, Fig.13 A perspective view of a clamping assembly and an applicator of a system;

[0036] Fig.16 shows the connected configuration, Fig.13 A longitudinal cross-sectional view of a clamping assembly and an applicator of the system;

[0037] Fig.17 shows a longitudinal side view of a system according to an alternative embodiment of the present disclosure;

[0038] Fig.18 Shows Fig.17 Another longitudinal side view of the system;

[0039] Fig.19 shows a cross-sectional perspective view of a system according to another exemplary embodiment of the present disclosure;

[0040] Fig. 20 Shows Fig.19 perspective of the system. DETAILED DESCRIPTION

[0041] The present disclosure may be further understood with reference to the following description and accompanying drawings, in which similar elements are marked with the same reference numerals. The present disclosure relates to a clamping system, and in particular to a reloadable endoscope clamping system. An exemplary embodiment of the present disclosure describes a clamping assembly that can be loaded onto the distal end of an applicator assembly prior to endoscopic surgery. Once the clamp has been arranged in the desired target area in the body, the applicator assembly can be reloaded with a new clamp. Specifically, the applicator assembly includes a locking sleeve for releasably engaging the clamping assembly. The locking sleeve may include: a release structure that assists in engaging the clamping assembly, and a release structure that assists in releasing the clamping assembly from the applicator assembly. It should be noted that the terms "proximal" and "distal" used herein are intended to refer to the direction toward (proximal) and away from (distal) the user of the device.

[0042] As in Figure 1-Figure 12 As shown in FIG. 1 , a system 100 according to an exemplary embodiment of the present disclosure includes a clamping assembly 102, an applicator 104, and a box 106. Figure 1-Figure 3 As shown in , before the system 100 is inserted into a living body for clamping a target tissue, a clamp assembly can be loaded onto the distal end of the applicator 104. The applicator 104 is configured so that after the clamp assembly 102 is arranged in the living body, a new clamp assembly 102 can be loaded onto the applicator 104 so that the new clamp assembly 102 can be delivered to a second portion of the target tissue in the living body using the same applicator 104. As shown in Figure 4 As shown in , each clamp assembly 102 according to this embodiment is stored in a box 106, which facilitates loading the clamp assembly 102 onto the applicator 104. Specifically, the applicator 104 includes a locking sleeve 108 at its distal end, which is used to detachably engage with the clamp assembly 102. As will be described in more detail below, the locking sleeve 108 includes: an engagement structure 110 at its distal end 112 to help engage with the clamp assembly 102, and a release structure 114 proximal to the engagement structure 110 to help release the clamp assembly 102 from the applicator 104.

[0043] The clamp assembly 102 includes a pair of clamp arms 118, the proximal ends 120 of which are connected to each other via a yoke 122 that is slidably received within an enclosure 124 in this embodiment. The clamp arms 118 of this embodiment are biased so that their distal ends 126 move away from each other to a tissue receiving configuration when not pulled into the enclosure 124. When pulled into the enclosure 124, the enclosure 124 constrains the clamp arms 118, thereby holding their distal ends 126 together in a tissue clamping configuration. The yoke 122 can be slid longitudinally within the enclosure 124 to move the clamp arms 118 between the tissue receiving configuration and the tissue clamping configuration.

[0044] Each clamp arm 118 extends from a proximal end 120 to a distal end 126. In this embodiment, the distal end 126 of each clamp arm 108 protrudes laterally inward toward the distal end 126 of the other clamp arm 118, thereby facilitating clamping of the target tissue between the two distal ends. The distal end 126 may also include other clamping features, such as teeth and / or protrusions. The proximal end of each clamp arm 118 may include an opening 128 that is sized and shaped to receive a corresponding protrusion 130 of the yoke 122 therein so that the clamp arm 118 is coupled and aligned with the yoke 122. Therefore, movement of the yoke 122 relative to the enclosure 124 causes the clamp arm 118 to move distally and proximally relative to the enclosure 124, thereby causing the clamp arm 118 to move between a tissue receiving configuration and a clamping configuration. As described above, according to this embodiment, the clamp arms 118 are biased toward the open configuration and are shaped so that when the yoke 122 is drawn proximally into the enclosure 124, the inner surface of the enclosure 124 engages with the outer surface of, for example, the shoulder 132 of the clamp arms 118, thereby drawing the pair of clamp arms together toward the tissue clamping configuration, as in FIG. Figure 5 When the yoke 122 is moved distally relative to the enclosure 124, the shoulder 132 of each clamp arm 118 extends distally beyond the distal end 134 of the enclosure 124, thereby releasing the clamp arms 118 to move away from each other toward the tissue receiving configuration under their natural bias.

[0045] Each proximal end 120 of the clamp arms 118 includes a locking tab 136 extending laterally outward therefrom. The clamp arms 118 are biased so that when the clamp arms 118 are locked in the tissue clamping configuration, the locking tab 136 of each clamp arm 118 springs outwardly to lockingly engage a portion of the enclosure 124. The engagement of the locking tab 136 with the enclosure 124 locks the clamp assembly 102 in the tissue clamping configuration so as to securely clamp any tissue received between the pair of distal ends 126 of the clamp arms 118 and prevent the clamp arms 118 from moving proximally out of the enclosure 124.

[0046] As in Figure 6As shown in , the yoke 122 extends longitudinally from a proximal end 138 to a distal end 140 and includes a pair of protrusions 130 extending laterally outward from an outer surface 142 thereof. Each protrusion 130 is sized and shaped to be received within a corresponding one of the openings 128 of the clamp arms 118. As described above, the clamp arms 118 are maintained in alignment relative to each other, the yoke 122, or the package 124 by receiving each protrusion 130 within a corresponding opening 128 of the clamp arms 118. The yoke 122 also includes a longitudinal slot 144 that extends from a proximal opening 145 located at the proximal end 138 of the yoke 122 along the longitudinal axis of the yoke 122 to a distal end 146 that is sized and shaped to receive an enlarged end 148 of a control member 150 of the applicator 104. As shown in FIG. Figure 7 In one exemplary embodiment shown in , the enlarged end 148 can be configured as a ball that is received within a correspondingly sized and shaped interface of the distal end 146. The proximal end 152 of the slot 144 extending between the proximal opening 145 and the distal end 146 has a cross-sectional area (e.g., diameter) that is smaller than the cross-sectional area of ​​the distal end 146, and opposing portions of the proximal end 152 are expandable to receive the enlarged end 148 and are biased toward each other so that once the enlarged end 148 passes distally into the distal end 146, the opposing portions of the proximal end 152 rebound to lock the enlarged end within the distal end 146, thereby coupling the control member 150 to the yoke 122. Thus, longitudinal movement of the control member 150 relative to the enclosure 124 can control movement of the clamp arm 118 between the tissue receiving configuration and the tissue clamping configuration.

[0047] According to this embodiment, the enlarged end 148 of the control member 150 can be inserted into the distal end portion 146 through the proximal opening 145 of the yoke 122. When the control member 150 is pushed distally into the yoke 122 beyond a predetermined threshold, the proximal opening 145 of the slot 144 deforms to allow the enlarged end 148 to pass through the proximal end portion 152 and into the distal end portion 146. In one embodiment, the opposing portions of the yoke 122 defining the slot 144 can be separated from each other to allow the enlarged end 148 to pass through the proximal end portion 152 and into the distal end portion 146. Once the enlarged end is received within the distal end portion 146, the proximal end portion 152 of the slot 144 returns to its original size, thereby retaining the enlarged end 148 of the control member 150 in the distal end portion 146.

[0048] The package body 124 extends longitudinally from the proximal end 154 to the distal end 134 and includes a passage 156 ( Figure 4 The channel 156 is sized and shaped to receive the yoke 122 and the proximal end of the clamp arm 118 therein. The enclosure 124 according to this embodiment includes a pair of locking windows 158 ( Fig.10 ), the pair of windows 158 are for engaging with the locking tabs 136 of the clamp arms 118 to lock the clamp arms 118 in the tissue clamping configuration. As described above, the proximal ends 120 of the clamp arms 118 are biased outwardly so that the locking tabs 136 can travel along the inner surface of the package body 124 until the locking tabs 136 are pulled proximally to align with the locking windows 158. The locking windows 158 can be located proximal to the proximal end 154 of the package body 124 so that the clamp arms 118 can be repeatedly moved between the tissue receiving configuration and the clamping configuration until it is desired to lock the clamp assembly 102 in the tissue clamping configuration by further moving the control wire 150 proximally so that the locking tabs 136 engage with the locking windows 158.

[0049] In this embodiment, the package body 124 also includes an engagement window 160, which is used to engage with a corresponding engagement structure 110 of the locking sleeve 108 of the applicator 104 when the clamp assembly 102 is loaded thereon. Each engagement window 160 extends laterally through the package body 124 and is sized and shaped to receive the engagement structure 110. In an exemplary embodiment, the package body 124 may include two engagement windows 160 for engaging with two engagement structures 110. However, the package body 124 may include any number of engagement windows 160 for receiving a corresponding number of engagement structures 110. The engagement window 160 may be offset from the locking window 158 about the longitudinal axis of the package body 124 to prevent the locking tab 136 from inadvertently engaging with any portion of the engagement window 160. In a specific embodiment, the engagement window 160 may be offset from the locking window 158 by 90°. Although the package body 124 is illustrated and described as including the engagement window 160 for engaging with the engagement structure 110 , the package body 124 may include other engagement structures as long as they are capable of engaging with the engagement structure 110 when the clip assembly 102 is loaded onto the package body 124 .

[0050] Prior to being loaded onto the applicator 104, the clamping assembly 102 is stored in a box 106, such as in Figure 4As shown in, the box 106 can be configured as a storage container including, for example, a bottom 162 and a cover 164. The bottom 162 and the cover 164 include features for coupling the bottom 162 and the cover 164 to each other so that the clamping assembly 102 can be securely stored therein. In one embodiment, the bottom 162 and the cover 164 each include a groove 166, which forms a space for accommodating the clamping assembly 102 when the bottom 162 and the cover 164 are assembled to each other. The clamping assembly 102 in the tissue receiving configuration can be stored in the assembled box 106. Therefore, the groove 166 can include: a distal end 168 of the clamp arm 118 whose size and shape are designed to be received in the tissue receiving configuration (that is, the distal end 126 is separated from each other), and a proximal end 170 of the size and shape designed to receive the package body 124. The proximal end portion 170 may include a proximal opening 172 through which the distal end portion of the applicator 104 may be inserted into the cassette 106 in order to load the clamp assembly 102 onto the cassette 106 .

[0051] Applicator 104 includes locking sleeve 108, flexible member 174 extending proximally from locking sleeve 108, and control member 150 extending through locking sleeve 108 and flexible member 174. The proximal end of flexible member 174 is connected to handle member 178, which includes an actuator, such as a barrel 180, connected thereto. Figure 1 In one example shown in FIG, a barrel shaft 180 is coupled to a proximal end 182 of a control member 150 so that once the clamp assembly 102 is loaded onto the applicator 104, the barrel shaft 180 can slide longitudinally along the handle member 178 to move the clamp assembly 102 between the tissue receiving configuration and the clamping configuration as described above. Specifically, the sliding of the barrel shaft 180 on the handle member 178 moves the control member 150 relative to the enclosure 124 engaged to the applicator 104. Thus, the barrel shaft 180 can also be moved relative to the handle member 178 to lock the clamp assembly 102 in the tissue clamping configuration and to deploy the clamp assembly in vivo.

[0052] The flexible member 174 may be formed as a coil through which the control member 150 extends from the enlarged distal end 148 to the proximal end 182. As will be appreciated by those skilled in the art, the coil is preferably sufficiently flexible to be able to pass through even the tortuous paths of a living body, and in this embodiment the size and shape of the coil are designed to allow it to pass through a working channel of an endoscope or other insertion device. Although the flexible member 178 is illustrated and described as a coil, it should be appreciated by those skilled in the art that any other suitable flexible structure may be employed, so long as the flexible member 174 is capable of providing a compressive force sufficient to offset the tension placed on the control member 150 by the clamp assembly 102. Although the applicator 104 is described as including a barrel 180, the applicator 104 may include any of a variety of actuation mechanisms for moving the control member 150 to control the movement of the clamp arm 118.

[0053] As described above, the control member 150 extends from the enlarged distal end 148 that is releasably coupled to the yoke 122 to the proximal end 182 that is connected to the barrel shaft 180. Figure 8 , a stop pad 192 can be slidably mounted on a portion of the length of the control member 150. The stop pad 192 can include an outer surface sized and shaped to engage the release structure 114 of the locking sleeve 108. For example, the outer surface of the stop pad 192 can include an obliquely disposed and / or curved groove 194 sized and shaped to receive at least a portion of the release structure 114 therein, as will be further described below.

[0054] As in Fig. 9 , the locking sleeve 108 extends longitudinally from a distal end 112 to a proximal end 116 and includes a passage 115 extending therethrough. As described above, the locking sleeve 108 includes an engagement structure 110 for connecting the applicator 104 to the clamp assembly 102, and a release structure 114 for releasing the clamp assembly 102 from the applicator 104. Specifically, according to this embodiment, the locking sleeve 108 defines at least one deflectable tab 184 extending longitudinally along a portion thereof, the deflectable tab 184 including the engagement structure 110 and the release structure 114. The deflectable tab 184 extends from a free distal end 186 located at the distal end 112 of the locking sleeve 108 to a proximal end 188 connected to the remaining portion 190 of the locking sleeve 108, so that the deflectable tab 184 can be deflected in a manner away from the longitudinal axis of the locking sleeve 108. For example, the connection between the proximal end 188 and the remainder 190 acts as a hinge that allows the distal end 186 of the deflectable tab 184 to move away from the longitudinal axis of the locking sleeve 108 so that the deflectable tab 184 is deflected away from the longitudinal axis, such as in Fig.10In one specific embodiment, the locking sleeve 108 includes two deflectable tabs 184 that are diametrically opposed to each other. However, the locking sleeve 108 may include any number of deflectable tabs 184, as long as the package body 124 includes a corresponding number of engagement windows 160 for engaging with the engagement structures 110 of each deflectable tab 184.

[0055] The engagement structure 110 of each deflectable tab 184 may be, for example, proximate to its distal end 186, while the release structure 114 of each deflectable tab 184 is proximate to its proximal end 188. The engagement structure 110 and the release structure 114 may each be configured to bend along the deflectable member 184. Specifically, the bends of the engagement structure 110 and the release structure 114 of this embodiment extend into the channel 115 of the locking sleeve 108. The bends of the engagement structure 110 and the release structure 114 may be formed, for example, as inclined and / or curved surfaces extending into the channel 115. Thus, when the locking sleeve 108 is moved distally along the package body 124 to be mounted thereover, the proximal end 154 of the package body 124 engages the engagement structure 110, thereby causing the deflectable member 184 to deflect away from the longitudinal axis of the locking sleeve 108 so that the engagement structure 110 travels against the outer surface of the package body 124 until the engagement structure 110 is received within the engagement window 160 of the package body 124. Receiving the engagement structure 110 within the engagement window 160 allows the deflectable member 184 to return to its original non-deflected configuration so that the applicator 104 can be releasably coupled to the clamp assembly 102, such as in Fig.11 as shown in .

[0056] Prior to engagement of the applicator 104 with the clamp assembly 102, the stop pad 192 is positioned within the interior of the locking sleeve 108 such that the stop pad 192 engages the release structure 114. According to this embodiment, the stop pad 192 is received radially within the locking sleeve 108 such that the groove 194 is aligned with and engages the curved portion of the release structure 114. Once the applicator 104 is loaded with the clamp assembly 102 and deployment of the clamp assembly 102 is desired, the control member 150 is pulled proximally relative to the clamp assembly 102 until the force applied by the enlarged end 148 to the slot 144 of the yoke 122 exceeds a threshold force, thereby separating the control member 150 from the yoke 122. As the control member 150 separates from the yoke 122, the enlarged end 148 contacts the distal end 196 of the stop pad 192, thereby moving the stop pad 192 proximally relative to the locking sleeve 108. As the stop pad 192 is moved proximally relative to the locking sleeve 108, the inclined / curved surface of the groove 194 interacts with the inclined / curved surface of the curved portion of the release structure 114, thereby deflecting the deflectable member 184 away from the package body 124. The deflection of the deflection member 184 causes the engagement structure 110 to separate from the engagement window 160, thereby releasing the release clamp assembly 102 from the applicator 104 and disposing the clamp assembly 102 inside the living body.

[0057] An exemplary method for loading the clamp assembly 102 contained within the cassette 106 into the applicator 104 includes inserting the control member 150 and the locking sleeve 108 of the applicator 104 through the proximal opening 172 of the cassette 106. The enlarged end 148 of the control member 150 is moved relative to the cassette 106 by, for example, distally moving the barrel 180 relative to the handle member 178. The enlarged end 148 is urged distally against the yoke 122 until the distal force of the enlarged end 148 abutting the yoke 122 exceeds a predetermined threshold, thereby deforming the proximal opening 145 of the slot 144 of the yoke 122 to allow the enlarged end 148 to pass through the opening 145 and into the distal end 146 of the slot 144. Once the enlarged end 148 is received within the distal end 146, the yoke 122 returns to its original shape, thereby retaining the enlarged end 148 therein.

[0058] Once the control member 150 is coupled to the yoke 122, the locking sleeve 108 is moved distally on the package body 124, and the deflectable member 184 is deflected away from its longitudinal axis so that the engagement structure 110 is advanced along the outer surface of the package body 124 until the engagement structure 110 is received in the engagement window 160. Once the engagement structure 110 has been received in the engagement window 160, the clamp assembly 102 is successfully loaded onto the applicator 104. Thus, the proximal movement of the control member 150 relative to the box 106 moves the clamp assembly 102 from the tissue receiving configuration to the tissue clamping configuration. Once the clamp assembly 102 is in the tissue clamping configuration, the entire applicator 104 can be moved proximally relative to the box 106 so that the clamp assembly 102 is pulled out of the box via the proximal opening 172.

[0059] In use, after the clamp assembly 102 has been loaded onto the applicator 104, the clamp assembly 102 is inserted through the working channel of the endoscope (or any other insertion device) and inserted into the body (e.g., through a natural body cavity) to a location adjacent to a target portion of tissue to be clamped. The clamp assembly 102 in a closed configuration is inserted into the target tissue to facilitate its passage through the working channel. Upon reaching the location of the target tissue, the clamp assembly 102 is advanced out of the distal end of the working channel and the clamp arm 108 is extended from the enclosure 124 so that the clamp arm 108 is moved to a tissue receiving configuration by, for example, sliding the barrel shaft 180 distally on the handle member 178. The handle member can be used to rotate the clamp assembly 102 360° so that the clamp arm 108 in a desired state is moved over the target portion of tissue. The clamp arms 108 may be repeatedly extended from and retracted into the enclosure 124 to move the clamp assembly between the open and closed configurations until the target portion of tissue is received between the pair of clamp arms 108 as desired. At this point in time, the clamp arms 108 are moved toward the closed configuration by moving the control member 150 proximally relative to the clamp assembly 102. When it is confirmed that the desired portion of tissue is clamped between the pair of clamp arms 108 (e.g., portions of tissue on opposite sides of a bleeding wound), the control member 150 is further pulled proximally relative to the clamp assembly 102 (using the barrel 180) to lock the clamp assembly 102 in the closed configuration. That is, the clamp arms 108 are further pulled proximally into the enclosure 124 until the locking tabs 136 at their proximal ends 120 engage the locking windows 158, thereby locking the clamp assembly 102 in the tissue clamping configuration.

[0060] When the clamp assembly 102 is locked in the tissue clamping configuration, the clamp arm 108 and the yoke 122 are fixed relative to the enclosure 124. Therefore, pulling the control member 150 further proximally relative to the clamp assembly 102 applies a force to the yoke 122. When the enlarged end 48 of the control member 150 applies a force to the yoke 122 and exceeds a predetermined threshold, the yoke 122 deforms (e.g., the proximal opening 145 expands) to allow the enlarged end 148 to be released from the opening 145. Fig.12 As shown in , once the enlarged end 148 is released from the yoke 122, the enlarged end 148 contacts the stop pad 192 engaged with the release structure 114 of the locking sleeve 108 and is pushed proximally so that the angle / curvature defining the groove 194 interacts with the inclined / curved surface of the release structure 114, thereby once again deflecting the deflection member 184 away from the package body 124. The deflection of the deflection member 184 causes the engagement structure 110 to separate from the engagement window 160. The control member 150 is pulled proximally until the locking sleeve 108 is completely separated from the package body 124, thereby releasing the clamp assembly 102 from the applicator 104. When the applicator 104 is removed from the body, the clamp assembly 102 remains in the body clamped above the target tissue. If necessary, a new clamp assembly 102 is then loaded onto the applicator 104 in the same manner as described above so that the device can then be used to clamp a second portion of tissue. This process is repeated using the same applicator 104 for as many times as desired or desired.

[0061] Although the exemplary system 100 is illustrated and described as loading the clamp assembly 102 onto the applicator 104 by mounting the locking sleeve 108 over the enclosure 124, the clamp assembly may also be releasably engaged to the applicator by receiving a portion of the applicator within the proximal opening of the enclosure. In addition, although the engagement structure 110 and the release structure 114 are illustrated and described as being along the curved portion of the deflectable member 184 of the locking sleeve 108, other engagement structures 110 and release structures are also possible.

[0062] For example, Figure 13-Figure 16A system 200 is shown according to an exemplary embodiment, which is generally similar to the system 100 described above except for the following description. The system 200 includes a clamp assembly 202 that can be loaded onto the distal end of an applicator 204 in the same manner as described above except for the differences outlined below. Similar to the system 100, the clamp assembly 202 is contained in a box that is configured so that a portion of the applicator 204 can be inserted therein to interconnect the clamp assembly 202 with the applicator 204 (e.g., load). Similar to the applicator 104, the applicator 204 includes a locking sleeve 208 having an engagement structure 210 for engaging with the enclosure 224 of the clamp assembly 202, and a release structure 214 for separating the applicator 204 from the clamp assembly 202. The applicator 204 is detachably coupled to the clamp assembly 202 in a manner generally as described above with respect to the system 100. Specifically, the control member 250 of the applicator 204 can be coupled to the yoke 222 in a manner generally as described above with respect to the control member 150 and the yoke 122. However, the locking sleeve 208 is not configured to be mounted above the proximal end 254 of the enclosure 224. Instead, the distal end 212 of the locking sleeve 208 is configured to be inserted into the proximal end 254 of the enclosure 224 in order to releasably couple the clamp assembly 202 to the applicator 204, as will be further described below.

[0063] The clamp assembly 202 is generally similar to the clamp assembly 102 described above with respect to the system 100, and includes a pair of arms whose proximal ends are connected to a yoke 222, which is slidably received within the enclosure 224 so as to move the arms between the tissue receiving configuration and the tissue clamping configuration as described above. However, the enclosure 224 does not include an engagement window extending laterally through its wall to engage with a portion of the locking sleeve 208 of the applicator 204. Instead, the proximal end 254 of the enclosure 224 defines a bend 260 or other engagement feature extending into the channel 256 of the enclosure 224, wherein the bend 260 is sized and shaped to engage with the engagement structure 210 of the locking sleeve 208.

[0064] The engagement structure 210 of this embodiment is configured as a window that extends laterally through the distal end of the deflectable tab 284 of the locking sleeve 208. The window of the engagement structure 210 can be sized and shaped to receive the curved portion 260 of the enclosure body 224 when the locking sleeve 208 is inserted into the proximal end 254 of the enclosure body. As the locking sleeve 208 is inserted into the enclosure body 224, the deflectable tab 284 of the locking sleeve 208 extends inwardly toward the longitudinal axis of the locking sleeve 208 until the curved portion 260 of the enclosure body 224 is received in the engagement structure 210 (e.g., window) of the locking sleeve 208. Once the curved portion 260 is received in the engagement structure 210, the deflectable tab 284 can return to its original position, thereby engaging the enclosure body 224 and the locking sleeve 208 with each other.

[0065] In this embodiment, the release structure 214 can be configured as a protrusion that extends inwardly toward the longitudinal axis of the locking sleeve 208, so that when the enlarged end 248 of the control member 250 is separated from the yoke 222 when the clamp assembly 202 is locked in the tissue clamping configuration, the control member 250 can be pulled further proximally until the enlarged end 248 contacts the protrusion. The protrusion can extend from a portion of the deflectable tab 284, so that when the enlarged end 248 is pressed proximally against the release structure 214, the proximal force acting on the release structure 214 causes the deflectable tab 284 to move inwardly, thereby releasing the curved portion 260 of the package body 224 from the window of the engagement structure 210. The control member 250 is pulled proximally until the locking sleeve 208 is completely separated from the package body 224, thereby releasing the clamp assembly 202 from the applicator 204. As shown in Fig.14 and Fig.16 As shown in , the locking sleeve 208 may include a pair of deflectable tabs 284 that are diametrically opposed to each other such that a protrusion of the release structure 214 extends from each deflectable tab 284.

[0066] Although the release structure 214 is described and illustrated as a protrusion in this embodiment, the release structure can have any of a variety of configurations. Figure 17-Figure 18In another embodiment shown in , the release structure 214' can also be configured as an element that extends through the passage 215' of the locking sleeve 208' between the deflectable tabs 284'. The element may include an opening extending therethrough, the size and shape of the opening being designed to slidably receive a certain length of the control wire 250' of the applicator 204' while preventing the enlarged end 248' of the control wire 250' from passing. The enlarged end 248' is located distal to the release structure 214' so that when it is desired to release the clamp assembly 202' from the applicator 204', the control wire 250' is moved proximally until the enlarged head 248' contacts the element of the release structure 214'. Similar to the release structure 214 described above, the proximal force of the enlarged head 248' of the release structure 214' causes the deflectable tabs 284' to move inwardly toward each other from engagement with the package body 224'. The elements of the release structure 214' of this embodiment may be shaped (e.g., angled or curved) to include a base sized and shaped to engage the enlarged head 248'. However, the release structure 214' may have any of a variety of configurations, so long as the release structure 214' is sized and shaped to interact with the enlarged end 248' to move the deflectable tabs 284' inwardly toward each other.

[0067] Although the package body 224 is described and illustrated as including a bend 260 for engaging with the engagement structure 210 configured as a window, it will be understood by those skilled in the art that the package body 224 and the locking sleeve 208 may include any of a variety of corresponding engagement features that can be releasably coupled to each other. For example, in another embodiment, the package body 224 may include an engagement window that is substantially similar to the engagement window 160 of the package body 224, and the engagement structure 210 of the locking sleeve 208 may be configured as a bend or other protrusion that extends outwardly away from its longitudinal axis. These corresponding engagement features can be coupled to each other in a manner substantially similar to the above-described method. It will be understood by those skilled in the art that the system 200 can be used in a manner substantially similar to the system 100.

[0068] As in Figure 19-20As shown in , the system 300 can be generally similar to the systems 100, 200 described above, and includes a clamp assembly 302 that can be loaded onto an applicator 304 via a locking sleeve 308 at a distal end thereof. The locking sleeve 308 can be generally similar to the locking sleeve 208 described above with respect to the system 200, and the locking sleeve 308 includes a deflectable tab 384 that can be received within the enclosure 324 of the clamp assembly 302 and engage with the enclosure 324. Specifically, the distal end of the deflectable tab 384 including the engagement structure 310 can be received within the enclosure 324 to engage with its corresponding engagement structure 360. However, the system 300 also includes an outer sleeve 400 that extends around a portion of the deflectable tab 384 and includes a release structure that, when engaged by the enlarged end 348 of the control member 350 of the applicator 304, causes the deflectable tab 384 to move out of engagement with the package body 324, thereby positioning the clamping assembly 302 in the body to be clamped above the target tissue.

[0069] Specifically, the outer sleeve 400 includes a first portion 402 extending around a portion of the deflectable tab 384 proximal to the engagement structure 310 (e.g., window) of the deflectable tab 384, and a second portion 404 extending proximally from the first portion 402. The first portion 402 can be configured as a ring extending around the deflectable tab 384, and the second portion 404 can be configured as a pair of arms extending proximally from the first portion 402. The pair of arms 404 can be diametrically opposed to each other and offset relative to the deflectable tab 384 such that a release tab 406 at a proximal end 408 of the arm 404 extends between the proximal end 385 of the deflectable tab 384 into the channel 315 of the locking sleeve 308. The release tab 406 extends laterally inward from the proximal end 408 of the arm 404 into the channel 315 to be engaged by the enlarged end 348 of the control member 350 of the applicator 304. In one embodiment, the release tabs 406 of each arm 404 can be separated from each other in a manner generally similar to the release structure 214 of the system 200. In another embodiment, the release tabs 406 can be formed integrally with each other, such that the release tabs 406 can form a single element extending through the channel 315 in a generally similar form to the release structure 214'.

[0070] When it is desired to deploy the clamp assembly 302, the control member 350 is separated from the clamp arm 318 of the clamp assembly 302 in a manner generally as described above with respect to the system 100 and is pulled proximally into the locking sleeve 308 until the enlarged end 348 contacts the release tab 406. The proximal force acting on the release tab 406 via the enlarged end 448 causes the first portion 402 (e.g., the ring portion) of the outer sleeve 400 to deform. The deformed first portion 402 presses against the deflectable tabs 384, thereby moving the deflectable tabs 384 toward each other and out of engagement with the package body 324. The applicator 404 can then be removed, leaving the clamp assembly 302 in the body.

[0071] It will be appreciated by those skilled in the art that various modifications can be made in the present disclosure without departing from the scope of the present disclosure.

Claims

1. A reloadable clamping system comprising: a first clamp assembly including a pair of first clamp arms, each first clamp arm extending from a proximal end to a distal end, the proximal end of each first clamp arm being slidably received within a channel of a first enclosure of the first clamp assembly so as to move from a tissue receiving configuration in which the distal ends of the first clamp arms are separated from each other to a tissue clamping configuration in which the distal ends of the first clamp arms are moved toward each other; and and a control member having an enlarged distal end that can be releasably connected to the first clamping arm and can be connected to the first packaging body via a deflectable tab, the deflectable tab being defined along the length of the locking sleeve from a free distal end to a proximal end connected to a remainder of the locking sleeve so that the deflectable tab can be deflected radially outwardly relative to the remainder, the deflectable tab including a control member configured to engage with the first clamping arm at an enlarged distal end of the first clamping arm. The deflectable tab further comprises a release structure proximal to the engagement structure, the release structure being engageable with a pad slidably received around the control member, the pad being configured to engage with the enlarged distal end of the control member, so that when the enlarged distal end of the control member moves proximally and disengages from the first clamp arm, the enlarged distal end pulls the pad proximally against the release structure, causing the deflectable tab to deflect radially outwardly to separate the engagement structure of the locking sleeve from the corresponding engagement structure of the first package body.

2. The system of claim 1 , further comprising a second clamping assembly comprising a pair of second clamping arms, each second clamping arm extending from a proximal end to a distal end, the proximal end of each second clamping arm being slidably received within a channel of a second enclosure of the second clamping assembly so as to move from a tissue receiving configuration in which the distal ends of the second clamping arms are separated from each other to a tissue clamping configuration in which the distal ends of the second clamping arms are moved toward each other, The second clamping assembly is configured such that: after the first clamping assembly is arranged from the applicator, the applicator can be releasably connected to the second clamping assembly, the control member is connected to the second clamp arm so that the second clamping assembly can be moved between the tissue receiving configuration and the tissue clamping configuration, and the locking sleeve is connected to the proximal end of the second package body by engagement between the deflectable tab and the engagement structure at the proximal end of the second package body, and the release structure can engage with the pad so that when the enlarged distal end of the control member moves proximally and disengages from the connection with the second clamp arm, the enlarged distal end pulls the pad proximally against the release structure, so that the deflectable tab is radially deflected outward to separate the engagement structure of the locking sleeve from the corresponding engagement structure of the second package body.

3. The system of claim 1 , wherein the engagement structure of the locking sleeve is a first bend along the distal end of the deflectable tab, and the corresponding engagement structure of the first package body is a window extending laterally therethrough, the window being sized and shaped to receive the first bend.

4. The system of claim 3, wherein the first bend extends inwardly into the longitudinal passage of the locking sleeve so that the locking sleeve can be mounted on the proximal end of the first enclosure and the deflectable tab can be deflected radially outwardly away from the longitudinal axis of the passage of the locking sleeve.

5. The system of claim 4, wherein the release structure is a second bend extending into the passageway of the locking sleeve.

6. A system according to claim 5, wherein: When the applicator is coupled to the first clamp assembly, the pad is located distal to the release structure.

7. A system according to claim 6, wherein: The proximal ends of the first clamp arms are connected to each other by a yoke that includes an interface sized and shaped to releasably receive the enlarged distal end of the body of the control member.

8. The system according to claim 7, wherein: The yoke includes a slot extending from a proximal opening narrower than the enlarged distal end to a cavity sized and shaped to receive the enlarged distal end, the yoke being configured to deform when a force applied to the yoke by the enlarged distal end exceeds a predetermined threshold so that the slot and the proximal opening are enlarged to allow the enlarged distal end to pass therethrough.

9. The system of claim 5 wherein the pad has a reduced diameter recess between the proximal and distal enlarged diameter portions thereof, and wherein the release structure is received within the recess of the pad when the applicator is coupled to the first clamping assembly.

10. A reloadable clamping device comprising a clamping assembly including a pair of clamping arms, each clamping arm extending from a proximal end to a distal end, the proximal ends of the clamping arms being interconnected via a yoke slidably received within the passage of the enclosure body to enable the clamping arms to move between a tissue receiving configuration in which the distal ends of the clamping arms are separated from each other and a tissue clamping configuration in which the distal ends of the clamping arms are moved toward each other; a box having a groove therein, the groove being sized and shaped to receive the clamp assembly, the box including a proximal opening in communication with the groove and open to an exterior of the box; a new clamping assembly comprising a pair of new clamping arms, each new clamping arm extending from a proximal end to a distal end, the proximal ends of the new clamping arms being interconnected via a new yoke slidably received within a channel of a new enclosure of the new clamping assembly to enable the new clamping arms to move between a tissue receiving configuration in which the distal ends of the new clamping arms are separated from each other and a tissue clamping configuration in which the distal ends of the new clamping arms are moved toward each other; a new box having a new groove therein, the new groove being sized and shaped to receive the new clamping assembly, the new box including a proximal opening in communication with the new groove and open to an exterior of the new box; an applicator having a distal end insertable through the proximal opening of the cassette to releasably couple to the clamp assembly, the applicator comprising: a control member having an enlarged distal end sized and shaped to be releasably received within the interface of the yoke; and a locking sleeve that can be connected to the proximal end of the package body via a locking sleeve engagement structure, the locking sleeve locking feature can be deflected toward the longitudinal axis of the locking sleeve to enter the inner cavity of the locking sleeve, the locking sleeve engagement structure is configured to engage with the package body engagement feature protruding into the channel of the package body, the locking sleeve further includes a release structure, the release structure is configured to engage with the enlarged distal end of the control member when the clamping assembly is arranged from the applicator, so that the locking sleeve engagement structure deflects radially inward and disengages from the engagement with the package body engagement feature to separate the clamping assembly from the applicator, the applicator is configured so that after the applicator has been disengaged from the clamping assembly, the distal portion of the applicator can be inserted through the proximal opening of the new box to be releasably connected to the new clamping assembly, so that the enlarged distal end of the control member can be releasably received in the interface of the new yoke, the locking sleeve is connected to the proximal end of the new package body, and the locking sleeve locking feature engages with the package body locking feature of the new package body.

11. A clamping device according to claim 10, wherein the locking sleeve engagement structure is formed on a locking sleeve tab extending distally from the main body of the locking sleeve, and the locking sleeve tab is positioned so that when the enlarged distal end of the control member is inserted into the package body, the locking sleeve tab is received in the package body to engage with the radial inner surface of the package body engagement feature.

12. A clamping device according to claim 11, wherein the locking sleeve engagement structure is formed as a window extending through the distal portion of the locking sleeve tab, and the window is positioned so that when the enlarged distal end of the control member is received in the yoke, the package body engagement feature protrudes radially inwardly through the window.

13. The clamping device of claim 12, wherein the release structure is formed as a protrusion extending radially from an inner surface of the locking sleeve tab into the inner cavity of the locking sleeve.

14. The clamping device according to claim 13, wherein: The projection is positioned such that, upon proximal withdrawal of the enlarged distal end of the control member from the yoke, the enlarged distal end pushes the projection proximally, deflecting the locking sleeve tab radially inwardly, thereby moving the window out of engagement with the enclosure engagement feature.

15. The clamping device of claim 14, wherein the package engagement feature comprises a deflectable package tab located at a proximal end of the package.

16. The clamping device of claim 15 wherein said enclosure engagement feature comprises a bend in said enclosure tab sized and positioned to enter said window to engage said locking sleeve with said enclosure when said enlarged distal end is received in said yoke.

17. The clamping device of claim 16, wherein the package tab is biased to a position in which the bend in the package tab extends radially inwardly to allow it to be pressed into the window under a natural bias.

18. A clamping device according to claim 17, wherein the package body tab includes an inclined proximal end so that when the distal end of the locking sleeve tab engages with the proximal end of the package body tab, the package body tab deflects outward to slide along the outer surface of the locking sleeve tab until the curved portion of the package body tab reaches the window.

19. The clamping device of claim 10, wherein the yoke is configured to deform when a force applied thereto by the enlarged distal end exceeds a predetermined threshold.

20. The clamping device of claim 10, wherein said clamping arms are biased toward said tissue receiving configuration.

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