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EP-4739225-A1 - OVER THE SCOPE BIFURCATION ASSEMBLY WITH CLIP RELEASE MECHANISM

EP4739225A1EP 4739225 A1EP4739225 A1EP 4739225A1EP-4739225-A1

Abstract

A system includes a cap, a clip having jaws movable between open and closed configurations, a tubing system, and a control assembly. The cap includes proximal and distal portions. The tubing system includes a proximal structure and distal structures. A proximal end of each of the structures is connected to a distal end of the structure via a bifurcation such that the structures are in communication with the structure. The distal end of each of the structures is connected to the cap. The assembly includes wires extending through the structure and a corresponding one of the structures to be releasably coupled to the clip, and overtubes received within the structures to extend over a portion of the wires. The wires and the overtubes longitudinally move relative to the cap to move the clip between insertion, closed and review configurations.

Inventors

  • JOHNSON, Austin, Grant
  • SINGH, RAJIVKUMAR
  • HARRIS, Colby
  • LEWITZKY, Jennifer

Assignees

  • Boston Scientific Medical Device Limited
  • Boston Scientific Scimed, Inc.

Dates

Publication Date
20260513
Application Date
20241127

Claims (15)

  1. 1. A clipping system for treating tissue, comprising: an end cap including a proximal portion configured to be coupled to a distal end of an insertion device and a distal portion extending distally from the proximal portion; a clip including first and second jaws movable relative to one another between an open configuration, in which the first and second jaws are separated from one another, and a biased closed configuration, in which the first and second jaws are moved toward one another, the clip configured to be mounted over the distal portion of the end cap in the open configuration; a bifurcated tubing system including a single proximal tubular structure extending from a proximal end to a distal end and a pair of distal tubular structures, each of which extends from a proximal end to a distal end, the proximal end of each of the distal tubular structures connected to the distal end of the single proximal tubular structure via a bifurcation such that the pair of distal tubular structures are in communication with the single proximal tubular structure, the distal end of the each of the distal tubular structures connected to the end cap; and a control assembly including a pair of control wires, each of which extends through the single proximal tubular structure and a corresponding one of the distal tubular structures to be releasably coupled to the clip, and a pair of overtubes received within the distal tubular structures to extend over a portion of the control wires received therein, the control wires and the overtubes configured to interface with one another and be longitudinally movable relative to the end cap to move the clip between an insertion configuration, in which the clip is mounted over the end cap in the open configuration, the closed configuration, in which the clip is moved distally off of the end cap to grip tissue therebetween, and a review configuration, in which the clip is physically separated from the end cap to enhance visual observation of the clip.
  2. 2. The system of claim 1, wherein the proximal portion of the end cap includes a pair of longitudinally extending grooves aligned with the distal tubular structures, a spacer received within each of the grooves and held thereagainst via an O-ring.
  3. 3. The system of claim 2, wherein the spacers are movable relative to the end cap from a first position, in which the overtubes is slidably receivable between the grooves and the spacers, and a second position, in which the O-ring compresses the spacer radially inward upon movement of the overtubes distally therepast so that openings formed between the spacers and the grooves are sized, shaped and configured to prevent proximal receipt of the overtubes therein.
  4. 4. The system of claim 3, wherein each of the overtubes include a first stop configured to engage a distal end of a corresponding one of the spacers when the corresponding one of the spacers is in the second position and a second stop configured to interface with a portion of the corresponding one of the control wires.
  5. 5. The system of claim 4, wherein each of the control wires includes a pusher element protruding from the control wire, the control wire received within the corresponding overtube so that the pusher element is positioned proximally of the second stop so that the pusher element engages the stop as the control wire is moved distally relative to the end cap to correspondingly move the overtube distally relative to the end cap.
  6. 6. The system of claim 4, wherein each of the control wires includes a protruding element along a portion of the control wire, and the control wire is received within the corresponding overtube so that the protruding element is positioned distally of the second stop to prevent the corresponding overtube from slipping thereof of subsequent to a deployment of the clip.
  7. 7. The system of claim 5, wherein one of the pusher element and the protruding element is configured as a hypotube crimped over a portion of the control wire.
  8. 8. The system of any of claims 1-7, wherein each of the control wires is releasably coupled to a corresponding one of the first and second jaws of the clip via an enlarged distal end received within a yoke of the corresponding one of the first and second jaws, and the enlarged distal end is connected to a remaining length thereof via a joint configured to separate the enlarged distal end from the remaining length when subject to a force exceeding a predetermined threshold value.
  9. 9. The system of claim 8, wherein each of the enlarged distal ends has a cross-sectional area that is larger than a cross-sectional area of an opening through which it enters the yoke of the corresponding jaw.
  10. 10. A clipping system for treating tissue, comprising: an end cap including a proximal portion couped to a distal end of an endoscope and a distal portion extending distally from the proximal portion; a clip mounted over the distal portion of the end cap so that first and second jaws of the clip are separated from one another toward an open configuration, the clip biased toward a closed configuration, in which the first and second jaws are moved toward one another; a bifurcated tubing system including a single proximal tubular structure and a pair of distal tubular structures, the single proximal tubular structure extends along a majority of a length of the endoscope from a proximal end connected to a user interface at a proximal end of an insertion device to a distal end, proximal ends of the distal tubular structures connected to the distal end of the single proximal tubular structure via a bifurcation such that the distal tubular structures are in communication with the single proximal tubular structure and distal ends of the distal tubular structures connected to the end cap; and a control assembly including a pair of control wires and a pair of overtubes, the control wires extending through the single proximal tubular structure and the distal tubular structures so that distal ends of the control wires extend distally past the distal ends of the distal tubular structures to be releasably coupled to the clip, the overtubes received within the distal tubular structures to extend over portions of the control wires received therein, the control wires and the overtubes interfacing with one another and movable relative to the insertion device to move the clip relative to the end cap between an insertion configuration, in which the clip is mounted over the end cap, the closed configuration, in which the clip is slid off of the end cap to grip tissue between the first and second jaws thereof, and a review configuration, in which the clip is physically separated from the end cap to enhance visual observation of the clip.
  11. 11. The system of claim 10, wherein the proximal portion of the end cap includes a pair of longitudinally extending grooves aligned with the distal tubular structures, spacers received within the grooves and held thereagainst via O-rings which moves the spacers from a first position, in which the overtubes are slidably receivable between the grooves and the spacers, and a second position, in which the O-rings compress the spacers radially inward upon movement of the overtubes distally therepast so that openings formed between the spacers and the grooves are sized, shaped and configured to prevent proximal receipt of the overtubes therein.
  12. 12. The system of claim 11, wherein each of the overtubes includes a first stop configured to engage a distal end of a corresponding one of the spacers when the corresponding one of the spacers is in the second position and a second stop configured to interface with a portion of the corresponding one of the control wires.
  13. 13. The system of claim 12, wherein each of the control wires includes a pusher element protruding from the control wire, the control wire received within the corresponding overtube so that the pusher element is positioned proximally of the second stop so that the pusher element engages the stop as the control wire is moved distally relative to the end cap to correspondingly move the overtube distally relative to the end cap.
  14. 14. The system of claim 13, further comprising: a user interface including a handle shaft connected to a proximal end of the insertion device and a slider slidably mounted over the handle shaft and connected to proximal end of the control wires so that a longitudinal movement of the slider relative to the handle shaft correspondingly moves the control wires relative to the endoscope.
  15. 15. The system of claim 14, wherein the user interface further includes a lock movable between the first position, in which the slider is prevented from being moved further distally relative to the handle shaft to prevent movement of the clip from the review configuration toward a deployed configuration, and the second position, in which the slider is distally movable relative to the handle shaft to initiate the deployed configuration in which the overtube is moved distally past the spacer.

Description

OVER THE SCOPE BIFURCATION ASSEMBLY WITH CLIP RELEASE MECHANISM Inventors: Austin Grant JOHNSON, Rajivkumar SINGH, Colby HARRIS, and Jennifer LEWITZKY Priority Claim [0001] The present disclosure claims priority to U.S. Provisional Patent Application Serial No. 63/612,158 filed December 19, 2023; the disclosure of which is incorporated herewith by reference. Field [0002] The present disclosure relates to endoscopic devices and, in particular, relates to endoscopic clipping devices for treating tissue along the gastrointestinal tract. Background [0003] Physicians have become more willing to perform aggressive interventional and therapeutic endoscopic gastrointestinal (GI) procedures, which may increase the risk of perforating the wall of the GI tract or may require closure of the GI tract wall as part of the procedure. Such procedures may include, for example, the removal of large lesions, tunneling under the mucosal layer of the GI tract to treat issues below the mucosa, full thickness removal of tissue, treatment of issues on other organs by passing outside of the GI tract, and endoscopic treatment/repair of post-surgical issues (e.g., post-surgical leaks, breakdown of surgical staple lines, and anastomotic leaks). [0004] Currently, tissue may be treated via endoscopic closure devices including through-the scope clips or over-the-scope clips. Over-the-scope clips may be particularly useful for achieving closure of larger tissue defects. These endoscopic closure devices can save costs for the hospital and may provide benefits for the patient. In some cases, however, current endoscopic closure devices may be difficult to use, time consuming to position, or insufficient for certain perforations, conditions and anatomies. For example, current over-the-scope clips generally require launching of the clip from a position in which the clip itself is not visible to the operator. That is, prior to clipping the operator may view the target tissue to be clipped and, based on this visualization of the target tissue may determine that the distal end of the device and the clip are in a desired position relative to the target tissue. Based on the observation of the target tissue, the operator then deploys the clip without being able to see the clip itself until it is deployed. Once deployed, such current over-the scope clips are generally incapable of being repositioned. Summary [0005] The present disclosure relates to a clipping system for treating tissue. The clipping system includes an end cap including a proximal portion configured to be coupled to a distal end of an insertion device and a distal portion extending distally from the proximal portion. The clipping system also includes a clip including first and second jaws movable relative to one another between an open configuration, in which the first and second jaws are separated from one another, and a biased closed configuration, in which the first and second jaws are moved toward one another, the clip configured to be mounted over the distal portion of the end cap in the open configuration. [0006] In addition, the clipping system includes a bifurcated tubing system including a single proximal tubular structure extending from a proximal end to a distal end and a pair of distal tubular structures, each of which extends from a proximal end to a distal end, the proximal end of each of the distal tubular structures connected to the distal end of the single proximal tubular structure via a bifurcation such that the pair of distal tubular structures are in communication with the single proximal tubular structure, the distal end of the each of the distal tubular structures connected to the end cap. Furthermore, a control assembly including a pair of control wires, each of which extends through the single proximal tubular structure and a corresponding one of the distal tubular structures to be releasably coupled to the clip, and a pair of overtubes received within the distal tubular structures to extend over a portion of the control wires received therein, the control wires and the overtubes configured to interface with one another and be longitudinally movable relative to the end cap to move the clip between an insertion configuration, in which the clip is mounted over the end cap in the open configuration, the closed configuration, in which the clip is moved distally off of the end cap to grip tissue therebetween, and a review configuration, in which the clip is physically separated from the end cap to enhance visual observation of the clip. [0007] In an embodiment, the proximal portion of the end cap includes a pair of longitudinally extending grooves aligned with the distal tubular structures, a spacer received within each of the grooves and held thereagainst via an O-ring. [0008] In an embodiment, the spacers are movable relative to the end cap from a first position, in which the overtubes is slidably receivable between the grooves and the spacers, and a second po