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EP-4739235-A1 - DEVICES, SYSTEMS, AND METHODS FOR IMAGING LESIONS

EP4739235A1EP 4739235 A1EP4739235 A1EP 4739235A1EP-4739235-A1

Abstract

An energy-delivering treatment system facilitating determination of various characteristics of a lesion and/or tissue at a treatment site, such as the size and/or location of the lesion; stiffness and/or elasticity of the tissue; impedance or resistance of the tissue (which may impact the form of energy such as electroporation and/or irreversible electroporation applied to the tissue); and/or the effects of a treatment applied to the lesion. Information gathered regarding the treatment site may be used to aid in predicting and measuring lesions, and/or in determining an appropriate treatment plan on a patient-by-patient basis. Markers may be used to facilitate locating of the treatment site after the energy-delivering assembly has been withdrawn from the treatment site.

Inventors

  • BECHLY, Jessica
  • WHITE, NATALIE
  • WIEDMANN, Alexander

Assignees

  • Boston Scientific Scimed, Inc.

Dates

Publication Date
20260513
Application Date
20240703

Claims (15)

  1. 1. Apparatus facilitating identification, characterization, and/or location of a site treated by application of therapeutic energy thereto, said apparatus comprising an energy-delivering assembly having an energy-delivering region along which an energy field is generated to apply therapeutic energy to a treatment site; and a device configured to characterize the treatment site for assessment by a medical professional in determining a treatment protocol generating an energy field with said energy-delivering region.
  2. 2. The apparatus of claim 1, wherein said device is configured to deploy a deployable marker at the treatment site.
  3. 3. The apparatus of claim 2, wherein the marker is an injectable material delivered through a lumen delivered with said energy-delivering assembly.
  4. 4. The apparatus of claim 3, wherein said energy-delivering assembly comprises an energydelivering member along which said energy-delivering region is defined, and said lumen is independent of said energy-delivering member.
  5. 5. The apparatus of any one of claims 3 or 4, wherein said energy-delivering assembly comprises an energy-delivering member defining the lumen through which the injectable is delivered therethrough.
  6. 6. The apparatus of any one of claims 2-5, wherein the marker is carried by said energydelivering assembly.
  7. 7. The apparatus of any one of claims 2-6, wherein the marker is delivered to the treatment site as a part of said energy-delivering assembly and separated from said energy-delivering assembly to be deployed at the treatment site.
  8. 8. The apparatus of any one of claims 2-7, wherein the marker is carried over said energydelivering assembly and slidable off said energy-delivering assembly to be deployed at the treatment site.
  9. 9. The apparatus of any one of claims 2-8, wherein said energy-delivering assembly defines a housing in which the marker is carried to the treatment site and from which the marker is released to be deployed at the treatment site.
  10. 10. The apparatus of any one of claims 1-9, wherein said device profiles a characteristic of the treatment site.
  11. 11. The apparatus of any one of claims 1-10, wherein said device uses one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging to map properties of the treatment site.
  12. 12. A system for identifying characteristics of a treatment site to aid in performing an energybased treatment at the treatment site, said system comprising: an energy-delivering device comprising an energy- delivering assembly with an energydelivering region along which an energy field is generated to apply therapeutic energy to a treatment site; a delivery device having a working channel through which said energy-delivering assembly is delivered to a treatment site; and a device configured to characterize the treatment site for assessment by a medical professional in determining a treatment protocol generating an energy field with said energy-delivering region.
  13. 13. The system of claim 12, wherein said device uses one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging to map properties of the treatment site, and said system further comprises a processor configured to receive information from said device and to develop models of the treatment site based on the received information.
  14. 14. The system of any one of claims 1-13, wherein said device is configured to deploy a deployable marker at the treatment site.
  15. 15. The system of any one of claims 1-14, wherein said deployable marker is identifiable after an energy field has been applied to the treatment site and the device has been removed from the treatment site.

Description

DEVICES, SYSTEMS, AND METHODS FOR IMAGING LESIONS CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/524,992, filed July 5, 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 devices, assemblies, systems, and methods utilizing an energy field to treat a patient. More particularly, the present disclosure relates to medical devices, assemblies, systems, and methods associated with therapies and treatments utilizing energy fields, including devices, assemblies, systems, and methods for imaging, sensing, locating, identifying, measuring, and determining treatment protocols utilizing energy fields. BACKGROUND [0003] 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 radio frequency (“RF”) heating, microwave heating, cryoablation, high intensity focused ultrasound (“HIFU”), etc. In contrast, electroporation and/or irreversible electroporation is a 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 energy 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). In the case of reversible electroporation, pores in cell walls open to facilitate absorption of materials into the cells which may otherwise not readily pass through the cell walls and/or channels therethrough. The cells otherwise remain substantially intact. In contrast, in the case of irreversible electroporation, the electric field disrupts homeostasis and kills the cells, such as through apoptosis and/or necrosis. Various challenges with treatments involving use of energy fields include determining the appropriate parameters of energy to be applied to create the energy field, and the resulting effect on the cells thereafter. In particular, with IRE, the effect on the cells may not be detectable for several hours, and sometimes even as much 24-72 hours or more. Moreover, the cells which are affected may be a very small volume, and therefore difficult to locate and/or identify several hours after the treatment has already been performed. 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, an apparatus is configured to facilitate identification, characterization, and/or location of a site treated by application of therapeutic energy thereto. In accordance with various principles of the present disclosure, the apparatus, includes an energy-delivering assembly having an energy-delivering region along which an energy field is generated to apply therapeutic energy to a treatment site; and a device configured to characterize the treatment site for assessment by a medical professional in determining a treatment protocol generating an energy field with said energydelivering region. [0006] In some aspects, the device is configured to deploy a deployable marker at the treatment site. In some aspects, the marker is an injectable material delivered through a lumen delivered with said energy-delivering assembly. In some aspects, the energy-delivering assembly includes an energy-delivering member along which the energy-delivering region is defined, and the lumen is independent of said energy-delivering member. In some aspects, wherein the lumen is de