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EP-4739239-A1 - MULTI-ELECTRODE DEVICES, SYSTEMS, AND METHODS FOR MEDICAL PROCEDURES

EP4739239A1EP 4739239 A1EP4739239 A1EP 4739239A1EP-4739239-A1

Abstract

A multi-electrode energy-delivering assembly configured to be delivered in a generally elongate delivery configuration. The multi-electrode energy-delivering assembly includes one or more spaced apart electrodes of a first polarity. The electrodes may be spaced apart axially and/or may be expanded apart from one another upon deployment. In some aspects, the electrodes may be electrically activated independently of one another.

Inventors

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

Assignees

  • Boston Scientific Scimed, Inc.

Dates

Publication Date
20260513
Application Date
20240703

Claims (15)

  1. 1. A multi-electrode energy-delivering assembly comprising: one or more electrodes of a first polarity; and a support structure coupling said one or more electrodes for delivery as an assembly within a patient; wherein said multi-electrode energy delivering assembly has an elongated compact delivery configuration for delivery through a lumen of a delivery device.
  2. 2. The multi-electrode energy-delivering assembly of claim 1, wherein said one or more electrodes include two or more electrodes of the first polarity axially spaced from one another and extending in a linear configuration when in the elongated compact delivery configuration.
  3. 3. The multi-electrode energy-delivering assembly of claim 2, wherein said two or more electrodes are formed from an elongate electrically-conductive member and defined by an insulation member extending over and exposing portions of said elongate electrically-conductive member.
  4. 4. The multi-electrode energy-delivering assembly of any one of claims 2 or 3, further comprising at least one electrode of a second polarity axially spaced from at least one of said two or more electrodes of the first polarity.
  5. 5. The multi- electrode energy-delivering assembly of claim 4, wherein said at least one electrode of a second polarity is formed from a tubular electrically-conductive member positioned over said insulation member.
  6. 6. The multi-electrode energy-delivering assembly of claim 5, further comprising at least one differentiating insulation member extending over a portion of said tubular electrically- conductive member to define two or more spaced apart electrodes of the second polarity.
  7. 7. The multi- electrode energy-delivering assembly of any one of claims 2-6, wherein said two or more electrodes are positioned on a support element expandable from the elongated delivery configuration into an expanded deployed configuration when extended out of a delivery device to increase the volume of an electric field to be defined by the electrodes when said support element is in the deployed configuration compared with an electric field which would he defined by the electrodes when said support element is in the delivery configuration.
  8. 8. The multi-electrode energy-delivering assembly of any one of claims 1-7, wherein said one or more electrodes comprise three or more electrodes movable with respect to one another.
  9. 9. The multi-electrode energy-delivering assembly of claim 8, wherein at least one of said three or more electrodes are configured to engage and remain engaged with tissue.
  10. 10. The multi- electrode energy-delivering assembly of claim 1, wherein said one or more electrodes of a first polarity comprises a fluid containing electrically-conductive particles injectable by the delivery device into a target site within a patient.
  11. 11. The multi-electrode energy-delivering assembly of claim 10, further comprising an additional electrode of a second polarity delivered to the target site with said fluid.
  12. 12. The multi-electrode energy-delivering assembly of any one of claims 1-11, wherein said multi-electrode energy-delivering assembly is expandable upon deployment from a delivery device.
  13. 13. The multi- electrode energy-delivering assembly of any one of claims 1-12, wherein: said multi-electrode energy-delivering assembly further includes a power connector configured to deliver energy to said one or more electrodes to generate an electric field among said one or more electrodes; and said multi-electrode energy-delivering assembly is deliverable to a target site within a patient, in an elongated compact delivery configuration, within a lumen of a tubular delivery device.
  14. 14. The multi- electrode energy-delivering assembly of claim 13, wherein said multi-electrode energy-delivering assembly is expandable upon deployment from the lumen of said delivery device.
  15. 15. The multi-electrode energy-delivering assembly of claim 13, wherein said one or more electrodes of said multi-electrode energy-delivering assembly comprise two or more electrodes extending axially spaced apart from one another when in the lumen of said delivery device.

Description

MULTI-ELECTRODE DEVICES, SYSTEMS, AND METHODS FOR MEDICAL PROCEDURES CROSS-REFERENCE TO RELATED APPLICATIONS [001] This application claims the benefit of priority to U.S. Provisional Application No. 63/525,004, 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 multi-electrode devices, assemblies, and systems applying energy, such as electrical energy such as for electroporation, and associated methods. BACKGROUND [003] Various devices, assemblies, systems, and methods exist for energy-based medical treatment and/or therapeutic protocols. For instance, various focal therapy devices are configured to apply energy to debulk target tissue or to eliminate malignant cells. Various technologies for such therapy rely on thermal effects, such as radiofrequency (“RF”) heating, microwave heating, cryoablation, high intensity focused ultrasound (“HIFU”), etc. In contrast, electroporation and/or irreversible electroporation is a primarily non-thermal therapy, and has significant potential benefits over thermal modalities. Energy may be applied to perform electroporation and/or irreversible electroporation (“IRE”) as a mode of treating various conditions and/or diseases using an electric field to interrupt and/or to change the nature of biological cellular matter. For instance, the applied electric field may significantly increase the electrical conductivity and permeability of the plasma in the cell membrane. The applied energy causes paths / pores to open within cell walls and/or membranes near the device applying the energy (e.g., near the electrode, probe, etc., thereof). The electric field disrupts homeostasis, and, in the case of IRE, kills the cells, such as through apoptosis and/or necrosis. Monopolar probes may be used to insert a single electrode / an electrode of a first polarity (typically an anode) within the patient, with energy directed to the second, ground electrode typically outside the patient (e.g., a grounding pad positioned on the skin of a patient). However, such configuration may have certain effects, such as muscle stimulation such as which may result in muscle contractions; cardiac interference, etc., which may not be desirable. To mitigate such effects, bipolar probes with two electrodes, typically separated by insulation, yet positioned close enough to create an energy field therebetween with fewer effects than caused by exposure to electrical fields created by monopolar probes. Once positioned within the target site (e.g., a tumor), the monopolar probe is activated, such as by generating an electric field between and/or around the electrodes of the device, for various therapeutic procedures. It is with respect to these and other considerations that the present improvements may be useful. SUMMARY [004] 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. [005] In accordance with various principles of the present disclosure, a multi-electrode energydelivering assembly is formed with at least one or more electrodes of a first polarity; and a support structure coupling the one or more electrodes for delivery as an assembly within a patient. In some aspects, the multi-electrode energy delivering assembly has an elongated compact delivery configuration for delivery through a lumen of a delivery device. [006] In some aspects, the one or more electrodes include two or more electrodes of the first polarity axially spaced from one another and extending in a linear configuration when in the elongated compact delivery configuration. In some aspects, the two or more electrodes are formed from an elongate electri