Axially adjustable electrode treatment systems and methods

Abstract

Devices, systems, and methods for providing controlled delivery of energy therapy to a tissue site are disclosed. Systems, devices, and methods may include designs having features for efficiently deploying and adjusting electrodes at a tissue site for treatment and features for facilitating retraction of the electrodes into the housing for removal after completion of the treatment. The systems, devices, and methods may further include an expansion member for radially expanding the flexible substrate to assist in positioning the electrode adjacent the tissue to facilitate treatment.

Description

[0001] This application claims priority under 35 U.S.C. 119(e) to U.S. Provisional Patent Application No. 63 / 585,463, filed on September 26, 2023, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention relates generally to the field of tissue treatment. In particular, the present disclosure relates to devices and methods with axially adjustable electrodes for ablating cells to treat target tissue. Background Art

[0003] Tissue within the body can be treated using surgical or medical procedures, using resection and removal. While these procedures may be necessary to treat more extensive injuries or address various medical conditions, in some cases, minimally invasive procedures may be used as an alternative. When applicable, such procedures may be more appropriate to reduce overall risk to the patient, damage to surrounding tissue, recovery time, discomfort, and potential harmful side effects compared to more invasive procedures. In minimally invasive tissue ablation, target tissue can be treated within the body (e.g., in situ) using procedures that do not involve resection or may require minimal resection. Some examples of minimally invasive tissue ablation techniques include electrolytic ablation, cryosurgery, chemical ablation (e.g., alcohol injection), thermal ablation (e.g., radiofrequency, microwave), and hydrothermal ablation. The primary purpose of these ablation procedures is to destroy abnormal tissue in the target area, as well as to promote the regeneration of healthy tissue.

[0004] Another minimally invasive treatment technique involves electroporation of the target tissue through the local application of an electric field to increase the permeability of the cell membrane, which then allows the introduction of drugs or other chemicals into the cells for treatment. Electroporation can also be used in combination with electrolysis as a method of tissue ablation through a process also known as electrolytic electroporation, electroporation electrolysis, or E2.

[0005] Tissue ablation is a therapeutic procedure used to treat injuries to various tissues, such as those of the gastrointestinal tract and other tissues. Damage to intestinal tissue can occur for a variety of reasons, but is often associated with chronic metabolic disorders, such as diabetes. For diabetic patients, damage to gastrointestinal tissue, particularly the duodenum, can cause problems with insulin resistance and / or impair the body's ability to process glucose. To help manage this disorder, duodenal mucosal resurfacing (DMR) has been proposed to resurface the patient's intestinal lining to help regenerate a healthy lining, thereby improving nutrient absorption at the duodenum. Improving the health of the intestinal lining may help correct absorption problems and produce a better therapeutic response to insulin for some patients, which in turn may allow patients to replace more aggressive insulin therapy (e.g., injections) with oral medications to help manage the condition.

[0006] Generally, DMR is a procedure that involves introducing a catheter (or other suitable medical device) into the duodenum, usually under endoscopic guidance, and ablating the inner lining of the duodenum. However, various ablation techniques and ablation device designs may not be suitable for intraluminal ablation, or may be difficult to control ablation to a desired depth via intraluminal application of the duodenum.

[0007] The inventors have determined that there is a need for an improved electrode treatment system for use with two or more electrodes to ablate cells to treat target tissue. In particular, an improved electrode treatment system for electroporation and / or electrolysis to ablate such cells. Some aspects of the improved electrode treatment system include axially adjustable electrodes that can be arranged with a desired target spacing between electrodes during, after, and / or before application of energy delivery for tissue treatment. In the examples described herein, the two or more electrodes can be two or more electrode arrays. Other aspects and advantages of such a system will become apparent by continuing to refer to the following detailed description of example embodiments with reference to the accompanying drawings. Summary of the invention

[0008] Various examples of electrode treatment systems for treating tissue are described herein. An exemplary system may include a first flexible member and a second flexible member, the first flexible member having a first expandable support member coupled thereto, the second flexible member having a second expandable support member coupled thereto, wherein each of the first expandable support member and the second expandable support member is configured to expand from a stowed configuration to a deployed configuration. The system further includes a first electrode coupled to the first expandable support member and a second electrode coupled to the second expandable support member, wherein the electrodes are configured to jointly deliver energy to a tissue surface to treat it, and wherein the position of the first expandable support member can be adjusted independently of the position of the second expandable support member to adjust a target spacing between the first electrode and the second electrode for treatment of the tissue surface. In some exemplary systems, the first electrode and the second electrode are electrode arrays, each electrode array comprising a plurality of electrodes.

[0009] In some exemplary systems, the first flexible member includes a hollow interior having a cavity extending therethrough and an opening at a distal portion of the first flexible member, wherein the second flexible member extends through the cavity of the first flexible member and extends distally of the distal portion of the first flexible member.

[0010] Some exemplary systems may further include a sheath including a hollow interior having a cavity extending therethrough and an opening at a distal portion of the sheath, and wherein both the first flexible member and the second flexible member extend through the cavity of the sheath and extend distally relative to the distal portion of the sheath. In some exemplary systems, when the first flexible member and the second flexible member are positioned in the cavity of the sheath, the first expandable support member and the second expandable support member are in a stowed configuration in the sheath. In other exemplary systems, the first flexible member and the second flexible member are capable of moving in an axial direction through the cavity of the sheath and moving distally of the sheath to expand the first expandable support member and the second expandable support member from the stowed configuration to the deployed configuration, wherein the first flexible member and the second flexible member are capable of retracting into the cavity in an axial direction to retract the first expandable support member and the second expandable support member from the deployed configuration to the stowed configuration. In some exemplary systems, in response to the corresponding first flexible member and the second flexible member extending to the distal side of the sheath, the first expandable support member and the second expandable support member each spontaneously expand from the stowed configuration to the deployed configuration. Some exemplary systems may include one or more expansion members coupled to one or both of the first expandable support member and the second expandable support member, wherein the one or more expansion members are capable of radially expanding to expand one or both of the first expandable support member and the second expandable support member from a stowed configuration to a deployed configuration.

[0011] In some exemplary systems, the first expandable support member and the second expandable support member each include a braided mesh frame. In some exemplary systems, the outer surface of the braided mesh frame includes a protective coating to reduce tissue trauma during delivery of the system to a tissue surface. In other exemplary systems, the first expandable support member and the second expandable support member are both expandable balloons.

[0012] In some exemplary systems, the first electrode and the second electrode are both annular structures disposed on the distal portions of the first expandable support member and the second expandable support member, respectively. In other exemplary systems, the first electrode and the second electrode are both point contact electrodes disposed on the distal portions of the first expandable support member and the second expandable support member, respectively.

[0013] Some example systems may include a locking mechanism operable to selectively lock a position of the first expandable support member relative to a position of the second expandable support member to maintain a target spacing between the first electrode and the second electrode during treatment of a tissue surface.

[0014] In some exemplary systems, a frame extends between and couples the first expandable support member and the second expandable support member to each other, wherein the frame is adjustable to adjust a target spacing between the first electrode and the second electrode as desired. In some exemplary systems, the frame, the first expandable support member, and the second expandable support member are all braided mesh frames. In other exemplary systems, at least one expansion member is coupled to the frame, wherein the expansion member is radially expandable to expand the frame and adjust a target spacing between the first electrode and the second electrode.

[0015] Another exemplary system for tissue treatment includes a delivery system having a first expandable support member and a second expandable support member, wherein the first expandable support member includes a first electrode coupled thereto, and the second expandable support member includes a second electrode coupled thereto, wherein the first electrode and the second electrode are configured to deliver energy to a tissue surface to treat it. The system further includes a controller in operable communication with the delivery system, and the controller is configured to independently adjust the relative positions of the first expandable support member and the second expandable support member based on a target energy level applied to the tissue surface to adjust a target spacing between the first electrode and the second electrode to treat the tissue surface, and to induce a voltage based on the target energy level and the target spacing between the first electrode and the second electrode to treat the tissue surface.

[0016] In some exemplary systems, a first expandable support member is coupled to a first flexible member and a second expandable support member is coupled to a second flexible member, and wherein a controller is operable to drive one or both of the first flexible member and the second flexible member relative to each other. In other exemplary systems, the first flexible member includes a hollow interior having a cavity extending therethrough and an opening at a distal portion of the first flexible member, wherein the second flexible member is adjustable via the controller through the cavity of the first flexible member and distal to the distal portion of the first flexible member.

[0017] Some exemplary systems further include a locking mechanism in operable communication with the controller, wherein the locking mechanism is operable to selectively lock the position of the first expandable support member relative to the position of the second expandable support member via the controller to maintain a target spacing between the first electrode and the second electrode during treatment of the tissue surface. In some exemplary systems, when the first electrode and the second electrode are locked at the target spacing, the controller is further operable to adjust the rate of movement of the first expandable support member and the second expandable support member while inducing the voltage to continuously treat the tissue surface.

[0018] Some exemplary systems further include one or more expansion members coupled to one or both of the first expandable support member and the second expandable support member, wherein the one or more expansion members are capable of radially expanding to expand one or both of the first expandable support member and the second expandable support member and adjust a target spacing between the first electrode and the second electrode. In some exemplary systems, a controller is in communication with the one or more expansion members, wherein the controller is operable to control an expansion rate of the one or more expansion members.

[0019] An exemplary method for treating tissue via an electrode treatment system includes delivering a first electrode and a second electrode to a target tissue surface for treatment. The method further includes axially adjusting the position of one or both of the first electrode and the second electrode relative to each other to set a target spacing separating the first electrode from the second electrode at the target tissue surface. Thereafter, the first electrode and the second electrode are energized to deliver energy to the target tissue surface, thereby treating with the electrodes positioned at the target spacing. In some examples, the step of axially adjusting one or both of the first electrode and the second electrode may occur prior to energizing the electrodes, or may also occur during the delivery of energy to the target tissue surface. In other examples, the first and second electrodes may be axially adjusted to retract the electrodes into the housing for removal after treatment is completed. In other exemplary methods, the first electrode is coupled to a first flexible member, and the second electrode is coupled to a second flexible member, and the step of axially adjusting one or both of the first electrode and the second electrode further includes axially adjusting one or both of the first flexible member and the second flexible member. In some examples, the first electrode and the second electrode are electrode arrays, each electrode array comprising a plurality of electrodes.

[0020] Some exemplary methods further include the step of determining a target energy level for application to the target tissue surface, wherein the step of axially adjusting one or both of the first electrode and the second electrode to set the target spacing is based on the determined target energy level.

[0021] In some exemplary methods, the first electrode is coupled to the first expandable support member and the second electrode is coupled to the second expandable support member, and the method further includes expanding the first expandable support member and the second expandable support member to adjust the position of the respective first and second electrodes. In other exemplary methods, the step of expanding the first and second expandable support members precedes the step of axially adjusting the position of one or both of the first and second electrodes.

[0022] Some exemplary methods further include the step of locking the first electrode and the second electrode at the target separation before energizing the first electrode and the second electrode.

[0023] It should be understood that the above summary provides various examples further described herein and is not intended to identify any key or important aspects of the disclosed or claimed subject matter. Further, aspects of the exemplary systems summarized above may be combined in any suitable manner without departing from the principles of the disclosed or claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The above and other features of the present disclosure will become more apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several examples in accordance with the present disclosure and are therefore not to be considered limiting in scope, the present disclosure will be described with additional specificity and detail through use of the accompanying drawings, in which:

[0025] Figure 1 is a schematic illustration of an electroporation and / or electrolysis system according to examples described herein.

[0026] Figure 2 is a schematic illustration of a robotic-assisted manipulator system according to examples described herein.

[0027] Figure 3A is a schematic illustration of a medical device system according to examples described herein.

[0028] Figure 3B An example of an expanded embodiment of an apparatus according to an example described herein is illustrated. Figure 3A The distal portion of a medical device system.

[0029] Figure 4 is a schematic diagram of a medical procedure for inserting an electrode therapy system according to examples described herein.

[0030] Figure 5A A method for delivering an electrode to a target area for treatment according to the examples described herein Figure 4 Schematic diagram of the electrode therapy system.

[0031] Figure 5B is a schematic diagram of an electrode therapy system illustrating axial repositioning of one electrode relative to another electrode according to one example.

[0032] Fig. 6A Illustrated is an example of an electrode therapy system for delivering electrodes to a target area for treatment according to examples described herein.

[0033] Figure 6B An example of a stowed configuration in which the electrode is within the sheath is shown. Fig. 6A Electrode therapy system.

[0034] Figure 7An electrode therapy system is illustrated disposed within a cavity of a target tissue region for treatment according to examples described herein.

[0035] Figure 8

[0013] Another example of an electrode therapy system for delivering electrodes to a target area for treatment according to examples described herein is illustrated.

[0036] Fig. 9

[0013] Another example of an electrode therapy system for delivering electrodes to a target area for treatment according to examples described herein is illustrated.

[0037] Fig.10

[0013] Still another example of an electrode therapy system for delivering electrodes to a target area for therapy according to examples described herein is illustrated. DETAILED DESCRIPTION

[0038] Certain details are set forth below to provide a full understanding of embodiments of the present disclosure. However, it will be clear to those skilled in the art that embodiments of the present disclosure may be practiced without these specific details. In addition, the specific embodiments of the present disclosure described herein are provided by way of example and should not be used to limit the scope of the claimed subject matter to these specific embodiments. In other cases, in order to avoid unnecessarily obscuring the embodiments, known materials, components, processes, controller components, software and / or anatomy are not described or shown in detail.

[0039] The present disclosure relates to devices and systems for providing controlled delivery of two or more electrodes (e.g., one or more pairs of electrodes) to a target tissue site for treatment (e.g., via electroporation and / or electrolysis). In general, methods of minimally invasive regenerative surgery are disclosed that include subjecting a target area in living tissue to ablation delivered via two or more electrodes. In some examples, the ablation energy can be a combination of one or more electric fields and electrolysis delivered via two or more electrodes. However, it should be understood that the example systems and methods described herein can be utilized for deploying electrodes using ablative methods other than electroporation and / or electrolysis (e.g., radiofrequency ablation), or for purposes other than ablation, such as electrical stimulation or diagnostic methods.

[0040] During an example procedure utilizing electroporation and / or electrolysis, electrodes are brought into proximity and / or contact with the target tissue, and an electric field is generated by applying a voltage and / or current between one or more pairs of electrodes. The electric field can be generated to have a size that permeabilizes the cell membrane in the desired ablation region. The electric field can be generated to produce electrolytic products whose size itself does not cause damage to cells or extracellular matrix located in and around the target treatment region. However, when sufficient electrolytic products are generated in the permeabilized cell region, cell death occurs in the region where the electric field is applied without damaging the extracellular matrix or scaffold to help promote tissue regeneration in the treated tissue region.

[0041] In some examples, after ablative energy is applied to one target area, the electrodes can be moved to other tissue locations by advancing and / or retracting the delivery catheter and the electrodes carried by the delivery catheter as needed and repeating the process. In this way, electroporation and / or electrolysis can be performed at multiple locations within a patient to cover a larger area of ​​tissue. In some examples, multiple sets of electrodes can be placed at multiple corresponding tissue sites so that electroporation and / or electrolysis can be performed in parallel at each site, thereby reducing and / or eliminating the need to repeat the procedure as the catheter is moved through the patient.

[0042] In some embodiments of the present disclosure, the systems and methods disclosed herein can be used to treat tissues of the gastrointestinal tract. In other embodiments, the systems and methods described herein can be used to treat any of a variety of tissues. Generally, tissues can be treated where tissue regeneration is desired or where it is desired to replace a cell with another cell. Examples include intestines, duodenum, stomach, bladder, uterus, endometrial wall, ovary, colon, rectum, sinuses, ducts, ureters, prostate, skin, muscle, nerve, diaphragm, momentum, kidney, follicle, brain, lymphatic vessels, breast, esophagus, lung, liver, kidney, lymph node, lymph node basin and / or heart. In places where it is desired to replace fibrotic cells with stem cells that can re-regulate the region or when islets are injected into a portion of the liver to generate a new source of insulin, a tissue can be replaced with another tissue in the fibrotic region. Other tissues can be treated in other examples. Other details related to an exemplary process of electroporation and / or electrolysis for tissue treatment according to some embodiments are provided below.

[0043] As described above, electroporation can be performed to permeabilize the cell membrane of the targeted cell. Reversible electroporation can be used, wherein permeabilization can be stopped after removing the electric field. Cells undergo reversible electroporation and can survive, wherein the pores in the membrane are resealed and homeostasis is restored. In irreversible electroporation, permeabilization of the cell membrane is permanent and causes cell death. Generally for biological tissues, electric fields below about 1500V / cm to about 200V / cm are considered to produce reversible electroporation, while electric fields above about 1500V / cm are considered to produce irreversible electroporation. The examples of the systems and methods described herein can utilize reversible electroporation to avoid the shortcomings of irreversible electroporation, which may include heating and thermal damage, the complexity of providing such a large electric field, and muscle contraction that may be caused by a large electric field. It should be understood that although the systems and methods described herein can be designed to utilize reversible electroporation, the following regions or accidental regions may occur, i.e., in these regions or accidental regions, irreversible electroporation or even thermal ablation may occur in a limited portion of the treated tissue.

[0044] In some treatment programs, the electrolysis product can be applied to the permeabilized cells, so as to cause the cell death of the permeabilized cells in the applied electric field, while keeping the extracellular matrix of the permeabilized cells intact. Extracellular matrix generally refers to the three-dimensional network of protein and / or other molecules (for example, collagen fibers, proteoglycans and / or proteins such as fibronectin and / or laminin), which provides structure for cells and tissues, and may provide signal conduction for cell growth and development. Extracellular matrix can be used as the support of tissue regeneration and / or engineering. For example, cells can be regenerated, grown, transplanted or otherwise cultivated on the extracellular matrix. By retaining the extracellular matrix in the region of other ablated cells as described herein, cell regeneration and / or tissue engineering can be carried out in the region of ablated cells. In some programs, the extracellular matrix can be transplanted from the region of ablated cells to another region (it may be another region of ablated cells), to promote regeneration and / or tissue engineering in the transplanted region. In some cases, once the extracellular matrix exists, material can be injected into the extracellular matrix to promote regeneration.

[0045] The example systems and methods described herein can utilize electrolysis products to cause cell death, while utilizing electroporation to permeabilize the cell membrane. The electrolysis products are sufficient to ablate (e.g., cause cell death) permeabilized cells in a relatively short time frame. However, the concentration and exposure time of the electrolysis products are not enough to cause cell death of non-permeabilized cells, thereby minimizing or avoiding the formation of scar tissue, fibrotic tissue or ulcers in the treatment area. Scar tissue and fibrosis indicate that the extracellular matrix has been affected, and the ability of cell regeneration and / or tissue engineering to occur in the ablation area may be suppressed. Therefore, the electrolysis products are only used to ablate permeabilized cells, while keeping the extracellular matrix intact to promote tissue regeneration. The electrolysis products may include products (cytotoxicity) that are toxic to cells. Electrolysis preferentially utilizes one or more inert electrodes, which, except as a source or sink / hole (sink) of electrons or as a catalyst, do not participate in the electrolysis process. When using the non-inert electrodes involved in the process, they can generate metal ions that may cause systemic damage to the body, such as excessive iron or even metal fragments.

[0046] Examples of systems disclosed herein include electrodes, power supplies, and controllers for applying energy to treat internal tissues. The energy applied may be electrolysis and / or electroporation in some examples, radiofrequency ablation in other examples, and other energy forms in other examples. When the energy is electroporation with or without electrolysis, the controller controls the charge delivered to the electrode to induce one or more electric fields. When electroporation and electrolysis are included, the electrode is used to generate a current to produce electrolysis products, and a voltage difference is generated to produce an electric field that induces electroporation. The duration and size of the applied charge determine the dosage of the electrolysis products and the degree of permeabilization of cells in the treatment site. Therefore, the area of ​​cell ablation can be determined by the area where the cells are exposed to a combination of permeabilization and electrolysis products that cause ablation. However, ablation can keep the extracellular matrix in the ablated cell area where the electric field has been applied intact. The composition of the electrode can be selected according to the desired product and electroporation effect.

[0047] Reference Figure 1 , a brief overview of an example system for delivering a medical device having electrodes to a target tissue site for treatment via electroporation and / or electrolysis is provided below. For clarity, the written description of various example embodiments and related drawings may refer to catheters used with the systems and methods described herein. However, it should be understood that other suitable medical devices (e.g., devices that may not be specifically classified as catheters) and other suitable energy modes (e.g., radiofrequency ablation) may be used in conjunction with the disclosed systems and methods without departing from the principles of the disclosed subject matter.

[0048] Figure 1is a schematic diagram of a system 10 arranged according to an exemplary embodiment described herein. In general, the example systems described herein may include a delivery system and a controller. Figure 1 In the example of FIG. 1 , the system 10 includes a controller 14 and a medical device system 40. Figure 4-Figure 10 Examples of other medical device systems that can be used with system 10 (or other suitable systems described herein), such as electrode therapy systems 400, 600, 700, 800, 900, 1000, are described in further detail. As further described below, in some examples, the controller 14 may include a processor 16, a computer-readable medium 18, and other computing system components, such as one or more input devices, output devices, sensors, and / or communication devices. Additional, fewer, and / or different components may be used in other examples. The computer-readable medium 18 includes executable instructions 20 for causing electroporation and / or electrolysis using the medical device system 40, and may include stored parameters 22 that can be used in causing electroporation or electrolysis, such as electric field strength, voltage and / or current levels, waveform shapes, exposure duration parameters, and any other suitable parameters. In Figure 1 In the example of FIG. 4 , a circle depicted around the end of the medical device system 40 may indicate a region of cells that may be permeabilized via an applied electric field.

[0049] Controller 14 can be implemented using a computing device. Examples of computing devices include controllers, microcontrollers, computers, servers, medical devices, smart phones, tablet computers, wearable devices, and the like. The computing device can be handheld and can also have other uses. Controller 14 may include one or more processors, such as processor 16. There may be any type or number of processors, including one or more central processing units (CPUs) or graphics processing units (GPUs) with any number of cores, controllers, microcontrollers, and / or custom circuits (such as one or more application-specific integrated circuits (ASICs) and / or field programmable gate arrays (FPGAs)).

[0050] The controller 14 described herein may include a computer readable medium 18, such as a memory. Any type or kind of memory may be present (e.g., read-only memory (ROM), random access memory (RAM), solid-state drive (SSD), secure digital card (SD card), and the like). Although Figure 1 A single box is depicted as computer readable medium 18, but there may be any number of computer readable medium devices 18. Computer readable medium 18 may be in communication with processor 16 (eg, electrically connected to processor 16).

[0051] As described above, the computer-readable medium 18 can store executable instructions for execution by the processor 16, such as the executable instructions 20 for causing electroporation and / or electrolysis with the medical device system 40, and can utilize the stored parameters 22 for the medical device system 40. In this manner, techniques for applying electroporation and / or electrolysis in tissue can be implemented herein, in whole or in part, in software.

[0052] The executable instructions 20 may include instructions for controlling the charge delivered to an electrode, such as an electrode 50 of the medical device system 40. Thus, the controller 14 may induce a voltage difference across the target tissue to generate an electric field that causes cell permeabilization in the tissue region targeted for treatment. The electrode 50 is illustrated in a cavity or lumen 32 formed within the tissue 30. Although the medical device system 40 is shown disposed within the cavity 32 of the tissue 30, the medical device system 40 may be located on the surface of the tissue 30, within the tissue 30, and / or near the tissue 30.

[0053] Controllers such as Figure 1 The controller 14 can activate one or more selected electrodes 50 to provide an electric field. In some embodiments, the controller 14 can alternately or otherwise select a pattern of activating electrodes 50 (e.g., activating electrode pairs in sequence) to shape or deliver a specific electric field. In some examples, a fluid or other substance can be injected into the tissue 30, contacted with the tissue 30, or otherwise placed in or around the tissue 30 to help shape the electric field generated in the tissue 30. For example, a conductive fluid can help shape the field (e.g., by extending the field). In other examples, a non-conductive fluid can help shape the field (e.g., by attenuating the field). In some examples, a non-conductive fluid or other substance can be injected or otherwise placed in the tissue to protect areas where ablation is not desired. The electric field may not penetrate and / or pass through the non-conductive fluid, so that the electric field does not reach the tissue where ablation is not desired, or at least the intensity of the presence is not sufficient to cause permeabilization or other cellular changes.

[0054] The controller 14 can also be used to induce an electric current through the tissue 30, such as between the electrodes 50, to generate electrolytic products. The electrolytic products may cause ablation of permeabilized cells, but are preferably insufficient to destroy the extracellular matrix in the permeabilized cell region. As previously described, the remaining intact extracellular matrix can allow tissue regeneration and tissue engineering.

[0055] In some embodiments, one or more of the electrodes 50 used to apply electroporation can also be used to generate electrolysis products (in other words, some or all of the electrodes can be used for electroporation and electrolysis). In other embodiments, the first subset of electrodes 50 used to apply electroporation can be different from the second subset of electrodes 50 used to generate electrolysis products.

[0056] In some embodiments, the power source 12 is integrated with the controller 14. The power source 12 can be implemented using any suitable power source such as one or more AC power sources, DC power sources, batteries, and / or waveform generators. The power source 12 can supply power to the electrodes 50 to generate voltage and / or current, thereby generating an electric field and / or electrolysis products in the tissue 30. In some examples, the power source 12 can be implemented using a signal generator such as an exponential decay wave generator (e.g., Harvard Apparatus BTX 630), although the present disclosure is not limited thereto or thereby.

[0057] The controller 14 can control the timing, intensity, and duration of the electric field and / or electrolysis product provided via the medical device system 40. For example, the controller 14 can be programmed to provide an electronic signal to the medical device system 40 via the power source 12, wherein the electronic signal can indicate a therapeutic dose, such as a dose of electrolysis product and / or a permeability level of the cells. The electronic signal can control the timing and magnitude of the generated electric field, which can allow a user to customize the treatment of the tissue 30 as desired. In some embodiments, the controller 14 can include such a program, or include one or more processing devices (e.g., processors) coupled to a computer readable medium 18 encoded with executable instructions 20 for electrolysis and permeabilization. Although in Figure 1 1 is shown as a separate component coupled to the medical device system 40, but in some embodiments, the controller 14 can be integrated as a part of the medical device system 40. In other embodiments, the controller 14 can include a programmable circuit coupled to the medical device system 40 via a wired or wireless connection.

[0058] As previously described, the system 10 may include any suitable parameters 22 for controlling various aspects of the electroporation and / or electrolysis process, such as electric field strength, voltage level, current level, waveform shape, exposure duration parameters, and any other suitable parameters. The parameters 22 may be stored in the computer-readable medium 18 or in other suitable databases in communication with the controller 14. In some embodiments, the controller 14 may be used to calculate the parameters 22, or the controller 14 may communicate with another system operable to calculate the parameters 22.

[0059] In some example embodiments, the parameters of a particular treatment regimen may be determined based on measurements taken in the tissue of interest or from different samples of similar tissue 22. For example, measurements may be taken at various voltage levels with a particular electrode configuration, and target voltage levels, currents, pulse patterns, time constants, and other factors may be identified that result in reversible electroporation and delivery of electrolysis products, thereby causing permeabilized cells to die in accordance with desired cell death.

[0060] In some embodiments, examples of parameters 22 that can be used include delivering voltage pulses between 1 and 50 between 50V and 1000V. Those pulses can be delivered in systems with capacitances between 50μF and 1000μF and resistances between 15-20 ohms. The amount of electrolytic products generated may be related to the delivered charge in coulombs. There are several ways to calculate the delivered charge. For example, the charge Q (in coulombs, abbreviated as C) stored in a capacitor is equal to the product of the capacitance C (in farads, abbreviated as F) of the capacitor and the voltage V (in volts, abbreviated as V) across its terminals. That is, Q=C·V. In addition, the current I (in amperes, abbreviated as A) multiplied by the time t=charge. I*t=Q. By defining the capacitance and the voltage across the capacitance, the charge can be defined, and thus the electrolytic performance is determined. When a capacitor discharges, it generates a current, and the current multiplied by the time must be equal to the charge in the capacitor. When a capacitor is discharging, the current is not constant—it decays exponentially. Therefore, the time measurement is expressed as an exponential decay time constant. Figure 1 The capacitor included in the power supply 12 obtains the capacitance of the control time constant.

[0061] In some embodiments, the time constant (e.g., the exponential decay time constant of the capacitor discharge) can range from 50 microseconds (μs) to 3 ms. Generally, the lower limit of the time constant is related to the time sufficient to ensure that the electrolytic substance (e.g., electrolysis product) penetrates into the target area of ​​the permeabilized cell. The upper limit of the time constant is generally related to the production of the electrolytic substance (e.g., electrolysis product) that can cause self-ablation. Therefore, electrolysis is generally targeted at an amount of time sufficient to allow the electrolytic product to diffuse through the area of ​​the permeabilized cell. However, the amount of time that the electrolysis is provided should be limited to ensure that the process does not result in ablation of non-permeabilized cells or damage the extracellular matrix in the area of ​​the ablated cells.

[0062] In some embodiments, the generated electric field ranges between 100 V / cm and 3500 V / cm. In other embodiments, the electric field can be between 100 V / m and 1500 V / m, or between 200 V / cm and 850 V / m. In other embodiments, the electric field can be less than 1400 V / cm in some examples, less than 1300 V / cm in some examples, less than 1000 V / cm in some examples, less than 800 V / cm in some examples, or less than 600 V / cm in some examples.

[0063] The system 10 may further include one or more sensors (not shown) for measuring pH, temperature, electric field strength, tissue resistivity or impedance and / or other suitable characteristics of the tissue 30 to optimize treatment. For example, in one embodiment, a pH sensor may be combined with the system 10. The pH sensor may be arranged in any of several configurations, such as coupled to a medical device system 40 adjacent to the electrode 50 to detect a pH value near the electrode 50. In another embodiment, the pH sensor may be provided at the outer edge of the tissue target area. In either configuration, the pH sensor may communicate with the controller 14, wherein the controller 14 may utilize one or more received pH values ​​as an indication of tissue ablation and / or monitor the occurrence of tissue damage based on the detected pH level of the treatment site and the surrounding area of ​​the tissue. In some embodiments, the controller 14 may adjust the voltage, current and / or electric field applied to the tissue in response to the detected pH level. For example, if the pH value of the tissue outside the treatment site is at or exceeds a threshold value for tissue damage, the controller 14 may reduce the size of the electric field, the duration between pulses, or stop applying the electric field. Similarly, if the pH of tissue within the target area is at or above a threshold for tissue ablation, controller 14 may stop applying current through the electrodes to stop the electrolysis process, either immediately and / or after a desired elapsed electrolysis time.

[0064] In some embodiments, a resistivity meter can be used to determine the resistance of the target tissue. For example, Figure 1 The controller 14 and / or power source 12 of the system 10 can provide impedance measurements. The impedance measurements can determine the resistivity of the tissue 30 contacted by the electrodes 50 of the system 10. For example, the controller 14 and / or power source 12 can provide a nominal amount of current (such as a direct current) through the tissue 30 and receive a resistivity measurement and / or calculate the resistivity of the tissue 30. In some examples, the applied voltage, current, and / or electric field can be selected, determined, and / or allowed based on the measured resistance of the tissue 30. In some examples, multiple pulses of applied voltage can be selected, determined, and / or otherwise used based on the measured resistance of the tissue.

[0065] In some embodiments, sensors for detecting and / or determining electric field strength, such as gauss meters and / or tesla meters, may also be used. In such embodiments, the sensors may be in operative communication with controller 14 to ensure that the electric field strength remains at a target level for a desired treatment regimen.

[0066] In some embodiments, an ablation device (e.g., Figure 1The medical device system 40). The manipulator system includes one or more manipulators that can be operated with the help of an electronic controller (e.g., a computer) to move and control the functions of one or more instruments when the one or more instruments are coupled to the manipulators. Figure 2 One exemplary embodiment of a robotic-assisted manipulator system 100 for use with the systems and methods described herein is illustrated. The manipulator system can be used, for example, in surgical, diagnostic, therapeutic, biopsy, or non-medical procedures.

[0067] Reference Figure 2 , the robot-assisted manipulator system 100 may include one or more manipulator assemblies 102 for operating one or more medical device systems 104 while performing various procedures on a patient P placed on an operating table T in a medical environment 101. For example, the manipulator assembly 102 may drive the movement of a medical device or end effector, may apply treatment to a target tissue, and / or may manipulate a control member. The manipulator assembly 102 may be a teleoperated, non-teleoperated, or hybrid teleoperated and non-teleoperated assembly, having selected degrees of freedom of motion that can be motorized and / or teleoperated, and selected degrees of freedom of motion that can be non-motorized and / or non-teleoperated. An operator input system 106, which may be inside or outside the medical environment 101, generally includes one or more control devices for controlling the manipulator assembly 102. The manipulator assembly 102 supports the medical device system 104, and may optionally include a plurality of actuators or motors that drive inputs on the medical device system 104 in response to commands from a control system 112. The actuator may optionally include a drive system that, when coupled to the medical device system 104, advances the medical device system 104 into a natural or surgically created anatomical orifice. Other drive systems are capable of moving the distal end of the medical device system 104 in multiple degrees of freedom, which may include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three degrees of rotational motion (e.g., rotation around the X, Y, and Z Cartesian axes). The manipulator assembly 102 may support various other systems for flushing, treatment, or other purposes. Such systems may include fluid systems (e.g., including reservoirs, heating / cooling elements, pumps, and valves), generators, lasers, interrogators, and ablation components.

[0068] The robot-assisted manipulator system 100 also includes a display system 110 for displaying images or representations of the surgical site and the medical instrument system 104 generated by the imaging system 109, which may include an imaging system such as an endoscopic imaging system. The display system 110 and the operator input system 106 may be oriented so that the operator O can control the medical instrument system 104 and the operator input system 106 through the perception of the telepresentation. The graphical user interface may be displayed on the display system 110 and / or on a display system of a separate planning workstation.

[0069] In some examples, the endoscopic imaging system components of the imaging system 109 can be integrally or removably coupled to the medical instrument system 104. However, in some examples, a separate imaging device, such as an endoscope, attached to a separate manipulator assembly can be used with the medical instrument system 104 to image a surgical site. The endoscopic imaging system 109 can be implemented as hardware, firmware, software, or a combination thereof interacting with or otherwise executed by one or more computer processors, which can include a processor of the control system 112.

[0070] The robot-assisted manipulator system 100 may also include a sensor system 108. The sensor system 108 may include a position / location sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and / or a shape sensor system (e.g., a fiber optic shape sensor) for determining the position, orientation, speed, velocity, posture, and / or shape of the medical device system 104. The sensor system 108 may also include a temperature, pressure, force, or contact sensor or the like.

[0071] The robot-assisted manipulator system 100 may also include a control system 112. The control system 112 includes at least one memory 116 and at least one computer processor 114 for implementing control between the medical device system 104, the operator input system 106, the sensor system 108, and the display system 110. The control system 112 also includes programming instructions (e.g., a non-transitory machine-readable medium storing instructions) to use the robot-assisted manipulator system to implement procedures, including navigation, steering, imaging, deployment or retraction of engagement features, application of treatment to target tissue (e.g., via application of energy), or the like.

[0072] The control system 112 may further optionally include a virtual visualization system to provide navigation assistance to the operator O when controlling the medical device system 104 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system can be based on a preoperative or intraoperative data set of an anatomical channel obtained with reference. The virtual visualization system processes images of the surgical site imaged using imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. The control system 112 can use the preoperative images to locate the target tissue (using visual imaging techniques and / or by receiving user input), and create a preoperative plan, including an optimal first position for performing treatment. The preoperative plan can include, for example, a planned size of the expandable device, a duration of treatment, a treatment temperature, and / or multiple deployment positions.

[0073] Figure 3A A medical device system 200 is illustrated according to some exemplary embodiments. The medical device system 200 can be used for image-guided medical procedures. In some embodiments, the medical device system 200 can be used for non-teleoperated exploratory procedures or procedures involving traditional manually operated medical devices such as endoscopes. In other embodiments, the medical device system 200 can be used with Figure 2 The medical device system 104 is interchangeable or a variation thereof.

[0074] The medical device system 200 includes an elongated flexible device 202, such as a flexible catheter, an endoscope (e.g., a gastroscope, a bronchoscope), or other suitable device coupled to a drive unit 204. The elongated flexible device 202 includes a flexible body 216 having a proximal portion 217 and a distal portion 218 including a terminal portion. In some embodiments, the flexible body 216 has an outer diameter of approximately 14-20 mm. Other embodiments of the flexible body 216 can have a larger or smaller outer diameter. When the flexible body 216 is inserted into the oral or nasal cavity of a patient, the flexible body 216 can have an appropriate length to reach certain parts of the anatomy, such as the lungs, sinuses, throat, or upper or lower gastrointestinal tract regions.

[0075] The medical device system 200 optionally includes a tracking system 230 for determining the position, orientation, speed, velocity, posture, and / or shape of the distal portion 218 and / or one or more segments 224 along the flexible body 216 using one or more sensors and / or imaging devices. The entire length of the flexible body 216 between the distal portion 218 and the proximal portion 217 can be effectively divided into the segments 224. The tracking system 230 can optionally be implemented as hardware, firmware, software, or a combination thereof interacting with or otherwise executed by one or more computer processors, which can include Figure 2 A processor of the control system 112 in the system.

[0076] Tracking system 230 can optionally track distal portion 218 and / or one or more of segments 224 using shape sensor 222. In some embodiments, tracking system 230 can optionally and / or additionally track distal portion 218 using orientation sensor system 220, such as an electromagnetic (EM) sensor system. In some examples, orientation sensor system 220 can be configured and positioned to measure six degrees of freedom, such as three orientation coordinates X, Y, Z and three orientation angles of pitch, yaw, and roll indicating a base point, or five degrees of freedom, such as three orientation coordinates X, Y, Z and two orientation angles of pitch and yaw indicating a base point.

[0077] The flexible body 216 includes one or more channels (eg, conduits) sized and shaped to receive one or more medical devices 226. In some embodiments, the flexible body 216 includes two channels 221 for individual devices 226, however, a different number of channels 221 may be provided. Figure 3B2 is a simplified diagram of an end of a flexible body 216 according to some embodiments, wherein a medical device 226 extends outwardly from the flexible body 216. In some embodiments, the medical device 226 can be used in procedures and various aspects of procedures, such as surgery, biopsy, ablation, mapping, imaging, lighting, irrigation, or suction. The medical device 226 can be deployed through the channel 221 of the flexible body 216 and used at a target location within the anatomy. The medical device 226 can include, for example, an image capture device, a biopsy instrument, an ablation instrument, a catheter, a laser ablation fiber, and / or other surgical, diagnostic, or therapeutic tools. The medical tool can include an end effector having a single working member such as a scalpel, a blunt blade, a lens, an optical fiber, an electrode, and / or the like. Other end effectors can include, for example, forceps, a grasper, a balloon, a needle, scissors, a clip applier, and / or the like. Other end effectors can further include electrically activated end effectors such as electrosurgical electrodes, expandable ablation members, transducers, sensors, imaging devices, and / or the like. The medical device 226 can be advanced from the opening of the channel 221 to perform a procedure (e.g., electroporation and / or electrolysis in the present disclosure), and then retracted into the channel 221 when the procedure is completed. The medical device 226 can be removed from the proximal end 217 of the flexible body 216 or from another optional instrument port (not shown) along the flexible body 216. The medical device 226 can also be used with an image capture device (e.g., an endoscopic camera) within the elongated flexible device 202. Alternatively, the medical device 226 itself can be an image capture device.

[0078] The medical device 226 may also house cables, linkages, or other actuation controls (not shown) extending between its proximal portion 217 and distal portion 218 to controllably bend the distal portion 218 of the medical device 226. The flexible body 216 may also house cables, linkages, or other steering controls (not shown) extending between the drive unit 204 and the distal portion 218 to controllably bend the distal portion 218, for example, as shown by a dashed line depiction 219 of the distal portion 218. In some examples, at least four cables are used to provide independent "up and down" steering to control the pitch motion of the distal portion 218, and "side to side" steering to control the yaw motion of the distal portion 218. In embodiments of the medical device system 200 actuated by a robotic-assisted assembly, the drive unit 204 may include a drive input that is removably coupled to and receives power from a drive element (such as an actuator) of a remotely operated assembly. In some embodiments, the medical device system 200 may include gripping features, manual actuators, or other components for manually controlling the movement of the medical device system 100. Information from the tracking system 230 may be sent to the navigation system 232, where it is combined with information from the visualization system 231 and / or preoperatively acquired models to provide real-time position information to the physician or other operator.

[0079] In some embodiments, the medical device system 200 can be guided manually or via a robot-assisted manipulator system 100 to deliver the medical device 226 to the target tissue site for treatment. In some procedures, the choice between manual or robotic delivery and the approach can be determined based on the medical application. For example, in some gastrointestinal applications, the medical device system 200 (or stand-alone medical device 226) can be delivered intracavitary via a manual or robotic delivery device through an oral or anal route. An abdominal route with an integrated monopolar or bipolar instrument, an insertion probe, or via a catheter can also be used. For urology applications, the medical device system 200 (or stand-alone medical device 226) can be delivered intracavitary via a manual or robotic delivery device through an integrated bipolar instrument, an insertion probe, or via a catheter, through the urethra route, through the perineum, preperitoneum, or abdominally. Similarly, for gynecological applications, the medical device system 200 (or stand-alone medical device 226) can be delivered intracavitary via a transvaginal route, transperineal or transabdominally with an integrated bipolar instrument, an inserted probe or via a catheter, via a manual or robotic delivery device. For hepatobiliary applications, the medical device system 200 (or stand-alone medical device 226) can be delivered intracavitary via a transoral route to the ampulla with an integrated bipolar instrument, an inserted probe or via a catheter, or via a transmural route into the liver or transabdominally with a manual or robotic delivery device. For neurovascular applications, the medical device system 200 (or stand-alone medical device 226) can be delivered via a manual or robotic delivery device via an intravascular route or keyhole craniotomy with an integrated bipolar instrument, an inserted probe or via a catheter. For cardiac applications, the medical device system 200 (or stand-alone medical device 226) can be delivered via an intravascular route or transthoracically with an integrated bipolar instrument, an inserted probe or via a catheter, via a manual or robotic delivery device.

[0080] Common Reference Figure 4-Figure 10 The following provides additional details of various embodiments and features related to the electrode therapy system design and its various components, which can be compared with the previously referenced Figure 1-Figure 3B The system 10, the robot-assisted manipulator system 100 and / or the medical device system 200 described herein are used together. Figure 4-Figure 10 The described electrode therapy system is designed to deliver electrodes for treating a target tissue site, wherein the electrodes can be independently controllable to adjust the spacing of the electrodes as desired to treat the target tissue surface, while maintaining an overall compact profile of the electrode therapy system for delivery to the target tissue site. Other features and advantages of the electrode therapy system design are further described below with reference to the accompanying drawings.

[0081] Figure 4-5B An electrode therapy system 400 is illustrated together according to an exemplary embodiment operable to deliver electrodes 410, 412 to a target tissue site 424. In some exemplary embodiments of the present disclosure, the electrode therapy system 400 may be used to provide electrolysis and / or electroporation therapy to the target tissue site 424, such as for duodenal mucosal surface replacement in the gastrointestinal tract. In other embodiments, the electrode therapy system 400 may be used to treat other target tissues using other treatment procedures.

[0082] General Reference Figure 4-5B , the electrode treatment system 400 includes an elongated flexible device 402 (such as a flexible catheter), an endoscope (e.g., a duodenoscope, a gastroscope, a bronchoscope), or other suitable components, wherein a body 404 has a proximal portion 406 and a distal portion 408. In some embodiments, the outer diameter of the body 404 may depend on the target anatomy for treatment. In some examples, the outer diameter may range between 2 mm and 12 mm. When the elongated flexible device 402 is inserted into the oral or nasal cavity of a patient (or introduced in other ways, such as via a surgical incision), the body 404 may have an appropriate length to reach certain parts of the anatomy, such as the lungs, sinuses, throat, or upper or lower gastrointestinal tract regions. In some embodiments, the length of the elongated flexible device 402 may range between 85 cm and 300 cm (or another suitable length) to reach the desired anatomical tissue area for treatment. It should be understood that in other embodiments, the elongated flexible device 402 and its components may have any suitable size, which may depend on the target tissue area, the surrounding anatomical structure, or other suitable factors.

[0083] Reference Figure 5A , the electrode treatment system 400 further includes a first electrode 410 and a second electrode 412 that are laterally or axially spaced apart from each other (e.g., along the longitudinal axis A), wherein the electrodes 410, 412 are at least adapted to provide one or both of electrolysis and electroporation to the target tissue in a manner similar to that previously described. The electrodes 410, 412 may be operable to generate (e.g., Figure 5A , Figure 5B 432 in the figure). For example, in one embodiment, the electrodes 410, 412 may include a plurality of metal traces placed on the expandable support member. Figure 6A-Figure 10Some exemplary configurations of electrodes 410, 412 and expandable support members of electrode treatment system 400 are provided. The metal traces may include any suitable conductive material such as gold, copper, stainless steel, titanium, graphene, graphite, and the like. Generally, the electrode material may be selected so that the electrode material does not actively participate in the electrolysis product and / or leaves material residues. In some embodiments, the electrode material may be selected to minimize the transfer of ions from the electrode material to the target tissue. Titanium and gold may participate in the electrolysis process to some extent, but they may not generate toxic residues and may be used in some examples. In other embodiments, electrodes 410, 412 may include other suitable shapes and configurations, including circular, square, rectangular or other shaped electrodes. Interdigitated electrodes may also be used. The electrodes 410, 412 and other electrodes included in the electrode treatment system described herein may each be part of two or more electrode arrays.

[0084] Generally, the electrodes used in the exemplary configurations described herein are arranged in a bipolar configuration. Typically, in a bipolar configuration, an electric current can travel from one electrode in a pair of electrodes to the other electrode of the pair of electrodes. Therefore, it can be said that the polarity of the electrodes in the pair is opposite. In some configurations, multiple pairs of electrodes can be used, wherein the current passes through each pair of electrodes.

[0085] In other examples, the electrodes may be arranged in a monopolar configuration, or in a combination of bipolar and monopolar configurations. The monopolar configuration may include an active electrode (e.g., an electrode on or in a surgical field) and a return electrode. The return electrode may be placed outside the surgical field, but in some examples in contact with the patient (e.g., using a pad with an electrode). In this way, one polarity (e.g., the polarity of the active electrode) is in the surgical field. Therefore, the monopolar configuration of the electrode may include a pair of electrodes, one of which is energized and one is used as a loop. The return electrode may not be arranged on the same device as the energized electrode. For example, the return electrode may be arranged on a pad placed near the tissue. In a monopolar configuration, there may be multiple active electrodes (e.g., two or more electrodes 410, 412), and in some examples multiple active electrodes may allow current to pass through a shared return electrode or in other examples may pass through respective return electrodes.

[0086] The electrode therapy system 400 further includes suitable wiring, circuitry, and other electronic components (not shown) for providing electrical signals, such as voltage and / or current, to the electrodes 410, 412. In one embodiment, the wiring may run down the length of the elongated flexible device 402 to the controller 14 and / or power source 12 (see FIG. Figure 1 ) or to the control system 112 (see Figure 2), the control system 112 can be outside the body. In other embodiments, other suitable wiring configurations can be used to power the electrodes 410, 412.

[0087] Specific reference Figure 5A , further details regarding an exemplary arrangement of electrodes 410, 412 of the elongated flexible device 402 are described below. Figure 5A , the electrode therapy system 400 may include a first flexible member 414 supporting the electrode 410 and a second flexible member 416 supporting the second electrode 412, wherein both flexible members 414, 416 are disposed within or extend through a cavity 418 of the elongated flexible device 402. The flexible members 414, 416 may be any suitable element capable of being received within the elongated flexible device 402 and driven relative to the elongated flexible device 402. In some exemplary systems, the flexible members 414, 416 may include a catheter, a guidewire, a shaft, or a second flexible member capable of being manually or via a control system (e.g., Figure 2 Other suitable drive elements driven by the control system 112).

[0088] In one exemplary configuration, the first flexible member 414 further includes a hollow interior having a cavity 420 extending therethrough and an opening at a distal portion 422 of the first flexible member 404. In some embodiments, the second flexible member 416 extends through the cavity 420 of the first flexible member 414 and extends distal to the distal portion 422 of the first flexible member 404 (e.g., when the electrode therapy system 400 is in a deployed or expanded configuration). As described, the first flexible member 414 and the second flexible member 416 are arranged in a generally telescoping configuration, wherein the second flexible member 416 is capable of axially moving within the cavity 420 of the first flexible member 414. In this configuration, as further described below, the first flexible member 414 and the second flexible member 416 can be independently adjusted relative to each other to adjust the spacing between the first electrode 410 and the second electrode 412 for treating a tissue surface. The flexible members 414, 416 can be controlled via the control system 112 (see Figure 2 ) or controller 14 (see Figure 1 ) or can be adjusted manually by an operator O, or can be adjusted in other ways via a combination of robotic and / or manual adjustment. Figure 6A-Figure 10 Additional details of other exemplary arrangements of electrode therapy systems are further provided.

[0089] Overall reference Figure 4-5B, the following describes an exemplary delivery procedure of the electrode treatment system 400 to the target tissue site 424 for treatment according to an exemplary embodiment. In one example, the manipulator system can be operated manually or via a computer-assisted remote control (see Figure 2 ) delivers an elongated flexible device (e.g., an endoscope) to the duodenum 426 in a transoral manner to ablate the mucosal lining (or other tissue site). For this procedure, delivery may include entering through the patient's esophagus 428, navigating through the stomach 430, and finally entering the duodenum 426 for treatment. In other examples, delivery may be performed via other routes including openings created via surgical incisions, and may include the use of other delivery systems.

[0090] With the electrode therapy system 400 in place at the duodenum 426, the first flexible member 414 and the second flexible member 416 are (independently or substantially simultaneously) advanced axially through the lumen 418 of the elongated flexible device 402 (or through the lumen of another suitable housing if the elongated flexible device 404 is not used) and distally through the distal end portion 408 thereof. Upon deployment of the flexible members 414, 416 distal to the elongated flexible device 402, the electrodes 410, 412 are expanded (e.g., passively or actively, as described below with reference to FIG. 4 ) within the duodenum 426. Fig. 6A and Figure 6B 426 ) until the electrodes 410, 412 are in place relative to the duodenum 426. In some embodiments, the electrodes 410, 412 can be in contact with the duodenum 426, while in other embodiments, the electrodes 410, 412 can be adjacent to the duodenum 426 but not in contact with the duodenum 426.

[0091] The axial or lateral position of one or both of the electrodes 410, 412 may be adjusted to ensure that a desired target spacing is achieved and maintained between the electrodes 410, 412 for treatment (e.g., before, during, and / or after energy delivery or electrode expansion). Figure 5B As shown in FIG. 1 , in one embodiment, one or both of the flexible members 414 , 416 may be moved relative to the other via the controller 14 , the control system 112 , or manually to position the electrodes 410 , 412 at a desired target spacing. Figure 5B In the embodiment, the second electrode 412 has been retracted so that the second electrode 312 is closer to the first electrode 410 (with Figure 5A In other embodiments, the electrode(s) may be moved further away. In this configuration, the electric field between electrodes 410, 412 (e.g., Figure 5B 432 in the figure) and Figure 5AThe arrangement of electrodes 410, 411 is more compact than that of the electrode therapy system 400. In some embodiments, an imaging system, a sensor system, or other suitable visualization system (not shown) of the electrode therapy system 400 can be used to guide adjustment and verify whether the electrodes 410, 412 are arranged in the desired position at the target tissue site 424. Once the electrodes 410, 412 are in the proper position, as previously described, the electrodes 410, 411 can be energized to ablate target cells within the duodenum 426. In some embodiments, the electrode therapy system 400 and other electrode therapy systems described herein can be manually actuated by a user. In other embodiments, the electrode therapy system can be coupled to an external device for actuation, such as a robot-assisted manipulator system (e.g., the robot-assisted manipulator system 100). In other embodiments, manual and robot-assisted actuation can be provided.

[0092] The electrode therapy systems described herein can be coupled to an external device to provide actuation, control, and / or power to the electrode therapy system. For example, the electrode therapy system 400 and other electrode therapy systems described herein can be actuated by a robotically assisted manipulator system (e.g., manipulator assembly 102). The electrode therapy system 400 (e.g., the elongated flexible device 402, the first flexible member 414, the second flexible member 416, and / or the expandable support member as described in more detail with respect to the electrode therapy system 600) can include a drive unit (e.g., drive unit 204) or (e.g., at the proximal portion 406) be coupled to a drive unit (e.g., drive unit 204), the drive unit having one or more drive inputs and being removably coupled to a drive element of the manipulator assembly 102, such as an actuator or motor, and receiving power therefrom. When the electrode therapy system 400 is coupled to the manipulator assembly, the drive input of the electrode therapy system can be coupled to a drive output of the manipulator assembly driven by the drive element of the manipulator assembly. In such an embodiment, the drive input of the electrode therapy system 400 can be coupled to the distal portion of the electrode therapy system 40 via one or more actuation drive members or elements (e.g., drive shafts, actuation cables, actuation rods, tension members, and the like) to perform actions such as advancing, retracting, or articulating the distal end of the electrode therapy system 200. Similarly, the drive input of the electrode therapy system 400 can be coupled to the first and second flexible members via one or more actuation drive members or elements to perform actions such as advancing, retracting, or articulating one or both of the flexible support members to adjust the relative axial spacing between the electrodes coupled thereto. In addition, the drive input of the electrode therapy system 400 can be coupled to the electrodes or expandable support members to perform actions such as expansion, deployment, and / or retraction of the electrodes and / or expandable support members between a deployed position for treatment and a stowed position for retraction as described herein. In addition, the drive unit 204 can be coupled to a controller (e.g., controller 14) and / or a power source (e.g., power source 12) to provide power to the electrodes of the electrode therapy system 400 as described above. The drive unit 204 may be electrically coupled to the electrodes via one or more cables extending along or through the electrode therapy system 400. In alternative embodiments, the controller and power supply may provide power to the cables without being coupled to the drive unit (e.g., the controller and power supply may be independent of the drive unit).

[0093] Overall reference Figure 6A-Figure 10 , the following sections provide additional details of other electrode therapy system embodiments that may be used with the previously described systems 10, 100, 200. Fig. 6A An example of an electrode therapy system 600 for delivering electrodes 612, 614 to a target area for treatment according to examples described herein is shown. In general, the electrode therapy system 600 may have the same configuration as previously described with reference to FIG. Figure 4-5B 4. The present invention relates to an electrode therapy system 600 that is described in detail below and that has the same or substantially similar features as the electrode therapy system 400 described above and operates in a substantially similar manner. Therefore, certain details of the electrode therapy system 600 may not be described in further detail below to avoid repetition and / or obscuring more relevant details of the embodiments. It should be understood that the description of the corresponding components and their related functions described with reference to the electrode therapy system 400 may also apply in whole or in part to the electrode therapy system 600 unless otherwise described below.

[0094] Reference Fig. 6A , the electrode therapy system 600 includes a first flexible member 602 and a second flexible member 604. In some embodiments, the flexible members 602, 604 may include a catheter, a guidewire, a shaft, or a plurality of flexible members that can be manually or via a control system (e.g., Figure 2 The first flexible member 602 includes a first expandable support member 606 coupled thereto, and the second flexible member 604 includes a second expandable support member 608 coupled thereto. The expandable support members 606, 608 can take any suitable shape and can be made of any suitable material. For example, in one embodiment, as described in further detail below, the expandable support members 606, 608 are each configured to expand from a stowed configuration (e.g., when compressed in the elongated flexible device 404, such as the sheath 610) after they are released from the elongated flexible device 402 or the sheath 610. Figure 6B The sheath 610 shown in the figure or other housing for delivering the electrode therapy system 600 to the target tissue site is expanded to a deployed configuration (such as Fig. 6A In one embodiment, the expandable support members 606, 608 can be formed of any suitable material as a braided mesh framework. For example, in one embodiment, the braided mesh framework can be formed of metal alloy wires that are braided into a generally conical, hemispherical, semi-elliptical, or other appropriately shaped structure having desired flexibility and radial strength characteristics. In some examples, such as Figure 6B The illustrated braided mesh framework may be compressed within the sheath 610 (or elongated flexible device 402) and as shown Fig. 6A The expandable support members 606, 608 are shown expandable after being released from the sheath 610. In one embodiment, the expandable support members 606, 608 can be formed of a nickel-titanium alloy (e.g., Nitinol) or other suitable material that preferably exhibits superelastic properties that allow the expandable support members 606, 608 to undergo large deformations (such as compressive forces within the sheath 610) and then return to an undeformed shape (such as a compression force) after the external force is removed. Fig. 6A expansion position shown in the figure).

[0095] like Fig. 6A, the electrode treatment system 600 includes a first electrode 612 coupled to a first expandable support member 606 and a second electrode 614 coupled to a second expandable support member 608. The electrodes 612, 614 may include any suitable arrangement and may be coupled to the respective expandable support members 606, 608 in any suitable manner. For example, in one embodiment, the electrodes 612, 614 may each be an annular structure disposed on a distal portion 616, 618 of the respective expandable support members 606, 608. In other embodiments, the electrodes 612, 614 may be coupled to any region of the expandable support members 606, 608 or otherwise incorporated along the region. In a manner similar to that described above, the electrodes 612, 614 are configured to collectively deliver energy to a tissue surface for treatment. As previously discussed, the treatment may be performed by Figure 1-Figure 2 The controller 14 and / or control system 112 provides electronic signals to the electrodes 612 , 614 .

[0096] In some embodiments, the outer surface of the expandable support members 606, 608 (e.g., a braided mesh frame) can be coated with (or can be made of) silicon or other suitable polymeric materials to form a protective coating for reducing friction and potential trauma during delivery, deployment, and retraction of the electrode treatment system 600. In addition, the protective coating can also help prevent the electrodes 612, 614 from sticking to tissue during retraction of the electrodes 612, 614 after treatment is completed. In some embodiments, the electrodes 612, 614 can be coated with chemicals or other suitable materials to assist in the electrolysis process and / or prevent the electrodes 612, 612 from corroding or oxidizing during the electrolysis process.

[0097] As described above, the electrode therapy system 600 may include a sheath 610 for housing the first flexible member 602 and the second flexible member 604 during delivery and retraction of the electrode therapy system 600. Figure 6B In one exemplary arrangement, the sheath 610 includes a hollow interior having a cavity 620 extending therethrough and an opening at a distal portion 622 of the sheath 610. When the flexible members 602, 604 are positioned within the cavity 620 of the sheath 610, the first expandable support member 606 and the second expandable support member 608 are in a compressed, stowed configuration within the sheath 610. In order to deploy the electrodes 612, 614 for treatment, the first flexible member 602 and the second flexible member 604 move in an axial direction (e.g., translate along the longitudinal axis B) through the cavity 620 and distally of the distal portion 622 of the sheath 610. As the flexible members 602, 604 move distally out of the sheath 610, the first expandable support member 606 and the second expandable support member 608 expand radially outward from the stowed configuration to a deployed configuration. Fig. 6AAs shown, when the electrode therapy system 600 is in a deployed configuration for treatment, the first flexible member 602 and the second flexible member 604 both extend through the cavity 620 and extend distally relative to the distal portion 622 of the sheath 610. In the deployed configuration, the expandable support members 606, 608 expand radially outward relative to the axis B to deploy the electrodes 612, 614. After treatment is completed, the first flexible member 602 and the second flexible member 604 can be retracted back (e.g., proximally) along the axis B into the cavity 620 to retract the first expandable support member 606 and the second expandable support member 608 from the deployed configuration to the collapsed configuration.

[0098] In some embodiments, as described above, in response to the corresponding first flexible member 602 and the second flexible member 604 extending distally of the sheath 610, the first expandable support member 606 and the second expandable support member 608 each expand (e.g., passively or elastically expand) from the stowed configuration to the deployed configuration without additional force. For example, after the flexible members 602 and 604 are driven to the distal side of the sheath 610, the expandable support members 606 and 608 automatically expand to the deployed configuration. In some embodiments, this expansion behavior may be caused by the material selection of the expandable support members 606 and 608 (e.g., nitinol or other superelastic materials). In other embodiments, the expandable support member can be actively expanded (e.g., after applying additional force). For example, one or more expansion members (e.g., expandable balloons or other suitable members) can be coupled to one or both of the expandable support members 606 and 608, wherein the expansion member can be radially expanded to cause the expandable support members 606 and 608 to expand from the stowed configuration to the deployed configuration. Conversely, the expansion member can also cause the expandable support member to retract from the deployed configuration to the collapsed configuration to retract or remove the electrode therapy system described herein.

[0099] As previously described, in some embodiments, the position of the first expandable support member 606 can be adjusted independently of the position of the second expandable support member 608 to adjust the target spacing between the first electrode 612 and the second electrode 614 for treating the tissue surface. For example, one or both of the first flexible member 602 and the second flexible member 604 can be driven within the sheath 610 and driven relative to each other to arrange the electrodes 612, 614 at the target spacing as desired. In some exemplary embodiments, the position and spacing of the electrodes 612, 614 can be manually adjusted. In other embodiments, the electrode treatment system 600 can be in operative communication with a control system for operation. Additional details of some exemplary embodiments are provided below.

[0100] Common Reference Figure 1-6BIn one embodiment, the control system 112 (or controller 14) is in operative communication with the electrode therapy system 600 and can be used to perform the above-described adjustment actions and manipulations of the flexible members 602, 604. For example, the control system 112 can be operable to adjust the relative positions of the expandable support members 606, 608 by driving one or both of the flexible members 602, 604 (to which the respective expandable support members 606, 608 are coupled) relative to each other. It should be understood that the above reference to Figure 4-6B Any actions described with respect to adjustment of the flexible members 602, 604 and components coupled thereto (such as the expandable support members 606, 608 and electrodes 612, 614) may also be performed by and / or assisted by the control system 112.

[0101] In some embodiments, the control system 112 can be operable to independently adjust the relative positions of the expandable support members 606, 608 to adjust the spacing between the electrodes 612, 614 based on the target energy level of the applied electric field to achieve the desired penetration depth applied to the target tissue surface. Once the target spacing has been set as desired, the control system can sense the voltage based on the target energy level and the target spacing of the electrodes 612, 614 to treat the tissue surface. In some embodiments, the control system 112 can be operable to change the applied energy level as needed based on the spacing of the electrodes 612, 614 (and / or vice versa). In other embodiments, the control system 112 can adjust the spacing between the electrodes 612, 614 as needed based on the desired intensity of the applied energy level.

[0102] In some embodiments, the control system 112 can further be connected to the locking system 118 (see Figure 2 ) are operably communicated with each other. In this configuration, the locking system 118 is operably communicated with the flexible members 602, 604 and can be operable to selectively lock the position of the flexible members 602 and 604 (and by extension, the position of the expandable support members 606, 608 and the electrodes 612, 614). Locking the position of these components helps to ensure that the target spacing between the first electrode 612 and the second electrode 614 is maintained during tissue surface treatment. For example, in one embodiment, the control system 112 can be used to adjust the position of the flexible members 602, 604 and ensure that the spacing between the electrodes 612, 614 meets the expectations of the treatment. Once the spacing is set as desired, the control system 112 can communicate with the locking system 118 to lock the position of the flexible members 602, 604 and prevent further adjustment or movement. With the position locked, the control system 112 can thereafter apply the target energy level to the electrodes 612, 614 for treatment.

[0103] In some embodiments, after treatment of the first target tissue site is completed, the control system 112 can advance or retract the electrode treatment system 600 to a second target tissue site, which can be adjacent to the first target tissue site. This further adjustment can be completed when the flexible members 602, 604 (and expandable support members 606, 608 and electrodes 612, 614) remain in a locked position for subsequent treatment to maintain consistent energy applied to the tissue at the two tissue sites. This repositioning process of the electrode treatment system 600 can be repeated as needed to complete treatment of larger tissue segments. In other embodiments, the control system 112 is further operable to adjust the movement rate of the flexible members 602, 604 (and expandable support members 606, 608 and electrodes 612, 614), and when a voltage is sensed to continuously treat the tissue surface, the flexible members 602, 604 are moved at a desired movement rate. In a further embodiment, the spacing between the electrodes or expandable support members is adjusted so that it is different between the first target tissue site and the second target tissue site.

[0104] As described above, in some embodiments, expansion members (not shown) (such as inflatable balloons and the like) can be coupled to the expandable support members 606, 608 to assist in their radial expansion from the collapsed configuration to the deployed configuration. In such embodiments, the control system 112 can communicate with the expansion members and can be operated to control the expansion rate of one or more expansion members to ensure that the expandable support members 606, 608 expand at a desired rate.

[0105] exist Fig. 6A , Figure 6B In the electrode treatment system 600 of FIG. 6 , electrodes 612, 614 are illustrated and described as being coupled to respective distal portions 616, 618 of expandable support members 606, 608. In other embodiments, the expandable support members 606, 608 may be made of a suitable conductive material so that the expandable support members 606, 608 themselves act as electrodes (or at least the portion of the expandable support members 606, 608 that contacts tissue acts as an electrode when the expandable support members 606, 608 are expanded). In other embodiments, a combination of these features may be implemented so that the electrodes 612, 614 along the distal portions 616, 618 may be selectively energized and used for electroporation, and the expandable support members 606, 608 (e.g., the portion that contacts tissue) may be selectively energized and used for electrolysis, wherein the larger surface area of ​​the expandable support members 606, 608 facilitates the generation of a larger volume of electrolysis products to optimize treatment.

[0106] Figure 7Another example of an electrode therapy system 700 for delivering electrodes 710, 712 to a target area for treatment according to examples described herein is illustrated. In general, the electrode therapy system 700 may have a similar operation as previously described with reference to FIG. Figure 4-6B The electrode therapy system 700 is described in detail below. The corresponding components of the electrode therapy system 400 and 600 are the same or substantially similar features. Therefore, some details of the electrode therapy system 700 may not be described in further detail below to avoid repetition and / or obscuring more relevant details of the embodiments. It should be understood that the description of the corresponding components and their related functions described with reference to the electrode therapy systems 400 and 600 is also applicable to the electrode therapy system 700.

[0107] In short, refer to Figure 7 , the electrode treatment system 700 includes a first flexible member 702 and a second flexible member 704, each of which includes an expandable support member 706, 708. Each expandable support member 706, 708 includes an electrode 710, 712, which is coupled along a corresponding distal portion 714, 716 of the expandable support member 706, 708. Figure 7 , electrodes 710, 712 are illustrated as generally circular or annular electrodes as previously described, but other suitable configurations may be employed in other embodiments. Electrode therapy system 700 may include expandable support members 706, 708, which include a braided mesh stent having a generally conical profile (or other suitable profile as previously described) when in a deployed configuration. When expandable support members 706, 708 are deployed within lumen 718, electrodes 710, 712 expand radially outward and are positioned adjacent to tissue 720 (or in contact with tissue 720) for treatment. Thereafter, electrodes 710, 712 may be energized via control system 112 in a manner similar to that previously described.

[0108] Figure 8 Another example of an electrode therapy system 800 for delivering electrodes 810, 812 to a target area for treatment according to examples described herein is illustrated. In general, the electrode therapy system 800 may have a similar operation as previously generally described. Figure 4-6B The electrode therapy system 800 is described in detail below. ...

[0109] In short, refer to Figure 8, the electrode treatment system 800 includes a first flexible member 802 and a second flexible member 804, each of which includes an expandable support member 806, 808, respectively. Each expandable support member 806, 808 includes an electrode 810, 812, which is coupled along a corresponding distal portion 814, 816 of the expandable support member 806, 808. In one embodiment, the electrodes 810, 812 may include a plurality of point-contact or marking electrodes disposed on the distal portions 814, 816 of the expandable support members 806, 808. The electrode treatment system 800 may include expandable support members 806, 808, which include a braided mesh stent having any suitable contour when in a deployed configuration. In a manner similar to that described above, when the expandable support members 806, 808 are deployed in a lumen (e.g., Figure 7 When within the cavity 718 of the embodiment, the electrodes 810, 812 expand radially outward and adjacent tissue (e.g., Figure 7 The tissue 720 (or in contact with the tissue 720) is positioned for treatment. Thereafter, the electrodes 810, 812 can be energized via the control system 112 in a similar manner as previously described.

[0110] Fig. 9 Another example of an electrode therapy system 900 for delivering electrodes 908, 910 to a target area for treatment according to examples described herein is illustrated. Fig. 9 , the electrode therapy system 900 includes a first expandable support member 902 and a second expandable support member 904, each support member having an electrode 908, 910 coupled thereto. In one embodiment, the electrodes 908, 910 may be point contact or marking electrodes as shown, but may take any other suitable form in other embodiments, including similar to the previously referenced Fig. 6A , Figure 6B and Figure 7 The electrode therapy system 900 further includes a frame 906 extending between and coupling the expandable support members 902, 904. In some examples, the frame 906 is expandable and compressible to adjust the spacing between the expandable support members 902, 904 (and by extension, the electrodes 908, 910) relative to each other. In one example, the frame 906, the first expandable support member 902, and the second expandable support member 904 can all be braided mesh frames. The braided mesh frame can be made of any suitable material such as nitinol, or other materials that preferably exhibit superelastic material properties to facilitate the expansion and contraction of the electrode therapy system 900 as desired. In some embodiments, the electrode therapy system 900 can further include one or more expansion members (e.g., balloons and the like) that can be radially expanded to expand the frame 906 and adjust the spacing between the electrodes 908, 910 relative to each other.

[0111] In some embodiments, the outer surfaces of expandable support members 902, 904 and frame 906 can be coated with (or can be made of) silicon or other suitable polymeric materials to create a protective coating to reduce friction and potential trauma during delivery, deployment, and retraction of electrode therapy system 900. In addition, the protective coating can also help prevent electrodes 908, 910 from sticking to tissue after treatment and during the process of retracting and removing electrode therapy system 900.

[0112] In some examples, the electrode therapy system 900 is deployed and used in a manner substantially similar to that previously described with reference to other embodiments. For example, the electrode therapy system 900 can be initially compressed in a sheath (e.g., Fig. 6A 610) or an elongated flexible device (e.g., Figure 2 The elongated flexible device 202 and Figure 4 The electrode therapy system 900 is inserted into the body of the sheath 610 (elongated flexible device 402) or into other housings for delivering the electrode therapy system 900 to the target tissue site. In this stowed and compressed configuration, the electrode therapy system 900 is delivered to the target tissue site for treatment. At the tissue site, the electrode therapy system 900 can be advanced out of the sheath 610 (or other suitable housing) in a similar manner as previously described to position the electrodes 908, 910 adjacent to the tissue or in contact with the tissue for treatment. In some embodiments, such as when nitinol or other superelastic materials are used to form the expandable support members 902, 904 and the frame 906, the expandable support members 902, 904 and the frame 906 automatically expand after being advanced out of the sheath 610 due to their material properties. In other embodiments, an expansion member (e.g., an inflatable balloon or other suitable device) can be used to promote and support the expansion of these components as described above. After the treatment is completed, the electrode therapy system 900 can be advanced or retracted to treat a different tissue site, or can be retracted into the sheath 610 (or other housing) to be removed from the patient. In a manner similar to that described with reference to previous examples, after being retracted into the sheath 610, the expandable support members 902, 904 and frame 906 are compressed to a stowed configuration to maintain a low overall profile of the electrode therapy system 900 and facilitate removal.

[0113] Fig.10 Another example of an electrode therapy system 1000 for delivering electrodes 1006, 1008 to a target area for treatment according to examples described herein is illustrated. In general, the electrode therapy system 1000 may have the same features as previously described with reference to FIG. Figure 4-6BThe present invention also relates to the electrode therapy systems 400 and 600 described herein. Therefore, certain details of the electrode therapy system 1000 may not be described in further detail below to avoid duplication and / or obscuring more relevant details of the embodiments. It should be understood that the description of the corresponding components and their related functions described with reference to the electrode therapy systems 400 and 600 is also applicable to the electrode therapy system 1000. In short, the description of the corresponding components and their related functions described with reference to the electrode therapy systems 400 and 600 is also applicable to the electrode therapy system 1000. Fig.10 , the electrode treatment system 1000 includes a first expandable support member 1002 and a second expandable support member 1004, each support member having electrodes 1006, 1008 coupled thereto. In one embodiment, the electrodes 1006, 1008 may be the same as previously described with reference to Fig. 6A , Figure 6B and Figure 7 The electrodes described are similar to ring electrodes, but in other embodiments may take any other suitable form, including reference Figure 8 and Fig. 9 The point contact or marking electrodes, or other suitable electrodes. In one embodiment, the electrodes 1006, 1008 are disposed on or adjacent to the distal portions 1010, 1012 of the expandable support members 1002, 1004.

[0114] Reference Fig.10 In some embodiments, each of the expandable support members 1002 and 1004 can be an expansion member that can be radially expanded relative to the flexible member 1014. The expansion member can be expanded in various different ways. For example, in some embodiments, the expansion member can be expanded with fluids such as air, saline, radiopaque solutions, and the like. In some embodiments, the fluid can be introduced into the expansion member through the lumen (not shown) of the flexible member 1014. The expansion member can have a length of approximately 4 cm in the unexpanded configuration and can be expanded to a diameter between 1 cm and 4 cm. In other embodiments, the length and expandable diameter of the expansion member can vary according to the characteristics and size of the tissue treatment target site. In other examples, the expansion member can be expanded in other suitable ways (e.g., rolling, unfolding, pushing). In the illustrated embodiment, the expansion member is illustrated as an expandable balloon. In some embodiments, the balloon can be a compliant balloon made of polyurethane, silicone, or other suitable material, which is designed to expand to several times its nominal size. In other embodiments, the balloon can be a semi-compliant balloon made of polyurethane or other suitable material, which is designed to expand less than a compliant balloon.

[0115] In some embodiments, the expansion member can be housed within a sheath (e.g., Fig. 6A610) or other suitable housing, and is configured to extend therethrough for deployment in a manner similar to that previously described. In short, after the electrode treatment system 1000 is advanced to the target tissue site, the expandable support members 1002, 1004 can be advanced to the distal side of the sheath 610 and expanded (or otherwise expanded) to expand the expandable support members 1002, 1004 toward the target tissue at the treatment site. When the expandable support members 1002, 1004 expand, the electrodes 1006, 1008 move to a position adjacent to (or in contact with) the target tissue. In some embodiments, the expansion rate and / or degree of the expandable support members 1002, 1004 can be controlled (such as via the control system 112) to ensure that the electrodes 1006, 1008 are in proper contact (or otherwise positioned close enough) to treat the tissue while avoiding over-expansion of the expandable support members 1002, 1004, which may cause tissue damage. With the electrodes 1006, 1008 in place relative to the tissue, the control system 112 may energize the electrodes 1006, 1008 to generate an electric field for treatment.

[0116] In some examples as described above, the electrode treatment system 1000 can be advanced or retracted to a different tissue site as needed to continue treatment. In some embodiments, the expandable support members 1002, 1004 can be partially or completely deflated (e.g., retracted, reduced) to facilitate movement of the electrode treatment system 1000 to a second (and other subsequent) tissue treatment site. Deflation of the expandable support members 1002, 1004 before moving the electrode treatment system 1000 can facilitate repositioning of the electrode treatment system 1000 by reducing its overall profile, and can also reduce the risk of inadvertent damage to surrounding tissues by the electrode treatment system 1000 during movement. Once treatment is completed, the expandable support members 1002, 1004 can be deflated and retracted into the sheath 610 or other housing. Thereafter, the electrode treatment system 1000 can be removed.

[0117] The exemplary embodiments of various electrode treatment systems described with reference to the accompanying drawings relate to a design in which the target spacing between electrodes is adjustable to increase flexibility and maximize overall treatment options. In other embodiments, the spacing between the electrodes may instead be fixed in the axial or longitudinal direction to ensure that the electrodes are always substantially spaced a set distance apart. In this design, the electrode treatment system can be used between various patients to treat any suitable tissue site without the need to adjust the energy level or otherwise compensate for changes in the spacing between the electrodes. Although the fixed design of the electrodes may result in a shorter treatment length (e.g., a smaller treatable tissue area each time the electrode treatment system is deployed) because the electrodes may be relatively close to each other to ensure that the electrode treatment system can be deployed across a range of tissues (including tissues that may have relatively narrow cavities), this potential compromise can be offset by uniformly adjusting the position of the electrode treatment system at a controlled rate during energy delivery to jointly ablate larger tissue segments.

[0118] It should be understood that the exemplary embodiments of the design of the electrode therapy system and potential clinical applications associated therewith provided herein are not intended to be limiting. There are many other configurations of the instrument system, and applications that would benefit from the use of the disclosed subject matter. In addition, it should be understood that according to the present systems, devices and methods, any of the above-described embodiments or processes, or specific features associated therewith, can be combined with one or more other embodiments and / or processes, or separated from and / or performed between separate devices or device portions.

[0119] Finally, the present disclosure is intended only to illustrate the present apparatus, devices, systems and methods, and should not be interpreted as limiting the appended claims to any particular embodiment or group of embodiments. Therefore, although the present disclosure has been described in particular detail with reference to exemplary embodiments, it should also be understood that many modified and alternative embodiments may be practiced without departing from the broader and intended spirit and scope of the present disclosure set forth in the appended claims. Therefore, the description and drawings should be viewed in an exemplary manner and are not intended to limit the scope of the appended claims.

Claims

1. An electrode therapy system, comprising: a first flexible member having a first expandable support member coupled thereto, wherein the first expandable support member is configured to expand from a collapsed configuration to a deployed configuration; a second flexible member having a second expandable support member coupled thereto, wherein the second expandable support member is configured to expand from a collapsed configuration to a deployed configuration; and a first electrode coupled to the first expandable support member and a second electrode coupled to the second expandable support member, wherein the first electrode and the second electrode are configured to collectively deliver energy to a tissue surface to treat the tissue, Wherein a position of the first expandable support member is adjustable independently of a position of the second expandable support member to adjust a target spacing between the first electrode and the second electrode for treatment of the tissue surface.

2. The system of claim 1 , wherein the first flexible member comprises a hollow interior having a cavity extending therethrough and an opening at a distal portion of the first flexible member, and wherein the second flexible member extends through the cavity of the first flexible member and extends distally of the distal portion of the first flexible member.

3. The system of claim 1 , further comprising a sheath comprising a hollow interior having a cavity extending therethrough and an opening at a distal portion of the sheath, and wherein both the first flexible member and the second flexible member extend through the cavity of the sheath and extend distally relative to the distal portion of the sheath.

4. A system according to claim 3, wherein when the first flexible member and the second flexible member are positioned within the cavity of the sheath, the first expandable support member and the second expandable support member are in the retracted configuration within the sheath.

5. A system according to claim 3, wherein the first flexible member and the second flexible member are capable of moving in an axial direction through the cavity of the sheath and moving distally of the sheath to expand the first expandable support member and the second expandable support member from the stowed configuration to the deployed configuration, and wherein the first flexible member and the second flexible member are capable of retracting into the cavity in the axial direction to retract the first expandable support member and the second expandable support member from the deployed configuration to the stowed configuration.

6. A system according to claim 5, wherein in response to the corresponding first flexible member and second flexible member extending to the distal side of the sheath, the first expandable support member and the second expandable support member each spontaneously expand from the stowed configuration to the deployed configuration.

7. The system according to claim 5 further comprises one or more expansion members, wherein the one or more expansion members are coupled to one or both of the first expandable support member and the second expandable support member, wherein the one or more expansion members are capable of radially expanding to expand one or both of the first expandable support member and the second expandable support member from the collapsed configuration to the deployed configuration.

8. The system of claim 1, wherein the first expandable support member and the second expandable support member each comprise a woven mesh frame.

9. The system of claim 8, wherein an outer surface of the braided mesh frame comprises a protective coating to reduce tissue trauma during delivery to the tissue surface.

10. The system of claim 1, wherein the first expandable support member and the second expandable support member are both radially expandable expansion members.

11. A system according to claim 1, wherein the first electrode is an annular structure and is disposed on the distal portion of the first expandable support member, and wherein the second electrode is an annular structure and is disposed on the distal portion of the second expandable support member.

12. A system according to claim 1, wherein the first electrode comprises a plurality of point contact electrodes disposed on a distal portion of the first expandable support member, and wherein the second electrode comprises a plurality of point contact electrodes disposed on a distal portion of the second expandable support member.

13. The system according to claim 1 further includes a locking mechanism, which is capable of being operated to selectively lock the position of the first expandable support member relative to the position of the second expandable support member to maintain the target spacing between the first electrode and the second electrode during treatment of the tissue surface.

14. A system according to claim 1, wherein the system further includes a frame extending between the first expandable support member and the second expandable support member and coupling the first expandable support member and the second expandable support member to each other, and the frame is adjustable to adjust the target spacing between the first electrode and the second electrode.

15. The system of claim 14, wherein the frame, the first expandable support member, and the second expandable support member are all woven mesh frames.

16. The system of claim 14, further comprising at least one expansion member coupled to the frame, wherein the expansion member is radially expandable to expand the frame and adjust the target spacing of the first electrode and the second electrode.

17. An electrode therapy system, the system comprising: a delivery system comprising a first expandable support member and a second expandable support member, wherein the first expandable support member comprises a first electrode coupled thereto and the second expandable support member comprises a second electrode coupled thereto, wherein the first electrode and the second electrode are configured to deliver energy to a tissue surface to treat the same; and a controller in operable communication with the delivery system, the controller being configured to: independently adjusting the relative positions of the first expandable support member and the second expandable support member to adjust a target spacing between the first electrode and the second electrode to treat the tissue surface based on a target energy level applied to the tissue surface; as well as Based on the target energy level and the target spacing between the first electrode and the second electrode, a voltage is induced to treat the tissue surface.

18. A system according to claim 17, wherein the first expandable support member is coupled to a first flexible member and the second expandable support member is coupled to a second flexible member, and wherein the controller is operable to drive one or both of the first flexible member and the second flexible member relative to each other.

19. The system of claim 18, wherein the first flexible member comprises a hollow interior having a cavity extending therethrough and an opening at a distal portion of the first flexible member, and wherein the second flexible member is adjustable via the controller through the cavity of the first flexible member and distal to the distal portion of the first flexible member.

20. The system of claim 18, further comprising a sheath comprising a hollow interior having a cavity extending therethrough and an opening at a distal portion of the sheath, and wherein both the first flexible member and the second flexible member are capable of adjusting passage through the cavity of the sheath via the controller.

21. A system according to claim 18, wherein the first flexible member and the second flexible member are capable of moving in an axial direction through the cavity of the sheath and moving distally of the sheath to expand the first expandable support member and the second expandable support member from a stowed configuration to a deployed configuration, and wherein the first flexible member and the second flexible member are capable of retracting into the cavity along the axial direction to retract the first expandable support member and the second expandable support member from the deployed configuration to the stowed configuration.

22. The system of claim 17, further comprising a locking mechanism operably communicating with the controller, wherein the locking mechanism is operable to selectively lock the position of the first expandable support member relative to the position of the second expandable support member via the controller to maintain the target spacing between the first electrode and the second electrode during treatment of the tissue surface.

23. A system according to claim 22, wherein when the first electrode and the second electrode are locked at the target spacing, the controller is further operable to adjust the movement rate of the first expandable support member and the second expandable support member while inducing voltage to continuously treat the tissue surface.

24. The system of claim 17, further comprising one or more expansion members coupled to one or both of the first expandable support member and the second expandable support member, wherein the one or more expansion members are capable of radially expanding to expand one or both of the first expandable support member and the second expandable support member and to adjust the target spacing between the first electrode and the second electrode.

25. The system of claim 24, wherein the controller is in communication with the one or more expansion members, and wherein the controller is operable to control a rate of expansion of the one or more expansion members.

26. The system of claim 17, wherein the first expandable support member is coupled to a first woven mesh frame, and wherein the second expandable support member is coupled to a second woven mesh frame.

27. The system of claim 26, wherein the first electrode is coupled along a distal portion of the first braided mesh frame, and wherein the second electrode is coupled along a distal portion of the second braided mesh frame.

28. The system of claim 27, wherein each of the first electrode and the second electrode is an annular array.

29. The system of claim 27, wherein each of the first electrode and the second electrode is a point contact array.

30. The system of claim 17, wherein the system further comprises a frame extending between the first expandable support member and the second expandable support member and coupling the first expandable support member and the second expandable support member to each other, the frame being adjustable to adjust the target spacing between the first electrode and the second electrode.

31. The system of claim 30, wherein the frame, the first expandable support member, and the second expandable support member are all woven mesh frames.

32. The system of claim 30, further comprising at least one expansion member coupled to the frame, wherein the expansion member is capable of radially expanding to expand the frame and adjust the target spacing of the first electrode and the second electrode.

33. The system of claim 30, wherein outer surfaces of the frame, the first expandable support member, and the second expandable support member comprise a protective coating to reduce tissue trauma during delivery to the tissue surface.

34. The system of claim 1 or 17, wherein the first electrode further comprises a first electrode array comprising a plurality of electrodes, and wherein the second electrode further comprises a second electrode array comprising a plurality of electrodes.

35. A method of treating tissue via an electrode treatment system, the method comprising: delivering a first electrode to a target tissue surface for treatment; delivering a second electrode to the target tissue surface for treatment; axially adjusting the position of one or both of the first electrode and the second electrode relative to each other to set a target spacing separating the first electrode from the second electrode at the target tissue surface; applying power to the first electrode and the second electrode; as well as Energy is delivered to the target tissue surface via the first electrode and the second electrode positioned at the target spacing for treatment.

36. The method of claim 35, wherein the step of axially adjusting one or both of the first electrode and the second electrode precedes the step of energizing the first electrode and the second electrode.

37. The method of claim 35, wherein the step of axially adjusting one or both of the first electrode and the second electrode occurs during the step of delivering energy to the target tissue surface.

38. The method of claim 35, wherein after delivering energy to the target tissue surface for treatment, the method further comprises axially adjusting the first electrode and the second electrode to retract the first electrode and the second electrode into a housing for removal.

39. The method of claim 35, further comprising determining a target energy level for delivery to the target tissue surface for treatment, wherein the step of axially adjusting one or both of the first electrode and the second electrode to set the target spacing is based on the target energy level.

40. The method of claim 35, wherein the first electrode is coupled to a first flexible member and the second electrode is coupled to a second flexible member, and wherein the step of axially adjusting one or both of the first and second electrodes further comprises axially adjusting one or both of the first and second flexible members.

41. The method of claim 35, wherein the first electrode is coupled to a first expandable support member and the second electrode is coupled to a second expandable support member, the method further comprising: expanding the first expandable support member to adjust the position of the first electrode relative to the target tissue surface; as well as The second expandable support member is expanded to adjust the position of the second electrode relative to the target tissue surface.

42. The method of claim 41, wherein the steps of expanding the first expandable support member and expanding the second expandable support member precede the step of axially adjusting the position of one or both of the first electrode and the second electrode.

43. The method of claim 35, further comprising locking the first electrode and the second electrode at the target spacing before energizing the first electrode and the second electrode.

44. The method of any one of claims 35 to 43, wherein the first electrode further comprises a first electrode array comprising a plurality of electrodes, and wherein the second electrode further comprises a second electrode array comprising a plurality of electrodes.

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