US-20260123933-A1 - GRAPPLING SYSTEMS AND METHODS FOR LUMEN APPOSITION OR WOUND DEFECTS

Abstract

A tissue-manipulating system including a tissue-manipulating device having shaft and a tissue grasper assembly. The tissue grasper assembly has at least one grasper arm resiliently expandable from a closed configuration, within and extending along the longitudinal axis of a shaft, to an open configuration outside the shaft with the grasper arm expanded in a direction transverse to the longitudinal axis of the shaft. In the open configuration, the at least one grasper arm may be engaged with tissue wall to manipulate or move the tissue wall, such as to move a distal tissue wall closer to a proximal tissue wall. The tissue grasper assembly may be deployable (such as by being separated from the shaft), such as to remain in place holding two tissue walls in apposition.

Inventors

• Andrew PIC
• Joseph W. King
• Gonzalo Jose SAENZ VILLALOBOS
• Deborah Amaya Pineda

Assignees

• BOSTON SCIENTIFIC SCIMED, INC.

Dates

Publication Date

20260507

Application Date

20251230

Claims (20)

1. 1 . A tissue manipulating device comprising: a shaft extending along a longitudinal axis and having a proximal end and a distal end; at least one grasper arm movable between a closed configuration and an open configuration; a grasper surface associated with said at least one grasper arm and configured to engage body tissue; and at least one tissue grasping feature associated with said at least one grasper arm and positioned along said grasper surface and configured to engage body tissue; wherein: in the closed configuration, said at least one grasper arm is held within a lumen of said shaft to present an atraumatic surface to body tissue; and in the open configuration, said at least one grasper arm extends away from said longitudinal axis such that said grasper surface is positioned to engage body tissue.
2. 2 . The tissue manipulating device of claim 1 , wherein said at least one grasper arm comprises a single grasper arm.
3. 3 . The tissue manipulating device of claim 2 , wherein said at least one tissue grasping feature comprises a plurality of tissue grasping features distributed along said grasper surface of said single grasper arm.
4. 4 . The tissue manipulating device of claim 1 , wherein said at least one grasper arm comprises one to four grasper arms.
5. 5 . The tissue manipulating device of claim 1 , wherein said atraumatic surface is convex, concave, or substantially flat.
6. 6 . The tissue manipulating device of claim 1 , wherein said at least one tissue grasping feature comprises a protrusion extending from said grasper surface.
7. 7 . The tissue manipulating device of claim 1 , wherein said at least one grasper arm comprises a plurality of tissue grasping features positioned along said grasper surface.
8. 8 . The tissue manipulating device of claim 1 , further comprising a capsule at said distal end of said shaft, wherein said at least one grasper arm is coupled to said capsule.
9. 9 . The tissue manipulating device of claim 1 , further comprising a sharpened element at said distal end of said shaft, said sharpened element configured to puncture tissue.
10. 10 . The tissue manipulating device of claim 1 , further comprising: a deploy collar positioned along said shaft; wherein: said at least one grasper arm comprises a wire extending through said deploy collar; and said deploy collar comprises a retaining feature configured to retain said wire in said closed configuration.
11. 11 . A tissue manipulating device comprising: a shaft extending along a longitudinal axis and having a proximal end and a distal end; a diverting feature at said distal end of said shaft; at least one exit opening formed in said shaft adjacent to said diverting feature; at least one grasper arm held along said shaft in a closed configuration; and a grasper surface associated with said at least one grasper arm and configured to engage body tissue; wherein: said at least one grasper arm is resiliently biased such that upon deployment from said shaft said at least one grasper arm encounters said diverting feature and is deflected transversely to said longitudinal axis to exit through said at least one exit opening into an open configuration; and in said open configuration, said grasper surface is positioned to engage body tissue.
12. 12 . The tissue manipulating device of claim 11 , wherein said at least one grasper arm comprises a single elongated grasper arm carrying a plurality of tissue grasping features.
13. 13 . The tissue manipulating device of claim 11 , wherein said at least one exit opening comprises a plurality of exit openings arranged circumferentially around said shaft.
14. 14 . The tissue manipulating device of claim 11 , wherein said at least one grasper arm is substantially straight when undeflected and forms a substantially T-shaped configuration relative to said longitudinal axis when deflected by said diverting feature.
15. 15 . The tissue manipulating device of claim 11 , wherein said at least one exit opening is formed on a lateral surface of said shaft.
16. 16 . The tissue manipulating device of claim 11 , wherein said diverting feature comprises a wall positioned to obstruct longitudinal movement of said at least one grasper arm.
17. 17 . A system for manipulating tissue comprising: an elongate delivery member having a working channel extending therethrough; and a tissue manipulating device advanceable through said working channel, said tissue manipulating device comprising: a shaft extending along a longitudinal axis; and a tissue grasper assembly deployable from said shaft, said tissue grasper assembly comprising at least one grasper arm movable between a closed configuration and an open configuration; wherein said at least one grasper arm comprises a grasper surface configured to engage tissue in said open configuration.
18. 18 . The system of claim 17 , wherein said elongate delivery member comprises an endoscope.
19. 19 . The system of claim 17 , wherein said tissue grasper assembly comprises: an inner shaft carrying a distal tissue retaining feature; and an outer shaft coaxial with said inner shaft and carrying a proximal tissue retaining feature; wherein said distal tissue retaining feature and said proximal tissue retaining feature are independently movable to grasp tissue therebetween.
20. 20 . The system of claim 17 , wherein said tissue grasper assembly further comprises: a deploy collar positioned along said shaft, said deploy collar comprising a retaining wall with a through-hole; and wherein: said at least one grasper arm comprises a wire passing through said through-hole; and said through-hole is configured to retain said wire in said closed configuration.

Description

PRIORITY This application is a continuation of and claims the benefit of the earlier filing date of United States Patent Application No. 18/394,043, filed December 22, 2023, which is a continuation of United States Patent Application No. 17/404,483, filed August 17, 2021, which claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Application Serial No. 63/073,192, filed September 1, 2020, and all of which applications are incorporated herein by reference in their entireties for all purposes. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 C.F.R. § 1.57. FIELD The present disclosure relates generally to apparatus and methods for manipulating a tissue wall and/or approximating tissue walls and/or maintaining tissue walls in apposition. BACKGROUND Tissue approximation is useful in many medical procedures for a variety of purposes. A number of medical procedures require a tissue wall (e.g., a body lumen wall or the wall of an organ) to be moved to a desired position, such as relative to another tissue wall to form an anastomosis between adjacent body lumens or to repair a body tissue. Challenges occur when moving a lumen towards another lumen and to anchor the two in place Improved tools, devices, systems, and methods for manipulating and moving body organs, tissues, lumens, and the like would thus be welcome in the medical field. SUMMARY This summary of the disclosure is given to aid understanding, and one of skill in the art will understand that each of the various aspects and features of the disclosure may advantageously be used separately in some instances, or in combination with other aspects and features of the disclosure in other instances. No limitation as to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, or the like in this summary. The present disclosure is directed to a tissue-manipulating device and system capable of manipulating, grappling, grasping, approximating, drawing, pulling, holding, etc., (such terms being used interchangeably herein without intent to limit) tissue walls. Optionally, the device and system may be used to hold the tissue together in apposition. It is desirable to provide improved protocols and access and tissue-grasping / tissue-grappling tools, devices, and systems for drawing tissues together, such as for forming an anastomosis or repairing tissue. It is further desirable to provide protocols, tools, devices, and systems facilitating quicker methods for forming anastomoses. It is further desirable to provide protocols, tools, devices, and systems for holding tissue in apposition (such as while also minimizing any risk of leakage between the tissues). In one aspect, the present disclosure relates to a tissue manipulating device comprising a shaft having a longitudinal axis, a tissue grasper assembly, and a controller. In some embodiments, the tissue grasper assembly comprises one or more resilient grasper arms expandable between a closed configuration extending within and along the longitudinal axis of the shaft, and an open configuration outside the shaft with the one or more grasper arms extending transversely away from the longitudinal axis of the shaft. In some embodiments, a grasper surface, is associated with at least one of the grasper arms, and is shaped and configured to engage a body tissue. In some embodiments, when the at least one grasper arm is in an open configuration and the grasper surface contacts a body tissue and the tissue-manipulating device is moved proximally, the tissue-manipulating device moves the body tissue proximally as well. In some embodiments, the controller is coupled to the tissue grasper assembly via a controller coupling and configured to move the grasper arms between the closed configuration and the open configuration. In some embodiments, the grasper arms are resiliently biased in an open configuration in a radially outward direction away from the shaft when positioned outside the shaft. In some embodiments, the grasper arms are resiliently held in an open configuration by a diverting feature formed on a distal end of the shaft. In some embodiments, the tissue grasper assembly is separable from the shaft and the controller to remain deployed grasping body tissue. In some additional embodiment, the tissue grasper assembly comprises a locking feature engageable to hold the at least one grasper arm engaging tissue when the tissue grasper assembly is separated from the shaft and the controller. In some additional or alternative embodiments, the tissue-manipulating device further comprises a controller coupling coupled between the grasper arms and the controller, and movable upon actuation of the controller to move the at least one grasper arm between the closed configuration and the open configuration, the controller being separable from the controller coupl