Patent Application
20250009404
The present disclosure relates generally to the field of medical devices, assemblies, systems, and methods used in applying energy to a patient such as for therapeutic purposes. More particularly, the present disclosure relates to the field of medical devices, assemblies, systems, and methods for applying electrical energy, such as therapeutic electrical pulses, to a patient. Even more particularly, the present disclosure relates to various devices, assemblies, systems, and methods for electroporation treatment. And, even more particularly, the present disclosure relates to multi-electrode devices, assemblies, and systems applying energy, such as electrical energy such as for electroporation, and associated methods.
Various devices, assemblies, systems, and methods exist for energy-based medical treatment and/or therapeutic protocols. For instance, various focal therapy devices are configured to apply energy to debulk target tissue or to eliminate malignant cells. Various technologies for such therapy rely on thermal effects, such as radiofrequency (“RF”) heating, microwave heating, cryoablation, high intensity focused ultrasound (“HIFU”), etc. In contrast, electroporation and/or irreversible electroporation is a primarily non-thermal therapy, and has significant potential benefits over thermal modalities. Energy may be applied to perform electroporation and/or irreversible electroporation (“IRE”) as a mode of treating various conditions and/or diseases using an electric field to interrupt and/or to change the nature of biological cellular matter. For instance, the applied electric field may significantly increase the electrical conductivity and permeability of the plasma in the cell membrane. The applied energy causes paths/pores to open within cell walls and/or membranes near the device applying the energy (e.g., near the electrode, probe, etc., thereof). The electric field disrupts homeostasis, and, in the case of IRE, kills the cells, such as through apoptosis and/or necrosis. Monopolar probes may be used to insert a single electrode/an electrode of a first polarity (typically an anode) within the patient, with energy directed to the second, ground electrode typically outside the patient (e.g., a grounding pad positioned on the skin of a patient). However, such configuration may have certain effects, such as muscle stimulation such as which may result in muscle contractions; cardiac interference, etc., which may not be desirable. To mitigate such effects, bipolar probes with two electrodes, typically separated by insulation, yet positioned close enough to create an energy field therebetween with fewer effects than caused by exposure to electrical fields created by monopolar probes. Once positioned within the target site (e.g., a tumor), the monopolar probe is activated, such as by generating an electric field between and/or around the electrodes of the device, for various therapeutic procedures. It is with respect to these and other considerations that the present improvements may be useful.
This Summary is provided to introduce, in simplified form, a selection of concepts described in further detail below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. One of skill in the art will understand that each of the various aspects and features of the present disclosure may advantageously be used separately in some instances, or in combination with other aspects and features of the disclosure in other instances, whether or not described in this Summary. No limitation as to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, or the like in this Summary.
In accordance with various principles of the present disclosure, a multi-electrode energy-delivering assembly is formed with at least one or more electrodes of a first polarity; and a support structure coupling the one or more electrodes for delivery as an assembly within a patient. In some aspects, the multi-electrode energy delivering assembly has an elongated compact delivery configuration for delivery through a lumen of a delivery device.
In some aspects, the one or more electrodes include two or more electrodes of the first polarity axially spaced from one another and extending in a linear configuration when in the elongated compact delivery configuration. In some aspects, the two or more electrodes are formed from an elongate electrically-conductive member and defined by an insulation member extending over and exposing portions of the elongate electrically-conductive member. In some aspects, the multi-electrode energy-delivering assembly further includes at least one electrode of a second polarity axially spaced from at least one of the two or more electrodes of the first polarity. In some aspects, the at least one electrode of a second polarity is formed from a tubular electrically-conductive member positioned over the insulation member. In some aspects, the multi-electrode energy-delivering assembly further includes at least one differentiating insulation member extending over a portion of the tubular electrically-conductive member to define two or more spaced apart electrodes of the second polarity.
In some aspects, the two or more electrodes are positioned on a support element expandable from the elongated delivery configuration into an expanded deployed configuration when extended out of a delivery device to increase the volume of an electric field to be defined by the electrodes when the support element is in the deployed configuration compared with an electric field which would be defined by the electrodes when the support element is in the delivery configuration.
In some aspects, the one or more electrodes include three or more electrodes movable with respect to one another. In some aspects, at least one of the three or more electrodes are configured to engage and remain engaged with tissue.
In some aspects, the one or more electrodes of a first polarity comprises a fluid containing electrically-conductive particles injectable by the delivery device into a target site within a patient. In some aspects, the multi-electrode energy-delivering assembly further includes an additional electrode of a second polarity delivered to the target site with the fluid.
In some aspects, the multi-electrode energy-delivering assembly is expandable upon deployment from a delivery device.
In accordance with various principles of the present disclosure, a multi-electrode energy-delivering treatment system includes a multi-electrode energy-delivering assembly, a power connector configured to deliver energy to one or more electrodes of the multi-electrode energy-delivering assembly to generate an electric field among the one or more electrodes; and a tubular delivery device having a lumen within which the multi-electrode energy-delivering assembly is deliverable to a target site within a patient. In some aspects, one or more electrodes of the multi-electrode energy-delivering assembly are of a first polarity; and the multi-electrode energy-delivering assembly further includes a support structure coupling the one or more electrodes for delivery as an assembly within a patient. In some aspects, the multi-electrode energy delivering assembly is delivered within the lumen of the delivery device in an elongated compact delivery configuration.
In some aspects, the multi-electrode energy-delivering assembly is expandable upon deployment from the lumen of the delivery device.
In some aspects, the one or more electrodes of the multi-electrode energy-delivering assembly include two or more electrodes extending axially spaced apart from one another when in the lumen of the delivery device.
In accordance with various principles of the present disclosure, a method of applying therapeutic energy to a patient includes delivering, to a target site within a patient, a plurality of electrodes of a first polarity in an elongated delivery configuration within a lumen defined in a delivery device; deploying the plurality of electrodes out of the lumen of the delivery device; and delivering energy to the deployed plurality of electrodes to create an energy field between the plurality of electrodes.
In some aspects, the method further includes spacing apart the electrodes of the plurality of electrodes from one another upon deployment thereof. Additionally or alternatively, the method further includes activating the plurality of electrodes independently of one another.
In some aspects, the plurality of electrodes includes a fluid containing a plurality of electrically-conductive particles, and the method further includes delivering the plurality of electrodes by injecting the fluid into the patient at the target site.
In some aspects, the delivery device includes an electrically-conductive material, and the method further includes delivering energy to the delivery device to generate an electric field between the electrically-conductive material of the delivery device and the electrically-conductive particles in the fluid.
These and other features and advantages of the present disclosure, will be readily apparent from the following detailed description, the scope of the claimed invention being set out in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be appreciated that individual aspects can be claimed separately or in combination with aspects and features of that embodiment or any other embodiment.
Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for purposes of illustration only, and the dimensions, positions, order, and relative sizes reflected in the figures in the drawings may vary. For example, devices may be enlarged so that detail is discernable, but is intended to be scaled down in relation to, e.g., fit within a working channel of a delivery catheter or endoscope. For purposes of clarity and simplicity, not every element is labeled in every figure, nor is every element of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure.
The detailed description will be better understood in conjunction with the accompanying drawings, wherein like reference characters represent like elements, as follows:
The following detailed description should be read with reference to the drawings, which depict illustrative embodiments. It is to be understood that the disclosure is not limited to the particular embodiments described, as such may vary. All apparatuses and systems and methods discussed herein are examples of apparatuses and/or systems and/or methods implemented in accordance with one or more principles of this disclosure. Each example of an embodiment is provided by way of explanation and is not the only way to implement these principles but are merely examples. Thus, references to elements or structures or features in the drawings must be appreciated as references to examples of embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features illustrated. Other examples of manners of implementing the disclosed principles will occur to a person of ordinary skill in the art upon reading this disclosure. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the present subject matter. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.
It will be appreciated that the present disclosure is set forth in various levels of detail in this application. In certain instances, details that are not necessary for one of ordinary skill in the art to understand the disclosure, or that render other details difficult to perceive may have been omitted. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless defined otherwise, technical terms used herein are to be understood as commonly understood by one of ordinary skill in the art to which the disclosure belongs. All of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.
As understood herein, corresponding is intended to convey a relationship between components, parts, elements, etc., configured to interact with or to have another intended relationship with one another. As used herein, “proximal” refers to the direction or location closest to the user (medical professional or clinician or technician or operator or physician, etc., such terms being used interchangeably herein without intent to limit, and including automated controller systems or otherwise), etc., such as when using a device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and/or closest to a delivery device, and “distal” refers to the direction or location furthest from the user, such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and/or closest to a delivery device. “Longitudinal” means extending along the longer or larger dimension of an element. A “longitudinal axis” extends along the longitudinal extent of an element, though is not necessarily straight and does not necessarily maintain a fixed configuration if the element flexes or bends, and “axial” generally refers to along the longitudinal axis. However, it will be appreciated that reference to axial or longitudinal movement with respect to the above-described systems or elements thereof need not be strictly limited to axial and/or longitudinal movements along a longitudinal axis or central axis of the referenced elements. “Central” means at least generally bisecting a center point and/or generally equidistant from a periphery or boundary, and a “central axis” means, with respect to an opening, a line that at least generally bisects a center point of the opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a channel, a cavity, or a bore. As used herein, a “free end” of an element is a terminal end at which such element does not extend beyond. It will be appreciated that terms such as at or on or adjacent or along an end may be used interchangeably herein without intent to limit unless otherwise stated, and are intended to indicate a general relative spatial relation rather than a precisely limited location. For the sake of convenience, reference may be made to terms such as therapy, treatment, diagnosis, procedure, etc., including various grammatical forms thereof, alternately and without intent to limit, reference to one such term not excluding the others unless explicitly stated. Moreover, it will be appreciated that reference may be made herein to a treatment site, target site, site, etc., interchangeably and without intent to limit. Finally, reference to “at” a location or site is intended to include at and/or about the vicinity of (e.g., along, adjacent, proximate, etc.) such location or site.
As generally used herein, the term “ablation” generally refers to removal of cells either directly or indirectly by supply of energy within an electric field and may include removal by loss of cell function, cell lysis, coagulation, protein denaturation, necrosis, apoptosis, and/or irreversible electroporation. “Ablation” may similarly refer to creation of a lesion by ablation. Additionally, the terms “undesirable tissue,” “target cells,” “diseased tissue,” “diseased cells,” “tumor,” “cell mass” may be used herein to refer to cells removed or to be removed, in whole or in part, by ablation, and are not intended to limit application of any assemblies, systems, devices, or methods described herein. For example, such terms include ablation of both diseased cells and certain surrounding cells, despite no definite indication that such surrounding cells are diseased. Ablation performed by assemblies, systems, devices, or methods described herein may be of cells located around a biological lumen, such as a vascular, ductal, or tract area, for example, to create a margin for a medical professional to resect additional cells by ablation or other method. In accordance with various principles of the present disclosure, devices, assemblies, systems, and methods disclosed herein may be configured for performing ablation via electroporation and/or IRE.
Electrical ablation devices accordance with various principles of the present disclosure and described herein include two or more, and even three or more, electrodes configured to be positioned into or proximal to undesirable tissue in a tissue treatment region (e.g., a target site or a worksite). The tissue treatment region may have evidence of abnormal tissue growth. In general, the electrodes may include an electrically conductive portion and may be configured to be electrically coupled to an energy source. In some aspects, the devices, assemblies, systems, and methods of the present disclosure are configured for use in electroporation and/or irreversible electroporation (“IRE”) treatments/therapies. For instance, devices, assemblies, systems, and methods may be configured in accordance with various principles of the present disclosure for minimally invasive ablation treatment of undesirable tissue through the use of IRE. Minimally invasive ablation treatment may be characterized by the ability to ablate selected tissue in a controlled and focused manner with reduced or no thermally-damaging effects to surrounding healthy tissue.
In accordance with various principles of the present disclosure, an energy-delivering treatment system (such as capable of performing electroporation and/or IRE) has a multi-electrode-energy-delivering assembly with two or more electrodes across which therapeutic energy is transferred, generally delivered and deployed together at/to/within/around a target site/treatment site within a patient's body. In some aspects, multi-electrode-energy-delivering assemblies formed in accordance with various principles of the present disclosure are bipolar or unipolar devices with at least one cathode and at least one anode positioned within the patient. In some aspects, the one or more cathodes and/or the one or more anodes are positioned within the patient in a manner configured to mitigate effects of monopolar devices. In some aspects, the electrodes are arranged to deliver therapeutic energy to a patient across the electrodes of the assembly, thereby limiting energy fields to the region of the electrodes. As such, transmission of energy through the patient's body is more confined than when similar amounts and types of energy are delivered with a monopolar device with a single electrode at the treatment site and utilizing another electrode (typically a return or grounding pad) positioned a distance away from the single electrode (typically outside the patient). Accordingly, in contrast with monopolar devices, the multi-electrode energy-delivering assemblies described herein may be considered to function as a bipolar or unipolar device (or devices) which mitigates some undesirable effects of monopolar probes used with living organisms such as human patients. And in contrast with various bipolar probes, multi-electrode energy-delivering assemblies disclosed herein include two or more electrodes, and even three or more electrodes, coupled together for delivery as an assembly/as a unit. Additionally or alternatively, various of the multi-electrode energy-delivering assemblies described herein have a compact delivery configuration facilitating deliver of the multi-electrode energy-delivering assembly as an assembly/as a unit, through a lumen or working channel of a delivery device, and/or percutaneously, and/or individually through luminal spaces in the patient's body. For instance, the electrodes of the multi-electrode energy-delivering assembly may be along a common member of the multi-electrode energy-delivering assembly. In some aspects, the multi-electrode energy-delivering assembly has a plurality of electrodes formed from an elongate electrically conductive element with portions/sections/regions thereof separated to define spaced apart electrodes therealong. In some aspects, the multi-electrode energy-delivering assembly includes a separate element, such as a support element, on which electrodes are mounted. The two or more electrodes may be generally axially spaced apart from one another, such as along an elongated common member. For instance, in some aspects, an electrode of a given polarity may extend along a support element such as an electrode of a different polarity, and/or a support element which may otherwise affect an energy field created with respect to the multi-electrode energy-delivering assembly. In some aspects, the two or more electrodes are delivered together as an assembly/as a unit generally coupled together, yet also movable with respect to one another. In some aspects, the two or more electrodes are delivered in a generally elongated configuration facilitating delivery through a lumen or working channel of a delivery device.
To effectively treat a target site with electroporation and/or IRE, an effective electric field must be created between the electrodes of a multi-electrode-energy delivering assembly formed in accordance with various principles of the present disclosure. More particularly, in the case of a bipolar probe, a first electrode of a first polarity must be electrically insulated from a second electrode of a second polarity. In accordance with various principles of the present disclosure, either or both electrodes of a multi-electrode-energy delivering assembly formed in accordance with various principles of the present disclosure are formed of an electrically-conductive material (e.g., medical grade stainless steel, platinum, gold, nitinol, a cobalt-chromium alloy, a nickel-cobalt alloy such as MP35N, copper, or other alloys, or materials plated with electrically-conductive materials, etc.). In some aspects, an insulation member is positioned between the electrodes, such as to electrically isolate the electrodes (typically with one electrode serving as an anode and another electrode serving as a cathode). The insulation member may be formed of any appropriate insulative material (e.g., a polymer extrusion, a polymer heat shrink, ceramic, a composite shaft, such as formed of fluoropolymer, polyimide, polyethylene terephthalate (PET), nylon, and/or any other suitable material of adequate dielectric strength and biocompatibility, and any combinations or composites thereof, etc.) capable of isolating electrodes of opposite polarities.
The various multi-electrode energy-delivering assemblies described herein may be deliverable through an elongate tubular member (e.g., a delivery sheath, catheter, working channel of an endoscope, etc.) inserted into a patient (such as through a natural anatomical passage or orifice and into a body lumen within a patient), or transcutaneously or percutaneously. The energy-delivering member of the energy-delivering assembly may be coupled to an energy source to energize the electrode portion thereof to apply an electric current to biological tissue. The energy source may be operative to generate an electric field between the electrode portion and another electrode portion, such as an electrode portion coupled to the energy source and having an opposite polarity, e.g., a return or ground. Once an energy-delivering assembly formed in accordance with various principles of the present disclosure is positioned at or near undesirable tissue, an energizing potential may be applied to the electrode portions thereof, such as to create an electric field to which the tissue at the target site is exposed. The energizing potential (and the resulting electric field) may be characterized by various parameters, such as, for example, frequency, amplitude, pulse width (duration of a pulse or pulse length). Suitable energy sources include electrical waveform generators, such as waveform generators capable of creating IRE, high frequency IRE, pulsed, nanopulse, and/or ablative waveforms. The energy source generates an electric field with desired characteristics for the treatment to be performed at the target site. For instance, the electric field may be generated to have suitable characteristic waveform output in terms of voltage, impedance, frequency, amplitude, pulse width, delays between pulses, number of pulses per burst, number of bursts, and polarity. Optionally, the pulse sequences are triggered in accordance with the patient's cardiac cycle (e.g., so as not to interfere with the patient's cardiac cycle). The electric current flows between the electrodes and through the tissue proportionally to the potential (e.g., voltage) applied to the electrodes. The supplied electric current provided by the energy source may deliver a pulse sequence to the target site. For example, an energy source may supply various waveforms in one or more pulse sequences tailored to the desired application.
Energy-delivering assemblies, devices, systems, and methods described herein may be utilized for electroporation, irreversible electroporation (IRE), reversible electroporation, and/or electropermeabilization techniques to apply external electric fields (electric potentials) to cell membranes to significantly increase permeability of the plasma membrane of the cell, such as to improve uptake of therapeutic materials by the cell. Optionally, the energy applied to the cell may change the characteristics of the cell membranes (e.g., porosity), such as irreversibly, resulting in cell death (e.g., by apoptosis and/or necrosis). Such techniques may advantageously be used to treat/apply therapy without raising the temperature of the surrounding tissue to a level at which permanent damage may occur to the surrounding tissue, support structure, and/or regional vasculature. Application of IRE pulses to cells may thus be an effective way for ablating large volumes of undesirable tissue with no or minimal detrimental thermal effects to the surrounding healthy tissue.
Various embodiments of electrode devices, assemblies, systems, and various associated methods will now be described with reference to examples illustrated in the accompanying drawings. Reference in this specification to “one embodiment,” “an embodiment,” “some embodiments”, “other embodiments”, etc. indicates that one or more particular features, structures, concepts, and/or characteristics in accordance with principles of the present disclosure may be included in connection with the embodiment. However, such references do not necessarily mean that all embodiments include the particular features, structures, concepts, and/or characteristics, or that an embodiment includes all features, structures, concepts, and/or characteristics. Some embodiments may include one or more such features, structures, concepts, and/or characteristics, in 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 can 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 can be mixed and matched to create hybrid embodiments, and such hybrid embodiment are within the scope of the present disclosure. Moreover, references to “one embodiment,” “an embodiment,” “some embodiments”, “other embodiments”, etc. in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. It should further be understood that various features, structures, concepts, and/or characteristics of disclosed embodiments are independent of and separate from one another, and may be used or present individually or in various combinations with one another to create alternative embodiments which are considered part of the present disclosure. Therefore, the present disclosure is not limited to only the embodiments specifically described herein, as it would be too cumbersome to describe all of the numerous possible combinations and subcombinations of features, structures, concepts, and/or characteristics, and the examples of embodiments disclosed herein are not intended as limiting the broader aspects of the present disclosure. It should be appreciated that various dimensions provided herein are examples and one of ordinary skill in the art can readily determine the standard deviations and appropriate ranges of acceptable variations therefrom which are covered by the present disclosure and any claims associated therewith. The following description is of illustrative examples of embodiments only, and is not intended as limiting the broader aspects of the present disclosure.
In the drawings, it will be appreciated that common features are identified by common reference elements and, for the sake of brevity and convenience, and without intent to limit, the descriptions of the common features are generally not repeated. For purposes of clarity, not all components having the same reference number are numbered.
Turning now to the drawings, an example of an embodiment of an energy-delivering treatment system 100 is illustrated in
In some aspects, the energy-delivering assembly 110 is delivered to a target site within a patient through a delivery device, such as a tubular element (e.g., catheter, sheath, endoscope, etc.) having a lumen or working channel therethrough sized to allow passage of the energy-delivering assembly 110 therein/therethrough. Such delivery device may be selected from a variety of delivery devices known to those of ordinary skill in the art, the present disclosure not being limited in this regard. Optionally, a protective sheath 106 is provided over the multi-electrode-energy delivering assembly 110 to protect the delivery device from a sharp distal tip or other features of the multi-electrode-energy delivering assembly 110. Such protective sheath 106 may be in a form generally known those of ordinary skill in the art such that illustration thereof is not necessary for one of ordinary skill in the art to understand the nature of such member.
The energy-delivering treatment system 100 optionally further includes a handle 104 operatively coupled with the multi-electrode energy-delivering assembly 110, such as to control elements of the multi-electrode energy-delivering assembly 110. For instance, the handle 104 may be configured to control the relative positions of the multi-electrode energy-delivering assembly 110 with respect to a delivery device and/or protective sheath, and/or to control and/or to adjust the position of one or more elements of the energy-delivering assembly 110.
In accordance with various principles of the present disclosure, as discussed briefly above, a multi-electrode-energy delivering assembly formed in accordance with various principles of the present disclosure has two or more electrodes to be delivered to a target site on/within a patient. The electrodes are arranged and/or configured such that application of energy thereto creates a field of therapeutic energy which is to be applied to the target site in accordance with various principles of the present disclosure. Various formations of multiple electrodes of multi-electrode-energy delivering assemblies formed in accordance with various principles of the present disclosure are illustrated in
The example of an embodiment of a multi-electrode-energy delivering assembly 210 illustrated in
In accordance with various principles of the present disclosure, the multi-electrode-energy delivering assembly 210 is a bipolar assembly. As understood herein and as by those of ordinary skill in the art, a bipolar assembly has an anode as well as a cathode/ground electrode positioned and delivered together at/to within/around a target site/treatment site within a patient's body. Such configuration may be readily understood by those of ordinary skill in the art to be in contrast with a monopolar probe which delivers only electrodes of one polarity to a target site, with the opposite polarity electrode delivered at a different anatomical location with respect to the target site, such as outside the body (in contrast with the monopolar probe delivered to a target site within the body). In the example of an embodiment of a multi-electrode-energy delivering assembly 210 illustrated in
In accordance with various principles of the present disclosure, the first energy-delivering member 220 of the example of an embodiment of a multi-electrode-energy delivering assembly 210 illustrated in
The multi-electrode-energy delivering assembly 210 illustrated in
In accordance with various principles of the present disclosure, an insulation layer or member 240 is provided between the first energy-delivering member 220 and the second energy-delivering member 230 to electrically isolate/insulate the electrically-conductive materials thereof from each other. The insulation member 240 may be formed of a layer and/or coating of insulative material (e.g., such as an insulative material as described above) which may be selected based on the material of the first energy-delivering member 220 and/or the second energy-delivering member 230. In some aspects, the insulation member 240 may be cut or etched away to reveal/expose the underlying material of the first energy-delivering member 220 to serve as an electrode of the multi-electrode-energy delivering assembly 210. For instance, as illustrated in
Optionally, if the second energy-delivering member 230 is formed of a single, generally continuous element extending over the first energy-delivering member 2220 (such as a hypotube or cut hypotube), a differentiating insulation member 250 may be provided over one or more portions/regions/sections (such terms being used interchangeably herein without intent to limit unless otherwise specified) to separate and define portions of the second energy-delivering member 230 as separate electrodes 230a, 230b (of the same polarity, opposite that of the first energy-delivering member 220). The differentiating insulation member 250 may be formed of an insulative material such as ceramic, polymer, etc., such as may be selected based on the material of the underlying second energy-delivering member 230.
As may be appreciated, the second energy-delivering member 230 is a different polarity than that of the first energy-delivering member 220, and thus is electrically-connected at its proximal end as well, such as in a manner known those of ordinary skill in the art. In the example of an embodiment illustrated in
In accordance with various principles of the present disclosure, the example of an embodiment of a multi-electrode energy-delivering assembly 210 illustrated in
It will be appreciated that the first energy-delivering member 220, and/or the second energy-delivering member 230, and/or the insulation member 240 therebetween, and/or the differentiating insulation member 250 may have alternative configurations than those illustrated in
In accordance with various principles of the present disclosure, a multi-electrode-energy delivering assembly may be advantageously formed in other than linear configurations, with the various electrodes thereof movable with respect to one another (in contrast with the electrodes 220, 230 of the above-described multi-electrode-energy delivering assembly 210 which are generally fixed with respect to each other). For instance, the example of an embodiment of a multi-electrode-energy delivering assembly 410 illustrated in
In some aspects, the example of an embodiment of a multi-electrode-energy delivering assembly 410 illustrated in
Each of the electrodes 420 may be individually and separately connected to an energy source (e.g., via a power connector 102, such as illustrated in
It will be appreciated that a multi-electrode-energy delivering assembly 410 formed in accordance with various principles of the present disclosure and configured as illustrated in
Another approach to a multi-electrode-energy delivering assembly 510 allowing a degree of adjustability of the electrodes thereof in accordance with various principles of the present disclosure is illustrated in
An example of an embodiment of a multi-electrode-energy delivering assembly 510, such as illustrated in
The injection device 530 has a lumen defined therethrough in which the electrically-conductive fluid 520 is transported to the target site T and/or from which the electrically-conductive fluid 520 is delivered to the target site T. The injection device 530 may be a needle, hot knife, or other appropriate medical instrument, tool, device, etc. In some aspects, the injection device 530 is formed of an electrically-conductive material (e.g., any of the above described electrically-conductive materials) and forms a second electrode of opposite polarity than the polarity of the first electrode formed by the electrically-conductive fluid 520. The injection device 530 may supply energy to the target site T or may be a return electrode which is grounded, such as depending on materials, structure, nature, and/or other features of the electrically-conductive fluid 520, the injection device 530, and/or the target site T. Optionally, a secondary electrode 532 extends from the injection device 530 and is manipulable with respect to the elongated body of the injection device 530 (e.g., through which the delivery lumen is formed, although the secondary electrode 532 may optionally include a lumen therethrough), such as illustrated in
It will be appreciated that the example of an embodiment of a multi-electrode-energy delivering assembly 510 may facilitate delivery of therapeutic energy over a surface area significantly larger than the delivery device by which the multi-electrode-energy delivering assembly 510 is delivered and deployed. For instance, injection of additional electrically-conductive fluid 520 to create a larger energy field (e.g., ablation field) generally does not require an increase in the size of the injection device 530 or any delivery device 406 such as described above with reference to
Additional example of embodiments of multi-electrode-energy delivering assemblies with separately formed and/or separately controlled electrodes are illustrated in
In the example of an embodiment of a multi-electrode energy-delivering assembly 610 illustrated in
To form a bipolar multi-electrode energy-delivering assembly 610 in accordance with various principles of the present disclosure, an electrode 630 with a polarity opposite the polarity of the electrode tines 622 is provided in the general vicinity of the electrode tines 622. More particularly, in the example of an embodiment of a multi-electrode energy-delivering assembly 610 illustrated in
In some aspects, the second, tubular electrode 630 is formed of an electrically-conductive material similar to the generally tubular second energy-delivering member 230 illustrated in
As may be appreciated, with the electrode tines 622 and the tubular electrode 630 having different polarities, an ablation zone A may be created/generated in the area between the electrode tines 622 and the tubular electrode 630. To maximize the size and to control the shape of the ablation zone A, the electrode tines 622 may have elongated straight sections (or additional curvature of) 622s extending proximally from the distal ends 622d thereof a distance selected to generate an ablation zone A of the desired size/volume and control the shape such as determined, in part, by the electrical field formed by the electrode tines 622 (e.g., such as may be determined based on various characteristics of the target site to be treated by the multi-electrode energy-delivering assembly 610). Alternatively or additionally, it will be appreciated that the configuration of the multi-electrode energy-delivering assembly 610 (e.g., monopolar, bipolar, or unipolar) affects/controls the ablation zone A. Furthermore, as may be appreciated, if the elongated shaft 624 from which the electrode tines 622 extend is polarized, an insulation layer or member 640 is provided between the elongated shaft 624 and the tubular electrode 630 to electrically isolate/insulate the electrically-conductive materials thereof from each other. The insulation member 640 may be a generally tubular member formed of insulative material (such as any of the insulative materials described above) which may be selected based on the material of the electrode tines 622 and/or the tubular electrode 630, and may extend the full longitudinal extent along which the elongate shaft 624 and the tubular electrode 630 are adjacent to each other.
In accordance with various principles of the present disclosure, an insulation sheath 660 may be provided over a proximal extent of the tubular electrode 630, such as to insulate the patient from energy delivered from an energy source coupled to a proximal end of the tubular electrode 630. Additionally or alternatively, the insulation sheath 660 may delimit an energy-delivery region 632 of the tubular electrode 630. The distance between the distal end 660d of the insulation sheath 660 and the distal end 630d of the tubular electrode 630 may be selected to generate an ablation zone A of the desired size/volume such as determined, in part, by the size of the electrode formed by the tubular electrode 630 (e.g., such as may be determined based on various characteristics of the target site to be treated by the multi-electrode energy-delivering assembly 610).
In some aspects, in accordance with various principles of the present disclosure, energy supplied to the various electrodes of a multi-electrode energy-delivering assembly with a multi-electrode needle such as illustrated in
A further example of an embodiment of a multi-electrode energy-delivering assembly with multiple, separate electrodes is illustrated in
In a delivery configuration, such as illustrated in
In accordance with various principles of the present disclosure, two or more electrodes 820 are provided axially spaced along the length of a support element 822. Each electrode 820 may be independently wired or selectively wire to an anode and cathode and therefore conduct the electrical signal between the anode and cathode electrodes and fired simultaneously or multiplexed. Additionally or alternatively, the energy-delivering assembly 810 may be a single monopolar electrode. The support element 822 is flexible to shift from a delivery configuration to a deployed configuration such as described herein. In some aspects, the support element 822 is formed of a shape memory material such as any of those described herein, and/or a shape memory nylon or plastic. Additionally or alternatively, an actuation element may extend to the support element 822 to form the desired shape of the multi-electrode energy-delivering assembly 810 upon deployment from a delivery device 106, such as using a method similar to spring forming (e.g., a rotational and/or axial mechanism operatively coupled with the multi-electrode energy-delivering assembly 810 to form the desired shape, such as a coil, for deployment with respect to a treatment site). Additionally or alternatively, the electrodes 820 may be made of a shape memory alloy such as nitinol, spring tempered steel, etc.
In the expanded deployment configuration illustrated in
In some aspects, such as illustrated in
The electrodes 820 of the multi-electrode energy-delivering assembly 810 illustrated in
It will be appreciated that any of the above-described multi-electrode probes may be used in a monopolar or bipolar manner. Moreover, it will be appreciated that provision of two, three, or more electrodes in accordance with various principles of the present disclosure described herein allow for various modifications and customizations of energy fields created by the energy-delivering assemblies described herein. It will be appreciated that the devices, systems, assemblies, and methods disclosed herein may be delivered endoscopically, or percutaneously, as well as use within other steerable luminal access devices. For instance, multi-electrode-energy delivering assemblies disclosed herein may be delivered in a configuration which is sufficiently compact to be delivered within a lumen of a delivery device which is inserted into and navigated within a patient to the target site at which the multi-electrode-energy delivering assembly is to be deployed. The configuration of the multiple (two, three, or more) electrodes and/or support structure therefor (e.g., one or more elements which may support the electrodes) of a multi-electrode energy-delivering assembly formed in accordance with various principles of the present disclosure allows for an energy field to be created which is larger and/or more customizable than achieved by a simple prior electrode/probe. For instance, an energy field formed by a multi-electrode energy-delivering assembly formed in accordance with various principles of the present disclosure may be able to produce larger and/or more customized energy field created than by two electrodes fixed on an elongate shaft, and/or may provide the ability to treat around a tumor mass or within a tumor based on need. Additionally or alternatively, a multi-electrode energy-delivering assembly formed in accordance with various principles of the present disclosure allows the shaping and sizing of the ablation zone based on the electrode(s) positioning and sizing in relation to each other along with the electrical waveform sent by the generator. Various of the components of the energy delivering assemblies described above may be formed of a shape memory material to allow formation of an electrode configuration suitable for treatment to be formed. The two, three, or more electrodes of any of the above-described multi-electrode energy-delivering assemblies may be coupled with an energy source outside the patient while the electrodes of the multi-electrode-energy delivering assembly are within the patient.
It will be appreciated that all structures, devices, systems, assemblies, and methods discussed herein are examples implemented in accordance with one or more principles of this disclosure, and are not the only way to implement these principles, and thus are not intended as limiting the broader aspects of the present disclosure. Thus, references to elements or structures or features in the drawings must be appreciated as references to examples of embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features illustrated. Other examples of manners of implementing the disclosed principles will occur to a person of ordinary skill in the art upon reading this disclosure. It should be apparent to those of ordinary skill in the art that variations can be applied to the disclosed devices, assemblies, systems, and/or methods, and/or to the sequence of steps of the method described herein without departing from the concept, spirit, and scope of the disclosure. It will be appreciated that various features described with respect to one embodiment typically may be applied to another embodiment, whether or not explicitly indicated. The various features hereinafter described may be used singly or in any combination thereof. Therefore, the present invention is not limited to only the embodiments specifically described herein, and all substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the disclosure as defined by the appended claims.
The foregoing discussion has broad application and has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be clear to those skilled in the art that principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the concept, spirit, or scope, or characteristics thereof. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of the certain aspects, embodiments, or configurations of the disclosure may be combined in alternate aspects, embodiments, or configurations. While the disclosure is presented in terms of embodiments, it should be appreciated that the various separate features of the present subject matter need not all be present in order to achieve at least some of the desired characteristics and/or benefits of the present subject matter or such individual features. One skilled in the art will appreciate that the disclosure may be used with many modifications or modifications of structure, arrangement, proportions, materials, components, and otherwise, used in the practice of the disclosure, which are particularly adapted to specific environments and operative requirements without departing from the principles or spirit or scope of the present disclosure. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of elements may be reversed or otherwise varied, the size or dimensions of the elements may be varied. Similarly, while operations or actions or procedures are described in a particular order, this should not be understood as requiring such particular order, or that all operations or actions or procedures are to be performed, to achieve desirable results. Additionally, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims, and not limited to the foregoing description or particular embodiments or arrangements described or illustrated herein. In view of the foregoing, individual features of any embodiment may be used and can be claimed separately or in combination with features of that embodiment or any other embodiment, the scope of the subject matter being indicated by the appended claims, and not limited to the foregoing description.
In the foregoing description and the following claims, the following will be appreciated. The phrases “at least one”, “one or more”, and “and/or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a”, “an”, “the”, “first”, “second”, etc., do not preclude a plurality. For example, the term “a” or “an” entity, as used herein, refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. As used herein, the conjunction “and” includes each of the structures, components, features, or the like, which are so conjoined, unless the context clearly indicates otherwise, and the conjunction “or” includes one or the others of the structures, components, features, or the like, which are so conjoined, singly and in any combination and number, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and/or the like) are only used for identification purposes to aid the reader's understanding of the present disclosure, and/or serve to distinguish regions of the associated elements from one another, and do not limit the associated element, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, engaged, joined, etc.) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority, but are used to distinguish one feature from another.
The following claims are hereby incorporated into this Detailed Description by this reference, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the terms “comprises”, “comprising”, “includes”, and “including” do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.
This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 63/525,004, filed Jul. 5, 2023, the entire disclosure of which is hereby incorporated by reference herein for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63525004 | Jul 2023 | US |
