Devices, systems, and methods for imaging lesions.

Abstract

An energy supply treatment system that enables determination of various characteristics of the lesion and / or tissue at the treatment site, such as the size and / or location of the lesion, the stiffness and / or elasticity of the tissue, the impedance or resistance of the tissue (which can affect the form of energy applied to the tissue, such as electroporation and / or irreversible electroporation), and / or the effect of the treatment applied to the lesion. Information collected regarding the treatment site can be used to help predict and measure the lesion and / or determine an appropriate treatment plan for each patient. Markers can be used to enable localization of the treatment site after the energy supply assembly has been withdrawn from the treatment site.

Description

Technical Field

[0001] The present disclosure generally relates to the field of devices, assemblies, systems, and methods for using energy fields to treat patients. More specifically, the present disclosure relates to medical devices, assemblies, systems, and methods related to treatments and procedures using energy fields, as well as devices, assemblies, systems, and methods for using energy fields to determine imaging, sensing, localization, identification, measurement, and treatment protocols.

Background Art

[0002] A variety of devices, assemblies, systems, and methods exist for energy-based medical procedures and / or treatment protocols. For example, various topical treatment devices are configured to apply energy to reduce the volume of target tissue or eliminate malignant cells. Various techniques for such treatments rely on thermal effects such as radiofrequency ("RF") heating, microwave heating, cryoablation, and high-intensity focused ultrasound ("HIFU"). In contrast, electroporation and / or irreversible electroporation are non-thermal treatments and have significant potential advantages over thermal modalities. Energy can be applied to perform electroporation and / or irreversible electroporation ("IRE") as a mode of treatment for various conditions and / or diseases by using an energy field to disrupt and / or alter the properties of biological cellular material. For example, an applied electric field can significantly increase the conductivity and permeability of the plasma membrane in cell membranes. The applied energy opens pathways / pores in the cell wall and / or membrane near the energy-applying device (e.g., near its electrodes, probes, etc.). In the case of reversible electroporation, the pores in the cell wall open, facilitating the absorption into the cell of substances that would not normally be able to easily pass through the cell wall and / or channels through the cell wall. The cell remains substantially intact in other respects. In contrast, in the case of irreversible electroporation, the electric field disrupts homeostasis and kills the cell by apoptosis and / or necrosis. Various challenges in therapies involving the use of energy fields include determining the appropriate parameters of the energy to be applied to generate the energy field, and the subsequent effects on the cell. In particular, with IRE, the effects on cells may be undetectable for several hours, and in some cases for 24-72 hours or more. Furthermore, the affected cells may be in very small volumes, and therefore, it may be difficult to locate and / or identify them several hours after the treatment has already been performed.In light of these and other considerations, this improvement may be useful. [Overview of the Initiative]

[0003] This summary of the invention is provided in a simplified form to introduce a selection of concepts that will be described in more detail in the embodiments for carrying out the invention described below. This summary is not intended to necessarily identify any major or essential features of the claimed subject matter, nor is it intended to be an aid in determining the scope of the claimed subject matter. Those skilled in the art will understand that each of the various aspects and features of the disclosure may be used advantageously, either separately in some cases or in combination with other aspects and features of the disclosure in other cases, whether or not they are described in this summary. No limitation on the scope of the claimed subject matter is intended by the inclusion or exclusion of any elements, components, etc., in this summary.

[0004] In accordance with various principles of this disclosure, the apparatus is configured to enable the identification, characterization, and / or localization of a site to be treated by the application of therapeutic energy. In accordance with various principles of this disclosure, the apparatus includes an energy supply assembly having an energy supply region, along which an energy field is generated for applying therapeutic energy to a treatment site, and a device configured to characterize the treatment site for evaluation by a medical professional when determining a treatment protocol that generates an energy field by the energy supply region.

[0005] In some embodiments, the device is configured to deploy a deployable marker to the treatment site. In some embodiments, the marker is an injectable material delivered through a lumen to which an energy supply assembly is delivered. In some embodiments, the energy supply assembly includes an energy supply member, along which an energy supply region is defined, and the lumen is independent of the energy supply member. In some embodiments, the lumen is delivered to the treatment site by the energy supply member. Additionally or alternatively, the energy supply assembly includes an energy supply member, which defines a lumen to which the injectable material is delivered. In some embodiments, the marker is supported by the energy supply assembly. In some embodiments, the marker is delivered to the treatment site as part of the energy supply assembly and separated from the energy supply assembly to be deployed at the treatment site. In some embodiments, the marker is transported on top of the energy supply assembly and deployed at the treatment site by sliding away from the energy supply assembly. In some embodiments, the energy supply assembly defines a housing, the marker is carried within the housing to the treatment site, and the marker is released from the housing to be deployed at the treatment site.

[0006] In some embodiments, the device profiles the characteristics of the treatment site. In some embodiments, the device maps the characteristics of the treatment site using one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging.

[0007] In accordance with various principles of this disclosure, the system is configured to identify the characteristics of a treatment site in order to assist in performing energy-based therapy at the treatment site. In accordance with various principles of this disclosure, the system includes an energy supply device comprising an energy supply assembly having an energy supply region, wherein an energy field is generated along the energy supply region for applying therapeutic energy to the treatment site; a delivery device having a working channel through which the energy supply assembly is delivered to the treatment site; and a device configured to characterize the treatment site for evaluation by a medical professional when determining a treatment protocol that generates an energy field by the energy supply region.

[0008] In some embodiments, the device maps the characteristics of the treatment site using one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging, and the system further includes a processor configured to receive information from the device and create a model of the treatment site based on the received information.

[0009] In some embodiments, the device is configured to deploy a deployable marker to the treatment site. In some embodiments, the deployable marker is identifiable after an energy field is applied to the treatment site and the device is removed from the treatment site.

[0010] A method for treating and characterizing a treatment site, in accordance with the various principles of this disclosure, includes the steps of: delivering an energy supply assembly of an energy supply device of an energy supply treatment system to the treatment site; generating an energy field along the energy supply region of the energy supply assembly and applying therapeutic energy to the treatment site; determining the properties or characteristics of the treatment site by the energy supply treatment system; and using the determined properties to influence the treatment being performed on or to be performed on the treatment site.

[0011] In some embodiments, the method includes the step of deploying a marker during or after the application of therapeutic energy to the treatment site, and the step of determining the characteristics or features includes the step of determining the location of the treatment site using the marker.

[0012] In some embodiments, the method includes the step of creating a three-dimensional map of the properties of the treatment site using the determined properties. In some embodiments, the method includes the step of using the map of the properties of the treatment site to assist in predicting and measuring the therapeutic energy applied to the treatment site.

[0013] These and other features and advantages of this disclosure will be readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the attached claims. The following disclosure is presented with respect to aspects or embodiments, but it should be understood that each aspect may be claimed separately or in combination with the aspects and features of that embodiment or any other embodiment. [Brief explanation of the drawing]

[0014] Non-limiting embodiments of this disclosure are described by reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and dimensions, locations, order, and relative sizes reflected in the figures within the drawings may vary. For example, devices may be enlarged to allow for the identification of details, but are intended to be reduced to fit within, for example, a delivery catheter or an endoscope working channel. For clarity and brevity, not all elements are labeled in all figures, and not all elements of each embodiment are shown where it is not necessary to illustrate them to enable those skilled in the art to understand this disclosure.

[0015] A more detailed explanation will be better understood in conjunction with the attached drawings, where similar reference numerals represent similar elements, as shown below. [Figure 1]This is a schematic diagram showing an energy supply treatment system formed according to an aspect of this disclosure being used in a schematic diagram of a treatment site. [Figure 1A] This is a schematic diagram that follows detail 1A of Figure 1. [Figure 2A] This is a front view of an example embodiment of an energy supply assembly that delivers an injectable marker. [Figure 2B] This is a front view of another example of an embodiment of an energy supply assembly that delivers an injectable marker. [Figure 3A] This is a front view of an example of an embodiment of an energy supply assembly that carries a marker that is not injected into the treatment site. [Figure 3B] Figure 3A is a front view of the energy supply assembly after the marker has been deployed to the treatment site. [Figure 4A] This is a front view of an example of an embodiment of an energy supply assembly that carries a marker that is not injected into the treatment site. [Figure 4B] Figure 4A is a front view of the energy supply assembly after the marker has been deployed to the treatment site. [Figure 5A] This is a front view of an example of an embodiment of an energy supply assembly that carries a marker that is not injected into the treatment site. [Figure 5B] Figure 5A is a front view of the energy supply assembly after the marker has been deployed to the treatment site. [Figure 6] This figure schematically illustrates various technologies and methods that can be used in conjunction with energy supply treatment systems in accordance with the various principles of this disclosure. [Modes for carrying out the invention]

[0016] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described and is therefore subject to change. All devices, systems, and methods described herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of this disclosure. Each example of an embodiment is provided for illustrative purposes and is merely an example, not the only way to implement these principles. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of this disclosure and should not be understood as limiting this disclosure to specific elements, structures, or features illustrated. Other examples of ways of implementing the disclosed principles will be recalled by those skilled in the art who have read this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in this disclosure without departing from the scope of the subject matter or the technical idea. For example, a feature illustrated or described as part of one embodiment can be used in conjunction with another embodiment to result in further embodiments. Therefore, this subject matter is intended to encompass such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0017] It will be understood that this disclosure is described in varying levels of detail in this application. In certain examples, details that are not necessary for a person skilled in the art to understand this disclosure, or that would make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by a person skilled in the art to which this disclosure belongs. All devices and / or methods disclosed and claimed herein can be manufactured and performed without undue experimentation in light of this disclosure.

[0018] As used herein, “proximal” refers to the direction or location closest to the user (such as a medical professional, clinician, technician, operator, or physician; such terms are used interchangeably herein without intent to limit them, including automated controller systems, etc.) when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery) and / or closest to the delivery device; “distal” refers to the direction or location furthest from the user when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery) and / or closest to the delivery device. “Longitudinal” means extending along the longitudinal or greater direction of an element. “Longitudinal axis” means extending along the longitudinal direction of an element, but not necessarily a straight line, and not necessarily maintaining a fixed shape if the element bends or curves. Also, “axial direction” generally refers to the direction along the longitudinal axis. However, it will be understood that references to axial or longitudinal movement relating to the system or its elements described above do not need to be strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the referenced element. "Center" means at least roughly bisecting the center point and / or being approximately equidistant from the periphery or boundary, and "central axis" means, with respect to an opening, a line that at least roughly bisects the center point of the opening and extends longitudinally along the length of the opening if the opening comprises, for example, a tubular element, channel, cavity, or bore. In this specification, "lumen," "channel," "bore," or "passage" are not limited to circular cross-sections. In this specification, the "free end" of an element means the end of the element that does not extend further. Terms such as "at the end," "on the end," "adjacent to the end," and "along the end" may be used interchangeably in this specification without any intention of limitation unless otherwise specified, and it will be understood that they are intended to indicate general relative spatial relationships rather than strictly limited locations. Finally, any reference to a place or part "in" is intended to include its vicinity (e.g., along, adjacent to, proximal to, etc.) and / or surrounding area.As used herein, the term "corresponding" is intended to convey a relationship between components, parts, elements, etc. that are configured to interact with each other or have other intended relationships.

[0019] The present disclosure describes various improvements related to medical procedures that apply energy to a treatment site within a patient's body. It should be understood that terms such as procedure, therapy, treatment, surgery, protocol, etc. (including their grammatical forms) may be used interchangeably herein without intention of limitation. Further, it will also be understood that terms such as treatment site, target site, anatomical site, treatment site, lesion site, tumor site, etc. (regardless of whether accompanied by the term "site") may be referred to interchangeably herein without intention of limitation. The following description generally relates to energy treatments in the form of electroporation and / or irreversible electroporation ("IRE"), but is also applicable to other forms of energy treatment.

[0020] As commonly used herein, the term “ablation” generally refers to the removal of cells, either directly or indirectly, by the supply of energy within an energy field such as an electric field, and may include removal by loss of cellular function, cell lysis, coagulation, protein denaturation, necrosis, apoptosis, and / or irreversible electroporation. “Ablation” may also refer to the formation of a cauterization by ablation. In addition, the terms “undesirable tissue,” “target cells,” “target tissue,” “disease tissue,” “disease cells,” “tumor,” and “cell mass” may be used herein to refer to cells that are removed, or should be removed, in whole or in part by ablation, but are not intended to limit the application of any assembly, system, device, or method described herein. For example, such terms include the ablation of both disease cells and specific surrounding cells, even if there is no explicit indication that such surrounding cells are diseased. Ablation performed by assemblies, systems, devices, or methods described herein may be performed on cells located around biological lumens, such as vascular regions, mammary duct regions, or tubular regions, so as to generate a margin for medical professionals to ablate additional cells by ablation or other methods. According to various principles of this disclosure, the devices, assemblies, systems, and methods disclosed herein may be configured to perform ablation by electroporation and / or IRE.

[0021] Energy treatments such as electroporation and / or IRE typically involve applying an energy-applying potential to one or more electrodes placed at a target site to generate an electric field to which the target (e.g., unwanted tissue) is exposed. In the case of electroporation, the porosity of the cells at the target site is increased to allow substances such as therapeutic substances to be absorbed by the cells while minimizing the effect on the surrounding tissue. In the case of IRE, sufficient energy can be applied to disrupt the cell wall, such as by disrupting the lipid bilayer of the cell wall. In some embodiments, the energy is pulsed or otherwise varied to open and close pores in the cell wall. After repeated opening and closing of the pores and / or after applying a certain amount of energy, the cell wall is permanently disrupted / damaged (e.g., broken), and the internal components of the cell and / or other substances from the cell are released and can enter the interstitial space and / or the patient's body. Such components and / or substances (e.g., antigens), when released from the cells and present in the body, can then further treat the target site (e.g., tumor) by stimulating the immune system to activate an immune response and attacking the remaining unwanted tissue, etc.

[0022] Energy to achieve the desired treatment can be applied to the target site via electrodes positioned adjacent to, at, near, or within the target site. The applied energy and / or energy-granting potential and / or the resulting energy field can be characterized by various parameters such as frequency, amplitude, pulse width (pulse duration or pulse length), and / or polarity. A suitable energy source includes an electrical waveform generator, such as an IRE, high-frequency IRE, nanopulse, and / or waveform generator capable of generating ablation waveforms. The energy source generates an energy field with desired characteristics for treatment performed at the target site, based on the treatment site, application, device, electrode configuration, etc. For example, the energy field can be generated to have a specific waveform output with respect to voltage, impedance, frequency, amplitude, pulse width, pulse delay, number of pulses per burst, number of bursts, and phase. Current can flow between electrodes and through tissue in proportion to the potential (e.g., voltage) applied to the electrodes. The supply current supplied by the energy source can deliver a pulse sequence to the target site. For example, an energy source may supply various waveforms in one or more pulse sequences that are tailored to the desired application.

[0023] Electroporation and / or IRE therapy may involve the application of highly focused energy to a target site, independent of thermal energy, and thus reduce and / or eliminate the risk of damage to surrounding cells that can typically occur with other forms of energy therapy. For example, due to inter-patient variability and tissue / tumor variability within a single patient, with respect to tissue characteristics (e.g., impedance, heterogeneity, nature of the tumor being treated, etc.), the initial parameters for the therapeutic energy protocol applied to a patient must be determined and evaluated for each patient on an individual basis to achieve the desired effect of IRE. Therefore, it is important to be able to determine and evaluate various parameters before applying the energy protocol. This disclosure describes various techniques for determining and evaluating various tissue characteristics and other information and parameters used in determining the treatment to be performed. In accordance with various principles of this disclosure, various tissue characteristics are imaged and mapped to assist in the prediction and measurement of electroporation lesions, IRE lesions, and / or thermal lesions. Alternatively, or additionally, information collected in accordance with the various principles of this disclosure may then be further used, in accordance with the various principles of this disclosure, to provide computational models that display real-time information such as estimates of thermal properties, IRE properties, and / or other lesion properties (such as size) for further therapeutic purposes.

[0024] This disclosure describes further techniques for determining information about treatment sites, such as lesions generated by energy applied according to various principles of this disclosure. For example, but not limited to, various techniques for determining and / or evaluating information about treatment sites, such as the location of a treated and / or formed lesion, the size of the lesion, and / or the ratio of thermal damage to IRE at a given target site, are disclosed according to various principles of this disclosure. Given patient variability, the treatment applied may have different effects and / or outcomes among patients, even if it has been properly evaluated and delivered by the techniques described herein before application to the patient. Characterizing the treatment area after the procedure has been performed (e.g., the area of ​​the formed IRE lesion) is generally considered important or essential to enable understanding, evaluating, and planning the care and / or additional treatment provided to the patient.

[0025] In addition, it is generally considered important to characterize the lesions formed after electroporation and / or IRE to understand the care that should be provided to the patient. For example, IRE typically preserves the extracellular matrix of the cells to which energy is applied. Even if cells are dead, the matrix supporting the cells generally remains relatively intact. Various devices, systems, and methods are disclosed for leaving markers in a treatment site that remains in place after energy therapy is completed (e.g., within a tumor, such as in the extracellular matrix that remains intact even after IRE has been performed), according to various principles of this disclosure. The markers may enable post-location and / or identification of the treatment site in order to evaluate the effect of the energy applied to the treatment site. The markers may be fluids (e.g., contrast agents, stains, dyes, etc.) and / or elements that generally have a fixed structure (as opposed to fluids). The markers may be injected before, during, or after the delivery of therapeutic energy. The marker may remain in place at the treatment site for at least a sufficient time to locate and / or identify the treatment site after the electrode or other energy supply device has been removed from the treatment site. For example, the marker may remain in place for more than 24 hours after the treatment procedure, for example, for at least 72 hours. In some embodiments, the marker does not need to be actively removed by any means other than natural bodily functions that can expel the marker and / or absorb it in other ways (e.g., in the case of bioabsorbable markers).

[0026] Electrode device assemblies, systems, and various related methods will be described below with reference to examples illustrated in the accompanying drawings. References in this specification to “one embodiment,” “a certain embodiment,” “several embodiments,” and “other embodiments” indicate that one or more specific features, structures, concepts, and / or properties according to the principles of this disclosure may be included in connection with that embodiment. However, such references do not necessarily mean that all embodiments include a particular feature, structure, concept, and / or property, or that one embodiment includes all of them. Some embodiments may include one or more such features, structures, concepts, and / or properties in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or properties described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or properties of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or properties described herein may be mixed and adapted to form a hybrid embodiment, and such hybrid embodiment is within the scope of this disclosure. Furthermore, references to “one embodiment,” “a certain embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive of other embodiments. Moreover, it should be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and distinct from one another and may be used or presented individually or in various combinations to create alternative embodiments that are considered part of this disclosure. Accordingly, this disclosure is not limited to the embodiments specifically described herein, and because it would be extremely cumbersome to describe all the numerous possible and partial combinations of features, structures, concepts, and / or characteristics, the examples of embodiments disclosed herein are not intended to limit the broader aspects of this disclosure.The various dimensions provided herein are examples, and those skilled in the art should understand that they can easily determine a suitable range of standard deviation and acceptable variation therefrom, which are included in this disclosure and any related claims. The following description is merely an illustrative example of embodiments and is not intended to limit any broader aspects of this disclosure.

[0027] Referring next to the drawings, Figure 1 shows an example of an embodiment of an energy supply treatment system 100 configured to apply therapeutic energy to a treatment site within a patient. The energy supply treatment system 100 includes an energy supply device 1000, such as an electroporation device, configured to supply therapeutic energy to a treatment site within a patient. In the example embodiment of the energy supply device 1000 shown in Figure 1, an energy supply assembly 1100 (which may alternatively be referred to as a probe) is provided at the distal end 1000d of the energy supply device 1000, as shown in more detail in Figure 1A. The energy supply assembly 1100 is deliverable into the patient's body (e.g., the digestive system as schematically shown in Figure 1, or other anatomical sites; this disclosure is not limited thereto) and is configured to establish a therapeutic energy field at the treatment site T.

[0028] As shown in Figure 1A, detail 1A of Figure 1, an illustrated example of an embodiment of the energy supply assembly 1100 includes at least one energy supply member 1102 that can be inserted into a treatment site T (e.g., a tumor, lesion, etc.). The energy supply member 1102 may have electrodes defined along its longitudinal direction (e.g., along the distal end 1100d of the energy supply assembly 1100). Thus, at least a portion of the energy supply member 1102 is formed of a conductive material such as medical-grade stainless steel, platinum, gold, nitinol, cobalt-chromium alloy, nickel-cobalt alloy such as MP35N, or other alloys, or a material plated with a conductive material. An insulating member 1104 is provided proximal to the distal end 1102d of the energy supply member 1102, thereby defining / partitioning a distal energy supply region 1106 of the energy supply assembly 1100 where an energy field is generated. In some embodiments, the distal end 1100d (e.g., the terminal) of the energy supply assembly 1100 has a sharp distal tip, such as one formed at or along the terminal of the energy supply member 1102. The sharp distal tip may be configured to puncture tissue / organ / tumor mass in embodiments well known to those skilled in the art. For example, the energy supply member 1102 may be in the form of a trocar, a needle, or the like.

[0029] The energy supply assembly 1100 can be delivered to the treatment site T through a delivery device 110, as schematically shown in Figure 1. The delivery device 110 (e.g., a tubular member, sheath, catheter, etc.) has a lumen or working channel inside which the size is determined to allow the energy supply assembly 1100 to pass through. In addition, the delivery device 110 is sized, shaped, constructed, and / or sized to be inserted into the human body through passages of natural anatomical passages, lumens, openings, etc. (e.g., esophagus, stomach, intestine, etc., and / or passages, lumens, channels, etc.). It will be understood that terms such as passages, lumens, openings, and channels may be used interchangeably herein without intent to limit them. In one example of an embodiment of the energy supply treatment system 1000 shown in Figure 1, the delivery device 110 is shown as an endoscope. However, this disclosure does not need to be limited in this respect. As can be understood by referring to Figures 1 and 1A, the delivery device 110 includes an insertion tube 112 through which an energy supply assembly 1100 can be delivered to the treatment site T. In one example of the embodiment shown in Figure 1, the energy supply assembly 1100 of the energy supply treatment system 1000 is inserted into a port 114 of the delivery device 110, such as being defined on the handle 116 of the delivery device 110, and accesses the working channel 111 of the insertion tube 112 (for example, shown in Figure 1A).

[0030] The energy supply assembly 1100 may further include a sheath 1110 that can deliver the energy supply assembly 1100 to a target site T through its interior, as shown in Figure 1A. The sheath 1110 may protect the passage into which the energy supply assembly 1100 is inserted (e.g., inside the working channel 111 of the insertion tube 112 of the delivery device 110, and / or an anatomical passage or structure) from the sharp distal end of the energy supply assembly 1100 (e.g., the distal end 1102d of the energy supply member 1102). The sheath 1110 may be selectively retractable proximal to the energy supply member 1102, and / or the energy supply member 1102 may extend distally to the sheath 1110, thereby exposing at least the distal energy supply region 1106 of the energy supply assembly 1100 to the treatment site T.

[0031] The energy supply member 1102 is electrically connected to the energy supply source 120, and therapeutic energy is applied to the treatment site T by generating an energy field (e.g., an electric field) along the energy supply region 1106 of the energy supply assembly 1110. For example, as shown in Figure 1, a power connector 1120 extending along the proximal end 1000p of the energy supply device 1000 may electrically connect the energy supply member 1102 to the energy supply source 120 of the energy supply treatment system 100. The power connector 1120 may be wiring or other conductive member configured to connect to the energy supply source. The energy supply source 120 may be an electroporation generator (e.g., an electric field generator, a waveform generator, an electric pulse generator, etc.) or any other energy generating device known to those skilled in the art for generating energy suitable for application to the energy supply assembly 1100 of the energy supply device 1000 for performing electroporation and / or IRE treatment. This disclosure is not limited to the details of the energy supply source.

[0032] In some embodiments, the energy supply device 1000 further includes a handle 1130 on which an energy supply assembly 1100 extends distally and a power connector 1120 extends proximal. The handle 1130 may be configured to control and / or adjust the position of the energy supply assembly 1100 and / or sheath 1110, for example, relative to each other and / or relative to the delivery device 110.

[0033] As described above, according to the various principles of this disclosure, an example embodiment of the energy supply treatment system 100 shown in Figure 1 may be configured to enable identification, characterization, localization, etc., of the treatment site T before, during, and / or after the application of therapeutic energy to the treatment site T. For example, according to the various principles of this disclosure, the energy supply treatment system 100 may be configured to mark the treatment site T to enable its identification, characterization, localization, etc.

[0034] In some embodiments, an energy delivery treatment system 100 formed according to various principles of this disclosure is configured to inject a substance before (e.g., immediately before), during, and / or after (e.g., immediately after) the delivery of electroporation or IRE energy to a treatment site T. For example, an injectable substance (e.g., a fluid or other) that is visualized by using a visualization device and / or other equipment (e.g., external visualization technology) or otherwise localizable and / or identifiable may be injected into the treatment site T. Such an injectable substance enables real-time and / or post-treatment identification of the treatment site T (e.g., the electroporation area and / or the thermal area). The injectable substance may be a contrast agent, a stain, a dye, a cell marker, a strain detection mechanism, etc., and remains in the treatment site T after injection. For example, cells killed by IRE can readily take up such an injectable substance. In some embodiments, dead cells may change to one color, and living cells may change to another color.

[0035] To deliver an injectable substance, an energy supply treatment system 100, formed according to various principles of this disclosure, includes a delivery lumen from which the injectable substance can be delivered and deployed within a treatment site T. For example, in some embodiments, the energy supply device 1000 may include a delivery lumen. In one embodiment of the energy supply assembly 1100 shown in Figure 2A, the injectable substance 130 (which may optionally be considered part of the energy supply treatment system 100 formed according to various principles of this disclosure) can be injected through a lumen formed separately from the energy supply member 1102 and further separately from the energy supply assembly 1100. For example, as shown in Figure 2A, a separate tubular member 140 may be inserted into the treatment site T together with the energy supply assembly 1100. For example, the separate tubular member 140 may be inserted through a working channel 111 of a delivery device 110 (e.g., an endoscope 110) as shown in Figures 1 and 1A. Alternatively, device replacement can be performed, allowing a tubular member, such as a separate hollow needle (e.g., not used for or during ablation), to pass through the working channel 111 of the delivery device 110. The injectable substance 130 of the energy supply treatment system 100 can be delivered to the tubular member in a manner well known to those skilled in the art, such as through the port 114 of the delivery device 110.

[0036] Additionally, or alternatively, the energy supply device 1000 may have an energy supply assembly with a delivery lumen defined through its components for delivering an injectable substance 130 to the treatment site T. For example, a lumen may be incorporated into the energy supply device 1000 shown in Figures 1 and 1A. More specifically, the lumen 2101 may be defined through an energy supply member 2102 of the energy supply assembly 2100, as shown in Figure 2B. It will be understood that an example embodiment of the energy supply assembly 2100 shown in Figure 2 may extend from the distal end 1000d of the example embodiment of the energy supply device 1000 in the example embodiment of the energy supply treatment system 100 shown in Figure 1 (e.g., forming part thereof, or otherwise being incorporated therein). After the distal end 2100d of the energy supply assembly 2100 enters the treatment site T, the injectable substance 130 may be delivered to the treatment site T via the lumen 2101, as shown in Figure 2. In accordance with various principles of this disclosure, the injectable substance 130 can be injected into the treatment site T before, during, or after the application of therapeutic energy to the energy supply assembly 2100 in order to generate an energy field configured to treat the treatment site T. Optionally, the injectable substance 130 is delivered to the lumen 2101 via the handle 1130 from a fluid source 150 fluidly coupled to the handle 1130, in a manner well known to those skilled in the art.

[0037] Similar to the energy supply assembly 1100 shown in Figure 1A, an example embodiment of the energy supply assembly 2100 shown in Figure 2 may have a sharp distal end 2100d configured to penetrate into the treatment site T (e.g., into a tumor). It will be understood that various other features and / or structures of the example embodiment of the energy supply assembly 2100 shown in Figure 2 may be similar to, or substantially identical to, the features and / or structures of the example embodiment of the energy supply assembly 1100 shown in Figure 1A. For the sake of brevity and without the intention of limitation, refer to the above description of such additional features and structures applicable to the energy supply assembly 2100 shown in Figure 2.

[0038] In accordance with various principles of this disclosure, the injectable substance 130 may be any of various substances that enable its detection (visualization) in any of various embodiments. In some embodiments, the injectable substance 130 may include a contrast agent that enables visualization of the treatment site T using computed tomography (CT). Such embodiments enable real-time CT imaging and real-time volumetric lesion assessment. In accordance with various principles of this disclosure, the injectable substance 130 is injected into the treatment site T immediately after or during treatment delivery and imaged. In accordance with various principles of this disclosure, care should be taken to ensure that the contrast-enhanced / stained / colored area is consistent with the ablated area or the various levels of applied electroporation.

[0039] Additionally, or alternatively, the injectable substance 130 may include a fluorescent staining agent that enables visualization of the injectable substance 130 and the treatment site T using a laser. For example, the injectable substance 130 may consist of molecules that fluoresce at different selected wavelengths of light, and / or may be a fluid containing such molecules. Such molecules may be designed to be taken up by cells at the treatment site T. An example of such molecules is propidium iodide, which can be taken up by electroporated cells and visually highlight the IRE ablation area. To visualize the treatment site T endoscopically, a laser may be used to emit light into the tumor and search for fluorescent molecules. A similar process may also be used in open surgery.

[0040] Additionally, or alternatively, the injectable substance 130 may include a contrast agent and / or a fluorescent stain that can be visualized using photoacoustic imaging. During photoacoustic imaging, laser pulses are delivered into the tissue. A portion of the laser energy is converted into heat, which expands the tissue, thereby enabling the visualization of light and pressure waves. According to various principles of this disclosure, a medium (which may be a contrast agent or a fluorescent stain) can be used to preferentially visualize either IRE lesions or thermal lesions. Care should be taken to correlate the stained area with tissue changes (levels such as electroporation or thermal ablation).

[0041] Additionally, or alternatively, the injectable substance 130 may include an electric field-responsive dye / contrast agent that can be visualized using fluorescence fluoroscopy and / or endoscopic ultrasound. Such an injectable substance 130 may or may not be taken up by cells. Instead, the molecules themselves change in response to an energy field, such as an electric field, applied during IRE treatment. When an energy treatment is applied to a treatment site T where the injectable substance 130 in the form of an electric field-responsive dye / contrast agent is deposited, the molecules of the injectable substance 130 resonate and emit light when exposed to a laser of a specific wavelength or a signal of a specific voltage. In some embodiments, multiple dyes with different thresholds for emission may be combined to produce more subtle images. In some embodiments, the dyes may be visible and selected so that one / multiple emissions correlate with the IRE lesion area.

[0042] In some embodiments, the injectable substance 130 may include a thermochromic dye that can be visualized using an endoscope, such as during the application of thermal energy therapy. The thermochromic dye may be selected to change color when exposed to a specific temperature. By injecting such a dye into the treatment site T before the application of therapeutic energy and visualizing such a dye (e.g., using an endoscope), a visual color map of any thermal tissue damage is provided.

[0043] In addition to, or instead of, injecting the injectable substances described above, one or more markers may be deployed in ways other than injection to enable identification, localization, etc., of the treatment site. Thus, in contrast to injectable substances, which can generally be fluid and cannot have a fixed shape (for example, their shape may change by taking the shape of the container they enclose and / or the lumen into which they are injected), additional or alternative markers, which generally have a non-fluid form (e.g., gels, biocompatible films, a series of nanobubbles, etc.), may be deployed by an energy supply treatment system 100 formed according to various principles of this disclosure. For example, additional or alternative markers not intended to be injected may be supported on a part of the energy supply assembly of the energy supply treatment system 100 (e.g., the outer part of the energy supply assembly). Such markers may be formed from a visible material, such as a radiopaque material (visible under X-rays), or a material otherwise configured to be compatible with various imaging modalities. In some embodiments, the markers are deployed after ablation for local identification of the treated area of ​​the treatment site T. In some embodiments, the marker is a biodegradable marker that does not leave a long-term foreign body in the patient. The marker may be formed from a polymer, a metal, or other visible material known to those skilled in the art (e.g., a radiopaque material). In some embodiments, the marker may not allow visualization of the entire area of ​​the treatment zone, but instead aids in more specific site identification of the ablated tissue at the treatment site (e.g., the location of dead cells). Such deployable markers configured to be deployed by means other than injection according to various principles of this disclosure may have any of the various possible configurations. For convenience, and without intent to limit, such markers are referred herein to as non-fluid markers deployed to a treatment site by means other than injection, in contrast to the injectable markers described above. Additionally or alternatively, such markers may be referred herein to as deployable markers supported by an energy supply assembly, which is a component or member of an energy supply treatment system formed according to various principles of this disclosure and delivered to a treatment site.However, it should be understood that the reference to the non-fluidic marker being supported by an energy supply assembly is not necessarily limited to a non-fluidic form and / or not limited to being supported solely by an energy supply assembly. The following examples of embodiments are just some of the various forms of deployable markers, and the markers may be of any other shape (cylindrical, spherical, prismatic, etc.), may be made of any other material, and / or may be delivered in any other manner (via an active or passive mechanism), and it should be understood that the principles of the disclosure are not limited by the examples of embodiments described herein.

[0044] Figure 3A shows an example of an embodiment of an energy supply assembly 3100 configured to carry, deliver, and deploy a non-fluidically deployable marker 360 at a treatment site T. It should be understood that the illustrated example of an embodiment of the energy supply assembly 3100 may extend from the distal end 100d of an energy supply treatment system 100, as shown in Figure 1. For brevity, the description of the energy supply treatment system 100 shown in Figure 1 will be used as an example of an embodiment of an energy supply treatment system that includes the example embodiment of the energy supply assembly 3100 shown in Figure 3A as a component. The example embodiment of the energy supply assembly 3100 shown in Figure 3A carries a non-fluidically deployable marker 360 formed according to various principles of this disclosure. The non-fluidically deployable marker 360 shown in Figure 3A is separable from and deployable from the energy supply assembly 3100. For example, the non-fluidically deployable marker 360 may form the distal end 3100d of the energy supply assembly 3100, or otherwise be coupled to it. The non-fluidically deployable marker 360 is configured to be detachable from the energy supply assembly 3100 in any of the various embodiments. For example, the non-fluidically deployable marker 360 may be a detachable tip of the energy supply assembly 3100. For example, in some embodiments, a mechanical actuator such as a button may extend from the non-fluidically deployable marker 360 to a location outside the patient's body (e.g., on the handle 116 of the delivery device 110) and be movable to push the deployable marker 360 out of a predetermined position relative to the energy supply assembly 3100. In other embodiments, the energy supply assembly 3100 may be manipulated to apply stress to the non-fluidically deployable marker 360 so that it can cause intentional breakage (e.g., by being rotated, bent, or torqued). In some embodiments, the non-fluidically deployable marker 360 may be supported during delivery, but the support structure may be removed by proximal retraction / withdrawal of the energy supply member 3102, thereby allowing the non-fluidically deployable marker 360 to fall or detach from the retracted portion of the energy supply member 3102.Alternatively, or additionally, proximal retraction / withdrawal of the energy supply member 3102 may cause the non-fluidically deployable marker 360 to hook onto or be captured by another component, allowing the non-fluidically deployable marker 360 to fall or detach from the retracted portion of the energy supply member 3102. Additionally, or alternatively, the energy supply member 3102 of the energy supply assembly 3100 may define a lumen within it, and the proximal end of the non-fluidically deployable marker 360 may be fitted into the lumen (e.g., by a detachable connection, friction fit, snap fit, etc.). A pusher, such as a stylet or other elongated member well known to those skilled in the art, may be movable through the lumen of the energy supply member 3102, pushing the proximal end of the non-fluidically deployable marker 360 distally from the lumen, thereby deploying the non-fluidically deployable marker 360 toward the treatment site T. After the non-fluidically deployable marker 360 is separated from the energy supply assembly 3100 and deployed at the treatment site T, the energy supply assembly 3100 can be retracted proximal to the treatment site T and removed, as shown in Figure 3B.

[0045] Figure 4A shows an example of an embodiment of an energy supply assembly 4100 configured to carry an additional or alternative non-fluidically deployable marker 460 and to deliver and deploy such a non-fluidically deployable marker 460 to a treatment site T. It should be understood that the illustrated example of an embodiment of the energy supply assembly 4100 may extend from the distal end 100d of an energy supply treatment system 100, as shown in Figure 1. For brevity, the description of the energy supply treatment system 100 shown in Figure 1 will be used as an example of an embodiment of an energy supply treatment system that includes the example embodiment of the energy supply assembly 4100 shown in Figure 4A as a component. The example embodiment of the energy supply assembly 4100 shown in Figure 4A is configured to carry a movable non-fluidically deployable marker 460 relative to the energy supply assembly 4100. For example, the non-fluidically deployable marker 460 may be movably or detachably (for example, slidably or otherwise) attached to a portion of the energy supply assembly 4100 (for example, on top of it, covering it circumferentially, or around it). For example, in one embodiment shown in Figure 4A, the non-fluidically deployable marker 460 is shown as being slidably attached to the energy supply member 4102 of the energy supply assembly 4100. In some embodiments, the non-fluidically deployable marker 460 may be attached at a distance proximal to the distal end 4100d (e.g., the free end) of the energy supply assembly 4100. The non-fluidically deployable marker 460 is movable relative to the energy supply assembly 4100 and configured to deploy from there in one of various embodiments. For example, the non-fluidically deployable marker 460 may be in the form of a band or ring extending substantially circumferentially around a portion of the energy supply assembly 4100 delivered to a treatment site T. A pusher, such as a stylet or other suitable member well known to those skilled in the art, is movable parallel to (for example, along) the energy supply assembly 4100 and can push distally a nonfluidally deployable marker 460 relative to (and generally away from) the energy supply assembly 4100, thereby deploying the nonfluidally deployable marker 460 toward the treatment site T.The pusher is optionally delivered through a delivery channel of a delivery device to which the energy supply assembly 4100 is delivered to the treatment site T, and / or associated with the energy supply assembly 4100 (e.g., movably coupled to it). In some embodiments, the pusher may be delivered along / outside the energy supply assembly 4100 and act like a movable sheath to push a non-fluidically deployable marker 460 from the energy supply member 4102. After the non-fluidically deployable marker 460 is separated from the energy supply assembly 4100 and deployed at the treatment site T, the energy supply assembly 4100 may be retracted proximal to it and removed from the treatment site T, as shown in Figure 4B.

[0046] Another example of an embodiment of the energy supply assembly 5100, configured to carry an additional or alternative non-fluidically deployable marker 560 and to deliver and deploy such non-fluidically deployable marker 560 to a treatment site T, is shown in Figure 5A. It should be understood that the illustrated example of an embodiment of the energy supply assembly 5100 may extend from the distal end 100d of an energy supply treatment system 100, as shown in Figure 1. For brevity, a description of the energy supply treatment system 100 shown in Figure 1 will be used as an example of an embodiment of an energy supply treatment system that includes the example embodiment of the energy supply assembly 5100 shown in Figure 5A as a component. The example embodiment of the energy supply assembly 5100 shown in Figure 5A is configured to carry a movable non-fluidically deployable marker 560 relative to the energy supply assembly 5100. For example, the non-fluidically deployable marker 560 is mounted relative to a portion of the energy supply assembly 5100, for example, within a housing 5103 or within another structure formed relative to the energy supply assembly 5100 and configured to support the non-fluidically deployable marker 560. For example, in one embodiment shown in Figure 5A, the housing 5103 is a recess formed on the outer surface of a portion or component of the energy supply assembly 5100, for example, along the outer surface of the energy supply member 5102 of the energy supply assembly 5100. The non-fluidically deployable marker 560 is mounted movably / removably relative to the energy supply assembly 5100, as shown in Figure 5B, and is separated from there and deployed toward the treatment site T. A pusher, such as a stylet or other suitable member well known to those skilled in the art, is movable relative to the energy supply assembly 5100 and can move the non-fluidically deployable marker 560 relative to the energy supply assembly 5100 (generally toward away from there) and deploy the non-fluidically deployable marker 560 toward the treatment site T. The pusher can be coupled to an actuator such as a button on the handle of the energy supply assembly 5100.In some embodiments, a compressible spring is provided to apply force to the non-fluidically deployable marker 560, thereby deploying / ejecting the non-fluidically deployable marker 560 from the energy supply assembly 5100. The pusher is optionally delivered through a delivery channel of a delivery device to which the energy supply assembly 5100 is delivered to the treatment site T, and / or associated with the energy supply assembly 5100 (e.g., movably coupled to it). After the non-fluidically deployable marker 560 is separated from the energy supply assembly 5100 and deployed at the treatment site T, the energy supply assembly 5100 may be retracted proximal to it and removed from the treatment site T, as shown in Figure 5B.

[0047] As described above, in accordance with the various principles of this disclosure, one or more of the markers described above may be deployed before, during, and / or after treatment of the treatment site. The markers enable the localization of the treatment site after the energy supply assembly used to apply therapeutic energy has been removed. Since the treatment site may be much smaller than the device or element used to apply therapeutic energy thereto, markers such as those disclosed herein may be useful in enabling the localization of the treatment site in order to evaluate the effect of the treatment on the treatment site, for example, in order to determine additional treatments, therapies, protocols, etc., that should be performed.

[0048] It should be understood that in order to determine the initial treatment to be performed at the treatment site, and / or the treatment, therapy, protocol, etc. to be performed, medical professionals may use various forms of information regarding the characteristics, features, etc. of the treatment site. An energy delivery treatment system 100, formed in accordance with the various principles of this disclosure and schematically shown in Figure 1, includes a processor 170 configured to receive information from the treatment site and / or present such information to a medical professional and / or control or otherwise influence the treatment applied to the treatment site. In some embodiments, if a fluid source / reservoir is operably connected to the processor 170, the processor 170 may control the injection of fluid into the target site. In one example of the embodiment shown in Figure 1, the processor 170 includes a console 172 configured to display information for use by a medical professional. The console 172 and / or an input device such as a keyboard 174 may be connected to the processor 170 and configured to allow medical professionals, etc., to input information to the processor 170. In addition, information regarding the treatment site is provided to the processor 170 via the energy supply device 1000 and / or further instruments or devices of the energy supply treatment system 100, as are well known to those skilled in the art.

[0049] Various techniques may be used to obtain information about a treatment site in accordance with the various principles of this disclosure. For example, various techniques may be used to evaluate, assess, and determine one or more characteristics of a treatment site; to detect and / or determine the location of a treatment site and / or disease area to be treated (e.g., lesion) and / or map (including, but not limited to, size, area, volume, and / or shape) the treatment site and / or disease area to be treated; to obtain information about the nature or state of a treatment site (e.g., diagnostic information); to assess the disease state of a treatment site; to determine the appropriate treatment to be applied; to predict the effect of the treatment to be applied; to evaluate, measure, and track the effect of treatment performed on a treatment site; and to obtain information about a treatment site for other related applications of treatment using an energy field. In some embodiments, various techniques may be used to create maps, such as a three-dimensional map of the treatment site. Evaluation of a treatment site may involve determining the nature, characteristics, parameters, etc., of a therapeutic energy treatment to be applied and / or evaluating the effect of such treatment after application to the treatment site. Various techniques that may be used to collect information about a treatment site and / or to influence / control a treatment applied to the treatment site T are schematically shown in Figure 6, in accordance with the various principles of this disclosure. Such information may be obtained using one or more elements, members, devices, assemblies, etc., of an energy supply treatment system 100 formed in accordance with the various principles of this disclosure, as schematically shown by block 6000 in Figures 1 and 6 and described in more detail below. The information obtained from the treatment site T may be transferred to a processor 170 of the energy supply treatment system 100, as further schematically shown in Figures 1 and 6. The information may be made available to a medical professional, as schematically shown by block 6002. The medical professional may use the collected information to control or otherwise influence a treatment protocol to be performed, for example, via input to the processor 170 (e.g., via a keyboard 174 schematically shown in Figure 1).The processor 170 may then process and control one or more elements, components, devices, assemblies, etc., of the energy supply treatment system 100 in order to achieve the desired treatment, in accordance with inputs provided by a medical professional, etc. While this disclosure generally refers to therapeutic energy treatments in the form of electroporation and / or IRE, other forms of treatment are also within the scope and spirit of this disclosure. Furthermore, while this disclosure refers to lesions caused by electroporation and / or IRE, the lesions may additionally or alternatively be other types of lesions, such as thermal lesions. Various techniques for collecting information about the treatment site T and / or executing a protocol (which may be determined based on the collected information) are described with reference to the schematic diagram in Figure 6.

[0050] In accordance with various principles of this disclosure, elastography 6010 (including, but not limited to, shear wave elastography) may be used to collect information about the treatment site T, as schematically shown in Figure 6. For example, elastography 6010 may be used to profile tissue stiffness by deforming the tissue and observing the tissue response in order to assess the stiffness and / or elasticity and / or density of the tissue. In accordance with various principles of this disclosure, the stiffness and other properties of tissue determined by elastography may be correlated with evidence of IRE and / or thermal damage or other effects of the treatment, for example, to measure the size of the lesion after the treatment. Methods for determining properties such as stiffness by deformation of tissue may be carried out in a variety of ways, including, but not limited to, physical probing, acoustic imaging, and during observation of one or more bodily functions or processes. In some embodiments, physical probing may be performed by pushing and / or moving tissue using components of an energy supply treatment system formed according to various principles of the Disclosure, for example, using components of an energy supply device formed according to various principles of the Disclosure. In some embodiments, acoustic imaging may be performed by using an ultrasonic emitting probe that generates pressure waves that strike and deform the tissue. Elements that impact and deform the tissue (e.g., physical probes or acoustic probes) may be delivered transluminally and optionally using energy supply devices formed according to various principles of the Disclosure. Additionally or alternatively, deformation of tissue within a patient and / or identification of a region of interest may occur as a result of movement within the patient's body and / or observation of movement within the patient's body, e.g., movement due to physiological processes (e.g., peristalsis along the gastrointestinal tract, heartbeat, etc.). Additionally, or alternatively, various tissue properties such as tissue stiffness and / or elasticity can be measured using pressure / stress sensors (e.g., those delivered transluminal, endoscopically, etc.), ultrasound, and / or magnetic resonance imaging (MRI).Information regarding tissue stiffness, elasticity, etc., as determined by elastography, is transmitted to the processor 170 in block 6000 and / or provided to a medical professional in block 6002, as schematically shown in block 6012. In some embodiments, the processor 170 is configured for data processing, such as for imaging modalities (e.g., MRI, elastography, hyperspectral imaging, etc.). A processor in the form of a tubular, elongated member of an endoscope may be operably associated with the system-wide processor 170 or may be maintained independently of the system-wide processor 170. The transmitted information may be used to determine and / or understand tissue characteristics, to predict the size and / or area of ​​a lesion (e.g., before treatment), and / or to visualize and / or evaluate the size of a lesion after treatment (e.g., with the assistance of dyes, auxiliary devices, etc., as described above). As can be understood, any of the above markers may also be used in combination with such profiling, evaluation, etc.

[0051] In some embodiments, further information about the treatment site useful in formulating treatment protocols may be obtained via magnetic resonance electrical impedance tomography (MR EIT). For example, MR EIT may be used to create a three-dimensional impedance map of the treatment site (e.g., tissue in the treatment site). As can be understood by those skilled in the art, the size of a lesion usually depends largely on tissue impedance. Furthermore, lower tissue impedance generally indicates zones affected by IRE. Thus, according to various principles of this disclosure, three-dimensional tissue impedance mapping may be used to predict IRE and thermal lesion zones before applying therapeutic energy to the treatment site. Additionally or alternatively, three-dimensional tissue impedance mapping may be used to evaluate the effectiveness of a therapeutic procedure, such as to assess the size of IRE lesions after treatment. According to various principles of this disclosure, an energy supply treatment system, such as an energy supply device formed according to various principles of this disclosure, may include an MRI-compatible endoscopic probe for creating such a map. The probe may be inserted as part of, or as a separate component of, an energy supply assembly used to apply the therapeutic energy field, when the impedance map is created before or immediately after treatment. The impedance measurement 6022 and / or resistance measurement 6024 thus obtained may be transmitted to the processor 170 in block 6000 and / or provided to a medical professional in block 6002. In some embodiments, the medical professional may or may not need to select each specific parameter or element of the waveform. For example, the medical professional may choose from a predetermined set of waveform options (instead of setting waveforms, voltages, currents, etc.). The final variables may be calculated by the processor 170 so as to generate desired values ​​for the selected variables.

[0052] In accordance with various further principles of this disclosure, in addition to or instead of the above techniques, hyperspectral imaging 6030 may be used to collect data on the characteristics of the treatment site. For example, hyperspectral imaging may be used to visualize the electromagnetic spectrum of tissue with very fine wavelength resolution. In accordance with various principles of this disclosure, changes in the electromagnetic spectrum may be correlated with differences in tissue properties and characteristics, and possibly differences in zones affected by thermal damage and / or IRE. In accordance with various principles of this disclosure, an energy supply treatment system, such as an energy supply device formed in accordance with various principles of this disclosure, may include an imaging tip capable of hyperspectral imaging of the treatment site. The imaging tip may be inserted separately from or together with (e.g., as part thereof or as a separate component thereof) an energy supply assembly used to apply a therapeutic energy field to the treatment site. The hyperspectral image of the electromagnetic spectrum 6032 thus obtained may be used by the processor 170 in block 6000 and / or provided to a medical professional in block 6002.

[0053] After the treatment site has been evaluated using any and / or other of the above-described techniques, information regarding the treatment site T (e.g., properties and characteristics and / or other properties of the treatment site T) may be processed by the processor 170 in block 6000 and / or provided to the medical professional in block 6002 of Figure 6. For example, as schematically shown in Figure 6, images of the treatment site (represented by block 6100), calculations of the size of the lesion area / treatment area (including predictions before treatment and / or visualizations after treatment) (represented by block 6110), or other information influencing the determination of the treatment protocol may be delivered to and / or displayed for the medical professional. The medical professional may use such information to determine a desired treatment protocol. For example, in order to achieve a desired treatment of the treatment site T, various parameters of the energy to be delivered to generate a therapeutic energy field at the treatment site T need to be evaluated, determined, selected, and communicated to the energy supply treatment system 100 to implement the desired protocol. For example, a medical professional typically needs to select an appropriate energy waveform 6200, energy pulse characteristics 6210, voltage 6220, or current 6230, etc. (it should be understood that a medical professional can typically adjust either the voltage or current of the applied energy, and the resistance value is set by the patient, for example, according to the characteristics of the patient's tissue). These are input directly to the processor 170 and / or to the energy supply treatment system 100, represented by block 6000, in order to generate an energy field capable of achieving the desired therapeutic effect at the treatment site T. Additionally, or alternatively, a medical professional can make various adjustments to the energy supply assembly (represented by block 6300) via the energy supply treatment system 100 and / or directly via the processor 170, etc., using information obtained in accordance with the various principles of this disclosure. Additionally or alternatively, a medical professional may use information obtained in accordance with the various principles of this disclosure to deploy one or more markers, such as one or more of the markers 130, 360, 460, and 560 described herein, as represented by block 6310.

[0054] In accordance with the various principles of this disclosure, various pieces of information collected using the energy delivery treatment system 100, as described herein or otherwise, may be used, but not limited to, to generate three-dimensional tissue mapping from any of the above-described techniques, and may provide and / or be used in compiling and creating computational models that display real-time estimates of the effects of a proposed treatment protocol on the treatment site, such as predicting the size of thermal lesions and / or IRE lesions. The computational models may display predictions based on selected energy outputs to be delivered to the treatment site T, taking into account the properties, characteristics, features, etc., of the treatment site T (e.g., via console 172 or other information display media, e.g., printouts). For example, the computational models may display predictions based on measured tissue characteristics and selected waveform values ​​to be delivered to the treatment site. This allows healthcare professionals to visualize and at least roughly estimate such treatment plans before actually proceeding with them. It will be understood that the above principles of this disclosure enable healthcare professionals to select waveforms and other energy input values ​​for each patient. The customizability for individual patients provided by this disclosure is particularly advantageous in light of the heterogeneity and other variability among patients that can dramatically affect the size of both IRE lesions and thermal lesions. The ability to locate and estimate the size of both IRE lesions and thermal lesions according to the various principles of this disclosure also enables medical professionals to avoid damaging important / critical anatomical structures (e.g., blood vessels) that are close to the treatment site of interest (e.g., which may be within the range of the applied energy field).

[0055] It should be understood that energy supply assemblies used to deliver energy-based therapies in accordance with the various principles of this disclosure may be any suitable form or configuration for delivering energy-based therapies. In some embodiments, the energy supply assembly may be a bipolar probe, such as a linear bipolar probe, having two electrodes delivered to the treatment site axially spaced apart from each other on the same energy supply assembly. However, it should be understood that non-bipolar and / or non-linear configurations are also within the scope and spirit of this disclosure. For example, energy supply assemblies having more than two electrodes, or unipolar devices and / or unipolar devices, may be used in conjunction with energy supply treatment systems formed in accordance with the various principles of this disclosure. Furthermore, the principles of this disclosure may also be applied to energies other than electroporation and / or IRE energy, such as other energy sources for ablation or other purposes.

[0056] It will be further understood that any or all of the above-described modes of delivery and deployment may be performed using appropriate imaging techniques that are well known to those skilled in the art. In addition, it will be understood that this disclosure is not limited to any type of processor, monitor, delivery device, or other device, system, or equipment that supports the therapeutic devices and related methods of this disclosure.

[0057] Finally, it should be understood that the devices, systems, assemblies, and methods disclosed herein may be delivered endoscopically, transluminally, or percutaneously, and may be used within other access devices such as maneuverable lumen access devices.

[0058] All structures, devices, systems, assemblies, and methods described herein are examples of implementations in accordance with one or more principles of the Disclosure, and are not the only ways of implementing these principles, and are therefore not intended to limit the broader aspects of the Disclosure. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of the Disclosure and should not be understood as limiting the Disclosure to any particular element, structure, or feature illustrated. Other examples of ways of implementing the disclosed principles can be imagined by those skilled in the art who have read this Disclosure. It will be apparent to those skilled in the art that modifications can be applied to the disclosed devices, assemblies, systems, and / or methods, and / or the sequence of steps of the methods described herein, without departing from the concepts, spirit, and scope of the Disclosure. It will be understood that various features described in relation to one embodiment can generally be applied to other embodiments, whether expressly indicated or not. The various features described below can be used individually or in any combination thereof. Accordingly, the present invention is not limited to the embodiments specifically described herein, and all substitutions and modifications that are obvious to those skilled in the art are deemed to be included within the spirit, scope, and concept of this disclosure as defined by the appended claims.

[0059] The foregoing description has broad applications and is presented for illustrative and explanatory purposes only; it is not intended to limit the disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure can be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from its concepts, technical ideas, scope, or characteristics. For example, various features of the disclosure are grouped together into one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the disclosure may be combined in alternative aspects, embodiments, or configurations. While the disclosure is presented with respect to embodiments, it should be understood that various distinct features of the subject matter do not all need to be present to achieve at least some of the desired characteristics and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that this disclosure can be used with numerous modifications, or modifications to the structure, arrangement, proportions, materials, components, etc., used in the implementation of this disclosure, without departing from the principles, technical ideas, or scope of this disclosure, or particularly suited to specific environmental and operating requirements. For example, an element shown as being formed as a whole may consist of multiple parts, or an element shown as multiple parts may be formed as a whole, the operation of an element may be reversed or modified, and the size or dimensions of an element may be modified. Similarly, while an operation or action or procedure is described in a particular order, this should not be understood as requiring such a particular order to achieve a desired result, or as meaning that all operations or actions or procedures should be performed. In addition, other forms of implementation are within the scope of the following claims. In some cases, the operations described in the claims may be performed in a different order, and the desired result may still be achieved.Accordingly, the embodiments currently disclosed should be considered in all respects to be illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to any specific embodiment or configuration described or illustrated herein. In consideration of the foregoing, individual features of any embodiment may be used, either separately or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0060] In the foregoing description and the following claims, it will be understood that: The terms “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions that are both conjunctive and disjunctive in their function. Terms such as “a,” “an,” “the,” “first,” and “second” do not exclude plurals. For example, the term “a” or “an” entity, as used herein, refers to one or more of those entities. Thus, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably herein. As used herein and in the appended claims, the term “or” is used generally to include “and / or,” unless the content explicitly states otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. thus combined unless the context explicitly indicates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. thus combined, either alone or in any combination and number, unless the context explicitly indicates otherwise. All directional references (e.g., proximal, distal, top, bottom, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or to distinguish areas of related elements from one another, and do not limit the elements relevant in particular with respect to the location, orientation, or use of this disclosure. References to connections (e.g., attached, combined, connected, engaged, joined, etc.) should be interpreted broadly and, unless otherwise indicated, may include intermediate members between sets of elements and relative movement between elements. Therefore, references to connections do not necessarily imply that two elements are directly connected or have a fixed relationship with one another. References to identifications (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0061] The following claims are incorporated by reference into this detailed description, and each claim stands independently as a distinct embodiment of the present disclosure. In the claims, the terms “equipped,” “equipped,” “included,” and “included” do not exclude the existence of other elements, components, features, groups, areas, integers, steps, operations, etc. In addition, individual features may be included in different claims, but they may be advantageously combined, and inclusion in different claims does not mean that the combination of features is not feasible and / or advantageous. In addition, singular references do not exclude plurals. Reference numerals in the claims are provided merely as examples for clarity and should never be construed as limiting the claims.

Claims

1. A device that enables the identification, characterization, and / or localization of a site to be treated by the application of therapeutic energy, An energy supply assembly having an energy supply region, wherein an energy field is generated along the energy supply region and therapeutic energy is applied to the treatment site, An apparatus comprising a device configured to characterize the treatment site for evaluation by a medical professional when determining a treatment protocol that generates an energy field using the energy supply region.

2. The apparatus according to claim 1, wherein the device is configured to deploy a deployable marker to the treatment site.

3. The apparatus according to claim 2, wherein the marker is an injectable material delivered through the lumen through which the energy supply assembly is delivered.

4. The apparatus according to claim 3, wherein the energy supply assembly includes an energy supply member, the energy supply region is defined along the energy supply member, and the lumen is independent of the energy supply member.

5. The apparatus according to claim 3 or 4, wherein the energy supply assembly includes an energy supply member that defines a lumen along the energy supply member from which the injectable material is delivered.

6. The apparatus according to any one of claims 2 to 5, wherein the marker is supported by the energy supply assembly.

7. The apparatus according to any one of claims 2 to 6, wherein the marker is delivered to the treatment site as part of the energy supply assembly and is separated from the energy supply assembly to be deployed at the treatment site.

8. The apparatus according to any one of claims 2 to 7, wherein the marker is supported on the energy supply assembly and is deployed to the treatment site by sliding away from the energy supply assembly.

9. The apparatus according to any one of claims 2 to 8, wherein the energy supply assembly defines a housing, the marker is carried within the housing to the treatment site, and the marker is released from the housing to be deployed at the treatment site.

10. The device is the apparatus according to any one of claims 1 to 9, which profiles the characteristics of the treatment site.

11. The apparatus according to any one of claims 1 to 10, wherein the device maps the characteristics of the treatment site using one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging.

12. A system for identifying the characteristics of a treatment site in order to assist in performing energy-based treatment at the treatment site, An energy supply device comprising an energy supply assembly having an energy supply region, wherein an energy field for applying therapeutic energy to a treatment site is generated along the energy supply region, The energy supply assembly comprises a delivery device having a working channel through which it is delivered to the treatment site, A system comprising a device configured to characterize the treatment site for evaluation by a medical professional when determining a treatment protocol that generates an energy field using the energy supply region.

13. The system according to claim 12, wherein the device maps the characteristics of the treatment site using one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging, and the system further comprises a processor configured to receive information from the device and create a model of the treatment site based on the received information.

14. The system according to any one of claims 1 to 13, wherein the device is configured to deploy a deployable marker to the treatment site.

15. The system according to any one of claims 1 to 14, wherein the deployable marker is identifiable after an energy field is applied to the treatment site and the device is removed from the treatment site.

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