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EP-4739228-A1 - DEVICES, SYSTEMS, AND METHODS FOR TUNNELING BETWEEN TISSUE LAYERS

EP4739228A1EP 4739228 A1EP4739228 A1EP 4739228A1EP-4739228-A1

Abstract

An assembly and/or system having a cutting device configured to cut tissue, and an inflatable device configured for insertion into the cut tissue to further separate the cut tissue. The inflatable device may be wedge shaped to separate the cut tissue upon insertion into the cut. The inflatable device is inflatable and otherwise adjustable to separate the tissue to a medically indicated extent. For instance, the inflatable device may be moved axially with respect to the cutting device; and/or may be sheathed or unsheathed to adjust an exposed inflated length thereof; and/or may include two or more separately inflatable elements. The inflatable device thus may be used to achieve blunt tissue dissection after an initial cut is made into the tissue with a sharper instrument.

Inventors

  • Johnson, Austin Grant
  • WEITZNER, BARRY
  • JORDAN, GARY A.

Assignees

  • Boston Scientific Scimed, Inc.

Dates

Publication Date
20260513
Application Date
20240703

Claims (15)

  1. 1. A tissue tunneling system having a proximal end and a distal end, said tissue tunneling system comprising: a control handle at the proximal end of the tissue tunneling system; an elongate delivery member extending distally from said control handle; a cutting device operatively associated with said elongate delivery member for delivery at the distal end of said tissue tunneling system; and an inflatable device operatively associated with the distal end of said tissue tunneling system.
  2. 2. The tissue tunneling system of claim 1, wherein said inflatable device is operatively associated with the distal end of said tissue tunneling system to be delivered to a target site proximal to said cutting device.
  3. 3. The tissue tunneling system of any one of claims 1-2, wherein said inflatable device is axially movable with respect to said cutting device.
  4. 4. The tissue tunneling system of any one of claims 1-3, wherein said inflatable device is operatively associated with a tubular elongate member axially shiftable with respect to said elongate delivery member.
  5. 5. The tissue tunneling system of claim 4, wherein said tubular elongate member defines a lumen therethrough in fluid communication with said inflatable device to deliver an inflation medium to said inflatable device to selectively expand said inflatable device.
  6. 6. The tissue tunneling system of claim 4, wherein said tubular elongate member defines a lumen therethrough and said elongate delivery member is insertable and axially translatable through the lumen of said tubular elongate member to move said cutting device and said inflatable device with respect to each other.
  7. 7. The tissue tunneling system of any one of claims 1-6, wherein, in addition to being inflatable, the configuration of said inflatable device is adjustable.
  8. 8. The tissue tunneling system of any one of claims 1 -7, further comprising a sheath defining a lumen therethrough sized for said inflatable device to fit therein, said sheath advanceable and retractable with respect to said inflatable device to extend over or to unsheathe said inflatable device.
  9. 9. The tissue tunneling system of any one of claims 1-8, wherein said inflatable device comprises two or more inflatable elements.
  10. 10. The tissue tunneling system of any one of claims 1-9, wherein said control handle comprises a first lumen for injection of fluid through a lumen defined through said cutting device, and a second lumen for injection of inflation fluid into said inflatable device.
  11. 11. A tissue tunneling assembly comprising: a cutting device at a distal end of said tissue tunneling assembly; and an inflatable device positioned proximal to said cutting device.
  12. 12. The tissue tunneling assembly of claim 11, wherein said inflatable device is axially movable with respect to said cutting device.
  13. 13. The tissue tunneling assembly of any one of claims 1 1-12, further comprising a sheath with a lumen therethrough, wherein said sheath is axially movable with respect to said inflatable device and said inflatable device and the lumen are sized for the inflatable device to be selectively fully or partially sheathed within the lumen, partially extended and inflated outside the lumen, or fully extended and inflated outside the lumen.
  14. 14. The tissue tunneling assembly of an one of claims 11-13, wherein said inflatable device comprises two or more separate independently inflatable elements.
  15. 15. The tissue tunneling assembly of any one of claims 11-14, wherein said cutting device is an electrosurgical knife.

Description

DEVICES, SYSTEMS, AND METHODS FOR TUNNELING BETWEEN TISSUE LAYERS CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/525,221, filed July 6, 2023, the entire disclosure of which is hereby incorporated by reference herein for all purposes. FIELD [0002] The present disclosure relates generally to the field of medical devices for accessing spaces within anatomical structures. In particular, the present disclosure relates to medical devices, systems, and methods for cutting or tunneling in and/or between tissue layers of an anatomical structure. BACKGROUND [0003] 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, laparosopically, 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., saline) 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 cutting knife may then be used to cut through the submucosa. While tunneling, the medical scope (e.g., gastroscope) may have a tapered distal cap mounted over the distal end thereof to help pass the scope through the tissue at the target site. Blunt tissue dissection may be performed using a mechanical force to separate tissue layers. In some aspects, a scope cap may provide a form of blunt tissue dissection as the scope tapers through the tissue. However, cutting instruments, such as electro surgical knives, typically arc predominantly used to tunnel through tissue in third space endoscopic procedures. 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 tunneling devices, systems, methods, etc., would be welcome in the field. It is with respect to these and other considerations that the present improvements may be useful. SUMMARY [0004] 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 noninclusion of elements, components, or the like in this Summary. [0005] In accordance with various principles of the present disclosure, a tissue tunneling system includes a control handle at the proximal end thereof; an elongate delivery member extending distally from the control handle; a cutting device operatively associated with the elongate delivery member for delivery at the distal end of the tissue tunneling system; and an inflatable device operatively associated with the distal end of the tissue tunneling system. [0006] In some aspects, the inflatable device is operatively associated with the distal end of the tissue tunneling system to be delivered to a target site proximal to the cutting device. [0007] In some aspects, the inflatable device is axially movable with respect to the cutting device. [0008] In some aspects, the inflatable device is operatively associated with a tubular elongate member axially shiftable with respect to the elongate delivery member. In some aspects, the tubular elongate member defines a lumen therethrough in fluid communication with the inflatable device to deliver an inflation medium to the inflatable device to selectively expand the i