Partially ovoid capsule for reloadable hemostatic clip applier

By designing a clamp assembly for the capsule and yoke, the problem of reusable endoscopic hemostatic clips was solved, enabling repeated loading of the clip assembly in vivo and reliable tissue clamping, thus improving surgical efficiency.

CN115054310BActive Publication Date: 2026-03-27BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2017-10-03
Publication Date
2026-03-27

AI Technical Summary

Technical Problem

Existing endoscopic hemostatic clips are difficult to use effectively to clamp tissue and are difficult to reuse, resulting in low surgical efficiency.

Method used

A clamp assembly comprising a capsule and a yoke is designed. The distal portion of the capsule is oval, allowing the yoke to switch between a tissue receiving mode and a clamping mode. The clamp assembly is reloadable and releasable via a breakable link, and can be deployed and reused in vivo using an endoscopic device.

Benefits of technology

This enables the reusability of the clamp assembly within the body, improving surgical efficiency and the reliability of tissue clamping, while reducing surgical steps and material waste.

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Abstract

A system for treating tissue includes an applicator having a cannula and a control member and a clip assembly having a capsule with a passage extending therethrough. The passage includes proximal and distal portions. The distal portion extends distally from the proximal portion and flares outward in a single plane to form opposing flared segments. The assembly further includes a clip arm including a proximal end slidably received within the passage to move the arm between a tissue receiving and a tissue clamping configuration. The assembly further includes a yoke including a distal portion connected to the arm and a proximal portion configured to be connected to the control member such that longitudinal movement of the control member relative to the capsule moves the arm between the tissue receiving and clamping configurations. The yoke is positioned in the capsule such that the yoke can deform within the plane in which the capsule flares outward.
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Description

[0001] (division of 201780061591.5)

[0002] Inventors: Joseph W. KING, Naroun SUON, Laurie A. LEHTINEN, Shawn RYAN, Norman C. MAY, and Ramon ESTEVEZ

[0003] CLAIM

[0004] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 404,992, filed October 6, 2016; the disclosure of which is incorporated herein by reference. BACKGROUND

[0005] Lesions of the gastrointestinal (GI) system, biliary tree, vascular system, and other body cavities and hollow organs are often treated by endoscopic procedures, many of which require hemostasis to control internal bleeding. Hemostatic clips grasp tissue around a wound and temporarily hold the wound edges together to allow the natural healing process to permanently close the wound. Specialized endoscopic clipping devices are used to deliver the clips at the desired location within the body, after which the clip delivery device is withdrawn, leaving the clip within the body. SUMMARY

[0006] The present invention relates to a system for treating tissue, comprising an applicator comprising a cannula and a control member extending through the cannula to an enlarged distal end; and a clip assembly releasably coupled to the applicator, the clip assembly comprising a capsule, a clip arm, and a yoke. The capsule extends from a proximal end to a distal end and comprises a channel extending longitudinally therethrough, the channel comprising a proximal portion and a distal portion, the distal portion extending distally from the proximal portion and flaring outward in a single plane to form opposing flared segments. The clip arm extends from a proximal end to a distal end, the proximal end being slidably received within the channel of the capsule to move the clip arm between a tissue receiving configuration in which the distal ends of the clip arm are separated from each other and a tissue clamping configuration in which the distal ends of the clip arm are moved toward each other. The yoke comprises a proximal portion connected to the distal portion of the clip arm and a distal portion configured to connect to the enlarged distal end of the control member, such that longitudinal movement of the control member relative to the capsule moves the clip arm between the tissue receiving configuration and the tissue clamping configuration, the yoke being positioned in the capsule such that the proximal portion of the yoke is deformable within the plane in which the capsule flares outward to receive the enlarged distal end therein.

[0007] In one embodiment, the proximal portion of the capsule can have a substantially circular cross-sectional area, and the distal portion of the capsule has a substantially oval cross-sectional area.

[0008] In one embodiment, the long axis of the ovoid distal portion of the capsule can be greater than the diameter of the proximal portion of the capsule.

[0009] In one embodiment, the short axis of the ovoid distal portion of the capsule can be substantially equal to the diameter of the proximal portion of the capsule.

[0010] In one embodiment, the proximal portion of the yoke can include opposing portions that are biased toward one another and define a space therebetween that is sized and shaped to receive the enlarged distal end, the opposing portions being spread apart to allow the enlarged distal end to pass distally thereinto.

[0011] In one embodiment, the opposing portions can move in a plane of expansion of the distal portion of the capsule such that when the opposing portions are deflected to receive the enlarged distal end within the space, the deflected opposing portions are received within opposing segments of expansion of the distal portion of the capsule.

[0012] In one embodiment, the proximal portion of the capsule can be sized and shaped such that when the yoke is received therein, the opposing portions are prevented from deflecting to release the enlarged distal end.

[0013] In one embodiment, the proximal and distal portions of the yoke can be connected to one another via a frangible link that is designed to fail when a force exerted thereon exceeds a predetermined threshold.

[0014] In one embodiment, the capsule can be releasably coupled to the applicator via one of a snap fit and a friction fit.

[0015] The present invention also relates to a clamping device that includes a pair of clamp arms that extend from a proximal end to a distal end, the proximal end being connected to a yoke that is slidably received within a channel of a capsule to move the clamp arms between a tissue receiving configuration in which the distal ends of the clamp arms are separated from one another and a tissue clamping configuration in which the distal ends of the clamp arms are drawn toward one another, the channel of the capsule including a proximal portion and a distal portion that extends distally from the proximal portion and expands outwardly in a single plane to form opposing segments of expansion, a portion of the yoke being deformed into one of the segments of expansion to receive the enlarged distal end of the control member therein.

[0016] In one embodiment, the yoke can include a distal portion that is connected to the clamp arms and a proximal portion that is configured to be coupled to the control member, the distal and proximal portions being connected to one another via a frangible link that is designed to fail when a force exerted thereon exceeds a predetermined threshold.

[0017] In one embodiment, the cross-sectional area of the proximal portion of the capsule can be substantially circular and the cross-sectional area of the distal portion of the capsule is substantially ovoid.

[0018] In one embodiment, the circular proximal portion and the ovoid distal portion can share a center point.

[0019] In one embodiment, the yoke can include opposing portions that are biased toward each other and define a space therebetween that is sized and shaped to receive the enlarged distal end, the opposing portions being spread apart to allow the enlarged distal end to pass distally thereinto.

[0020] In one embodiment, the proximal portion of the capsule can be sized and shaped such that when the yoke is received therein, the yoke is prevented from deforming to dislodge the enlarged distal end of the control member.

[0021] The present invention is also directed to a method for treating tissue, comprising loading a first clip assembly on an applicator by pressing distally an enlarged distal end of a control member of the applicator against a first yoke connected to a proximal end of a first clip arm such that opposing portions of the first yoke deform to allow the enlarged distal end to be received therebetween, wherein the opposing portions deform within an expansion segment of a distal portion of a capsule that slidably receives the first yoke; inserting the loaded clip assembly into a target site in a living body via a working channel of an endoscope; moving the first clip assembly between a tissue-receiving configuration in which distal ends of the first clip arms are separated from each other and a tissue-clamping configuration in which the distal ends of the first clip arms are moved toward each other by longitudinally moving the control member relative to a locking sleeve until target tissue is clamped therebetween; locking the first clip assembly in the tissue-clamping configuration by pulling the clip arms proximally into the capsule until locking features of the clip arms engage corresponding locking features of the capsule; and releasing the clip assembly from the applicator by pulling the control member proximally relative to the clip arms beyond a predetermined threshold to cause a frangible link of the first yoke to fail, thereby separating the control member from the first clip arms. BRIEF DESCRIPTION OF DRAWINGS

[0022] FIG. 1 a longitudinal cross-sectional view of a system according to one exemplary embodiment of the present invention is shown;

[0023] FIG. 2 another longitudinal cross-sectional view of the system of FIG. 1 is shown;

[0024] FIG. 3 a plan view of the system of FIG. 1 is shown from a distal end of a capsule of the system. DETAILED DESCRIPTION

[0025] The present application can be further understood with reference to the following description and drawings in which like elements are referred to with the same reference numerals. The present application relates to a clipping system, and in particular to a reloadable endoscopic clipping system. Exemplary embodiments of the present application describe a clip assembly that can be loaded onto a distal end of an applicator assembly prior to an endoscopic procedure. Once the clip is deployed at a desired target region within the body, the applicator assembly can be reloaded with a new clip. In particular, the clip assembly includes clip arms that have proximal ends connected to a yoke that is slidably received within a capsule, such that the clip arms can be moved between an open tissue-receiving configuration and a closed tissue-clipping configuration via control wires coupled to the yoke. The yoke is coupled to enlarged distal ends of the control wires via opposing portions of the yoke that are coupled to one another, which opposing portions are expandable to allow the enlarged distal ends to receive the control members therein. A proximal portion of the capsule can have a substantially circular cross-sectional area, while a distal portion of the capsule can have a substantially oval cross-sectional area, such that when the yoke is in the distal portion, the opposing portions of the yoke are allowed to expand to receive the enlarged distal ends therein, and when the yoke is in the proximal portion, the opposing portions of the yoke are prevented from expanding. Thus, when the yoke is in the proximal portion and a proximal force on the yoke via the control wires exceeds a predetermined threshold, the yoke breaks, ruptures, or separates, thereby releasing the clip assembly from the control members to deploy the clip assembly within the body.

[0026] As FIGS. 1-2As shown in the figures, a system 100 according to one exemplary embodiment of the present application includes a clip assembly 102 that can be loaded onto an applicator 104 prior to insertion of the system 100 into a living body to clamp a target tissue. The applicator 104 is configured such that after deployment of the clip assembly 102 within the living body, a new clip assembly 102 can be loaded onto the applicator 104 so that the same applicator 104 can be used to deliver a new clip assembly 102 to a second portion of the target tissue within the living body. Each clip assembly 102 according to this embodiment includes a pair of clip arms 106 having proximal ends 108 coupled to a yoke 110 that is slidably received within a capsule 112 so that the clip arms 106 are movable between an open tissue-receiving configuration and a closed tissue-clamping configuration. The yoke 110 is configured to receive an enlarged distal end 116 of a control member 114 of the applicator 104 so that longitudinal movement of the control member 114 relative to the capsule 112 moves the clip arms 106 between the tissue-receiving and tissue-clamping configurations. The capsule 112 includes a proximal portion 118 having a substantially circular cross-sectional area and a distal portion 120 having a substantially oval cross-sectional area. In particular, the distal portion 120 is sized and shaped so that when the yoke 110 is therein, the mutually opposed portions 122 of the yoke 110 are allowed to spread apart to receive the enlarged distal end 116 therein. However, the proximal portion 118 is sized and shaped so that when the yoke 110 is drawn therein, the mutually opposed portions 122 of the yoke 110 are prevented from spreading apart to release the enlarged distal end 116 of the control member 114. Thus, when the yoke 110 is drawn into the proximal portion 118 and the force exerted on the yoke 110 via the enlarged distal end 116 exceeds a predetermined threshold, the yoke ruptures, breaks, or otherwise separates from the clip arms 106 for intracorporeal deployment of the clip assembly.

[0027] As described above, the clip assembly 102 includes a pair of clip arms 106 having proximal ends 108 coupled to a yoke 110 that is slidably received within a capsule 112. Each of the clip arms 106 extends from the proximal end 108 coupled to the yoke 110 to a distal end 124. The yoke 110 is configured to be coupled to the control member 114 so that when the yoke 110 and the control member 114 are coupled, the control member 114 can be moved longitudinally relative to the capsule 112 to move the clip arms 102 between the tissue-receiving and tissue-clamping configurations. The clip arms 106 of this embodiment are biased toward the open tissue-receiving configuration so that when constrained within the capsule 112, the clip arms 106 are urged toward the open tissue-receiving configuration. In the tissue-receiving configuration, the distal ends of the clip arms 106 are spread apart from one another to receive tissue therebetween. When the clip arms 106 are drawn into the capsule 112, the capsule 112 constrains the clip arms 106, thereby drawing their distal ends 124 together and holding them in the tissue-clamping configuration.

[0028] As will be appreciated by those skilled in the art, the distal ends 124 of the clip arms 106 can include optional clamping features configured to enhance clamping of tissue therebetween. For example, the distal ends 124 of the clip arms 106 can include tips and / or teeth, protrusions, spikes, or other structures that extend laterally inward toward one another that are configured to clamp tissue between the distal ends 124 of the clip arms 106. One or both of the clip arms 106 can also include a locking feature (or a complementary locking feature) configured to lock the clip arms 106 in a tissue-clamped configuration once the target tissue has been clamped by the clip arms 106 as desired. In one embodiment, one or both of the clip arms 106 includes a locking tab that extends laterally outward therefrom that is configured to engage a portion of the capsule 112 when the clip arms 106 have been pulled into the capsule 112 beyond a predetermined distance. For example, the locking tab can be received within a locking window of corresponding size, shape, and position that extends laterally through the capsule 112 wall to lock the clip arms 106 relative to the capsule 112 in the tissue-clamped configuration.

[0029] In one embodiment, the proximal ends 108 of the clip arms 106 can be connected to one another to form one integral piece that is connected to the yoke 110. In another embodiment, the proximal ends 108 can be connected to one another via the yoke 110. The yoke 110 includes a distal portion 126 configured to be connected to the clip arms 106 and a proximal portion 128 configured to be connected to the enlarged distal end 116 of the control member 114. The distal and proximal portions 126, 128 of the yoke 110 of this embodiment are connected to one another via a frangible link 130 that is configured to fail when a force exerted thereon exceeds a predetermined threshold. The frangible link 130 can include, for example, a weakened portion of the yoke 110 via which the cross-sectional area of the yoke 110 decreases. In this embodiment, the distal and proximal portions 126, 128 can be integrally formed from a single piece of material. In another embodiment, the frangible link 130 can include a weld, adhesive, or other coupling that connects the distal and proximal portions 126, 128. In this embodiment, the distal and proximal portions 126, 128 can be two separate elements that are coupled to one another via the frangible link 130.

[0030] The distal portion 126 can be connected to the arms 106 in any of a variety of ways. In one example, the distal portion 126 can be received within a correspondingly sized and shaped space 132 at the proximal ends 108 of the clip arms 106 such that the yoke 110 is substantially fixed relative thereto when the distal portion 126 is received within the space 132. Accordingly, movement of the yoke 110 correspondingly moves the clip arms 106.

[0031] The proximal portion 128 is configured to be connected to the enlarged distal end 116 of the control member 114 of the applicator 104 via opposing portions 122 of one another that define a longitudinal slot 134 extending along a longitudinal axis of the yoke 110 from a proximal opening 136 at a proximal end of the yoke 110 to a distal portion 138 sized and shaped to receive the enlarged distal end 116. A proximal portion 140 of the slot 134 extending between the proximal opening 136 and the distal portion 138 has a cross-sectional area (e.g., diameter) that is less than that of the distal portion 138. The opposing portions 122 are expandable to receive the enlarged distal end 116 and biased toward one another such that once the enlarged end 116 is passed distally into the distal portion 138 of the longitudinal slot 134, the opposing portions 122 spring back to lock the enlarged distal end 116 in the distal portion 138, thereby coupling the control member 114 to the yoke 110. Accordingly, longitudinal movement of the control member 114 relative to the capsule 112 can control movement of the clamp arms 106 between the tissue-receiving and tissue-clamping configurations.

[0032] According to this embodiment, the enlarged distal end 116 of the control member 114 can be inserted into the distal portion 138 via the proximal opening 136 of the yoke 110. When the control member 114 is pushed distally into the yoke 110 with a force greater than a predetermined threshold, the proximal portion 140 deforms to allow the enlarged distal end 116 to pass therethrough into the distal portion 138. In other words, the opposing portions 122 separate from one another to allow the enlarged distal end 116 to move through the proximal portion 140 into the distal portion 138. Once the enlarged distal end 116 has been received within the distal portion 138, the proximal portion 140 of the slot 134 returns to its original size, thereby retaining the enlarged distal end 116 of the control member 114 in the distal portion 138. In one embodiment, the proximal portion 140 of the slot 134 can include features to facilitate passage of the enlarged distal end 116 distally therethrough. For example, the proximal portion 140 can taper from the proximal opening 136 to the distal portion 138 such that the enlarged distal end 116 can slide distally thereagainst as the enlarged distal end 116 is inserted into the yoke 110. Once the enlarged distal end 116 is received in the distal portion 138 of the longitudinal slot 134, the enlarged distal end 116 is prevented from moving proximally therefrom via a proximal shoulder 142 of the distal portion 138.

[0033] The capsule 112 extends from a proximal end 144 to a distal end 146 and includes a passage 148 extending longitudinally therethrough. The proximal end 144 can be releasably connected to the applicator 104 in any of a variety of ways. In one embodiment, the capsule 112 engages a sleeve 150 of the applicator 104 in a manner that allows the clip arms 106 to move distally relative to the capsule 112 from an initial insertion configuration, in which the clip arms 106 are constrained by the inner surface of the capsule 120, to a tissue receiving configuration that is substantially similar to the tissue clamping configuration. The initial distal movement of the clip arms 106 relative to the capsule 112 from the insertion configuration to the tissue receiving configuration can cause the capsule 112 to disengage the applicator 104. Thus, once the target tissue is received between the distal ends 124 of the clip arms 106 and the clip arms 106 are pulled proximally relative to the capsule 112 to draw the clip arms 106 toward one another, the capsule 112 will also be moved proximally until the capsule 112 contacts the distal end 152 of the sleeve 150. Once the capsule 112 abuts the distal end 152 of the sleeve 150, the clip arms 106 can be further pulled proximally relative to the capsule 112 toward the tissue clamping configuration. Upon disengagement of the clip arms 106 from the control member 114, the clip assembly 102 is deployed intracorporeally, as will be described in greater detail below. As will be appreciated by those skilled in the art, such releasable connection can be achieved via, for example, a friction fit or a loose snap connection.

[0034] In another embodiment, the capsule 112 can be releasably connected to the applicator 104 in such a manner that the capsule 112 is released from the applicator 104 upon disengagement of the control member 114 from the clip arms 106. For example, the yoke 110 and proximal portion and / or a portion of the control member 114 can be engaged with a coupling mechanism between the capsule 112 and the sleeve 150 such that removal of the control member 114 therefrom releases the capsule 112 from the applicator 104 to deploy the clip assembly 102 intracorporeally.

[0035] The passage 148 of the capsule 112 is sized and shaped to slidably receive at least a proximal portion of the yoke and clip arms 106. In particular, the passage 148 of the capsule 112 includes a proximal portion 118 having a substantially circular cross-section and a distal portion 120 having a substantially oval cross-section. The short axis A of the oval cross-section of the distal portion 120 can be substantially the same as the diameter of the proximal portion 118, while the long axis B of the oval cross-section is greater than the diameter of the proximal portion 118. In other words, the passage 148 of the capsule 112 can have a substantially cylindrical shape along the proximal portion 118 that flares outward in a single plane including the longitudinal axis of the capsule 112 (e.g., along the long axis B) to form a substantially oval shape along the distal portion 120. The proximal and distal portions 118, 120 can be coaxially extended relative to one another, sharing a center point C, such that the edges of the opposing flared segments 154 of the distal portion 120 are substantially equidistant from the center point (e.g., the longitudinal axis of the capsule 112).

[0036] The yoke 110 is positioned within the passage 148 such that the opposing portions 122 are aligned along the long axis B. The distal portion 120 is sized and shaped such that, when the yoke 110 is received within the distal portion 120, the opposing portions 122 of the yoke 110 are permitted to flare to allow the enlarged distal end 116 to be received therein. However, when the yoke 110 is drawn proximally into the proximal portion 118, the opposing portions 122 are constrained via their inner surfaces such that the opposing portions 122 cannot flare, thereby preventing the enlarged distal end 116 from being disengaged therefrom. Although the exemplary embodiment illustrates and describes the cross-sectional areas of the proximal and distal portions 118, 120 as substantially circular and oval, respectively, those skilled in the art will appreciate that the proximal and distal portions 118, 120 can have any of a variety of shapes and sizes, so long as the yoke 110 is permitted to open (e.g., to allow the enlarged distal end 116 to pass therethrough) when within the distal portion 120 and is prevented from opening (e.g., to prevent allowing the enlarged distal end 116 to be disengaged from the yoke) when within the proximal portion 118. For example, in an alternative embodiment, the proximal portion 118 can have a substantially square cross-section, while the distal portion 120 can have a substantially rectangular cross-section.

[0037] Furthermore, according to the illustrated embodiment, the proximal and distal portions 118, 120 of the passage 148 are defined via the exterior shape of the capsule 112. However, those skilled in the art will appreciate that the exterior shape of the capsule 112 need not correspond to the shape of the proximal and distal portions 118, 120 of the passage 148. For example, in another embodiment, the exterior shape of the capsule 112 can be constant along its entire length, with only the shape of the proximal and distal portions 118, 120 of the passage 148 varying therein.

[0038] The clip assembly 102 can be stored in a cartridge prior to loading onto the applicator 104, the cartridge configured to facilitate loading of the clip assembly 102 onto the applicator 104. The cartridge can be configured to store a container that defines a space within its interior that is sized and shaped to accommodate the clip assembly 102 with the clip arms 106. In a tissue-receiving configuration, the clip assembly 102 can be contained within the cartridge. The cartridge includes a proximal opening through which a distal portion of the applicator 104 can be inserted to couple to the clip assembly 102, as will be described in further detail below. The cartridge holds the clip assembly 102 in place for loading onto the applicator 104.

[0039] The applicator 104 includes a sleeve 150 or catheter, a flexible member (not shown) extending proximally therefrom, and a control member 114. A proximal end of the flexible member can be connected to a handle portion. The sleeve 150 extends longitudinally from a proximal end connected to the flexible member to a distal end 152 configured to releasably connect to the capsule 112 of the clip assembly 102. The control member 114 extends from the enlarged distal end 116 through the sleeve 150 and the flexible member to a proximal end connected to an actuator of the handle portion. The flexible member can be formed as a coil or wire that is sufficiently flexible to pass through even tortuous paths of a living body, and in this embodiment, is sized and shaped to pass through a working channel of an endoscope of another insertion device. However, the flexible member can be formed of any other suitable flexible structure so long as the flexible member is capable of providing a compressive force sufficient to counteract a tensile force to be placed on the control member 114 from the clip assembly 102.

[0040] An exemplary method for loading the clip assembly 102 onto the applicator 104 includes pushing the enlarged distal end 116 of the control member 114 distally against the proximal portion 128 of the yoke 110 (which can be pre-assembled with the clip assembly 102) until a distal force exerted on the proximal portion 140 of the longitudinal slot 134 exceeds a predetermined threshold, thereby causing the opposing portions 122 of the yoke 110 to deflect away from each other to allow the enlarged distal end 116 to move distally therethrough. As described above, the opposing portions 122 are positioned such that they deflect in a plane defined by the long axis B of the ovoid distal portion 120 of the capsule 112. In other words, the deflected opposing portions 122 are received within the opposing flared segments 154 of the distal portion 120 of the capsule 112. After the enlarged distal end 116 passes through the proximal portion 140 and into the distal portion 138, the proximal portion 140 returns to its naturally biased position retaining the enlarged distal end 116 therein. The sleeve 150 can also be pressed distally against the capsule 112 to releasably couple the capsule 112 to the sleeve 150 while the control member 114 is coupled to the yoke 110.

[0041] As described above, with the clip assembly 102 housed within the case, the sleeve 150 and enlarged distal end 116 of the control member 114 can be inserted through the proximal opening of the case to couple to the clip assembly 102 in substantially the same manner as described above. Once the sleeve 150 has been releasably connected to the capsule 112 and the enlarged distal end 116 is coupled to the clip arms 106, the control member 114 can be moved proximally to pull the clip assembly 102 toward the closed, clamped configuration. Subsequently, in the closed configuration, the entire applicator 104 can be moved proximally relative to the case via the proximal opening to pull the clip assembly 102 out of the case.

[0042] In use, after the clip assembly 102 is loaded onto the applicator 104, the clip assembly 102 is inserted through the working channel of an endoscope (or any other insertion device) and inserted into the body (e.g., through a natural body lumen) to a site proximate the target portion of tissue to be clamped. The clip assembly 102 is inserted into the target tissue in the tissue clamping configuration to reduce trauma and facilitate its passage through the working channel. Upon reaching the site of the target tissue, the clip assembly 102 is pushed out of the distal end of the working channel by moving the control member 114 distally relative to the sleeve 150, thereby causing the clip arms 106 to extend distally out of the capsule 112 and move the clip arms 106 to the tissue receiving configuration. Once the target tissue has been received between the clip arms 106, the clip assembly 102 can be moved toward the tissue clamping configuration so that the target tissue is clamped between its distal ends 124. The clip arms 106 are moved toward the tissue clamping configuration by pulling the control member 114 proximally relative to the sleeve 150 and the capsule 112. Once the clip assembly 102 is in the tissue clamping configuration, the control member 114 can be further pulled proximally relative to the capsule 112 to lock the clip arms 106. As the control member 114 is moved proximally, the yoke 110 is pulled into the circular proximal portion 118 of the capsule 112, which is sized and shaped to prevent the mutually opposing portions 122 of the yoke 110 from spreading apart or deflecting so as to release the enlarged distal end 116 therefrom.

[0043] Thus, to deploy the clip assembly 102, the control member 114 is pulled further proximally. Because the clip arms 106 are fixed relative to the capsule 122 and the yoke 110 is prevented from releasing the enlarged distal end 116, the proximal movement of the control member 114 causes the distal end 116 of the control member 114 to exert a force on the yoke 110. When the force exerted on the yoke 110 exceeds a predetermined threshold, the frangible link 130 connecting the distal and proximal portions 126, 128 of the yoke 110 fails, thereby causing the control member (which is connected to the proximal portion 128) to separate from the clip arms 106 (which are connected to the distal portion 126). As noted above, the disengagement of the control member 114 from the clip arms 106 also releases the capsule 112 from the applicator 104. Thus, the applicator 104 can be withdrawn proximally from the body, leaving the clip assembly 102 clamped to the target tissue. Once the applicator 104 is removed from the body, the proximal portion 128 of the yoke 110, which remains connected to the enlarged distal end 116 of the control member 114, can be removed from the distal end 116 by pulling the proximal portion 128 away from the distal end 116. When the force on the proximal portion 126 exceeds a predetermined threshold, the longitudinal slot 134 yields or deforms to allow the enlarged distal end 116 to be removed therefrom. If desired, a new clip assembly 102 is loaded onto the applicator 104 in the same manner as described above, so that a second portion of tissue can subsequently be clamped using the system. The process can be repeated as many times as necessary or desired, using the same applicator 104.

[0044] It will be apparent to those skilled in the art that various modifications can be made in the present application without departing from the scope of the application.

Claims

1. A clamping device comprising: an applicator having a control member extending from a proximal end connected to an actuator to an enlarged distal end; a first clip having a pair of first clip arms having proximal ends received within a first channel of a first capsule, the proximal ends of the first clip arms connected to a first yoke slidably received within the first channel to move the first clip arms between a tissue receiving configuration in which distal ends of the first clip arms are separated from each other and a tissue clamping configuration in which the distal ends of the first clip arms are drawn toward each other, the first channel including a proximal portion and a distal portion, the distal portion of the first channel extending distally from the proximal portion of the first channel and flaring outward in a single plane to form first opposing flared segments, first opposing portions of the first yoke deformed into the first opposing flared segments to receive the enlarged distal end of the control member therein; and a second clip having a pair of second clip arms having proximal ends received within a second channel of a second capsule, the proximal ends of the second clip arms connected to a second yoke slidably received within the second channel to move the second clip arms between a tissue receiving configuration in which distal ends of the second clip arms are separated from each other and a tissue clamping configuration in which the distal ends of the second clip arms are drawn toward each other, the second channel including a proximal portion and a distal portion, the distal portion of the second channel extending distally from the proximal portion of the second channel and flaring outward in a single plane to form second opposing flared segments, second opposing portions of the second yoke deformed into the second opposing flared segments to receive the enlarged distal end of the control member therein after the proximal portions of the first yoke have been removed from the enlarged distal end of the control member.

2. The clamping device of claim 1, wherein the first yoke has a distal portion connected to the first clip arms and a proximal portion configured to couple with the control member, the distal and proximal portions of the first yoke connected to each other via a frangible link designed to fail when a force exerted thereon exceeds a predetermined threshold.

3. The clamping device of claim 1, wherein a cross-sectional area of the proximal portion of the first capsule is substantially circular and a cross-sectional area of the distal portion of the first capsule is substantially oval.

4. The clamping device of claim 3, wherein the circular proximal portion and the oval distal portion of the first capsule share a center point.

5. The clamping device of claim 4, wherein a major axis of the oval distal portion of the first capsule is greater than a diameter of the proximal portion of the first capsule.

6. The clamping device of claim 4, wherein a minor axis of the oval distal portion of the first capsule is substantially equal to the diameter of the proximal portion of the first capsule.

7. The clip device of claim 1, wherein the first yoke includes opposing portions that are biased toward each other and define a space therebetween, the space being sized and shaped to receive the enlarged distal end, the spreading apart of the opposing portions of the first yoke allowing the enlarged distal end to pass distally into the space between the opposing portions of the first yoke.

8. The clip device of claim 7, wherein the opposing portions of the first yoke are movable in the plane of the distal portion of the first capsule to such that when the opposing portions of the first yoke are deflected to receive the enlarged distal end within the space between the opposing portions of the first yoke, the deflected opposing portions of the first yoke are received within the first opposing flared segments of the distal portion of the first capsule.

9. The clip device of claim 1, wherein a proximal portion of the first capsule is sized and shaped such that when the first yoke is received therein, the first yoke is prevented from deforming to disengage the enlarged distal end of the control member.

10. The clip device of claim 1, wherein the first clip arms are drawn proximally into the first capsule, the first capsule constraining the first clip arms in a tissue clipping configuration.

11. The clip device of claim 1, further comprising a gripping feature on a distal end of at least one of the first clip arms, the gripping feature configured to enhance tissue gripping between the first clip arms.

12. The clip device of claim 11, wherein the gripping feature is a structure extending laterally inwardly from a first one of the first clip arms toward a second one of the first clip arms.

13. The clip device of claim 1, further comprising a locking feature configured to lock the first clip arms in a tissue clipping configuration.

14. The clip device of claim 13, wherein the locking feature is a locking tab extending laterally outwardly from one of the first clip arms, the locking tab configured to engage a portion of the first capsule when the first clip arms have been drawn proximally into the first capsule beyond a predetermined distance.

15. A clip device comprising: a pair of retractable clip arms extending from a proximal end to a distal end, a capsule including a proximal portion, a distal portion, and a passage extending longitudinally therethrough, wherein the passage includes a proximal portion and a distal portion, the proximal and distal portions of the passage corresponding to the proximal and distal portions of the capsule, respectively, the distal portion of the capsule flaring radially outwardly to form a pair of flared segments opposite each other relative to a longitudinal axis of the capsule; a control member extending longitudinally between a proximal end and an enlarged distal end, the control member being slidably movable through the passage; and ​ A yoke having a distal portion and a proximal portion connected to one another via a frangible link, the yoke being slidably received within the channel and configured to be connected to the control member, the proximal portion of the yoke including a pair of opposing portions configured to receive an enlarged distal end of the control member therebetween, the distal portion of the capsule being sized and shaped such that, when the yoke is received in the distal portion of the channel, the opposing portions of the proximal portion of the yoke are permitted to spread apart from one another such that the enlarged distal end can be inserted into a space defined between the opposing portions, the proximal ends of the clip arms being connected to the yoke such that the proximal ends of the clip arms can be slidably moved within the channel to move the clip arms between a tissue receiving configuration in which the distal ends of the clip arms are spread apart from one another and a tissue clamping configuration in which the distal ends of the clip arms are drawn toward one another, wherein the clip arms are constrained in the tissue clamping configuration when drawn proximally into the channel.

16. The clamping device of claim 15, wherein the distal portion of the yoke is connected to the clip arms, the distal and proximal portions of the yoke being connected to one another via a frangible link.

17. The clamping device of claim 15, wherein a cross-section of the proximal portion of the capsule perpendicular to a longitudinal axis of the capsule is circular and a cross-section of the distal portion of the capsule perpendicular to the longitudinal axis of the capsule is oval.

18. The clamping device of claim 17, wherein the proximal and distal portions of the capsule share a common center point.

19. The clamping device of claim 18, wherein a major axis of the oval cross-section of the distal portion of the capsule is greater than a diameter of the cross-section of the proximal portion of the capsule.

20. The clamping device of claim 18, wherein a minor axis of the oval cross-section of the distal portion of the capsule is equal to the diameter of the cross-section of the proximal portion of the capsule.

21. The clamping device of claim 15, wherein the opposing portions of the yoke are biased toward one another and define a space therebetween, the space being sized and shaped to receive the enlarged distal end, the spreading apart of the opposing portions allowing the enlarged distal end to pass distally into the space.

22. The clamping device of claim 21, wherein the opposing portions are configured to move away from one another in the pair of flared segments of the distal portion of the capsule such that, when the enlarged distal end is moved into the space between the opposing portions, the deflected opposing portions move radially outward into the pair of flared segments of the distal portion of the capsule.

23. The clamping device of claim 15, wherein the proximal portion of the capsule is sized and shaped such that, when the yoke is received therein, the opposing portions of the yoke are constrained and prevented from moving away from one another out of engagement with the enlarged distal end of the control member.

24. The clamping device of claim 15, wherein the capsule constrains the clip arms in a tissue clamping configuration when the clip arms are drawn proximally into the capsule.

25. The clamping device of claim 15, further comprising a clamping feature on a distal end of at least one of the clip arms, the clamping feature configured to enhance tissue clamping between the clip arms.

26. The clamping device of claim 25, wherein the clamping feature is a structure extending laterally inward from one of the clip arms toward the other.

27. The clamping device of claim 15, further comprising a locking feature configured to lock the clip arms in a tissue clamping configuration.

28. The clamping device of claim 27, wherein the locking feature is a locking tab extending laterally outward from at least one of the clip arms, the locking tab configured to engage a portion of the capsule when the clip arms have been drawn proximally into the capsule beyond a predetermined distance.

29. A reloadable clamping device comprising: an applicator having a control member extending from a proximal end connected to an actuator to an enlarged distal end; a first clip having a pair of first clip arms, proximal ends of which are received within a first channel of a first capsule, the proximal ends of the first clip arms being connected to a first yoke slidably received within the first channel to move the first clip arms between a tissue receiving configuration in which distal ends of the first clip arms are separated from each other and a tissue clamping configuration in which the distal ends of the first clip arms are drawn toward each other, the first channel including a proximal portion and a distal portion, the distal portion of the first channel extending distally from the proximal portion of the first channel and flaring outward to form first opposed flared segments, first opposed portions of the first yoke deformed into the first opposed flared segments to receive the enlarged distal end of the control member therein, wherein the first yoke has a distal portion connected to the first clip arms and a proximal portion configured to couple with the control member, the distal and proximal portions of the first yoke connected to each other via a frangible link designed to fail when a force exerted thereon exceeds a predetermined threshold to leave the control member intact for coupling a subsequent clip; and a second clip having a pair of second clip arms, proximal ends of which are received within a second channel of a second capsule, the proximal ends of the second clip arms being connected to a second yoke slidably received within the second channel to move the second clip arms between a tissue receiving configuration in which distal ends of the second clip arms are separated from each other and a tissue clamping configuration in which the distal ends of the second clip arms are drawn toward each other, the second channel including a proximal portion and a distal portion, the distal portion of the second channel extending distally from the proximal portion of the second channel and flaring outward to form second opposed flared segments, second opposed portions of the second yoke deformed into the second opposed flared segments to receive the enlarged distal end of the control member therein, wherein the second yoke has a distal portion connected to the second clip arms and a proximal portion configured to couple with the control member, the distal and proximal portions of the second yoke connected to each other via a frangible link designed to fail when a force exerted thereon exceeds a predetermined threshold to leave the control member intact for coupling a subsequent clip. a second clip having a pair of second clip arms with proximal ends received within a second channel of a second capsule, the proximal ends of the second clip arms connected to a second yoke slidably received within the second channel to move the second clip arms between a tissue receiving configuration in which distal ends of the second clip arms are separated from each other and a tissue clamping configuration in which the distal ends of the second clip arms are drawn toward each other, the second channel including a proximal portion and a distal portion, the distal portion of the second channel extending distally from the proximal portion of the second channel and flaring outward in a single plane to form second opposed flared segments, the second opposed portions of the second yoke deformed into the second opposed flared segments to receive the enlarged distal end of the control member therein after the proximal portion of the first yoke has been removed from the enlarged distal end of the control member.

Citation Information

Patent Citations

  • Ligating apparatus

    CN102204838A