Electrode treatment device with actuatable deployment system and related methods of deployment and treatment

Abstract

An electrode therapy device (300, 600, 700, 800, 900, 902, 1000, 1100, 1200, 1300, 1400, 1400', 1400a, 1400b, 1400c, 1600, 1600', 1800, 1900, 2000, 2100, 2200, 2300, 2400) for treating gastrointestinal tissue or other tissues includes an actuable electrode deployment system (310, 610, 710, 810, 910, 912, 1010, 1110, 1210, 1310, 1410, 1410', 1410a, 1410b, 1410c, 1610, 1610', 1810, 1910, 2010, 2110, 2210, 2310, 2410), the actuable electrode deployment system (310, 610, 710, 810, 910, 912, 1010, 1110, 1210, 1310, 1410, 1410', 1410a, 1410b, 1410c, 1610, 1610', 1810, 1910, 2010, 2110, 2210, 2310, 2410) can be attached to the endoscope (320) and flexible electrodes (366, 666, 766, 1066, 1166, 1266, 1366, 1466, 2466), such as flexible printed circuit strips, can be moved from a collapsed configuration to a deployment configuration in situ with the tissue. When in the retracted configuration, the electrodes are at least partially coiled within the housing (1316, 1416, 1616, 2016, 2116), and the actuating elements (1314, 1414, 1414a, 1414b, 1414c, 1614) are mounted at the proximal end (1306) of the endoscope or anterior to the distal end (328) of the endoscope and at least partially located within the housing. Deployment of the electrodes can be automatically stopped or controlled based on a current drawn by the actuating elements, indicating the mechanical resistance encountered by the electrodes. The electrode treatment system may include shafts (370, 770, 870, 970, 972, 1370, 1470, 2470) that pass through the working channel (372) of the endoscope and are electrically and / or mechanically connected to a controller (14) and / or an actuating element at the proximal end.

Description

Technical Field

[0001] This disclosure generally relates to the field of internal tissue treatment, and more specifically to apparatus and methods for treating targeted tissues by having electrodes capable of being deployed from an endoscope or catheter to ablate / ablate cells. Background Technology

[0002] Tissue within the body can be treated by excision and removal in surgical or medical procedures. While such procedures may be necessary for treating larger lesions or addressing a variety of medical conditions, minimally invasive procedures can also be used as an option in certain situations. These procedures, where applicable, may be more beneficial than more invasive surgical procedures in reducing overall patient risk, damage to surrounding tissues, recovery time, discomfort, and potentially harmful side effects. In minimally invasive tissue ablation, targeted tissue can be treated within the body (e.g., in situ) using procedures that do not involve excision or 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 primary purpose of these ablation procedures is to destroy abnormal tissue in the target area and promote the regrowth of healthy tissue.

[0003] Another known minimally invasive treatment technique involves electroporating a target tissue by applying a local electric field to increase cell membrane permeability, allowing drugs or other chemicals to be delivered into the cells for treatment. Electroporation can also be used in combination with electrolysis, through a process also known as electrolytic electroporation, electroporation-electrolysis, or E2, as a method of tissue ablation.

[0004] Tissue ablation is a treatment procedure used to treat various types of abnormal or damaged tissue, such as abnormal or damaged tissue in the gastrointestinal tract. Damage to intestinal tissue can be caused by several factors, but is often associated with chronic metabolic disorders such as diabetes. In patients with diabetes, damage to gastrointestinal tissue, especially the duodenum, can lead to insulin resistance and / or impaired ability to process glucose. To help improve patient management of this disorder, duodenal mucosal resurfacing (DMR) has been developed to rebuild the intestinal lining and help regenerate a healthy lining, thereby improving nutrient absorption in the duodenum. Improved intestinal lining health helps correct absorption problems and can lead to better insulin responses, which in turn allows some patients to use oral medications instead of more aggressive insulin therapies (e.g., injections) to help control their condition.

[0005] In general, DMR is a procedure involving the insertion of a catheter (or other suitable medical device) into the duodenum, typically under endoscopic guidance, and the ablation of the duodenal lining. However, various ablation techniques and ablation device designs may not be well-suited for endoscopic ablation, or may make it difficult to control the desired depth of ablation by application from within the duodenal lumen.

[0006] 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 tissues, such as gastrointestinal tissue. Summary of the Invention

[0007] An electrode deployment system attachable to an endoscope includes an actuable electrode deployment mechanism that moves a flexible electrode from a retracted configuration to a deployment configuration that is in apposition to tissue to be treated by electrolysis and / or electroporation, or to apply other or additional energy waveforms using the electrode, or for sensing. The system is particularly suitable for duodenal mucosal resurfacing (DMR). An actuating element (such as an electric motor) of the electrode deployment mechanism may be at least partially housed within a housing located distal to the endoscope, and when in the retracted configuration, an electrode array may be at least partially coiled within the housing. The actuating element may be activated to rotatably drive a portion of the mechanism, thereby unfurling and furling the flexible electrode between the retracted and deployment configurations. The deployment of the electrodes can be performed automatically or semi-automatically by sensing the current drawn by the actuating element during operation and automatically shutting off the actuating element in response to the current exceeding a predetermined threshold indicating mechanical resistance encountered by the electrodes in contact with the tissue. Further, incremental extension of the electrodes can be selectively initiated, for example, by manually pressing a button on a controller. Embodiments of the deployment mechanism can be tightly integrated with an endoscope to achieve a relatively small overall profile, thereby enhancing maneuverability.

[0008] In some embodiments, the electrode deployment mechanism and its actuating elements may be mounted anterior to the distal end of the endoscope and may be positioned off-center from the endoscope to provide enhanced visibility of the electrodes and the tissue treatment site during deployment and retraction. The system may include a shaft attached to the deployment mechanism, the shaft passing through a distal opening of a working channel at the distal end of the endoscope. After the shaft passes through the working channel of the endoscope, the proximal end of the shaft may be connected to a handle or robotic manipulator, and an electrical connector at the proximal end of the shaft is capable of connecting to a mating electrical connector power-coupled to the system.

[0009] In other embodiments, the electrode deployment mechanism may be mounted anterior to the distal end of the endoscope and driven by an actuating element mounted proximally on the endoscope, for example via a drive shaft passing through the working channel of the endoscope and coupling the electrode deployment mechanism to the actuating element to achieve mechanical power transmission from the actuating element to the electrode deployment mechanism. For example, the shaft may be rotatably driven by the actuating element. In another example, the shaft may be hollow and may serve as a conduit for transmitting hydraulic or pneumatic fluid from the actuating element through the shaft to the electrode deployment mechanism to achieve hydraulic or pneumatic actuation.

[0010] Subsystems for cleaning and rinsing may also be included in the electrode therapy system disclosed herein.

[0011] Other aspects and advantages will become apparent from the following detailed description of preferred embodiments with reference to the accompanying drawings. Attached Figure Description

[0012] The accompanying drawings depict only a few examples according to this disclosure and should not be considered as limiting the scope. Exemplary embodiments will be described with additional specificity and detail using the accompanying drawings, in which: Figure 1 This is a schematic diagram of an electroporation and / or electrolysis system based on the examples described herein.

[0013] Figure 2 This is a schematic diagram of a robot-assisted manipulator system based on the example described in this article.

[0014] Figure 3A This is a schematic diagram of an instrument system based on the example described in this article.

[0015] Figure 3B Show Figure 3A The instrument system has a distal portion of an extended example of the instrument described herein.

[0016] Figure 4 This is a left anterior isometric view of an electrode therapy device consistent with embodiments of this disclosure, wherein the endoscope, drive shaft, and electrical connection tab of the electrode therapy device are shown as truncated at the left rear side of the figure. Figure 4 In the image, the electrode strips of the electrode therapy device are shown in a retracted configuration.

[0017] Figure 5A It is along Figure 4 The line cut from 5A-5A Figure 4 A longitudinal cross-sectional view of the electrode therapy device.

[0018] Figure 5B It is along Figure 4 The line 5B-5B cut Figure 4 A cross-sectional view of the electrode deployment system of the electrode therapy device, with the endoscope omitted.

[0019] Figure 6 yes Figure 4 The left rear isometric view of the electrode therapy device shows the electrode strips of the electrode therapy device in the deployment configuration.

[0020] Figure 7 It is along Figure 6 The line 7-7 was cut Figure 4 A cross-sectional view of the electrode therapy device, showing the electrode strips in a deployment configuration.

[0021] Figure 8A and Figure 8B It is along Figure 6 The line cut from 8-8 Figure 4 A cross-sectional end view of the electrode therapy device, schematically showing the electrode strips in the retracted and deployed configurations, respectively.

[0022] Figure 9 yes Figures 4-7 and Figure 10 A layout view of an exemplary electrode strip of an electrode therapy device.

[0023] Figure 10 This is an isometric view of an electrode treatment device and an electrode deployment system according to an embodiment of the present disclosure, wherein the first and second components of the electrode deployment system are formed with a frame and a window to allow the endoscope to view the tissue treatment site.

[0024] Figure 11 This is an isometric view of an electrode treatment device and an electrode deployment system according to an embodiment of the present disclosure, wherein the electrode winding mechanism of the electrode deployment system is eccentrically positioned distal to the endoscope to which it is attached.

[0025] Figure 12 It is along Figure 11 The line 12-12 in the middle is cut off Figure 11 A cross-sectional view of the electrode therapy device.

[0026] Figure 13A and Figure 13B yes Figures 11-12 A partial assembly view of the electrode winding mechanism and electrode strips of the electrode therapy device, showing the retracted configuration and the deployed configuration, respectively.

[0027] Figure 14The photograph was taken by an optical imaging system of an electrode therapy device consistent with embodiments of the present disclosure, with the electrode therapy device inserted into the gastrointestinal tract.

[0028] Figure 15 This is a side view of an electrode therapy device according to one embodiment, wherein the electrode coiling mechanism of the device is angled relative to the longitudinal axis of the endoscope.

[0029] Figure 16A This is an isometric view of an electrode treatment device according to one embodiment, wherein an electrode deployment system is eccentrically positioned distal to an endoscope to which it is attached, and wherein the drive shaft of the electrode deployment system extends through the working channel of the endoscope.

[0030] Figure 16B This is an isometric view of an electrode therapy device according to one embodiment, wherein the electrode deployment system is offsetly positioned distal to the endoscope to which it is attached and at an angle relative to the longitudinal axis of the endoscope, and wherein the drive shaft of the electrode deployment system extends through the working channel of the endoscope. Figure 17 This is an isometric view of an electrode therapy device, which includes an electrode deployment system supported on an endoscope and includes electrode strips coiled around an inflatable bladder.

[0031] Figure 18 yes Figure 17 An isometric view of an electrode therapy device, in which electrode strips and expandable bladders are shown in an expanded and deployed configuration.

[0032] Figure 19A and Figure 19B This is a photograph of one embodiment of an expandable electrode deployment system, which includes electrodes having a braided sleeve surrounding an expandable bladder-like component, shown in a stowed configuration and a deployed configuration, respectively.

[0033] Figure 20 This is a side view schematic diagram of an electrode therapy device, which includes an expandable electrode deployment system surrounding the distal portion of an endoscope.

[0034] Figure 21A and Figure 21B This is an isometric view of an electrode therapy device according to one embodiment, wherein the electrodes of the electrode therapy device are shown in a retracted configuration and a deployed configuration, respectively.

[0035] Figure 21C yes Figure 21A A longitudinal cross-sectional view of the electrode therapy device shows the electrically actuated elements within the electrode deployment mechanism of the device, and the electrodes of the device in a retracted configuration.

[0036] Figure 22 According to one embodiment Figure 21A , Figure 21B and Figure 21C An isometric view of an electrode therapy device, wherein the electrode therapy device is positioned distal to the distal end of an endoscope and attached to the endoscope via a control axis extending through the working channel of the endoscope, wherein the electrodes of the electrode therapy device are in a retracted configuration.

[0037] Figure 23 yes Figure 22 An isometric view of the electrode therapy device, showing its electrodes uncoiled and laterally extended into the deployment configuration.

[0038] Figure 24 yes Figure 22 A longitudinal cross-sectional view of the electrode therapy device.

[0039] Figure 25 yes Figure 22 A longitudinal cross-sectional view of the control shaft and proximal portion of the handle of the electrode therapy device, showing details of the electrical connector.

[0040] Figure 26 This is a side view of an electrode therapy device according to another embodiment.

[0041] Figure 27 yes Figure 26 A longitudinal cross-sectional view of the electrode therapy device.

[0042] Figure 28 yes Figure 26 The partial exploded view of the electrode therapy device shows the details of the electrode deployment mechanism of the electrode therapy device.

[0043] Figure 29A It is along Figure 27 The line 29A-29A is cut off. Figure 26 An enlarged cross-sectional view of the electrode therapy device shows details of the planetary gear set of the electrode deployment mechanism.

[0044] Figure 29B yes Figure 26 Enlarged detail of the planetary gear set of the electrode deployment mechanism of the electrode therapy device, with the end cap and external first component omitted to show certain features in more detail.

[0045] Figure 30 It is a longitudinal cross-sectional view of an electrode therapy device having an electrode deployment mechanism without a planetary gear set.

[0046] Figure 31 yes Figures 26-30The image shows a side view of an electrode therapy device of the type shown, wherein the actuating element is positioned within the electrode deployment mechanism of the device.

[0047] Figure 32 This is a side view of an electrode therapy device, in which the actuating element is positioned proximally adjacent to the electrode deployment mechanism of the device.

[0048] Figure 33 This is a side view of an electrode therapy device, in which the actuating element is positioned distally adjacent to the electrode deployment mechanism of the device.

[0049] Figure 34 It is a longitudinal cross-sectional view of an electrode treatment device with an actuating element positioned at the proximal end of the device and coupled to an electrode deployment mechanism at the distal end of the device via a drive shaft extending through the working channel of the endoscope.

[0050] Figure 35 It is a longitudinal cross-sectional view of an electrode therapy device with an actuating element and a shaft, the actuating element being positioned at the proximal end of the device, and the shaft coupling the actuating element to the mechanical power transmission within an electrode deployment mechanism at the distal end of the device.

[0051] Figure 36 yes Figure 28 An isometric proximal view of the internal second component of the electrode deployment mechanism shows details of the electrode mounting channel with a textured adhesive surface.

[0052] Figure 37 yes Figure 36 An isometric distal view of the second component, showing the opposite side of the second component.

[0053] Figure 38 yes Figure 36 A side view of the second component, wherein the electrode strip is fixed thereto via the electrode mounting channel of the second component.

[0054] Figure 39 This is a bottom view of the end of the electrode strip, showing the roughened bottom surface used to improve the adhesive connection between the electrode strip and the electrode deployment mechanism.

[0055] Figure 40 yes Figure 28 A view of the external first component and end cap of the electrode deployment mechanism, showing the mating features used to align and mechanically couple the end cap to the first component.

[0056] Figure 41A yes Figures 36-37An exploded assembly view of the second component and the drive shaft shows details of the keyed coupling structure, which is used to transfer rotational force from the drive shaft to the second component and provides good tensile strength in the coupling structure.

[0057] Figure 41B yes Figure 41A An enlarged, tilted, distal view of the second component reveals internal details of the key-lock coupling features.

[0058] Figure 42 This is an isometric view of one embodiment of an electrode therapy device, which includes a cleaning brush lined in a slot within the electrode therapy device, with the electrode strips of the device omitted to show details of the cleaning brush.

[0059] Figure 43 This is an isometric view of one embodiment of an electrode therapy device, which includes a wiper lined with a slot in the electrode therapy device, wherein the electrode strips of the device are omitted to show details of the wiper.

[0060] Figure 44 This is one embodiment of an electrode therapy device, in which the electrode strips of the device are omitted, and arrows indicate that fluid for cleaning the electrodes or rinsing tissue flows outward from the side of the electrode therapy device.

[0061] Figure 45 yes Figure 44 A longitudinal cross-sectional view of an electrode therapy device, showing the fluid flow path through the axis of the device according to one embodiment.

[0062] Figure 46 This is a longitudinal cross-sectional view of an electrode therapy device according to one embodiment, wherein fluid is delivered via a secondary hose or tube laterally adjacent to the axis.

[0063] Figure 47 This is a visual view of one embodiment of an electrode therapy device, which includes a flushing nozzle for radially outward jetting fluid toward a target tissue.

[0064] Figure 48 This is a view of another embodiment of an electrode therapy device, which has a flushing nozzle and a deflector for longitudinally guiding fluid jets along the side of the device.

[0065] Figure 49 This is a view of another embodiment of an electrode therapy device, which includes a means for reading instructions such as... Figure 50 The indicator features a scale indicating the diameter of the deployed electrodes.

[0066] Figure 50 It comes from Figure 49 The illustration shows a video display of an endoscope of an electrode therapy device in use, with the electrode strips deployed. It displays the scale on the inside of the electrode strips and an indicator on the housing of the therapy device for reading the diameter of the deployed electrode strips.

[0067] Figure 51 According to one embodiment Figure 49 and Figure 50 The layout view of the electrode strips shows details of the scales printed on them. Specific Implementation This disclosure relates to devices and systems for the controlled delivery of one or more flexible electrodes to a target tissue site for therapeutic purposes, such as ablation via electroporation and / or electrolysis, or for other purposes. Generally, a method for minimally invasive regenerative surgery is disclosed, comprising subjecting a target area in living tissue to ablation delivered via one or more electrodes. In some examples, the ablation energy may be in the form of a combination of one or more electric fields and electrolysis. However, it should be understood that the example systems and methods described herein can be used to deploy flexible substrates for delivering electrodes employing ablation modalities other than electroporation and / or electrolysis (e.g., radiofrequency ablation), or for purposes other than ablation, such as electrical stimulation or diagnostic methods.

[0069] In example procedures employing electroporation and electrolysis, electrodes (one or more) are brought close to and / or in contact with the target tissue, and an electric field is generated by applying a voltage and / or current between the electrodes. An electric field of sufficient magnitude can be generated to permeate the area of ​​the cell membrane to be ablated. The generated electric field may produce a quantity of electrolytic products that, in themselves, do not damage the cells or extracellular matrix located within and around the target treatment area. However, when sufficient electrolytic products are generated in the permeated cellular area, cell death occurs within the area where the electric field is applied without damaging the extracellular matrix or scaffolding, thereby contributing to promoting tissue regeneration in the treated tissue area.

[0070] In some examples, after ablation energy is applied to a target area, the electrodes (one or more) can be moved to other tissue locations by advancing and / or retracting the delivery catheter and repeating this process. In this way, electroporation and electrolysis can be performed at multiple sites within the patient, thereby covering a larger area of ​​tissue. In some examples, multiple sets of electrodes can be positioned at multiple corresponding tissue sites, allowing electroporation and / or electrolysis to be performed in parallel at various sites, thereby reducing and / or eliminating the need to repeat the procedure as the catheter moves through the patient.

[0071] In some embodiments of this disclosure, the systems and methods disclosed herein can be used to treat gastrointestinal tissues. In other embodiments, the systems and methods described herein can be used to treat any of a variety of other tissues. Generally, tissues can be treated when tissue regeneration is required or when one type of cell needs to be replaced by another. Examples include the intestine, duodenum, stomach, bladder, uterus, endometrial lining, ovary, colon, rectum, sinus, duct, ureter, prostate, skin, muscle, nerve, diaphragm, momentum, kidney, follicle, brain, lymphatic vessels, breast, esophagus, lung, liver, kidney, lymph nodes, lymph node basins, and / or heart. Replacement of one type of tissue with another can occur in fibrotic areas (where fibrotic cells need to be replaced with stem cells capable of readjusting the region) or when islets of Langerhans are injected into a portion of the liver to generate a new source of insulin. In other examples, other tissues can be treated. Additional details related to example procedures for electroporation and / or electrolysis for tissue treatment according to some embodiments are provided below.

[0072] As described above, electroporation can be performed to permeate the cell membrane of a target cell. Reversible electroporation can be employed, in which permeation can be stopped upon removal of the electric field. Cells can survive in reversible electroporation as the pores within the membrane reseal and homeostasis is restored. In irreversible electroporation, permeation of the cell membrane is permanent, leading to cell death. Generally, for biological tissues, electric fields below about 1500 V / cm to about 200 V / cm are considered to produce reversible electroporation, while electric fields above about 1500 V / cm are considered to produce irreversible electroporation. Examples of the systems and methods described herein utilize reversible electroporation to avoid the disadvantages 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 induced by the large electric field. It should be understood that although the systems and methods described herein can be designed to utilize reversible electroporation, there may also be locations or regions where conditions allow irreversible electroporation, or even thermal ablation, to occur in a limited portion of the treated tissue.

[0073] In some therapeutic procedures, electrolytes can be used to permeate cells to induce cell death within the applied electric field while maintaining the integrity of the permeable cell's extracellular matrix. The extracellular matrix generally refers to a three-dimensional network of proteins and / or other molecules (e.g., collagen fibers, proteoglycans, and / or proteins such as fibronectin and / or laminin) that provides structure for cells and tissues and also provides signaling for cell growth and development. The extracellular matrix can be used as a scaffold for tissue regeneration and / or engineering. For example, cells can be regenerated, grown, transplanted, or otherwise cultured on the extracellular matrix. Cell regeneration and / or tissue engineering can occur in the ablated cellular region by retaining the extracellular matrix within it, as described herein. In some procedures, the extracellular matrix can be transplanted from one ablated cellular region to another region (which may be another region of ablated cells) to promote regeneration and / or tissue engineering in the transplanted region. In some cases, materials can be injected into the extracellular matrix once it is present to enhance regrowth.

[0074] The example systems and methods described herein utilize electrolytic products and electroporation to induce cell death, thereby permeating cell membranes. The electrolytic products are sufficient to ablate (e.g., induce cell death) permeable cells within a relatively short timeframe. However, the concentration and exposure time of the electrolytic products are insufficient to induce cell death in unpermeable cells, thus minimizing or avoiding the formation of scar tissue, fibrosis, or ulceration 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 inhibited. Therefore, the electrolytic products are used only to ablate permeable cells while maintaining the integrity of the extracellular matrix to promote tissue regeneration. Electrolytic products may include cytotoxic products. Electrolysis preferentially employs one or more inert electrodes that do not participate in the electrolysis process, in addition to acting as a source or sink of electrons or as a catalyst. When non-inert electrodes are used in this process, they can generate metal ions, which can cause systemic damage to the body, such as excess iron or even metal fragments.

[0075] Examples of the devices and systems disclosed herein include one or more electrodes, a power source, and a controller to apply energy for the treatment of internal tissue. The applied energy may be used for electrolysis and / or electroporation in some examples, for radiofrequency ablation in others, and for other energy modes in still others. When the energy is for electroporation in the presence or absence of electrolysis, the controller controls the charge delivered to the electrodes(one or more) to induce one or more electric fields. In cases involving both electroporation and electrolysis, the electrodes(one or more) are used to generate a current to produce an electrolytic product and to generate a voltage difference to produce an electric field that induces electroporation. The duration and magnitude of the applied charge and current determine the dose of the electrolytic product and the degree of cell permeation at the treatment site. Therefore, the cell ablation zone can be determined by the area where cells are exposed to a combination of permeation and electrolytic products that induce ablation. However, ablation can maintain the integrity of the extracellular matrix in the ablated cell region where an electric field has been applied. The composition of the electrodes(one or more) can be selected based on the desired product and electroporation effect.

[0076] refer to Figure 1 The following provides a brief overview of example systems for delivering electrode-bearing catheters to target tissue sites for treatment via electroporation and / or electrolysis. For clarity, the written descriptions and associated drawings of the various example embodiments generally relate to the use of catheters 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.

[0077] Figure 1 This is a schematic diagram of a system 10 arranged according to the exemplary embodiments described herein. Generally, the exemplary system described herein may include a conveying system and a controller. Figure 1 In this example, system 10 includes a power supply 12 coupled to controller 14, and conduit 40. Examples of other suitable conduits that can be used with system 10 are referenced below. Figures 4-20 This can be described in further detail. (See reference) Figure 1 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 in some examples. Additional, fewer, and / or different components may be used in other examples. The computer-readable medium 18 includes executable instructions 20 for regulating the output of the power supply 12 to induce electroporation and electrolysis using the conduit 40, and may include stored parameters 22 that can be used during the induction of 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, the circle drawn around one end of the conduit 40 can indicate a cellular region that can be permeated by an applied electric field.

[0078] Controller 14 may be implemented using a computing device. Examples of computing devices include controllers, microcontrollers, computers, servers, medical devices, smartphones, tablets, wearable devices, etc. The computing device may be handheld and may also have other uses. Controller 14 may include one or more processors, such as processor 16. Any type or number of processors may be present, including one or more central processing units (CPUs) or graphics processing units (GPUs) having any number of cores, controllers, microcontrollers, and / or custom circuitry, such as one or more application-specific integrated circuits (ASICs) and / or field-programmable gate arrays (FPGAs).

[0079] The controller 14 described herein may include a computer-readable medium 18, such as 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 in Figure 1 A single box is depicted as computer-readable medium 18, but any number of computer-readable medium 18 devices may exist. Computer-readable medium 18 may communicate with processor 16 (e.g., be electrically connected to processor 16).

[0080] The executable instructions 20 for electroporation and electrolysis may include instructions to control the charge delivered to an electrode (such as electrode 50 of catheter 40). Thus, controller 14 may sense a voltage difference across the target tissue, thereby generating an electric field that causes permeation of cells in the treatment target tissue region. Electrode 50 is shown positioned within a cavity 32 (such as a lumen) formed within tissue 30. Although catheter 40 is shown positioned within cavity 32 of tissue 30, catheter 40 may be on the surface of tissue 30, inside tissue 30, and / or close to tissue 30. Furthermore, although catheter 40 is shown for delivering and positioning electrode 50 to permeate and / or generate electrolytic products to treat tissue 30, other suitable delivery systems may be used in other embodiments.

[0081] Controller, such as Figure 1The 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 mode of activated electrodes 50 (e.g., sequentially activating electrode pairs) to shape or deliver a specific electric field. In some examples, a fluid or other substance may be injected into, contacted with, or otherwise placed in or around tissue 30 to help shape the electric field generated in tissue 30. For example, a conductive fluid may help shape the field (e.g., by spreading 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 tissue to protect areas that do not require ablation. The electric field may not penetrate and / or pass through the non-conductive fluid, such that the field does not reach tissue that does not require ablation, or at least is insufficient in intensity to cause permeation or other cellular changes.

[0082] The controller 14 can also be used to sense current passing through tissue 30, such as between electrodes 50, thereby generating electrolytic products. These electrolytic products can cause ablation of permeable cells, but preferably are insufficient to destroy the extracellular matrix in the permeable cell region. As previously described, the remaining intact extracellular matrix allows for tissue regeneration and tissue engineering.

[0083] In some embodiments, one or more of the electrodes 50 used to apply electroporation may also be used to generate electrolytic products (in other words, some or all of the electrodes may be used for both electroporation and electrolysis). In other embodiments, the first subset electrode 50 used to apply electroporation may be different from the second subset electrode 50 used to generate electrolytic products.

[0084] In some embodiments, power supply 12 is integrated with controller 14. Power supply 12 can be implemented using any suitable power source, such as one or more AC power supplies, DC power supplies, batteries, and / or waveform generators. Power supply 12 can supply power to electrode 50 to generate voltage and / or current, and thus generate electric fields and / or electrolytic products in tissue 30. In some examples, power supply 12 can be implemented using a signal generator, such as an exponentially decaying wave generator.

[0085] The controller 14 can control the timing, intensity, and duration of the electric field and / or electrolytic products provided via the catheter 40. The controller 14 can, for example, be programmed to provide electrical signals to the catheter 40 via a power source 12, wherein the electrical signals can indicate a therapeutic dose, such as the dose of the electrolytic products and / or the permeability level of the cells. The electrical signals can control the timing and magnitude of the generated electric field, which allows a user to customize treatment of the tissue 30 as needed. In some embodiments, the controller 14 may include such a program, or include one or more processing devices (e.g., processors) coupled to a computer-readable medium 18 encoded with electrolysis and permeation executable instructions 20. Although in Figure 1 While shown as a separate component coupled to catheter 40, in some embodiments, controller 14 may be integrated as part of catheter 40. In other embodiments, controller 14 may include programmable circuitry coupled to catheter 40 via a wired or wireless connection.

[0086] As previously described, system 10 may include any suitable parameters 22 for controlling various aspects of the electroporation and electrolysis processes, such as electric field strength, voltage level, current level, waveform shape, exposure duration parameters, and any other suitable parameters. Parameters 22 may be stored in computer-readable medium 18 or in another suitable database in communication with controller 14. In some embodiments, controller 14 may be used to calculate parameters 22, or controller 14 may communicate with other systems operable to calculate parameters 22.

[0087] In some example embodiments, parameters 22 of a specific treatment regimen can be determined based on measurements taken in the tissue of interest or from different samples of similar tissues. For example, measurements can be taken at various voltage levels with specific electrode configurations, and target voltage levels, currents, pulse patterns, time constants, and other factors that lead to reversible electroporation and the delivery of electrolysis products, thereby inducing cell death in permeable cells as desired.

[0088] In some embodiments, examples of the parameter 22 that can be used include the delivery of 1 to 50 voltage pulses between 50 V and 1000 V. Those pulses can have a voltage range of 50 V. F and 1000 The capacitance between capacitors F and the resistance between 0 ohms and 100 ohms is transferred in the system. The amount of electrolytic product produced can be related to the transferred charge in coulombs. There are several ways to calculate the transferred charge. For example, the charge Q (in coulombs) stored in a capacitor is equal to the product of the capacitor's capacitance C (in farads) and the voltage V (in volts) between its terminals. That is, Q = C·V. Furthermore, charge is the product of current I (in amperes) and time t (in seconds). That is, I·t = Q. By defining capacitance and the voltage across the capacitor, charge can be defined, and electrolytic performance can be determined accordingly. When a capacitor discharges, it produces a current, and the current multiplied by time must equal the charge in the capacitor. When a capacitor is positively discharging, the current is not constant—it decays exponentially. Therefore, the time measure is given as an exponentially decaying time constant. The capacitance controlling the time constant is usually determined by the capacitor connected in parallel to the power source (e.g., Figure 1 The capacitor in power supply 12) is obtained.

[0089] In some embodiments, the time constant (e.g., the exponential decay time constant of capacitor discharge) can range from 50 microseconds (μs) to 50 milliseconds (ms). Generally, the lower limit of the time constant relates to the time sufficient to ensure that the electrolyte (e.g., electrolyte products) permeates the target region of the permeable cell. The upper limit of the time constant generally relates to the generation of the electrolyte (e.g., electrolyte products) that itself can cause ablation. Therefore, electrolysis is generally targeted to allow sufficient time for the electrolyte products to diffuse through the permeable cell region. However, the amount of time provided for electrolysis should be limited to ensure that the process does not lead to the ablation of unpermeable cells or otherwise damage the extracellular matrix in the ablated cell region.

[0090] In some embodiments, the generated electric field 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 still 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.

[0091] System 10 may further 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 tissue 30 to optimize treatment. For example, in one embodiment, a pH sensor may be integrated with system 10. The pH sensor may be arranged in any of several configurations, such as being coupled to a conduit 40 adjacent to electrode 50 to detect pH values ​​near electrode 50. In another embodiment, the pH sensor may be provided at the outer edge of the targeted tissue region. In any configuration, the pH sensor may communicate with controller 14, which may utilize one or more received pH values ​​as an indication of tissue ablation and / or monitor the occurrence of tissue damage based on pH levels detected at the treatment site and around the tissue region. In some embodiments, 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 tissue located outside the treatment site is at or above a threshold for tissue damage, 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 the tissue in the target area is at or above the threshold for tissue ablation, the controller 14 may immediately and / or stop applying current through the electrodes after the required elapsed electrolysis time to stop the electrolysis process.

[0092] In some embodiments, a resistivity meter can be used to determine the resistance of a target tissue. For example, Figure 1 The controller 14 and / or power supply 12 can provide impedance measurements. Impedance measurements determine the resistivity of the tissue 30 in contact with the electrodes 50 of the system 10. For example, the controller 14 and / or power supply 12 can provide a nominal amount of current (such as DC current) through the tissue 30 and receive resistivity measurements 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, the number of pulses of applied voltage can be selected, determined, and / or otherwise used based on the measured resistance of the tissue.

[0093] In some embodiments, sensors for detecting and / or determining the electric field strength, such as gaussmeters and / or teslameters, may also be used. In such embodiments, the sensors may be operatively communicated with controller 14 to ensure that the electric field strength is maintained at the target level for the desired treatment regimen.

[0094] In some embodiments, an ablation device for delivering electrolytic electroporation (e.g., Figure 1The conduit 40 can be delivered via a computer-aided remote manipulator system, sometimes referred to as a robot-assisted system or a robotic system. The manipulator system includes one or more manipulators that are capable of operating 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 example embodiment of a robot-assisted manipulator system 100 for use with the systems and methods described herein is shown. The manipulator system can be used for, for example, surgical, diagnostic, therapeutic, biopsy, or non-medical procedures.

[0095] refer to Figure 2 The robot-assisted manipulator system 100 may include one or more manipulator components 102 for operating one or more medical device systems 104 while performing various procedures on a patient P positioned on a table T in a medical environment 101. For example, the manipulator component 102 may drive the movement of a catheter or end effector, apply treatment to target tissue, and / or manipulate control members. The manipulator component 102 may be a remotely operated, non-remotely operated, or hybrid remotely and non-remotely operated component, having selectable degrees of freedom of motion that are maneuverable and / or remotely operated, as well as selectable degrees of freedom of motion that are non-maneuverable and / or non-remotely operated. An operator input system 106, which may be located inside or outside the medical environment 101, generally includes one or more control devices for controlling the manipulator component 102. The manipulator component 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 the 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 opening. Other drive systems enable the distal end of the medical device system 104 to move in multiple degrees of freedom, which may include three linear degrees of motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three rotational degrees of motion (e.g., rotation about the X, Y, Z Cartesian axes). The manipulator assembly 102 may support a variety of 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.

[0096] The robot-assisted manipulator system 100 also includes a display system 110 for displaying images or representations of the surgical site and medical device system 104 generated by imaging system 109, which may include an imaging system such as an endoscopic imaging system. The display system 110 and operator input system 106 may be configured to enable operator O to control the medical device system 104 and operator input system 106 using telepresent perception. A graphical user interface may be displayed on the display system 110 and / or the display system of a stand-alone planning workstation.

[0097] In some examples, the endoscopic imaging system components of imaging system 109 may be integrally or detachably coupled to medical device system 104. However, in some examples, a separate imaging device (such as an endoscope) attached to a separate manipulator assembly may be used in conjunction with medical device system 104 to image the surgical site. Endoscopic imaging system 109 may be implemented as hardware, firmware, software, or a combination thereof, which interact with or are otherwise executed by one or more computer processors—which may include the processor of control system 112.

[0098] The robot-assisted manipulator system 100 may also include a sensor system 108. The sensor system 108 may include an orientation / position sensor system (e.g., an actuator encoder or electromagnetic (EM) sensor system) and / or a shape sensor system (e.g., a fiber optic shape sensor) for determining the orientation, orientation, velocity, rate, attitude, and / or shape of the medical device system 104. The sensor system 108 may also include temperature, pressure, force, or contact sensors, etc.

[0099] 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 controlling 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 the instructions) to implement programs using the robot-assisted manipulator system, including navigation, steering, imaging, deployment or retraction of engagement features, application of treatment to target tissue (e.g., via energy application), etc.

[0100] The control system 112 may optionally further include a virtual visualization system to provide navigational 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 a reference to a preoperative or intraoperative dataset of the acquired anatomical access. The virtual visualization system processes images of the surgical site imaged using imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluorescein 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 preoperative images to locate target tissue (using visual imaging techniques and / or by receiving user input) and create a preoperative plan, including an optimal first location for performing the treatment. The preoperative plan may include, for example, a plan size for extending the scalable device, treatment duration, treatment temperature, and / or multiple deployment locations.

[0101] Figure 3A A medical device system 200 is illustrated according to some example embodiments. The medical device system 200 can be used in image-guided medical procedures. In some embodiments, the medical device system 200 can be used in non-remotely operated exploratory procedures or procedures involving conventionally manually operated medical instruments, such as endoscopy. In other embodiments, the medical device system 200 is associated with… Figure 2 The medical device system 104 is interchangeable or a variant thereof.

[0102] Medical device system 200 includes an elongated flexible device 202, such as a flexible catheter, endoscope (e.g., gastroscope, bronchoscope, duodenoscope), or other suitable device coupled to 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 ranging from about 6 mm to about 20 mm, or preferably from about 9 mm to about 16 mm. Other embodiments of the flexible body 216 may have a larger or smaller outer diameter. When the flexible body 216 is inserted into a patient's mouth or nasal cavity, the flexible body 216 may have an appropriate length to reach portions of anatomical structures, such as the lungs, sinuses, larynx, or upper or lower gastrointestinal regions.

[0103] The medical device system 200 optionally includes a tracking system 230 for determining the orientation, velocity, rate, attitude, 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 flexible body 216 can be effectively divided into segments 224 along its entire length between the distal portion 218 and the proximal portion 217. The tracking system 230 may optionally be implemented as hardware, firmware, software, or a combination thereof, with one or more computer processors—including… Figure 2 The processor of the control system 112 in the system—interacts with or otherwise executes by it.

[0104] Tracking system 230 may optionally track one or more of distal portions 218 and / or segments 224 using shape sensor 222. In some embodiments, tracking system 230 may optionally and / or additionally use orientation sensor system 220 (such as an electromagnetic (EM) sensor system) to track distal portion 218. In some examples, orientation sensor system 220 may be configured and positioned to measure six degrees of freedom (e.g., three azimuth coordinates X, Y, and Z and three orientation angles indicating pitch, yaw, and roll of a reference point) or five degrees of freedom (e.g., three azimuth coordinates X, Y, and Z and two orientation angles indicating pitch and yaw of a reference point).

[0105] The flexible body 216 includes one or more channels (e.g., pathways or ports) that are sized and shaped to receive one or more medical devices 226. In some embodiments, the flexible body 216 includes two channels 221 for a single device 226; however, a different number of channels 221 may be provided. Figure 3BThis is a simplified diagram of an end portion of a flexible body 216 according to some embodiments, from which a medical device 226 extends outward. In some embodiments, the medical device 226 may be used for procedures and aspects thereof, such as surgery, biopsy, ablation, mapping / drawing, imaging, illumination, irrigation, or aspiration. The medical device 226 may be deployed through channels 221 of the flexible body 216 and used at a target location within an anatomical structure. In other embodiments, the medical device may be integrated with the flexible body 216 rather than being received in or deployed through channels of the flexible body 216. The medical device 226 may include, for example, an image capturing device, a biopsy instrument, ablation instrument, catheter, laser ablation fiber, and / or other surgical, diagnostic, or therapeutic tool. Medical tools may include end effectors having a single working component such as a scalpel, blunt blade, lens, fiber optic cable, electrode, and / or the like. Other end effectors may include, for example, forceps, clamps, balloons, needles, scissors, clamp applicators, and / or the like. Other end effectors may further include electrically activated end effectors, such as electrosurgical electrodes, expandable ablation components, transducers, sensors, imaging devices, and / or the like. Medical device 226 may be advanced from an opening in channel 221 to perform a procedure (e.g., electroporation and / or electrolysis in this disclosure) and then retracted into channel 221 upon completion of the procedure. Medical device 226 may be removed from the proximal portion 217 of flexible body 216 or from another optional device port (not shown) along flexible body 216. Medical device 226 may be used in conjunction with an image capturing device (e.g., an endoscope camera) also located within elongated flexible device 202. Alternatively, medical device 226 itself may be an image capturing device.

[0106] Medical device 226 may additionally accommodate cables, linkages, or other actuation controls (not shown) extending between its proximal portion 217 and distal portion 218, thereby controllably bending the distal portion 218 of medical device 226. Flexible body 216 may also accommodate cables, linkages, or other steering controls (not shown) extending between drive unit 204 and distal portion 218, thereby controllably bending the distal portion 218, as illustrated by dashed line 219 of distal portion 218. In some examples, at least four cables are used to provide independent "up / down" steering to control the pitch motion of distal portion 218, and to provide independent "left / right" steering to control the yaw motion of distal portion 218. In embodiments where medical device system 200 is actuated by a robot-assisted component, drive unit 204 may include a drive input detachably coupled to and receiving power from a drive element (such as an actuator) of a remotely operated component. In some embodiments, the medical device system 200 may include a gripping feature, a manual actuator, or other components for manually controlling the movement of the medical device system 200. Information from the tracking system 230 may be sent to the navigation system 232, where the information is combined with information from the visualization system 231 and / or a preoperatively acquired model to provide real-time location information to the physician or other operator.

[0107] In some embodiments, the medical device system 200 may be manually or guided via a robot-assisted manipulator system 100 to deliver the medical device 226 to a target tissue site for treatment. In some procedures, the choice between manual or robotic delivery and the appropriate route may be determined based on the medical application. For example, in some gastrointestinal applications, the medical device system 200 (or the stand-alone medical device 226) may be delivered intracavitarily via a manual or robotic delivery device via an oral or anal route. A transabdominal route employing integrated monopolar or bipolar instruments, drop-in probes, or catheters may also be used. For urinary applications, the medical device system 200 (or the stand-alone medical device 226) may be delivered intracavitarily via a manual or robotic delivery device via an integrated bipolar instrument, drop-in probe, or catheter, through a transurethral, ​​perineal, preperitoneal, or transabdominal route. Similarly, for gynecological applications, the medical device system 200 (or stand-alone medical device 226) can be delivered intracavitarily via a manual or robotic delivery device using an integrated bipolar device, a drop-in probe, or a catheter, through the vagina, perineum, or abdomen. For hepatobiliary applications, the medical device system 200 (or stand-alone medical device 226) can be delivered intracavitarily via a manual or robotic delivery device using an integrated bipolar device, a drop-in probe, or a catheter, through the mouth to the ampulla of Vater, or through the gastrointestinal wall or abdomen to the liver. For neurovascular applications, the medical device system 200 (or stand-alone medical device 226) can be delivered intravascularly via a manual or robotic delivery device using an integrated bipolar device, a drop-in probe, or a catheter, through a keyhole craniotomy or via an intravascular approach. For cardiac applications, the medical device system 200 (or stand-alone medical device 226) can be delivered via an integrated bipolar device, a drop-in probe, or via a catheter, through an intravascular route or through the thoracic cavity, via a manual or robotic delivery device.

[0108] Now refer to Figures 4-20 This description illustrates embodiments of a medical device system including an electrode deployment system within the context of an electrosurgical electrode therapy device. Various embodiments of the electrode therapy devices and electrode deployment systems disclosed herein may include electrode devices for electrosurgery (such as electrolysis and / or electroporation), or electrode devices for sensing or other purposes. In some embodiments, the electrode deployment system according to this disclosure is slidably, detachably, or permanently attached to an endoscope. In some embodiments, the electrode deployment system according to this disclosure may be operatively coupled to and received in an endoscope, catheter, or referenced above. Figure 3A and Figure 3B The electrode deployment system can be deployed in and / or from any other elongated flexible device 202 described. In other embodiments, the electrode deployment system according to this disclosure can be integrated with the body of an endoscope, catheter, or other elongated flexible device.

[0109] refer to Figure 4 An electrode treatment device 300 according to one embodiment includes an electrode deployment system 310 supported on a distal portion 316 of an endoscope 320 or another elongated flexible device. The endoscope 320 includes an elongated flexible body 324 having a distal end 328 (for illustrative purposes, in...). Figure 4 (Shown as truncated). In the illustrated embodiment, the electrode deployment system 310 engages on the body 324 adjacent to its distal end 328, such that the electrode coiling mechanism 330 of the electrode deployment system 310 surrounds and concentrically mounts the distal portion 316 of the endoscope 320. In some embodiments, the electrode coiling mechanism 330 may slidably engage or press-fit onto the distal portion 316 of the body 324. In other embodiments, the electrode coiling mechanism 330 may engage onto the distal portion 316 via engaging grooves or pawl features (not shown) on the distal portion 316 and / or a portion of the electrode coiling mechanism 330. In other embodiments, such as Figure 19A , Figure 19B and Figure 20 As shown, the electrode deployment system includes electrode deployment mechanisms or devices other than the winding mechanism. The electrode winding mechanism 330 includes a first component 340 (also referred to herein as an outer component 340) and a second component 360 (also referred to herein as an inner component 360). For example, the first component 340 is the outer shell of the electrode winding mechanism, while the second component 360 is the inner shell of the electrode winding mechanism.

[0110] Common Reference Figure 4 , Figure 5A and Figure 5B The electrode winding mechanism 330 includes a first gear 344 (such as an annular gear formed on the annular inner surface 348 of the first member 340) and a second gear 354 (such as a pinion). In other embodiments (not shown), the first gear 344 may be a separate component attached to the first member 340 and may be an annular gear or other types of gears (such as crown gears). In the illustrated embodiment, the first member 340 is generally tubular and rotatably supported on a second member 360 of the electrode winding mechanism 330. In the illustrated embodiment, the second member 360 is a generally tubular component inserted between the first member 340 and the body 324 and at least partially positioned within the first member 340. The first member 340 overlaps with the second member 360 in an axial overlap region 362, wherein the second member 360 (or a portion thereof) is positioned within the first member. Annular gap 368 ( Figure 5A and Figure 8B It is formed between the inner and outer components in the axially overlapping region 362.

[0111] A first portion 364 of the flexible electrode strip 366 is wound around the first member 340, while the remaining portion of the electrode strip 366 is coiled around the second member 360 in the gap 368 between the first member 340 and the second member 360. In alternative embodiments, all or almost all of the electrode strips 366 may be coiled around the first member 340. The flexible electrode strip as described herein may include one, two, or any suitable number of electrodes (e.g., an electrode array). In the illustrated embodiment, the second member 360 is longitudinally longer than the first member 340 and the electrode strip 366 (e.g., the second member 360 extends proximally relative to the proximal end 369 of the first member 340). In some embodiments, one or both of the first member 340 and the second member 360 may extend proximally relative to the electrode strip 366. In some embodiments, such as Figure 10 In the embodiment shown, the first and second components have approximately the same longitudinal length, which is just long enough (e.g., sufficiently long) to support the electrode strip 366 thereon.

[0112] In the illustrated embodiment, the first component 340 and the second component 360 are made of a transparent material (such as a transparent thermoplastic resin), as described below. Figure 6 This reasoning will be discussed in more detail. When the corresponding electrode strips as described herein are in a retracted configuration, the electrode therapy device consistent with this disclosure can have a total outer diameter in the range of 10 mm to 17 mm. The relatively small diameter of such electrode therapy devices and their electrode deployment systems facilitates maneuverability and navigation in the gastrointestinal region, the duodenum, and especially at the pylorus and duodenojejunal junction.

[0113] The second gear 354 is mounted on the drive shaft 370 and is used to rotate with the drive shaft 370 about its axis of rotation 374. The drive shaft 370 extends through and out of the working channel 372 (e.g., see also reference). Figure 12 and Figures 16A-16B An embodiment is illustrated; sometimes referred to as the “working port”), with a working channel 372 extending longitudinally through the body 324 of the endoscope 320. In other embodiments (not shown), the drive shaft 370 may extend from the working channel 372 or the working port of the endoscope 320, but not entirely through the body 324, for example, if the drive shaft 370 is driven from within the body 324 of the endoscope 320. A second gear 354 meshes with or otherwise engages with a first gear 344 such that rotation of the drive shaft 370 drives the first member 340 to rotate relative to the second member 360 about a common central axis 376 of the first member 340 and the distal end 328. In other words, the second member 360 is rotationally fixed relative to the first member 340. As the first member 340 rotates relative to the second member 360, the electrode strip 366 is deployed laterally outward from the endoscope 320, such as Figure 6 , Figure 7 and Figure 8B The figures are shown and further described below with reference to these figures. Thus, the drive shaft 370 is operatively coupled to the first member 340 via a first gear 344 and a second gear 354, such that rotation of the drive shaft 370 relative to the body 324 of the endoscope 320 imparts relative movement between the first member 340 and the second member 360, for changing the electrode strip 366 between a retracted configuration and a deployed configuration (e.g., by unfolding and retracting the electrode strip 366). The gear ratio between the second gear 354 and the first gear 344 can be in the range of about 1:20 to 1:2. In the illustrated embodiment, the first gear 354 has 48 teeth, while the second gear 344 has 18 teeth, resulting in a gear ratio of 3:8.

[0114] Handle (see) Figure 11 A handle 792 may be attached to the proximal portion of the drive shaft 370 to facilitate manipulation of the drive shaft 370 and operation of the electrode deployment system 310. In some embodiments, the handle may be manually actuated by a user. In other embodiments, the handle 792 or linkage or other coupling device or feature at the proximal end of the drive shaft 370 may be coupled to an external device for actuation of the electrode deployment system 310, such as a robot-assisted manipulator system. In still other embodiments, both manual and robot-assisted actuation may be provided.

[0115] The electrode therapy devices described herein can be coupled to external devices to provide actuation, control, and / or power to the electrode therapy devices. For example, electrode therapy device 300 and other electrode therapy devices described herein can be actuated by a robot-assisted manipulator system (e.g., manipulator assembly 102). Electrode therapy device 300 (e.g., handle, drive shaft 370, and / or control shaft 1370) Figures 21A-25 The electrode therapy device 300 may include or be coupled to a drive unit (e.g., drive unit 204), which has one or more drive inputs detachably coupled to and receiving power from a drive element (such as an actuator) of the manipulator assembly. When the electrode therapy device 300 is coupled to the manipulator assembly, the drive inputs of the electrode therapy device 300 may be coupled to a drive output of the manipulator assembly driven by a drive element of the manipulator assembly. Furthermore, the drive inputs of the electrode therapy device 300 may be coupled to the distal portion 316 of the electrode therapy device 300 via one or more actuation drive members (e.g., actuation cables, actuation rods, tensioning members, etc.) to perform actions such as advancing, retracting, or hinged the distal portion 316 of the electrode therapy device 300 and extending and / or retracting the electrodes (e.g., electrode strips 366) described herein. Figures 17-18 Electrode strip 1066, Figure 19A , Figure 19B and Figure 20 Braided electrodes 1166, 1266, and Figures 21A-24 The electrode strip 1366 allows for adjustment of the electrodes between a deployed configuration and a retracted configuration. Furthermore, the drive unit 204 may 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 device 300. The drive unit 204 may be electrically coupled to the electrodes via one or more cables, wires, or traces extending along or through the electrode therapy device 300. In alternative embodiments, the controller and power source may provide power to the cables, wires, or traces without being coupled to the drive unit (e.g., the controller and power source may be independent of the drive unit).

[0116] exist Figures 4-10 In the illustrated embodiment, the first components 340, 640 rotate about the second components 360, 660 and the endoscope 320, while the second components 360, 660 are constrained and do not rotate relative to the endoscope 320. In other embodiments, as described below... Figures 11-16B In some embodiments, the inner member is rotatable relative to the outer member. In still other embodiments, each of the first and second members (the inner and outer members) is rotatable relative to the other of the first and second members about a central axis (e.g., central axis 376) or an eccentric axis to deploy electrodes (e.g., electrode strip 366) by unwinding or other means. Thus, the drive shaft 370 can be operatively coupled to one or both of the first and second members of the winding mechanism in various embodiments to impart relative movement between the first and second members.

[0117] Back Figure 4 , Figure 5A and Figure 5B The second gear 354 is rotatable within a cover 378 formed at the distal end of the second member 360. Except for the meshing or engaging portion of the first and second gears, the cover 378 extends circumferentially to cover most of the gear assembly of the first gear 344 and the second gear 354, while outlining the engagement point of the first gear 344 and the second gear 354, thereby preventing the gear teeth of the first gear 344 and the second gear 354 from being exposed to tissue when using the electrode treatment device 300. The cover 378 also provides support and guidance for the second gear 354. In some embodiments, a guidewire 380 extends distally from the drive shaft 370 and the second gear 354. The guidewire 380 is marked with a distance indicator mark 384 (…). Figure 4 The distance indicator marker 384 is visible to the optical imaging system 109 and 390 of the endoscope 320.

[0118] The drive shaft 370 may include a torque tube or other flexible, elongated torque transmission device (e.g., a flexible drive shaft). In embodiments including a torque tube, a guide wire 380 may extend through the lumen of the torque tube. The drive shaft 370 may be generally cylindrical in shape. The drive shaft 370 may include a shaped fitting 446 at its distal end, such as a hexagonal fitting as shown, for engaging with a similarly shaped hole or socket in the second gear 354 and transmitting torque to the second gear 354, which transmits torque to the first member 340 via the first gear 344. The second gear 354 may be press-fitted to the fitting 446 or attached to the drive shaft 370 by other means, such as welding or bonding. The drive shaft 370, fitting 446, and second gear 354 may be made of metal (such as stainless steel or titanium), high-strength plastic, or other materials. In some embodiments, drive shaft 370 and / or fitting 446 are made of metal, while the second gear 354 is made of a high-strength thermoplastic resin or composite material (such as glass fiber or carbon fiber reinforced resin). In other embodiments, different types of mechanisms or devices for transmitting torque or power from drive shaft 370 to first component 340 may be used instead of first gear 344 and second gear 354. One or more bearings (though not shown, see...) Figure 12 The bearing 796 in the middle can be inserted between the first member 340 and the second member 360 at the bearing interface therebetween to reduce friction during relative rotation between the first member 340 and the second member 360.

[0119] Figure 4 , Figure 5A , Figure 5B and Figure 8A An electrode therapy device 300 is shown, wherein the electrode deployment system 310, the electrode winding mechanism 330, and the electrode strip 366 are in a retracted configuration. Electrode strip 366—in one embodiment—is shown... Figure 9 As shown (flattened) and further described below, it includes opposite first ends 422 and second ends 424, and an intermediate portion 426 inserted between the first ends 422 and the second ends 424. A lead tab 428 extends laterally from the electrode strip 366. (See attached image.) Figure 4 As shown, the first end 422 is fixedly coupled to the first member 340 in the axial overlap region 362 by means such as welding, adhesive, fasteners or other direct attachment. Figure 5A On the outer surface of the first member 340, and at least partially wrapped around the outer side of the first member 340. The electrode strip 366 then passes through a slot 440 extending longitudinally through a tubular section of the first member 340, while the remaining portion of the electrode strip 366 is in a retracted configuration (e.g., Figure 8AAs best shown below, the second end 424 is coiled around the second member 360 within the gap 368 in the axial overlap region 362 between the first member 340 and the second member 360. The second end 424 is constrained from moving or rotating about the central axis 376—such as by fixing the second end 424 to the second member 360 (e.g., by welding, adhesive, fasteners or other direct attachment means) in the axial overlap region 362 (e.g. Figure 8A and Figure 8B (As best shown in the example). The slot 440 can be approximately 20 mils wide, which is more than twice the thickness of the electrode strip 366 in the illustrated embodiment.

[0120] Figure 6 , Figure 7 and Figure 8B An electrode therapy device 300 is shown, in which an electrode deployment system 310, an electrode winding mechanism 330, and an electrode strip 366 are in a deployment configuration, wherein the middle portion 426 of the electrode strip 366 is opposite to... Figure 4 , Figure 5A , Figure 5B and Figure 8A The collapsed configuration shown extends laterally and radially outward from the first member 340.

[0121] Electrode deployment system 310 can be deployed from a first axial position ( Figure 4 and Figure 5A ) is propelled or otherwise axially moved to the second axial position ( Figure 6 and Figure 7 Conversely, for example, deployment, retraction, and / or removal. When the electrode strip 366 is in a retracted configuration and / or deployed configuration, and / or during treatment, the electrode deployment system 310 can be advanced longitudinally (axially) or retracted. For example, portions of the electrode deployment system 310 can extend telescopically beyond the distal end 328 of the endoscope 320, or be retracted to the vicinity of the distal end 328 of the endoscope 320. The drive shaft 370 is moved distally relative to the endoscope 320 to cause the first member 340 relative to the endoscope 320 from... Figure 4 and Figure 5A The first axial position shown is axially slidably movable further to the side and extends to Figure 6 and Figure 7 The second axial position shown is different from the first axial position. In the second axial position, all or part of the first member 340 and all or part of the electrode strip 366 are moved to the distal side of the distal end 328 of the endoscope 320, and optionally are located in the optical imaging system 390. Figure 4Within the field of view of the endoscope 320. In the illustrated embodiment, the second member 360 is also slidably slidable distally relative to the endoscope 320. In other embodiments (not shown), longitudinal movement of the second member 360 relative to the endoscope 320 can be prevented, and the first member 340 is capable of longitudinal / distal extensional movement relative to the second member 360. In yet another embodiment (not shown), the first member 340 and the second member 360 may be slidably mounted on a stationary third member inserted between the second member 360 and the body 324 of the endoscope 320, and wherein the third member is securely supported on the distal portion 316 of the endoscope 320, for example by a press-fit, such that the third member provides a stationary platform or rail for longitudinal sliding movement of the first member 340 and the second member 360.

[0122] In some embodiments, the aforementioned telescopic extension or retraction is driven by drive shaft 370. The telescopic extension or other extension of electrode deployment system 310 facilitates precise placement and deployment of electrode strip 366 in place of the target tissue for electrosurgical treatment by allowing the operator to view the position of electrode strip 366 during lateral and / or radial deployment relative to the target tissue using optical imaging systems 109, 390. Distance indicator marks 384 on guidewire 380 can be used as a reference point for the degree to which electrode deployment system 310 has been extended (i.e., the distance by which the first member 340 has been longitudinally moved relative to endoscope 320), or as a reference point for the placement of electrode treatment device 300, or as a reference for the distance by which the first member 340 must be longitudinally moved relative to endoscope 320 to allow electrode strip 366 to reach the target tissue. Distance indicator marks 384 may be spaced apart from the width W of electrode strip 366. Figure 9 They are roughly the same width.

[0123] As previously described, the first component 340 may be made of a transparent material that provides visibility through the optical imaging system 390, thereby enabling the electrode strip 366 to be imaged upon deployment. In some embodiments, the second component 360 is also made of a transparent material for the same reason. In some embodiments, at least a portion of the electrode strip 366 may be made of a transparent or translucent flexible material, such as transparent polyimide (PI) or transparent polyethylene terephthalate (PET), thereby allowing the target tissue to be seen through the electrode strip 366. In some embodiments, the electrode strip 366 may include one or more holes, windows, or other openings 460 formed therein to provide visibility through the electrode strip 366 (e.g., when the electrode strip 366 is made of an opaque material), particularly when the electrode strip 366 is laterally extended. Figure 6 When the deployment (expanded) configuration is shown.

[0124] The electrode therapy device 300 can be operated by first inserting the electrode therapy device 300, including an endoscope 320 and an electrode deployment system 310 (e.g., intracavitary) into the patient's body, and then guiding the electrode therapy device to the treatment site (such as a location in the duodenum or other gastrointestinal sites) via the endoscope 320. The position of the electrode therapy device 300 relative to the target tissue at the treatment site can be visually measured by viewing the distance indicator mark 384 on the guide wire 380 via the optical imaging system 390 of the endoscope 320. Once positioned at the treatment site, the electrode deployment system 310 can be advanced distally into the field of view of the optical imaging system 390 by moving the drive shaft 370 distally relative to the endoscope 320, and then the drive shaft 370 is moved along a first direction 398 (…). Figure 8B The electrode strip 366 is rotated to unwind (unwind) and deploy laterally outward from the first member 340 into a deployment configuration co-located with the target tissue. Once the electrode strip 366 is deployed in contact with the target tissue, electrical energy can be applied to the electrode strip 366 to achieve electrosurgical treatment of the tissue (e.g., by electrolysis, electroporation, or both). In some embodiments, the electrode strip 366 may be used alone or in combination with one or more electronic sensors (not shown) formed thereon to sense the state of the tissue or patient by measuring the electrical signals transmitted by the electrode strip 366.

[0125] After completing an electrosurgical procedure or other procedure using the electrode treatment device 300 at the treatment site or test site (e.g., a first tissue treatment site), the electrode strip 366 can be restored to its original position by rotating the drive shaft 370 in a second direction opposite to the first direction 398, causing the electrode winding mechanism 330 to wind the electrode strip 366 around the second member 360 (e.g., roll up the electrode strip 366). Figure 4 Figure 5 and Figure 8A The retracted configuration is shown. Additional treatment or sensing can then be performed by advancing the electrode strip 366, either by attaching the telescopic electrode deployment system 310 relative to the endoscope 320 or by moving the endoscope 320 (i.e., moving the entire electrode treatment device 300) to a second tissue treatment site (in some cases, the second tissue treatment site may overlap with the first treatment site). At the second treatment site, the electrode strip 366 can again be deployed laterally outward from the first member 340 as described above, positioned co-located with the tissue at the second treatment site, and energized for electrosurgical treatment or sensing. After one or more treatments have been performed at one or more treatment sites, the electrode strip 366 can be retracted back to the retracted configuration via rotation of the drive shaft 370 in the second direction to coil the electrode strip 366. Furthermore, the electrode deployment system 310 can be retracted proximally to a first axial position (e.g., adjacent to the distal end 328 of the endoscope 320) by moving the drive shaft 370 proximally relative to the endoscope 320.

[0126] Now go to Figure 9 The exemplary electrode device 500 embodying electrode strip 366 includes a flexible printed circuit 502 (also referred to as a flexible circuit), which includes conductive electrodes 510, 520 deposited on the outer surface of a flexible polymer substrate 530 (Note: for the sake of simplicity, from...). Figure 4 Figure 5 Figure 6 , Figure 7 , Figure 10 , Figure 11 and Figure 12 Electrodes 510 and 520 are omitted in the electrode strip 366 shown. In some embodiments, the electrode device 500 may have a shape that differs from a simple strip configuration—for example, Figure 9 The L-shaped configuration shown has an electrode strip 366 (i.e., the "electrode strip portion" of the device 500) forming one leg of the L-shape, while the lead tab 428 forms the other leg of the L-shape. In other embodiments (not shown), the entire electrode device 500 may be formed as a strip, such as a simple foil strip operating as a monopolar electrode.

[0127] The substrate 530 of the flexible printed circuit 502 may consist of or include films of the following materials: polyimide, polyester, polyethylene terephthalate (PET), or other suitable flexible insulating materials. The thickness of the substrate 530 may range from 2 mils to 10 mils or greater (0.051 to 0.254 mm). The thickness of the substrate may depend on the required stiffness or relative flexibility of the electrode strip 366, with the aim of preventing buckling during deployment and achieving the desired dimensional expansion and structural isotropic forces. This may also be influenced by the width W of the electrode strip 366 and other factors such as electrode configuration and material properties. The width W of the electrode strip 366 may range from 5 to 50 mm or greater, and is preferably in the range of 10 to 30 mm. Reducing the width of the electrode strip 366 and the entire electrode deployment system 310 improves the maneuverability of the endoscope 320 and electrode treatment device 300 during navigation through the gastrointestinal pathway, but reduces the tissue coverage area of ​​the electrode strip 366, which may increase the number of electrosurgical contacts and energizing steps required to treat larger areas of tissue. Depending on the diameter of the electrode coiling mechanism 330, the length L of the electrode strip 366 can be approximately 40 to 200 mm, and more preferably in the range of approximately 80 mm to 140 mm. For an electrode coiling mechanism 330 with an outer diameter of approximately 32 mm, the length of the electrode strip 366 can be in the range of approximately 110 mm to 130 mm.

[0128] Figure 9An embodiment of the electrode device 500 shown includes a dual-electrode array, namely a first electrode 510 and a second electrode 520, connected to corresponding first leads 512 and second leads 522 for bipolar operation. In other embodiments, more than two electrodes may be used. Each electrode 510, 520 in the illustrated embodiment includes one or more corresponding fingers 514, 524 extending from bus regions 516, 526 of the electrodes 510, 520 located at corresponding second ends 424 and first ends 422 of the electrode strip 366 onto the substrate 530. The fingers 514, 524 may extend along a large portion of the length of the electrode strip 366. As shown, the fingers 514, 524 may be staggered and spaced along the width of the electrode strip 366 to provide a controlled, fixed, and uniform distance between adjacent finger portions 514, 524 of the respective first electrode 510 and second electrode 520 (i.e., between each pole along the surface of the electrode strip 366). By alternating the fingers 514, 524 of the first electrode 510 and the second electrode 520, it is possible to have an electrode array with an increased treatment area, while maintaining a consistently small spacing between the first electrode 510 and the second electrode 520, which avoids the need for increased voltage and / or power for electrosurgery. The fingers 514, 524 can be regularly spaced in the space between the apertures 460 formed in or through the substrate 530. In some embodiments, the electrode strip 366 may include one, two, three, four, five, six or more fingers 514 of the first electrode 510 spaced apart across the width W of the substrate 530, and the same or slightly different number of fingers 524 of the second electrode 520 arranged alternately and continuously. Those skilled in the art will understand that the electrode arrangement or array on the electrode strip 366 can be implemented in a variety of different shapes, patterns and configurations than those shown herein.

[0129] Electrodes 510, 520 (including fingers 514, 524) may be formed of one or more metals deposited on substrate 530 via a printing method, as is known in the field of flexible circuit manufacturing. Suitable metals for electrodes 510 and 520 may include copper, nickel, gold, tin, alloys, or laminates of two or more such metals (e.g., a copper substrate covered by a nickel layer, followed by a gold overlay) to prevent corrosion of the copper or nickel layer and any undesirable biochemical effects. Insulating film segments 532, 534 of polyimide, PET, or other insulating resin material may be applied to electrodes 510, 520 at corresponding first and second ends 422 and 424 of electrode strip 366, and segments 534 may also cover leads 512, 522 at lead tabs 428. The insulating film segments 532 and 534 facilitate the fixation of the electrode strip 366 to the electrode winding mechanism 330 or other deployment mechanism or device, and prevent damage to the first electrode 510 and the second electrode 520 or electrical short circuits between the first electrode 510 and the second electrode 520 in areas where it is not necessary for the electrodes 510 and 520 to be exposed to contact with the target tissue.

[0130] In some embodiments, the electrode strip 366 may be heat-treated or thermoformed to provide shape memory, preferably in a coiled, folded configuration. By heat-treating or thermoforming the electrode strip 366 in a folded configuration, the electrode strip 366 may tend to return to the folded position when the rotational force is removed from the drive shaft 370, or in the event that either the first end 422 or the second end 424 of the electrode strip 366 detaches from the first member 340 or the second member 360, which facilitates the removal of the electrode therapy device 300 from the patient's body.

[0131] For ease of illustration, lead connector 428 and leads 512, 522 are shown in... Figure 9 The portion of electrode strip 366 shown is relatively short in length. However, in some embodiments, the lead tab 428 and leads 512, 522 may be made longer, such as long enough to extend along the entire endoscope 320 to the vicinity of the operator controls of the endoscope 320, or to the power source. In other embodiments, wires may be coupled to leads 512, 522 to complete an electrical connection to the power source.

[0132] Figure 10 Another embodiment of the electrode treatment device 600, electrode deployment system 610, and electrode winding mechanism 630 is shown, which is carried by the endoscope 320 and is shown in an extended and deployed configuration. Reference Figure 10 The electrode deployment system 610 is similar in configuration and operation to Figure 4The electrode deployment system 310 in Figure 8, except that the first component 640 and the second component 660 of system 610 are formed by a frame with an opening 670, is intended to allow the optical imaging system 390 to view the electrode strip 666 of system 610 and the target tissue. In this way, the first component 640 and the second component 660 do not need to be made of transparent material. This frame construction also increases the flexibility of the electrode coiling mechanism 630 along the axis of endoscope 320, thereby improving maneuverability. Similarly, Figures 4-7 The first component 340 and the second component 360 of the system 310 may be provided with a frame with an opening instead of being made of a transparent material, or may be provided with a frame with an opening in addition to being made of a transparent material.

[0133] Figure 11 Different embodiments of the electrode therapy device 700 are shown, which includes an electrode deployment system 710 supported by an endoscope 320 adjacent to its distal end 328. The electrode deployment system 710 includes an electrode coiling mechanism 730, which will be referenced below. Figure 12 To describe it in more detail. The electrode coiling mechanism 730 is offset from the central axis 376 of the endoscope 320 (e.g., the central axis 774 of the cylindrical cavity 750 of the electrode coiling mechanism 730 is offset from the longitudinal central axis 376 of the endoscope 320), and is positioned distal to the objective lens of the optical imaging system 390 to provide the optical imaging system 390 with visibility of the various parts of the electrode deployment system 710 (e.g., the electrode coiling mechanism 730), and when in... Figure 11 When retracted, the optical imaging system 390 provides external visibility of the electrode strips 766. The electrode deployment system 710 includes a mounting section 732 that securely attaches the electrode deployment system to the distal portion 316 of the endoscope 320 in a rotatable manner, as described in more detail below.

[0134] Figure 12 It is along Figure 11 A cross-sectional view of the electrode treatment device 700, taken along line 12-12. (Reference) Figure 12The electrode winding mechanism 730 includes an outer first member 740, which is non-rotatable relative to the mounting section 732 and can be integrally formed from a single-piece construction. The mounting section 732 and the first member 740 may be molded from, for example, a thermoplastic material, or may be made from other structural materials such as metal. A spindle-shaped second member 760 (an inner member) is at least partially positioned within a generally cylindrical cavity 750 formed in the distal end 752 of the first member 740. In other embodiments (not shown), the cylindrical cavity 750 may be formed in the proximal end 754 of the first member 740 opposite to the distal end 752. The cylindrical cavity 750 and the second member 760 are coaxially aligned on a central axis 774. The central axis 774 is also the axis of rotation of a drive shaft 770, which is operatively coupled to the second member 760 and offset from the longitudinal central axis 376 of the endoscope 320. A drive shaft 770 extends through an opening in the proximal end of the first member 740 and is fixedly coupled to the second member 760 such that rotation of the drive shaft 770 directly drives the second member 760 to rotate relative to the first member 740 (which is rotatably fixed to the endoscope 320 as described above) for deploying (extending) and / or retracting (retracting) the electrode strip 766, as further described below. The drive shaft 770 may include a torque tube 778 covered by a sheath or insulating layer 782. A bearing 796 may be provided between the first member 740 and the second member 760 to reduce friction therebetween during rotation of the second member 760 relative to the first member 740. The bearing 796 may include a dry sliding bearing, such as solid polytetrafluoroethylene (PTFE) material commonly known under the trademark TEFLON, or other low-friction materials. In some embodiments, the bearing 796 may include an annular bearing, which may have an O-ring shape or different shapes or configurations.

[0135] The operation of the electrode winding mechanism 730 is in Figure 13A and Figure 13B As shown in the figure, Figure 13A and Figure 13B Depicting Figures 11-12 The electrode deployment system 710 includes an electrode winding mechanism 730 and corresponding retractable and deployed configurations of the electrode strips 766 deployed by the electrode winding mechanism 730. (See reference...) Figure 13A A first end 722 of the electrode strip 766 is attached, affixed, or otherwise attached to the outer surface of the first member 740, adjacent to a slot 744 formed therein, while a second end 724 of the electrode strip 766 is attached, affixed, or otherwise attached to the outer surface of the second member 760. At least a portion of the intermediate portion 726 of the electrode strip 766 between the first end 722 and the second end 724 extends through the slot 744 and coils around the second member 760. As described above, refer to Figures 11-12The outer first component 740 is rotatably fixed relative to the endoscope 320, while the inner second component 760 is rotatable and attached to the drive shaft 770. Figures 11-12 ). Through Figure 13A and Figure 13B In the image, the second component 760 rotates counterclockwise in the first direction, and the electrode strip 766 rotates from... Figure 13A The collapsed configuration transforms into Figure 13B The image shows a laterally extended deployment configuration. Counterclockwise rotation of the second member 760 causes the electrode strip 766 to unwind and be ejected from the slot 744. The desired stiffness of the electrode strip 766 can be provided to prevent or reduce warping within the annular gap 746 between the first member 740 and the second member 760. As the electrode strip 766 is released, it can rub against the inner cylindrical surface of the first member 740, generating friction somewhat like a winch effect. This winch effect is not a problem, or... Figures 4-10 The electrode winding mechanisms 330 and 630 are used to reduce the size, wherein the (outer) first components 340 and 640 rotate around the (inner) second components 360 and 660. To reduce... Figure 11 , Figure 12 , Figure 13A and Figure 13B In the embodiment of the winch effect, the inner second member 760 rotates relative to the outer first member 740, and the surface of the cavity 750 (the inner cylindrical surface of the outer first member 740) may be coated with a lubricant (such as KRYTOX grease) or lined with a PTFE tape or film to reduce friction between the electrode strip 766 and the inner cylindrical surface of the outer first member 740 when the electrode strip 766 is deployed. Furthermore, a portion of the first end 722 of the electrode strip 766 may also extend partially over the slot 744 and rub against the middle portion 726 of the electrode strip 766 as the electrode strip 766 is deployed (unwinding) and retracted (winding / coiling around the second member 760).

[0136] exist Figure 11 and Figure 12 In the illustrated embodiment, the mounting section 732 includes a slotted clip 734 having an externally threaded tubular neck with a longitudinal slot 736. The mounting section 732 further includes an internally threaded retaining nut 738, which is threaded onto and tightened to securely clamp and attach the slotted clip 734 of the electrode deployment system 710 to the distal portion 316 of the endoscope 320. Various other mounting and clamping arrangements are also within the scope of this disclosure. For example, the mounting section 732 can be slidably mounted to the endoscope 320 to allow axial movement of the electrode deployment system 710 relative to the endoscope 320, similar to... Figure 6 and Figure 7The illustrated embodiment. In such an embodiment, the mounting section 732 may be rotatably constrained to prevent the mounting section 732 and the first component 740 from rotating relative to the endoscope 320.

[0137] The drive shaft 770 of the electrode deployment system 710 can extend next to and adjacent to the body of the endoscope 320, such as... Figure 11 and Figure 12 As shown (see also) Figure 15 The drive shaft 870), or the working channel 372 that can extend through the endoscope 320, such as Figure 16A and Figure 16B As shown and described below, a guidewire 780 extends from a flexible nasal cone 788 attached to the distal end of the electrode coiling mechanism 730. A lead tab 728 with charged leads extends proximally from the electrode strip 766 for connection to a control system or power source (not shown) of the electrode treatment device 700. A control handle 792 is connected proximally to a drive shaft 770 for moving the drive shaft relative to the endoscope 320 (e.g., rotatably moving the electrode strip 766 between a retracted configuration and a deployed configuration and / or axially translating the electrode strip 766 distally or proximally relative to the endoscope 320). A collar 794 is attached to a sheath around the drive shaft 770 to counteract torque applied to the handle 792 and the shaft 770. As described above, in some embodiments, the handle 792 can be manually actuated by a user. In other embodiments, the handle 792 (or a different linkage or coupling structure at the proximal end of the drive shaft 770) may be coupled to an external actuation device, such as a robot-assisted manipulator system. In still other embodiments, both manual and robot-assisted actuation may be provided.

[0138] Electrode strip 766 in Figure 13A and Figure 13B The middle part is shown as having four electrodes 714, which can be referenced above. Figure 9 The described method uses alternating polarities to achieve bipolar operation, such that electrode strip 766 includes two pairs of staggered electrode fingers. In other embodiments, electrode strip 766 may include one, two, or any number of suitable electrodes to provide bipolar or unipolar operation as needed. This is to aid visibility via endoscope 320 ( Figures 11-12 The electrode strip 766 may provide a series of oval slots 716 in the substrate between adjacent pairs of electrodes 714.

[0139] Figure 14 These are photographs taken by the optical imaging system of the electrode deployment system when it is inserted into the gastrointestinal tract. Figure 14 The electrode deployment system has the same characteristics as Figure 11 , Figure 12 , Figure 13A and Figure 13BThe electrode deployment system 710 shown is essentially the same design, with its electrode winding mechanism and electrode strip 766' mounted off-center from the endoscope 320 and distal to the distal end 328, in order to avoid covering or obstructing the optical imaging system 390 (Note: Figure 14 Implementation examples and Figure 11 , Figure 12 , Figure 13A and Figure 13B The difference in the embodiment is that the electrode strip 766' does not have the oval slot 716 ( Figure 13A , Figure 13B )). Figure 14 The diagram shows how both the exterior of the retracted electrode strip 766' and the adjacent target tissue 786 are within the field of view of the optical imaging system 390 of the endoscope 320, which facilitates the placement of the electrode deployment system 710 before and / or during and / or during electrosurgical treatment of the target tissue 786.

[0140] Figure 15 An embodiment of an electrode therapy device 800 is depicted, comprising an electrode deployment system 810 with an electrode winding mechanism 830, the electrode winding mechanism being functionally similar to... Figure 12 The electrode winding mechanism 730 has a rotation axis 874 that is angled (e.g., non-zero angle, oblique angle) relative to the longitudinal axis 376 of the endoscope 320, such that the electrode winding mechanism 830 extends distally from the distal end 328 of the endoscope 320 and converges toward the longitudinal axis 376 (and may intersect the longitudinal axis 376 at a distal location, as shown). The angled electrode deployment system 810 relative to the endoscope 320 makes the electrode treatment device 800 more maneuverable during intraluminal insertion and removal, particularly during navigation through tortuous areas such as the pylorus and duodenojejunal junction. The angled electrode deployment system 810 also aids in the visibility of the electrode deployment system 810 and its electrodes (not shown) toward the optical imaging system 390 of the endoscope 320.

[0141] Electrode deployment system 810 may include an elastomeric guide tip 844 extending distally from the distal end of electrode winding mechanism 830. This guide tip 844 may be integrally or partially integrated into any electrode deployment system described herein. The guide tip 844 may be made of any of a variety of soft elastomeric materials (such as silicone) and may act as a buffer to suppress trauma when the electrode therapy device 800 is “blindly / gropedly” pushed through the gastrointestinal lumen during pink-outs (e.g., in the case of tissue-obstructed optical imaging system 390). The drive shaft 870 of electrode deployment system 810 extends proximally from electrode winding mechanism 830 along axis of rotation 874, but because the drive shaft 870 is flexible, it can be easily accommodated during insertion, manipulation, and navigation of the electrode therapy device 800 through the gastrointestinal passage.

[0142] Figure 16A An electrode therapy device 900 according to another embodiment is depicted, wherein an electrode deployment system 910 is mounted to the distal portion of an endoscope 320 and offset eccentrically relative to the longitudinal axis 376 of the endoscope 320. An electrode coiling mechanism 930 of the electrode deployment system 910 is disposed distal to the distal portion of the endoscope 320 such that at least a portion of the electrodes (not shown) of the device 900 is within the field of view of the optical imaging system 390 of the endoscope 320. The electrode coiling mechanism 930 has a rotation axis 940 substantially parallel to the longitudinal axis 376 of the endoscope 320. The electrode therapy device 900 may include one or more features, wholly or partially identical or similar to other electrode therapy devices described herein (e.g., electrode therapy devices 300, 600, 700, 800). In this embodiment, the electrode coiling mechanism 930 is driven by a drive shaft 970 extending through a working channel 372 of the endoscope 320.

[0143] Figure 16B An electrode treatment device 902 according to yet another embodiment is depicted, wherein an electrode deployment system 912 is offset relative to a longitudinal axis 376 and mounted to a distal portion 316 of an endoscope such that at least a portion of the electrodes (not shown) of the electrode treatment device 902 is within the field of view of the optical imaging system 390 of the endoscope 320. An electrode coiling mechanism 932 of the electrode treatment device 902, positioned distal to the distal portion 316, has an angled (e.g., non-zero angle, oblique angle) axis of rotation 942 such that the electrode coiling mechanism 932 extends distally from the distal end 328 of the endoscope 320 and converges toward the longitudinal axis 376 (and may intersect the longitudinal axis 376 at a distal position, as shown). A drive shaft 972 of the electrode treatment device 902 extends through the working channel 372 of the endoscope 320. Figure 16AThe electrode treatment device 902 may include one or more features that are wholly or partially the same as or similar to those of other electrode treatment devices described herein (e.g., electrode treatment devices 300, 600, 700, 800).

[0144] Figure 17 and Figure 18 An electrode therapy device 1000 is shown, which includes an electrode deployment system 1010 with an electrode winding mechanism 1030 in which pre-formed wound electrode strips 1066 are wound around an inflatable sac-like member 1040 (such as an elastomeric or non-elastomeric balloon). Figure 17 The electrode deployment system 1010 is shown in its retracted state, while Figure 18 The electrode deployment system 1010 is shown in an extended, partially deployed state. (Reference) Figure 17 A capsule 1040 is attached around an inflation hose 1070, which extends alongside the endoscope 320 and is supported by a mounting bracket 1032 attached to the distal portion 316 of the endoscope 320. The inflation hose 1070 may include any tube capable of delivering air or other gases to inflate the capsule 1040, such as a torque tube. The mounting bracket 1032 may include a tubular section 1034 adjacent to the distal portion 316 alongside the body 324 of the endoscope 320. In some embodiments, the tubular section 1034 may serve as a receiver port for the electrode deployment system 1010. In other words, in some embodiments (not shown), the capsule 1040 and electrode strips 1066 may be retracted into the tubular section 1034, at which point the electrode deployment system 1010 is in a retracted configuration, and the capsule 1040 and electrode strips 1066 may extend distally toward the endoscope 320, ready for expansion and deployment. The nose portion 1088 extends distally from the bladder-shaped member 1040 and can be attached to the distal end of the inflatable hose 1070. The first end 1022 of the electrode strip 1066 is freely movable and unattached, such that when the bladder-shaped member 1040 expands by injecting air or other gas via the inflatable hose 1070, the electrode strip 1066 can freely unwind around the expanded bladder-shaped member 1040, as... Figure 18 As shown in the diagram. After applying voltage and / or current to the electrode strip 1066 to perform an electrosurgical procedure, the bladder 1040 can be deflated to allow further movement or withdrawal of the electrode treatment device. In some embodiments (not shown), deflating the bladder 1040 allows the electrode coiling mechanism 1030 to be retracted into the tubular section 1034 of the mounting bracket 1032 via the retraction of the inflation hose 1070.

[0145] Figure 19A and Figure 19B An alternative electrode deployment system 1110 is shown, in which an expandable bladder-like element is located within an electrode 1166 in the form of a flexible braided sleeve with conductive fibers. Figure 19A The electrode deployment system 1110 is shown in a collapsed configuration, with its inflatable bladder deflated. Figure 19B An electrode deployment system 1110 in a deployment configuration is shown, its expandable bladder-like component being expanded to increase the outer diameter of the braided sleeve electrode 1166. (See image.) Figure 19B As shown, when the bladder is expanded, the length of electrode 1166 shortens to accommodate the lateral / radial expansion of the braided sleeve.

[0146] Figure 20 An electrode treatment device 1200 according to another embodiment is depicted, wherein an expandable electrode deployment system 1210 is mounted around the distal portion of an endoscope 320. Reference Figure 20 The expandable capsule 1240 of the electrode deployment system 1210 surrounds the distal portion 316 of the endoscope 320, and the electrodes 1266 of the electrode deployment system 1210 surround the expandable capsule 1240. The electrodes 1266 may be... Figure 19A and Figure 19B The braided sleeve type shown. In an alternative embodiment (not shown), electrode 1266 may be... Figures 17-18 The diagram shows a pre-formed coil-type electrode strip or another type of electrode array. In either case, when the inflatable bladder 1240 is inflated via the inflatable tubing 1270, the electrode 1266 is laterally extended into the deployment configuration shown. Wires (not shown) may also pass through the inflatable tubing 1270 and connect to a conductive cap 1280 at the distal end of the electrode deployment system 1210 for a reliable electrical connection with the electrode 1266. By moving the inflatable tubing 1270 in a distal direction, the electrode deployment system 1210 can slide distally along the endoscope to facilitate treatment of tissue located behind the distal end 328 of the endoscope 320. For this purpose, the electrode deployment system 1210 may include a rigid internal tubular cylinder (not shown) to support the inflatable bladder 1240 and prevent it from inflating / encroaching inward as the electrode deployment system 1210 is moved distally to the distal end 328 of the endoscope 320.

[0147] Figure 21A and Figure 21B An electrode therapy device 1300 according to yet another embodiment is depicted, wherein the electrode strips 1366 of the electrode therapy device 1300 are shown in corresponding retracted and deployed configurations. Figure 21C This is a longitudinal cross-sectional view of the electrode deployment system 1310 of the electrode therapy device 1300. (See image.) Figures 22-25 As shown, the electrode deployment system 1310 can be attached to the endoscope 320. (Reference) Figures 22-24 As described in more detail below, the electrode deployment system 1310 may be positioned distal to the distal end 328 of the endoscope 320 and distal to the objective lens 392 of the optical imaging system 390 near the distal end 328, such that the electrode deployment system 1310 is within the field of view of the optical imaging system 390.

[0148] Common Reference Figures 21A-21C The electrode deployment system 1310 includes an actuable electrode winding mechanism 1330 that winds a flexible electrode (such as an electrode strip 1366) from a retracted configuration. Figure 21A Move to deployment configuration ( Figure 21B Conversely, the electrode strip 1366 is expanded from a retracted configuration to a deployed configuration. The electrode deployment system 1310 can be powered or otherwise driven to cause the electrode strip 1366 to switch between the retracted and deployed configurations. When attached to an endoscope, the electrode deployment system 1310 and the electrode winding mechanism 1330 remain attached to the endoscope (e.g., endoscope 320), as... Figures 22-23 As shown in the diagram. Electrode strip 1366 may include flexible printed circuitry, as previously described above with respect to electrode strip 366. In some embodiments, at least a portion of electrode strip 1366 may be made of a transparent or translucent flexible material as described above. In other embodiments, electrode strip 1366 may optionally be provided with a slot-shaped aperture 1356 cut through the flexible printed circuitry to provide the optical imaging system 390 with better visibility of tissue treatment sites (not shown) outside electrode strip 1366 when electrode strip 1366 is in a deployment configuration.

[0149] refer to Figure 21CThe actuating element 1314 of the electrode deployment system 1310 (e.g., one or more electric motors, helical spring motors, hydraulic rotary actuators, pneumatic rotary actuators, other motors or power drives, gears, pistons, rotatable shafts, etc.) may be at least partially housed within the housing 1316 of the electrode deployment system 1310, and the electrode strip 1366 may be at least partially coiled around and / or within the housing 1316. Positioning the actuating element 1314 (e.g., particularly the motor of an actuator) at least partially within the housing 1316 and the electrode strip 1366, rather than at or near the proximal portion 1304 of the control shaft 1370, can provide the user or system (e.g., robot-assisted or actuated) with more accurate or useful data—including (e.g., current, torque, opening distance of the electrode strip 1366)—to improve the operation and / or treatment (e.g., desired adequate tissue isotope) of the electrode therapy system 1310, as described below. The outer casing 1316 includes a first component 1340 (outer component) and a second component 1360 (inner component), the second component 1360 being disposed at least partially within a cylindrical cavity 1350 in the first component 1340.

[0150] In the illustrated embodiment, the proximal portion 1354 of the first member 1340 is attached to the distal portion 1372 of the control shaft 1370, for example by firmly pressing, welding, fastening, or otherwise securely attaching the first member 1340 to the control shaft 1370 to prevent rotation of the first member 1340 relative to the control shaft 1370. The control shaft 1370 may be, for example, a torque tube or other type of shaft or tube capable of providing sufficient torsional and bending stiffness to coil and unwind the electrode strip 1366 and position the electrode deployment system 1310 at a target location traversing a tortuous anatomical structure, as described in more detail below. Furthermore, as discussed below, the control shaft 1370 may also be translational or slidable to allow the operator to rotate the electrode deployment system 1310 rotatably, distally, and / or proximally—for example, by manipulating the handle 1392 of the electrode treatment device 1300 attached to the proximal portion 1304 of the control shaft 1370. Figures 22-25Alternatively, via a robot-assisted manipulator system attached to the proximal portion 1304 of the control axis 1370 and / or the handle 1392, as described above with respect to the electrode therapy device 300. An actuating element 1314 is operably inserted between the first member 1340 and the second member 1360, for example by securing a first end 1318 of the actuating element 1314 to the first member 1340 and coupling the second member 1360 to the output shaft 1334 of the actuating element (opposite to the first end 1318), such that operation of the actuating element 1314 causes the second member 1360 to rotate within the cavity 1350 relative to the control axis 1370 and the first member 1340 about the central axis 1374, as further described below.

[0151] Optionally, bearing 1376, a pair of PTFE O-rings as shown, may be inserted between the first member 1340 and the second member 1360, for example, around the proximal and distal ends of the second member 1360, as shown. Bearing 1376 reduces friction between the first member 1340 and the second member 1360 during operation of the actuation element 1314 for the deployment and shifting of the electrode strip 1366. Bearing 1376 also keeps the second member 1360 centered within the cylindrical cavity 1350 of the first member 1340 and provides a seal to inhibit or prevent (e.g., from the patient's body) fluid from reaching the actuation element 1314.

[0152] The proximal portion 1354 of the first member 1340 may be necked to achieve strength and provide an additional surface area for attachment of the control shaft 1370, in which the control shaft 1370 is press-fitted into an attachment hole 1308 in the proximal portion 1354. In the illustrated embodiment, the necked attachment hole 1308 is concentric with the first member 1340; and because the working channel 372 is eccentric to the longitudinal axis 376 of the endoscope 320, the electrode deployment system 1310 is mounted eccentrically to the distal end 328 of the endoscope 320. The control shaft 1370 may be hollow to accommodate wires 1380 or other control elements, as further described below, and may have a length ranging from 1 to 3 meters (m), or preferably about 1.8 m. The control shaft 1370 is preferably tubular, possessing sufficient torsional stiffness to support the delivery of torque to the second member 1360, and preferably sufficient flexibility / bendability to allow lateral displacement of the electrode deployment system during endoluminal navigation, yet rigid enough to maintain its shape, thereby facilitating maneuverability and navigation in the gastrointestinal region, duodenum, and particularly at the pylorus and duodenojejunal junction. For example, the control shaft 1370 may have a torque of 0.01 lb·in². 2 ) to 10 lb·in 2 (2.87x10) -5 N·m 2up to 0.0287 N·m 2 The bending stiffness (flexural stiffness) within the range of 10:1 to 1:1 and the ratio between absolute input rotation (from rest) and synthetic output rotation at the distal end of the 1.8 m long control shaft 1370.

[0153] In some embodiments (not shown), the attachment hole 1308 in the proximal portion 1354 of the first member 1340 can be offset eccentrically, thereby allowing adjustment of the lateral position of the electrode winding mechanism 1330 relative to the longitudinal axis 376 of the endoscope 320 by manual or robot-assisted rotation of the control axis 1370. For example, the attachment hole 1308 can be offset eccentrically from the central axis 1374 by a sufficient distance to align the electrode winding mechanism 1330 with the longitudinal axis 376 of the endoscope 320, which facilitates intracavitary navigation. In alternative embodiments, as referenced below... Figures 26-46 In the described embodiments, the control shaft 1370 is fixedly attached to the second member 1360, allowing the first member 1340 to rotate about and relative to the control shaft 1370 and the second member 1360. In some embodiments, the actuating element 1314 may be directly attached to the control shaft 1370 and may be connected, for example via a gear assembly, to one or both of the first member 1340 and the second member 1360, allowing one or both of the first member 1340 and the second member 1360 to rotate relative to the control shaft 1370. In yet another embodiment (not shown), the attachment hole 1308 may be obliquely positioned or arranged relative to the longitudinal axis 376, such that the electrode winding mechanism 1330 and its axis of rotation (coinciding with the central axis 1374) are aligned with... Figure 15 and Figure 16B The embodiment shown is similar in that it is angled relative to the longitudinal axis 376 of the endoscope 320.

[0154] A first member 1340 overlaps with a second member 1360 in an axial overlap region 1362, and an electrode strip 1366 is coiled around the axial overlap region 1362. The first member 1340 and the second member 1360 are configured and arranged to form an annular gap 1346 between the first member 1340 and the second member 1360 in the axial overlap region 1362. In the retracted configuration, at least a portion of the electrode strip 1366 is coiled in the annular gap 1346. A first end 1322 of the electrode strip 1366 is securely attached to the outer surface 1320 of the first member 1340, adjacent to a slot 1344 extending longitudinally through the first member 1340 in the axial overlap region 1362. A second end 1324 of the electrode strip 1366 is securely attached to the second member 1360. And when the actuating element 1314 is operated, the intermediate portion 1326 of the electrode strip 1366 between the first end 1322 and the second end 1324 is unwound and released from the annular gap 1346 through the slot 1344, thereby expanding the arrangement of the electrode strip 1366 to form a loop (or approximately a loop) in a deployment configuration around the electrode winding mechanism 1330, such as Figure 21B As shown in the illustration. In the illustrated embodiment, a first portion of the electrode strip 1366, including a second end 1324, is coiled around the second member 1360, while a second portion of the electrode strip 1366, including a first end 1322, extends partially around the first member 1340. (For brevity, see above references.) Figure 13A and Figure 13B The described winch effect means that the inner cylindrical surface of the first member 1340 may be lined with a PTFE strip or film, or coated with a lubricant such as KRYTOX grease. In other embodiments (not shown), the electrode strip 1366 may be at least partially coiled around the first member 1340, or may be coiled around both the first member 1340 and the second member 1360. The first end 1322 may be... Figure 13A and Figure 13B The same manner shown partially or completely overlaps with slot 1344.

[0155] In the illustrated embodiment, the actuating element 1314 is positioned within the first member 1340 and partially within the second member 1360. Therefore, in the embodiment where the electrode deployment system 1310 is attached to the endoscope 320 ( Figures 22-25In this configuration, an actuation element 1314 is disposed distal to the distal end 328 of the endoscope 320, the objective lens 392, and the optical imaging system 390, and an electrode strip 1366 is coiled around the actuation element 1314. Other configurations are also possible: for example, where the actuation element 1314 is positioned at least partially within the first member 1340 and outside the second member 1360, or where the actuation element 1314 is positioned at least partially within the second member 1360 but outside the first member 1340 (or at least outside the cavity 1350). The electric motor of the actuation element 1314 may have an outer diameter of approximately 6 to 8 mm and an internal gearbox having a gear ratio, for example, ranging from approximately 100:1 to 1000:1, or more preferably between approximately 550:1 and 700:1. In some embodiments, the actuation element 1314 may include a brushless DC motor, which includes position encoding of the output shaft 1334 for controlling electrode deployment. In another embodiment (not shown), the actuation element 1314 may include a miniature DC motor located in the control shaft 1370, and only the output shaft of the motor may extend beyond the control shaft 1370 and the distal end 328 of the endoscope 320.

[0156] In the illustrated embodiment, the actuating element 1314 is directly connected to the first member 1340 and the second member 1360, wherein the output shaft 1334 of the actuating element 1314 is keyed into a hole 1336 in the distal portion 1338 of the second member 1360 and optionally glued or otherwise securely coupled thereto. In other embodiments, the output shaft 1334 may be coupled to one or both of the first member 1340 and the second member 1360 via a mechanical power transmission device such as a belt or gear assembly. A cap 1332 is attached to the distal portion 1352 of the first member 1340 and includes an axial hole 1342 that rotatably supports the second end 1338 for rotation therein.

[0157] Electrode strip 1366 may include a single electrode for unipolar operation or two electrodes for bipolar operation, or more than two electrodes, as referenced above. Figure 9 Described, Figure 9Electrodes 510 and 520 of electrode strip 366 are described. The flexible printed circuit including electrode strip 1366 may further include lead tabs 1328 connected to and extending longitudinally from electrode strip 1366. Lead tabs 1328 may extend into a recess 1358 in a proximal portion 1354 of first member 1340 and may terminate in electrical connector assembly 1382 to facilitate electrical connection of lead tabs 1328 to one or more wires 1380 extending through control shaft 1370. Electrical connector assembly 1382 may include a first connector 1384 attached to lead tab 1328 and configured to mate with a second connector 1386 attached to one or more wires 1380. In other embodiments, wires 1380 may be directly connected to lead tab 1328, for example, via solder joints. During the manufacture of the electrode deployment system 1310, the arrangement of the open recess 1358 allows the lead tab 1328 to be connected to a wire 1380 outside the recess 1358 (e.g., using an electrical connector assembly 1386 or by direct connection to the wire). The lead tab 1328 (and the electrical connector assembly 1386, if present) are then placed into the recess 1358, and the wire 1380 is then threaded through the control shaft 1370. Additional wires 1380 extending through the control shaft 1370 may be directly or indirectly connected to the actuator 1314 for operating the actuator 1314, as further described below. After assembling the electrode deployment system 1310 and connecting the wire 1380 to the actuator 1314 (e.g., with an electrical connector assembly 1382), the recess 1358 may be filled with resin or sealant to prevent fluid from contacting the electrical connector assembly 1382 and the actuator 1314. Cable 1380 is directly or indirectly connected to the controller at the proximal portion 1304 of control shaft 1370 (e.g., Figure 1 Controller 14 or Figure 2 The control system 112) and the power supply of the system (e.g., Figure 1 The controller and / or power supply provide energy to the electrode strip 1366 for electrosurgical tissue treatment (such as electrolysis or electroporation) and / or sensing the electrophysiological state of the tissue. The controller and / or power supply may also provide power to operate the actuation element 1314. Alternatively, a separate second controller and second power supply may provide power to the actuation element 1314.

[0158] like Figures 22-25As shown, the electrode deployment system 1310 can be attached to the endoscope 320 via a control axis 1370 extending through the working channel 372 of the endoscope 320. The control axis 1370 is slidable within the working channel 372 to allow an operator to rotatably move the electrode deployment system 1310 relative to the endoscope 320, distally and / or proximally—for example, by manipulating a handle 1392 of the electrode treatment device 1300 attached to the proximal portion 1304 of the control axis 1370, or by manipulating a robot-assisted manipulator system attached to the proximal portion 1304 of the control axis 1370 and / or the handle 1392, as described above with respect to the electrode treatment device 300. In other embodiments (not shown), the electrode deployment system 1310 can be attached to the endoscope 320 by attaching the control axis 1370 to one side of the endoscope (as described above with respect to the endoscope 300). Figure 17 and Figure 18 In other embodiments, the installation of the inflatable hose 1070 is similar. In still other embodiments, the electrode deployment system 1310 may be provided separately from and in conjunction with the endoscope 320, mounted on the endoscope 320, and / or both (e.g., separately, but some procedures are used in conjunction with it while others are mounted on the endoscope).

[0159] Go to Figure 25A wire 1380 extending through the control shaft 1370 connects to an electrical connector 1390 near or within the proximal portion 1304 of the control shaft. The electrical connector 1390 can be attached to the proximal portion 1304. The electrical connector 1390 may include an audio (phone) connector (also known as a headphone jack), such as a subminiature audio connector, for example, a 2.5 mm diameter 4-conductor TRRS audio connector plug. Axially mounting the subminiature electrical connector 1390 to the control shaft 1370 allows the control shaft 1370 to be mounted and loaded from the distal end 328 of the endoscope 320 into the working channel 372 (e.g., in a distal-to-proximal direction). In other embodiments (not shown), nano-scale circular connectors or other non-coaxial connectors may be used for the electrical connector 1390. After the control shaft 1370 is slidably loaded into the working channel 372, the electrical connector 1390 is inserted into a control system (not shown), which controls the power supply to power the actuator 1314 and the electrode strip 1366. The control system may be part of or adjacent to a robot-assisted manipulator system. Because the electrical connector 1390 is located at the proximal portion 1304 of the control shaft 1370, the mating connector of the controller (to which the electrical connector 1390 is connected) does not need to be sterile when the electrode therapy device 1300 is used in conjunction with a robot-assisted manipulator system. In some embodiments, a handle 1392 is attached to the control shaft 1370 before the controller cable is connected to the electrical connector 1390. An opening 1394 is provided in the handle 1392 to allow the mating connector (not shown) on the cable to couple to the electrical connector 1390.

[0160] Electrode therapy device 1300 may further or alternatively include one or more features that are wholly or partially the same as or similar to other electrode therapy devices described herein (e.g., electrode therapy devices 300, 600, 700, 800, 900, 902, 1000, 1200, 1400, 1400', 1400a-c, 1600, 1600', 2000, 2100, 2200, 2300 and 2400).

[0161] Therefore, the method of deploying electrodes may include the following steps: (1) loading the electrode treatment device 1300 onto the endoscope 320 by: (a) inserting the control shaft 1370 into the working channel 372 via an opening at the distal end 328 of the endoscope 320, and (b) sliding the control shaft 1370 through the working channel 372 (e.g., in a direction from distal to proximal) until the control shaft 1370 extends beyond the proximal end 1306 of the endoscope 320 (FIG. 21) and the electrode deployment device 1310 is positioned distally adjacent to the distal end 328; then (b) electrically connecting a power source to the proximal portion 1304 of the control shaft 1370, for example by coupling an electrical connector 1390 to a mating electrical socket connector of a controller connected to a power source. Once connected, the electrode deployment device 1310 can be operated to move the electrode strip 1366 between a retracted configuration and a deployed configuration, as described above with reference to FIG. 21 and Figure 22 As described. In order to facilitate the insertion of the control shaft 1370 into the general endoscope 320 and its sliding through the working channel 372, the control shaft may have an outer diameter between 2.5 mm and 4.0 mm, or more preferably about 2.7 mm (+ / - 0.1 mm).

[0162] The method of deploying electrodes may also involve an automatic or semi-automatic method of controlling the electrode strip 1366 to change from a retracted configuration to a deployed configuration. In a first step, the actuating element 1314 is initially activated, for example by an activation signal generated by a user pressing a control button (e.g., a short press). Once initially activated, the actuating element 1314 causes the electrode strip 1366 to unwind or otherwise deploy. When the actuating element 1314 operates to unfold the electrode strip 1366, the controller (e.g., Figure 1 Controller 14 or Figure 2The control system 112 senses and monitors the current supplied to the actuating element 1314. When the electrode strip is in place with the tissue, a larger load is generated at the actuating element 1314, thereby increasing the current drawn by the actuating element 1314. The controller senses the current supplied to the actuating element 1314 and automatically cuts off the current (i.e., cuts off the power to the electric motor of the actuating element 1314) when the current drawn by the actuating element 1314 exceeds a predetermined threshold indicating tissue placement. Monitoring elapsed time and / or visual observation may also be used in conjunction with sensing the current, or in addition to sensing the current, monitoring elapsed time and / or visual observation may be used to determine when to cut off the current to achieve the target or desired placement force or pressure against the target tissue, and / or as a safety mechanism (e.g., over-deployment of the electrode strip 1366). Therefore, the deployment of the electrode strip 1366 can be automatically stopped according to the method of this disclosure. After the initial deployment is stopped, the user may further press the control button once or multiple times (e.g., using the same short press as used in the initial activation and deployment sequence), and with each further short press of the button, a step signal is generated that selectively activates the actuator 1314 at predetermined intervals, thereby progressively deploying the electrode strip 1366 until it is visually observed by the endoscope 320 or otherwise confirmed to be adequately aligned with the target tissue. The initial activation signal and the step signal (one or more) may be the same. Both the step of activating the actuator 1314 and the step of further progressively activating the actuator 1314 will cause the actuator 1314 to operate in a first direction.

[0163] After deployment, electrical energy can be applied to the electrode strip 1366 to perform therapeutic or sensing operations on the target tissue. After treatment or sensing of the tissue, the electrode strip 1366 can be returned to a retracted configuration by activating the actuator 1314 in a second direction opposite to the first direction to coil or otherwise wind up the electrode strip 1366. The actuator 1314 can be activated at any time in the second direction to retract the electrode strip 1366 by sending a retraction signal to the controller. The retraction signal can be generated by a user pressing a button for a prolonged period (significantly different from and longer than a short press), or by some other control device or method, such as by a computerized response to an unsafe condition. For safety reasons, the retraction signal and the operation in the second direction can be initiated at any time—including during the initial activation of the motor in the first direction or its subsequent steps.

[0164] The deployment and operation of the electrode therapy device 1300 may further include many other optional steps and processes that will be understood by those skilled in the art.

[0165] Now go to Figures 26-29BAnother embodiment of the electrode therapy device 1400 includes an electrode deployment system 1410, wherein an actuating element 1414 (e.g., one or more electric motors, helical spring motors, hydraulic rotary actuators, pneumatic rotary actuators, other motors or power drives, gears, pistons, rotatable shafts, etc.) is at least partially positioned within an electrode winding mechanism 1430, the electrode winding mechanism 1430 including a first member (outer member) 1440 arranged to rotate about a second member (inner member) 1460 fixed to a control shaft 1470 (e.g., opposite to the electrode winding mechanism 1330).

[0166] refer to Figure 27 and Figure 28 The actuable electrode winding mechanism 1430 moves the flexible electrode (such as electrode strip 1466) from its retracted configuration. Figure 26 and Figure 27 (As shown) Move to the deployment configuration (not shown, but see [link]). Figure 21B Conversely, the electrode strip 1466 is expanded from a retracted configuration to a deployed configuration. The electrode deployment system 1410 can be powered or otherwise driven to cause the electrode strip 1466 to switch between the retracted and deployed configurations. The electrode strip 1466 may have the features described above. Figure 9 and Figures 22-24 The electrode strip 1366 described or referenced below Figures 49-51 The electrode strip 2466 may have one or more of the features described above; and the actuating element 1414 may have the features described above. Figure 21C One or more of any of the features of the described actuating element 1314. The housing 1416 includes a first member 1440 and a second member 1460, wherein the second member 1460 is at least partially disposed within a cylindrical cavity 1450 in the first member 1440.

[0167] The proximal portion 1454 of the second member 1460 is attached to the distal portion 1472 of the control shaft 1470, for example, by firmly pressing, welding, fastening, or otherwise securely attaching the second member 1460 to the control shaft 1470 to prevent rotation of the second member 1460 relative to the control shaft 1470 (e.g., such that the second member 1460 is rotatably fixed in place relative to the first member 1440 and the control shaft 1470). Figure 41AIn the embodiment shown in the exploded view, as further described below, the distal portion 1472 of the control shaft 1470, or the distal portion 1472 of the flexure shaft passing through it, includes a key 1404 that engages with a corresponding keyway 1406 in the proximal portion 1454 of the second member 1460, thereby facilitating the transmission of torque from the control shaft 1470 (or the flexure shaft passing through it) to the second member 1460. The control shaft 1470 is also, for example, securely connected by a press-fit to the cover 1412 or protective shield of the electrode treatment device 1410 (in... Figure 26 (Seen in dashed lines). Control axis 1470 may be, for example, a torque tube or other type of shaft or tube. Control axis 1470 may be translational or slidable to allow an operator to rotatably move electrode deployment system 1410 distally and / or proximally—for example, by manipulating a handle of electrode treatment device 1400 attached to the proximal portion of control axis 1470, or by manipulating a robot-assisted manipulator system attached to the proximal portion of control axis 1470 and / or handle, as described above with respect to electrode treatment devices 300 and 1300. Control axis 1470 may be hollow to accommodate wire 1480 or other control elements, and may have the features described above. Figure 21C and Figures 22-24 The control axis 1370 may have one or more of any other features and characteristics described therein. Similarly, the wire 1480 may have the same characteristics as described in the control axis 1370. Figure 21C and Figures 22-24 The wire 1380 of the embodiment has one or more of the same characteristics, functions and purposes (e.g., for coupling electrode strip 1466 and / or actuation element 1414 to one or more controllers and / or power sources to provide energy to electrode strip 1466 for electrosurgical tissue treatment (such as electrolysis or electroporation) and / or to sense the electrophysical state of tissue and / or to provide power to operate actuation element 1414).

[0168] and Figures 22-24 The embodiment of the electrode deployment system 1310 is the same. Figure 25-Figure 2 The electrode deployment system 1410 of the 9 can be attached to the endoscope 320. After being attached to the endoscope 320, the electrode deployment system 1410 is positioned distal to the distal end 328 of the endoscope 320 and near the objective lens of the distal end 328. Figure 24 Distal to the endoscope 392), such that the electrode deployment system 1410 is positioned within the optical imaging system of the endoscope 320 (e.g., Figure 2 109 in the middle, and Figure 24 (390 in the middle) or visualization system (e.g., Figure 3A Within the field of view of 231).

[0169] Electrode deployment system 1410 can be referenced above. Figures 22-25A similar manner (e.g., in a direction from distal to proximal) is used to attach the control axis 1470 to the endoscope 320 via the working channel 372, providing the same or similar functionality as described above. In other embodiments, the electrode deployment system 1410 may be attached to one side of the endoscope 320. In still other embodiments, the electrode deployment system 1410 may be provided as separate from and in conjunction with the endoscope 320, mounted on the endoscope 320, and / or both (e.g., separate, but some procedures are used in conjunction with it while others are mounted on the endoscope).

[0170] An actuating element 1414 is operably inserted between a first member 1440 and a second member 1460, for example, by securing a first end 1418 of the actuating element 1414 to the second member 1460 and coupling an output shaft 1434 of the actuating element (opposite to the first end 1418) to the first member 1440, such that operation of the actuating element 1414 causes the first member 1440 to rotate about a central axis 1474 relative to the control shaft 1470, the second member 1460, and the cover 1412, for winding and unwinding the electrode strip 1466, as further described below. The output shaft 1434 may be coupled to the first member 1440 via a gear set 1550 (or gear train) or other coupling structure, as referred to below. Figures 28-30 Described.

[0171] and Figures 22-24 The implementation is the same as the previous one. Figures 26-28 In one embodiment, a first member 1440 overlaps with a second member 1460 in an axial overlap region 1462, and an electrode strip 1466 is coiled around the axial overlap region 1462. The first member 1440 and the second member 1460 are configured and arranged to form an annular gap 1446 between the first member 1440 and the second member 1460 in the axial overlap region 1462. In a retracted configuration, at least a portion of the electrode strip 1466 is coiled in the annular gap 1446. A first end 1422 of the electrode strip 1466 is securely attached to the outer surface 1420 of the first member 1440, adjacent to a slot 1444 extending longitudinally through the first member 1440 in the axial overlap region 1462. A second end 1424 of the electrode strip 1466 is securely attached to the second member 1460. And when the actuating element 1414 is operated, the intermediate portion 1426 of the electrode strip 1466 between the first end 1422 and the second end 1424 is unwound and released from the annular gap 1446 through the slot 1444, thereby expanding the arrangement of the electrode strip 1466 to form a loop (or approximately a loop) in a deployment configuration around the electrode winding mechanism 1430. Figures 26-28In the illustrated embodiment, a first portion of the electrode strip 1466, including a second end 1424, is coiled around a second member 1460, while a second portion of the electrode strip 1466, including a first end 1422, extends partially around a first member 1440. (For brevity, see above references.) Figure 13A and Figure 13B The described winch effect means that the inner cylindrical surface of the first member 1440 may be lined with a PTFE or other low-friction material sleeve 1448 or film, or coated with a lubricant such as KRYTOX grease. The first end 1422 can be coupled with... Figure 13A and Figure 13B The same manner shown partially or completely overlaps with slot 1444.

[0172] Electrode strip 1466 may include a single electrode for unipolar operation or two electrodes for bipolar operation, or more than two electrodes, and may have the same features as described above. Figures 22-24 Electrode strip 1366 or Figure 9 The same properties or characteristics are described in electrode strip 366.

[0173] Bearings 1476 (a pair of PTFE O-rings as shown) may be inserted between the first member 1440 and the second member 1460, for example, around the proximal and distal ends of the second member 1460, as shown. Each bearing 1476 may be located in a retainer, such as formed on the outer surface of the second member 1460 (e.g., Figure 27 The annular recess 1478 in the inner surface (not shown) of the first member 1440 or the annular recess 1478 in the first member 1440. Figure 37 The bearing 1476 reduces friction between the first member 1440 and the second member 1460 during operation of the actuation element 1414 for the deployment and shifting of the electrode strip 1466. The bearing 1476 also allows the first member 1440 to rotate relative to the second member 1460. The bearing 1476 also holds the second member 1460 centered within the cylindrical cavity 1450 of the first member 1440 and provides a seal to inhibit or prevent (e.g., from the patient's body) fluid from reaching the actuation element 1414. When in... Figure 27 In the position shown, additional O-ring seals 1488 can create a fluid seal between the gear set 1550 and the first member 1440. The O-ring seals 1488 can be located in an annular groove 1468 formed in the member of the gear set 1550. Figure 28-Figure 2 9), to help keep the second component 1460 adjacent to the distal portion 1452 of the first component 1440 during normal operation.

[0174] refer to Figure 27 , Figure 28 and Figure 40The cap 1432 is attached to the distal portion 1452 of the first member 1440, for example, by adhesive, welding, or otherwise removably or securely securing the cap 1432 against the distal portion 1452. The cap 1432 may include an axially centered hole 1442. Figure 27 and Figure 40 When the cap 1432 is attached to the distal portion 1452 of the first member 1440, the retaining groove 1428 ( Figure 27 An O-ring seal 1488 is formed therein, and is partially received or located within the retaining groove 1428. For example... Figure 40 As best shown, the cap 1432 and the distal portion 1452 may include key lock features that mate together during assembly to ensure proper alignment. For example, the cap 1432 may include one or more key lock lugs 1456 (two in the illustrated embodiment), each key lock lug slidably engaging a corresponding key lock slot 1458 formed on the distal portion 1452 of the first member; and the distal portion 1452 may include one or more key lock pins 1482 (two in the illustrated embodiment), each key lock pin slidably inserted into a corresponding key lock hole 1484 in the cap 1432.

[0175] Actuation element 1414 may be positioned within or partially within the first member 1440, and within or partially within the second member 1460. Thus, in an embodiment where electrode deployment system 1410 is attached to endoscope 320, actuation element 1414 is positioned distal to the distal end 328 of endoscope 320, and electrode strip 1466 is coiled around actuation element 1414. Other configurations are also possible: for example, where actuation element 1414 is positioned at least partially within the first member 1440 and external to the second member 1460, or where actuation element 1414 is positioned at least partially within the second member 1460 but external to the first member 1440 (or at least external to cavity 1450), or adjacent to the first member 1440 and the second member 1460, as referenced below. Figures 31-33 The actuating element 1414 may include an electric motor having the characteristics described above. Figure 21C and Figures 22-24 The characteristics described for the motor of the actuator element 1314 in the embodiment are the same.

[0176] exist Figure 27-Figure 2 In the embodiment shown in 9, the actuating element 1414 is positioned within the second member 1460 and is fixed thereto, for example, by adhesive or with potting material 1496. The output shaft 1434 of the actuating element 1414 extends in the distal direction through an opening 1436 at the distal portion 1438 of the second member 1460. Figure 37And engage gear set 1550, which will now be described.

[0177] exist Figure 27 , Figure 28 , Figure 29A and Figure 29B In the embodiments shown, and especially with reference to Figure 28 , Figure 29A and Figure 29B The gear set 1550 includes a planetary gear train in the form of a planetary gear set. This planetary gear train includes a sun gear 1560 attached to the output shaft 1434 of an electric motor of actuator 1414, and a plurality of planetary gears 1570 mounted on a second member 1460 and meshing with the sun gear 1560. The planetary gears 1570 also mesh with a ring gear 1580, which is formed on the inner annular surface of the distal portion 1452 of the first member 1440 and surrounds the set of sun and planetary gears. The output shaft 1434 can be keyed into a hole 1562 in the sun gear 1560 for slip-free torque transmission. For example, both the output shaft 1434 and the hole 1562 can have a D-shaped cross-section. The hole 1562 can extend completely through the sun gear 1560 and can be axially longer than the output shaft 1434, leaving the distal end of the hole 1562 accessible at the distal portion 1568 of the sun gear 1560. The sun gear 1560 is preferably attached to the output shaft 1434, for example by press-fit, bonding, or fastening, to prevent the sun gear 1560 from slipping off the output shaft 1434. In the example shown, the gear set 1550 includes five planetary gears 1570, each of which is mounted on a pin 1572, which is secured to a series of holes or grooves 1574 formed in the distal portion 1438 of the second member 1460. Figure 28 , Figure 37 In one of the following embodiments, however, more or fewer planetary gears 1570 may be used depending on the desired gear reduction ratio. The sun gear 1560 may include a flange 1564 or other retaining features that hold the planetary gear 1570 on the pin 1572 and the second member 1460. The sun gear 1560 may also include an annular groove 1468 and an O-ring seal 1488. Figure 27 The output shaft 1434 typically resides within the annular groove 1468. Rotation of the output shaft 1434 causes the sun gear 1560 to rotate relative to the second member 1460, but because the planet gear 1570 is carried by the pin 1572 attached to the second member 1460, the planet gear 1570 does not orbit or revolve around the sun gear 1560. Instead, the rotation of the planet gear 1570 and its engagement with the annular gear 1580 cause the first member 1440 to rotate around the second member 1460.

[0178] The gear reduction provided by the gear set 1550 slows down the unfolding and rolling of the electrode strip 1466 between the retracted and deployed states, reduces the load on the actuator 1414, and increases the effective output torque on the first member 1440, which provides improved control over the deployment of the electrode strip 1466.

[0179] Figure 30 Another embodiment of the electrode therapy device 1400' shown is similar to Figure 26-Figure 2 The electrode therapy device 1400 is identical to that of the 9th generation, except that the planetary gear set 1550 is replaced by a direct drive coupling structure to rotatably couple the output shaft 1434 and the first component 1440. For example, the planetary gear set 1550 can be replaced by a single spur gear 1550'. (See reference...) Figure 30 The spur gear 1550' is attached to the output shaft 1434 of the actuator 1414 and meshes with the ring gear 1580 in the first member 1440 via a spline structure to establish a direct drive coupling structure between the output shaft 1434 and the first member 1440. The spur gear 1550' is preferably attached to the output shaft 1434, for example by press-fit, bonding, or fastening, to prevent the spur gear 1550' from slipping off the output shaft 1434.

[0180] In other embodiments (not shown), the output shaft 1434 may be coupled to the first member 1440 via different mechanical power transmission devices (such as a drive belt or different types of gear assemblies).

[0181] Now go to Figures 31-33 Actuating elements (e.g., electric motors) can be integrated with the electrode winding mechanism of the electrode deployment system described herein in various ways. For example, as... Figure 31 As shown, the actuating element 1414a of the electrode deployment system 1410a of the electrode treatment device 1400a is coupled with... Figure 21C , Figures 22-24 and Figures 27-30 The embodiments are positioned within the electrode winding mechanism 1430a in the same or similar manner. Alternatively, as in other embodiments... Figure 32 As shown, the actuating element 1414b can be positioned adjacent to the proximal portion 1408b of the electrode winding mechanism 1430b and its first and second components, thereby achieving a smaller overall diameter (e.g., relative to) the electrode treatment device 1400b. Figure 31(Electrode therapy device 1400a). The output shaft 1434b of the actuating element 1414b—which is much thinner than its body—may extend partially into or through the electrode winding mechanism 1430b to couple with the first and / or second components of the electrode winding mechanism 1430b (e.g., via a power transmission device such as a gear set (not shown), thereby actuating the inner first component and / or the outer second component of the electrode winding mechanism 1430b for deploying the electrode strip 1466b. Figure 33 Other alternative embodiments are shown, in which the actuating element 1414c is positioned adjacent to the distal end of the electrode winding mechanism 1430c and its first and second components. Figure 32 Similar to the embodiments described above, the output shaft 1434c of the actuating element 1414c may extend partially into or through the electrode winding mechanism 1430c to be optionally coupled to a first and / or second member of the electrode winding mechanism 1430c via a power transmission device (not shown). The smaller diameter profiles of the electrode treatment devices 1400b and 1400c relative to the electrode treatment device 1400a improve their ability to pass through narrow cavities, channels, or tubes within the patient's body to better reach some treatment locations, but at the cost of an increased overall length relative to the electrode treatment device 1400a, which may affect maneuverability in some cases.

[0182] In other embodiments (not shown), a separate motor or other independent actuating element may be provided as a separate tool and carried by a second bearing inserted through the second working channel of the dual-channel endoscope. The independent actuating element will be coupled to a separate unpowered electrode winding mechanism or electrode deployment mechanism to provide prime drive for deploying and retracting the electrodes of the assembly. This arrangement, compared to other arrangements, allows for a significant reduction in the overall width profile of the assembly.

[0183] Figure 34 Another embodiment of the electrode therapy device 1600 is shown, which includes an electrode deployment system 1610 optionally carried by an endoscope 320, wherein the instrument head 1602 of the electrode deployment system 1610 (e.g., an electrode coiling mechanism) is positioned distal to the distal end 328 of the endoscope 320. Reference Figure 34The actuating element 1614 of the electrode deployment system 1610 is positioned at the proximal end 1606 of the electrode treatment device 1600 (e.g., the proximal end of the endoscope 320 or catheter 1670), rather than inside, near, or partially inside the instrument head 1602. This configuration creates an opportunity for a reduction in the size of the instrument head 1602, as there is no longer space required for the actuating element, allowing the electrode treatment device 1600 to be used within smaller diameter anatomical structures. In this embodiment, the rotational output of the actuating element 1614 is transmitted via a flexible torque transmission shaft 1608 (commonly referred to as a flexure shaft) passing through the catheter 1670 to the electrode coiling device 1630 at the distal instrument head 1602 of the electrode deployment system 1610. These types of flexible drive shafts are commonly used in medical devices such as rotational atherosclerosis resection devices operating at rotational shaft speeds exceeding 100,000 RPM, thereby delivering considerable mechanical power to the distal end of the device. Shaft 1608 may be constructed from multiple generally metallic wires spirally wound one or more layers around a central core or a central rope core also composed of multiple wound wires. Alternatively, shaft 1608 may be constructed as a torque coil having one or more layers of wire wound around a central hollow lumen. In further embodiments, shaft 1608 may comprise a flexible hypo tube made of stainless steel or nitinol, which may be laser-cut to enhance flexibility. In its simplest form, shaft 1608 can comprise a single solid wire, for example made of nitinol, wired through conduit 1670. In further embodiments, combinations of different types of flexural shafts may be used for shaft 1608, such as, for example, a hypo tube with a torque coil welded to its distal end, to enhance flexibility where shaft 1608 exits the distal end 328 of endoscope 320. The diameter of such a solid or hollow flexible drive shaft may range from 0.2 mm to up to 6 mm, depending on the anatomical structure being treated and the torque required (e.g., for electrode strip deployment).

[0184] Actuating element 1614 may include a DC electric motor or other suitable motor, for example, mounted inside the handle 1692 of the electrode therapy device 1600 or as part of a robotic manipulator. Because it is located outside the instrument head 1602, the motor of actuating element 1614 can be larger and more powerful (e.g., relatively...). Figure 21C , Figures 22-24 and Figures 27-30 The embodiment includes an actuating element 1414, wherein the actuating element 1414 is at least partially located within the instrument head or winding mechanism. This increased power can be delivered via high-speed, low-torque rotation of the shaft 1608, and then converted into low-speed, high-torque rotation via a compact reduction gear system located in the instrument head 1602.

[0185] exist Figure 34In the illustrated embodiment, shaft 1608 drives the sun gear 1622 of planetary gear set 1624 located inside instrument head 1602. Planetary gear set 1624 is coupled to first member 1640 via ring gear 1626 formed on the inner annular surface of first member 1640. Planetary gear set 1624 may be similar to Figure 27-Figure 2 The gear set 1550 shown in 9 is constructed to achieve this.

[0186] Actuating element 1614 and shaft 1608 can also be used with other types of torque-increasing mechanical power transmission systems. For example, such as Figure 35 As shown in the electrode therapy device 1600', shaft 1608 can be coupled to gearbox 1628 located within second member 1660, gearbox 1628 engaging with gear set 1624' (gear set 1624' can be a direct drive coupling structure or a torque-reducing planetary gear set). For example, gearbox 1628 can be a set of custom spur gears or a packaged commercial gearbox. Other types of torque-increasing gear systems can be used for gearbox 1628. Such gear systems are known in the art and include worm gears, bevel gears, bevel gears, strain wave gears, wheel drives, or combinations of such gear systems.

[0187] exist Figure 34 and Figure 35 In the illustrated embodiment, the output shaft 1634 of the actuator 1614 is directly connected to the drive shaft 1680. However, in other embodiments, the position of the actuator 1614 at the proximal end 1606 of the electrode treatment devices 1600, 1600' allows for the use of an output gear set (not shown) to couple the output shaft 1634 to the shaft 1680 and increase the torque output by the output shaft 1634 to ensure sufficient torque is delivered to the electrode winding mechanisms 1630, 1630'.

[0188] In another embodiment (not shown), shaft 1608 can directly drive the rotation of the first member 1640 or the second member 1660, such that one rotation of shaft 1608 imparts one rotation to the first member or the second member. For example, shaft 1608 can be driven via a direct drive coupling structure (such as...) Figure 30 The spur gear and ring gear coupling structure shown is coupled to the first member 1640.

[0189] Placing the actuating element 1614 outside the instrument head 1602 and at the proximal end 1606 of the electrode treatment device 1600 also enables different types of actuation besides shaft-driven actuation, such as hydraulic or pneumatic actuation. For example, instead of the torque transmission shaft 1608, power can also be transmitted from the actuating element 1614 to the electrode winding mechanism 1630 (shaft 1608 omitted) via a fluid charge within the conduit 1670. In such an embodiment, fluid is pumped or its pressure is otherwise controlled via the actuating element 1614 and converted into mechanical driving force via a hydraulic or pneumatic power transmission element at the electrode winding mechanism 1630.

[0190] Figures 36-39 Details of the second member 1460 and electrode strip 1466 for facilitating a secure attachment of the second end 1424 of electrode strip 1466 to the second member 1460 are shown. In some embodiments, similar methods and structures described below can be used to facilitate a secure attachment of the first end 1422 of electrode strip 1466 to the first member 1440. Reference Figure 36 The outer surface of the second member 1460 may include an anchoring surface 1702. The anchoring surface may include an array or pattern of recesses 1704 that can be molded into the anchoring surface 1702. In some embodiments, the recesses 1704 or other texturing on the anchoring surface 1702 may improve the adhesion of the adhesive material or other substrate material that secures the second end 1424 of the electrode strip 1466 to the second member 1460, as further described below. In other embodiments, the second end 1424 of the electrode strip 1466 may be secured to the anchoring surface 1702 by heat staking, ultrasonic welding, laser welding, overmolding, or other methods. The anchoring surface 1702 may be defined by ribs or frames 1708 for aligning the edges of the second end 1424 with the second member 1460 during assembly.

[0191] Retaining slots 1712, 1714 formed in the respective proximal portions 1454 and distal portions 1438 of the second member 1460 may abut the anchoring surface 1702. One or more of the retaining slots 1712, 1714 may be closed slots (as shown in retaining slot 1714), and one or more of the retaining slots 1712, 1714 may be open slots (as shown in retaining slot 1712). When the electrode strip is attached to the second member 1460, retaining lugs 1722, 1724 are sized to fit within the respective retaining slots 1712, 1714, as shown in the image. Figure 38As shown, this is to improve mechanical coupling and retention during the deployment and winding of electrode strip 1466. Electrode contact pads 1730 for each electrode of electrode strip 1466 may be positioned on or above a retaining lug proximal to the retaining lug 1724 and staggered to prevent (e.g., by soldering, electrical connectors, or other means for electrical connections to wires or other electrical conductors) short-circuiting of the electrical connection formed with it.

[0192] In some embodiments, the electrode strip 1466 may be fixed to the anchoring surface 1702 by an adhesive material (such as epoxy resin or other resin), and the pits 1704 or other textures on the anchoring surface 1702 may improve the adhesive strength and shear strength of the bond. Similarly, the inward-facing bottom surface 1746 of the second end 1424 of the electrode strip 1466 may be textured to improve adhesion, for example by molding, punching, laser etching, chemical etching, or sandblasting of the bottom surface 1746. Figure 39 As depicted in the diagram, injection port 1750 may be provided in the second component 1460 for injecting components of adhesive material or other substrate material, or multi-component adhesive material or substrate material (such as epoxy resin), into the interface between the base surface 1746 and the anchoring surface 1702. Injection ports 1750 and 1752 may allow delivery of adhesive or other substrate material after the electrode strip 1466 is properly assembled and aligned on the second component 1460, thereby allowing additional time for component assembly and alignment before the application of adhesive material or other fast-curing substrate material, and additional time for final assembly after the application of adhesive material or other substrate material. Injection ports 1750 and 1752 may also allow some components of the electrode deployment system 1410 to be isolated from other components; enable more targeted and consistent dispensing of adhesive material or other substrate material; and prevent excess adhesive material or other substrate material from being discharged from the anchoring surface 1702 or transferred to other adjacent surfaces. The inlet opening 1756 may be located on the side of the second member 1460 opposite to the injection port 1750 to allow the syringe nozzle of the adhesive applicator (not shown) to be inserted therethrough, thereby reaching the injection port 1750 from inside the second member 1460. The injection ports 1750, 1752 and the inlet opening 1756 may also allow for targeted dispensing of grease during the assembly of the electrode deployment system 1410.

[0193] refer to Figure 41A and Figure 41BThe control shaft 1470 may include a key 1404 at its distal portion 1472. The key 1404 is sized to fit through a keyway 1406 in the proximal portion 1454 of the second member 1460. The control shaft 1470 is first inserted into the second member 1460 by fully inserting the key 1404 through the keyway 1406, and then the control shaft 1470 is rotated to offset the key 1404 relative to the keyway, thereby coupling the control shaft 1470 to the second member 1460. (Reference) Figure 41B A notch 1486 is formed in the inner surface 1490 of the end wall of the proximal portion 1454 and adjacent to the keyway 1406. The notch 1486 is sized to receive the key 1404 and includes a stop 1492 for limiting rotation of the key 1404. After the control shaft 1470 and the key 1404 are rotated into position with the key 1404 adjacent to the stop 1492, the cavity 1494 (or its proximal portion) of the second member 1470 can be filled with resin, adhesive, or other curable material (not shown) to secure the control shaft 1470 to the second member 1460, with the key 1404 located in the notch 1486. ​​The keyway 1406 may also be filled with resin or other curable material. The resin or other curable material can be injected, for example, via the inlet opening 1756 or via the distal end of the second member 1460. The robust mechanical connection achieved by this coupling arrangement provides enhanced tensile strength and excellent torque transmission from the control shaft 1470 to the second member 1460. The torsional coupling between the control shaft 1470 and the second member 1460—whereby the radially extending key 1404 on the control shaft 1470 mates with the notch 1486—can be considered a bayonet mount or a semi-bayonet mount. Other torsional or non-torsional mechanical coupling arrangements can alternatively be used for a robust connection between the control shaft 1470 and the second member 1460.

[0194] Now go to Figures 42-43 Embodiments of electrode therapy devices 1800 and 1900 with cleanliness features will be described. (See reference...) Figure 42 and Figure 43 Each of the electrode therapy devices 1800 and 1900 includes electrode deployment systems 1810 and 1910, respectively, having cleaning strips 1820 and 1920, respectively. However, they can also be configured in the same or similar manner as any of the electrode deployment systems 310, 610, 710, 810, 910, 912, 1010, 1110, 1210, 1310, 1410, 1410', 1610, 1610', 2010, 2110, 2210, 2310, and 2410 described herein. When the electrode strip 1466 is unwound and coiled between a deployed state and a retracted state, the cleaning strips 1820 and 1920 are provided for mechanically wiping and cleaning the electrode strip 1466 (for clarity, from...). Figures 42-43 Electrode strip 1466 is omitted. Figure 42 In one embodiment, the cleaning strip 1820 of the electrode deployment system 1810 includes a cleaning brush mounted to one or both sides of the first member 1440 along a slot 1444 formed in the first member 1440 (for clarity, Figure 42 Only one brush is shown in the image. The cleaning brush may be the same as or similar to a brush section of, for example, a medical cleaning brush, an endoscope cleaning brush, or an endoscopic cytology brush. Figure 43 In one embodiment, the cleaning strip 1920 of the electrode deployment system 1910 may include one or more resilient wiper blades mounted to the first member 1440 along one or both sides of the slot 1444.

[0195] refer to Figures 44-46 Electrode therapy devices 2000 and 2100 (which may otherwise be identical or similar to any of the electrode therapy devices 300, 600, 700, 800, 900, 902, 1000, 1100, 1200, 1300, 1400, 1400', 1600, 1600', 1800, 1900, 2000, 2100, 2200, 2300, and 2400 disclosed herein) may include channels for delivering and applying cleaning fluid to their electrode deployment systems 2010 and 2110. Note that electrode strips of electrode therapy devices 2000 and 2100 are omitted to reveal details of the cleaning system. Figure 44 The diagram shows how the cleaning fluid (indicated by arrows) is discharged from the slot 1444 of the first member 1440 when the cleaning fluid leaves the housing 2016, 2116 of the electrode deployment system 2100 or 2110. Figure 44 The diagram shows a cleaning fluid being supplied to the electrode deployment system 2010 via its control axis 1470. Figure 45 The diagram illustrates how cleaning fluid is supplied to the electrode deployment system 2110 via a separate fluid conduit 2120 (separate from the control shaft 1470) connected to a port in the cover 2112 of the electrode deployment system 2110. In either case, the cleaning fluid can be routed and guided by the shape of the various elements of the electrode deployment systems 2010, 2110 to provide uniform flow on the electrode strip 1466.

[0196] refer to Figures 47-48Electrode therapy devices 2200 and 2300 include electrode deployment systems 2210 and 2310 that are identical or similar to any of the electrode deployment systems 310, 610, 710, 810, 910, 912, 1010, 1110, 1210, 1310, 1410, 1410', 1610, and 1610' disclosed herein. Electrode therapy devices 2200 and 2300 further include corresponding irrigation systems 2230 and 2230, which are deployed together with or integrated into endoscope 320 for irrigation of target tissue and / or electrode strip 1466 (not shown). Reference Figure 47 The flushing system 2230 of the electrode treatment device 2200 includes one or more jet nozzles 2240, which are configured and positioned to laterally guide the jet of flushing fluid 2260 from the distal portion 316 of the endoscope 320. Figure 48 In one embodiment, the electrode therapy device 2300 is provided with one or more jet nozzles 2340 that guide a jet of flushing fluid 2360 longitudinally forward (in a distal direction) toward the electrode therapy device 2310. A deflector plate 2350 or other deflector structure or device may optionally be provided near one or more of the jet nozzles 2340 to redirect and control the direction of the flushing jet. In either embodiment of the electrode therapy devices 2200, 2300, the jet nozzles 2240, 2340 may be attached to the end of a fluid conduit passing through or formed within the endoscope 320.

[0197] Figures 49-51 An electrode therapy device 2400 is shown, which includes a measuring device 2404 and a system for indicating the extent to which the electrode strips 2466 of the electrode therapy device 2400 are deployed. The system may also indicate the lumen or cavity 2420 of the deployed electrode strips 2466 and the patient or tissue site in which the electrode strips 2466 are deployed. Figure 50 The size (e.g., diameter) of the electrode treatment device 2400 is used in conjunction with... Figures 26-28 The electrode therapy device 1400 shown is illustrated in a form and arrangement consistent with that of the electrode therapy device 1400, and may include some or all of the same components and functional elements as the electrode therapy device 1400, in addition to the measuring device 2404 further described below. The electrode therapy device may further or alternatively include one or more features that are wholly or partially identical to or similar to any of the electrode therapy devices 300, 600, 700, 800, 900, 902, 1000, 1200, 1300, 1400, 1400', 1400a-c, 1600, 1600', 2000, 2100, 2200, and 2300 described herein.

[0198] Figure 49An electrode deployment system 2410 of an electrode therapy device 2400 is shown attached to the distal end of an endoscope 328 of the electrode therapy device 2400, which extends from the distal end 328 of the endoscope 320 of the electrode therapy device 2400. Figure 50 A video image from endoscope 320 is shown, displaying the electrode 2466 of the electrode therapy device 2466 in a deployed state. Reference Figures 49-50 The indicator 2422 of the measuring device 2404 is provided along the outer surface of the cover 2412 located at the proximal end of the electrode deployment system 2410. In the illustrated embodiment, the indicator 2422 is in the form of an embossed line extending longitudinally along the surface of the cover 2412. In some embodiments, the embossed line of the indicator 2422 may taper in width (e.g., Figure 49 As shown), so that when the optical imaging system 390 of the endoscope 390 (as shown) is in the endoscope 390 Figure 4 (For example, its wide-angle or fisheye lens) produces a video image that appears uniformly wide when viewed, as in Figure 50 The image depicted in the video is shown. In other embodiments, the indicator 2422 may be some other marking or reference feature, such as an arrow, notch, circle, dot, or other shape or visual feature, which may be raised, embossed, printed, marked, or otherwise placed on the cover 2412 or the optical imaging system 390 of the electrode deployment system 2410 to the endoscope 320. Figure 4 On another visible component.

[0199] Figure 51 The layout of the inner surface 2434 of the electrode strip 2466 is shown. (Reference) Figure 50 and Figure 51 The inner surface 2434 of the electrode strip 2466 is marked with a measuring scale 2450, which includes... Figure 51 The hash mark 2452 is best illustrated in the diagram. The hash mark 2452 of the scale 2450 may include groups of primary and secondary hash marks that define various distance increments along the electrode strip 2466 or the length of the electrode strip 2466. The hash marks may be evenly and regularly spaced, or they may be spaced in different ways, such as logarithmically. The scale 2450 may further include additional marks numbered 2454 or indicating measurements of distance along the electrode strip and the circumference or diameter or other deployment measurements of the electrode strip 2466. Reference Figure 50The distal portion 2424 of the indicator 2422, relative to the electrode strip 2466 and the scale 2450, indicates the degree of deployment and arrangement of the electrode strip, and can represent the diameter, circumference, or other dimensional measurements of the deployed electrode strip 2466, and / or the dimensions of the lumen or cavity 2420 when the electrode strip 2466 is in a deployed state in contact with the lumen or cavity 2420. Therefore, the scale 2450 and the indicator 2422 cooperate to form the measuring device 2404. For example, Figure 50 A measurement of approximately 5 is shown on scale 2450. In other embodiments, the scale may be arranged in different locations or in different ways, and the indicator 2422 may be positioned in different ways. In some embodiments (not shown), scale 2450 and / or indicator 2422 may be projected onto electrode deployment system 2410 and / or electrode strip 2466 and / or cavity 2420, for example, via a laser emitted from endoscope 320 or by some other optical technique.

[0200] The diameter or size of the electrode strip 2466 deployed using the measuring device 2404 can be used to inform the magnitude of the electrical signal or power delivered to one or more electrodes on the electrode strip 2466, in order to ensure uniform delivery of charge for electrosurgery or sensing, regardless of the degree of deployment of the electrode strip 2466. Regardless of the rotational orientation of the electrode deployment system 2410 and the cover 2412 relative to the endoscope 320, and the placement (e.g., up, down, right, left) of the indicator 2422 relative to the cavity 2420 and / or the measuring scale 2450, the measuring device 2404 can achieve an accuracy of approximately + / - 10% using the illustrated measuring scale 2450 and indicator 2422.

[0201] This document illustrates embodiments of electrode deployment systems within the context of electrode therapy devices for electrosurgery and soft tissue ablation. However, electrode deployment systems consistent with the disclosed embodiments can be used for electrical stimulation, electrosensing purposes, or as part of other devices or facilities for medical or non-medical purposes. For example, a device incorporating the electrode deployment system disclosed herein can be used as a stabilizing device, such as a stabilizing device for ultrasound elements, wherein the device deploys an ultrasound transmitter and / or sensor array in symmetry with the tissue for imaging.

[0202] Therefore, it should be understood that the exemplary embodiments of the catheter delivery system design and its potential clinical applications described herein are not intended to be limiting. Furthermore, it should be understood that any of the above embodiments or processes, or specific features associated therewith, according to the system, apparatus, and method may be combined with one or more other embodiments and / or processes, or may be performed separately and / or between individual devices or device parts. Finally, this disclosure is intended to be illustrative of the apparatus, device, system, and method only, and should not be construed as limiting the appended claims to any particular embodiment or group of embodiments.

[0203] Other embodiments of this disclosure are described by way of examples and elements numbered below, which can exist independently or can be combined with the solutions according to the main claims (one or more) in any selective and combined manner: 1. An electrode deployment system comprising: First component; Second component; Electrodes, which are coupled to the first component and the second component; and An actuating element operable to move at least one of the first member and the second member relative to the other, thereby moving the electrode between a retracted configuration and a deployed configuration, wherein the electrode is extended into the deployed configuration relative to the retracted configuration and coiled around one or both of the first member and the second member when in the retracted configuration, and wherein the actuating element is operable to rotate at least one of the first member and the second member relative to the other to uncoil the electrode and extend it from the retracted configuration into the deployed configuration.

[0204] 2. The system according to Example 1, wherein the body of the actuating element is disposed in one of the following locations: at least partially within the first member, proximally adjacent to the proximal end of the first member, distally adjacent to the distal end of the first member, and proximally adjacent to the proximal end of an endoscope coupled to the first member.

[0205] 3. The system according to Example 1 or 2, wherein the actuating element includes an output shaft, wherein the output shaft is one of: coupled to the second member to rotate the second member relative to the first member, and coupled to the first member to rotate the first member relative to the second member.

[0206] 4. The system according to Example 3, wherein the output shaft is coupled to the first member via a gear set.

[0207] 5. The system according to Example 4, wherein the gear set includes a sun gear attached to the output shaft of an actuating element and a plurality of planetary gears carried on a second member, wherein the plurality of planetary gears mesh with the sun gear and an annular gear on an inner annular surface of a distal portion of the first member, and wherein the annular gear surrounds the sun gear and the planetary gears.

[0208] 6. The system according to any one of Examples 1 to 5, wherein: The first component has a slot formed therein; The second component is at least partially disposed within the first component; and The electrode includes a first end and a second end opposite to each other, the first end being fixed to the first member and the second end being fixed to the second member, and the electrode extends through the slot and coils around one or both of the first member and the second member.

[0209] 7. The system according to any one of Examples 1 to 6, wherein: The first component overlaps with the second component in the axial overlap region; The first member and the second member are configured and arranged to form an annular gap between the first member and the second member in the axially overlapping region, and At least a portion of the electrode is coiled in the annular gap.

[0210] 8. The system according to any one of Examples 1 to 7 further includes a control shaft sized for insertion through the working channel of an endoscope, the control shaft being attached to one of the first member and the second member, and the other of the first member and the second member being driven by the actuating element to rotate relative to the control shaft.

[0211] 9. The system according to Example 8, wherein the control shaft is hollow and further comprises one or more wires, each wire being electrically connected to the actuating element or the electrode, and the wires extending through the control shaft to connect to a controller.

[0212] 10. The system according to Example 8, further comprising an endoscope, wherein the control axis is configured to be inserted through the working channel of the endoscope in a direction from distal to proximal.

[0213] 11. The system according to Example 10, wherein the body of the actuating element is disposed proximally to the proximal end of the endoscope.

[0214] 12. The system according to any one of Examples 1 to 11, wherein the actuating element comprises an electric motor.

[0215] 13. The system according to any one of Examples 1 to 12, further comprising a cleaning strip for cleaning the electrode as the electrode transitions between the deployed state and the retracted state.

[0216] 14. The system according to any one of Examples 1 to 13, further comprising a system for dispensing fluid in the vicinity of the electrode or tissue treatment site or both.

[0217] 15. The system according to any one of Examples 1 to 14, further comprising a measuring scale on the electrode and an indicator positioned on a cover proximal to the first and second components.

[0218] 16. An electrode therapy device comprising: An endoscope, comprising an optical imaging system, wherein an objective lens is located near the distal end of the endoscope; An electrode deployment system is attached to the endoscope such that the electrodes of the electrode deployment system are positioned distal to the objective lens. The electrode deployment system is operable to switch the electrodes between a retracted configuration and a deployed configuration while the electrode deployment system remains attached to the endoscope, wherein the electrodes are laterally extended into the deployed configuration relative to the retracted configuration.

[0219] 17. The apparatus according to Example 16, wherein the electrode deployment system is positioned within the field of view of the optical imaging system.

[0220] 18. The apparatus according to Example 16 or 17, wherein the electrode deployment system is eccentrically mounted to the endoscope at the distal end.

[0221] 19. The device according to any of the foregoing examples, wherein the electrode comprises a flexible printed circuit.

[0222] 20. The apparatus according to Example 19, wherein the flexible printed circuit includes an aperture formed therein, the aperture allowing the optical imaging system to see a tissue treatment site outside the flexible printed circuit through the flexible printed circuit.

[0223] 21. The device according to any of the foregoing examples, further comprising an elastomeric guide tip extending distally to the electrode deployment system.

[0224] 22. The apparatus according to any of the foregoing examples, wherein the electrode deployment system has an axis angled relative to the longitudinal axis of the endoscope, such that the axis of the electrode deployment system converges toward the longitudinal axis of the endoscope.

[0225] 23. The apparatus according to any one of Examples 16 to 22, wherein the electrode deployment system includes an expandable sac-like element surrounded by the electrodes.

[0226] 24. The apparatus according to any one of Examples 16 to 23, wherein: The electrode deployment system includes a first component and a second component, at least one of the first component and the second component being movable relative to the other; and The electrode includes a first end and a second end opposite to the first end, and the first end is attached to the first member and the second end is attached to the second member, and at least one of the first member and the second member includes a textured anchoring surface, and the corresponding first end or second end of the electrode is attached to the textured anchoring surface.

[0227] 25. The apparatus according to any one of Examples 16 to 24, wherein: The electrode deployment system includes a first component and a second component, at least one of the first component and the second component being movable relative to the other; and The electrode includes a first end and a second end opposite to the first end, the first end being attached to the first member and the second end being attached to the second member, and the electrode includes a retaining lug at the first end and / or the second end, the retaining lug mechanically engaging with at least one of the first member and the second member.

[0228] 26. The apparatus according to any one of Examples 16 to 23, wherein the electrode deployment system includes a rotatable member, and wherein the electrode includes a first end attached to the rotatable member and a second end opposite to the first end, the second end being constrained to prevent rotational movement relative to the endoscope, whereby rotation of the rotatable member extends the electrode into the deployment configuration.

[0229] 27. The apparatus according to any one of Examples 16 to 26, further comprising a drive shaft operatively coupled to the electrode deployment system, the drive shaft extending through the working channel of the endoscope.

[0230] 28. The apparatus according to any one of Examples 16 to 26, further comprising a drive shaft operatively coupled to the electrode deployment system, the drive shaft extending alongside the endoscope.

[0231] 29. The apparatus according to Example 27 or 28, wherein the drive shaft is operatively coupled to the electrode deployment system via a gear set.

[0232] 30. The device according to any of the foregoing examples further includes an actuation element operable to move the electrode between the retracted configuration and the deployed configuration.

[0233] 31. The apparatus according to Example 28 or 29 further includes an actuating element disposed proximal to the endoscope, and the actuating element is coupled to the drive shaft.

[0234] 32. The apparatus according to any one of Examples 16 to 26 further includes an actuation element disposed on the distal side of the objective lens, the actuation element being operable to move the electrode between the retracted configuration and the deployed configuration.

[0235] 33. The apparatus according to Example 32, wherein the electrode is coiled around the actuating element.

[0236] 34. The apparatus according to any one of Examples 30 to 33, wherein the actuating element comprises a motor.

[0237] 35. The apparatus according to any one of Examples 30 to 34, wherein the electrode deployment system is attached to the endoscope via a control shaft that extends through the working channel of the endoscope.

[0238] 36. The apparatus according to Example 35, wherein the electrode deployment system comprises: External components; and An internal component, which is at least partially disposed within the external component; and The control shaft is attached to one of the external component and the internal component, and the other of the external component and the internal component is driven by the actuating element to rotate relative to the control shaft.

[0239] 37. The apparatus according to Example 36, wherein the actuating element is at least partially disposed within the outer member, at least partially disposed within the inner member, or both.

[0240] 38. The apparatus according to Example 36 or 37, wherein: The outer component has a generally cylindrical cavity with a central axis, and the outer component has a slot formed therein; The internal component is at least partially disposed within the cylindrical cavity of the external component; and The electrode includes an electrode strip having opposite first and second ends, the first end being fixed to the outer member and the second end being fixed to the inner member. The electrode strip extends through the slot. When in the retracted configuration, the electrode strip coils around one or both of the outer member and the inner member, and the actuating element is operatively coupled to the outer member and the inner member to rotate at least one of the outer member and the inner member relative to the other about the central axis, thereby causing the electrode strip to switch between the retracted configuration and the deployed configuration.

[0241] 39. The apparatus according to Example 38, wherein the first end of the electrode strip is attached to the outer surface of the outer member adjacent to the slot.

[0242] 40. The apparatus according to any one of Examples 36 to 39, wherein the outer member overlaps with the inner member in an axially overlapping region, the electrode deployment system is configured to form an annular gap between the inner member and the outer member in the axially overlapping region, and wherein at least a portion of the electrode is coiled in the annular gap.

[0243] 41. The apparatus according to any one of Examples 36 to 40, wherein the inner member and the outer member have proximal and distal portions, and the actuating element is disposed adjacent to the distal portion of the inner member and the outer member, or adjacent to the proximal portion of the inner member and the outer member.

[0244] 42. The apparatus according to any one of Examples 16 to 41 further includes a cleaning strip for cleaning the electrode as the electrode transitions between the deployed state and the retracted state.

[0245] 43. The apparatus according to any one of Examples 16 to 42, further comprising a system for dispensing fluid in the vicinity of the electrode or tissue treatment site or both.

[0246] 44. An electrode deployment system comprising: First component; Second component; Electrodes, which are coupled to the first component and the second component; and An actuating element, at least partially housed within the first member, is operable to move at least one of the first member and the second member relative to the other, thereby moving the electrode between a retracted configuration and a deployed configuration, wherein the electrode is extended into the deployed configuration relative to the retracted configuration.

[0247] 45. The system according to Example 44, wherein when in the retracted configuration, the electrode is coiled around one of the first member and the second member, and the actuation element is operable to rotate at least one of the first member and the second member relative to the other, thereby uncoiling the electrode and extending it into the deployment configuration.

[0248] 46. ​​The system according to Example 44 or 45, wherein the actuating element is mounted on the first member and includes an output shaft coupled to the second member for rotating the second member relative to the first member.

[0249] 47. The system according to Example 44 or 45, wherein the actuating element is mounted on the second member and includes an output shaft coupled to the first member for rotating the first member relative to the second member.

[0250] 48. The system according to Example 47, wherein the output shaft is coupled to the first member via a gear set.

[0251] 49. The system according to any one of Examples 44 to 48 further includes a measuring scale on the electrode and an indicator positioned proximal to the first and second components.

[0252] 50. The system according to any one of Examples 44 to 49, wherein: The first component has a slot formed therein; The second component is at least partially disposed within the first component; and The electrode includes a first end and a second end opposite to each other, the first end being fixed to the first member and the second end being fixed to the second member, and the electrode extends through the slot and coils around one or both of the first member and the second member.

[0253] 51. The system according to any one of Examples 44 to 50, wherein: The first component overlaps with the second component in the axial overlap region; The first member and the second member are configured and arranged to form an annular gap between the first member and the second member in the axially overlapping region, and At least a portion of the electrode is coiled in the annular gap.

[0254] 52. The system according to any one of Examples 44 to 51 further includes a control shaft sized for insertion through the working channel of an endoscope, the control shaft being attached to one of the first member and the second member, and the other of the first member and the second member being driven by the actuating element to rotate relative to the control shaft.

[0255] 53. The system according to Example 52 further includes an electrical connector attached to the proximal portion of the control shaft and electrically coupled to the actuating element and the electrode.

[0256] 54. The system according to Example 53, wherein the electrical connector includes a subminiature audio plug connector that extends coaxially from the proximal portion of the control shaft.

[0257] 55. The system according to any one of Examples 52 to 54, wherein the control shaft is hollow and further comprises one or more wires, each wire being electrically connected to the actuating element or the electrode, and the wires extending through the control shaft to connect to a controller.

[0258] 56. The system according to any one of Examples 44 to 55, wherein the actuating element comprises an electric motor.

[0259] 57. The system according to any one of Examples 44 to 56, wherein the electrode comprises a flexible printed circuit having at least a first electrode and a second electrode formed on the flexible printed circuit.

[0260] 58. The system according to Example 57, wherein the electrode strip includes a first end and a second end opposite to the first end, and the first end is attached to the first member and the second end is attached to the second member, and at least one of the first member and the second member includes a textured anchoring surface, wherein the corresponding first end or second end of the electrode strip is attached to the textured anchoring surface.

[0261] 59. The system according to Example 57 or 58, wherein the electrode strip includes a retaining lug at the first end and / or the second end, and the retaining lug is mechanically engaged with at least one of the first member and the second member.

[0262] 60. The system according to any one of Examples 44 to 59, wherein the first member and the second member have proximal and distal portions, and the actuating element is disposed adjacent to the distal portion of the inner member and the outer member, or adjacent to the proximal portion of the inner member and the outer member.

[0263] 61. The system according to any one of Examples 44 to 60, further comprising a cleaning strip for cleaning the electrode as the electrode transitions between the deployed state and the retracted state.

[0264] 62. The system according to any one of Examples 44 to 61, further comprising a system for dispensing fluid in the vicinity of the electrode or tissue treatment site or both.

[0265] 63. A method for deploying electrodes, comprising the following steps: The electrode deployment system is mounted onto the endoscope by inserting the shaft of the electrode deployment system into the working channel of the endoscope through an opening at the distal end of the endoscope and sliding the shaft through the working channel until the shaft extends beyond the proximal end of the endoscope and the electrode deployment device of the electrode deployment system, which is attached to the distal portion of the shaft, is positioned distally adjacent to the distal end of the endoscope. Operate the electrode deployment device to move the flexible electrode of the electrode deployment system between a retracted configuration and a deployed configuration.

[0266] 64. The method according to Example 63, wherein the electrode deployment device includes an electric motor.

[0267] 65. The method according to Example 63 or 64, wherein the outer diameter of the shaft is between 2.5 mm and 4.0 mm.

[0268] 66. The method according to Example 65, wherein the outer diameter of the shaft is approximately 2.7 mm.

[0269] 67. The method according to any one of Examples 63 to 66, further comprising the step of electrically connecting a power source to the proximal portion of the shaft.

[0270] 68. The method according to Example 67, wherein an electrical connector is provided at the proximal portion of the shaft, and wherein the step of electrically connecting the power supply to the proximal portion of the shaft includes coupling the electrical connector to a mating electrical connector electrically connected to the power supply.

[0271] 69. The method according to Example 68, wherein the electrical connector comprises a subminiature audio plug connector extending coaxially from the proximal portion of the shaft.

[0272] 70. The method according to any one of Examples 67 to 69, wherein the step of electrically connecting the power source to the proximal portion of the shaft includes connecting a handle or robot manipulator to the proximal portion of the shaft.

[0273] 71. The method according to Example 70, further comprising rotating the axis by manipulating the handle or by operating the robot manipulator.

[0274] 72. The method described according to any one of Examples 63 to 71, wherein: The flexible electrode includes an electrode strip, which is coiled when in the collapsed configuration; and The steps of operating the electrode deployment device include moving the electrode strip from the retracted configuration to the deployment configuration by at least partially uncoiling the electrode strip.

[0275] 73. A method for deploying electrodes, comprising the following steps: Activate an actuating element operably coupled to a coiled flexible electrode strip to deploy the electrode strip; and The current supplied to the actuating element is sensed to drive the actuating element to unfold the electrode strip, and the current is automatically cut off when the current exceeds a predetermined threshold, thereby stopping the unfolding of the electrode strip.

[0276] 74. The method according to Example 73, further comprising the step of applying energy to the electrode strip to perform a therapeutic or sensing operation on internal tissue.

[0277] 75. The method according to Example 73 or 74, further comprising, after the step of automatically cutting off the current, selectively activating the actuating element for one or more additional predetermined intervals, thereby further unfolding the flexible electrode strip in a progressive manner.

[0278] 76. The method according to Example 75, wherein the step of selectively activating the actuating element is performed in response to the controller receiving a step signal initiated by the user.

[0279] 77. The method according to Example 76, wherein the step of activating the actuating element is performed in response to the controller receiving an activation signal initiated by the user.

[0280] 78. The method according to Example 77, wherein the activation signal and the step signal are each generated by the user pressing a button in a similar manner.

[0281] 79. The method according to any one of Examples 73 to 78, wherein the step of activating the actuating element causes the actuating element to operate in a first direction, and the method further includes activating the actuating element in a second direction opposite to the first direction to roll up the electrode strip after unfolding the electrode strip.

[0282] 80. The method according to Example 79, wherein the step of activating the actuating element in the second direction is performed in response to the controller receiving a second signal different from the activation signal.

[0283] 81. The method according to Example 80, wherein the second signal is initiated by the user.

[0284] 82. The method according to any one of Examples 73 to 81, wherein the actuating element comprises an electric motor.

[0285] 83. An electrode therapy device, comprising: An endoscope comprising a body having a distal end, the body having a working port extending longitudinally through the body; An electrode deployment system, which is supported by the endoscope adjacent to its distal end; Electrodes, which are supported on the electrode deployment system; and A drive shaft extending through the working port is operatively coupled to the electrode deployment system and movable relative to the body within the working port to drive the electrode deployment system for moving the electrode between a retracted configuration and a deployed configuration, wherein the electrode is laterally extended relative to the retracted configuration into the deployed configuration.

[0286] 84. The apparatus according to Example 83, wherein the electrode comprises a flexible printed circuit.

[0287] 85. The apparatus according to Example 84, wherein the flexible printed circuit includes a plurality of electrodes formed on the outer surface of the flexible printed circuit.

[0288] 86. The apparatus according to any one of Examples 83 to 85, wherein the drive shaft includes a torque tube.

[0289] 87. The apparatus according to any one of Examples 83 to 86, wherein the electrode deployment system comprises: External components, and An internal component, at least partially located within the external component, has a drive shaft coupled to at least one of the internal and external components such that movement of the drive shaft relative to the body of the endoscope imparts relative movement between the internal and external components to switch the electrodes between the retracted configuration and the deployed configuration.

[0290] 88. The apparatus according to Example 87, wherein the electrodes are attached to the internal component and the external component.

[0291] 89. The apparatus according to Example 87, wherein the electrode comprises an electrode strip having opposite first and second ends, wherein the first end is directly attached to the external member and the second end is directly attached to the internal member.

[0292] 90. The apparatus according to Example 89, wherein at least one of the internal member and the external member includes a textured anchoring surface, and a corresponding first end or second end of the electrode strip is attached to the textured anchoring surface.

[0293] 91. The apparatus according to Example 89 or 90, wherein the electrode strip includes a retaining lug at the first end and / or the second end, and the retaining lug is mechanically engaged with at least one of the internal member and the external member.

[0294] 92. The apparatus according to any one of Examples 89 to 91, wherein the outer member overlaps with the inner member in an axially overlapping region, and wherein opposite first and second ends of the electrodes are attached to the respective inner member and the outer member in the axially overlapping region.

[0295] 93. The apparatus according to Example 92 further includes an annular gap formed between the inner member and the outer member in the axially overlapping region, wherein the relative movement of the inner member and the outer member causes the electrode to be coiled in the annular gap.

[0296] 94. The apparatus according to any one of Examples 83 to 93, wherein at least a portion of the electrode deployment system comprising the electrode is movable from the proximal side of the distal end of the endoscope to the distal anterior side of the distal end of the endoscope.

[0297] 95. The apparatus according to any one of Examples 83 to 94, wherein the electrode deployment system is concentric with the distal end of the endoscope.

[0298] 96. The apparatus according to any one of Examples 83 to 94, wherein the electrode deployment system is eccentrically mounted to the body of the endoscope.

[0299] 97. The apparatus according to any one of Examples 83 to 96, wherein at least one electrical conductor is coupled to the electrode and extends along the body toward the proximal end of the body.

[0300] 98. The apparatus according to any one of Examples 83 to 97, further comprising an electric motor coupled to the drive shaft for rotating the drive shaft within the working port to move the electrode between the retracted configuration and the deployed configuration.

[0301] 99. An electrode deployment system for treating tissue, comprising: An external component having a generally cylindrical cavity with a central axis, the external component having a slot formed therein; An internal component, at least partially positioned within the cylindrical cavity of the external component and coaxial with the external component, wherein one of the internal component and the external component is configured for attachment to the distal portion of an endoscope; and An electrode strip has opposite first and second ends, the first end being fixed to the outer member, and the electrode strip is at least partially wound around the outer member, passes through the slot, and coils around the inner member, and the second end of the electrode strip is fixed to the inner member. At least one of the inner member and the outer member is rotatable relative to the other about the central axis to unwind the electrode strip, thereby deploying at least a portion of the electrode strip radially outward from the outer member through the slot.

[0302] 100. The system according to Example 99, wherein the external member is attachable to an endoscope and the internal member is rotatable relative to the external member about the central axis.

[0303] 101. The system according to Example 100 further includes a drive shaft directly coupled to the internal member, such that rotation of the drive shaft causes the internal member to rotate relative to the external member to deploy the electrode strip.

[0304] 102. The system according to Example 99 further includes a drive shaft coupled to at least one of the inner member and the outer member, such that rotation of the drive shaft imparts the relative rotation between the inner member and the outer member.

[0305] 103. The system according to Example 102 further includes a first gear on at least one of the internal member and the external member, and a second gear mounted on the drive shaft for rotating together with the drive shaft, wherein the second gear meshes with the first gear to drive the first gear to rotate relative to the endoscope in response to rotation of the drive shaft, thereby deploying the electrode strip.

[0306] 104. The system according to Example 103, wherein the first gear includes an annular gear on the outer member, the annular gear having teeth disposed on an inner annular surface.

[0307] 105. The system according to any one of Examples 99 to 104, wherein the first end of the electrode strip is attached to the outer surface of the outer member adjacent to the slot.

[0308] 106. The system according to any one of Examples 99 to 105, wherein the outer member overlaps with the inner member in an axially overlapping region, and wherein the first end and the second end of the electrode strip are fixed to the respective outer member and the inner member in the axially overlapping region.

[0309] 107. The system according to Example 106 further includes an annular gap formed between the inner member and the outer member in the axially overlapping region, wherein the electrode is coiled in the annular gap.

[0310] 108. The system according to any one of Examples 99 to 107, wherein the internal component is attachable to an endoscope and an external component is mounted on the internal component for rotation about the central axis relative to the internal component.

[0311] 109. The system according to any one of Examples 99 to 108, wherein the electrode strip comprises a flexible printed circuit.

[0312] 110. The system according to Example 109, wherein the flexible printed circuit includes paired electrodes formed on the outer surface of the flexible printed circuit in a bipolar arrangement.

[0313] 111. The system according to Example 109, wherein the flexible printed circuit is formed on a polymer substrate with a thickness in the range of 2 mil to 10 mil.

[0314] 112. An electrode therapy device, comprising: An endoscope, comprising an optical imaging system, wherein an objective lens is located proximal to the distal end of the endoscope; and An electrode deployment system is attached to the endoscope such that the electrodes of the electrode deployment system are positioned distal to the objective lens. The electrode deployment system is operable to switch the electrodes between a retracted configuration and a deployed configuration while the electrode deployment system remains attached to the endoscope, wherein the electrodes are laterally extended into the deployed configuration relative to the retracted configuration.

[0315] 113. The apparatus according to Example 112, wherein the electrode deployment system is positioned within the field of view of the optical imaging system.

[0316] 114. The apparatus according to Example 112 or 113, wherein the electrode deployment system is eccentrically mounted to the endoscope at the distal end.

[0317] 115. The device according to any one of Examples 112 to 114, wherein the electrode includes a flexible printed circuit having an aperture formed therein, the aperture allowing the optical imaging system to see a tissue treatment site outside the flexible printed circuit through the flexible printed circuit.

[0318] 116. The device according to any one of Examples 112 to 115, further comprising an elastomeric guide tip extending distally to the electrode deployment system.

[0319] 117. The apparatus according to any one of Examples 112 to 116, wherein the electrode deployment system has an axis angled relative to the longitudinal axis of the endoscope, such that the axis of the electrode deployment system converges toward the longitudinal axis of the endoscope.

[0320] 118. The apparatus according to any one of Examples 112 to 117, wherein the electrode deployment system includes an expandable sac-like member surrounded by the electrodes.

[0321] 119. The apparatus according to any one of Examples 112 to 118, wherein the electrode deployment system includes a rotatable member, and wherein the electrode includes a first end attached to the rotatable member and a second end opposite to the first end, the second end being constrained to prevent rotational movement relative to the endoscope, whereby rotation of the rotatable member extends the electrode into the deployment configuration.

[0322] 120. The apparatus according to any one of Examples 112 to 119, further comprising a drive shaft operatively coupled to the electrode deployment system, the drive shaft extending through the working port of the endoscope.

[0323] 121. The apparatus according to any one of Examples 112 to 119 further includes a drive shaft operatively coupled to the electrode deployment system, the drive shaft extending alongside the endoscope.

[0324] 122. A method for deploying electrodes, comprising: With the inner component at least partially positioned within the cylindrical cavity of the outer component, one of the inner component and the outer component is rotated relative to the other, while a flexible electrode strip having opposite first and second ends is fixed at its first end to the outer surface of the outer component and at its second end to the inner component, wherein the electrode strip passes through a slot in the outer component. The rotation step includes: Rotation of at least one of the internal and external components in a first direction causes a portion of the electrode strip to be deployed outward from the external component through the slot into a deployment configuration, and Rotating at least one of the inner and outer components in a second direction opposite to the first direction causes a portion of the electrode strip to move laterally inward and coil around the inner component into a folded configuration.

[0325] 123. The method according to Example 122 further includes supporting the internal component, the external component, and the electrode strip at the distal end of the endoscope adjacent to the endoscope, and inserting the endoscope, the internal component, the external component, and the electrode strip into the patient's body and positioning the electrode strip near the first tissue treatment site.

[0326] 124. The method according to Example 123, further comprising moving the internal member and the external member distally relative to the endoscope into the field of view of the optical imaging system of the endoscope.

[0327] 125. The method according to Example 124, wherein the rotation of at least one of the inner member and the outer member causes the electrode strip to be deployed in place with the target tissue at the first tissue treatment site, and further comprises: When the electrode strip is in the same position as the target tissue, energy is applied to the electrode strip to treat the target tissue.

[0328] 126. The method according to Example 125, further comprising, after the step of rotating at least one of the internal member and the external member along the second direction, advancing the internal member and the external member and the electrode strip cavity into a second tissue treatment site different from the first tissue treatment site.

[0329] 127. An electrode therapy device comprising: An endoscope, comprising an elongated body with a distal end; Drive shaft, which is rotatable relative to the endoscope; and An electrode winding mechanism, supported by the endoscope near its distal end, the electrode winding mechanism comprising: A first component, which is supported on the endoscope near the distal end for rotation relative to the endoscope, the first component having a first gear; An electrode strip having opposing first and second ends, the first end being attached to the first member, and the second end being constrained to prevent rotational movement relative to the endoscope; and A second gear, which is mounted on the drive shaft for rotating with the drive shaft, meshes with the first gear to drive the first member rotatably relative to the endoscope in response to the rotation of the drive shaft, thereby moving the electrode strip between a retracted configuration and a deployed configuration, wherein the electrode strip is laterally extended relative to the retracted configuration.

[0330] 128. The apparatus according to Example 127, wherein the first gear includes an annular gear on the first member.

[0331] 129. The apparatus according to Example 127 or 128, wherein the electrode strip comprises a flexible printed circuit.

[0332] 130. The apparatus according to Example 129, wherein the flexible printed circuit includes a plurality of electrodes formed on the outer surface of the flexible printed circuit.

[0333] 131. The apparatus according to any one of Examples 127 to 130, wherein the electrode winding mechanism further includes a second member, the second member being at least partially positioned within the first member and rotatedly constrained relative to the endoscope.

[0334] 132. The apparatus according to Example 131, wherein the second end of the electrode strip is attached to the second member.

[0335] 133. The apparatus according to any one of Examples 127 to 132, wherein the electrode winding mechanism is concentric with the distal end of the endoscope.

[0336] 134. The apparatus according to any one of Examples 127 to 132, wherein the electrode winding mechanism is eccentric to the body of the endoscope and is mounted on the endoscope.

[0337] 135. The apparatus according to any one of Examples 127 to 134, wherein the drive shaft extends through the working channel of the endoscope.

[0338] 136. An electrode deployment system configured to be carried by an endoscope, the endoscope including an optical imaging system having a field of view extending beyond the distal end of the endoscope, the system comprising: A first component carrying an electrode, the electrode being attached to the first component, the first component being configured to be slidably mounted on an endoscope for moving longitudinally from a retracted configuration to an extended configuration relative to the endoscope. In the retracted configuration, a large portion of the first component and the electrode are positioned proximally to the distal end of the endoscope. In the extended configuration, the first component is moved distally relative to the endoscope to a position where at least a portion of the electrode is deployed distally to the distal end of the endoscope and within the field of view of the endoscope's optical imaging system, while the first component remains mounted on the endoscope.

[0339] 137. The system according to Example 136 further includes an elongated actuation device coupled to the first member and capable of sliding relative to the endoscope to move the first member between the retracted configuration and the extended configuration.

[0340] 138. The system according to Example 137, wherein the drive device extends through the working port of the endoscope and is capable of sliding longitudinally relative to the endoscope.

[0341] 139. The system according to Example 137 or 138, wherein the drive device includes a flexible drive shaft.

[0342] 140. The system according to Example 139, wherein the drive device further includes a first gear attached to the drive shaft, and the first member includes a second gear thereon meshing with the first gear, such that rotation of the drive shaft drives the first member to be rotatable relative to the endoscope.

[0343] 141. The system according to Example 137 or 138, further comprising an inflatable bladder carried by the first member, wherein the drive device comprises an inflation tube.

[0344] 142. The system according to any one of Examples 136 to 140, further comprising a second member configured to be slidably mounted on the endoscope for movement relative to the endoscope in the longitudinal direction, the first member being mounted on the second member for movement together with the second member in the longitudinal direction, one of the first member and the second member being rotatable relative to the other and relative to the endoscope.

[0345] 143. The system according to Example 142 further includes a third member configured to be securely mounted on the endoscope near the distal end, wherein the first member and the second member are slidably mounted on the third member and are movable relative to it in the longitudinal direction.

[0346] 144. The system according to Example 142 or 143, wherein the electrode comprises an electrode strip having a first end attached to the first member and a second end opposite to the first end attached to the second member.

[0347] 145. The system according to Example 144, wherein the electrode strip includes an intermediate portion inserted between opposite first and second ends of the electrode strip, the first end being attached to a rotatable one of the first and second members, and the second end being constrained to prevent rotational movement relative to the endoscope, whereby rotation of the rotatable one of the first and second members extends the electrode strip into a deployment configuration in which the intermediate portion of the electrode strip extends outward from the first and second members.

[0348] 146. The system according to any one of Examples 136 to 145, wherein the electrode includes a flexible printed circuit having an aperture formed therein, the aperture allowing the optical imaging system to view a tissue treatment site outside the flexible printed circuit through the flexible printed circuit when the system is in use.

[0349] 147. A method for deploying electrodes, comprising: The distal end of the endoscope supports the electrode deployment system on the endoscope, the electrode deployment system having: A first component, rotatable relative to the endoscope, having a first gear. A flexible electrode strip has opposite first and second ends, the first end being attached to the first member, and the second end being constrained to prevent rotational movement relative to the endoscope. drive shaft, and A second gear is mounted on the drive shaft for rotating together with the drive shaft, and the second gear meshes with the first gear. The endoscope and the electrode deployment system are inserted into the patient's body cavity, and the electrode deployment system is positioned close to the first tissue treatment site; and The drive shaft is rotated, thereby causing the first component to rotate relative to the endoscope via the first gear and the second gear and causing the electrode strip to move laterally relative to the endoscope between a retracted configuration and a deployed configuration, wherein the electrode strip is laterally extended relative to the retracted configuration into the deployed configuration.

[0350] 148. The method according to Example 147, further comprising moving the drive shaft distally relative to the endoscope, thereby extending the first member and the electrode strip distal to the distal end of the endoscope into the field of view of the optical imaging system of the endoscope.

[0351] 149. The method according to Example 148, wherein the step of rotating the drive shaft is performed after moving the drive shaft in the distal direction, and the step of rotating the drive shaft includes rotating the drive shaft in a first direction to move the electrode strip laterally outward to the deployment configuration co-located with the target tissue at the first tissue treatment site, and subsequently rotating the drive shaft in a second direction opposite to the first direction to move the electrode strip laterally inward, and further includes applying energy to the electrode strip while the electrode strip is co-located with the target tissue.

[0352] 150. The method according to Example 149, further comprising, after rotating the drive shaft in the second direction, advancing the electrode deployment system cavity into a second tissue treatment site different from the first tissue treatment site.

[0353] 151. A method for deploying electrodes, comprising: The distal end of the endoscope slidably supports the electrode deployment system on the endoscope, the electrode deployment system including a first component that carries the electrodes; The first component and the electrode are moved longitudinally from a retracted configuration to an extended configuration relative to the endoscope. In the retracted configuration, a majority of the first component and the electrode are positioned proximally to the distal end of the endoscope. In the extended configuration, the first component is moved distally relative to the endoscope to a position where at least a portion of the electrode is deployed distally to the distal end of the endoscope and within the field of view of the endoscope's optical imaging system. While the first component remains supported on the endoscope, the electrode is deployed laterally outward from the first component to be in sync with the target tissue at the first tissue treatment site.

[0354] 152. The method according to Example 151, further comprising operably coupling a drive device to the first member, wherein the step of moving the first member and the electrode in the longitudinal direction comprises moving the drive device in the longitudinal direction.

[0355] 153. The method according to Example 152, further comprising, prior to operably coupling the drive device to the first member, slidably inserting the drive device through the working port of the endoscope.

[0356] 154. The method according to Example 152 or 153, wherein the electrode deployment system further includes a second member capable of longitudinal movement relative to the endoscope, and the first member is rotatable relative to the second member, and the drive device includes a drive shaft, and the step of laterally deploying the electrode outward includes rotating the drive shaft relative to the endoscope to rotate the first member relative to the second member.

[0357] 155. The method according to any one of Examples 152 to 154, wherein operatively coupling the drive device to the first member includes coupling the drive shaft to a gear assembly.

[0358] 156. The method according to Example 152 or 153, wherein the driving device includes an inflation tube, and operatively coupling the driving device to the first member includes a capsule-shaped element that couples the inflation tube to the electrode deployment system.

[0359] 157. The method according to any one of Examples 151 to 156, further comprising applying energy to the electrode when the electrode is in the same position as the target tissue.

[0360] 158. The method according to Example 157, further comprising, after applying energy to the electrode, moving the electrode laterally inward toward the first member and advancing the first member and the electrode cavity into a second tissue treatment site different from the first tissue treatment site.

[0361] It will be apparent to those skilled in the art that various changes can be made to the details of the above embodiments without departing from the basic principles of the invention. Therefore, the scope of the invention should be determined only by the appended claims.

Claims

1. An electrode deployment system, comprising: First component; Second component; Electrodes, which are coupled to the first component and the second component; and An actuating element operable to move at least one of the first member and the second member relative to the other, thereby moving the electrode between a retracted configuration and a deployed configuration, wherein the electrode is extended into the deployed configuration relative to the retracted configuration and coiled around one or both of the first member and the second member when in the retracted configuration, and wherein the actuating element is operable to rotate at least one of the first member and the second member relative to the other to uncoil the electrode and extend it from the retracted configuration into the deployed configuration.

2. The system of claim 1, wherein the body of the actuating element is disposed in one of the following locations: at least partially within the first member, proximally adjacent to the proximal end of the first member, distally adjacent to the distal end of the first member, and proximally adjacent to the proximal end of an endoscope coupled to the first member.

3. The system of claim 1 or 2, wherein the actuating element includes an output shaft, wherein the output shaft is one of: coupled to the second member to rotate the second member relative to the first member, and coupled to the first member to rotate the first member relative to the second member.

4. The system of claim 3, wherein the output shaft is coupled to the first member via a gear set.

5. The system of claim 4, wherein the gear set comprises a sun gear attached to the output shaft of an actuating element and a plurality of planetary gears carried on a second member, wherein the plurality of planetary gears mesh with the sun gear and an annular gear on an inner annular surface of a distal portion of the first member, and wherein the annular gear surrounds the sun gear and the planetary gears.

6. The system according to any one of claims 1 to 5, wherein: The first component has a slot formed therein; The second component is at least partially disposed within the first component; and The electrode includes a first end and a second end opposite to each other, the first end being fixed to the first member and the second end being fixed to the second member, and the electrode extends through the slot and coils around one or both of the first member and the second member.

7. The system according to any one of claims 1 to 6, wherein: The first component overlaps with the second component in the axial overlap region; The first member and the second member are configured and arranged to form an annular gap between the first member and the second member in the axially overlapping region, and At least a portion of the electrode is coiled in the annular gap.

8. The system according to any one of claims 1 to 7, further comprising a control shaft sized for insertion through a working channel of an endoscope, the control shaft being attached to one of the first member and the second member, and the other of the first member and the second member being driven by the actuating element to rotate relative to the control shaft.

9. The system of claim 8, wherein the control shaft is hollow and further comprises one or more wires, each wire being electrically connected to the actuating element or the electrode, and the wires extending through the control shaft to connect to a controller.

10. The system of claim 8, further comprising the endoscope, wherein the control axis is configured to be inserted through the working channel of the endoscope in a direction from distal to proximal.

11. The system of claim 10, wherein the body of the actuating element is disposed proximally to the proximal end of the endoscope.

12. The system according to any one of claims 1 to 11, wherein the actuating element comprises an electric motor.

13. The system according to any one of claims 1 to 12, further comprising: A cleaning strip is used to clean the electrode as it transitions between the deployment configuration and the retracted configuration. Or a system for dispensing fluid at or near the electrode or tissue treatment site.

14. The system of claim 8, wherein the distal portion of the control shaft includes a first engagement member configured to be secured to a corresponding second engagement member of the proximal portion of the second member to secure the control shaft to the second member.

15. The system according to any one of claims 1 to 14, further comprising a measuring scale on the electrode and an indicator positioned proximal to the first member and the second member.

16. An electrode therapy device, comprising: An endoscope, comprising an optical imaging system, wherein an objective lens is located near the distal end of the endoscope; An electrode deployment system is attached to the endoscope such that the electrodes of the electrode deployment system are positioned distal to the objective lens. The electrode deployment system is operable to switch the electrodes between a retracted configuration and a deployed configuration while the electrode deployment system remains attached to the endoscope, wherein the electrodes are laterally extended into the deployed configuration relative to the retracted configuration.

17. The apparatus of claim 16, wherein the electrode deployment system is disposed within the field of view of the optical imaging system.

18. The apparatus of claim 16 or 17, wherein the electrode deployment system is eccentrically mounted to the endoscope at the distal end.

19. The apparatus according to any one of the preceding claims, wherein the electrode comprises a flexible printed circuit.

20. The apparatus of claim 19, wherein the flexible printed circuit includes an aperture formed therein, the aperture allowing the optical imaging system to see the tissue treatment site outside the flexible printed circuit through the flexible printed circuit.

21. The device according to any one of the preceding claims, further comprising an elastomeric guide tip extending distally to the electrode deployment system.

22. The apparatus according to any one of the preceding claims, wherein the electrode deployment system has an axis angled relative to the longitudinal axis of the endoscope, such that the axis of the electrode deployment system converges toward the longitudinal axis of the endoscope.

23. The apparatus of any one of claims 16 to 22, wherein the electrode deployment system comprises an expandable sac-like element surrounded by the electrodes.

24. The apparatus according to any one of claims 16 to 23, wherein: The electrode deployment system includes a first component and a second component, at least one of the first component and the second component being movable relative to the other; and The electrode includes a first end and a second end opposite to the first end, and the first end is attached to the first member and the second end is attached to the second member, and at least one of the first member and the second member includes a textured anchoring surface, and the corresponding first end or second end of the electrode is attached to the textured anchoring surface.

25. The apparatus according to any one of claims 16 to 24, wherein: The electrode deployment system includes a first component and a second component, at least one of the first component and the second component being movable relative to the other; and The electrode includes a first end and a second end opposite to the first end, the first end being attached to the first member and the second end being attached to the second member, and the electrode includes a retaining lug at the first end and / or the second end, the retaining lug mechanically engaging with at least one of the first member and the second member.

26. The apparatus of any one of claims 16 to 23, wherein the electrode deployment system includes a rotatable member, and wherein the electrode includes a first end attached to the rotatable member and a second end opposite to the first end, the second end being constrained to prevent rotational movement relative to the endoscope, whereby rotation of the rotatable member extends the electrode into the deployment configuration.

27. The apparatus of any one of claims 16 to 26, further comprising a drive shaft operatively coupled to the electrode deployment system, the drive shaft extending through the working channel of the endoscope.

28. The apparatus of any one of claims 16 to 26, further comprising a drive shaft operably coupled to the electrode deployment system, the drive shaft extending alongside the endoscope.

29. The apparatus of claim 27 or 28, wherein the drive shaft is operatively coupled to the electrode deployment system via a gear set.

30. The apparatus according to any one of the preceding claims, further comprising an actuation element operable to move the electrode between the retracted configuration and the deployed configuration.

31. The apparatus of claim 28 or 29, further comprising an actuating element disposed proximal to the endoscope, and said actuating element being coupled to the drive shaft.

32. The apparatus according to any one of claims 16 to 26, further comprising an actuating element disposed distal to the objective lens, the actuating element being operable to move the electrode between the retracted configuration and the deployed configuration.

33. The apparatus of claim 32, wherein the electrode is coiled around the actuating element.

34. The apparatus according to any one of claims 30 to 33, wherein the actuating element comprises a motor.

35. The apparatus of any one of claims 30 to 34, wherein the electrode deployment system is attached to the endoscope via a control shaft that extends through the working channel of the endoscope.

36. The apparatus of claim 35, wherein the electrode deployment system comprises: External components; and An internal component, which is at least partially disposed within the external component; and The control shaft is attached to one of the external component and the internal component, and the other of the external component and the internal component is driven by the actuating element to rotate relative to the control shaft.

37. The apparatus of claim 36, wherein the actuating element is at least partially disposed within the outer member, at least partially disposed within the inner member, or both.

38. The apparatus according to claim 36 or 37, wherein: The outer component has a generally cylindrical cavity with a central axis, and the outer component has a slot formed therein; The internal component is at least partially disposed within the cylindrical cavity of the external component; and The electrode includes an electrode strip having opposite first and second ends, the first end being fixed to the outer member and the second end being fixed to the inner member. The electrode strip extends through the slot and, when in the retracted configuration, coils around one or both of the outer and inner members. The actuating element is operatively coupled to the outer and inner members to rotate at least one of the outer and inner members about the central axis relative to the other, thereby causing the electrode strip to switch between the retracted configuration and the deployed configuration.

39. The apparatus of claim 38, wherein the first end of the electrode strip is attached to the outer surface of the outer member adjacent to the slot.

40. The apparatus of any one of claims 36 to 39, wherein the outer member overlaps with the inner member in an axially overlapping region, the electrode deployment system is configured to form an annular gap between the inner member and the outer member in the axially overlapping region, and wherein at least a portion of the electrode is coiled in the annular gap.

41. The apparatus according to any one of claims 36 to 40, wherein the internal member and the external member have proximal portions and distal portions, and the actuating element is disposed adjacent to the distal portions of the internal member and the external member, or adjacent to the proximal portions of the internal member and the external member.

42. The apparatus according to any one of claims 16 to 41, further comprising a cleaning strip for cleaning the electrode as the electrode transitions between the deployed state and the retracted state.

43. The apparatus according to any one of claims 16 to 42, further comprising a system for dispensing fluid in the vicinity of the electrode or the tissue treatment site, or both.

44. The apparatus according to any one of claims 16 to 43, further comprising a measuring scale on the electrode and an indicator at the proximal portion of the electrode deployment system.

45. An electrode deployment system comprising: First component; Second component; Electrodes, which are coupled to the first component and the second component; and An actuating element, at least partially housed within the first member, is operable to move at least one of the first member and the second member relative to the other, thereby moving the electrode between a retracted configuration and a deployed configuration, wherein the electrode is extended into the deployed configuration relative to the retracted configuration.

46. ​​The system of claim 45, wherein when in the retracted configuration, the electrode is coiled around one of the first member and the second member, and the actuation element is operable to rotate at least one of the first member and the second member relative to the other, thereby uncoiling the electrode and extending it into the deployment configuration.

47. The system of claim 45 or 46, wherein the actuating element is mounted on the first member and includes an output shaft coupled to the second member for rotating the second member relative to the first member.

48. The system of claim 45 or 46, wherein the actuating element is mounted on the second member and includes an output shaft coupled to the first member for rotating the first member relative to the second member.

49. The system of claim 48, wherein the output shaft is coupled to the first member via a gear set.

50. The system according to any one of claims 45 to 49, further comprising a measuring scale on the electrode and an indicator positioned proximal to the first member and the second member.

51. The system according to any one of claims 45 to 50, wherein: The first component has a slot formed therein; The second component is at least partially disposed within the first component; and The electrode includes a first end and a second end opposite to each other, the first end being fixed to the first member and the second end being fixed to the second member, and the electrode extends through the slot and coils around one or both of the first member and the second member.

52. The system according to any one of claims 45 to 51, wherein: The first component overlaps with the second component in the axial overlap region; The first member and the second member are configured and arranged to form an annular gap between the first member and the second member in the axially overlapping region, and At least a portion of the electrode is coiled in the annular gap.

53. The system according to any one of claims 45 to 52, further comprising a control shaft sized for insertion through a working channel of an endoscope, the control shaft being attached to one of the first member and the second member, and the other of the first member and the second member being driven by the actuating element to rotate relative to the control shaft.

54. The system of claim 53, further comprising an electrical connector attached to a proximal portion of the control shaft and electrically coupled to the actuating element and the electrode.

55. The system of claim 54, wherein the electrical connector comprises a subminiature audio plug connector that extends coaxially from the proximal portion of the control shaft.

56. The system according to any one of claims 53 to 55, wherein the control shaft is hollow and further comprises one or more wires, each wire being electrically connected to the actuating element or the electrode, and the wires extending through the control shaft to be connected to a controller.

57. The system according to any one of claims 45 to 56, wherein the actuating element comprises an electric motor.

58. The system according to any one of claims 45 to 57, wherein the electrode comprises a flexible printed circuit having at least a first electrode and a second electrode formed on the flexible printed circuit.

59. The system of claim 58, wherein the electrode strip includes a first end and a second end opposite to the first end, and the first end is attached to the first member and the second end is attached to the second member, and at least one of the first member and the second member includes a textured anchoring surface, wherein a corresponding first end or second end of the electrode strip is attached to the textured anchoring surface.

60. The system of claim 58 or 59, wherein the electrode strip includes a retaining lug at the first end and / or the second end, and the retaining lug is mechanically engaged with at least one of the first member and the second member.

61. The system according to any one of claims 45 to 60, wherein the first member and the second member have proximal portions and distal portions, and the actuating element is disposed adjacent to the distal portions of the inner member and the outer member, or adjacent to the proximal portions of the inner member and the outer member.

62. The system according to any one of claims 45 to 61, further comprising a cleaning strip for cleaning the electrode as the electrode transitions between the deployed state and the retracted state.

63. The system according to any one of claims 45 to 62, further comprising a system for dispensing fluid in the vicinity of the electrode or the tissue treatment site, or both.

64. A method for deploying electrodes, comprising the following steps: The electrode deployment system is mounted onto the endoscope by inserting the shaft of the electrode deployment system into the working channel of the endoscope through an opening at the distal end of the endoscope and sliding the shaft through the working channel until the shaft extends beyond the proximal end of the endoscope and the electrode deployment device of the electrode deployment system, which is attached to the distal portion of the shaft, is positioned distally adjacent to the distal end of the endoscope. Operate the electrode deployment device to move the flexible electrode of the electrode deployment system between a retracted configuration and a deployed configuration.

65. The method of claim 64, wherein the electrode deployment device comprises an electric motor.

66. The method according to claim 64 or 65, wherein the outer diameter of the shaft is between 2.5 mm and 4.0 mm.

67. The method of claim 66, wherein the outer diameter of the shaft is approximately 2.7 mm.

68. The method according to any one of claims 64 to 67, further comprising the step of electrically connecting a power source to the proximal portion of the shaft.

69. The method of claim 68, wherein an electrical connector is provided at the proximal portion of the shaft, and wherein the step of electrically connecting the power supply to the proximal portion of the shaft comprises coupling the electrical connector to a mating electrical connector electrically connected to the power supply.

70. The method of claim 69, wherein the electrical connector comprises a subminiature audio plug connector extending coaxially from the proximal portion of the shaft.

71. The method of any one of claims 68 to 70, wherein the step of electrically connecting the power source to the proximal portion of the shaft comprises connecting a handle or robot manipulator to the proximal portion of the shaft.

72. The method of claim 71, further comprising rotating the axis by manipulating the handle or by operating the robot manipulator.

73. The method according to any one of claims 64 to 72, wherein: The flexible electrode includes an electrode strip, which is coiled when in the collapsed configuration; and The steps of operating the electrode deployment device include moving the electrode strip from the retracted configuration to the deployment configuration by at least partially uncoiling the electrode strip.

74. A method for deploying electrodes, comprising the following steps: Activate an actuating element operably coupled to a coiled flexible electrode strip to deploy the electrode strip; and The current supplied to the actuating element to drive the actuating element to unfold the electrode strip is sensed, and the current is automatically cut off when the current exceeds a predetermined threshold, thereby stopping the unfolding of the electrode strip.

75. The method of claim 74, further comprising the step of applying energy to the electrode strip to perform a therapeutic or sensing operation on internal tissue.

76. The method of claim 74 or 75, further comprising, after the step of automatically cutting off the current, selectively activating the actuating element for one or more additional predetermined intervals, thereby further unfolding the flexible electrode strip in a progressive manner.

77. The method of claim 76, wherein the step of selectively activating the actuating element is performed in response to the controller receiving a step signal initiated by the user.

78. The method of claim 77, wherein the step of activating the actuating element is performed in response to the controller receiving an activation signal initiated by the user.

79. The method of claim 78, wherein both the activation signal and the step signal are generated by the user pressing a button in a similar manner.

80. The method of any one of claims 74 to 79, wherein the step of activating the actuating element causes the actuating element to operate in a first direction, and the method further comprises, after unfolding the electrode strip, activating the actuating element in a second direction opposite to the first direction to roll up the electrode strip.

81. The method of claim 80, wherein the step of activating the actuating element in the second direction is performed in response to the controller receiving a second signal different from the activation signal.

82. The method of claim 81, wherein the second signal is initiated by the user.

83. The method according to any one of claims 74 to 82, wherein the actuating element comprises an electric motor.

84. An electrode therapy device, comprising: An endoscope comprising a body having a distal end, the body having a working port extending longitudinally through the body; An electrode deployment system, which is supported by the endoscope adjacent to its distal end; Electrodes, which are supported on the electrode deployment system; and A drive shaft extending through the working port is operatively coupled to the electrode deployment system and movable relative to the body within the working port to drive the electrode deployment system for moving the electrode between a retracted configuration and a deployed configuration, wherein the electrode is laterally extended relative to the retracted configuration into the deployed configuration.

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