Crimp attachment of clip for remountable hemostatic device
By designing a reinstallable clamping system, using the hook-like engagement of the fixture arm and the bushing, the problem of hemostasis fixture falling off during endoscopic gastrointestinal surgery is solved, the reusable and stable fixture is achieved, and the safety and efficiency of the fixture is improved.
Patent Information
- Application Number
- CN202510682680.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2019-07-16
- Filing Date
- 2020-06-18
- Publication Date
- 2025-08-15
AI Technical Summary
In existing endoscopic gastrointestinal surgery, hemostatic fixtures are prone to fall off, resulting in risk of tissue perforation and failure of surgery, and the existing fixtures cannot be reused, increasing the complexity and cost of the surgery.
A reassembleable clamping system is designed, including a clamp and an applicator. The clamping arm can slide in the cabin and engage the hook of the bushing through the connecting element to achieve reusable and no shedding. It utilizes elastic and plastic deformation of the metal material to ensure the stability of the clamp during tissue clamping and deployment.
The reusable fixture is realized, reducing the risk of falling off parts during surgery, improving the safety and efficiency of the surgery, and reducing the complexity and cost of the surgery.
Smart Images
Figure CN120477862A_ABST
Abstract
Description
Inventors: Joseph W. King, Laurie A. Lehtinen, and Henry Stock Priority claim
[0001] This disclosure claims priority to U.S. Provisional Patent Application Serial No. 62 / 874,695, filed on July 16, 2019; the disclosure of which is incorporated by reference in its entirety. Technical Field
[0002] The present disclosure relates to endoscopic devices, and in particular to endoscopic gripping devices for treating tissue along the gastrointestinal tract. Background Art
[0003] During endoscopic gastrointestinal (GI) surgery, patients may be at risk for perforation of the wall of the GI tract, or may require closure of the GI tract wall as part of the procedure. Hemostatic clips can be used, for example, to stop bleeding from mucosal / submucosal defects, bleeding ulcers, arteries, polyps, diverticula, and to close luminal perforations. Depending on the size of the defect, multiple clips may be used. Summary of the Invention
[0004] The present disclosure relates to a reloadable clamping system for treating tissue, the reloadable clamping system comprising a clamp and an applicator. The clamp comprises a pair of clamp arms, each of the clamp arms extending from a proximal end to a distal end, the proximal ends of the clamp arms being received within a channel of a pod to move between an open configuration and a closed configuration. The proximal end of the pod comprises a plurality of connecting elements extending proximally therefrom, each of the connecting elements comprising a hook along a proximal portion thereof. The applicator comprises an elongated flexible member and a control member extending therethrough. The control member comprises a distal end configured to be connected to the clamp arms to move the clamp assembly between an open configuration and a closed configuration. The distal end of the elongated flexible member comprises a bushing comprising a first inclined portion and a necked portion, the first inclined portion tapering to the distal end of the bushing, the necked portion extending proximally from the first inclined portion. The proximal end of the first angled portion includes a lip defined by a recess extending between an interior surface of the first angled portion and an exterior surface of the necked portion, the lip being configured to engage the hook when the connecting element is crimped thereon.
[0005] In one embodiment, the bushing may include a second inclined surface that flares proximally from the proximal end of the necked portion.
[0006] In one embodiment, the connecting element may be formed from a metal material configured to allow elastic deformation thereof during loading of the fixture, whereby the connecting element slides proximally along the outer surface of the first inclined portion, and plastic deformation of the connecting element, whereby the compressive force applied to the connecting element exceeds a predetermined threshold, causing the connecting element to slide proximally along the second inclined portion of the bushing toward a deployment configuration in which the bushing is releasable therefrom.
[0007] In one embodiment, the reloadable clamping system may further include a barrel comprising a space and a longitudinal slot extending proximally from the space, the space being sized and shaped to accommodate the clamp therein in an open configuration, the longitudinal slot being sized and shaped to receive a distal portion of the applicator therein.
[0008] In one embodiment, the longitudinal slot may include a crimping feature configured to engage a distal portion of the connecting element when the connecting element is moved proximally therethrough such that the hook of the connecting element crimps the hook onto the lip of the first angled portion.
[0009] In one embodiment, the crimping feature may include an inclined surface that tapers toward the distal end such that the inclined surface applies radially inward and distal forces to the hook such that the tip of the hook is received within the cavity defining the lip.
[0010] In one embodiment, the longitudinal slot can include a stop along a portion thereof configured to engage a portion of the bushing to prevent distal movement of the bushing beyond the stop.
[0011] In one embodiment, the first and second angled portions may define a generally conical portion of the bushing, with the neck portion extending along the cylindrical portion of the bushing.
[0012] In one embodiment, the hook may extend along a generally J-shape such that the tip of the hook extends in a distal direction.
[0013] The present disclosure relates to a reloadable clamp device comprising a clamp and a barrel. The clamp comprises a pair of clamp arms, each of the clamp arms extending from a proximal end to a distal end, the proximal ends of the clamp arms being slidably received within a channel of a pod to move between an open configuration and a closed configuration. The proximal end of the pod comprises a plurality of connecting elements extending proximally therefrom, each of the connecting elements comprising a hook along a proximal portion thereof. The barrel comprises a space and a longitudinal slot extending proximally therefrom, the space being sized and shaped to accommodate the clamp therein in an open configuration, the longitudinal slot being sized and shaped to receive therein a distal portion of an applicator to be coupled to the clamp.
[0014] In one embodiment, the connecting element may be formed of a metallic material configured to allow elastic deformation thereof during coupling of the pod to a portion of the applicator and plastic deformation thereof when a force applied thereto exceeds a predetermined threshold.
[0015] In one embodiment, the longitudinal slot may include a crimping feature configured to engage a distal portion of the connecting element when the connecting element is moved proximally therethrough such that the hook of the connecting element crimps the hook to a corresponding portion of an applicator receivable therebetween.
[0016] In one embodiment, the crimping feature may include an inclined surface that tapers toward the distal end such that the inclined surface applies both a radially inward force and a distal force to the hook.
[0017] In one embodiment, the longitudinal slot may include a stop along a portion thereof configured to engage a portion of an applicator receivable therein.
[0018] In one embodiment, the hook may extend along a generally J-shape such that the tip of the hook extends in a distal direction.
[0019] The present disclosure also relates to a method for loading a clamp onto an applicator of a reloadable clamping system. A distal portion of the applicator is inserted through a longitudinal slot of a barrel in which the clamp is stored, the longitudinal slot extending proximally from a space within the barrel, the barrel being sized and shaped to accommodate the clamp in an open configuration. A control member of the applicator is moved distally relative to the barrel until an enlarged distal end of the control member is coupled to a proximal end of a clamp arm of the clamp. A housing of the clamp is moved proximally relative to the housing via the control member so that a connecting element extending proximally from the proximal end of the housing slides along an outer surface of a first inclined portion of a bushing of the applicator until a hook at the proximal end of each of the connecting elements moves distally beyond the proximal end of the first inclined portion, thereby snapping onto it to form a preliminary engagement. The applicator is pulled proximally relative to the barrel, causing the connecting element initially engaged to the pod of the bushing to move proximally along the longitudinal slot of the barrel from the crimping feature which engages the hook to crimp the hook onto the lip at the proximal end of the first inclined portion.
[0020] In one embodiment, the distal portion of the applicator is inserted through the longitudinal slot until a portion of the hub engages a stop that extends along a portion of the longitudinal slot.
[0021] In one embodiment, the crimping feature is configured as an angled, sloped surface such that as the connecting element is moved proximally therealong, the sloped surface exerts both distal and radially inward forces on the hook to crimp the hook onto the lip.
[0022] In one embodiment, the lip is defined by a cavity extending between an interior surface of the first angled portion and an exterior surface of a neck portion extending proximally from the first angled portion; when the hook is crimped onto the lip, the tip of the hook is received in the cavity.
[0023] In one embodiment, the hub of the applicator includes a second inclined portion that flares proximally from the proximal end of the neck portion. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 A cutaway perspective view of a portion of a reloadable clamping system is shown according to an exemplary embodiment of the present disclosure; Figure 2 according to Figure 1 The system shows a perspective view of the applicator; Figure 3 according to Figure 1 The system shows a perspective view of a portion of a cartridge for storing clamps; Figure 4 according to Figure 1 The system of FIG. 1 shows a side view of the capsule and bushing within the barrel prior to loading the clamp onto the applicator; Figure 5 according to Figure 1 The system shows a side view of the capsule being pulled proximally on the bushing during loading of the fixture; Figure 6 according to Figure 1 The system of FIG. 1 shows an enlarged side view of a portion of a pod and a liner in initial engagement with one another during loading of a fixture; Figure 7 according to Figure 1 The system shows an enlarged side view of the connection element of the capsule engaging the crimp feature of the barrel during loading of the fixture; Figure 8 according to Figure 1 The system shows an enlarged side view of a connecting element crimped onto a portion of a bushing during loading of the fixture; and Figure 9 according to Figure 1 The system of FIG. 1 shows the assembled fixture and applicator withdrawn from the barrel. DETAILED DESCRIPTION
[0024] The present disclosure may be further understood with reference to the following description and accompanying drawings, in which like elements are designated by the same reference numerals. The present disclosure relates to a clamping system, and in particular to a reloadable endoscopic clamping system, in which a clamp can be loaded onto the distal end of an applicator prior to an endoscopic procedure. Once the clamp has been deployed to the desired target area in the body, the applicator can be reloaded with a new clamp. Although dislodged parts (e.g., parts left in the body after deployment of the clamp) typically pass naturally from the body, dislodged parts may become trapped in larger defects after closure.
[0025] An exemplary embodiment of the present disclosure includes a clamp comprising a clamp arm that is slidable within a housing to move between an open configuration and a closed configuration as needed to clamp tissue. A proximal end of the housing includes a pair of connecting elements extending proximally therefrom and configured to be crimped onto a portion of an applicator via crimping features in a barrel that holds and stores the clamp prior to loading the clamp onto the applicator. The crimped connection between the clamp and the applicator facilitates a direct releasable connection to the applicator, which minimizes or eliminates the possibility of parts falling off after deployment of the clamp. It will be understood by those skilled in the art that, as used herein, the terms proximal and distal are intended to refer to directions toward and away from a user of the device, respectively.
[0026] like Figures 1 to 9 As shown, the reloadable clamping system 100 includes a clamp 102 that is configured to be loaded onto an applicator 104 prior to inserting the system 100 into the body to clamp target tissue therein. The clamp 102 includes a pair of clamp arms 106, the proximal ends 110 of which are slidably received within a housing 108 such that the clamp arms 106 can be moved between an open configuration (in which the distal ends 112 of the clamp arms 104 are separated from each other) and a closed configuration (in which the distal ends 112 are pulled toward each other to grasp tissue). The proximal end 114 of the housing 108 includes a pair of connecting elements 116 that extend proximally therefrom and are configured to be crimped onto, for example, a sleeve 118 of the applicator 104 during loading of the clamp 102 onto the applicator 104.
[0027] Prior to loading the clamp 102 into the applicator 104, the clamp 102 is stored in the barrel 124, which includes the crimping feature 146, such that when the distal portion of the applicator 104 is inserted into the barrel 124, the capsule 108 can be pulled proximally over the bushing 118 until the crimping feature 146 of the applicator 104 engages the connecting element 116 to crimp the connecting element 116 onto a portion of the bushing 118. During loading of the clamp 102, the enlarged distal end 122 of the control member 120 of the applicator 104 is also coupled to the clamp arm 106 such that longitudinal movement of the control member 120 relative to the capsule 108 moves the clamp 102 between the open and closed configurations.
[0028] As will be described in greater detail below, once the target tissue has been clamped (as desired), the user of the system 100 (e.g., a physician) initiates a deployment process in which a compressive load is applied to the connecting element 116, causing the connecting element 116 to move away from the centerline of the pod 108 toward a deployed configuration, releasing the sleeve 118 therefrom. In the deployed configuration, the connecting element 116 plastically deforms without breaking to release the sleeve 118 therefrom, allowing the deployment of the clamp 102 without leaving any dislodged parts in the body. The applicator 104 is configured such that, after deployment of the clamp 102, a new clamp 102 can be loaded onto the applicator 104, allowing the same applicator 104 to be used to deliver the new clamp 102 to a second portion of the target tissue in the body. Each clamp 102 according to this embodiment is stored in a barrel 124, which facilitates loading the clamp assembly 102 onto the applicator 104.
[0029] like Figure 1 As shown, the clamp 102 includes a pair of clamp arms 106; in this embodiment, the proximal ends 110 of the clamp arms 106 are connected to each other via a bracket 126, which is slidably received within the housing 108. In this embodiment, the clamp arms 106 are biased toward an open configuration such that when not constrained by the housing 108, the clamp arms 106 move under their natural bias to the open configuration, wherein the distal ends 112 of the clamp arms 106 spread apart to receive tissue therebetween. When the clamp arms 106 are drawn into the housing 108, the housing 108 constrains the clamp arms 106, thereby holding the distal ends 112 together so that tissue can be grasped therebetween. The bracket 126 is longitudinally slidable within the housing 108 to allow the clamp arms 106 to move proximally and distally relative to the housing 108 between the open and closed configurations.
[0030] Each of the clamp arms 106 extends from a proximal end 110 connected to the bracket 126 to a distal end 112. The distal end 112 of one or both of the clamp arms 106 may include a tip that extends laterally inward toward the other clamp arm 106, wherein the tip includes, for example, teeth, protrusions, spikes, or other structures configured to grasp tissue between the distal ends 112. One or both of the clamp arms 106 may also include a locking feature configured to lock the clamp arm 106 in a tissue-grasping configuration after the target tissue has been grasped by the clamp arm 106 as desired. In one embodiment, one or both of the clamp arms 106 include a locking tab extending laterally outward therefrom that is configured to engage a portion of the pod 108 when the clamp arm 106 has been pulled a predetermined distance into the pod 108. For example, the locking tab can be received within a correspondingly sized, shaped, and positioned locking window that extends laterally into or through the wall of the pod 108 to lock the clamp arm 106 relative to the pod 108 in a tissue grasping configuration.
[0031] The bracket 126 is connected to the proximal end 110 of the clamp arm 106 and is configured to be connected to the enlarged distal end 122 of the control member 120. In this embodiment, the bracket 126 includes a proximal portion 128 and a distal portion 130 connected to each other at a point 132, and the point 132 is configured to break or separate when subjected to a force exceeding a predetermined threshold. For example, the point 132 may include a weld, a reduced diameter portion, or an adhesive that breaks or otherwise separates when sufficient force is applied thereto. The distal portion 130 is configured to engage the proximal portion of the clamp arm 106 via, for example, a pair of protrusions extending therefrom and received within correspondingly sized and shaped openings extending through the proximal portion of the clamp arm 106 so that the clamp arms 106 are maintained in position relative to each other.
[0032] The proximal portion 128 is configured to engage the enlarged distal portion 122 of the control member. In one embodiment, the proximal portion 128 includes a cavity 134 sized and shaped to receive the enlarged distal end 122 and a longitudinal slot 136 extending proximally from the cavity 134 to a proximal end 138 of the bracket 126. The longitudinal slot 136 is sized and shaped to receive a portion of the control member 120 extending proximally from the enlarged distal end 122. In one embodiment, the opening of the longitudinal slot 136 at the proximal end 138 includes an angled surface 140 that tapers toward its distal end to facilitate distal insertion of the enlarged distal end 122 through the longitudinal slot 136 and into the cavity 134 during loading of the clip 102 onto the applicator 104. The cavity 134 and the longitudinal slot 136 are configured such that once the enlarged distal end 122 has been forced through the slot 136 into the cavity 134, the diameter of the slot 136 retracts to prevent the enlarged distal end 122 from being withdrawn proximally therefrom. Thus, longitudinal movement of the control member 120 relative to the capsule 108 moves the clamp arm 106 between the open configuration and the closed configuration.
[0033] The pod 108 extends longitudinally from the proximal end 114 to the distal end 142 and includes a channel 144 extending longitudinally therethrough. The channel 144 is sized and shaped to slidably receive the bracket 126 and the clamp arm 106 therein. As described above, the pod 108 of the present embodiment also includes a locking structure (e.g., a locking window) for engaging a corresponding locking feature (e.g., a locking tab) of the clamp arm 106. The pod 108 includes connecting elements 116 that extend proximally from the proximal end 114 in an initial configuration such that the connecting elements 116 are generally diametrically opposed to each other. Although the pod 108 is shown and described as including two connecting elements 116, those skilled in the art will appreciate that the pod 108 may include more than two connecting elements; and according to another embodiment, for example, may include four connecting elements 116 extending proximally from the proximal end 114 around its perimeter.
[0034] As will be appreciated by those skilled in the art, the connecting elements 116 can be distributed around the circumference of the pod 108 in any desired pattern, but are typically evenly dispersed therearound. A distal portion 148 of each of the connecting elements 116 extends away from the longitudinal axis of the pod 108 at an angle relative to the longitudinal axis of the pod 108, thereby flaring out away from the longitudinal axis of the pod 108. A proximal portion 150 of each of the connecting elements 116 includes a hook 152 configured to engage a corresponding portion of the bushing 118. As will be described in further detail below, the proximal portion 150 is crimped onto the bushing 118 such that the hook 152 engages a corresponding portion of the bushing 118. In one embodiment, the proximal portion of the hook 152 extends along a generally J-shaped curve such that the tip 154 of the hook 152 extends in a distal direction.
[0035] like Figure 2 As shown, the applicator 104 includes a flexible member 156 (such as, for example, a catheter) extending from a proximal end connected to a handle portion 158 (which remains outside the body during clamping of target tissue) to a distal end that includes, for example, a hub 118 for connecting the applicator 104 to the clamp 102. A control member 120 extends through the flexible member 156 from a proximal end connected to the handle portion 158 that includes an actuator for controlling movement of the clamp 102 to the enlarged distal end 122 once the clamp 102 has been loaded onto the applicator 104.
[0036] In this embodiment, a bushing 118 is connected to the distal end of the flexible member 156 and is configured to connect to the clamp 102 via the connecting element 116 of the pod 108. The bushing 118 extends from a proximal end 160 to a distal end 162 and includes a channel 164 extending therethrough. The proximal end 160 is connected to the distal end of the flexible member 154, while the distal end 162 is configured to engage the connecting element 116. When the bushing 118 is coupled to the pod 108, the channel 164 of the bushing 118 is generally aligned with the channel 144 of the pod 108. The bushing includes a first inclined portion 166 configured to engage the connecting element 116 during loading of the clamp 102 onto the applicator 104 and a second inclined portion 168 that facilitates separation of the pod 108 from the bushing 118 during deployment of the clamp 102. In this embodiment, the first angled portion 166 and the second angled portion 168 are connected to each other via a neck portion 170. The first angled portion 166 and the second angled portion 168 extend around the periphery of the bushing 118 and, in one embodiment, form a generally conical portion of the bushing 118. The neck portion 170 similarly extends around the periphery of the bushing 118 along the generally conical portion of the bushing 118 proximally from the first angled portion 166 toward the distal end of the second angled portion 168.
[0037] The outer surface 172 of the first angled portion 166 tapers to a distal end to facilitate receipt of the bushing 118 between the connecting elements 116. The first angled portion 166 includes a lip 174 at its proximal end, defined by a space formed between the inner surface of the first angled portion 166 and an outer surface 176 of the neck portion 170. The portion of the first angled portion 166 forming the lip 174 has a larger diameter than the distal end 162, so that as the pod 108 is pulled proximally relative to the bushing 118 during loading of the clamp 102, the hook 152 slides along the outer surface 172 of the first angled portion 166, causing the connecting element 116 to elastically deform to receive the first angled portion 166 therebetween. Once the hook 152 has moved proximally past the lip 174, the connecting element 116 snaps radially inward, thereby returning to its initial configuration.
[0038] In this configuration, the hook 152 and the first angled portion 166 form a preliminary engagement, with the tip 154 of the hook 152 abutting the edge 176 of the lip 174. As will be described in further detail below, once the capsule 108 and the bushing 118 have formed this preliminary engagement, the applicator 104 is pulled away from the barrel 124 and the clamp 102 engages the crimping feature 146 of the barrel 124 with the proximal portion 150 of the connecting element 116, causing the hook 152 to crimp onto the lip 174 of the first angled portion 166, thereby loading the clamp 102 onto the applicator 104. After the hook 152 has been crimped onto the lip 174, the clamp 102 remains coupled to the bushing 118 of the applicator 104 until deployment.
[0039] The second angled portion 168 extends proximally from the neck portion 170, flaring outward therefrom such that a proximal end 178 of the second angled portion 168 has a larger diameter than both the neck portion 170 and the portion of the first angled portion 166 including the lip 174. Once the clamp 102 has been clamped to the target tissue as desired, the control member 120 is pulled proximally relative to the capsule 108 until the clamp arms 106 are locked relative to the capsule 108 (e.g., via locking tabs of the clamp arms 106 received within locking windows of the capsule 108) in the closed configuration. Further proximal movement of the control member 120 thereafter pulls the capsule 108 proximally against the bushing 118, causing the hook 152 to slide proximally along the second angled portion 166 in a direction away from the longitudinal axis of the capsule 108 when sufficient compressive force is applied to the connecting element 116, thereby moving the connecting element 116 toward the deployed configuration. The connecting elements 116 plastically deform toward a deployed configuration that disengages the liner 118 so that the liner 118 may be proximally removed from between the connecting elements 116 of the pod 108 without leaving any dislodged parts in the body.
[0040] In one embodiment, the connecting tab 116 is formed of a metal selected to allow for the slight elastic deformation required to achieve initial engagement of the connecting element 116 with the first inclined portion 166 and to plastically deform during deployment of the clamp 102. The connecting element 116 can be formed of a metal (such as, for example, stainless steel) that can be annealed or work hardened (by stamping, drawing, extrusion, etc.) so that when crimped onto the bushing 118, the metal will carry the load of the clamp 102 moving between the open and closed configurations without any deformation. However, once sufficient compressive force has been applied to the connecting element 116, the connecting tab 116 will plastically deform toward the deployed configuration.
[0041] Prior to being loaded onto the applicator, the clamp 102 of this embodiment is stored in a barrel 124 that is configured to facilitate loading of the clamp assembly 102 onto the applicator 104. Figure 3 As shown, the barrel 124 is configured as a storage container including a base 125 and a lid (not shown) defining a space 180 therein that is sized and shaped to accommodate the clamp 102. Figure 3 Only the base 125 of the container 124 is shown, but a corresponding cap is coupled to the base 125 to completely enclose the clamp 102. In this embodiment, the clamp 102 is stored in an open configuration within the barrel 124. A longitudinal slot 182 extends proximally from the space 180, through which a distal portion of the applicator 104 is inserted to couple to the clamp assembly 102, as will be described in further detail below.
[0042] In this embodiment, the longitudinal slot 182 includes a stop configured as a shoulder 184 that is sized to engage the proximal end 178 of the second angled portion 168 so that the bushing 118 cannot extend distally therebeyond. Figure 4 184 . The crimping feature 146 is located within the longitudinal slot 182 immediately distal to the shoulder 184. In this embodiment, the crimping feature 146 is configured as an inclined surface 186 that flares distally from the shoulder 184, such that the inclined surface 186 is angled relative to the longitudinal axis of the pod 108. The cross-sectional area (e.g., diameter) of the longitudinal slot 182 at a proximal end 188 of the inclined surface 186 is smaller than the cross-sectional area (e.g., diameter) at a distal end 190 of the inclined surface 186, such that the proximal end 188 protrudes into the longitudinal slot 182 toward its centerline to provide a crimp to the connecting element 116.
[0043] During loading of the clamp 102 onto the applicator 104, the applicator 104, including a distal portion of the bushing 118, is inserted through the longitudinal slot 182 of the barrel 124 until the proximal end 178 of the second angled portion 168 abuts the shoulder 18, thereby preventing the bushing 118 from moving beyond it. In one embodiment, the control member 120 is then moved distally relative to the flexible member 156 until the enlarged distal end 122 of the control member 120 extends distally through the bushing 118 to engage the bracket 126. After the control member 120 is connected within the bracket 126, the control member 120 is pulled proximally relative to the flexible member 156 to move the clamp 102 toward the closed configuration. Once in the closed configuration, continued proximal movement of the control member 120 causes the capsule 108 to move proximally relative to the barrel 124 until the connecting element at the proximal end 114 of the capsule 108 moves proximally over the first angled portion 166, as shown. Figure 5 shown.
[0044] In another embodiment, the shoulder 184 can be positioned in such a way that the user engages the connecting element 116 directly onto the bushing 118 and then engages the control member 120 with the bracket 126 to fully crimp the clamp onto the bushing 118 before finally removing the entire assembly from the barrel 12. The hook 152 of each of the connecting elements 116 slides proximally along the outer surface 172 of the first inclined portion 166, thereby elastically deforming to accommodate the first inclined portion 166, until the hook 152 moves proximally past the lip 174, at which point the connecting element 116 returns to its original configuration. In particular, the hook 152 snaps onto the first inclined portion 166, as shown in FIG. Figure 6 As shown, the hook 152 is initially engaged with the engagement lip 174, as shown in FIG. Figure 6 As shown, the tip 154 of the hook 152 engages the edge 176 of the lip 174 .
[0045] The snapping of the hook 152 on the first inclined portion 166 provides tactile feedback to the user, making the user aware that preliminary engagement has been achieved between the capsule 108 and the bushing 118. The user can then pull the entire applicator 104 proximally relative to the barrel 124, causing the capsule 108 to also be pulled proximally through the longitudinal slot 182 of the barrel 124 until the proximal portion 150 of the connecting element 116 engages the crimping feature 146. In particular, the hook 152 of the distal portion slides proximally along the inclined surface 186, as shown in FIG. Figure 7 As shown, the crimping feature 146 provides both radially inward and distal forces to the hook 152, thereby crimping the hook 152 onto the lip 174 of the first inclined portion 166, as shown. Figure 8 shown.
[0046] For example, the tip 154 of the hook 152 can be received in the space defined between the outer surface of the neck portion 170 and the inner surface of the angled portion 166. The remainder of the proximal portion 150 of the connecting element 116 is pressed against the outer surface of the lip 174, thereby forming a crimped connection that carries the load of opening and closing the clamp 102. Once the clamp 102 has been loaded onto the applicator via the crimping of the connecting element 116, further proximal movement of the applicator 104 (e.g., Figure 9 ) moves the bushing 118 and capsule 108 proximally through the crimping feature 146 so that the assembly fixture 102 and applicator 104 can be removed from the barrel 124.
[0047] In use, after the clamp 102 has been loaded onto the applicator 104, the clamp 102 is inserted into the body, in a closed configuration, through a working channel of, for example, an endoscope, into a location adjacent to target tissue. Once the clamp 102 has reached the target tissue, the clamp 102 is moved toward the open configuration to receive the target tissue between the distal ends 112 of the clamp arms 106. As needed, the clamp 102 can be moved between the open configuration and the closed configuration until the target tissue is clamped between the clamp arms 106. Once the clamp 102 is in the closed configuration to clamp the target tissue as needed, the control member 120 (e.g., via an actuator of the handle portion 158) is moved proximally relative to the pod 108 until the locking features of the clamp arms 106 engage corresponding locking structures of the pod 108, thereby locking the clamp arms 106 in the closed configuration relative to the pod 108.
[0048] To release the clamp 102 from the applicator 104, the control member 120 is pulled further proximally until the capsule 108 is pulled proximally against the bushing 118 and the compressive load on the connecting elements 116 exceeds a predetermined threshold, thereby forcing the connecting elements 116 (particularly the hooks 152) to disengage from the lip 174 and slide proximally along the second inclined portion 168. The sliding of the hooks 152 along the second inclined portion 168 plastically deforms the connecting tabs 116 so that they remain in a more radially outward position away from the longitudinal axis of the capsule 108 and out of engagement with the bushing 118. The bushing 118 can be withdrawn proximally from between the connecting elements 116, leaving the clamp 102 in place to clamp the target tissue.
[0049] The user continues to apply proximal force to the control member 120 until the bracket 126 breaks, fails, or otherwise separates at point 132, releasing the clamp arm 106 from the control member 120, thereby releasing the clamp 102 and locking the clamp 102 closed on the target tissue. The entire applicator 104 (including the control member 120 and the proximal portion 128 of the bracket 126) can then be withdrawn proximally from the body, leaving the clamp 102 clamped on the target tissue. If necessary, a new clamp 102 can be loaded onto the applicator 104 in the same manner as described above, so that the system 100 can then be used to clamp a second portion of tissue. This process can be repeated as many times as needed or desired using the same applicator 104.
[0050] Although the connecting element 116 is described and shown as extending proximally from the pod 108 to engage a portion of the bushing 118, those skilled in the art will appreciate that the connecting element 116 can similarly extend distally from the bushing of the applicator to engage a corresponding portion of the pod of the clamp. Alternatively, a coupler including a crimpable connecting element can be attached to either the pod or the bushing to be crimped onto a corresponding portion of the other.
[0051] It will be apparent to those skilled in the art that various modifications can be made to the present disclosure without departing from the scope of the disclosure.
Claims
1. A reloadable clamping system for treating tissue, comprising: a clamp assembly comprising a pair of clamp arms, a capsule configured to receive proximal ends of the clamp arms therein, and a first deformable element extending proximally from the proximal ends of the capsule, the first deformable element including a first hook extending from a proximal portion thereof; and An applicator having a distal end, the distal end including a distal portion configured to be engaged by the first hook when the first hook is crimped thereon in a locked configuration, the distal end of the applicator configured such that when a compressive force applied to the first deformable element exceeds a predetermined threshold, the first deformable element plastically deforms and disengages from the distal end of the applicator.
2. The system according to claim 1, wherein: The distal portion includes a first inclined portion that tapers to a distal end of the distal portion and a necked portion that extends proximally from the first inclined portion.
3. The system according to claim 2, wherein: The proximal end of the first angled portion includes a lip defined by a recess extending between an interior surface of the first angled portion and an exterior surface of the necked portion, the lip being configured to engage the first hook when the first hook is crimped thereon in the locked configuration.
4. The system according to claim 2, wherein: The distal portion includes a second inclined portion that flares proximally from a proximal end of the necked portion.
5. The system according to claim 4, wherein: The first and second inclined portions define a generally tapered portion of the distal end of the applicator, while the neck portion extends along a cylindrical portion of the distal end of the applicator.
6. The system according to claim 1, wherein: The distal end of the applicator includes a bushing, and the distal portion of the distal end of the applicator is formed on the bushing, the distal portion being configured to be engaged by the first hook when the first hook is crimped thereon in the locked configuration.
7. The system according to claim 1, wherein: The first deformable element is formed of a metal material configured to allow the first deformable element to be elastically deformed during loading of the clamping assembly, whereby the first deformable element slides proximally along the outer surface of the distal portion until the first hook snaps onto the distal portion to connect the capsule to the distal end of the applicator.
8. The system of claim 1 , further comprising: A barrel includes a void sized and shaped to accommodate the clamp assembly therein and a longitudinal slot extending proximally therefrom, the void sized and shaped to receive the distal end of the applicator therein.
9. The system according to claim 8, wherein: The longitudinal slot includes a crimping feature configured to engage the deformable portion of the first deformable element such that when the first deformable element moves proximally through the crimping feature, the first hook of the first deformable element is crimped onto the distal portion in the locking configuration.
10. The system according to claim 9, wherein: The crimping feature includes an inclined surface that tapers toward a distal end such that the inclined surface applies radially inward and distal forces to the first hook such that the tip of the first hook is received within a cavity defined in the distal portion.
11. The system according to claim 8, wherein The longitudinal slot includes a stop along a portion thereof that is configured to engage a portion of the distal end of the applicator to prevent the distal end of the applicator from moving distally beyond the stop.
12. The system according to claim 1, wherein: The first hook extends along a generally J-shape such that the tip of the first hook extends in a distal direction.
13. The system of claim 1, wherein: The clamping assembly includes at least one additional deformable element extending proximally from the proximal end of the housing, the additional deformable element including an additional hook extending from a proximal portion thereof and configured to be crimped onto the distal portion in the locking configuration.
14. The system according to claim 13, wherein: The distal end of the applicator is configured such that, when the compressive force applied to the further deformable element exceeds a predetermined threshold, the further deformable element plastically deforms out of engagement with the distal end of the applicator.
15. The system of claim 1, wherein: The proximal ends of the clamp arms are connected to each other via a bracket that is coupleable to an enlarged distal end of a control member extending through an elongated flexible member of the applicator.
16. The system according to claim 15, wherein: The bracket includes a proximal portion and a distal portion connected to each other at a point configured to separate when a predetermined force is applied thereto.
17. A clamping device comprising: a pair of clamp arms, each of the clamp arms extending from a proximal end to a distal end; a pod configured to receive the proximal end of the clamp arm therein; and A first deformable element extends proximally from the proximal end of the capsule, the first deformable element comprising a first hook extending from the proximal portion of the first deformable element to be crimped onto the distal portion of the distal end of the applicator so that, when the compressive force applied to the first deformable element exceeds a predetermined threshold, the first deformable element plastically deforms and disconnects from the distal end of the applicator.
18. The device according to claim 17, wherein The first deformable element is formed of a metallic material configured to allow elastic deformation of the first deformable element during coupling of the capsule to the distal end of the applicator.
19. The apparatus according to claim 17, further comprising: at least one additional deformable element extending proximally from the proximal end of the capsule, the additional deformable element including an additional hook extending from a proximal portion thereof and configured to be crimped onto the distal portion in a locking configuration such that when a compressive force applied to the additional deformable element exceeds a predetermined threshold, the additional deformable element plastically deforms to disengage from the distal end of the applicator.
20. The apparatus according to claim 17, wherein The first hook extends along a generally J-shape such that the tip of the first hook extends in a distal direction.
21. A reinstallable clamping device comprising: a clamp comprising clamp arms, each of the clamp arms extending from a proximal end to a distal end, the proximal ends of the clamp arms being slidably received within a channel of a housing to move between an open configuration in which the distal ends of the clamp arms are separated from one another and a closed configuration in which the distal ends of the clamp arms are drawn together to clamp tissue, the proximal end of the housing comprising a plurality of connecting elements extending proximally therefrom, each of the plurality of connecting elements comprising a hook along a proximal portion thereof, wherein the plurality of connecting elements are configured to plastically deform without breaking when a compressive force applied to the plurality of connecting elements exceeds a predetermined threshold; and a barrel comprising a void sized and shaped to house the clamp in the open configuration and a longitudinal slot extending proximally therefrom, the void sized and shaped to receive therein a distal portion of an applicator to be coupled to the clamp.
22. The device according to claim 21, wherein The connecting element is formed of a metallic material configured to allow elastic deformation of the connecting element during coupling of the pod to the applicator and to allow plastic deformation of the connecting element without breaking when a force applied to the connecting element exceeds the predetermined threshold.
23. The device according to claim 21, wherein The longitudinal slot includes a crimping feature configured to engage the distal portion of each of the connecting elements as the connecting elements move proximally therethrough such that the hook of each of the connecting elements is crimped onto a corresponding portion of the applicator receivable between the connecting elements.
24. The device according to claim 23, wherein The crimping feature includes an inclined surface that tapers toward a distal end such that the inclined surface applies both a radially inward force and a distal force to each of the hooks.
25. The apparatus according to claim 21, wherein The longitudinal slot includes a stop along a portion thereof, the stop configured to engage a portion of the applicator receivable in the longitudinal slot.
26. The apparatus according to claim 21, wherein Each of the hooks extends along a J-shape such that a tip of each of the hooks extends in a distal direction.
27. The apparatus according to claim 21, wherein Each of the hooks is configured to snap onto a corresponding portion of the applicator to produce tactile feedback when crimped.
28. The apparatus according to claim 21, wherein A first one of the clamp arms includes a protrusion extending laterally inwardly from a distal end thereof toward a second one of the clamp arms.
29. The apparatus according to claim 28, wherein The first clamp arm includes a locking feature configured to lock the first clamp arm and the second clamp arm in the closed configuration.
30. The apparatus according to claim 29, wherein The locking feature includes a locking tab extending laterally outward from the first clamp arm to engage a portion of the capsule.
31. The apparatus of claim 24, wherein: A first diameter of the longitudinal slot at a proximal end of the inclined surface is smaller than a second diameter of the longitudinal slot at a distal end of the inclined surface such that the proximal end of the inclined surface protrudes inwardly toward a centerline of the longitudinal slot.