US-20260123951-A1 - DEVICES, SYSTEMS, AND METHODS FOR SEPARATING TISSUE

US20260123951A1US 20260123951 A1US20260123951 A1US 20260123951A1US-20260123951-A1

Abstract

Devices, systems, and methods for separating tissue using blunt tissue-separators. The blunt tissue separators may include two or more elongated elements with distal ends adjacent each other when inserted into tissue to be separated. The distal ends are moved apart to separate the tissue, such as by snapping the tissue without cutting the tissue. The distal ends of the tissue separators may be moved proximally in addition to laterally to pull apart tissue as well as to further advance the device into tissue.

Inventors

Alexander R. Cohen
Ryan Davis Gilkey

Assignees

BOSTON SCIENTIFIC SCIMED, INC.

Dates

Publication Date: 20260507
Application Date: 20251015

Claims (20)

1 . A device for separating tissue, said device comprising:
2 . an elongate member having a proximal end and a distal end;
3 . a first tissue-separating member having a proximal end operably coupled with the distal end of said elongate member, and a distal end extending distally from the elongate member;
4 . a second tissue-separating member having a proximal end operably coupled with the distal end of said elongate member, and a distal end extending distally from the elongate member;
5 . a first tissue-separator actuator having a distal end operably coupled with the distal end of said first tissue-separating member; and
6 . a second tissue-separator actuator having a distal end operably coupled with the distal end of said first tissue-separating member;
7 . wherein said first tissue-separator actuator and said second tissue-separator actuator are shiftable to shift said first tissue-separating member and said second tissue-separating member between a first configuration, in which the distal ends of said first tissue-separating member and said second tissue-separating member are adjacent each other, and a second configuration, in which the distal ends of said first tissue-separating member and said second tissue-separating member are spaced apart from each other.
8 . The device of claim 1 , wherein when said first tissue-separating member and said second tissue-separating member are in the first configuration, the distal ends of said first tissue-separating member and said second tissue-separating member are at a first axial distance from the proximal ends of said first tissue-separating member and said second tissue-separating member, and when said first tissue-separating member and said second tissue-separating member are in the second configuration, the distal ends of said first actuator and said second actuator are at a second axial distance from the proximal ends of said first tissue-separating member and said second tissue-separating member, the second axial distance being less than the first axial distance.
9 . The device of claim 1 , wherein said first tissue-separator actuator and said second tissue-separator actuator are shiftable to shift the distal ends of said first tissue-separating member and said second tissue-separating member from the first configuration adjacent each other and at a first axial distance from the proximal ends of said first tissue-separating member and said second tissue-separating member to a configuration in which the distal ends of said first tissue-separator actuator and said second tissue-separator actuator are at a second axial distance from the proximal ends of said first tissue-separating member and said second tissue-separating member, the second axial distance being less than the first axial distance.
10 . The device of claim 1 , wherein said first tissue-separating member and said second tissue-separating member bend away from each other when shifting from the first position to the second position.
11 . The device of claim 1 , wherein shifting of said first tissue-separating member and said second tissue-separating member to the second configuration moves tissue contacted by said first tissue-separating member and said second tissue-separating member apart as well as proximally.
12 . The device of claim 1 , further comprising a control handle and an actuator extending from a proximal end operably associated with said control handle distally to a distal end operably coupled with said first tissue-separator actuator and said second tissue-separator actuator to axially shift said first tissue-separator actuator and said second tissue-separator actuator to shift said first tissue-separating member and said second tissue-separating member between the first configuration and the second configuration.
13 . The device of claim 1 , wherein:
14 . in the first configuration, said first tissue-separating member is adjacent said first tissue-separator actuator and said second tissue-separating member is adjacent said second tissue-separator actuator; and
15 . in the second configuration, said first tissue-separating member is spaced apart from said first tissue-separator actuator and said second tissue-separating member is spaced apart from said second tissue separator actuator.
16 . The device of claim 1 , wherein said first tissue-separating member comprises a pair of tissue-separating members, and said second tissue-separating member comprises a pair of tissue-separating members.
17 . The device of claim 1 , wherein said first tissue-separating member and said second tissue-separating member are formed from shape memory materials.
18 . A device for separating tissue, said device comprising.
19 . a first tissue separator having a proximal end and a distal end and comprising a flexible portion and an actuator portion extending between the proximal end and the distal end; and
20 . a second tissue separator having a proximal end and a distal end and comprising a flexible portion and an actuator portion extending between the proximal end and the distal end;

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 63/709,196, filed Oct. 18, 2025, the entire disclosure of which is hereby incorporated by reference herein for all purposes. FIELD The present disclosure relates generally to the field of medical devices, systems, and methods for separating tissue. More particularly, the present disclosure relates to medical devices, systems, and methods using a blunt device with a pair of separators configured to mechanically separate or dissect tissue, such as tissue which is readily separable without a sharp cutting instrument. BACKGROUND Various devices, assemblies, systems, methods, techniques, etc., exist for cutting, dissecting, resecting, excising, etc., anatomical structures (e.g., biological tissue, including lesions, etc.). The configurations of the cutting device (which may include a blade, needle, laser, or other structure capable of cutting anatomical structures) may be selected based on the particular procedure to be performed. The procedures may be performed using open surgery (accessing the interior of a patient's body by cutting open the body) or minimally invasive surgery (e.g., percutaneously, laparoscopically, endoscopically, etc.). One endoscopic procedure is third space endoscopy (also known as submucosal endoscopy), which may access deeper layers of tissue within the body (e.g., the gastrointestinal (GI) tract) by tunneling into the tissue, such as between structurally differentiated layers of tissue. For instance, in the GI system, tunneling may be performed in the submucosal space with an endoscope, without compromising the integrity of the overlying mucosa. Typically, a fluid (e.g., water, saline, air, etc.) is injected at the treatment site to elevate/lift the tissue (to create a “bleb”) to facilitate cutting of the tissue, such as with a knife. For instance, a lifting agent may be injected into the submucosal layer to separate the mucosal layer from the muscularis layer. A sharp cutting instrument such as a blade, a knife, an electrosurgical knife, etc., may then be used to cut through the submucosa. Typically, the cutting instrument is used to make multiple small cuts, typically sequentially, to create a desired separation of tissue gradually, such as to reduce the risk of creating too large a cut in the tissue. Safer and more efficient devices, systems, methods, etc., such as using blunt instruments, would be welcome in the field. SUMMARY This Summary is provided to introduce, in simplified form, a selection of concepts described in further detail below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. One of skill in the art will understand that each of the various aspects and features of the present disclosure may advantageously be used separately in some instances, or in combination with other aspects and features of the disclosure in other instances, whether or not described in this Summary. 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. In accordance with various principles of the present disclosure, a device for separating tissue includes a first tissue separating member and a second tissue separating member which move apart from each other to separate tissue. In some aspects, the tissue separating members each have a blunt distal end so that the device may be considered a blunt tissue separator. In some aspects, the tissue separating members are configured to have an increased range of motion relative to tissue separating members of prior devices. In some aspects, the tissue separating members achiever a greater amount of tissue separation than prior devices, such as by the unique movements of the tissue separating members. In some aspects, the device for separating tissue includes an elongate member having a proximal end and a distal end; a first tissue-separating member having a proximal end operably coupled with the distal end of the elongate member, and a distal end extending distally from the elongate member; a second tissue-separating member having a proximal end operably coupled with the distal end of the elongate member, and a distal end extending distally from the elongate member; a first tissue-separator actuator having a distal end operably coupled with the distal end of the first tissue-separating member; and a second tissue-separator actuator having a distal end operably coupled with the distal end of the first tissue-separating member. In some aspects, the first tissue-separator actuator and the second tissue-separator actuator are shiftable to shift the first tissue-separating member and the second tissue-separating member between