Crimp Attachment of a Clamp for a Reusable Hemostatic Device
By designing a reassembleable clamping system for endoscopic gastrointestinal surgery, the problem of perforation and closure of the gastrointestinal wall during the operation is solved, and a safer and more efficient surgical process is achieved.
Patent Information
- Application Number
- CN202080041834.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-07-16
- Filing Date
- 2020-06-18
- Publication Date
- 2025-06-10
- Estimated Expiration
- 2040-06-18
AI Technical Summary
During endoscopic gastrointestinal surgery, patients may face the risk of perforation of the gastrointestinal wall or need to undergo closure of the wall as part of the surgery, and the prior art is difficult to effectively address these problems.
A reassembleable clamping system is designed, including a clamp and an applicator, which consists of a pair of clamp arms that move between the open and closed configurations through the passage of the cabin, and the connecting elements are crimped connections through bushings and longitudinal slots, ensuring that the clamp does not miss any fallen parts after deployment.
The system uses crimp connection technology to ensure that the fixture does not miss any shed parts after deployment, reducing risks during surgery and improving the safety and efficiency of the surgery.
Smart Images

Figure CN114007524B_ABST
Abstract
Description
[0001] Inventors: Joseph W. KING, Laurie A. LEHTINEN, and Henry STOCK
[0002] Priority Claim
[0003] 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 hereby incorporated by reference in its entirety. Technical Field
[0004] This disclosure relates to endoscopic devices and, in particular, to endoscopic clamping devices for treating tissue along the gastrointestinal tract. Background Art
[0005] During endoscopic gastrointestinal (GI) surgery, a patient may be at risk of perforation of the wall of the gastrointestinal tract or may require closure of the gastrointestinal wall as part of the surgery. Hemostatic clamps can be used, for example, for hemostasis of mucosal / submucosal defects, bleeding ulcers, arteries, polyps, diverticula, and closure of lumen perforations. Depending on the size of the defect, multiple clamps may be used. Summary of the Invention
[0006] This disclosure relates to a reloadable clamping system for treating tissue, the reloadable clamping system including a clamp and an applicator. The clamp includes 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 channels of a cartridge to move between an open configuration and a closed configuration. The proximal end of the cartridge includes a plurality of connecting elements extending proximally therefrom, each of the connecting elements including a hook along its proximal portion. The applicator includes an elongate flexible member and a control member extending therethrough. The control member includes a distal end configured to connect to the clamp arms to move the clamp assembly between an open configuration and a closed configuration. The distal end of the elongate flexible member includes a bushing, the bushing including a first tapered portion and a necked portion, the first tapered portion tapering to the distal end of the bushing, the necked portion extending proximally from the first tapered portion. The proximal end of the first tapered portion includes a lip defined by a recess extending between an inner surface of the first tapered portion and an outer surface of the necked portion, the lip configured to engage the hook when the connecting element is crimped thereon.
[0007] In one embodiment, the bushing may include a second tapered surface that flares proximally and outwardly from the proximal end of the necked portion.
[0008] In one embodiment, the connecting element may be formed of a metallic material configured to allow elastic deformation thereof during loading of the clip, where the connecting element slides proximally along an outer surface of the first inclined portion, and to allow plastic deformation of the connecting element when a compressive force applied to the connecting element exceeds a predetermined threshold, such that the connecting element slides proximally along a second inclined portion of the bushing toward a deployed configuration, in which the bushing is releasable therefrom.
[0009] In one embodiment, the reloadable clamping system may further include a barrel that includes a space and a longitudinal slot extending proximally from the space, the space sized and shaped to receive the clip therein in an open configuration, and the longitudinal slot sized and shaped to receive a distal portion of an applicator therein.
[0010] In one embodiment, the longitudinal slot may include a crimping feature configured to engage a distal portion of the connecting element as the connecting element moves proximally therethrough, such that a hook of the connecting element crimps the hook onto a lip of the first inclined portion.
[0011] In one embodiment, the crimping feature may include an inclined surface tapering toward a distal end, such that the inclined surface applies a radially inward force and a distal force to the hook, such that a tip of the hook is received within a chamber defining the lip.
[0012] In one embodiment, the longitudinal slot may include a stop along a portion thereof configured to engage a portion of the bushing to prevent the bushing from moving distally beyond the stop.
[0013] In one embodiment, the first and second inclined portions may define a generally conical portion of the bushing, while a neck portion extends along a cylindrical portion of the bushing.
[0014] In one embodiment, the hook may extend generally in a J shape such that a tip of the hook extends in a distal direction.
[0015] The present disclosure relates to a reloadable clip device that includes a clip and a barrel. The clip includes a pair of clip arms, each of the clip arms extending from a proximal end to a distal end, the proximal ends of the clip arms slidably received within channels of a housing to move between an open configuration and a closed configuration. A proximal end of the housing includes a plurality of connecting elements extending proximally therefrom, each of the connecting elements including a hook along a proximal portion thereof. The barrel includes a space and a longitudinal slot extending proximally from the space, the space sized and shaped to receive the clip therein in an open configuration, and the longitudinal slot sized and shaped to receive a distal portion of an applicator to be coupled to the clip therein.
[0016] In one embodiment, the connecting element may be formed of a metallic material configured to permit elastic deformation thereof during coupling of the cartridge to a portion of the applicator and to permit plastic deformation thereof when a force applied thereto exceeds a predetermined threshold.
[0017] In one embodiment, the longitudinal slot may include a crimping feature configured to engage a distal portion of the connecting element as the connecting element moves proximally therethrough such that the hook of the connecting element crimps the hook onto a corresponding portion of the applicator receivable therebetween.
[0018] In one embodiment, the crimping feature may include 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 the hook.
[0019] In one embodiment, the longitudinal slot may include a stop along a portion thereof configured to engage a portion of the applicator receivable therein.
[0020] In one embodiment, the hook may extend generally in a J-shape such that the tip of the hook extends in a distal direction.
[0021] The present disclosure also relates to a method for loading a clip onto an applicator of a reloadable gripping system. A distal portion of the applicator is inserted through a longitudinal slot of a barrel in which the clip is stored, the longitudinal slot extending proximally from a space within the barrel, the barrel sized and shaped to receive the clip 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 clip arm of the clip. The cartridge of the clip is moved proximally relative to the cartridge such that a connecting element extending proximally from a proximal end of the cartridge slides along an outer surface of a first inclined portion of a bushing of the applicator until the hooks at proximal ends of each of the connecting elements move distally beyond a proximal end of the first inclined portion and snap thereonto to form a preliminary engagement. The applicator is pulled proximally relative to the barrel such that the connecting elements of the cartridge preliminarily engaged to the bushing move proximally along the longitudinal slot of the barrel from a crimping feature that engages the hooks to crimp the hooks onto a lip at the proximal end of the first inclined portion.
[0022] In one embodiment, the distal portion of the applicator is inserted through the longitudinal slot until a portion of the bushing engages a stop that extends along a portion of the longitudinal slot.
[0023] In one embodiment, the crimping feature is configured as an angled inclined surface such that when the connecting element moves proximally therealong, the inclined surface applies both a distal force and a radially inward force to the hook to crimp the hook onto the lip.
[0024] In one embodiment, the lip is defined via a chamber that extends between an inner surface of the first inclined portion and an outer surface of the neck portion, which extends proximally from the first inclined portion; when the hook is crimped onto the lip, a tip of the hook is received within the chamber.
[0025] In one embodiment, the bushing of the applicator includes a second inclined portion that flares outwardly proximally from a proximal end of the neck portion. BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Figure 1 A cross-sectional perspective view of a portion of a reloadable clamping system is shown in accordance with an exemplary embodiment of the present disclosure;
[0027] Figure 2 According to Figure 1 the system shows a perspective view of the applicator;
[0028] Figure 3 According to Figure 1 the system shows a perspective view of a portion of the barrel for storing the clamp;
[0029] Figure 4 According to Figure 1 the system shows a side view of the capsule and the bushing within the barrel before loading the clamp onto the applicator;
[0030] 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 clamp;
[0031] Figure 6 According to Figure 1 the system shows an enlarged side view of a portion of the capsule and the bushing being initially engaged with each other during loading of the clamp;
[0032] Figure 7 According to Figure 1 the system shows an enlarged side view of a connecting element of the capsule engaging a crimping feature of the barrel during loading of the clamp;
[0033] Figure 8 According to Figure 1 the system shows an enlarged side view of a connecting element being crimped onto a portion of the bushing during loading of the clamp; and
[0034] Figure 9 According to Figure 1 the system shows the assembled clamp and applicator withdrawn from the barrel. DETAILED DESCRIPTION
[0035] The present disclosure can be further understood with reference to the following description and drawings, in which like elements are referred to by the same reference numerals. The present disclosure relates to a clamping system, and particularly 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 in a desired target area within the body, the applicator can be reloaded with a new clamp. Although shed parts (e.g., parts left in the body after deployment of the clamp) typically pass naturally out of the body, the shed parts may become trapped in a larger defect after closure.
[0036] Exemplary embodiments of the present disclosure include a clamp that includes clamp arms that are slidable within a housing to move between an open configuration and a closed configuration as needed to clamp tissue. The proximal end of the housing includes a pair of connection elements that extend proximally therefrom and are configured to be crimped to a portion of an applicator via a crimp feature in a barrel that holds and stores the clamp prior to loading the clamp onto the applicator. The crimp connection between the clamp and the applicator facilitates a direct releasable connection with the applicator, which minimizes or eliminates the possibility of shed parts after deployment of the clamp. Those skilled in the art will understand that, as used herein, the terms proximal and distal are intended to refer to directions toward and away from the user of the device, respectively.
[0037] As Figures 1 to 9 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 move between an open configuration (wherein the distal ends 112 of the clamp arms 104 are separated from each other) and a closed configuration (wherein the distal ends 112 are pulled toward each other to grasp tissue). The proximal end 114 of the housing 108 includes a pair of connection elements 116 that extend proximally therefrom and are configured to be crimped to, for example, a bushing 118 of the applicator 104 during loading of the clamp 102 onto the applicator 104.
[0038] Before the clip 102 is loaded into the applicator 104, the clip 102 is stored in a barrel 124 that includes a crimp feature 146 such that when the distal portion of the applicator 104 is inserted into the barrel 124, the cartridge 108 can be pulled proximally on the bushing 118 until the crimp feature 146 of the applicator 104 engages the connection element 116 to crimp the connection element 116 onto a portion of the bushing 118. During loading of the clip 102, the enlarged distal end 122 of the control member 120 of the applicator 104 is also coupled to the clip arm 106 such that longitudinal movement of the control member 120 relative to the cartridge 108 moves the clip 102 between an open configuration and a closed configuration.
[0039] As will be described in more detail below, once the target tissue has been clamped (as needed), the user (e.g., a doctor) of the system 100 initiates a deployment process in which a compressive load is applied to the connection element 116, thereby causing the connection element 116 to move away from the centerline of the cartridge 108 toward a deployed configuration such that the bushing 118 is released therefrom. In the deployed configuration, the connection element 116 plastically deforms without breaking to release the bushing 118 therefrom such that deployment of the clip 102 leaves no shed parts in the body. The applicator 104 is configured such that after deployment of the clip 102, a new clip 102 can be loaded onto the applicator 104 such that the same applicator 104 can be used to deliver the new clip 102 to a second portion of the target tissue in the body. Each clip 102 according to this embodiment is stored in the barrel 124, which facilitates loading of the clip assembly 102 onto the applicator 104.
[0040] As Figure 1 shown, the clip 102 includes a pair of clip arms 106; in this embodiment, the proximal ends 110 of the clip arms 106 are connected to each other via a bracket 126 that is slidably received within the cartridge 108. In this embodiment, the clip arms 106 are biased toward an open configuration such that when unrestrained by the cartridge 108, the clip arms 106 move to the open configuration under their natural bias, wherein the distal ends 112 of the clip arms 106 spread apart to receive tissue therebetween. When the clip arms 106 are pulled into the cartridge 108, the cartridge 108 constrains the clip arms 106, thereby holding the distal ends 112 together such that tissue can be grasped therebetween. The bracket 126 is longitudinally slidable within the cartridge 108 to move the clip arms 106 proximally and distally relative to the cartridge 108 between the open configuration and the closed configuration.
[0041] Each of the clamp arms 106 extends from a proximal end 110 connected to the carriage 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 transversely inwardly toward the other clamp arm 106, where 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 further include a locking feature configured to lock the clamp arms 106 in a tissue grasping configuration after the target tissue has been grasped by the clamp arms 106 as needed. In one embodiment, one or both of the clamp arms 106 include a locking tab that extends transversely outwardly therefrom and is configured to engage a portion of the housing 108 when the clamp arms 106 have been pulled into the housing 108 a predetermined distance. For example, the locking tab may be received within a locking window that is sized, shaped, and positioned such that it extends laterally into or through the wall of the housing 108 to lock the clamp arms 106 relative to the housing 108 in a tissue grasping configuration.
[0042] The carriage 126 is connected to the proximal end 110 of the clamp arms 106 and is configured to be connected to the enlarged distal end 122 of the control member 120. In the present embodiment, the carriage 126 includes a proximal portion 128 and a distal portion 130 that are connected to each other at a point 132 that 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 arms 106 via, for example, a pair of protrusions that extend therefrom and are received within openings that are sized and shaped such that they extend through the proximal portion of the clamp arms 106, such that the clamp arms 106 are held in position relative to each other.
[0043] 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 chamber 134 and a longitudinal slot 136, the chamber 134 being sized and shaped to receive the enlarged distal end 122, and the longitudinal slot 136 extending proximally from the chamber 134 to the proximal end 138 of the carriage 126. The longitudinal slot 136 is sized and shaped to receive a portion of the control member 120, 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, the angled surface 140 tapering towards its distal end to facilitate insertion of the enlarged distal end 122 distally through the longitudinal slot 136 and into the chamber 134 during loading of the clip 102 onto the applicator 104. The chamber 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 chamber 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 housing 108 moves the clip arm 106 between the open configuration and the closed configuration.
[0044] The housing 108 extends longitudinally from the proximal end 114 to the distal end 142 and includes a passage 144 extending longitudinally therethrough. The passage 144 is sized and shaped to slidably receive the carriage 126 and the clip arm 106 therein. As described above, the housing 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 clip arm 106. The housing 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 housing 108 is shown and described as including two connecting elements 116, those skilled in the art will understand that the housing 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.
[0045] As will be understood by those skilled in the art, these connecting elements 116 can be distributed around the circumference of the housing 108 in any desired pattern, but are typically evenly dispersed therearound. The distal portion 148 of each of the connecting elements 116 extends away from the longitudinal axis of the housing 108 at an angle with respect to the longitudinal axis of the housing 108, so as to flare away from the longitudinal axis of the housing 108. The 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 the 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 the distal direction.
[0046] As Figure 2 As shown, the applicator 104 includes a flexible member 156 (such as, for example, a catheter) that extends from a proximal end connected to a handle portion 158 (which remains outside the body during clamping of the target tissue) to a distal end that includes, for example, a bushing 118 for connecting the applicator 104 to the clamp 102. A control member 120 extends from a proximal end connected to the handle portion 158 through the flexible member 156, and the handle portion 158 includes an actuator for controlling movement of the clamp 102 to expand the distal end 122 once the clamp 102 has been loaded onto the applicator 104.
[0047] In the present embodiment, the bushing 118 is connected to the distal end of the flexible member 156 and is configured to be connected to the fixture 102 via the connecting element 116 of the housing 108. The bushing 118 extends from a proximal end 160 to a distal end 162 and includes a passage 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 housing 108, the passage 164 of the bushing 118 is generally aligned with the passage 144 of the housing 108. The bushing includes a first inclined portion 166 and a second inclined portion 168. The first inclined portion 166 is configured to engage the connecting element 116 during loading of the fixture 102 onto the applicator 104, and the second inclined portion 168 facilitates separation of the housing 108 from the bushing 118 during deployment of the fixture 102. In the present embodiment, the first inclined portion 166 and the second inclined portion 168 are connected to each other via a neck portion 170. The first inclined portion 166 and the second inclined portion 168 extend around the perimeter 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 perimeter of the bushing 118 along the generally conical portion of the bushing 118 from the first inclined portion 166 proximally toward the distal end of the second inclined portion 168.
[0048] The outer surface 172 of the first inclined portion 166 tapers to the distal end to facilitate receipt of the bushing 118 between the connecting elements 116. The first inclined portion 166 includes a lip 174 at its proximal end, which is defined by a space formed between the inner surface of the first inclined portion 166 and the outer surface 176 of the neck portion 170. A portion of the first inclined portion 166 forming the lip 174 has a larger diameter than the distal end 162 such that as the housing 108 is pulled proximally relative to the bushing 118 during loading of the fixture 102, the hook 152 slides along the outer surface 172 of the first inclined portion 166 such that the connecting element 116 elastically deforms to receive the first inclined portion 166 therebetween. Once the hook 152 has moved proximally through the lip 174, the connecting element 116 snaps radially inwardly and thus returns to its initial configuration.
[0049] In this configuration, the hook 152 and the first inclined portion 166 form a preliminary engagement, where the tip 154 of the hook 152 abuts the edge 176 of the lip 174. As will be described in further detail below, once the housing 108 and the bushing 118 have formed this preliminary engagement, the applicator 104 and the clamp 102 pulled away from the barrel 124 engage the crimp feature 146 of the barrel 124 with the proximal portion 150 of the connecting element 116, such that the hook 152 is crimped onto the lip 174 of the first inclined 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.
[0050] The second inclined portion 168 extends proximally from the neck portion 170, thereby flaring out therefrom such that the proximal end 178 of the second inclined portion 168 has a diameter that is larger than both the neck portion 170 and the portion of the first inclined portion 166 that includes the lip 174. Once the clamp 102 has been clamped onto the target tissue as desired, the control member 120 is pulled proximally relative to the housing 108 until the clamp arms 106 are locked (e.g., via locking tabs of the clamp arms 106 received within locking windows of the housing 108) relative to the housing 108 in a closed configuration. Further proximal movement of the control member 120 after this pulls the housing 108 proximally against the bushing 118 such that when sufficient compressive force is applied to the connecting element 116, the hook 152 slides proximally along the second inclined portion 166 in a direction away from the longitudinal axis of the housing 108, thereby moving the connecting element 116 toward a deployed configuration. The connecting element 116 plastically deforms toward the deployed configuration in which it is disengaged from the bushing 118 such that the bushing 118 can be removed proximally between the connecting elements 116 of the housing 108 without leaving any shed parts in the body.
[0051] In one embodiment, the connecting tab 116 is formed of a metal selected to permit the slight elastic deformation required to effect the preliminary 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, stretching, extrusion, etc.) such 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.
[0052] Before being loaded onto the applicator, the clamp 102 of this embodiment is stored within the barrel 124, which is configured to facilitate loading of the clamp assembly 102 onto the applicator 104. AsFigure 3 As shown, the barrel 124 is configured as a storage container that includes a base 125 and a lid (not shown), and a space 180 is defined within the storage container. The size and shape of the space 180 are set to accommodate the fixture 102. It should be noted that although Figure 3 only the base 125 of the container 124 is shown, the corresponding lid is coupled to the base 125 to completely enclose the fixture 102. In the present embodiment, the fixture 102 is stored within the barrel 124 in an open configuration. A longitudinal slot 182 extends proximally from the space 180, and a distal portion of the applicator 104 is inserted through the longitudinal slot 182 to be coupled to the fixture assembly 102, as will be described in further detail below.
[0053] In the present embodiment, the longitudinal slot 182 includes a stop that is configured as a shoulder 184. The size of the shoulder 184 is set to engage the proximal end 178 of the second inclined portion 168 such that the bushing 118 cannot extend distally beyond it, as Figure 4 shown. A crimping feature 146 is located within the longitudinal slot 182 immediately distal to the shoulder 184. In the present embodiment, the crimping feature 146 is configured as an inclined surface 186 that flares outwardly distally from the shoulder 184 such that the inclined surface 186 is angled relative to the longitudinal axis of the housing 108. The cross-sectional area (e.g., diameter) of the longitudinal slot 182 at the proximal end 188 of the inclined surface 186 is less than the cross-sectional area (e.g., diameter) at the distal end 190 of the inclined surface 186 such that the proximal end 188 projects towards its centerline into the longitudinal slot 182 to provide a crimp to the connecting element 116.
[0054] During loading of the fixture 102 onto the applicator 104, the distal portion of the applicator 104 that includes the bushing 118 is inserted through the longitudinal slot 182 of the barrel 124 until the proximal end 178 of the second inclined 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 fixture 102 towards the closed configuration. Once in the closed configuration, continued proximal movement of the control member 120 causes the housing 108 to move proximally relative to the barrel 124 until the connecting element at the proximal end 114 of the housing 108 moves proximally along the first inclined portion 166, as Figure 5 shown.
[0055] In another embodiment, the shoulder 184 may be positioned such that the user directly engages the connecting element 116 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 hooks 152 of each of the connecting elements 116 slide proximally along the outer surface 172 of the first inclined portion 166, thereby elastically deforming to accommodate the first inclined portion 166 until the hooks 152 move proximally through the lip 174, at which point the connecting element 116 returns to its initial configuration. In particular, the hooks 152 snap onto the first inclined portion 166, as Figure 6 shown, thereby forming a preliminary engagement of the hooks 152 with the engagement lip 174, as Figure 6 shown, where the tip 154 of the hook 152 engages the edge 176 of the lip 174.
[0056] The snapping of the hooks 152 onto the first inclined portion 166 provides tactile feedback to the user, such that the user is aware that the cartridge 108 and the bushing 118 have formed a preliminary engagement. The user can then pull the entire applicator 104 proximally relative to the barrel 124, such that the cartridge 108 is also pulled proximally through the longitudinal slot 182 of the barrel 124 until the proximal portion 150 of the connecting element 116 engages the crimp feature 146. In particular, the hooks 152 of the distal portion slide proximally along the inclined surface 186, as Figure 7 shown, such that the crimp feature 146 provides both a radially inward force and a distal force to the hooks 152, thereby crimping the hooks 152 onto the lip 174 of the first inclined portion 166, as Figure 8 shown.
[0057] For example, the tip 154 of the hook 152 may be received within a space defined between the outer surface of the neck portion 170 and the inner surface of the inclined portion 166. The remainder of the proximal portion 150 of the connecting element 116 presses against the outer surface of the lip 174, thereby forming a crimp connection that bears the load of the opening and closing of 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 (as Figure 9 shown) moves the bushing 118 and the cartridge 108 proximally through the crimp feature 146, such that the assembled clamp 102 and applicator 104 can be removed from the barrel 124.
[0058] In use, after the clip 102 has been loaded onto the applicator 104, the clip 102 in the closed configuration is inserted through a working channel of, for example, an endoscope into a position adjacent to the target tissue within the body. Once the clip 102 has reached the target tissue, the clip 102 is moved towards the open configuration to receive the target tissue between the distal ends 112 of the clip arms 106. As needed, the clip 102 can be moved between the open and closed configurations until the target tissue has been clamped between the clip arms 106. Once the clip 102 is in the closed configuration clamping 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 housing 108 until the locking features of the clip arms 106 engage corresponding locking structures of the housing 108, thereby locking the clip arms 106 relative to the housing 108 in the closed configuration.
[0059] To release the clip 102 from the applicator 104, the control member 120 is pulled further proximally until the housing 108 is pulled proximally against the bushing 118 and the compressive load on the connecting element 116 exceeds a predetermined threshold, thereby forcing the connecting element 116 (specifically, the hook 152) to disengage from the lip 174 and slide proximally along the second inclined portion 168. The sliding of the hook 152 along the second inclined portion 168 plastically deforms the connecting tabs 116 such that they remain in a more radially outward position further away from the longitudinal axis of the housing 108 and do not engage the bushing 118. The bushing 118 can be withdrawn proximally between the connecting elements 116, thereby leaving the clip 102 in place clamping the target tissue.
[0060] The user continues to apply a proximal force on the control member 120 until the bracket 126 breaks, fails, or otherwise separates at point 132, releasing the clip arms 106 from the control member 120 and thereby releasing the clip 102, and locking the clip 102 closed on the target tissue. Then, the entire applicator 104 (including the proximal portion 128 of the control member 120 and the bracket 126) can be withdrawn proximally from the body, thereby leaving the clip 102 clamped on the target tissue. If desired, a new clip 102 can be loaded onto the applicator 104 in the same manner as described above, such that the system 100 can then be used to clamp a second portion of tissue. Using the same applicator 104, this process can be repeated as needed or desired multiple times.
[0061] Although the connecting element 116 is described and shown as extending proximally from the housing 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 a bushing of the applicator to engage a corresponding portion of a housing of the clip. Alternatively, a coupler including a crimpable connecting element can be attached to the housing or the bushing to crimp onto a corresponding portion of the other of the housing or the bushing.
[0062] 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 thereof.
Claims
1. A reloadable clamping system for treating tissue, the reloadable clamping system comprising: a clamp including 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 housing to move the housing between an open configuration and a closed configuration, the proximal end of the housing including a plurality of connecting elements extending proximally therefrom, each of the connecting elements including a hook along its proximal portion; and an applicator including an elongate flexible member and a control member extending therethrough, the control member including a distal end configured to connect to the clamp arms to move the clamp assembly between the open configuration and the closed configuration, the distal end of the elongate flexible member including a bushing, the bushing including a first tapered portion and a necked portion, the first tapered portion tapering to the distal end of the bushing, the necked portion extending proximally from the first tapered portion, the proximal end of the first tapered portion including a lip defined by a recess extending between an inner surface of the first tapered portion and an outer surface of the necked portion, the lip configured to engage the hook when the connecting element is crimped thereon, the bushing further including a second inclined surface configured such that when the clamp is deployed, the hook slides along the second inclined surface such that the connecting element plastically deforms without breaking to release the bushing from the housing.
2. The system according to claim 1, wherein the connecting element is formed of a metallic material configured to allow elastic deformation thereof during loading of the clamp, wherein the connecting element slides proximally along an outer surface of the first tapered portion; and to allow plastic deformation of the connecting element when a compressive force applied to the connecting element exceeds a predetermined threshold such that the connecting element slides proximally along a second tapered portion of the bushing toward a deployed configuration, the bushing being releasable therefrom in the deployed configuration.
3. The system according to claim 1 or 2, further comprising a barrel including a space and a longitudinal slot extending proximally from the space, the space sized and shaped to receive the clamp therein in the open configuration therein, the longitudinal slot sized and shaped to receive a distal portion of the applicator therein.
4. The system according to claim 3, wherein the longitudinal slot includes a crimping feature configured to engage a distal portion of the connecting element when the connecting element moves proximally therethrough such that the hook of the connecting element crimps the hook onto the lip of the first tapered portion.
5. The system according to claim 4, wherein the crimping feature includes an inclined surface tapering toward a distal end such that the inclined surface applies a radially inward force and a distal force to the hook such that a tip of the hook is received within a chamber defining the lip.
6. The system according to claim 3, wherein the longitudinal slot includes a stop along a portion thereof, the stop being configured to engage a portion of the bushing to prevent the bushing from moving distally beyond the stop.
7. The system according to claim 1 or 2, wherein the first and second inclined portions define a generally conical portion of the bushing, and the neck portion extends along a cylindrical portion of the bushing.
8. The system according to claim 1 or 2, wherein the hook extends generally in a J shape such that the tip of the hook extends in a distal direction.
9. A reloadable fixture device comprising: a fixture including a pair of fixture arms, each of the fixture arms extending from a proximal end to a distal end, the proximal ends of the fixture arms being slidably received within a channel of a housing to move the housing between an open configuration and a closed configuration, the proximal end of the housing including a plurality of connection elements extending proximally therefrom, each of the connection elements including a hook along its proximal portion to engage a corresponding portion of a bushing, wherein when the fixture is deployed, the connection elements are configured to engage an inclined surface of the bushing such that the connection elements plastically deform without breaking to release the bushing from the housing; and a barrel including a space and a longitudinal slot extending proximally from the space, the space being sized and shaped to receive the fixture therein in the open configuration, the longitudinal slot being sized and shaped to receive a distal portion of an applicator to be coupled to the fixture therein.
10. The device according to claim 9, wherein the connection element is formed of a metallic material configured to permit elastic deformation thereof during coupling of the housing to a portion of the applicator, and to permit plastic deformation thereof when a force applied thereto exceeds a predetermined threshold.
11. The device according to claim 9 or 10, wherein the longitudinal slot includes a crimping feature configured to engage the distal portion of the connection element as the connection element moves proximally therethrough such that the hook of the connection element crimps the hook onto a corresponding portion of the applicator receivable therebetween.
12. The device according to claim 11, wherein the crimping feature includes an inclined surface tapering toward a distal end such that the inclined surface applies both a radially inward force and a distal force to the hook.
13. The device according to claim 9 or 10, wherein the longitudinal slot includes a stop along a portion thereof, the stop being configured to engage a portion of the applicator receivable therein.
14. The device according to claim 9 or 10, wherein the hook extends generally in a J shape such that the tip of the hook extends in a distal direction.
Citation Information
Patent Citations
Compressive coupler for reloadable hemostasis clipping device
US20180153552A1