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EP-4739238-A1 - ADJUSTABLE NEEDLE ELECTRODES FOR MEDICAL PROCEDURES AND ASSOCIATED SYSTEMS AND METHODS

EP4739238A1EP 4739238 A1EP4739238 A1EP 4739238A1EP-4739238-A1

Abstract

Bipolar or monopolar adjustable energy-delivering assemblies. The assemblies are configured for transluminal (e.g., endoscopic) delivery within a patient. A first energy-delivering member defines a first electrode portion formed of an electrically-conductive material so that energy may be delivered to the first energy-delivering member to create an energy field along the first electrode portion to apply to a target site within a patient. The first energy-delivering member may define a lumen therethrough allowing delivery of materials distally therethrough to a target site and/or allows materials from the target site to be aspirated proximally therethrough. Optionally, a second energy-delivering member and a second insulation member form a second electrode portion. Optionally, either or both electrode portions may be adjustable. Additionally or alternatively, the first electrode portion and the second electrode portion are adjustable with respect to each other.

Inventors

  • SCOTT, Serena
  • OSTROOT, TIMOTHY A.
  • SABBAN, LAURA EMILY

Assignees

  • Boston Scientific Scimed, Inc.

Dates

Publication Date
20260513
Application Date
20240703

Claims (15)

  1. 1. An energy-delivering assembly comprising: a first energy-delivering member having a sharp distal tip configured to puncture tissue, and a lumen defined therethrough and having a distal opening adjacent the sharp distal tip for delivery of materials distally through the lumen and out the distal opening thereof and/or for aspiration of materials into the distal opening of the lumen and proximally through the lumen; and a first insulation member extending over said first energy-delivering member and having a distal end; wherein a first electrode portion of said energy-delivering assembly is defined along said first energy-delivering member between the sharp distal tip thereof and the distal end of said first insulation member.
  2. 2. The energy-delivering assembly of claim 1, wherein said first electrode portion is adjustable by moving said first insulation member with respect to said first energy-delivering member.
  3. 3. The energy-delivering assembly of any one of claims 1-2, wherein said first electrode portion and said first insulation member have substantially the same outer diameters.
  4. 4. The energy-delivering assembly of any one of claims 1-3, further comprising: a second energy-delivering member positioned over said first insulation member and having a distal end; and a second insulation member extending over said second energy-delivering member and having a distal end; wherein a second electrode portion of said energy-delivering assembly is defined along said second energy-delivering member between the distal end thereof and the distal end of said second insulation member.
  5. 5. The energy-delivering assembly of claim 4, wherein at least one of said first energydelivering member, said first insulation member, said second energy-delivering member, or said second insulation member is movable with respect to another of said first energy-delivering member, said first insulation member, said second energy-delivering member, or said second insulation member to adjust at least one of the first electrode portion or the second electrode portion.
  6. 6. The energy-delivering assembly of any one of claims 1-5, wherein said first insulation member is movable with respect to said first energy-delivering member to adjust the first electrode portion.
  7. 7. The energy-delivering assembly of any one of claims 4-6, wherein said second energydelivering member is movable with respect to said first insulation member.
  8. 8. The energy-delivering assembly of any one of claims 4-7, wherein said second insulation member is movable with respect to said second energy-delivering member.
  9. 9. The energy-delivering assembly of any one of claims 4-8, wherein said first energydelivering member and said first insulation member are fixed with respect to each other, and said second energy-delivering member and said second insulation member are fixed with respect to each other.
  10. 10. The energy-delivering assembly of any one of claims 4-11 , wherein said second energydelivering member is distally advanccablc to move the distal end thereof distal to the distal end of said first energy-delivering member to sheathe the sharp distal tip of said first energydelivering member.
  11. 11. The energy-delivering assembly of any one of claims 4-10, wherein said first electrode portion and said second electrode portion have substantially the same outer diameters.
  12. 12. The energy-delivering assembly of any one of claims 4-12, wherein a window is defined in said second insulation member to expose varying lengths of said second electrode portion, and the distal end of said second insulation member is movable over said first electrode portion to expose varying lengths of said first electrode portion.
  13. 13. An energy-delivering treatment system comprising: an energy-delivering assembly comprising: a first energy-delivering member having a sharp distal tip configured to puncture tissue, and a lumen defined therethrough and having a distal opening adjacent the sharp distal tip for delivery of materials distally through the lumen and out the distal opening thereof and/or for aspiration of materials into the distal opening of the lumen and proximally through the lumen; and a first insulation member extending over said first energy-delivering member and having a distal end; wherein a first electrode portion of said energy-delivering assembly is defined along said first energy-delivering member between the sharp distal tip thereof and the distal end of said first insulation member; and a handle, said energy-delivering assembly extending distally from said handle, wherein said handle: has a first control section operatively coupled with said first insulation member to adjust the position of said first insulation member with respect to said first energy-delivering member; and is configured to be operatively coupled with an energy source to supply energy to said first energy-delivering member.
  14. 14. The energy-delivering treatment system of claim 13, further comprising: a sheath extending distally from said handle, said first energy-delivering member and said first insulation member extending distally from said handle through said sheath; and a second control section operatively coupled with said first energy -delivering member to adjust a position thereof relative to said sheath.
  15. 15. The energy-delivering treatment system of any one of claims 13-14, further comprising: a second energy-delivering member positioned over said first insulation member and having a distal end; a second insulation member extending over said second energy-delivering member and having a distal end; and a third control section operatively coupled with said second insulation member to adjust a position thereof relative to said second energy-delivering member; wherein a second electrode portion of said energy-delivering assembly is defined along said second energy-delivering member between the distal end thereof and the distal end of said second insulation member.

Description

ADJUSTABLE NEEDLE ELECTRODES FOR MEDICAL PROCEDURES AND ASSOCIATED SYSTEMS AND METHODS CROSS-REFERENCE TO RELATED APPLIC TIONS [001] This application claims the benefit of priority to U.S. Provisional Application No. 63/524,999, filed July 5, 2023, the entire disclosure of which is hereby incorporated by reference herein for all purposes. FIELD [002] The present disclosure relates generally to the field of medical devices, assemblies, systems, and methods used in applying energy to a patient, such as for therapeutic purposes. More particularly, the present disclosure relates to the field of medical devices, assemblies, systems, and methods for applying electrical energy, such as therapeutic electrical pulses, to a patient. Even more particularly, the present disclosure relates to various devices, assemblies, systems, and methods for electroporation treatment. And, even more particularly, the present disclosure relates to adjustable length medical treatment devices, assemblies, and systems applying energy, such as electrical energy such as for electroporation, and associated methods. BACKGROUND [003] Various devices, assemblies, and systems exist for energy-based medical treatment or therapeutic protocols. Currently, bipolar devices (with two electrodes) may be inserted percutaneously or endoscopically into a patient. Once positioned within the target site (e.g., a tumor), the device is activated, such as by generating an electric field between and/or around the two electrodes of the device, for various therapeutic procedures. For instance, energy may be applied to perform radiofrequency ablation (RFA), electroporation, and/or irreversible electroporation (IRE) as a mode of treating various conditions and/or diseases by interrupting and/or changing the nature of biological cellular matter. Irreversible electroporation energy applied by the device causes pores to open within cell membranes near the device. The electric field disrupts homeostasis, killing the cells. Radiofrequency ablation causes thermal coagulation of the tissue. [004] Bipolar electroporation devices generally produce less muscle contractions than monopolar devices which have a single active electrode and a return grounding pad positioned on the patient’s skin. However, in contrast with monopolar devices, bipolar devices may have lower ablation volumes, arcing between electrodes, greater complexity, and multiple layers of electrodes and insulation between them to fit into a small diameter needle. In contrast with bipolar devices, monopolar devices may be considered simpler in nature, may create a larger ablation volume, may have reduced risks of arcing, and may afford space for other features or structures or devices, such as increased insulation thickness. Thicker insulation afforded by monopolar devices, in turn, may allow for improved dielectric strength, improved electrical safety, and the ability to be used at higher voltages for higher ablation volumes. [005] An adjustable length electrode (either monopolar or bipolar) may provide various benefits, such as ensuring that ablation volumes are well-conformed to target sites (e.g., tumor volumes), ensuring full ablation of the tumor volume, and helping to avoid ablation of nontargeted nearby anatomy, such as healthy tissue (e.g., pancreatic tissue, GI tract walls, etc.) and/or blood vessels. It is with respect to these and other considerations that the present improvements may be useful. SUMMARY [006] 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. [007] In accordance with various principles of the present disclosure, an energy-delivering assembly includes a first energy-delivering member having a sharp distal tip configured to puncture tissue, and a lumen defined therethrough and having a distal opening adjacent the sharp distal tip for delivery of materials distally through the lumen and out the distal opening thereof and/or for aspiration of materials into the distal opening of the lumen and proximally through the lumen; and a first insulation member extending over the first energy-delivering member and having a distal end. In some aspects, the first electrode portion of the energy-delivering assembly is defined along the first ene