Spiral electrode treatment device and related treatment method

Abstract

The invention relates to a spiral electrode treatment device and a related treatment method. An electrode treatment device includes an electrode band arranged in a spiral shape, where a first end of the electrode band is attached to an elongate flexible body, such as a catheter, and a second end of the electrode band is attached to a flexible shaft extending from the body. When the spiral electrode contracts about the body and / or shaft, the device may have a diameter of less than 2 mm to facilitate endoluminal insertion and treatment of, for example, gastrointestinal or lung tissue. The shaft is rotatable relative to the body to radially expand the helix to a deployed position co-located with target tissue to power surgical treatment (e.g., intraluminal treatment). The electrode strip may be comprised of a conductive foil, or may include a flexible printed circuit on which one or more electrodes are formed. The device is operable by a robotic manipulator.

Description

Technical Field

[0001] The present disclosure relates generally to the field of tissue treatment. In particular, the present disclosure relates to devices and methods for ablating cells using deployable electrodes to treat targeted tissues. Background Art

[0002] Tissue within the body can be treated by excision and removal in surgical or medical procedures. While such 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 option. Such procedures, where applicable, may be more beneficial than more invasive surgical procedures in reducing overall patient risk, damage to surrounding tissue, recovery time, discomfort, and potentially harmful side effects. In minimally invasive tissue ablation (ablation), targeted tissue can be treated within the body (e.g., in situ) using procedures that do not involve excision or that may require minimal excision. 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 main purpose of these ablation procedures is to destroy abnormal tissue in the targeted area and promote the regrowth of healthy tissue.

[0003] Another known minimally invasive treatment technique involves electroporation of targeted tissues by locally applying an electric field to increase the permeability of cell membranes, which allows the introduction of drugs or other chemicals into cells for treatment. Electroporation can also be used in conjunction with electrolysis as a method of tissue ablation, through a process also known as electrolytic electroporation, electroporation-electrolysis, or E2.

[0004] Tissue ablation is a procedure used to treat various types of abnormal or damaged tissue, such as that of the gastrointestinal tract. Damage to intestinal tissue can occur for a variety of reasons, but is often associated with chronic metabolic disorders, such as diabetes. For patients with diabetes, damage to gastrointestinal tissue, particularly the duodenum, can lead to problems with insulin resistance and / or compromise the body's ability to process glucose. To help improve patient management of this disorder, duodenal mucosal resurfacing (DMR) has been proposed to reshape a patient's intestinal lining and help regenerate a healthy lining, thereby improving nutrient absorption in the duodenum. Improved intestinal lining health can help correct absorption problems and may allow patients to respond better to insulin therapy, which in turn may allow some patients to replace more aggressive insulin therapies (e.g., injections) with oral medications to help manage their condition.

[0005] In general, DMR is a procedure that involves introducing a catheter (or other suitable medical device) into the duodenum, generally 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 the desired depth by applying from within the duodenal lumen.

[0006] Tissue ablation also has the potential to be a minimally invasive treatment procedure for targeted treatment of lung cancer. However, the inventors have recognized that deployment of electrodes for electrolysis and / or electroporation is complicated by size limitations and guidance issues associated with navigating catheters through relatively small bronchiolar trees leading to targeted lung tissue. Navigation of bronchiolar trees may require steerable catheters with diameters less than 3.5 mm. The inventors have recognized the challenges associated with designing electrode arrays that are small enough to be delivered by such catheters, but that can be deployed at the treatment site or expanded to contact a larger area of ​​tissue.

[0007] The inventors have identified a need for an improved medical device having a flexible substrate with one or more electrodes to ablate cells to treat targeted tissue such as, for example, gastrointestinal tissue or lung tissue. Summary of the invention

[0008] An electrode treatment device includes: an elongated body, such as a catheter tube, having a distal portion terminating at a tip; a shaft rotatably supported by the body and extending beyond the tip of the body; and an electrode strip, such as a flexible printed circuit having one or more electrodes extending along its length. The electrode strip has a first end attached to the distal portion of the body and a second end attached to the shaft at a location distal to the tip of the body, and is wound around the body and / or the shaft to form a helix. The electrode strip can be coupled to a power source by a wire or other conductive path. The shaft is rotatable relative to the body in a first direction to radially expand the helix so as to deploy the electrode strip in apposition with the targeted tissue at a treatment site to perform an electrosurgical procedure such as DMR or other functions. The shaft is also rotatable relative to the body in a second direction opposite to the first direction to radially contract the helix around the body and / or the shaft to facilitate withdrawal of the electrode strip from the treatment site. In some embodiments, the shaft can also be slidably moved inwardly and distally outwardly relative to the body to adjust the pitch of the helix during expansion (deployment) and / or contraction.

[0009] In some embodiments, the electrode tape may be arranged to leave no gaps between turns of the helix when the electrode tape is retracted about the body and / or the shaft, or when the electrode tape is in an expanded (deployed) position, and in some embodiments, the electrode tape is thermoformed or heat treated so that when no force is applied to the electrode tape via the shaft and / or the body, the electrode tape tends to resume a helical shape.

[0010] In some embodiments, the shaft is movable relative to the body to move the electrode band between a retracted position and a maximum expanded position, and the maximum expansion ratio of the electrode band exceeds 5:1 or 10:1 or 20:1, or is in the range of 5:1 to 30:1.

[0011] In some embodiments, the electrode therapy device is operated by a robotic manipulator. The robotic manipulator may include a rotational actuator and a translational actuator, which may be independently controlled in some embodiments. In some embodiments, the rotational actuator and the translational actuator are integrated into a single actuator.

[0012] Other aspects and advantages will become apparent from the following detailed description of preferred embodiments with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The accompanying drawings depict only several examples according to the present disclosure and therefore should not be considered to limit the scope. Through the use of the accompanying drawings, the exemplary embodiments will be described with additional specificity and detail, in which:

[0014] Figure 1 is a schematic diagram of an electroporation and / or electrolysis system according to examples described herein;

[0015] Figure 2 is a schematic diagram of a robot-assisted manipulator system according to examples described herein;

[0016] Figure 3A is a schematic diagram of an apparatus system according to an example described herein;

[0017] Figure 3B Show Figure 3A An instrument system with a distal portion of an extended example of an instrument according to examples described herein;

[0018] Figure 4 An electrode device is shown with an example helical electrode band in a retracted position according to the examples described herein;

[0019] Figure 5 Figure 2 shows the helical electrode band deployed to the expanded position. Figure 4 Electrode devices;

[0020] Fig. 6A , Figure 6B and Figure 6C Schematically illustrating an electrode instrument according to examples described herein, wherein the body and shaft of the instrument are both rotatable and slidably translatable relative to each other to control the pitch of the helical electrode; and

[0021] Fig. 7A , Figure 7B and Figure 7C The helical electrode is shown progressively advanced along the treatment site to a series of overlapping contact areas or treatment zones. DETAILED DESCRIPTION

[0022] The present disclosure relates to devices and systems for providing controlled delivery of one or more flexible electrodes to a targeted tissue site for treatment, such as ablation by electroporation and / or electrolysis, or for other purposes. In general, a method for minimally invasive regenerative surgery is disclosed, which includes subjecting a target area in living tissue to ablation delivered via one or more electrodes. In some examples, the ablative energy can be in the form of one or more electric fields in combination with electrolysis. However, it should be understood that the example systems and methods described herein can be used to deploy flexible substrates that deliver electrodes that employ ablation modes other than electroporation and / or electrolysis (e.g., radiofrequency ablation), or for purposes other than ablation, such as electrical stimulation or diagnostic methods.

[0023] In an example procedure using electroporation and electrolysis, an electrode (one or more) is 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 electrodes. An electric field of a certain magnitude may be generated to permeabilize the area of ​​the cell membrane that needs to be ablated. The generated electric field may produce a certain magnitude of electrolytic products, which itself does not cause damage to cells or extracellular matrix located in and around the target treatment area. However, when sufficient electrolytic products are produced in the permeabilized cell area, cell death occurs in the electric field application area without damaging the extracellular matrix or scaffolding, thereby helping to promote tissue re-growth in the treated tissue area.

[0024] In some examples, after ablative energy is applied to a target area, the electrode(s) may be moved to other tissue locations by advancing and / or retracting a delivery catheter that delivers the electrode(s) and repeating the process. In this manner, electroporation and electrolysis may be performed at multiple sites within a patient, thereby covering a larger area of ​​tissue. In some embodiments, multiple sets of electrodes may be positioned at multiple corresponding tissue sites such that electroporation and electrolysis may 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.

[0025] In some embodiments of the present disclosure, the systems and methods disclosed herein can be used to treat gastrointestinal tissue. In other embodiments, the systems and methods described herein can be used to treat any of lung tissue or a variety of other tissues. In general, when tissue regeneration is required or when one cell needs to be replaced with another cell, the tissue can be treated. Examples include intestine, duodenum, stomach, bladder, uterus, endometrial (endometrial lining), ovary, colon, rectum, sinus, duct, ureter, prostate, skin, muscle, nerve, diaphragm, momentum (momentum), kidney, follicle, brain, lymphatic vessel, breast, esophagus, lung, liver, kidney, lymph node, lymph node basin (lymph node basins) and / or heart. Replacing one type of tissue with another type of tissue can be in a fibrotic area (in a fibrotic area, it is necessary to replace fibrotic cells with stem cells that can re-regulate the area) or when pancreatic islets are injected into a portion of the liver to produce a new source of insulin. In other examples, other tissues can be treated. Additional details related to an example process of electroporation and / or electrolysis for tissue treatment according to some embodiments are provided below.

[0026] As mentioned above, electroporation can be performed to permeabilize the cell membrane of the target cell. Reversible electroporation can be used, wherein permeabilization can be stopped after the electric field is removed. Cells can survive in reversible electroporation, and the holes in the membrane are resealed and the steady state is restored. In irreversible electroporation, the permeabilization of the cell membrane is permanent, resulting in cell death. Generally for biological tissues, an electric field lower than about 1500V / cm to about 200V / cm is considered to produce reversible electroporation, while an electric field higher than about 1500V / cm is considered to produce irreversible electroporation. The example of the system and method described herein can utilize reversible electroporation to avoid the disadvantages of irreversible electroporation, which can include heating and thermal damage, the complexity of providing such a large electric field, and the muscle contraction that may be caused by the large electric field. It should be understood that although the systems and methods described herein may be designed to utilize reversible electroporation, there may be locations or incidental areas where conditions are such that irreversible electroporation, or even thermal ablation, may occur in limited portions of the treated tissue.

[0027] In some treatment procedures, the electrolysis product can be used for permeabilized cells, so that the permeabilized cells in the applied electric field die, while keeping the extracellular matrix of the permeabilized cells intact. Extracellular matrix generally refers to a three-dimensional network of proteins 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 can also provide signal conduction for cell growth and development. Extracellular matrix can be used as a scaffold for tissue regeneration and / or engineering. For example, cells can be regenerated, grown, transplanted or otherwise cultivated on the extracellular matrix. By making the extracellular matrix remain in the cell region of the other ablation described herein, cell regeneration and / or tissue engineering can occur in the cell region of the ablation. In some programs, the extracellular matrix can be transplanted from a cell region of ablation to another region (which can 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 enhance regrowth.

[0028] The example systems and methods described herein can utilize electrolysis products and electroporation to cause cell death, thereby permeabilizing cell membranes. 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 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 that are toxic to cells (cytotoxicity). Except as an electronic pull-out (source) or pouring (sink) or as a catalyst, electrolysis preferentially uses one or more inert electrodes that do not participate in the electrolysis process. When using non-inert electrodes in the process, they can produce metal ions, which may cause systemic damage to the body, such as excessive iron, or even metal fragments.

[0029] Examples of systems disclosed herein include one or more electrodes, power supplies, and controllers to apply energy for treating internal tissues. The energy applied can be used for electrolysis and / or electroporation in some examples, for radiofrequency ablation in other examples, and for other energy modes in other examples. When energy is used for electroporation in the presence or absence of electrolysis, the controller controls the charge delivered to the electrode (one or more) to induce one or more electric fields. In the case of including electroporation and electrolysis, the electrode (one or more) is used to generate a current to produce electrolysis products, and to generate a voltage difference to generate an electric field that induces electroporation. The duration and magnitude of the applied charge determine the dosage of the electrolysis product and the degree of permeabilization of the cells in the treatment site. Therefore, the cell ablation area can be determined by the area where the cell is exposed to the combination of permeabilization and electrolysis products that cause ablation. However, ablation can keep the extracellular matrix intact in the ablated cell area where the electric field has been applied. The composition of the electrode (one or more) can be selected according to the desired product produced and the electroporation effect.

[0030] refer to Figure 1 , a brief overview of an example system for delivering a catheter with electrodes to a targeted tissue site for treatment via electroporation and / or electrolysis is provided below. For clarity, the written description of various example embodiments and the associated drawings generally relate to the use of a catheter in conjunction 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 also be used in conjunction with the disclosed systems and methods without departing from the principles of the disclosed subject matter.

[0031] Figure 1 is a schematic diagram of a system 10 arranged according to example embodiments 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 power source 12 coupled to a controller 14, and a catheter 40. Examples of other suitable catheters that can be used with the system 10 are described below. Figure 4 -7 is described in further detail. Figure 1 , the controller 14 may include a processor 16, a computer-readable medium 18, and other computing system components, such as, in some examples, 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 adjusting the output of the power supply 12 to cause electroporation and electrolysis using the catheter 40, and may include stored parameters 22 that may be used in causing electroporation and electrolysis, such as electric field strength, voltage and / or current levels, waveform shape, exposure duration parameters, and any other suitable parameters. Figure 1In the example of FIG. 4 , a circle depicted around one end of catheter 40 may indicate a region of cells that may be permeabilized via an applied electric field.

[0032] The controller 14 may be implemented using a computing device. Examples of computing devices include controllers, microcontrollers, computers, servers, medical devices, smart phones, tablet computers, wearable devices, etc. The computing device may be handheld and may also have other uses. The 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).

[0033] 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), etc.). Although Figure 1 A single block is depicted as computer readable medium 18 in FIG. 1 , but there may be any number of computer readable medium 18 devices. Computer readable medium 18 may be in communication with processor 16 (eg, electrically connected to processor 16 ).

[0034] The executable instructions 20 for electroporation and electrolysis may include instructions for controlling the charge delivered to the electrodes, such as the electrodes 50 of the catheter 40. Thus, the controller 14 may sense a voltage difference across the targeted tissue, thereby generating an electric field that causes permeabilization of cells in the targeted tissue region for treatment. The electrodes 50 are shown in a cavity or chamber 32 formed in the tissue 30. Although the catheter 40 is shown disposed in the cavity 32 of the tissue 30, the catheter 40 may be on the surface of the tissue 30, in the tissue 30, and / or near the tissue 30. In addition, although the catheter 40 is shown for delivery and placement of the electrodes 50 to permeabilize and / or generate electrolysis products to treat the tissue 30, in other embodiments, other suitable delivery systems may be used.

[0035] Controllers, such as Figure 1The controller 14 may activate one or more selected electrodes 50 to provide an electric field. In some embodiments, the controller 14 may alternately or otherwise select a pattern of activated 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 may 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 may help shape the field (e.g., by expanding the field). In other examples, a non-conductive fluid may help shape the field (e.g., by attenuating the field). In some examples, a non-conductive fluid or other substance may be injected or otherwise placed into the tissue to protect areas that do not require ablation. The electric field may not penetrate and / or pass through the non-conductive fluid, so that the field does not reach tissue that does not require ablation, or at least the intensity is not sufficient to cause permeabilization or other cellular changes.

[0036] The controller 14 can also be used to induce an electric current through the tissue 30, such as between the electrodes 50, thereby generating electrolytic products. The electrolytic products can cause ablation of permeabilized cells, but are preferably insufficient to destroy the extracellular matrix in the area of ​​the permeabilized cells. As previously described, the remaining intact extracellular matrix can allow for regeneration and tissue engineering of the tissue.

[0037] In some embodiments, one or more of the electrodes 50 used to apply electroporation can also be used to produce electrolysis products (in other words, some or all of the electrodes can be used for both 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 produce electrolysis products.

[0038] 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, and thus generate 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.

[0039] The controller 14 can control the timing, intensity, and duration of the electric field and / or electrolysis products provided via the catheter 40. The controller 14 can be programmed, for example, to provide an electrical signal to the catheter 40 via the power source 12, wherein the electrical signal can indicate a treatment dose, such as a dose of electrolysis products and / or a level of permeabilization of cells. The electrical 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) that are coupled to a computer readable medium 18 encoded with electrolysis and permeabilization executable instructions 20. Although in Figure 1 Controller 14 is shown as a separate component coupled to catheter 40, but in some embodiments, controller 14 may be integrated as a part of catheter 40. In other embodiments, controller 14 may include a programmable circuit coupled to catheter 40 via a wired or wireless connection.

[0040] As previously described, the system 10 may include any suitable parameters 22 for controlling various aspects of the electroporation and 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 other systems that are operable to calculate the parameters 22.

[0041] In some example embodiments, 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 to induce cell death of permeabilized cells as desired.

[0042] In some embodiments, examples of parameters 22 that can be used include the delivery of 1 to 10 voltage pulses between 100V and 1000V. Those pulses can be delivered in a system with a capacitance between 50μF and 100μF and a resistance between 15-20 ohms. The amount of electrolytic product produced can be related to the delivered charge in coulombs. There are several ways to calculate the delivered charge. For example, the charge Q (in coulombs) stored in a capacitor is equal to the product of the capacitance C (in farads) of the capacitor and the voltage V (in volts) between its terminals. That is, Q=C·V. In addition, the charge is the product of the current I (in amperes) and the time t (in seconds). That is, I·t=Q. By defining the capacitance and the voltage across the capacitance, the charge can be defined and the electrolytic performance can be determined accordingly. When the capacitor discharges, it produces a current, and the current multiplied by the time must be equal to the charge in the capacitor. When the capacitor is discharging, the current is not constant-it decays exponentially. The time measurement is therefore given by an exponentially decaying time constant. The capacitor that controls the time constant is usually connected to the power supply (e.g. Figure 1 The power supply 12) is obtained by the capacitor in the power supply 12).

[0043] In some embodiments, the time constant (e.g., the exponential decay time constant of the capacitor discharge) may be between 1.7 milliseconds (ms) and 1.8 ms. In other embodiments, the time constant may range from 50 microseconds (s) to 3 ms. In general, the lower limit of the time constant is related to the time sufficient to ensure that the electrolytic species (e.g., electrolysis products) permeabilize the targeted area of ​​the permeabilized cell. The upper limit of the time constant is generally related to the generation of electrolytic species (e.g., electrolysis products) that can cause ablation itself. Therefore, electrolysis is generally targeted to allow the electrolysis products to diffuse through the permeabilized cell area. However, the amount of time for providing electrolysis should be limited to ensure that the process does not result in ablation of non-permeabilized cells or otherwise damage the extracellular matrix in the ablated cell area.

[0044] In some embodiments, the electric field generated ranges from 100 V / cm to 3500 V / cm. In other embodiments, the electric field may be between 100 V / cm and 1500 V / cm, or between 200 V / cm and 850 V / cm. In yet other embodiments, the electric field may 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.

[0045] The system 10 may also include one or more sensors (not shown) for measuring the pH, temperature, electric field strength, tissue resistivity or impedance and / or other suitable properties of the tissue 30 to optimize the 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 being coupled to a catheter 40 adjacent to the electrode 50 to detect the pH value near the electrode 50. In another embodiment, the pH sensor may be provided at the outer edge of the targeted tissue area. In either configuration, the pH sensor may communicate with the controller 14, wherein the controller 14 may use one or more received pH values ​​as an indication of tissue ablation and / or monitor the occurrence of tissue damage based on the pH level detected at the treatment site and around the tissue area. 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 the threshold of tissue damage, the controller 14 may reduce the magnitude of the electric field, the duration between pulses, or stop applying the electric field. Similarly, if the pH of tissue within the targeted area is at or above the threshold for tissue ablation, controller 14 may stop applying current through the electrodes immediately and / or after a desired elapsed electrolysis time to stop the electrolysis process.

[0046] 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 (e.g., DC current) through the tissue 30, and receive resistivity measurements and / or calculate the resistivity of the tissue 30. In some examples, the voltage, current, and / or electric field applied can be selected, determined, and / or allowed based on the measured resistance of the tissue 30. In some examples, the number of pulses of applied voltage can be selected, determined, and / or otherwise used based on the measured resistance of the tissue.

[0047] 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 the desired treatment regimen.

[0048] In some embodiments, an ablation device (e.g., Figure 1The catheter 40) can be delivered via a computer-assisted, remotely operated manipulator system, which is sometimes referred to as a robot-assisted system or a robotic system. The manipulator system includes one or more manipulators that can be operated with the assistance of an electronic controller (e.g., a computer) to move and control the functions of one or more instruments when they are coupled to the manipulators. Figure 2 An exemplary embodiment of a robot-assisted manipulator system 100 for use with the systems and methods described herein is shown. The manipulator system may be used, for example, in surgical, diagnostic, therapeutic, biopsy, or non-medical procedures.

[0049] refer to 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 when performing various procedures on a patient P positioned on a table T in a medical environment 101. For example, the manipulator assembly 102 may drive the movement of a catheter 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 movement that can be motorized and / or teleoperated and selected degrees of freedom of movement 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 naturally occurring or surgically created anatomical orifice. Other drive systems can enable the distal end of the medical device system 104 to move with 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, Z Cartesian axes). The manipulator assembly 102 may support various other systems for irrigation, treatment, or other purposes. Such systems may include fluid systems (including, for example, reservoirs, heating / cooling elements, pumps, and valves), generators, lasers, interrogators, and ablation components.

[0050] 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 use the perception of telepresence to control the medical instrument system 104 and the operator input system 106. The graphical user interface may be displayed on the display system 110 and / or the display system of the independent planning workstation.

[0051] In some examples, the endoscopic imaging system components of the imaging system 109 may be integrally or removably coupled to the medical instrument system 104. However, in some examples, a separate imaging device (e.g., an endoscope) attached to a separate manipulator assembly may be used in conjunction with the medical instrument system 104 to image a surgical site. The endoscopic imaging system 109 may be implemented as hardware, firmware, software, or a combination thereof interacting with or otherwise executed by one or more computer processors, which may include a processor of the control system 112.

[0052] 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 temperature, pressure, force, or contact sensors, etc.

[0053] 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 implement procedures using the robot-assisted manipulator system, including navigation, steering, imaging, deployment or retraction of engagement features, application of treatment to target tissue (e.g., by applying energy), etc.

[0054] The control system 112 may optionally further 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 may be based on reference to a preoperative or intraoperative data set of an acquired anatomical channel. The virtual visualization system processes images of the surgical site imaged using imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, infrared imaging (thermography), ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or similar techniques. The control system 112 may 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 may include, for example, a planned size to expand the expandable device, a duration of treatment, a treatment temperature, and / or multiple deployment positions.

[0055] Figure 3A 2 shows a medical device system 200 according to some example 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 for procedures involving traditional manually operated medical devices, such as endoscopy. In other embodiments, the medical device system 200 can be used with Figure 2 The medical device system 104 may be interchangeable, or variations thereof.

[0056] The medical device system 200 includes an elongated flexible device 202, such as a flexible catheter, an endoscope (e.g., a gastroscope, a bronchoscope, a duodenoscope), 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 tip portion. In some embodiments, the flexible body 216 has an outer diameter of approximately 14-20 mm. Other embodiments of the flexible body 216 may 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 may have an appropriate length to reach certain portions of the anatomical structure, such as the lungs, sinuses, larynx, or upper or lower gastrointestinal regions.

[0057] 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, in conjunction with one or more computer processors, which may include Figure 2 A processor of the control system 112 in the system 100—interacting or otherwise being executed thereby.

[0058] 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 use orientation sensor system 220 (e.g., electromagnetic (EM) sensor system) to track distal portion 218. In some examples, orientation sensor system 220 can be configured and positioned to measure six degrees of freedom (e.g., three orientation coordinates X, Y, and Z and three orientation angles indicating pitch, yaw, and roll of a base point) or five degrees of freedom (e.g., three orientation coordinates X, Y, and Z and two orientation angles indicating pitch and yaw of a base point).

[0059] The flexible body 216 includes one or more channels (eg, passageways) 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 the end of the flexible body 216 according to some embodiments, wherein the medical device 226 extends outward from the end. In some embodiments, the medical device 226 can be used for procedures and various aspects of the procedure, such as surgery, biopsy, ablation, mapping / mapping, imaging, lighting, flushing or suction. The medical device 226 can be deployed through the channel 221 of the flexible body 216 and used at the target position within the anatomical structure. In other embodiments, the medical device can be integrated with the flexible body 216, rather than being received in the channel of the flexible body 216 or deployed through the channel of the flexible body 216. 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 with 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, tweezers, clamps, a balloon, a needle, scissors, a clip applier and / or the like. Other end effectors may 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 may 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 may 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 may be used in conjunction with an image capture device (e.g., an endoscopic camera) also located within the elongated flexible device 202. Alternatively, the medical device 226 itself may be an image capture device.

[0060] The medical device 226 may additionally 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, such as shown by the 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 to provide independent "side to side" steering to control the yaw motion of the distal portion 218. In embodiments where the medical device system 200 is actuated by a robotically assisted assembly, the drive unit 204 can include a drive input that is removably coupled to and receives power from a drive element (e.g., an actuator) of a remotely operated assembly. In some embodiments, the medical device system 200 can include gripping features, manual actuators, or other components for manually controlling the movement of the medical device system 200. Information from the tracking system 230 can 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 a physician or other operator.

[0061] 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 approach can be determined based on the medical application. For example, in some gastrointestinal applications, the medical device system 200 (or a stand-alone medical device 226) can be delivered intracavitary via an oral or anal approach, via a manual or robotic delivery device. An abdominal approach using an integrated monopolar or bipolar instrument, drop-in probes, or via a catheter can also be used. For urological applications, the medical device system 200 (or a stand-alone medical device 226) can be delivered intracavitary via a transurethral approach, perineum, preperitoneum, or abdomen, via a manual or robotic delivery device using an integrated bipolar instrument, drop-in probe, or via a catheter. Similarly, for gynecological applications, the medical device system 200 (or the stand-alone medical device 226) can be delivered intracavitary via a transvaginal route, transperineal route, or transabdominal route, via a manual or robotic delivery device, using an integrated bipolar instrument, a drop-in probe, or via a catheter. For hepatobiliary applications, the medical device system 200 (or the stand-alone medical device 226) can be delivered intracavitary via a manual or robotic delivery device, using an integrated bipolar instrument, a drop-in probe, or via a catheter, via a transoral route to the ampulla or via a transgastric wall route or transabdominally into the liver from the outside. For neurovascular applications, the medical device system 200 (or the stand-alone medical device 226) can be delivered via a manual or robotic delivery device, using an integrated bipolar instrument, a drop-in probe, or via a catheter, via an intravascular route or via a keyhole craniotomy. For cardiac applications, the medical device system 200 (or stand-alone medical device 226) may be delivered using an integrated bipolar device, a drop-in probe, or via a catheter, either intravascularly or transthoracically, via manual or robotic delivery devices.

[0062] Now refer to Figure 4 , Figure 5 , Fig. 6A , Figure 6B , Figure 6C , Fig. 7A , Figure 7B and Figure 7C Embodiments of electrode deployment systems and electrode treatment devices are described in the context of an electrode instrument 300 for electrosurgery (e.g., electrolysis and / or electroporation). In some embodiments, electrode treatment devices and electrode deployment systems (e.g., electrode instrument 300) according to the present disclosure may be received in an endoscope, catheter, or other device described above. Figure 3A and Figure 3BThe electrode device 300 may be disposed in and / or from a channel of any other elongated flexible device 202 described herein. In other embodiments, an electrode device 300 according to the present disclosure may be integrated with the body of an endoscope, catheter, or other elongated flexible device.

[0063] refer to Figure 4 , the electrode device 300 includes an elongated body 310, which is shown as a flexible catheter, but it may include other types of tubular structures or hollow structures suitable for insertion into a patient's body, such as a torque tube or an endoscope having a channel or passageway therethrough. A flexible shaft 320, such as a wire, cable, small torque tube or other drive element, extends through a lumen 324 of the body 310 and is rotatably movable relative to the body 310 about the longitudinal axis of the shaft 320. In some embodiments, the shaft 320 may also slide longitudinally relative to the body 310, as described below with reference to Fig. 6A , Figure 6B and Figure 6C The handle 330 is attached to the proximal portion 332 of the shaft 320 to facilitate manipulation of the shaft 320. In some embodiments, the handle 330 can be manually actuated by a user. In other embodiments, the handle 330 can be coupled to an external device for actuation, such as a robot-assisted manipulator system. In yet other embodiments, a combination of manual and robot-assisted actuation can be provided.

[0064] The electrode instrument described herein may be coupled to an external device to provide actuation, control and / or power to the electrode instrument. For example, the electrode instrument 300 and other electrode instruments described herein may be actuated by a robot-assisted manipulator system (e.g., manipulator assembly 102). The electrode instrument 300 (e.g., handle 330, body 310 and / or shaft 320) may include or be coupled to a drive unit (e.g., drive unit 204) having one or more drive inputs, which are detachably coupled to a drive element (e.g., actuator) of the manipulator assembly and receive power therefrom. When the electrode instrument 300 is coupled to the manipulator assembly, the drive input of the electrode instrument 300 may be coupled to a drive output of the manipulator assembly driven by the drive element of the manipulator assembly. In addition, the drive input of the electrode instrument 300 can also be coupled to the distal portion of the electrode instrument 300 via one or more actuation drive members (e.g., actuation cables, actuation rods, tension members, etc.) to perform actions such as advancing, retracting, or articulating the distal end of the electrode instrument 300, as well as expansion and / or retraction of the electrode band (e.g., electrode band 340) described herein to adjust the electrode band between the deployed position and the retracted position. In some embodiments, the body 310 and / or the shaft 320 of the electrode instrument 300 can be coupled to the drive unit 204 for adjusting the electrode band between the deployed position and the retracted position. In addition, the drive unit 204 can also 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 instrument 300. The drive unit 204 can be electrically coupled to the electrodes via one or more cables extending along or through the electrode instrument 300. In alternative embodiments, the controller and power supply may provide power to the cable without being coupled to the drive unit (eg, the controller and power supply may be independent of the drive unit).

[0065] The electrode strip 340 is wrapped around the distal portion 342 of the body 310, wherein the first end 346 of the electrode strip 340 is attached to the distal portion 342 of the body 310, and the second end 348 of the electrode strip 340 is attached to the tip 354 ( Figure 5 ) is a distal portion 352 of the shaft 320 distal to the electrode strip 340. The first end 346 is a proximal portion of the electrode strip 340, and the second end 348 is a distal portion of the electrode strip 340. The connection locations of the first end 346 and the second end 348 of the electrode strip 340 are longitudinally spaced apart from each other so that the electrode strip 340 is wound in the configuration of a helix 360. The helix 360 is formed in a middle portion 376 of the electrode strip 340 between the first end 346 and the second end 348, and the first end 346 and the second end 348 are curved away from the middle portion 376 toward their connection with the body 310 and the shaft 320.

[0066] Figure 4The helically arranged electrode strip 340 is shown in a retracted position or configuration, wherein the electrode strip 340 is tightly wound around the body 310 and the shaft 320. For clarity of illustration, Figure 4 The electrode band 340 is shown slightly expanded from a fully retracted position, wherein the electrode band 340 is tightly wrapped around the body 310. In the retracted position, the electrode instrument 300 can be inserted intraluminally into the patient's body to treat tissue. The retracted position also facilitates movement of the electrode instrument 300 within the patient's body and removal of the electrode instrument 300 from the patient's body. In some embodiments, the entire distal portion 350 of the electrode instrument 300, including the electrode band 340, can be retracted into a sheath or shield, such as into the channel 221 of the endoscope 202 ( Figure 3A and Figure 3B ). By covering the edge of the electrode band 340, retracting the distal portion 350 of the electrode instrument 300 into the sheath can facilitate insertion and navigation of the electrode instrument 300 in the patient's body, which would otherwise increase friction with or become stuck in the surrounding tissue during insertion or navigation. When the electrode instrument 300 is conveyed in the working channel 221 of the endoscope and the distal portion 350 of the electrode instrument 300 is retracted into the working channel 221 of the endoscope, the endoscope provides a robust vehicle for delivering the electrode instrument 300 to the target tissue and for removing the electrode instrument 300 from the patient's body.

[0067] The shaft 320 is capable of transmitting torque to move the second end 348 of the electrode strip 340 relative to the body 310 to deploy the electrode strip 340. Figure 5 , after the electrode device 300 is positioned in the patient's body, the electrode belt 340 is at a treatment site 362 adjacent to a targeted tissue 364, and the electrode belt is moved outward from its sheath (if any), the helix 360 is radially expanded by rotating the shaft 320 relative to the body 310 in a first direction indicated by arrow 366 via the handle 330 or via a robotic manipulator, thereby deploying the electrode belt 340 to be co-located with the targeted tissue 364 at the treatment site. Conversely, rotation of the shaft 320 relative to the body 310 in a first direction can be achieved by rotating the body 310 relative to the shaft 320 in an opposite direction indicated by arrow 370. In some embodiments (not shown), the shaft 320 is driven by a motor or other mechanism. In some embodiments, the shaft 320 does not extend completely through the body 310, but instead extends from the tip 354 of the body 310 and is rotationally driven from within the body 310 or by other means. Figure 5In the illustrated embodiment, the first rotational direction 366 of the handle 330 is counterclockwise, while the relative rotational direction 370 of the body 310 is clockwise - for dilating the helix 360. In another embodiment (not shown), the direction of the helix (i.e., handedness) can be reversed such that the first rotational direction of the handle 330 is clockwise, while the relative rotational direction of the body 310 is counterclockwise.

[0068] When in Figure 5 In the expanded position or configuration shown, the electrode band 340 is spaced apart from the shaft 320 and the body 310 in a middle portion 376 between the first end 346 and the second end 348 and is in position with the target tissue 364. Once the electrode band 340 is in contact with the target tissue 364, an electrical potential and / or current can be applied to the electrode band 340 to complete an electrosurgical procedure, as further described below. After the electrosurgical procedure is completed, the electrode band 340 can be restored to the retracted position ( Figure 4 ). Conversely, rotation of the shaft 320 in the second direction may be achieved by rotating the body 310 relative to the shaft 320 in the second direction opposite to arrow 370. After returning the electrode band 340 to the retracted position, the electrode instrument 300 may be moved longitudinally forward or backward along the treatment site 362 or to a different treatment site, or removed from the patient. In some cases, the electrode band 340 may be retracted into a sheath, such as into the working channel 221 of an endoscope, before the electrode instrument 300 is moved within or removed from the patient.

[0069] The expansion ratio of the electrode instrument 300 is defined as the diameter of the helix 360 when in the expanded position divided by the diameter of the helix 360 when in its retracted position. The diameter of the helix 360 is measured as the diameter of a circle circumscribing the axial projection of the helix 360, taking into account the deformation at the first end 346 and the second end 348 of the electrode strip 340. Therefore, the "maximum expansion ratio" of the electrode instrument 300 is defined as the maximum diameter of the electrode strip 340 in its maximum expanded position divided by the minimum diameter of the electrode strip 340 in its fully retracted position. For clarity, in the maximum expanded position, the electrode strip 340 must still extend at least one full turn or revolution (at least 360 degrees), it being understood that less than one full turn or revolution of the helix 360 may result in the electrode strip 340 extending radially a greater distance, but extending primarily or only from one side of the body 310. In some embodiments, the maximum expansion ratio of the electrode instrument 300 may exceed 5:1 or may exceed 10:1 or 20:1. In some embodiments, the maximum expansion ratio may be in the range of 5:1 to 30:1. Notably, the available expansion ratio or "maximum available expansion ratio" may be slightly less than the maximum expansion ratio and may depend on the mechanical properties of the electrode strip 340. For example, a very flexible electrode strip 340 may be tightly wrapped around the body 310 to a very small minimum diameter and, when expanded, may conform ideally to tissue 362 lining an irregular cavity shape, but when expanded to its maximum diameter, the electrode strip 340 may not be able to generate sufficient force to align with the tissue 362 to achieve sufficient electrical contact required to perform a particular electrosurgical function (e.g., electrolysis and / or electroporation). Conversely, a stiffer electrode strip 340 may expand to a larger overall diameter while still providing sufficient aligning force and sufficient electrical contact with the tissue to achieve an electrosurgical function, but may be less able to conform to an irregular cavity shape and may be more difficult or impossible to wrap tightly around the body 310, resulting in a larger minimum diameter in its collapsed position. Therefore, the term "maximum expansion ratio" should be understood to be potentially different from the maximum available expansion ratio.

[0070] In some embodiments, the electrode strip 340 includes a foil strip that forms a single electrode of the electrode device for monopolar operation. In some embodiments, the electrode strip 340 may include a flexible printed circuit (FPS) in which one or more conductive lines or patterns (e.g., a metal layer) are exposed on the outer surface of the FPS to form one or more electrodes of the electrode device 300. When multiple electrodes are used, the electrode device 300 is capable of bipolar operation, such as for electrolysis and / or electroporation. Figure 4 and Figure 5 In the illustrated embodiment, the electrode strip 340 comprises an FPS in which two conductors form two electrodes 380 extending the entire length of the electrode strip 340. Various conductor shapes and electrode configurations may be present on the surface of the FPS. In some embodiments, each electrode 380 is connected to the FPS by a wire 388 ( Figure 4 ) to a power source (e.g. Figure 1 In some embodiments, the electrodes 380 may be connected to the power source 12 via a different conductive path, such as via the shaft 320 or the body 310 (e.g., if made of or including a conductive material). When the shaft 320 and / or the body 310 form a conductive path for one or more electrodes 380, the shaft 320 and / or the body 310 may have an electrically insulating surface to prevent electrical shorting between the shaft 320 and the body 310, prevent electrical contact between the body 310 and tissue, and / or prevent electrical contact or shorting with an electrode strip (e.g., when a foil strip) at an undesirable location below the helix 360. When the shaft 320 and / or the body 310 form a conductive path for one or more electrodes 380, in some embodiments, electrical connection to the power source 12 can be achieved by contact pads (not shown) formed on the proximal portion 336 of the body 310 and / or the proximal portion 332 of the shaft 320 and / or formed in the handle 330, which can be electrically coupled to the power source 12 through corresponding contacts, brushes or other means (such as inductive coupling (not shown)). In other embodiments, the wire 388 can be connected to the handle 330 and / or one or both proximal portions 336 and / or 332 of the corresponding body 310 and / or shaft 320.

[0071] Figure 4 The electrode band 340 is shown in a retracted position with at least a portion of its first end 346 tightly wrapped around the distal end portion 342 of the body 310 and at least a portion of its second end tightly wrapped around the tip 354 ( Figure 5 ) around the distal end portion 352 of the shaft 320 extending from the body 310. In some embodiments, all or substantially all of the electrode strip 340 may be helically wrapped around the body 310, while in most embodiments, at least a small portion of the second end 348 of the electrode strip 340 is wrapped around the tip 354 ( Figure 5 ) around the distal portion 352 of the shaft 320 extending from the electrode strip 340. In most embodiments, the entire electrode strip 340 is wrapped around the shaft 320, wherein the distal portion 342 of the body 310 is between the electrode strip 340 and the shaft 320 along at least a portion of the length of the spiral body 360 of the electrode strip 340. In some embodiments, as described below Fig. 6A , Figure 6B and Figure 6C, the shaft 320 extends a considerable distance from the tip 354 of the body 310, and the first end 346 of the electrode strip 340 is attached to the distal portion 342 of the body at or near the tip 354 so that most or all of the electrode strip 340 is just wrapped around the shaft 320. In some embodiments, the diameter of the distal portion 350 of the electrode device 300 can be less than 2 mm, or less than 1.2 mm in diameter, or between 0.8 mm and 3 mm in diameter, or between 1.2 mm and 2 mm in diameter. Such a small profile of the electrode device 300 can facilitate its use in treating the duodenum, small intestine, nasal passages, primary, secondary, or tertiary bronchi or bronchioles of lung tissue, or other narrow luminal areas of the patient's body.

[0072] The first end 346 and the second end 348 of the electrode strip 340 may be attached to the respective body 310 and the shaft 320 by various means. In some embodiments, at least one end of the electrode strip 340 is attached to the body 310 or the shaft 320 via an adhesive. In some embodiments, at least one end of the electrode strip 340 is welded to the body 310 or the shaft 320. In some embodiments, at least one end of the electrode strip 340 is tacked or pinned to the body 310 or the shaft 320. In some cases, the first end 346 and the second end 348 are attached in different ways, and in some cases, the attachment ways are the same.

[0073] In some embodiments, the electrode strip 340 can be heat treated or thermoformed to provide shape memory, preferably in the retracted position. By heat treating or thermoforming the electrode strip 340 in the retracted position, when the rotational force is removed from the body 310 and / or the shaft 320, or in the event that the first end 346 or the second end 348 of the electrode strip 340 is detached from the body 310 or the shaft 320, the electrode strip 340 will tend to return to the retracted position, which can facilitate removal of the device from the patient's body.

[0074] refer to Figure 4 and Figure 5 When the electrode strip 340 is in the retracted position, the electrode strip 340 may be arranged to leave a small gap 394 between adjacent turns of the helix 360, such as Figure 4 As shown, when the electrode belt 340 is rotated and deployed, the gap increases, as shown in FIG. Figure 5396 in the expanded gaps 396. In some embodiments, when in the retracted position, the electrode strips 340 can be arranged to leave no gaps or substantially no gaps between turns of the helix 360. In some embodiments, the electrode strips 340 are arranged to leave no gaps or substantially no gaps between adjacent turns of the helix 360 when deployed at the treatment site 362 in the expanded position. When arranged to leave substantially no gaps or no gaps between turns of the helix 360 in the expanded position, the electrode strips 340 can overlap in the retracted position.

[0075] In some embodiments, the shaft 320 is slidably movable proximally or inwardly (e.g., retractable) and distally outwardly (e.g., extendable) relative to the body 310, and / or the body 310 is longitudinally slidable along the shaft 320 to adjust the pitch of the helix 360 during deployment and / or retraction, such as Fig. 6A , Figure 6B , Figure 6C This longitudinal sliding movement of the shaft 320 may be performed independently of the rotation of the shaft 320 or simultaneously with the rotation of the shaft 320 . Fig. 6A An electrode instrument 400 is shown in which a first end of an electrode strip 440 is connected to a body 410 and a second end of the electrode strip is attached to a shaft 420, and in which the electrode strip 440 is arranged to form a helix 460 and is disposed in a Fig. 6A Shown in the retracted position. Figure 6B A partially deployed electrode belt 440 is shown, wherein the body 410 is rotated relative to the axis 420 and is slidably advanced, as indicated by the arrows, thereby Fig. 6A In contrast, the shaft 420 is slightly retracted relative to the body 410. And Figure 6C The electrode band 440 is shown in an expanded position, wherein the body 410 is further rotated relative to the shaft 420 and slidably advanced along the shaft 420. Fig. 6A , Figure 6B and Figure 6C In each case, as the body 410 and shaft 420 are relatively rotated to expand the helix 460, the pitch of the helix 460 can be kept constant by moving the body 410 in a distal, outward direction relative to the shaft 420 (retracting the shaft 420 by moving it inward relative to the body 410). By controlling the pitch of the helix 360, 460 by a combination of rotation of the shafts 320, 420 and inward / outward sliding movement, smaller or no gaps between turns and improved electrical contact with the target tissue 364 can be achieved in the deployed position while allowing the electrode to be retracted to a small diameter in the retracted position.

[0076] In some cases, the connection angle between the first and second ends of the electrode strips 340, 440 can be varied by pivoting the ends of the electrode strips 340, 440 with the respective bodies 310, 410 and shafts 320, 420 so that the electrode strips 340, 440 do not buckle when expanded and / or contracted. This variable connection angle can instead allow the helical body 360, 460 to maintain a generally cylindrical outer profile when the shaft 320, 420 moves distally outward or inward relative to the body 310, 410 during respective deployment and retraction.

[0077] In various embodiments, deployment and retraction of the electrode strip 340 may be accomplished by any combination of sliding (eg, axial) movement and / or rotation of the shaft 320 and / or body 310 relative to one another.

[0078] In some embodiments, the shaft 320 and / or the body 310 are slidable (e.g., axially movable) relative to each other for deployment / retraction of the electrode belt 340, while there is no relative rotation between the shaft 320 and the body 310 (e.g., relative rotation is fixed or prevented). For example, the shaft 320 and / or the body 310 may have a keyed or interlocked relationship that prevents relative rotation between the two, such as one of the shaft 320 and / or the body 310 having a groove and the other having a protrusion or key that slides in the groove but prevents or hinders rotation. As another example, the shaft 320 and / or the body 310 may have a corresponding non-circular cross-section (e.g., polygonal, such as a triangle, square, rectangle, parallelogram, pentagon, hexagon, etc.) that prevents or hinders relative rotation. In another example, the shaft 320 and / or the body 310 may be in the form of a spline shaft (e.g., containing ridges or teeth) that allows relative translation but prevents rotation. As another example, the shaft 320 and / or the body 310 can each have a separately actuatable proximal portion (e.g., a handle, etc.) that can be actuated by a user and / or a robotic manipulator when operably coupled to the manipulator. The proximal portions can have the above-mentioned interlocking features to prevent relative rotation, which can be selectively activated.

[0079] In some embodiments, the shaft 320 and / or the body 310 can rotate relative to each other for the electrode belt 340 to be deployed / retracted, without relative translation between the shaft 320 and the body 310 (e.g., relative axial movement is fixed or prevented). For example, the shaft 320 and / or the body 310 may have a mechanical constraint that allows rotation but prevents relative axial movement. As another example, the shaft 320 and / or the body 310 may each have a proximal portion (e.g., a handle, etc.) that can be actuated separately, and when operably coupled to the manipulator, the proximal portion that can be actuated separately can be actuated by a user and / or a robotic manipulator. The proximal portion may have an interlocking feature to prevent relative rotation, and the interlocking feature can be selectively activated.

[0080] In some embodiments, the shaft 320 and / or the body 310 can move in both relative translation and relative rotation for deployment / retraction of the electrode band 340. For example, the shaft 320 and / or the body 310 can move relatively rotationally during a portion of the deployment / retraction and can move relatively translationally during another portion of the deployment / retraction. In such embodiments, the shaft 320 and the body 310 can be coupled by a spiral cam groove arrangement or threaded engagement to coordinate rotational movement and longitudinal movement. For example, the body 310 can include a cam groove and the shaft 320 can include a follower that rides in the cam groove.

[0081] When the electrode device 300 is coupled to a robotic manipulator (eg Figure 2 In embodiments where the system includes a manipulator assembly 102 and receives an actuation force from the manipulator, in some embodiments, translation and rotation may be independently driven by separate actuators. That is, the system may include a first actuator that drives rotation and a second actuator that drives translation. The control system may send signals to the corresponding actuators to drive relative axial movement and / or relative rotation for deployment / contraction of the electrode belt 340. In some examples, the translational degree of freedom and the rotational degree of freedom are independently actuated. During deployment / contraction, both the translational actuator and the rotational actuator may be actuated simultaneously or sequentially to cause deployment and contraction. As an example of sequential actuation, during contraction, the first rotational actuator may be driven to gradually reduce (wind down) the electrode belt 340 to a preset amount (e.g., from full deployment to 20% deployment, or to 15% deployment, or 25% deployment, etc.), then the second translational actuator may be driven to axially stretch the helical body 360 (i.e., change its pitch), and then the first rotational actuator may be driven to gradually reduce the remaining deployment of the electrode belt 340. In some embodiments, the system may include separate actuators for driving translation and rotation, with coupling control between the actuators. That is, the control of each degree of freedom is coupled so that actuating a specific amount of movement of the rotary actuator will cause the translation actuator to move a corresponding length. In some examples, the control system may send a signal to drive axial motion via a translation actuator without driving rotation, or may send a signal to drive rotation via a rotary actuator without driving translation. For example, the control system may send a signal to an actuator for relative axial movement between the drive shaft 320 and the body 310. The control system may optionally send a signal to lock, disengage or otherwise not drive the actuator for relative rotation between the drive shaft 320 and the body 310. Similarly, the control system may send a signal to an actuator for relative rotational movement between the drive shaft 320 and the body 310. The control system may optionally send a signal to lock, disengage or not drive the actuator for relative axial movement between the drive shaft 320 and the body 310.

[0082] In some embodiments, where the electrode instrument 300 is coupled to a robotic manipulator and receives actuation force from the manipulator, one actuator of the manipulator is coupled to drive both translational and rotational movement.

[0083] In some embodiments, the robotic manipulator can infer the diameter of the helix 360 based on an algorithmic model of the electrode treatment device and the amount of rotational actuation and / or translational actuation of the shaft 320 and / or body 310 relative to the other. The amount of rotational movement and / or translational movement can be determined by an encoder on the actuator (one or more), or inferred by the time and rate at which the actuator (one or more) drives the electrode instrument 300. In some embodiments, the electrical contact of the electrode belt 340 with the tissue can be detected by measuring the resistance between the electrodes 380 of the electrode belt 340. In some embodiments, the electrical input to the robotic actuator or the electrical characteristics of the robotic actuator can be monitored to detect the complete deployment of the electrode belt 340 in full apposition with the tissue. For example, the robotic manipulator can monitor the actuator drive torque by measuring the absolute current value (one or more) and / or the rate of change (slope) of the drive current (one or more) during rotation and / or translation of the electrode device. In some embodiments, apposition can be detected by sensing that the actuator is drawing current but not rotating (which can be detected by the encoder on the actuator).

[0084] Fig. 7A , Figure 7B and Figure 7C The steps in the processing technique to address the presence of large gaps 396 between turns of the helix 360 when in the deployed position are schematically illustrated. Fig. 7A A first contact region or treatment region 510 of a helical electrode (not shown but of the same shape as the contact region) is shown, wherein the treatment region is achieved by applying an electrical potential and / or current to the electrode to perform an electrosurgical technique such as electrolysis and / or electroporation. Figure 7B A second contact area or treatment area 520 is shown which overlaps the first contact area or treatment area 510 along its edge. Figure 7C A third contact area or treatment area 530 is shown which overlaps the second contact area or treatment area 520 along its edges. Fig. 7A and Figure 7B between treatment steps and during Figure 7B and Figure 7C Between treatment steps, the electrode strip is retracted, then incrementally advanced along the treatment site a distance less than the helical pitch, and then expanded again to align with the tissue. Figure 7A-7B - Figure 7C In the embodiment shown, each advancement is approximately 1 / 3 of the pitch of the deployed helix.

[0085] Embodiments of the electrode deployment system are shown herein in the context of an electrosurgical electrode instrument 300. However, electrode deployment systems consistent with the disclosed embodiments may be used for purposes of electrical stimulation, electrical sensing, or as part of other instruments or mechanisms for medical use, or as part of instruments or mechanisms for non-medical use.

[0086] Therefore, it should be understood that the exemplary embodiments of the design of the catheter delivery system and the potential clinical applications associated therewith described herein are not intended to be limiting. In addition, it should be understood that any of the above-mentioned embodiments or processes, or specific features associated therewith, may be combined with one or more other embodiments and / or processes, or may be separated and / or performed between separate devices or device parts, according to the present systems, devices, and methods. Finally, the present disclosure is intended to be merely illustrative of the present devices, apparatus, systems, and methods, and should not be interpreted as limiting the appended claims to any particular embodiment or group of embodiments.

[0087] It will be apparent to those skilled in the art that various changes may be made to the details of the above-described embodiments without departing from the basic principles of the invention. Therefore, the scope of the present invention should be determined solely by the appended claims.

Claims

1. An electrode treatment device, comprising: an elongated body having a distal portion terminating in a tip; a shaft rotatably supported by the body and extending beyond the tip of the body; and An electrode band having a first end attached to the distal portion of the body and a second end attached to the shaft at a position distal to the tip of the body, the electrode band being wound around the body and / or the shaft to form a helix, the shaft being rotatable relative to the body in a first direction to radially expand the helix to deploy the electrode band at a treatment site, and the shaft being rotatable relative to the body in a second direction opposite to the first direction to radially contract the helix around the body and / or the shaft to facilitate withdrawal of the electrode band from the treatment site.

2. The electrode therapy device of claim 1, wherein the elongated body comprises a catheter and the shaft extends through the catheter.

3. An electrode therapy device according to claim 1 or 2, wherein the shaft is capable of slidably moving inwardly and distally outwardly relative to the body.

4. The electrode therapy device according to any one of claims 1 to 3, wherein the electrode belt comprises a flexible printed circuit.

5. The electrode therapy device of claim 4, wherein the flexible printed circuit includes a plurality of electrodes formed thereon.

6. The electrode therapy device according to any one of claims 1 to 3, wherein the electrode strip comprises a foil strip.

7. An electrode therapy device according to any of the preceding claims, wherein at least one wire is coupled to the electrode band and extends along the body toward its proximal end.

8. An electrode therapy device according to any one of the preceding claims, wherein the body or the shaft, or both, provides an electrically conductive path to the electrode belt.

9. The electrode therapy device of claim 8, wherein the body or the shaft, or both, have an electrically insulating surface.

10. An electrode therapy device according to any one of the preceding claims, wherein the electrode strip is arranged to leave no gaps between turns of the helix when deployed at the treatment site.

11. An electrode therapy device according to any one of the preceding claims, wherein the electrode band is arranged so that no gaps remain between turns of the helix when the electrode band is retracted around the body and / or the shaft.

12. An electrode therapy device according to any one of the preceding claims, wherein the electrode band is thermoformed or heat treated to restore the shape of the helix when no force is applied to the electrode band via the shaft and / or the body.

13. The electrode therapy device of any of the preceding claims, wherein the shaft comprises a torque tube.

14. The electrode therapy device of any of the preceding claims, wherein the body comprises a torque tube.

15. The electrode therapy device of any of the preceding claims, further comprising a robotic manipulator coupled to the shaft and / or the body.

16. The electrode therapy device of claim 15, wherein the robotic manipulator comprises a rotational actuator for rotating the shaft relative to the body and a translational actuator for axially moving the shaft relative to the body.

17. The electrode therapy device of claim 16, wherein the rotational actuator and the translational actuator are integrated into a single actuator device.

18. The electrode therapy device according to claim 16 or 17, further comprising a control device for independently controlling the rotation actuator and the translation actuator.

19. An electrode therapy device according to any one of claims 16 to 18, wherein a deployment control device detects when the electrode belt is deployed in situ with a target tissue by sensing an electrical input and / or electrical characteristic of at least one of the rotational actuator and the translational actuator.

20. An electrode treatment device, comprising: an elongated body having a distal portion terminating in a tip; a shaft extending from the tip of the body and movable relative to the body; and An electrode band having a first end attached to the distal portion of the body, a second end attached to the shaft at a position distal to the tip of the body, and an intermediate portion between the first and second ends, the electrode band being wound around the shaft or the body, or both, and the shaft being movable relative to the body to move the electrode band between a retracted position in which the electrode band is tightly wound around the shaft or the body, or both, and a maximum expanded position in which the intermediate portion of the electrode band is spaced apart from the shaft and the body, wherein the electrode band has a maximum expansion ratio exceeding 5:

1.

21. The electrode therapy device of claim 20, wherein the elongated body comprises a catheter and the shaft extends through the catheter.

22. An electrode therapy device according to claim 20 or 21, wherein the shaft is rotatable relative to the body.

23. The electrode therapy device of any one of claims 20 to 22, wherein the shaft is slidably movable inwardly and distally outwardly relative to the body.

24. An electrode therapy device according to any one of claims 20 to 23, wherein the electrode strip comprises a flexible printed circuit.

25. The electrode therapy device of claim 24, wherein the flexible printed circuit includes a plurality of electrodes formed thereon.

26. An electrode therapy device according to any one of claims 20 to 23, wherein the electrode strip comprises a foil strip.

27. An electrode therapy device according to any one of claims 20 to 26, wherein at least one wire is coupled to the electrode band and extends along the body towards a proximal end thereof.

28. An electrode therapy device according to any one of claims 20 to 27, wherein the body or the shaft, or both, provides an electrically conductive path to the electrode belt.

29. The electrode therapy device of claim 28, wherein the body or the shaft, or both, have an electrically insulating surface.

30. The electrode therapy device of any one of claims 20 to 29, wherein the shaft comprises a torque tube.

31. The electrode therapy device of any one of claims 20 to 30, wherein the body comprises a torque tube.

32. An electrode therapy device according to any one of claims 20 to 31, wherein the maximum expansion ratio exceeds 10:

1.

33. The electrode therapy device of any one of claims 20 to 31, wherein the expansion ratio is in the range of 5:1 to 30:

1.

34. An electrode therapy device according to any one of claims 20 to 33, wherein the electrode band is helically wound around the shaft or the body or both.

35. An electrode therapy device according to claim 34, wherein the electrode band is thermoformed or heat treated to return to the retracted position of the helix when no force is applied to the electrode band via the shaft and / or the body.

36. The electrode therapy device of any one of claims 20 to 35, further comprising a robotic manipulator coupled to the shaft and / or the body.

37. The electrode therapy device of claim 36, wherein the robotic manipulator comprises a rotational actuator for rotating the shaft relative to the body and a translational actuator for axially moving the shaft relative to the body.

38. The electrode therapy device of claim 37, wherein the rotational actuator and the translational actuator are integrated into a single actuator device.

39. The electrode therapy device according to claim 37 or 38 further comprises a control device for independently controlling the rotation actuator and the translation actuator.

40. An electrode therapy device according to any one of claims 37 to 39, wherein a deployment control device detects when the electrode belt is deployed in situ with a targeted tissue by sensing an electrical input and / or electrical characteristic of at least one of the rotational actuator and the translational actuator.

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