Apparatus, system and method for imaging lesions

Abstract

An energy delivery therapy system facilitates determining 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; an impedance or resistance of the tissue (which may affect the form of energy, such as electroporation and / or irreversible electroporation applied to the tissue); and / or the effect of the treatment applied to the lesion. The collected information about the treatment site may be used to assist in predicting and measuring lesions, and / or to determine an appropriate treatment plan based on the condition of each patient. After the energy delivery assembly has been withdrawn from the treatment site, indicia may be used to facilitate localization of the treatment site.

Description

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 incorporated herein by reference for all purposes. Technical Field

[0002] This invention generally relates to the field of devices, components, systems, and methods for treating patients using energy fields. More particularly, this invention relates to medical devices, components, systems, and methods associated with therapies and treatments utilizing energy fields, including devices, components, systems, and methods for imaging, sensing, locating, identifying, measuring, and determining treatment protocols utilizing energy fields. Background Technology

[0003] Devices, components, systems, and methods exist for energy-based medical treatments and / or therapeutic protocols. For example, various local therapeutic devices are configured to apply energy to devolve or eliminate malignant cells in target tissue. Various techniques used for such treatments rely on thermal effects, such as radiofrequency (“RF”) heating, microwave heating, cryoablation, high-intensity focused ultrasound (“HIFU”), etc. In contrast, electroporation and / or irreversible electroporation are non-thermal therapies and offer significant potential benefits compared to thermal modalities. Energy can be applied to perform electroporation and / or irreversible electroporation (“IRE”) as a mode of treating various conditions and / or diseases by using energy fields 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 plasma in cell membranes. The applied energy causes pathways / pores to open within the cell walls and / or cell membranes in the vicinity of the energy-applying device (e.g., near its electrodes, probes, etc.). In reversible electroporation, pores in the cell wall open to allow material to be absorbed into the cell, whereas in other cases, material may not be able to easily pass through the cell wall and / or its channels. Otherwise, the cell remains essentially intact. Conversely, in irreversible electroporation, the electric field disrupts homeostasis in vivo and kills cells, such as through apoptosis and / or necrosis. Various challenges associated with treatments involving energy fields include determining the appropriate parameters of the energy to be applied to create the energy field, and the resulting effects on the cells. In particular, with IREs, effects on cells may not be detectable within hours, and sometimes even for 24–72 hours or longer. Furthermore, affected cells may be very small and therefore difficult to locate and / or identify within hours after treatment has been performed. The improvements of the present invention may be useful in light of these and other considerations. Summary of the Invention

[0004] This summary provides a simplified overview of a series of concepts, which will be further described in the detailed description below. This summary is not intended to necessarily identify key or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter. Those skilled in the art will understand that various aspects and features of the invention may be advantageously used alone in some cases, or in combination with other aspects and features of the invention in others, whether or not they are described in this summary. The inclusion or exclusion of elements, components, etc., in this summary is not intended to limit the scope of the claimed subject matter.

[0005] According to various principles of the invention, a device is configured to facilitate the identification, characterization, and / or localization of a treatment site by applying therapeutic energy thereto. According to various principles of the invention, the device includes an energy delivery assembly having an energy delivery region, an energy field generated along the energy delivery region to apply therapeutic energy to the treatment site; and means configured to characterize the treatment site for evaluation by a medical professional to determine a treatment regimen utilizing the energy field generated by the energy delivery region.

[0006] In some aspects, the device is configured to deploy a deployable marker at a treatment site. In some aspects, the marker is an injectable material delivered via a lumen delivered together with an energy delivery assembly. In some aspects, the energy delivery assembly includes an energy delivery member defining an energy delivery region along the energy delivery member, and the lumen is independent of the energy delivery member. In some aspects, the lumen is delivered to the treatment site together with the energy delivery member. Alternatively or additionally, the energy delivery assembly includes an energy delivery member defining a lumen through which the injectable material is delivered. In some aspects, the marker is transported by the energy delivery assembly. In some aspects, the marker is delivered to the treatment site as part of the energy delivery assembly and is detached from the energy delivery assembly for deployment at the treatment site. In some aspects, the marker is transported on and detachable from the energy delivery assembly for deployment at the treatment site. In some aspects, the energy delivery assembly defines a housing in which the marker is transported to the treatment site, and the marker is released from the housing for deployment at the treatment site.

[0007] In some aspects, the device maps the characteristics of the treatment site. In other aspects, the device uses one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging to map the characteristics of the treatment site.

[0008] According to various principles of the invention, a system is configured to identify features of a treatment site to assist in performing energy-based therapy at the treatment site. According to various principles of the invention, the system includes an energy delivery device comprising an energy delivery assembly having an energy delivery region along which an energy field is generated to apply therapeutic energy to the treatment site; a delivery device having a working channel through which the energy delivery assembly delivers energy to the treatment site; and a device configured to characterize the treatment site for evaluation by a medical professional to determine a treatment regimen utilizing the energy field generated by the energy delivery region.

[0009] In some aspects, the device uses one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging to map the characteristics of the treatment site, and the system also includes a processor configured to receive information from the device and develop a model of the treatment site based on the received information.

[0010] In some respects, the device is configured to deploy a deployable marker at the treatment site. In other respects, the 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.

[0011] According to various principles of the present invention, a method for treating and characterizing a treatment site includes delivering an energy delivery component of an energy delivery device of an energy delivery system to the treatment site; generating an electric field along an energy delivery region of the energy delivery component to apply therapeutic energy to the treatment site; determining the nature or characteristics of the treatment site using an energy delivery treatment system; and using the determined nature to influence the treatment performed, or to further treatment performed in relation to the treatment site.

[0012] In some aspects, the method includes deploying markers during or after the application of therapeutic energy to the treatment site, wherein determining the nature or characteristics includes using the markers to determine the location of the treatment site.

[0013] In some aspects, the method includes using defined properties to create a three-dimensional map of the properties of the treatment site. In other aspects, the method includes using a characteristic map of the treatment site to aid in predicting and measuring the therapeutic energy to be applied to the treatment site.

[0014] These and other features and advantages of the invention will become apparent from the following detailed description, in which the scope of the claimed invention is set forth in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be understood that individual aspects may be claimed individually or in combination with aspects and features of that embodiment or any other embodiment. Attached Figure Description

[0015] Non-limiting embodiments of the invention are described by way of example with reference to the illustrative and not scaled-up accompanying drawings. The drawings are provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures may vary. For example, devices may be enlarged to make details discernible, but are intended to be scaled down, for example, when fitted within the working channel of a delivery catheter or endoscope. For clarity and simplicity, not every element is labeled in every figure, and not all elements of each embodiment that are not essential for understanding this disclosure by those skilled in the art are shown.

[0016] A detailed description will be better understood in conjunction with the accompanying drawings, wherein similar reference characters denote similar elements, as described below:

[0017] Figure 1 A schematic diagram of an energy delivery therapy system according to various aspects of the present invention, relating to a treatment site, is shown.

[0018] Figure 1A It shows along Figure 1 A schematic diagram of detail 1A in the diagram.

[0019] Figure 2A A front view of an example embodiment of an energy delivery assembly that delivers injectable markers is shown.

[0020] Figure 2B A front view of another embodiment of an energy delivery assembly for delivering injectable markers is shown.

[0021] Figure 3A A front view of an example embodiment of an energy delivery assembly that delivers a marker that is not injected into the treatment site is shown.

[0022] Figure 3B for Figure 3A A front view of the energy delivery component after it has been deployed relative to the treatment site.

[0023] Figure 4A A front view of an example embodiment of an energy delivery assembly that delivers a marker that is not injected into the treatment site is shown.

[0024] Figure 4B After deploying markers to the relevant treatment site Figure 4A A front view of the energy delivery component.

[0025] Figure 5A A front view of an example embodiment of an energy delivery assembly that delivers a marker that is not injected into the treatment site is shown.

[0026] Figure 5BAfter deploying markers to the relevant treatment site Figure 5A A front view of the energy delivery component.

[0027] Figure 6 Various techniques and methods that can be used with energy delivery therapy systems based on various principles of the present invention are illustrated schematically. Detailed Implementation

[0028] The following detailed description should be read with reference to the accompanying drawings, which depict illustrative embodiments. It should be understood that the invention is not limited to the specific embodiments described and therefore variations are possible. All devices, systems, and methods discussed herein are examples of devices and / or systems and / or methods implemented according to one or more principles of the invention. Each example of an embodiment is provided by way of explanation and is not the only way to implement these principles, but merely an example. Therefore, references to elements or structures or features in the drawings must be understood as references to examples of embodiments of the invention and should not be construed as limiting the invention to the specific elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will occur to those skilled in the art upon reading this invention. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made to the invention without departing from the scope or spirit of the subject matter. For example, features illustrated and described as part of one embodiment may be used with another embodiment to produce further embodiments. Therefore, this subject matter is intended to cover such modifications and variations within the scope of the appended claims and their equivalents.

[0029] It should be understood that the invention has been described in various levels of detail in this application. In some cases, details that are unnecessary for those skilled in the art to understand the invention or that make other details difficult to perceive may have been omitted. The terminology used herein is for describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, the technical terminology used herein should be understood as commonly understood by those skilled in the art to which this invention pertains. According to the invention, all the apparatuses and / or methods disclosed and claimed herein can be manufactured and performed without requiring extensive experimentation.

[0030] As used herein, “proximal” means the direction or location closest to the user (medical professional, clinician, technician, operator, or physician, etc.; this term is used interchangeably herein and is not intended to be limiting, and includes automated control systems or others), such as when the device is used (e.g., during insertion into a patient, or during implantation, positioning, or delivery) and / or closest to the delivery device, and “distal” means the direction or location furthest from the user, such as when the device is used (e.g., during insertion into a patient, or during implantation, positioning, or delivery) and / or closest to the delivery device. “Longitudinal” means extending along the longer or larger dimension of the element. “Longitudinal axis” extends along the longitudinal extent of the element, but is not necessarily straight, and does not necessarily remain in a fixed shape if the element is buckled or bent, and “axial” generally refers to along the longitudinal axis. However, it should be understood that references to axial or longitudinal movement relating to the aforementioned system or its elements are not necessarily strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the referenced element. "Center" means that the center point is at least substantially bisected and / or substantially equidistant from the periphery or boundary, and "central axis" means a line that, in relation to an opening, at least substantially bisectes the center point of the opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, channel, cavity, or orifice. As used herein, "cavity," "channel," "orifice," or "passage" is not limited to a circular cross-section. As used herein, the "free end" of an element is the end beyond which such element does not extend. It should be understood that, unless otherwise stated, terms such as at or on or near or along are used interchangeably herein, are not intended to be restrictive, unless otherwise stated, and are intended to indicate a generally relative gap relationship, rather than a precisely defined location. Finally, references to "at" a location or part are intended to include at and / or near such location or part (e.g., along it, adjacent to it, immediately adjacent to it, etc.). As understood herein, correspondences are intended to convey relationships between parts, sections, elements, etc., configured to interact with each other or to have another intended relationship.

[0031] This invention describes various improvements to medical procedures for applying energy to treatment sites within a patient's body. It should be understood that terms such as surgery, therapy, treatment, operation, protocol, etc., including their other grammatical forms, are used interchangeably herein and are not intended to be limiting. It should also be understood that references herein to treatment site, target site, anatomical site, therapeutic site, lesion site, tumor site, etc. (whether or not accompanied by the term "site") are used interchangeably and are not intended to be limiting. The following description is generally relevant to energy therapy employing the forms of electroporation and / or irreversible electroporation ("IRE"), but is also applicable to other forms of energy therapy.

[0032] As is generally used herein, the term “ablation” generally refers to the direct or indirect removal of cells by supplying energy to the cells, such as in an energy field, such as an electric field, and may include removal of cells by loss of cell function, cell lysis, coagulation, protein denaturation, necrosis, apoptosis, and / or irreversible electroporation. “Ablation” can similarly refer to the creation of a lesion by ablation. Additionally, the terms “unhealthy tissue,” “target cell,” “disease tissue,” “disease cell,” “tumor,” and “cell cluster” may be used herein to refer to cells that are removed or to be removed, wholly or partially, by ablation, and are not intended to limit the application of any of the components, systems, devices, or methods described herein. For example, such terms include both ablation of diseased cells and certain surrounding cells, however, without explicitly indicating that such surrounding cells are diseased. Ablation performed by the components, systems, devices, or methods described herein may target cells located around biological cavities, such as regions of blood vessels, catheters, or conduits, for example, to create margins for medical professionals to remove additional cells by ablation or other methods. According to various principles of the invention, the apparatuses, components, systems and methods disclosed herein can be configured to perform ablation via electroporation and / or IRE.

[0033] Energy therapies, such as electroporation and / or IRE, typically involve applying an excitation potential to one or more electrodes positioned at a target site to create an electric field that exposes the target (e.g., dysplastic tissue). In the case of electroporation, the porosity of cells at the target site increases to allow for the absorption of materials, such as therapeutic materials, by the cells with minimal impact on surrounding tissues. 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 respects, energy is applied in pulses or otherwise varied to force the pores of the cell wall to open and close. After repeated opening and closing of the pores and / or application of a certain amount of energy, the cell wall may be permanently disrupted / damaged (e.g., broken down), and the internal components of the cell and / or other substances from the cell may be released and enter the interstitial space and / or the patient's body. Once released from the cells and body, these components and / or substances (e.g., antigens) trigger the immune system to activate an immune response to further treat the target site (e.g., tumor), such as by attacking the remaining dysplastic tissue.

[0034] Energy for achieving the desired treatment can be applied to the target site via electrodes positioned adjacent to, near, close to, or at the target site. The applied energy and / or excitation potential and / or the generated electric field can be characterized by various parameters, such as, for example, frequency, amplitude, pulse width (pulse duration or pulse length), and / or polarity. Suitable energy sources include electrical waveform generators, such as waveform generators capable of creating IREs, high-frequency IREs, nanopulses, and / or ablation waveforms. The energy source generates an energy field with the desired characteristics for the treatment to be performed at the target site, such as based on the treatment site, application, device, electrode configuration, etc. For example, an energy field can be generated to have a characteristic waveform output suitable in terms of voltage, impedance, frequency, amplitude, pulse width, delay between pulses, number of pulses per pulse train, number of pulse trains, and phase. Current can flow between the electrodes and through the tissue in proportion to the potential (e.g., voltage) applied to the electrodes. The supply current provided by the energy source can deliver a pulse sequence to the target site. For example, the energy source can supply various waveforms in one or more pulse sequences tailored to the desired application.

[0035] Electroporation and / or IRE therapies do not rely on thermal energy and may involve applying highly focused energy to the target site, thus generally reducing and / or eliminating the risk of damage to surrounding cells that might be caused by other forms of energy therapy. Due to patient-to-patient variability and the variability of tissue / tumor in individual patients, such as those relating to tissue properties (e.g., impedance, heterogeneity, nature of the tumor to be treated, etc.), it is necessary to determine and evaluate the initial parameters of the therapeutic energy regimen to be applied to the patient on an individual basis to achieve the desired effect of IRE. Therefore, it is important to determine and evaluate various parameters before applying the energy regimen. This invention describes various techniques for determining and evaluating various tissue properties and other information and parameters for determining the therapy to be performed. According to various principles of the invention, various tissue properties are imaged and mapped to aid in the prediction and measurement of electroporation, IRE, and / or thermal lesions. Alternatively or additionally, according to various principles of the invention, information collected according to various principles of the invention can then be further utilized to inform a computational model that displays real-time information, such as estimates of thermal, IRE, and / or other lesion characteristics, such as size, for further therapeutic purposes.

[0036] This invention describes further techniques for determining information about treatment sites, such as lesions created by energy applied according to various principles of the invention. For example, various techniques for determining and / or assessing information about treatment sites, such as, but not limited to, the location of the treated and / or created lesion; the size of the lesion; and / or the percentage of thermal damage to IRE at a given target site, are disclosed according to various principles of the invention. Given the differences between patients, even with appropriate assessment and delivery according to the techniques described herein, the applied treatment will have different effects and / or outcomes depending on the patient before application to the patient. It is generally considered, if not critical, at least important to characterize the treatment area after treatment has been performed (e.g., an IRE lesion has been created) to understand, assess, plan, and otherwise provide care and / or further treatment to the patient.

[0037] Additionally, once electroporation and / or IRE have been performed, it is generally considered important to characterize the created lesion to understand the care to be provided to the patient. For example, IRE typically preserves the extracellular matrix of the cells to which energy has been applied. Even if the cells undergo apoptosis, the matrix supporting the cells usually remains relatively intact. Various devices, systems, and methods are disclosed for leaving markers at the treatment site (e.g., within a tumor, such as within the extracellular matrix that remains intact even after IRE has been performed), which remain in place after energy therapy has been completed. The markers facilitate subsequent localization and / or identification of the treatment site to assess the effectiveness of the energy applied to the treatment site. The markers can be fluids (e.g., contrast agents, stains, dyes, etc.) and / or elements with a generally fixed structure (opposite to the fluid). The markers can be injected before, during, or after the delivery of therapeutic energy. The markers can remain in situ at the treatment site for at least a sufficiently long time to allow for localization and / or identification of the treatment site even after the electrode or other energy delivery device has been withdrawn. For example, the marker can remain in place for more than 24 hours after treatment, such as at least 72 hours. In some respects, the marker does not need to be actively removed by any means other than the natural bodily functions that may expel the marker and / or absorb it in other ways (e.g., in the case of using bioabsorbable markers).

[0038] Various embodiments of apparatuses, components, systems, and methods will now be described with reference to the examples shown in the accompanying drawings. References throughout this specification to “one embodiment,” “embodiment,” “some embodiments,” “other embodiments,” etc., indicate that the embodiment may include one or more specific features, structures, concepts, and / or characteristics according to the principles of the invention. However, such references do not necessarily imply that all embodiments include specific features, structures, concepts, and / or characteristics, or that one embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics employing various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein may be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the invention. Furthermore, references throughout the specification to “one embodiment,” “embodiment,” “some embodiments,” “other embodiments,” etc., do not necessarily refer to the same embodiment, nor are they necessarily separate or alternative embodiments mutually exclusive with other embodiments. It should also be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and separate from each other, and may be used or presented individually or in various combinations thereof to create alternative embodiments considered part of the invention. Therefore, the invention is not limited to the embodiments specifically described herein, as describing all possible combinations and sub-combinations of features, structures, concepts, and / or characteristics would be overly cumbersome, and the examples of embodiments disclosed herein are not intended to limit the broader aspects of the invention. It should be understood that the various dimensions provided herein are examples, and those skilled in the art can readily determine the appropriate range of standard deviations and acceptable variations covered by the invention and any claims associated therewith. The following description is merely illustrative examples of embodiments and is not intended to limit the broader aspects of the invention.

[0039] Now turn to the attached diagram. Figure 1 An example embodiment of an energy delivery therapy system 100 configured to apply therapeutic energy to a treatment site within a patient is shown. The energy delivery therapy system 100 includes an energy delivery device 1000, such as an electroporation device, configured to deliver therapeutic energy to a treatment site within a patient. Figure 1 In the illustrated embodiment of the energy delivery device 1000, the energy delivery component 1100 (which may alternatively be referred to as a probe) is disposed at the distal end 1000d of the energy delivery device 1000, such as... Figure 1A As shown in further detail below. The energy delivery component 1100 can be located within the patient's body (e.g., within the gastrointestinal system, such as...). Figure 1(Illustrated in the schematic, or in other anatomical locations, the invention is not limited in this respect) delivers and is configured to establish a therapeutic energy field at the treatment site T.

[0040] As shown Figure 1 Details 1A Figure 1A As shown, an example of one embodiment of the energy delivery assembly 1100 includes at least one energy delivery member 1102 insertable relative to a treatment site T (e.g., tumor, lesion, etc.). The energy delivery member 1102 may be defined along its defining electrodes, such as along the distal end 1100d of the energy delivery assembly 1100. Therefore, at least a portion of the energy delivery 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 may be disposed proximal to the distal end 1102d of the energy delivery member 1102 to define / define a distal energy delivery region 1106 of the energy delivery assembly 1100, along which an energy field is generated. In some aspects, the distal end 1100d (e.g., a terminal) of the energy delivery assembly 1100 has a sharp distal tip, such as formed at or along the terminal of the energy delivery member 1102. The sharp distal tip can be configured to pierce tissue / organ / tumor mass, as known to those skilled in the art. For example, the energy delivery component 1102 can take the form of a cannula, needle, etc.

[0041] The energy delivery component 1100 can deliver energy to the treatment site T via the delivery device 110, such as... Figure 1 The delivery device 110 (e.g., a tubular member, sheath, catheter, etc.) is schematically illustrated. It has a lumen or working channel extending through it, sized to allow the energy delivery assembly 1100 to pass through. Additionally, the size, shape, construction, and / or dimensions of the delivery device 110 are configured for insertion into the human body via pathways, such as natural anatomical pathways, cavities, orifices, etc. (e.g., esophagus, stomach, intestine, etc. and / or pathways, lumens, channels, etc.). It should also be understood that terms such as pathway, lumen, orifice, channel, etc., are used interchangeably herein and are not intended to be limiting. Figure 1 In one embodiment of the energy delivery therapy system 1000 shown, the delivery device 110 is illustrated as an endoscope. However, the invention is not limited in this respect. (See reference...) Figure 1 and Figure 1A Understandably, the delivery device 110 includes an insertion tube 112 that defines a working channel 111 through which the energy delivery assembly 1100 can deliver energy to the treatment site T via the working channel 111. Figure 1In the illustrated embodiment example, the energy delivery component 1100 of the energy delivery therapy system 1000 is inserted into the port 114 of the delivery device 110, such as that defined on the handle 116 of the delivery device 110, to enter the working channel 111 of the insertion tube 112 (e.g., Figure 1A As shown in the image).

[0042] The energy delivery assembly 1100 may further include a sheath 1110, through which the energy delivery assembly 1100 can deliver energy to a target site T, such as... Figure 1A As shown. The sheath 1110 can protect the pathway through which the energy delivery assembly 1100 extends (e.g., the interior and / or anatomical pathways or structures of the working channel 111 of the insertion tube 112 of the delivery device 110) from damage due to the sharp distal tip of the energy delivery assembly 1100 (e.g., at the distal end 1102d of the energy delivery member 1102). The sheath 1110 can be selectively retracted proximally relative to the energy delivery member 1102 and / or the energy delivery member 1102 can extend distally relative to the sheath 1110 to expose at least the distal energy delivery region 1106 of the energy delivery assembly 1100 to the treatment site T.

[0043] To apply therapeutic energy to the treatment site T, such as by generating an energy field (e.g., an electric field) along the energy delivery region 1106 of the energy delivery assembly 1110, the energy delivery member 1102 is electrically connected to the energy source 120. For example, as Figure 1 As shown, a power connector 1120 extending along the proximal end 1000p of the energy delivery device 1000 can electrically connect the energy delivery component 1102 to the energy source 120 of the energy delivery therapy system 100. The power connector 1120 can be a wiring harness or other conductive component configured to connect to the energy source. The energy source 120 can be an electroporation generator (e.g., an electric field generator, waveform generator, electrical pulse generator, etc.), or any other energy generation device, such as those known to those skilled in the art for generating energy suitable for application to the energy delivery component 1100 of the energy delivery device 1000 for performing electroporation and / or IRE therapy. The invention is not necessarily limited to the details of the energy source.

[0044] In some aspects, the energy delivery device 1000 also includes a handle 1130 from which the energy delivery assembly 1100 extends distally, and a power connector 1120 extends proximally from the handle 1130. The handle 1130 can be configured to control and / or adjust the position of the energy delivery assembly 1100 and / or the sheath 1110, such as relative to each other and / or relative to the delivery device 110.

[0045] As discussed above, according to various principles of the present invention, Figure 1 An example of one embodiment of the energy delivery therapy system 100 shown is configured to facilitate the identification, characterization, and localization of the treatment site T before, during, and / or after the application of therapeutic energy. For example, according to various principles of the invention, the energy delivery therapy system 100 may be configured to mark the treatment site T for easy identification, characterization, and localization.

[0046] In some aspects, the energy delivery therapy system 100, formed according to various principles of the invention, 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 the treatment site T. For example, an injectable substance (e.g., a fluid or other) capable of being visualized or otherwise located and / or identified, such as by using visualization and / or other devices (e.g., external visualization techniques), can be injected into the treatment site T. This injectable substance thus allows for 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 can be a contrast agent, staining agent, dye, cell marker, strain sensing mechanism, etc., which remains in the treatment site T after injection. For example, cells that have died from IRE can readily take up the injectable substance. In some aspects, dead cells will turn one color, and surviving cells will turn another color.

[0047] For delivering injectable substances, the energy delivery therapy system 100, formed according to various principles of the present invention, includes a delivery cavity through which the injectable substance can be delivered and deployed within a treatment site T. For example, in some aspects, the energy delivery device 1000 may include a delivery cavity. Figure 2A In the illustrated embodiment of the energy delivery assembly 1100, injectable substance 130 (optionally, which may be considered part of an energy delivery therapy system 100 formed according to various principles of the invention) can be injected via a lumen formed separately from and even separately from the energy delivery member 1102 and the energy delivery assembly 1100. For example, as Figure 2A As shown, the individual tubular member 140 can be inserted together with the energy delivery assembly 1100 into the treatment site T. For example, the individual tubular member 140 can be inserted through the working channel 111 of the delivery device 110 (e.g., endoscope 110), such as... Figure 1 and Figure 1AAs shown. Alternatively, device replacement can be performed, and tubular components, such as individual hollow needles (e.g., not used for ablation or not used during ablation), can travel along the working channel 111 of the delivery device 110. The injectable material 130 of the energy delivery therapy system 100 can be delivered to the tubular component in a manner known to those skilled in the art, such as via port 114 of the delivery device 110.

[0048] Alternatively or concurrently, the energy delivery device 1000 may have an energy delivery assembly having a delivery cavity defined by its components for delivering the injectable substance 130 to the treatment site T. For example, the lumen may be incorporated into... Figure 1 and Figure 1A In the energy delivery device 1000 shown. More specifically, the lumen 2101 can be accessed via, for example... Figure 2B The energy delivery component 2102 of the energy delivery assembly 2100 shown is defined. It should be understood that the embodiment examples of the energy delivery assembly 2100 shown in FIG. 2 can be derived from... Figure 1 The distal end 1000d of the energy delivery device 1000, an example of the energy delivery system 100 shown, extends (e.g., forms part of it or is otherwise incorporated therein). Once the distal end 2100d of the energy delivery assembly 2100 has entered the treatment site T, the injectable substance 130 can be delivered to the treatment site T via the lumen 2101, as shown in FIG. 2. According to various principles of the invention, the injectable substance 130 can be injected into the treatment site T before, during, or after therapeutic energy is applied to the energy delivery assembly 2100 to create an energy field configured to treat the treatment site T. Alternatively, the injectable substance 130 can be delivered to the lumen 2101 via a handle 1130 from a fluid source 150 fluidly connected to the handle 1130, as in a manner known to those skilled in the art.

[0049] and Figure 1A Similar to the energy delivery assembly 1100 shown above, an example of an embodiment of the energy delivery assembly 2100 shown in FIG2 may have a sharp distal end 2100d, which is configured to enter the treatment site T (e.g., into a tumor). It should be understood that various other features and / or structures of the example of an embodiment of the energy delivery assembly 2100 shown in FIG2 may be present. Figure 1A The energy delivery assembly 1100 shown in the illustration has similar or substantially the same features and / or structure as one embodiment. For the sake of brevity and not intended to be limiting, reference is made to the description of such additional features and structures above, which also applies to the energy delivery assembly 2100 shown in FIG. 2.

[0050] According to various principles of the invention, the injectable substance 130 can be any of a variety of substances that allow for detection (visualization) in any of a variety of ways. In some aspects, the injectable substance 130 may include a contrast agent that allows visualization of itself and the treatment site T using computed tomography (CT). This embodiment will enable real-time CT imaging and real-time volumetric lesion assessment. According to various principles of the invention, the injectable substance 130 is injected into the treatment site T and imaging is performed immediately after or during treatment delivery. According to various principles of the invention, care should be taken to ensure that the contrast / staining / coloring area corresponds to the ablation area or the area where different degrees of electroporation are applied.

[0051] Alternatively or concurrently, the injectable substance 130 may include a fluorescent staining agent that allows visualization of itself and the treatment site T using a laser. For example, the injectable substance 130 may be made of molecules that fluoresce at different selected wavelengths of light and / or a fluid containing such molecules. Such molecules will be programmed for absorption by cells at the treatment site T. An example of such a molecule is propidium iodine, which can be absorbed by cells that have been electroporated and will visually highlight the IRE ablation area. To visualize the treatment site T endoscopically, a laser can be used to illuminate the tumor and locate the fluorescent molecules. A similar process can be used in open surgery.

[0052] Alternatively or concurrently, the injectable substance 130 may include a contrast agent and / or a fluorescent staining agent that can be visualized using photoacoustic imaging. During photoacoustic imaging, laser pulses are delivered to the tissue. Some of the laser energy is converted into heat, which causes the tissue to expand, thereby allowing light waves and pressure waves to facilitate visualization. According to the principles of the invention, some medium (which may be a contrast agent or a fluorescent staining agent) can be used to preferentially visualize IRE or thermal lesions. It should be noted that the stained area should be correlated with tissue changes (electroporation, degree of thermal ablation, etc.).

[0053] Alternatively or concurrently, the injectable substance 130 may comprise an electric field-responsive dye / contrast agent, which can be visualized using fluoroscopy and / or endoscopic ultrasound. The injectable substance 130 may or may not be absorbed by cells. Instead, the molecule itself responds to an energy field, such as a change in electric field applied during IRE treatment. When energy therapy is applied to a treatment site T in which the injectable substance 130, in the form of an electric field-responsive dye / contrast agent, has been deposited, the molecules of the injectable substance 130 resonate and emit light upon exposure to a laser of a specific wavelength or a signal of a specific voltage. In some aspects, dyes with different emission thresholds can be combined to create more detailed images. In some aspects, the dye is visible and can be selected such that its emission / emission is correlated with the IRE lesion area.

[0054] In some respects, the injectable substance 130 may contain a thermochromic dye that can be visualized using an endoscope, such as during the application of thermal energy for treatment. The thermochromic dye may be selected to change color at certain temperatures. Injecting such a dye into the treatment site T prior to the application of therapeutic energy, and visualizing such a dye (e.g., using an endoscope), will provide a visual color distribution map of any thermal tissue damage.

[0055] In addition to or as a supplement to injectable substances as described above, one or more markers can be deployed in a manner other than injection to facilitate identification, localization, etc., of treatment sites. Therefore, compared to injectable substances that are typically fluid and do not have a fixed shape (e.g., their shape may vary, such as by presenting the shape of a blood vessel or a cavity through which the injection passes), additional or alternative markers having a generally non-fluid form (e.g., gel, biocompatible film, a series of nanobubbles, etc.) can be deployed by the energy delivery therapy system 100 formed according to various principles of the invention. For example, additional or alternative markers not intended for injection can be delivered on a portion of the energy delivery component of the energy delivery therapy system 100, such as on the exterior of the energy delivery component. The marker can be formed from a visual material, such as a radiopaque material (visible under X-rays), or otherwise configured to be compatible with various imaging modalities. In some aspects, the marker is deployed after ablation for site identification of the treatment area of ​​treatment site T. In some aspects, the marker is a biodegradable marker, such as to avoid leaving a long-term foreign body in the patient's body. The markers can be formed from polymers, metals, or other visual materials (e.g., radiopaque materials), such as those known to those skilled in the art. In some respects, the markers may not facilitate visualization of the entire treatment area, but rather aid in more specific site identification of ablated tissue at the treatment site (e.g., the location of dead cells). Such deployable markers configured for deployment by means other than injection according to various principles of the invention can have any of a variety of possible configurations. For convenience and not intended to be limiting, such markers are referred herein as non-fluid markers, which are to be deployed in relation to the treatment site in a manner other than injection, in contrast to the injectable markers described above. Additionally or alternatively, such markers may be referred herein as deployable markers transported by an energy delivery assembly, since the energy delivery assembly is generally a component or element of an energy delivery therapy system formed according to various principles of the invention and delivered to the treatment site. However, it should be understood that reference to non-fluid markers transported by an energy delivery assembly is not necessarily limited to non-fluid forms and / or transported solely by an energy delivery assembly. It should be understood that the examples of the following embodiments are merely some of the various forms of deployable markers, and the markers may have any of a variety of other shapes (cylindrical, spherical, prismatic, etc.), be made of a variety of other materials, and / or be delivered in a variety of other ways (via active or passive mechanisms). The principles of the invention are not limited to the examples of the embodiments described herein.

[0056] exist Figure 3AAn example embodiment of an energy delivery assembly 3100 configured to transport, deliver, and deploy a non-fluid deployable marker 360 at a treatment site T is shown. It should be understood that the illustrated example of one embodiment of the energy delivery assembly 3100 can be derived from, for example... Figure 1 The distal end 100d of the energy delivery therapy system 100 shown extends. For brevity, reference can be made to the description of the energy delivery therapy system 100 shown in FIG1, which serves as an example embodiment of an energy delivery therapy system, and an example embodiment of the energy delivery assembly 3100 shown in FIG3A is a component thereof. Figure 3A An example of one embodiment of the energy delivery assembly 3100 shown transports a non-fluid deployable marker 360 formed according to various principles of the invention. Figure 3AThe non-fluid deployable marker 360 shown can be detached and deployed from the energy delivery assembly 3100. For example, the non-fluid deployable marker 360 can form on or otherwise attach to the distal end 3100d of the energy delivery assembly 3100. The non-fluid deployable marker 360 is configured to be detachable from the energy delivery assembly 3100 in any of a variety of ways. For example, the non-fluid deployable marker 360 can be a detachable tip of the energy delivery assembly 3100. For example, in some embodiments, a mechanical actuator, such as a button, can extend from the non-fluid deployable marker 360 to a location outside the patient's body (e.g., on the handle 116 of the delivery device 110) and can be moved to push the deployable marker 360 out of its proper position relative to the energy delivery assembly 3100. In other embodiments, the energy delivery assembly 3100 can be manipulated (e.g., rotated, bent, twisted, etc.) to apply stress to the non-fluid deployable marker 360 to cause it to break in a predetermined manner. In some embodiments, the non-fluid deployable tag 360 may be supported during delivery, but the support structure can be removed by retracting / extracting the energy delivery member 3102 proximally, allowing the non-fluid deployable tag 360 to detach or break off from the retracted portion of the energy delivery member 3102. Alternatively or additionally, the retracting / extracting energy delivery member 3102 proximally may cause the non-fluid deployable tag 360 to hook or snap onto another component, allowing the non-fluid deployable tag 360 to detach or break off from the retracted portion of the energy delivery member 3102. Additionally or alternatively, the energy delivery member 3102 of the energy delivery assembly 3100 may define a lumen therethrough in which the proximal end of the non-fluid deployable tag 360 is fitted (e.g., by a disconnectable connection, friction fit, snap-fit, etc.). A pusher, such as a needle or other elongated member known to those skilled in the art, can translate through the lumen of the energy delivery member 3102 to distally push the proximal end of the non-fluid deployable marker 360 out of the lumen to deploy the non-fluid deployable marker 360 in relation to the treatment site T. Once the non-fluid deployable marker 360 has been separated from the energy delivery assembly 3100 and deployed at the treatment site T, the energy delivery assembly 3100 can be retracted proximally and removed from the treatment site T, such as... Figure 3B As shown.

[0057] exist Figure 4A The diagram illustrates an example of an embodiment of an energy delivery assembly 4100 configured to deliver additional or alternative non-fluid deployable markers 460 to a treatment site T, and to deliver and deploy such non-fluid deployable markers 460. It should be understood that the illustrated example of an embodiment of the energy delivery assembly 4100 can be derived from, for example, […]. Figure 1 The distal end 100d of the energy delivery therapy system 100 shown extends. For simplicity, see the section on... Figure 1The description of the energy delivery therapy system 100 shown is an example of an embodiment of an energy delivery therapy system. Figure 4A The embodiment of the energy delivery assembly 4100 shown is an example of its components. Figure 4A An example of one embodiment of the energy delivery assembly 4100 shown is configured to deliver a non-fluid deployable tag 460 that is associated with its movement. For example, the non-fluid deployable tag 460 may be movably or removably (e.g., slidably or otherwise) mounted associated with a portion of the energy delivery assembly 4100 (e.g., on top of it, on it, such as circumferentially on it, or around it). Figure 4A In one example of the embodiment shown, a non-fluid deployable marker 460 is shown slidably mounted on the energy delivery member 4102 of the energy delivery assembly 4100. In some aspects, the non-fluid deployable marker 460 may be mounted proximally spaced from the distal end 4100d (e.g., a free end) of the energy delivery assembly 4100. The non-fluid deployable marker 460 is configured to be movable relative to the energy delivery assembly 4100 for deployment therefrom in any of a variety of ways. For example, the non-fluid deployable marker 460 may take the form of a band or loop that extends circumferentially around a portion of the energy delivery assembly 4100 delivered to the treatment site T. A pusher, such as a needle or other suitable member known to those skilled in the art, may translate relative to the energy delivery assembly 4100 (e.g., side-by-side therewith) to push the non-fluid deployable marker 460 distally relative to (and generally away from) the energy delivery assembly 4100 to deploy the non-fluid deployable marker 460 relative to the treatment site T. The pusher is optionally conveyed through the delivery channel of the delivery device, through which the energy delivery assembly 4100 is delivered to the treatment site T, and / or associated with (e.g., movably coupled thereto) the energy delivery assembly 4100. In some aspects, the pusher may be delivered side-by-side with / outside the energy delivery assembly 4100, acting similarly to pushing a non-fluid deployable marker 460 away from the movable sheath of the energy delivery member 4102. Once the non-fluid deployable marker 460 has been separated from the energy delivery assembly 4100 and deployed at the treatment site T, the energy delivery assembly 4100 can be retracted proximally and removed from the treatment site T, such as... Figure 4B As shown.

[0058] exist Figure 5A The diagram illustrates yet another embodiment example of an energy delivery assembly 5100 configured to deliver additional or alternative non-fluid deployable markers 560 for deployment at a treatment site T. It should be understood that the illustrated embodiment example of the energy delivery assembly 5100 can be derived from, for example... Figure 1The distal end 100d of the energy delivery therapy system 100 shown extends. For simplicity, see the section on... Figure 1 The description of the energy delivery therapy system 100 shown is an example of an embodiment of the energy delivery therapy system, and an example of an embodiment of the energy delivery assembly 5100 shown in FIG5A is a component thereof. Figure 5A The illustrated embodiment of the energy delivery assembly 5100 is configured to transport a non-fluid deployable tag 560 associated with its movement. For example, the non-fluid deployable tag 560 may be mounted associated with a portion of the energy delivery assembly 5100, such as within a housing 5103 or other structure formed associated with the energy delivery assembly 5100 and configured to transport the non-fluid deployable tag 560. For example, in Figure 5A In the illustrated embodiment example, housing 5103 is formed on the exterior of a portion or component of energy delivery assembly 5100, such as a recess along the exterior of energy delivery member 5102 of energy delivery assembly 5100. Non-fluid deployable marking 560 may be movably / removably mounted with respect to energy delivery assembly 5100 for separation and deployment relative to treatment site T, such as... Figure 5B As shown. An actuator, such as a needle or other suitable component known to those skilled in the art, can be moved relative to the energy delivery assembly 5100 to move a non-fluid deployable marker 560 relative to the energy delivery assembly 5100 (and generally away from it) to deploy the non-fluid deployable marker 560 relative to the treatment site T. The actuator can be coupled to an actuator, such as a button, located on a handle of the energy delivery assembly 5100. In some embodiments, a spring is provided, which may be compressible to apply force to the non-fluid deployable marker 560 to deploy / eliminate the non-fluid deployable marker 560 from the energy delivery assembly 5100. The actuator is optionally conveyed through a delivery channel of a delivery device through which the energy delivery assembly 5100 is delivered to the treatment site T, and / or associated with (e.g., may be movably coupled to) the energy delivery assembly 5100. Once the non-fluid deployable marker 560 has been separated from the energy delivery assembly 5100 and deployed at the treatment site T, the energy delivery assembly 5100 can be retracted proximally and removed from the treatment site T, such as Figure 5B As shown.

[0059] As described above, according to various principles of the invention, one or more markers, such as those described above, can be deployed before, during, and / or after treatment of the treatment site according to various principles of the invention. Markings facilitate the location of the treatment site after the energy delivery assembly for applying therapeutic energy has been removed. Since the treatment site may be much smaller than the means or elements used to apply therapeutic energy to it, markings such as those disclosed herein can help facilitate the identification of the treatment site's location for evaluating the therapeutic effect on the treatment site, such as determining further treatments, therapies, protocols, etc., to be performed.

[0060] It should be understood that, in order to determine the initial treatment to be performed at the treatment site and / or to determine further treatments, therapies, protocols, etc., to be performed, medical professionals may use information in various forms regarding the nature, characteristics, etc., of the treatment site. Based on various principles of the invention, and based on various principles of the invention... Figure 1 The schematically illustrated energy delivery therapy system 100 includes a processor 170 configured to receive information from a treatment site and / or present such information to a medical professional and / or control or otherwise influence the treatment to be applied to the treatment site. In some aspects, if a fluid source / reservoir is operatively coupled to the processor 170, the processor 170 can control the injection of fluid into the target site. Figure 1 In one example of the illustrated embodiment, processor 170 includes a console 172 configured to display information for use by a medical professional. Console 172 and / or input devices, such as keyboard 174, may be coupled to processor 170 and configured to allow input of information, such as by a medical professional, to processor 170. Additionally, information relating to the treatment site is provided to processor 170 via energy delivery device 1000 and / or other instruments or devices of energy delivery therapy system 100, such as those known to those skilled in the art.

[0061] According to various principles of the present invention, various techniques can be used to obtain information about the treatment site, such as for evaluating, assessing, and determining one or more properties of the treatment site; detecting and / or otherwise determining the location of the treatment site and / or the diseased area to be treated (e.g., lesion) and / or mapping (including, but not limited to, size, area, volume, and / or shape); obtaining information about the nature or condition of the treatment site (e.g., diagnostic information); assessing the disease state of the treatment site; determining the appropriate treatment to be applied; predicting the effect of the treatment to be applied; evaluating, measuring, tracking, and other effects of treatment performed on the treatment site; and other related uses related to treatment using energy fields. In some aspects, various techniques can be used to create maps of the treatment site, such as three-dimensional maps. The assessment of the treatment site can be used to determine the nature, characteristics, parameters, etc., of the therapeutic energy therapy to be applied and / or to assess the effect of the therapy after it is applied to the treatment site. Figure 6 The illustration schematically depicts various techniques that can be used, according to various principles of the invention, to collect information about the treatment site and / or influence / control the therapy to be applied to the treatment site T. Such information can be obtained using one or more elements, components, devices, assemblies, etc., of an energy delivery therapy system 100 formed according to various principles of the invention, such as… Figure 1 and Figure 6 The information obtained from the treatment site T is schematically shown in box 6000 and described in further detail below. This information can be transmitted to the processor 170 of the energy delivery treatment system 100, such as... Figure 1 and Figure 6 Further illustrated in the diagram. This information can be used by medical professionals, as illustrated in box 6002. Medical professionals can use the collected information to control or otherwise influence treatment protocols, such as via input to processor 170 (e.g., via... Figure 1 The keyboard 174 is schematically shown. The processor 170 can then process and control one or more elements, components, devices, assemblies, etc., of the energy delivery therapy system 100 to achieve the desired therapy, such as based on input provided by a medical professional. Although the present invention generally relates to therapeutic energy therapy in the form of electroporation and / or IRE, other forms of therapy are also within the scope and spirit of the invention. Furthermore, although the present invention relates to lesions caused by electroporation and / or IRE, the lesions may additionally or alternatively be other types of lesions, such as thermal lesions. Reference Figure 6 The schematic diagram illustrates various techniques used to collect information about the treatment site T and / or to develop a protocol (which may be determined based on the collected information).

[0062] According to various principles of the present invention, such as Figure 6As schematically illustrated, elastography 6010 (including, but not limited to, shear wave elastography) can be used to collect information about the treatment site T. For example, elastography 6010 can be used to depict tissue stiffness distribution, such as by deforming the tissue and observing its response, to assess tissue stiffness and / or elasticity and / or, in some cases, density. According to various principles of the invention, tissue stiffness, etc., determined by elastography is related to other effects of IRE and / or thermal damage or treatment, such as for measuring lesion size after treatment. Tissue properties, such as stiffness, can be determined by deforming the tissue in various ways, such as, but not limited to, via physical probing, acoustic imaging, or during observation of one or more bodily functions or processes. In some aspects, physical probing can be performed by pushing the tissue and / or moving the tissue with components of an energy delivery treatment system formed according to various principles of the invention, such as with components of an energy delivery device formed according to various principles of the invention. In some aspects, acoustic imaging can be performed using an ultrasonic emitting probe that creates pressure waves that affect the tissue to deform it. Elements that influence tissue to cause tissue deformation (e.g., physical or acoustic probes) can be delivered to the treatment site via a cavity, and optionally using an energy delivery device formed according to various principles of the invention. Alternatively or additionally, tissue deformation and / or differentiation of regions of interest within the patient may arise from movement within the patient and / or observation of movement within the patient, such as movement caused by physiological processes (e.g., peristalsis along the gastrointestinal tract, heartbeat, etc.). Alternatively or additionally, pressure / stress sensors (e.g., delivered via a cavity, endoscope, etc.), ultrasound, and / or magnetic resonance imaging (MRI) can be used to measure various properties of the tissue, such as tissue stiffness and / or elasticity. Information regarding tissue stiffness, elasticity, etc., such as that determined by elastography, is schematically represented by box 6012 as being transmitted to processor 170 at box 6000 and / or provided to a medical professional at box 6002. In some aspects, processor 170 is configured to perform data processing, such as for imaging modalities (e.g., MRI, elastography, hyperspectral imaging, etc.). The processor, employing a tubular, elongated component in the form of an endoscope, can be operatively associated with the processor 170 of the system as a whole or can remain independent of the processor 170. The transmitted information can be used to determine and / or understand tissue properties; predict lesion size and / or area (e.g., prior to treatment); and / or visualize and / or assess lesion size after treatment (e.g., with the aid of dyes, assistive devices, etc., as described above). It should be understood that any of the foregoing markings can be used in conjunction with such profiling, assessment, etc.

[0063] In some respects, further information about the treatment site that can aid in treatment planning can be obtained via magnetic resonance electrical impedance tomography (MR EIT) 6020. For example, MR EIT can be used to create a three-dimensional impedance map of the treatment site (e.g., the tissue at the treatment site). As those skilled in the art will understand, lesion size is generally highly dependent on tissue impedance. Furthermore, lower tissue impedance generally indicates the area affected by IRE. Therefore, according to various principles of the invention, mapping of three-dimensional tissue impedance can be used to predict IRE and thermal lesion areas before applying therapeutic energy to the treatment site. Additionally or alternatively, mapping of three-dimensional tissue impedance can be used to assess the effectiveness of treatment after treatment, such as for assessing IRE lesion size. According to various principles of the invention, energy delivery treatment systems, such as energy delivery devices, formed according to various principles of the invention can include MRI-compatible endoscopic probes to create such maps. If an impedance map is to be created before or immediately after treatment, the probe can be inserted together with, as part of, or as a separate component of, the energy delivery assembly used to apply the therapeutic energy field. The impedance measurement 6022 and / or resistance measurement 6024 obtained in this manner can be transmitted to the processor 170 at box 6000 and / or provided to a medical professional at box 6002. In some respects, the medical professional may or may not need to select every specific parameter or aspect of the waveform. For example, the medical professional can select from a range of predetermined waveforms (rather than setting waveforms, voltages, currents, etc.). The final variable can be calculated by the processor 170 to generate the desired value for the selected variable.

[0064] According to various further principles of the invention, in addition to or as an alternative to the techniques described above, hyperspectral imaging 6030 can be used to collect data relating to the properties of the treatment site. For example, hyperspectral imaging can be used to visualize the electromagnetic spectrum of tissues at very fine wavelength resolution. According to various principles of the invention, variations in the electromagnetic spectrum can be correlated with tissue properties and characteristics, and may even be differences in areas affected by thermal damage and / or IRE. According to various principles of the invention, energy delivery therapy systems, such as energy delivery devices, formed according to various principles of the invention can include an imaging tip capable of hyperspectral imaging of the treatment site. The imaging tip can be inserted separately from or together with the energy delivery assembly (e.g., as part of or as a separate component), the energy delivery assembly being used to apply a therapeutic energy field to the treatment site. The hyperspectral image of the electromagnetic spectrum 6032 obtained in this way can be used by the processor 170 at box 6000 and / or provided to a medical professional at box 6002.

[0065] Using any of the above-described techniques and / or other techniques, after the treatment site has been evaluated, information about the treatment site T (e.g., characteristics and properties and / or other properties of the treatment site T) can be processed, such as by the processor 170 at box 6000 and / or provided to it. Figure 6 The medical professional at box 6002. For example, as Figure 6 As schematically illustrated, images of the treatment site (represented by box 6100), calculations of the size of the lesion / treatment area (including predictions, such as pre-treatment and / or visualizations, such as post-treatment) (represented by box 6110), or other information influencing treatment decisions can be delivered to and / or displayed for use by a medical professional. The medical professional can use this information to determine the desired treatment plan. For example, to achieve the desired treatment at treatment site T, various parameters of the energy to be delivered to generate the therapeutic energy field at treatment site T must be evaluated, determined, selected, and transmitted to the energy delivery therapy system 100 for the desired plan. For example, the medical professional must typically select appropriate energy waveforms 6200, energy pulse characteristics 6210, voltages 6220, or currents 6230 (it should be understood that the medical professional can typically adjust the voltage or current of the applied energy, the resistance set by the patient, such as the properties of their tissues), which are input to processor 170 and / or directly to the energy delivery therapy system 100, represented by box 6000, to create an energy field capable of achieving the desired therapeutic effect at treatment site T. Alternatively or additionally, medical professionals may use information obtained according to various principles of the invention to make various adjustments to the energy delivery components (represented by box 6300), such as via the energy delivery therapy system 100 and / or directly via the processor 170. Alternatively or additionally, medical professionals may use information formed according to various principles of the invention to deploy one or more markers, such as one or more of markers 130, 360, 460, and 560 as described herein, as represented by box 6310.

[0066] According to various principles of the invention, information collected using the energy delivery therapy system 100, such as that described herein or elsewhere, can be used to generate three-dimensional tissue maps, such as according to any of the techniques described above, for notification and / or for compiling and creating computational models that display real-time estimates of the effects of a proposed treatment regimen on the treatment site, such as, but not limited to, predicting thermal and / or IRE lesion size. Given the nature, characteristics, and properties of the treatment site T, the computational model can display predictions based on selected energy outputs to be delivered to the treatment site T (e.g., via console 172 or other information display media, such as printouts). For example, the computational model can display predictions based on measured tissue properties and selected waveform values ​​to be delivered to the treatment site. This allows healthcare professionals to visualize and at least roughly estimate a treatment plan before actually implementing such a treatment plan. It should be understood that the above-described principles of the invention allow healthcare professionals to select waveforms and other energy input values ​​based on each patient's situation. Given the heterogeneity between patients and other variations that can significantly affect IRE and thermal lesion size, this customizability provided by the invention for individual patients is particularly advantageous. The ability to locate and estimate the size of both the IRE and the thermal lesion, based on various principles of the invention, also enables medical professionals to avoid damage to important / critical anatomical structures (e.g., blood vessels) that may be close to the treatment site of interest (e.g., within the range of the energy field to be applied).

[0067] It should be understood that energy delivery components for delivering energy-based therapy according to various principles of the present invention can take any suitable form or configuration to deliver energy-based therapy. In some aspects, the energy delivery component can be a bipolar probe, such as a linear bipolar probe, having two electrodes axially spaced apart from each other on the same energy delivery component and delivered to the treatment site. However, it should also be understood that configurations other than bipolar and / or linear are also within the scope and spirit of the invention. For example, energy delivery components with more than two electrodes or monopolar / monopolar devices can be used with energy delivery therapy systems formed according to various principles of the present invention. Furthermore, the principles of the invention can be applied to energy other than electroporation and / or IRE energy, such as other energy sources for ablation or other purposes.

[0068] It should also be understood that any or all aspects of the above delivery and deployment can be performed using suitable imaging techniques available, such as those known to those skilled in the art. Furthermore, it should be understood that the present invention is not limited to processors, monitors, delivery devices, or other means, systems, devices, etc., that support the therapeutic apparatus and associated methods of the present invention.

[0069] Ultimately, it should be understood that the devices, systems, components, and methods disclosed herein can be delivered endoscopically, transcavitarily, or percutaneously, and can be used in other access devices, such as steerable cavity access devices.

[0070] It should be understood that all structures, apparatuses, systems, components, and methods discussed herein are examples of implementations of one or more principles of the invention, and are not the only ways to implement these principles, and are therefore not intended to limit the broader aspects of the invention. Therefore, references to elements or structures or features in the drawings must be understood as references to examples of embodiments of the invention and should not be construed as limiting the invention to the specific elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will conceive of those skilled in the art upon reading this invention. It will be apparent to those skilled in the art that variations can be applied to the disclosed apparatuses, components, systems, and / or methods and / or the series of steps described herein without departing from the concept, spirit, and scope of the invention. It should be understood that various features described with respect to one embodiment can typically be applied to another embodiment, whether or not explicitly indicated. The various features described thereafter can be used alone or in any combination thereof. Therefore, the invention is not limited to the embodiments specifically described herein, and all substitutions and modifications are considered by those skilled in the art to be within the spirit, scope, and concept of the invention as defined by the appended claims.

[0071] The foregoing discussion is of broad applicability and has been set forth for illustrative and descriptive purposes, and is not intended to limit the invention to the forms disclosed herein. It should be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the invention. In particular, it will be apparent to those skilled in the art that the principles of the invention can be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from its concept, spirit, scope, or characteristics. For example, various features of the invention are combined in one or more aspects, embodiments, or forms to simplify the invention. However, it should be understood that various features of certain aspects, embodiments, or forms of the invention can be combined in alternative aspects, embodiments, or forms. Although the invention has been presented in the form of embodiments, it should be understood that not all of the various individual features of the subject matter need to be present in order to achieve at least some of the desired characteristics and / or benefits of the subject matter or such individual features. Those skilled in the art will understand that the invention can be used with many modifications or alterations to the structures, arrangements, proportions, materials, components, and others used in the practice of the invention, which are particularly suited to specific environments and operational requirements, without departing from the principles, spirit, or scope of the invention. For example, an element shown as integrally formed may be composed of multiple parts or elements shown as being integrally formed, the operation of the element may be reversed or otherwise varied, and the size or dimensions of the element may vary. Similarly, although operations or actions or procedures are described in a particular order, this should not be construed as requiring such a particular order, or that all operations or actions or procedures must be performed to achieve the desired result. Additionally, other embodiments are also within the scope of the following claims. In some cases, the actions recited in the claims may be performed in a different order and still achieve the desired result. Therefore, the embodiments disclosed herein should be shown in all respects as illustrative rather than restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or specific embodiments or arrangements described or shown herein. In view of the foregoing, individual features of any embodiment may be used and may be claimed individually or in combination with features of that embodiment or any other embodiment, the scope of which is indicated by the appended claims and is not limited to the foregoing description.

[0072] The following will be understood in the description above and the claims below. As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are operationally both conjunctions and non-conjunctions. The terms “a,” “an,” “the,” “first,” “second,” etc., do not exclude multiple entities. For example, the term “a” or “an” as used herein refers to one or more of that entity. Therefore, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein. As used in this specification and the appended claims, the term “or” is generally used in the sense of including “and / or” unless the context explicitly indicates otherwise. As used herein, the conjunction “and” includes each of the structures, components, features, etc. so connected, unless the context explicitly indicates otherwise, and the conjunction “or” includes one or more of the structures, components, features, etc. so connected individually and in any combination and number, unless the context explicitly indicates otherwise. All directional references (e.g., proximal, distal, up, down, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or similar) are for identification purposes only, to aid the reader in understanding the invention, and / or to distinguish areas of associated elements from one another, and do not limit the associated elements, in particular not limiting the location, orientation, or use of the invention. Unless otherwise indicated, connection references (e.g., attachment, joint, connection, engagement, bonding, etc.) are to be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements. In this respect, a connection reference does not necessarily imply that two elements are directly connected and have a fixed relationship with each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to signify importance or priority, but are used to distinguish one feature from another.

[0073] The following claims are incorporated herein by reference into the detailed description, wherein each claim exists independently as a separate embodiment of the invention. In the claims, the terms “comprising,” “including,” “containing,” and “including” do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Furthermore, although individual features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not imply that such combinations of features are impractical and / or advantageous. Additionally, singular references do not exclude plural references. Reference numerals in the claims are provided only as clarifying examples and should not be construed as limiting the scope of the claims in any way.

Claims

1. A device for facilitating the identification, characterization, and / or localization of a site for treatment by applying therapeutic energy, said device comprising: An energy delivery assembly having an energy delivery region, wherein an energy field is generated along the energy delivery region to apply therapeutic energy to a treatment site; as well as A device configured to characterize the treatment site for evaluation by medical professionals to determine a treatment regimen that utilizes the energy delivery region to generate an energy field.

2. The device of claim 1, wherein the means is configured to deploy a deployable marker at the treatment site.

3. The device of claim 2, wherein the marking is an injectable material delivered through a lumen delivered together with the energy delivery assembly.

4. The device of claim 3, wherein the energy delivery assembly includes an energy delivery member, the energy delivery region is defined along the energy delivery member, and the lumen is independent of the energy delivery member.

5. The device according to any one of claims 3 or 4, wherein the energy delivery assembly includes an energy delivery member defining the lumen through which the injectable material is delivered.

6. The device according to any one of claims 2 to 5, wherein the mark is transported by the energy delivery component.

7. The device according to any one of claims 2 to 6, wherein the marker is delivered to the treatment site as part of the energy delivery assembly and is separated from the energy delivery assembly for deployment at the treatment site.

8. The device according to any one of claims 2 to 7, wherein the mark is transported on the energy delivery assembly and is detachable from the energy delivery assembly for deployment at the treatment site.

9. The device according to any one of claims 2 to 8, wherein the energy delivery assembly defines a housing, the marker is delivered within the housing to the treatment site, and the marker is released from the housing for deployment at the treatment site.

10. The device according to any one of claims 1 to 9, wherein the means describes the features of the treatment site.

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

12. A system for identifying features of a treatment site to assist in performing energy-based treatment at the treatment site, the system comprising: An energy delivery device, the energy delivery device including an energy delivery component having an energy delivery region, an energy field being generated along the energy delivery region to apply therapeutic energy to a treatment site; A delivery device having a working channel, through which the energy delivery component delivers energy to the treatment site; as well as A device configured to characterize the treatment site for evaluation by medical professionals to determine a treatment regimen that utilizes the energy delivery region to generate an energy field.

13. The system of claim 12, wherein the device uses one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging to map the characteristics of the treatment site, and the system further includes a processor configured to receive information from the device and develop 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 at the treatment site.

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

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